🏥 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 💀 🏥 🚑 ⚠️
2851640 11 M NM 07/29/2025 HEPA
GLAXOSMITHKLINE BIOLOGICALS
42DM9
No adverse event, Wrong product administered No adverse event, Wrong product administered
patient was given Hep A instead of HPV9. Patient tolerated vaccine well with no adverse reaction not... patient was given Hep A instead of HPV9. Patient tolerated vaccine well with no adverse reaction noted. I have called and spoke to mother to check on the child and his well being. She states he is doing well and will return to clinic for the correct vaccine. More
2851641 20 F OR 07/29/2025 HEPA
GLAXOSMITHKLINE BIOLOGICALS
T9TL9
No adverse event, Wrong product administered No adverse event, Wrong product administered
Pt did not experience any adverse SE's. Was mistakenly given Havrix -Adult instead of Hepilisav... Pt did not experience any adverse SE's. Was mistakenly given Havrix -Adult instead of Hepilisav- B on Friday July 25th, pt called by this RN to report incident and need to return to clinic for administration of second Heplisav-B required by her nursing school on 7/28/25 when error was discovered during count. Pt returned later that day, denies difficulty with Havrix. More
2851642 68 F NC 07/29/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
332l4
Contusion, Pain in extremity Contusion, Pain in extremity
Bruise with rash and sore arm. Occurred the next morning of vaccine. The bruise and rash still prese... Bruise with rash and sore arm. Occurred the next morning of vaccine. The bruise and rash still present 1 week later. No fever More
2851643 1 M MD 07/29/2025 MMR
GLAXOSMITHKLINE BIOLOGICALS
72AB2
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
During administration the child's parent was not holding them still. The child began to fight t... During administration the child's parent was not holding them still. The child began to fight the Medical Assistant and parent causing the needle to come out of the skin prematurely during administration. Due to this there was concern that the child did not receive the full dose of the vaccine. More
2851644 41 F IN 07/29/2025 HEPAB
GLAXOSMITHKLINE BIOLOGICALS
p2443
Erythema, Pain, Skin warm, Swelling Erythema, Pain, Skin warm, Swelling
Patient reported redness and swelling about a quarter size and seems to be growing, hot to the touch... Patient reported redness and swelling about a quarter size and seems to be growing, hot to the touch. Patient seen in urgent care 07/28/25 and was instructed to apply Benadryl cream. Patient reports full mobility but soreness and improvement in redness post application of Benadryl cream (07/29/25). More
2851645 70 F GA 07/29/2025 PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH


Asthenia, Dysphagia, Feeling abnormal, Incontinence, Pain; Pyrexia, Respiratory ... Asthenia, Dysphagia, Feeling abnormal, Incontinence, Pain; Pyrexia, Respiratory tract congestion, Vomiting More
pt states that evening after being vaccinated she was a little off and was feeling funny. She became... pt states that evening after being vaccinated she was a little off and was feeling funny. She became congested and felt like couldn't swallow. She tried to eat a little something but she automatically vomited it up. She was achy, feverish, and weak. She only wanted to lie still and rest then she became incontinent. She felt unsettled and unsure what was going on. She took some Tylenol Cold and Flu over a weeks time to help her get through her symptoms. She has never had any reaction to other flu vaccines in the past and was concerned as she lives alone. She is now getting stronger and starting to feel back to normal. She called the clinic to let them know she had this reaction to the vaccine. More
2851646 0.5 F 07/29/2025 DTPPVHBHPB
MSP VACCINE COMPANY
U7446AA
Expired product administered Expired product administered
Patient was given an expired vaccine Vaxelis (Dtap/Hep B/HIB/IPV). This vaccine expired 6/25/2025. Patient was given an expired vaccine Vaxelis (Dtap/Hep B/HIB/IPV). This vaccine expired 6/25/2025.
2851647 29 M TX 07/29/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
9JT4S
Gaze palsy, Seizure Gaze palsy, Seizure
Approximately 1?2 minutes after receiving the vaccine, the patient?s eyes rolled back and he began s... Approximately 1?2 minutes after receiving the vaccine, the patient?s eyes rolled back and he began sliding out of his chair. Patient was experiencing a seizure. He remained conscious and communicative throughout, lying on the floor for approximately five minutes. When asked, both he and his partner declined EMS assistance or contacting anyone. I advised them to remain in the waiting area for additional observation. More
2851648 2 F OR 07/29/2025 DTPPVHBHPB
DTPPVHBHPB
MMR
MMR
VARCEL
VARCEL
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
U7535AA
U7535AA
X018904
X018904
Y014181
Y014181
Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bear... Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty; Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty; Injection site pain, Irritability, Malaise, Pyrexia, Sleep disorder; Weight bearing difficulty More
Parents report that after the last vaccines in 4/17/25, patient was not feeling well for a couple w... Parents report that after the last vaccines in 4/17/25, patient was not feeling well for a couple weeks post vaccination. She had a sore leg for 3 days (due to vaccination struggles and safety concerns, all 3 doses were given in 1 leg). Mom notes patient avoided putting weight on her legs for about 3 days. Her sleep was disturbed, waking up intermittently (every 2 hrs) outside of her normal, grumpy (modified temperament) for a 2-3 weeks, and not interacting with her normal play activities. She also developed a low grade fever that resolved with Tylenol. I discussed with the parents that her response was likely due to the pain of all 3 vaccines given in the single leg. After further discussion, we have agreed on a modified schedule moving forward. More
2851649 76 F MD 07/29/2025 RSV
RSV
RSV
RSV
RSV
RSV
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
255T2
255T2
255T2
255T2
255T2
255T2
Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site r... Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site reaction, Mobility decreased, Oropharyngeal pain, Pain in extremity; Arthralgia, Dyspnoea, Injection site swelling; Arthralgia, Dysphagia, Dysphonia, Fatigue, Injection site pain; Injection site reaction, Mobility decreased, Oropharyngeal pain, Pain in extremity; Arthralgia, Dyspnoea, Injection site swelling More
pt states when she received the vaccine it was painful. She had a huge red mark at the injection. B... pt states when she received the vaccine it was painful. She had a huge red mark at the injection. By the next day her hands and every joint in her body hurt. Her fingers were hurting so bad she could not lift anything and she couldn't bend her fingers. Her throat was very sore and it became hard to swallow. Her voice sounded different with a high pitch sound. She became very tired and had extreme fatigue. By the second day she could not raise her arms above her head. She started taking Tylenol and antihistamine to help with the symptoms. These symptoms lasted about a week. At this point she remains very tired but the pain is getting better. She went to her PCP on 7/24. He checked her lymph glands and was told everything seemed to be okay but to keep him posted. More
2851650 19 F TX 07/29/2025 HEP
TDAP
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
946060
793pt
Anxiety, Feeling hot, Flushing, Syncope, Vomiting; Anxiety, Feeling hot, Flushin... Anxiety, Feeling hot, Flushing, Syncope, Vomiting; Anxiety, Feeling hot, Flushing, Syncope, Vomiting More
During Hep B vaccine, Pt reported feeling warm and looked anxious immediately after recieving the va... During Hep B vaccine, Pt reported feeling warm and looked anxious immediately after recieving the vaccine. I waited a few minutes for the patient to calm down and she told me when she was ready to revieve the next vaccine. During the Tdap vaccine, Pt experienced brief syncope and vomited after the vaccination. Pt reported feeling very warm and her cheeks were flushed. This happened within a minute after the Tdap vaccine. Her boyfriend who was with her caught her and she regained consciousness within that brief moment. Her blood pressure was taken and she was given oral fluids (Gatorade). After several minutes of observation by myself and my supervising Pharmacist, she was advised not to recieve the last vaccine she asked for (MMR) until the following day. She went home and reported feeling no further symptoms the following day. More
2851653 18 F OK 07/29/2025 MENB
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
xx33p
u7852ab
Nausea, Presyncope, Vomiting; Nausea, Presyncope, Vomiting Nausea, Presyncope, Vomiting; Nausea, Presyncope, Vomiting
pre-syncope including nausea/vomiting within 10 minutes, resolved after 20 minutes pre-syncope including nausea/vomiting within 10 minutes, resolved after 20 minutes
2851654 11 F TN 07/29/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
EK7DG
Injection site reaction, Injection site swelling, Injection site warmth, Rash pr... Injection site reaction, Injection site swelling, Injection site warmth, Rash pruritic More
rash slowly got bigger, swollen itchy, and warm to the touch L upper arm- first time pt ever receive... rash slowly got bigger, swollen itchy, and warm to the touch L upper arm- first time pt ever received MCV4. Pt mother reported trying cold compresses, Benadryl, Tylenol and Ibuprofen. More
2851655 54 M WI 07/29/2025 PNC20
PNC20
PNC20
VARZOS
VARZOS
VARZOS
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
LN4928
LN4928
LN4928
332L4
332L4
332L4
Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reac... Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Chills, Computerised tomogram thorax; Dyspnoea exertional, Fatigue, Pleuritic pain, Pulmonary embolism, Pulmonary infarction; Pyrexia, Scan with contrast; Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Chills, Computerised tomogram thorax; Dyspnoea exertional, Fatigue, Pleuritic pain, Pulmonary embolism, Pulmonary infarction; Pyrexia, Scan with contrast More
Patient developed subjective fever/chills in day 2-3 post vaccination and subsequently developed rig... Patient developed subjective fever/chills in day 2-3 post vaccination and subsequently developed right sided pleuritic pain about 1 week after with ongoing relapsing/remitting low grade fever, fatigue, and dyspnea on exertion. He never was hypoxic. He was subsequently evaluated and diagnosed with sub-seqmental pulmonary embolism, largest in the right lower lobe with associated subsegmental pulmonary infarction. He was started on oral anti-coagulation on 7/29/25. More
2851656 16 F MA 07/29/2025 MNQ
MNQ
SANOFI PASTEUR
SANOFI PASTEUR
U8369BA
U8369BA
Abdominal pain, Blood glucose normal, Dizziness, Dysmenorrhoea, Hyperhidrosis; P... Abdominal pain, Blood glucose normal, Dizziness, Dysmenorrhoea, Hyperhidrosis; Pallor, Syncope More
Near syncopal episode while standing at checkout. Became very pale and dizzy, sweating. BP 92/62, HR... Near syncopal episode while standing at checkout. Became very pale and dizzy, sweating. BP 92/62, HR 62, 100%. Then proceeded to start with severe lower abdominal cramping and menstrual cramping and needed to use the restroom for a BM. Remained sweaty and dizzy while on the toilet. No LOC. No vomiting. Rested in room and had sips of juice and bites of a cookie. Dizziness improved but then continued with lower abdominal cramping. More
2851657 13 F MO 07/29/2025 MNQ
TDAP
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
U8370AA
X449Y
Rash, Rash papular; Rash, Rash papular Rash, Rash papular; Rash, Rash papular
Per patient's mother, patient has a slightly raised rash "all over entire body" but m... Per patient's mother, patient has a slightly raised rash "all over entire body" but mostly concentrated on arms and legs. She states it resembles "goose bumps". Mother denies any signs of anaphylaxis. States rash is not painful or itching. She administered Benadryl. More
2851658 4 F MI 07/29/2025 VARCEL
MERCK & CO. INC.
Y015108
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient came in for an appointment on 7/25/25 for a preschool form to be filled out. patient was due... Patient came in for an appointment on 7/25/25 for a preschool form to be filled out. patient was due for vaccines. Patient was due for Kinrix and Proquad. Patient was given Kinrix and MMR on 7/25/25. Upon putting in the vaccines in the patients chart it was noticed that patient did not receive Proquad (MMR and Varicella combo vaccine), patient only received the MMR portion of the vaccine that could have been a combo. Patients mom was contacted and mom stated she would bring the patient back in for the varicella portion of the vaccine. Patient came in today (7/29/25) and got varicella. Patients immunization registration flagged that the varicella was invalid. Health department contacted and stated the live virus vaccines can be given on the same day separately but if given on separate days then they need to be 28 days apart. Patients mom was contacted and informed that patient will need the varicella vaccine again in October as the dose given today (7/29/25) was invalid. Correct vaccines were given but in the wrong time frame. More
2851659 0.33 M VA 07/29/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
5h95b
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Vaccination was given as an off label use. Regional Immunization Nurse Consultant contacted. Mother ... Vaccination was given as an off label use. Regional Immunization Nurse Consultant contacted. Mother of the patient contacted, denied any symptoms of an adverse reaction. More
2851660 18 M AL 07/29/2025 MENB
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
Z39XM
U8558BA
Cold sweat, Hypotonia, Loss of consciousness, Pallor; Cold sweat, Hypotonia, Los... Cold sweat, Hypotonia, Loss of consciousness, Pallor; Cold sweat, Hypotonia, Loss of consciousness, Pallor More
Patient received 2 vaccines- one in each arm. No complaints during vaccination. Patient was seated... Patient received 2 vaccines- one in each arm. No complaints during vaccination. Patient was seated during vaccine administration. Following vaccine administration, nurse sat at her desk to document vaccines and patient passed out and slumped over in his chair. Skin was noted to be pale and clammy. The chair had arms so patient remained in chair and no injury occured. , feet were elevated in another chair, cool rag aplied to his neck, B/P monitored and WNL. Patient was alert and orientented x 3 within about 10 seconds. He was monitored x 15 minutes and denied any dizziness, headache, blurred vision. He stated he felt completely normal and was discharged in stable condition. More
2851661 4 M KY 07/29/2025 DTAPIPV
MMRV
SANOFI PASTEUR
MERCK & CO. INC.
U7931AB
Z008501
Injection site erythema, Injection site swelling, Injection site warmth, Vaccina... Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site eschar; Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site eschar More
Within hours after receiving vaccine child's arm became red, hot, and doubled in size from shou... Within hours after receiving vaccine child's arm became red, hot, and doubled in size from should down to mid forearm. Side effect persisted over the weekend. Today (4/5 days after the date) it is onlky a little warm and red over the deltoid. He had fragile tissue and got a little eschar when the band aid was removed that is healing now. More
2851663 63 M GA 07/29/2025 COVID19
FLU3
PNC20
MODERNA
SANOFI PASTEUR
PFIZER\WYETH
B0002
UT8408NA
HH1326
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
No symptoms of adverse event reported by patient. No symptoms of adverse event reported by patient.
2851664 49 F MN 07/29/2025 HEP
PNC20
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
4BX39
LN4930
Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm; Erythem... Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm More
left arm started to swell and get red and hot on 7/26/25; she now has reported swelling size of a ba... left arm started to swell and get red and hot on 7/26/25; she now has reported swelling size of a baseball, hard, warm and very painful arm. She has used ice but this is not helping. More
2851665 12 F AK 07/29/2025 HPV9
MNQ
TDAP
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
Y00799
U8375AA
4K7JP
Photopsia, Syncope; Photopsia, Syncope; Photopsia, Syncope Photopsia, Syncope; Photopsia, Syncope; Photopsia, Syncope
Patient tolerated IM vaccine administration, she sat for 3 minutes in chair prior to standing. She h... Patient tolerated IM vaccine administration, she sat for 3 minutes in chair prior to standing. She had what appeared to be a Vasovagal syncope event. Eyes opened the entire time and gently guided to the floor. She blinked and then began talking within few seconds of lying down. Patient admitted to feeling like she was seeing stars when she stood up and tried walking. Patient requested to be sitting rather than lying down and sat for about 10minutes and stood with stand by assist. She denied any symptoms of dizziness or concerns. She left clinic with parent and no other concerning symptoms. More
2851666 10 F MA 07/29/2025 MNQ
TDAP
SANOFI PASTEUR
SANOFI PASTEUR
U8558AA
4CA04C1
Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue
Both Tdap and Menquadfi where drawn up into the same syringe accidentally and given to patient. Both Tdap and Menquadfi where drawn up into the same syringe accidentally and given to patient.
2851667 68 F MN 07/29/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Rash, Rash erythematous, Rash pruritic Rash, Rash erythematous, Rash pruritic
Patient called today 7/29 stating that she has had small red bumps/ itchy rash on both arms starting... Patient called today 7/29 stating that she has had small red bumps/ itchy rash on both arms starting 1 week or so after second vaccine in the series. No problems reported from the first vaccine in the series. We consulted her to call her MD and can use topical cortisone to possible help with the itchiness. More
2851668 64 M MI 07/29/2025 ADEN_4_7
ADEN_4_7
TEVA PHARMACEUTICALS
TEVA PHARMACEUTICALS


Balance disorder, Computerised tomogram head, Deafness unilateral, Ear discomfor... Balance disorder, Computerised tomogram head, Deafness unilateral, Ear discomfort, Electrocardiogram; Full blood count, Metabolic function test, Tinnitus, Walking aid user More
1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a can... 1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a cane to help keep me from falling over. Loud ringing in right ear. Low grade fever of 100. I still can't even hear a smoke alarm going off. A feeling of pressure in ear More
2851669 18 F WA 07/29/2025 MENB
NOVARTIS VACCINES AND DIAGNOSTICS
TH9NR
Syncope Syncope
Patient had syncope episode after receiving the vaccines. She was laid down on the table and was coh... Patient had syncope episode after receiving the vaccines. She was laid down on the table and was coherent after 20 seconds. Legs were bent at the knees. Nurse was brought into the room and did vitals. Patient was given juice and crackers. Vitals were monitored while the doctor was brought into the room. More
2851670 56 F MI 07/29/2025 TDAP
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
H4279
PJ353
Pain in extremity, Peripheral swelling, Skin warm; Pain in extremity, Peripheral... Pain in extremity, Peripheral swelling, Skin warm; Pain in extremity, Peripheral swelling, Skin warm More
PROGRESSIVE SWELLING OF THE ARM FROM SHOULDER TO ELBOW,HOT TO TOUCH AND PAINFUL PROGRESSIVE SWELLING OF THE ARM FROM SHOULDER TO ELBOW,HOT TO TOUCH AND PAINFUL
2851671 51 F NC 07/29/2025 HEPAB
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
P2443
PJ353
Injection site erythema, Injection site inflammation, Injection site pain, Injec... Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth; Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth More
Patient has a very red inflamed spot on her arm where the vaccine for shingrix was administered, and... Patient has a very red inflamed spot on her arm where the vaccine for shingrix was administered, and a 4 in diameter of red inflamed area around it and feels very warm and tender to touch. patient continues to have full range of motion on this arm . She is on day 6 today since vaccination and it is not improved More
2851672 66 M ND 07/29/2025 HEP
GLAXOSMITHKLINE BIOLOGICALS
JB4K2
Underdose Underdose
Hep B pediatric was given instead of Hep B adult. Hep B pediatric was given instead of Hep B adult.
2851674 57 F NJ 07/29/2025 PNC21
VARZOS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
Z003579
93N4J
Pruritus, Urticaria; Pruritus, Urticaria Pruritus, Urticaria; Pruritus, Urticaria
Patient said they had hives and itchiness in left arm two days after getting both vaccines. They tr... Patient said they had hives and itchiness in left arm two days after getting both vaccines. They tried Benadryl but it did not help, so she went to the emergency room. She is better today. More
2851675 54 M CO 07/29/2025 MMR
GLAXOSMITHKLINE BIOLOGICALS
57DD5
Product preparation issue Product preparation issue
Administered the diluent only, forgot to mix in the freeze dried vaccine. New type of brand of vacci... Administered the diluent only, forgot to mix in the freeze dried vaccine. New type of brand of vaccine and was first time giving it. More
2851676 16 F OK 07/29/2025 MNQ
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
XL223
XL223
Depressed level of consciousness, Hypotonia, Immediate post-injection reaction, ... Depressed level of consciousness, Hypotonia, Immediate post-injection reaction, Nausea, Pallor; Seizure, Somnolence, Unresponsive to stimuli More
Patient had brief seizure (<30 seconds) which involved her eyes and all 4 extremities immediately... Patient had brief seizure (<30 seconds) which involved her eyes and all 4 extremities immediately after the vaccine was given. Afterward, she was sleepy and had a decreased level of consciousness (unable to respond to questions) for several minutes and had to lie on the table for about 30 minutes before she could leave the office. She appeared limp and pale and felt nauseous but did not vomit. 7/21/2021, she received her first meningococcal vaccine (Menactra lot #U6951AA) along with HPV9 and Tdap (all on the same day). She had an identical reaction at that time which was thought to be due to the HPV vaccine. With her second HPV vaccine, she had no reaction however so the original culprit must have been the meningococcal vaccine. More
2851677 73 F MS 07/29/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
FT95n
Arthralgia, Injection site rash Arthralgia, Injection site rash
Rash at site of injection, shoulder joint pain. She said that the reaction lasted a few days. Rash at site of injection, shoulder joint pain. She said that the reaction lasted a few days.
2851678 50 F NC 07/29/2025 MENB
NOVARTIS VACCINES AND DIAGNOSTICS
CD44A
Inappropriate schedule of product administration Inappropriate schedule of product administration
3RD an final Bexsero to be administered 6 months or after from Day 0, per guidelines. This patient ... 3RD an final Bexsero to be administered 6 months or after from Day 0, per guidelines. This patient received her first dose on 01/31/25, 2nd dose 03/28/2025 and 3rd dose due on or after 07/31/2025. In this case, Bexsero 3rd dose administered on 07/25/2025, six days prior to recommended dosing schedule. Notified nursing and pharmacist, and requested that the pharmacist reach out to the HCP and notify them of the above. More
2851681 F FL 07/29/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.
Y013469

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years o... Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years old but received their second dose at age 46 years old on 7-MAR-2025. Caller states patient is now requesting their 3rd dose to complete the series bu; Information has been received from Business Partner/CRO on 08-Jul-2025. This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), dose number 1, (indication, expiration date, and lot # were not reported). On 07-Mar-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (lot #Y013469, expiration date: 10-Oct-2026), dose number 2, for an unknown indication (Inappropriate schedule of vaccine administered). More
2851682 KY 07/29/2025 VARCEL
MERCK & CO. INC.
Y006523
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; Pharmacist calling to report inadvertently administering VARIVAX to patients after... no adverse event; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Sep-2024, the patient was inadvertently vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y006523, expiration date: 25-Mar-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). It was mentioned that the vaccine was "issued" to the facility on 09-AUG-2024 and was inadvertently stored in the refrigerated throughout administrations. The temperature excursion was: Temperature 2 to 8�C, the time frame was and previous temperature excursion was Unknown. No adverse events reported.; Reporter's Comments: Keywords : More
2851683 VA 07/29/2025 VARCEL
MERCK & CO. INC.
Y019318
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; VARIVAX was administered following the excursion; This spontaneous report was rece... No additional AE; VARIVAX was administered following the excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y019318, expiration date: 21-Nov-2026 (dose number, route of administration, and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiration date were not reported). On an unknown date, before administration, the vaccine underwent a temperature excursion of 52.2 degrees Fahrenheit (F), time frame was unknown by reporter. No symptoms or side effects, no additional adverse events were reported. More
2851684 CA 07/29/2025 HPV9
MERCK & CO. INC.
Z005469
Syringe issue Syringe issue
HCP calling to report a PQC for GARDASIL 9. Caller states "the syringe broke" following t... HCP calling to report a PQC for GARDASIL 9. Caller states "the syringe broke" following the administration of a GARDASIL 9 dose to a patient. Caller states the "glass part" near the plunger broke for one of the syringes of GARDASIL 9.; Syringe broken; No adverse event; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, "the syringe broke" following the administration of a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis to the patient. The primary reporter stated that the "glass part near the plunger" near the plunger broke for one of the syringes of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The break was noticed after the administration and the needle was removed from the patient's arm. Caller states the break occurred prior to placing the needle cover. Even with the break, the HCP administering the vaccine was able to cover the needle with the safety cover. The patient received the full dose. Other doses from the box have been administered with no issues. No adverse event reported.; Reporter's Comments More
2851685 GA 07/29/2025 MMRV
MMRV
MMRV
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Z007213
Y013580

No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered... Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter. More
2851686 17 CA 07/29/2025 MMRV
MERCK & CO. INC.

No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
HCP reporting PROQUAD administered to a 17 year old patient.; No additional AE; This spontaneous rep... HCP reporting PROQUAD administered to a 17 year old patient.; No additional AE; This spontaneous report was received from a nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, at the age of 17 years old, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). No additional adverse event was reported. Lot# is being requested and will be submitted if received. More
2851687 1 IA 07/29/2025 MMR
MMR
MMRV
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

Y018703
Z005153

Extra dose administered, Inappropriate schedule of product administration, No ad... Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event More
Patient is not symptomatic. No additional AE; Received their first dose of MMR-II on 08/17/2023. Adm... Patient is not symptomatic. No additional AE; Received their first dose of MMR-II on 08/17/2023. Administration of MMR-II on 07/25/25; HCP calling to report the inadvertent administration of PROQUAD and MMR-II today (07/25/25).; This spontaneous report was received from a registered nurse (R.N.) and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 17-AUG-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both administered for prophylaxis (dose, formulation, route of administration, anatomical site of injection, lot number and expiration date were not reported), which were both reconstituted with sterile diluent (MERCK STERILE DILUENTE) (lot number and expiration date not provided). On 25-JUL-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y018703 has been verified to be valid for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live [M-M-R II], expiration date 11-NOV-2026) (Inappropriate schedule of product administration), and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) dose number 1 (lot number Z005153 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 25-AUG-2026); both vaccines were administered for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided) and both were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported). The administered vaccines were giving inadvertently on the same date (Accidental overdose). The patient was no symptomatic and no additional adverse event was reported. No other information provided This is one of two reports from the same reporter. More
2851688 WV 07/29/2025 MMRV
MERCK & CO. INC.
Y002374
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE reported; PROQUAD was administered to a 22-year-old consumer; This spontaneous repo... No additional AE reported; PROQUAD was administered to a 22-year-old consumer; This spontaneous report was received from a/an Other health professional and refers to a 22-year-old patient of unknown gender. The patient's previous adverse drug reaction history and family adverse drug reactions were not reported. The patient's concomitant therapies, medical histories and drug allergies were not applicable. On 07-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y002374, expiration date: 14-Jul-2025) (strength, formulation route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) for Prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (Product administered to patient of inappropriate age). No additional AE reported. No PQC reported. No additional information provided. More
2851689 GA 07/29/2025 MMRV
MMRV
MMRV
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Z007213
Y013580

No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered... Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter. More
2851690 GA 07/29/2025 MMRV
MMRV
MMRV
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Z007213
Y013580

No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered... Symptoms were not reported. No additional AE; Customer called to report TE. PROQUAD was administered to 3 patients on 07/23/2025; This spontaneous report was received from an Administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-Jul-2025, the patient was vaccinated with an improperly stored dose of with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z007213, expiration date: 05-Oct-2026 or lot #Y013580, expiration date: 03-Feb-2026) 0.5 mL administered for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: 35 Fahrenheit (F) for 72 hours (product storage error, onset date: 23-JUL-2025). Previous temperature excursion was reported as no. Lot # Y013580 was administered to 1 patient and lot # Z007213 was administered to 2 patients. Symptoms were not reported. There was no additional adverse event reported (no adverse event). This is one of three reports received from the same reporter. More
2851693 11 M IA 07/29/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
AMVB064A
Product preparation error Product preparation error
Wrong solution used in drug reconstitution; Wrong solution used in drug reconstitution; This non-ser... Wrong solution used in drug reconstitution; Wrong solution used in drug reconstitution; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 14-JUL-2025, the patient received Menveo (intramuscular, left deltoid). On 14-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong solution used in drug reconstitution) and inappropriate dose of vaccine administered (Verbatim: Wrong solution used in drug reconstitution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter stated that a male patient received the Lyophilized Conjugate component only of Menveo reconstituted with a Merck diluent that is used for the Proquad Vaccine instead of reconstituted with the Liquid conjugate for Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with case US2025091804, reported by the same reporter.; Sender's Comments: US-GSK-US2025091804:same reporter, different patient, 2 of 2 More
2851694 M FL 07/29/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination Incomplete course of vaccination
he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose; This non-serious case was... he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: he received dose one of SHINGRIX in 2019 and has not yet had the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The reporter was an older male who stated that he received dose one of Shingrix in 2019 and had not yet had the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. This case US2025AMR094554 was reporter by same reporter.; Sender's Comments: US-GSK-US2025AMR094554:Same reporter,different patient More
2851695 07/29/2025 HEPAB
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination Incomplete course of vaccination
the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B); This... the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B); This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 2 doses on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Twinrix. The patient had incomplete course of vaccination (Verbatim: the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B)). The outcome of the incomplete course of vaccination 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: 21-JUL-2025 The pharmacist reported that the patient was given the first two doses of Twinrix but the third dose was only the Hepatitis B vaccine (not the A and B). The Hepatitis B vaccine that was administered was Dynavax and the drug name the Heplisav. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine (Hepatis A antigen), which led to incomplete course of vaccination. More
2851696 14 F MO 07/29/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS

Extra dose administered Extra dose administered
inadvertently given menveo 1 year apart and once at 13 and once at 14 years old; This non-serious ca... inadvertently given menveo 1 year apart and once at 13 and once at 14 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a child female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (received 1st dose at age of 13 years old). On 23-JUL-2025, the patient received the 2nd dose of Menveo (intramuscular) .5 ml. On 23-JUL-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: inadvertently given menveo 1 year apart and once at 13 and once at 14 years old). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 The reporter reported that they have inadvertently given Menveo 1 year apart which was once at 13 and once at 14 years old, which led to extra dose administered. The reporter asked was there any side effects or problems that they should know about, and she will still need another at 16 years, correct More
2851697 07/29/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination Incomplete course of vaccination
was not able to get 2nd shot in 6 months due to pandemic recently got the second dose; This non-seri... was not able to get 2nd shot in 6 months due to pandemic recently got the second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in MAR-2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: was not able to get 2nd shot in 6 months due to pandemic recently got the second dose). The outcome of the social problem was not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. Patient got first Shingrix vaccine in March 2020 but was not able to get 2nd shot in 6 months due to pandemic. Patient got the 2nd Shingrix vaccine, but it has been 5 years since 1st one. Patient wanted to know if they need to get 3rd vaccine. More