๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2853991 16 M GA 08/13/2025 HEP
HEP
HEPA
HEPA
IPV
IPV
MNQ
MNQ
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
MERCK & CO. INC.
 7NX57
7NX57
J4K4X
J4K4X
Y1A212M
Y1A212M
AH7Z3
AH7Z3
Z008196
Z008196
Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli;... Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli; Vision blurred; Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli; Vision blurred; Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli; Vision blurred; Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli; Vision blurred; Blood glucose normal, Dizziness, Hyperhidrosis, Pallor, Unresponsive to stimuli; Vision blurred More
Patient was sitting down in chair and receiving vaccines at approximately 10:30. After 5th vaccine o... Patient was sitting down in chair and receiving vaccines at approximately 10:30. After 5th vaccine out of 8 scheduled patient began feeling lightheaded, dizzy, and reported blurry vision. Patient became pale and sweaty and was conscious but not responding for several minutes. Vital signs were taking starting at 10:35 and were: B/P: 70/39, HR: 48, O2: 97%. Then at 10:40 B/P: 113/75, HR: 66, O2: 95%. At 10:45 B/P: 111/70, HR: 60, O2: 96%. And at 10:50 the final set of vitals were: B/P: 113/73, HR: 54, O2: 97%, Temp: 97.6 F, and Blood Glucose: 122 after giving patient orange juice. Patient was evaluated by EMS and deemed stable. Parent declined going to hospital. Patient was stable and able to walk out of clinic today. More
2853992 59 F PA 08/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 p2443
Blood pressure increased, Dizziness, Feeling abnormal Blood pressure increased, Dizziness, Feeling abnormal
Patient received 2nd vaccine around 10am and returned to the pharmacy at 3pm noting lightheadedness/... Patient received 2nd vaccine around 10am and returned to the pharmacy at 3pm noting lightheadedness/dizziness and feeling "off". Her blood pressure was elevated (135/82) from her reported baseline (108/76). We gave her cold water and she sat by the pharmacy for 20 minutes. A 2nd blood pressure was taken after 20 minutes and read 136/80. Per patient she was still feeling "off' but safe to drive home. If symptoms worsen or persist longer than 48 hours patient was advised to call MD. More
2853993 14 M CA 08/13/2025 HPV9
 MERCK & CO. INC.
 Z002580
Fall, Head injury, Loss of consciousness, Syncope Fall, Head injury, Loss of consciousness, Syncope
HPV vaccine was administered. Approximately three minutes post-administration, the 14-year-old patie... HPV vaccine was administered. Approximately three minutes post-administration, the 14-year-old patient fainted, striking the back of his head on the counter during fall. More
2853994 12 F GA 08/13/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8508AA
U8508AA
U8353AA
U8353AA
Dizziness, Dyskinesia, Lethargy, Loss of consciousness, Pallor; Somnolence; Dizz... Dizziness, Dyskinesia, Lethargy, Loss of consciousness, Pallor; Somnolence; Dizziness, Dyskinesia, Lethargy, Loss of consciousness, Pallor; Somnolence More
About 3 mins after last vaccine was given, while nurse was completing paper work for school patient ... About 3 mins after last vaccine was given, while nurse was completing paper work for school patient became pale and stated she was feeling "dizzy". Propped feet up in chair and placed cool paper towel on patients face and neck area. Asked mom if child had anything to eat this morning and she said that child "only drank some Sprite". 09:08 am - BP 86/51 P-53 . 9:10am- BP- 85/40 P-61. Patient became lethargic and passed out while sitting on bench with feet propped up. Patient displayed some light jerking movements. Talked to patient and reassured her that she was okay. Patient came around and was able to talk to staff. Patient given a few sips of coke but she didn't want any crackers. 9:15am BP-69/33 P-53. Patient was able to stand and with the assistance of mom and RN we were able to lay patient down on mat on left side in recovery position. Patient complain of just "feeling sleepy". Mom stated that she has history of fainting as well as her other two children but this is the first time patient has had this occur. 9:25am BP check with manual cuff because we could not get a reading with electronic machine. BP - 98/48. Patient states that "she's feeling better." Color has returned to patient's face and she is no longer lethargic. Assisted patient to sit up. 9:35am BP-101/71 P-57 (electric cuff). Patient was able to stand and ambulate without any difficulty. Advised mom to wait an additional 15 mins in lobby for us to continue to monitor patient. Advised mom to get patient something to eat when she leaves. Mom voiced understanding. During today's visit a total of 45 minutes was spent face-to-face with parent and patient to include counseling for immunizations, possible side-effects and treatment in addition to emergency care rendered. This includes accessing and managing patient's healthcare needs as documented in the patient's record. Copy of 3231 form, immunization records and school excuse given to mom. More
2853995 0.33 F IN 08/13/2025 DTPPVHBHPB
PNC15
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
 U7829AA
Z008265
2142142
Crying, Injection site erythema, Injection site reaction, Injection site swellin... Crying, Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness; Crying, Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness; Crying, Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness More
Shiny, tight, redness, swollen on right leg knee to foot, inconsolable crying, right leg kicking. Wa... Shiny, tight, redness, swollen on right leg knee to foot, inconsolable crying, right leg kicking. Warm/cold/warm compress. 2.5 mL of Tylenol. Pt did spit up Tylenol after taking. Lasted 1 hour, 15 minutes. Pt then fell asleep. More
2853996 16 M GA 08/13/2025 HPV9
IPV
MENB
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS



Dizziness, Hyperhidrosis, Vomiting; Dizziness, Hyperhidrosis, Vomiting; Dizzines... Dizziness, Hyperhidrosis, Vomiting; Dizziness, Hyperhidrosis, Vomiting; Dizziness, Hyperhidrosis, Vomiting; Dizziness, Hyperhidrosis, Vomiting More
at 1439 after receiving Meningitis B, HPV, TDAP, IPV pt became visibly distressed. c/o sweating, vom... at 1439 after receiving Meningitis B, HPV, TDAP, IPV pt became visibly distressed. c/o sweating, vomiting, light-headedness. Vital checks q 5 minutes( 1441 BP- 102/66 P- 60 02-98% 1445 BP 103/66 P-65 02- 90% 1450 BP- 100/67 P- 65 02-99%), ice pack, water, recline and rest. 1451 pt was amulatory and no longer c/o dizziness/light-headedness. pt states he is feeling better and is comfortable with leaving at this time. pt was ambulatory and left the facility with brother. More
2853997 62 M NY 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 gj952
Facial paralysis, Paraesthesia Facial paralysis, Paraesthesia
patient received vaccine on 8/1/25, started to feel tingling in hand 8/1/25 evening, woke up in the ... patient received vaccine on 8/1/25, started to feel tingling in hand 8/1/25 evening, woke up in the middle of the night with face paralysis More
2853998 5 M NC 08/13/2025 MMRV
 MERCK & CO. INC.
 Z008499
Extra dose administered Extra dose administered
Pt was administered two MMRV (Proquad) vaccines on accident. Incident report has been completed. Pat... Pt was administered two MMRV (Proquad) vaccines on accident. Incident report has been completed. Patients mother was educated on side effects of double vaccination of MMRV. MMRV vaccine sheet was discussed in detail. Informed mom that he will be more likely to have injection site reaction including redness, swelling and tenderness. Provider informed mom that he may get a fever. A dose of Tylenol was given here in office. Provider recommended another dose for later that night. Provider attempted to contact pt's mother today to follow up/check on patient following double MMRV vaccines on 8/12/25. No answer. Voicemail was left for mom call us back. More
2853999 14 F MA 08/13/2025 MMRV
MNQ
TDAP
VARCEL
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 Y005808
U8369AA
3CA30C1
Y014511
Blindness, Hyperhidrosis, Pallor, Photophobia; Blindness, Hyperhidrosis, Pallor,... Blindness, Hyperhidrosis, Pallor, Photophobia; Blindness, Hyperhidrosis, Pallor, Photophobia; Blindness, Hyperhidrosis, Pallor, Photophobia; Blindness, Hyperhidrosis, Pallor, Photophobia More
8/13/2025: Pt finished vaccines at 1:36pm. Pt was noted to be anxious prior to vaccines but tolerate... 8/13/2025: Pt finished vaccines at 1:36pm. Pt was noted to be anxious prior to vaccines but tolerated vaccination. Pt's mother was educated to wait 20 minutes in the waiting room to make sure pt is okay after vaccination. Pt's mother decline and stated "we are very busy today." Pt's mother was educated on signs and symptoms to monitor for and when to see a provider. Pt's mother stated that she understood the instructions. pt and pt's mother left and came back in less than 10 minutes around 1:45pm. Pt was noted to be cool, pale, diaphoretic. pt reporting that she was losing her vision. AOx4, no LOC. Pt's mother stated that they were walking out the building when she noticed that the pt was pale and sweaty, which they decided to bring her back to the clinic. This RN called 911. Pt's vitals were 148/82, RR 24, O2 sat 97% on RA, HR 88. Ambulance, fire, and police arrived and pt's condition improved. Pt was more alert, talking, vision improved but still having photophobia, and was still diaphoretic. Pt was taken to hospital by EMS. More
2854000 29 M WI 08/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
Dyskinesia, Loss of consciousness, Muscle rigidity, Mydriasis Dyskinesia, Loss of consciousness, Muscle rigidity, Mydriasis
Patient became uncouncious, rigid, jerking motions and pupils dialated Patient became uncouncious, rigid, jerking motions and pupils dialated
2854001 0.33 M WA 08/13/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK109AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
This RN was doing reconciliation report and counting vaccines. Discovered the ActHib vial in box wit... This RN was doing reconciliation report and counting vaccines. Discovered the ActHib vial in box without the partner Dtap/IPV vial. Ran a report to see if any Pentacel's had been given since last reconciliation and only 1 had on 7/10/25 to this pt. Assuming that the vaccinator did not mix the Dtap/IPV liquid with the ActHib and only gave the Dtap/IPV vial. This RN discussed with vaccinator that gave the vaccine. Teaching done. Child has had no adverse reactions or events from vaccine error. Notified parents. PCP aware More
2854002 18 F WA 08/13/2025 MENB
 PFIZER\WYETH
 lx26362025
Heart rate decreased, Hypotension, Loss of consciousness, Syncope Heart rate decreased, Hypotension, Loss of consciousness, Syncope
syncope, patient passed out low BP and HR . Mom is a RN monitored and observed patient fully recove... syncope, patient passed out low BP and HR . Mom is a RN monitored and observed patient fully recovered and left facility More
2854003 84 F CA 08/13/2025 COVID19
 PFIZER\BIONTECH
 LM2211
Vertigo Vertigo
Patient came to pharmacy today (8/13/25) to discuss vaccinations. While we were talking, she informe... Patient came to pharmacy today (8/13/25) to discuss vaccinations. While we were talking, she informed me that she experienced severe vertigo for about 4 months that started 10 days after she was vaccinated with the covid vaccine. She also mentioned that she was hospitalized for the vertigo for a period of time (did not get dates for this). She said this reaction never happened with any of the other covid shots she got (all Pfizer) More
โœ“
2854004 73 F SC 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Hyperhidrosis, Pyrexia Chills, Hyperhidrosis, Pyrexia
Severe chills, fever, and perfuse sweating. Severe chills, fever, and perfuse sweating.
2854005 3 M MO 08/13/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019171
Y007637
Wrong patient, Wrong product administered; Wrong patient, Wrong product administ... Wrong patient, Wrong product administered; Wrong patient, Wrong product administered More
Child was accidentally given the MMRV that was meant for his sibling instead of MMR. Child was accidentally given the MMRV that was meant for his sibling instead of MMR.
2854006 0.83 M ND 08/13/2025 DTAPHEPBIP
PNC13
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 ZK4XF
GH6086
Bronchial hyperreactivity, Chest X-ray abnormal, Eczema, Screaming, Wheezing; Br... Bronchial hyperreactivity, Chest X-ray abnormal, Eczema, Screaming, Wheezing; Bronchial hyperreactivity, Chest X-ray abnormal, Eczema, Screaming, Wheezing More
Screaming for 3 days. Developed eczema - face, trunk, extremities. Upper airway - wheezing. ENT chec... Screaming for 3 days. Developed eczema - face, trunk, extremities. Upper airway - wheezing. ENT checked - no findings, related to lungs, did get tubes (unrelated). Aquaphor / OTC treatment. Tried steroid cream at one point - not helpful. More
2854007 5 F OH 08/13/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 5G23D
Y018703
Y011018
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event More
Patient moved knee and kicked while actively injecting MMR vaccine causing unknown amount of vaccine... Patient moved knee and kicked while actively injecting MMR vaccine causing unknown amount of vaccine to be administered outside of skin and not given to patient; unknown amount of vaccine was given to patient. Patient parent agreeable to returning for MMR vaccine 1 month after incident. No adverse reaction reported or observed. More
2854008 64 F FL 08/13/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 tfaa2502
lx4482
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
redness, swelling, soreness, and heat around the injection site which is currently ongoing at time o... redness, swelling, soreness, and heat around the injection site which is currently ongoing at time of reporting. patient states that after the initial pain from the shot, the other symptoms followed a day or two later. More
2854009 F OH 08/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Hypoacusis, SARS-CoV-2 test COVID-19, Drug ineffective, Hypoacusis, SARS-CoV-2 test
Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday a... Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive; Tested positive; speak louder cause I can't really hear; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious) with onset 2025, outcome "unknown", described as "speak louder cause I can't really hear"; DRUG INEFFECTIVE (medically significant) with onset 05Aug2025, outcome "unknown", described as "Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive"; COVID-19 (medically significant) with onset 05Aug2025, outcome "unknown", described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2025) positive; (05Aug2025) positive. Clinical course: The patient mentioned taking the vaccines (clarified as Pfizer Covid-19 Vaccine) in the past. Took antigen test yesterday and it tested positive and just was prescribed the medication (Clarified as Paxlovid) today and some cough syrup. Patient have covid and head feels like it's underwater and can't hear really well. Patient have not taken Paxlovid yet and have to go pick it up. Patient was not feeling well. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854012 M NC 08/13/2025 COVID19
 PFIZER\BIONTECH
Asthma, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective Asthma, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective
COVID after Pfizer COVID shots; COVID after Pfizer COVID shots; Asthma; COPD; This is a spontaneous ... COVID after Pfizer COVID shots; COVID after Pfizer COVID shots; Asthma; COPD; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shots"; ASTHMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". The events "covid after pfizer covid shots", "asthma" and "copd" required physician office visit. Additional information: patient went to the pharmacy, diagnosed with COVID, for Paxlovid. The doctors prescribed this medication from Urgent Care. Patient had asthma with COPD. All his shots were with Pfizer and added he "got all of them except the last one" and his primary doctor told him to wait a while to get it cause he had done all the rest of them. Patient added "the last one got bout the same thing that the one before that had in it". Primary doctor will let him know when to come get it (COVID shot). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854013 M 08/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Diabetes mellitus, Drug ineffective, Lung neoplasm malignant, Pulmonar... COVID-19, Diabetes mellitus, Drug ineffective, Lung neoplasm malignant, Pulmonary sarcoidosis More
diabetes; lung cancer; sarcoid of the lung; COVID; COVID; This is a spontaneous report received from... diabetes; lung cancer; sarcoid of the lung; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "COVID"; LUNG NEOPLASM MALIGNANT (medically significant) with onset 2025, outcome "unknown", described as "lung cancer"; PULMONARY SARCOIDOSIS (medically significant) with onset 2025, outcome "unknown", described as "sarcoid of the lung"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". Clinical course: Patient recently fell Ill to COVID, and was informed he was able to get Paxlovid. Much to his surprise of the cost of this medicine (stated as ridiculous). Patient and his wife did get the Pfizer shot at the start of year (2025). Patient is also dealing with diabetes, sarcoid of the lung (an autoimmune disease) and recently found out to have lung cancer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854014 08/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
did not work; did not work; This is a spontaneous report received from a Consumer or other non HCP. ... did not work; did not work; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not work". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2854015 8 M 08/13/2025 DTAP
 SANOFI PASTEUR
No adverse event, Wrong product administered No adverse event, Wrong product administered
provider ordered wrong vaccine MA did not catch prior to administration with no reported adverse eve... provider ordered wrong vaccine MA did not catch prior to administration with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 years old male patient and it was reported that the provider ordered wrong diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and medical assistant did not catch prior to administration with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of wrong diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination and medical assistant did not catch prior to administration with no reported adverse event (wrong product administered) (same day latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2854016 21 F 08/13/2025 TDAP
 SANOFI PASTEUR
 48563AA
No adverse event, Product storage error No adverse event, Product storage error
vaccine fridge temperature out of range , vaccine administered with no reported adverse event; Initi... vaccine fridge temperature out of range , vaccine administered with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 years old female patient (170 cm and 95 kg) as Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] fridge temperature out of range , vaccine administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection lot 48563AA expiry date-30-Apr-2027 (strength unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) fridge temperature out of range , vaccine administered with no reported adverse event (poor quality product administered) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2854017 9 M UT 08/13/2025 HPV9
 MERCK & CO. INC.
 Z009260
Anxiety, Gaze palsy, Hypotonia, Pallor, Seizure Anxiety, Gaze palsy, Hypotonia, Pallor, Seizure
Patient was in for a 9 year well child check. At the end of the visit he was going to be getting his... Patient was in for a 9 year well child check. At the end of the visit he was going to be getting his 1st dose of HPV, I gave him the vaccine he was very anxious and worked up. He also was also going to be getting a finger prick to do his lipid POC and that's when he started to slouch a little and mom asked if he was okay and i said yes, that sometimes happens when they're over anxious with this vaccines but then his eyes rolled to the back of his head and he went pale and was on his side and the seizure started, no longer than 10 secs, I ran out and grabbed ARPN who instructed I grab the oxygen tank (that wasn't used) as patient was coming back to. Dr. kept patient an extra 30 minutes for monitoring before going home, and apple juice was given. After some time patient felt better, and stat's were in normal range. More
2854018 69 M TX 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fluid retention, Thrombosis Fluid retention, Thrombosis
PATIENT REPRESENATATIVE STATED THAT PATIENT HAS FLUID BUILD UP AND BLOOD CLOTS. THE REP DID NOT ELAB... PATIENT REPRESENATATIVE STATED THAT PATIENT HAS FLUID BUILD UP AND BLOOD CLOTS. THE REP DID NOT ELABORATE, AND WE HAVE NOT BEEN ABLE TO GET IN CONTACT WITH PATIENT More
2854019 69 F ID 08/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4279
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received 10 year booster on 07/16/2025. Then on 07/28/25 they received a duplicate dose. Pat... Patient received 10 year booster on 07/16/2025. Then on 07/28/25 they received a duplicate dose. Patient is okay and they were contacted about the situation. No side effects were reported. More
2854040 4 M FL 08/13/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8209cb
U8209cb
Y016874
Y016874
Blister, Erythema, Fatigue, Pyrexia, Skin irritation; Wound secretion; Blister, ... Blister, Erythema, Fatigue, Pyrexia, Skin irritation; Wound secretion; Blister, Erythema, Fatigue, Pyrexia, Skin irritation; Wound secretion More
Severe dermal reaction including weeping wound, blistering, redness, irritation for 7 days. Fever an... Severe dermal reaction including weeping wound, blistering, redness, irritation for 7 days. Fever and fatigue from afternoon of injection for 5 days. Required 5 telehealth visits from day 2 - day 3 with doctors office. Required treatment with benedryl, oral/topical antibiotics, and fever reducers. More
2854041 2 M NM 08/13/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 A32BB
Expired product administered Expired product administered
Vaccine was given, with an expiration date passed 3 days. Vaccine was given, with an expiration date passed 3 days.
2854042 18 M IL 08/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVBO43A
Dizziness, Extra dose administered, Panic attack Dizziness, Extra dose administered, Panic attack
Patient made an online appointment to get meningitis vaccine. Upon arrival, technician performed all... Patient made an online appointment to get meningitis vaccine. Upon arrival, technician performed all checked-in questions and completed VAR(vaccine administration report). Patient did not clarify which kind he wanted and confirmed that he needs it for school requirement, so we processed meningitis ACWY and administered it to the patient. Patient was actually looking to get meningitis B vaccine. Patient then clarified that he already received meningitis ACWY from the doctor office last month. Patient started having panic attacks, almost got little dizzy but did not faint. Patient was feeling okay, pharmacist called EMS,paramedics arrived and checked his vitals. Patient walked out perfectly okay from the pharmacy. More
2854043 48 M CA 08/13/2025 FLU3
FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2XTD9
2XTD9
2XTD9
Asthenia, Blood pressure decreased, Electrocardiogram abnormal, Electromyogram a... Asthenia, Blood pressure decreased, Electrocardiogram abnormal, Electromyogram abnormal, Fatigue; Hyperhidrosis, Hypertensive crisis, Injection site pain, Injection site reaction, Injection site swelling; Lower limb fracture, Mobility decreased, Muscle atrophy, Syncope More
PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTEN... PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING More
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2854044 52 F CO 08/13/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3RE73
GK2AZ
Asthenia, Pain in extremity; Asthenia, Pain in extremity Asthenia, Pain in extremity; Asthenia, Pain in extremity
Severe pain in right arms and weakness Severe pain in right arms and weakness
2854045 74 F MN 08/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 p2443
Trigger finger Trigger finger
She stated that she developed trigger finger in one of her finger the following day. She is unsure ... She stated that she developed trigger finger in one of her finger the following day. She is unsure if it's related or not but she does not remember starting any new medications aside from a blood draw earlier the day prior to the vaccine administration. More
2854046 61 M NC 08/13/2025 PNC20
 PFIZER\WYETH
Electric shock sensation, Injection site pain, Injection site pruritus, Swelling Electric shock sensation, Injection site pain, Injection site pruritus, Swelling
Experienced more swelling than typical with other vaccines. Starting 3 days after vaccine injection ... Experienced more swelling than typical with other vaccines. Starting 3 days after vaccine injection area became itchy. Now, 9 days later, I?m experiencing electrical/nerve-like pain at injection site when lifting my arm overhead /above shoulder. More
2854047 42 F UT 08/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 NDC 58160-842-4
Arthralgia, Loss of personal independence in daily activities, Muscular weakness... Arthralgia, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity More
Patient's own words "I have been having complications after the T dap vaccination. By the ... Patient's own words "I have been having complications after the T dap vaccination. By the end of the first day, I had intense pain in my shoulder down into my hand. It got worse over the next day to the point where it is the worst pain that I've ever had. I started a steroid burst dose pack which has brought the pain down to where it is bearable as long as I don't use my right arm. I have weakness in my hand and have had difficulty typing and have been dropping things." More
2854048 23 F AZ 08/13/2025 VARCEL
 MERCK & CO. INC.
 Z003883
Asthenia, Dizziness, Feeling abnormal, Loss of consciousness Asthenia, Dizziness, Feeling abnormal, Loss of consciousness
Patient received a flu shot and was fine, then patient received a Varivax 5 minutes later. 30 secon... Patient received a flu shot and was fine, then patient received a Varivax 5 minutes later. 30 seconds after administration patient started to feel dizzy but was still talking, then she reported that she is stating to feel worse and we asked if she wanted to lay down, then she started to pass out. We called 911, she regained consciousness in about 30 seconds and was responsive. We waited for the paramedics to come and she was sitting in the chair while they arrived. The paramedics checked here vitals, they reported she had low blood pressure, they gave her an IV in the store and they then moved her to the gurney to take her the the hospital. She left the store still weak but was responsive. More
2854049 74 F FL 08/13/2025 PNC20
 PFIZER\WYETH
 LP4948
Burning sensation, Pain, Rash erythematous Burning sensation, Pain, Rash erythematous
Large red rash, very sore, burning sensation, Large red rash, very sore, burning sensation,
2854050 19 F WA 08/13/2025 HEPAB
TYP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 P2443
Y2A031M
Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli
Client attest to feeling well today, ate lunch about 12:30 PM today. Client traveling from 8/30/25 -... Client attest to feeling well today, ate lunch about 12:30 PM today. Client traveling from 8/30/25 - 9/13/25 for mission. Client declined recommended vaccines due to perceived as low risk. Client educated concerning the risk for rabies, and pre/post -exposure prophylaxis. Teaching given on food and water safety, TD prevention and treatment, mosquito prevention. VIS, SE, risk / benefits reviewed. Health Alerts reviewed. Client declined Azithromycin for TD and declined malarone for malaria prevention. Client received full dose Typhoid Vi on the left deltoid and full dose Hep A/B (Twinrix) on the right deltoid at about 14:56. About 1 minute after vaccine administration, nurse noticed client became pale whole body including face, unresponsive less than 30 seconds, stiff whole body as if having a seizure, and gasping for breath. Client already siting in the recliner in the treatment room both legs were elevated, and cold compress applied to chest area. Clients husband was present and assisted nurse by bringing water for client to drink. Client regained full consciousness in less than 2 minutes. Client declined paramedics / 911 called at this time. Vital sigs taken were B/P 117/66 P70, Temp 98, R18, O2sat 99%. Client alert and oriented, talking to staff and spouse, with skin color returned to normal. Client reported feeling dizzy, nauseous, hot and cold flushes, slightly diaphoretic during episode. Client states never had any issues with receiving vaccination in the past. Clients medical history includes no allergies and no medication. Phone call to nurse Supervisor at about 1512 to report the incidence. Client remained in the clinic for about 30 minutes post episode and left home with husband as the driver. Client educated to call 911 if symptoms continues as well as follow up the primary care provider for further evaluation. Client had no further questions. Nurse placed a phone call to client later in the day to check to see if arrived home safely went to voice mail. More
2854066 18 M SC 08/13/2025 UNK
 UNKNOWN MANUFACTURER
 amvb072a
Asthenia, Dizziness, Hypoaesthesia, Nausea, Vomiting Asthenia, Dizziness, Hypoaesthesia, Nausea, Vomiting
Reaction after menveo numbness in hands, dizziness, weakness, nausea/vomiting. EMS called Was given ... Reaction after menveo numbness in hands, dizziness, weakness, nausea/vomiting. EMS called Was given soda and crackers and felt better; left on own with mother More
2854067 1 F WV 08/13/2025 HEPA
HEPA
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 DN273
DN273
Y0175T2
Y0175T2
Decreased appetite, Lacrimation increased, Rash, Rash erythematous, Rhinorrhoea;... Decreased appetite, Lacrimation increased, Rash, Rash erythematous, Rhinorrhoea; Sensitive skin; Decreased appetite, Lacrimation increased, Rash, Rash erythematous, Rhinorrhoea; Sensitive skin More
Evening of 8/10 patient developed a red dot like rash starting on posterior scalp and progressed dow... Evening of 8/10 patient developed a red dot like rash starting on posterior scalp and progressed downward to feet. No mouth involvement. Skin seemed sensitive to wearing clothing but ok with touch. Fever tmax 100 but did have tylenol/motrin. Decreased appetite but ok with liquid intake. (+) nasal d/c and watery eyes. No cough/diarrhea No emesis More
2853673 F NY 08/12/2025 PNC21
 MERCK & CO. INC.
 Z004302
Erythema, Inflammation, Injection site vesicles, Pain, Skin warm Erythema, Inflammation, Injection site vesicles, Pain, Skin warm
she now has blistering at the site covering an area about 2-3 inches wide by 3-4 inches long.; Patie... she now has blistering at the site covering an area about 2-3 inches wide by 3-4 inches long.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; Patient received CAPVAXIVE on 7/17/2025 and same day reported redness, inflammation and became painful and hot to touch.; This spontaneous report was received from a Medical Assistant and refers to a 57-year-old female patient. The patient's medical history included pneumonia. The patient's concurrent conditions and concomitant therapies were not reported. On 17-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered intramuscularly; lot # Z004302 has been verified to be valid, expiration date: 04-Sep-2026; given as vaccination. On the same day, the patient experienced redness (Vaccination site erythema), inflammation (Vaccination site inflammation) and became painful (Vaccination site pain) and hot to touch (Vaccination site warmth). On 21-Jul-2025 (Also reported as this morning), patient called HCP and stated reaction had gotten progressively worse over the past few days and she now had blistering at the site (Vaccination site vesicles) covering an area with about 2-3 inches wide by 3-4 inches long. The patient sent pictures, and prednisone was given as treatment. It was also reported that she sought medial attention. At the reporting time, the outcome of all the events was unknown. The causal relationship between all the events with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. More
2853674 IL 08/12/2025 VARCEL
 MERCK & CO. INC.
 Z004454
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; a patient who was administered improperly stored VARIVAX; This spontaneous report ... No adverse event; a patient who was administered improperly stored VARIVAX; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies were not reported. On an unknown date, the vaccine Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL/dose, #Z004454, expiration date: 13-Feb-2027 was temperature excursion (TE) from -12.6C / -14๏ฟฝC up to -10๏ฟฝC (worst-case scenario, no TE assessment) for 0 Hours 45 Minutes 0 Seconds (worst-case scenario, no TE assessment). The previous temperature excursion was unknown. Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was unable to be assessed using in-house stability data due to data logger discrepancies. On 28-Jul-2025, this vaccine was vaccinated to the patient for prophylaxis (strength, and route of administration were not provided) (Product storage error). No symptoms reported. No additional AE details reported. More
2853675 27 M NC 08/12/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 lg749
Underdose Underdose
adult given pediatric dose; adult given pediatric dose; This non-serious case was reported by a othe... adult given pediatric dose; adult given pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 27-year-old male patient who received HBV (Engerix B pediatric) (batch number lg749, expiry date 13-SEP-2026) for prophylaxis. On 29-JUL-2025, the patient received Engerix B pediatric. On 29-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult given pediatric dose) and accidental underdose (Verbatim: adult given pediatric dose). The outcome of the adult use of a child product and accidental underdose were not applicable. Additional Information: GSK Receipt Date:29-JUL-2025 The reporter an adult need hepatitis b vaccine but they gave Engerix-B pediatric dose instead of adult dose, which led to accidental underdose and adult use of child product. Reached to quality and safety and to immuration org and someone asked the same question and recommendation was to go ahead and give the other half of the pediatric if patient was inside the clinic but if the mistake was found later then you would just count it as void and Start the series over, so quality and safety got to touch with manufacturing and see what the guidance would be if patient had already left the office but checking to see if he/she could call back the patient and saw if they get the 2nd half at the time of reporting, it was administered. The reporter consented to follow up. More
2853676 6 M NY 08/12/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Expire dose; This non-serious case was reported by a other health professional via call center repre... Expire dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 01-AUG-2025, the patient received the 1st dose of Engerix B. On 01-AUG-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used 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: 04-AUG-2025 The reporter stated that they had a patient, who got a vaccine, it was the Hep B vaccine (Engerix-B), and it was expired by a couple of months, which led to expired vaccine used. More
2853677 7 F OH 08/12/2025 IPV
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
getting an extra dose of IPOL with no reported adverse event; Initial information received on 04-Aug... getting an extra dose of IPOL with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old female patient who experienced getting an extra dose of IPV (Vero) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jan-2021 she also received a unknown (dose 4 ) dose of suspect IPV (VERO) Suspension for injection via unknown route in unknown administration site. On 06-May-2024, the patient received a 0.5 ml (dose 5) dose of suspect IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization with no reported adverse event (extra dose administered) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853678 1 M OR 08/12/2025 HIBV
 SANOFI PASTEUR
 UK208AA
Product preparation error Product preparation error
they might have reconstituted ACTHIB with sterile water and it was administered to a patient, with n... they might have reconstituted ACTHIB with sterile water and it was administered to a patient, with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 years old male patient to whom they might have reconstituted HIB (PRP/T) Vaccine [ACT-HIB] with sterile water and it was administered to a patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine (Hepatitis A) for Immunisation. On 17-Jun-2025, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK208AA, expiry date 28-Feb-2026, strength standard and frequency once) via intramuscular route in Right central lateral for Immunisation and it was reconstituted with sterile water and was administered to a patient, with no reported adverse event (product preparation error). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853679 1 F DE 08/12/2025 HIBV
 SANOFI PASTEUR
 UK210AA
No adverse event, Product preparation error No adverse event, Product preparation error
ACT-HIB was reconstituted with sterile water and administered to a patient with no reported adverse ... ACT-HIB was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient received HIB (PRP/T) vaccine [ACT-HIB] was reconstituted with sterile water and administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date in Jul-2025, the patient received dose 4 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK210AA and expiry date 28-Feb-2026 via intramuscular route in unknown administration site that was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency same day) Reportedly, Nurse stated that they found a vial of saline diluent they believe goes with the HIB part of the vaccine, meaning they believe that part may have been reconstituted with sterile water, not the provided diluent. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853680 48 M UT 08/12/2025 HIBV
 SANOFI PASTEUR
 UK201AC
No adverse event, Product preparation error No adverse event, Product preparation error
ACTHIB reconstituted with incorrect diluent, nurse used 0.9% Normal Saline with ACTHIB instead of th... ACTHIB reconstituted with incorrect diluent, nurse used 0.9% Normal Saline with ACTHIB instead of the provided Diluent with no reported AE; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old male patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with incorrect diluent, nurse used 0.9% normal saline instead of the provided diluent with no reported adverse event. The patient's past medical history included Splenectomy in 2025. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine polysacch (Meningococcal polysaccharide) for Immunisation. On 05-Aug-2025, the patient received 0.5ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (frequency once) Strength Standard, lot UK201AC and expiry date Apr-2026 via intramuscular route in the deltoid NOS (not otherwise specified) for immunization, which was reconstituted with incorrect diluent, nurse used 0.9% normal saline instead of the provided diluent with no reported ae (product preparation error) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853681 1 M DE 08/12/2025 HIBV
 SANOFI PASTEUR
 UK175AA
No adverse event, Product preparation error No adverse event, Product preparation error
medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water with no re... medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water with no reported adverse event; medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water and then administered to a patient with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old male patient who had medication error/an inappropriate use due to HIB (PRP/T) Vaccine [ACT-HIB] was reconstituted with sterile water and then administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 31-Jul-2025, the patient received a dose 4 with dosage 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK175AA, Expiry: 31-Oct-2025, Strength: Standard, Frequency: once) via intramuscular route in the Left Vastus Lateralis as Immunization which was reconstituted with sterile water instead of the diluent it came with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853682 11 F NJ 08/12/2025 TDAP
 SANOFI PASTEUR
 2CA56C1
Expired product administered Expired product administered
medication error/an inappropriate use due to administering an expired adacel with no reported advers... medication error/an inappropriate use due to administering an expired adacel with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who received an expired dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo) for Immunisation. On 07-Aug-2025, the patient received an expired 0.5ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength Standard, lot 2CA56C1 and expiry date 12-May-2025 via intramuscular route in right deltoid for immunization, with no reported adverse event (expired product administered) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
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