🏥 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 💀 🏥 🚑 ♿ ⚠️
2819032 4 M MI 01/02/2025 DTAP
IPV
MMR
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 3CA11C1
W1A101M
X028014
Y005921
Product preparation error; Product preparation error; Product preparation error;... Product preparation error; Product preparation error; Product preparation error; Product preparation error More
Clinical prepared MMR with the incorrect diluent designated for Hib, not MMR and administered Clinical prepared MMR with the incorrect diluent designated for Hib, not MMR and administered
2819033 2 F PA 01/02/2025 FLU3
 SANOFI PASTEUR
 U8523DA
Extra dose administered Extra dose administered
Patient had already received a flu vaccine for the season on 9/20/24. Flu was mistakenly administere... Patient had already received a flu vaccine for the season on 9/20/24. Flu was mistakenly administered again. More
2819034 1.08 M MI 01/02/2025 HIBV
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UJ995AA
LC5482
Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue
Hib may not have been administered, only the diluent Hib may not have been administered, only the diluent
2819035 1.25 F AZ 01/02/2025 COVID19
HEPA
HIBV
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 LN8272
5JA57
UK025AA
No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue More
The child may have only received diluent instead of HIB reconstituted with diluent. There were three... The child may have only received diluent instead of HIB reconstituted with diluent. There were three patients of which may have been affected. Two received appropriately prepared HIB vaccines and one received diluent. It is unclear which patient of the three received only diluent. No adverse reactions have occurred since the time of administration. The dose is planned to be repeated during the childs 18 month visit to ensure proper vaccination, and the child will be monitored for any reactions at that time. Parents have been notified and expressed understanding of the situation and have no further concerns. More
2819036 73 F AR 01/02/2025 FLU3
 SANOFI PASTEUR
 U8524DA
Cellulitis, Peripheral swelling Cellulitis, Peripheral swelling
PATIENT STATES THAT ARM SWELLED UP AND SHE WENT TO THE HOSPITAL AND THEY HAVE SINCE PRESCRIBED HER A... PATIENT STATES THAT ARM SWELLED UP AND SHE WENT TO THE HOSPITAL AND THEY HAVE SINCE PRESCRIBED HER ANTIBIOTICS FOR CELLULITIS. TODAY ON 1/2/2025 ARM DIDN'T LOOK SWOLLEN ANY MORE. PATIENT SAYS THIS HAS HAPPENED BEFORE WITH A PNEUMONIA SHOT GIVEN AT HER DOCTOR'S OFFICE. More
2819037 62 M MN 01/02/2025 COVID19
 MODERNA
 040A21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2819038 16 F TN 01/02/2025 HPV9
 MERCK & CO. INC.
 Y007322
Extra dose administered Extra dose administered
PATIENT DID NOT NEED THIRD DOSE RECEIVED DOSE 3/7/2018 / 8/26/2024 AND 11/15/2024 PATIENT DID NOT NEED THIRD DOSE RECEIVED DOSE 3/7/2018 / 8/26/2024 AND 11/15/2024
2819039 71 M MN 01/02/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2819040 72 F ME 01/02/2025 PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LJ5280
LJ5280
LJ5280
Injection site pain, Loss of personal independence in daily activities, Pain, Sl... Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder; Asthenia, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pain; Pain in extremity, Sleep disorder; Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder; Asthenia, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pain; Pain in extremity, Sleep disorder More
Ache in arm at injection site with radiation to left forearm, impacting ability to sleep and exercis... Ache in arm at injection site with radiation to left forearm, impacting ability to sleep and exercise, constant. 8 weeks of pain. More
2819041 12 F IL 01/02/2025 COVID19
 PFIZER\BIONTECH
 HD9835
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
This immunization event occurred after the specified maximum age for this vaccine This immunization event occurred after the specified maximum age for this vaccine
2819042 70 M OH 01/02/2025 RSV
 PFIZER\WYETH
 hy1811
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient was given two RSV (Abrysvo) shots. 1) first on 09/27/2023. 2) second on 10/16/2024. No adv... patient was given two RSV (Abrysvo) shots. 1) first on 09/27/2023. 2) second on 10/16/2024. No adverse events experienced. More
2819043 14 F IL 01/02/2025 COVID19
 PFIZER\BIONTECH
 HD9835
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
This immunization event occurred after the specified maximum age for this vaccine This immunization event occurred after the specified maximum age for this vaccine
2819044 66 M MN 01/02/2025 COVID19
 MODERNA
 027B21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2819045 62 F VT 01/02/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 AW1671A
AW1671A
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient scheduled a flu shot in the health center today. Patient was vaccinated in health center to... Patient scheduled a flu shot in the health center today. Patient was vaccinated in health center today 1/2/2025. After discharge, vaccine was documented in immunization registry and staff discovered patient received identical flu vaccine on 11/6/2024 from same lot at an off site flu clinic this fall. Patient was notified of repeat vaccine and stated " I forgot I had a flu shot". Patient had no adverse or side effect from original vaccine on 11/6/2024 and reports no adverse effect today. More
2819046 1.42 M OK 01/02/2025 HIBV
PNC20
 MERCK & CO. INC.
PFIZER\WYETH
 Y005366
HR3649
Abscess drainage, Abscess sterile, Culture tissue specimen negative, Injection s... Abscess drainage, Abscess sterile, Culture tissue specimen negative, Injection site reaction; Abscess drainage, Abscess sterile, Culture tissue specimen negative, Injection site reaction More
No reaction directly following vaccine injection but 6 weeks after vaccine was given pt developed a ... No reaction directly following vaccine injection but 6 weeks after vaccine was given pt developed a abcess on his left thigh in the location the vaccine was given. pt then had abcess drained and it came back sterile. pt is in healing process now. No abnormalities noted on right thigh at this time. pt has had abcesses in the past in both thighs and has been seen by infectious disease specialist but cause is still unknown. More
✓
2819047 60 M NY 01/02/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Anaphylactic reaction, Dyspnoea, Flushing, Nausea, Rash; Rash erythematous, Swol... Anaphylactic reaction, Dyspnoea, Flushing, Nausea, Rash; Rash erythematous, Swollen tongue, Urticaria More
1/1/2025 about 10:45 Anaphylaxis. I have NEVER had this in my life before. i did not have this wi... 1/1/2025 about 10:45 Anaphylaxis. I have NEVER had this in my life before. i did not have this with the 1st shot. Flushed face, swollen tongue, trouble breathing, red rash and hives over legs, groin, stomach, upper back and neck, nausea, More
2819048 0.5 M MO 01/02/2025 DTAPHEPBIP
HIBV
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 77J49
x009000
X026480
Injection site nodule; Injection site nodule; Injection site nodule Injection site nodule; Injection site nodule; Injection site nodule
Patient with nontender, non erythematous firm nodule at site of injection site on bilateral thighs. Patient with nontender, non erythematous firm nodule at site of injection site on bilateral thighs.
2819049 4 M LA 01/02/2025 DTAPIPV
MMRV
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.


Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
I accidentally gave the MMRV and the varivax instead of the MMR. I just picked up the wrong one and ... I accidentally gave the MMRV and the varivax instead of the MMR. I just picked up the wrong one and even though I check my meds twice-I never saw the V on the end of it. Child had no adverse events and is fine per mothers statement. More
2819050 7 M TX 01/02/2025 COVID19
FLU3
HEP
MMRV
TDAP
 PFIZER\BIONTECH
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
 LM2045
UT8485KA
XO27728
Y013575
U8231AA
Vaccination site erythema, Vaccination site pain; Vaccination site erythema, Vac... Vaccination site erythema, Vaccination site pain; Vaccination site erythema, Vaccination site pain; Vaccination site erythema, Vaccination site pain; Vaccination site erythema, Vaccination site pain; Vaccination site erythema, Vaccination site pain More
REDDNESS TO AREA OF VACCINAE SITE, TENDER TO TOUCH, REDDNESS TO AREA OF VACCINAE SITE, TENDER TO TOUCH,
2819051 16 F AR 01/02/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 X025115
U8194AA
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient given Menquadfi as above at 1310 which was 3rd dose of meningoccal and should not have been ... Patient given Menquadfi as above at 1310 which was 3rd dose of meningoccal and should not have been administered. It was dicsovered after given. Immunization Program nurse notified by Nursing Supervisor that 3rd dose of meningoccal given after second given in 6/2024. Received word from DH Vaccine Program nurse that patient should not have negative outcome from extra dose but Dr would also be notified. Patient did not exhibit any adverse side effects while in clinic around 30-35 minutes when she left at 1345. Mom aware of extra dose as well as she was out in car when vaccine administered. More
2819052 0.58 M OR 01/02/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3044211
UT8488LA
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient was scheduled to receive the flu vaccine, but the COVID vaccine was administered by mistake.... Patient was scheduled to receive the flu vaccine, but the COVID vaccine was administered by mistake. The flu vaccine was administered after. Patient did not have any adverse reaction to the COVID vaccine. They were eligible to receive that vaccine and were given the correct dose, it was simply against their wishes to receive it. More
2819053 1.25 M VT 01/02/2025 HEPA
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 5JA57
UK025AA
No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More
The child may have only received diluent instead of HIB reconstituted with diluent. There were three... The child may have only received diluent instead of HIB reconstituted with diluent. There were three patients of which may have been affected. Two received appropriately prepared HIB vaccines and one received diluent. It is unclear which patient of the three received only diluent. No adverse reactions have occurred since the time of administration. The dose is planned to be repeated during the child's 18 month visit to ensure proper vaccination, and the child will be monitored for any reactions at that time. Parents have been notified and expressed understanding of the situation and have no further concerns. More
2819054 75 M OR 01/02/2025 COVID19
VARZOS
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3044091
MS245
Underdose; Underdose Underdose; Underdose
75 yo patient received Moderna vaccine for pediatric dose, not adult dose. Have scheduled to receive... 75 yo patient received Moderna vaccine for pediatric dose, not adult dose. Have scheduled to receive correct dosing for 01/20/2025. More
2819055 5 M CO 01/02/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8009AB
Y014436
Product administered at inappropriate site; Product administered at inappropriat... Product administered at inappropriate site; Product administered at inappropriate site More
Pt came into clinic for wcc, was given vaccine at end of visit, MMRV and quadracel. Both vaccines we... Pt came into clinic for wcc, was given vaccine at end of visit, MMRV and quadracel. Both vaccines were given in the left arm, quadracel was given IM and mmrv was given slightly below, SC. Patient aslo did have pretzels in clinic prior to leaving and receiving vaccines. Prior to today's vaccines, pt had received mmr and var in seperate vaccines. More
2819056 72 F NC 01/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Dyspnoea, Fall, Intensive care, Neuralgia, Thrombectomy; Thrombosis, Troponin in... Dyspnoea, Fall, Intensive care, Neuralgia, Thrombectomy; Thrombosis, Troponin increased More
WOKE UP WENT OUT TO PLACE WHERE EXCERCISE HOLDING ONTO CHAIR WHERE I DO LEG DIDN'T EVEN START T... WOKE UP WENT OUT TO PLACE WHERE EXCERCISE HOLDING ONTO CHAIR WHERE I DO LEG DIDN'T EVEN START THEM SAID 'YOU NEED TO COME NOW' SAW ME 'SOFT FALL' DON'T REMEMBER THE FALL BUT "I WAS ON THE FLOOR GASPING FOR AIR" . CALLED 911 THEY DIRECTED HIM TO GIVE HIM AN ASPIRIN (325 MG) , SX: NON THAT I WAS AWARE OF ON 10/25 TAKEN BY AMBULANCE {TO HOSPITAL] ADMITTED TO ICU MET WITH CARDIAC TEAM. NEVER LOST CONSCIOUSNESS, TROPONIN WAS WAY OFF THE CHARTS, HAD A "WINDOW OF TIME" THAT WAS EXPLAINED. MADE DECISION TO HAVE [BLOOD CLOT REMAOVED] . I HAD ... CATHETERIZATION, THEY WENT UP THROUGH THE GROIN . OUTCOME WAS THAT I WAS 2 DAYS IN THE ICU THEN WENT TO POST OP [AFTER THAT] 2 DAYS POST OP, CAME HOME ON THE 29TH . PER HUSBAND, SAID THEY GOT "95-98% OF [THE CLOT]" . SUBSEQUENTLY HAD "LITTLE PINGS" FROM PARTS OF THE CLOT "HITTING THE NERVES" . MD PLANS FOLLOW UP ON 2/8 FOR VASCULAR. IN DISCUSSION, MD ASKED "WHAT HAD I BEEN DOING" ; PATIENT EXPLAINED "I HAD THE COVID VACCINE ON WEDNESDAY" AT WHICH TIME MD'S "EYES WENT UP". PATIENT WAS ADVISED NOT TO TAKE ANY MORE VACCINES. More
✓
2819057 43 M OR 01/02/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8081260
UT8488LA
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient was scheduled to receive the flu vaccine, but the COVID vaccine was administered by mistake.... Patient was scheduled to receive the flu vaccine, but the COVID vaccine was administered by mistake. The flu vaccine was administered after. Patient did not have any adverse reaction to the COVID vaccine. They were eligible to receive that vaccine and were given the correct dose, it was simply against their wishes to receive it. More
2819058 80 F OR 01/02/2025 COVID19
 MODERNA
 3044091
Underdose Underdose
80 yo patient received Moderna vaccine for pediatric dose, not adult dose. Have scheduled to receive... 80 yo patient received Moderna vaccine for pediatric dose, not adult dose. Have scheduled to receive correct dosing for 01/20/2025. More
2819059 6 M OR 01/02/2025 COVID19
 PFIZER\BIONTECH
 LN8272
No adverse event, Underdose No adverse event, Underdose
Pt did not have any adverse effects, I by mistake gave patient a smaller dose then was needed (6 mon... Pt did not have any adverse effects, I by mistake gave patient a smaller dose then was needed (6 months- 4 years) and pt is 6. I informed the mother of pt and my supervisor, I will be filling out an incident report and calling mother of child to schedule them for a correct dose 28 days from today. More
2819060 1.5 F ME 01/02/2025 FLU3
 SANOFI PASTEUR
 UT8485NA
Extra dose administered Extra dose administered
Patient received a Flu Vaccine already this season, and received an extra dose. Patient received a Flu Vaccine already this season, and received an extra dose.
2819061 61 F WA 01/02/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4S5YG
4S5YG
Dyspnoea, Erythema, Paraesthesia, Pruritus, Swelling face; Tongue pruritus Dyspnoea, Erythema, Paraesthesia, Pruritus, Swelling face; Tongue pruritus
Patient called clinic approximately 15-20 minutes after receiving vaccination, reporting significant... Patient called clinic approximately 15-20 minutes after receiving vaccination, reporting significant full body itching, hand erythema, and itching on tongue. At time of call with RN did not have further symptoms. Was advised to take PO benadryl immediately, monitor for worsening symptoms and if so call 911. Later received update that patient reported shortness of breath, facial swelling, and tingling, but airway intact. 50mg IV benadryl given by EMS prior to arrival to local ER. Currently in ER for monitoring. More
2819062 11 F MA 01/02/2025 COVID19
 PFIZER\BIONTECH
 LP2219
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
12+ dose given instead of 5-11 year dose 12+ dose given instead of 5-11 year dose
2819063 46 F MI 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 XD7Y2
Product preparation issue Product preparation issue
Zoster (Shingles) Administering Vaccines The medical assistant inadvertently administered a 0.5 mL... Zoster (Shingles) Administering Vaccines The medical assistant inadvertently administered a 0.5 mL dose of the Shingrix diluent only. The dose did not contain any antigen powder. The pt and provider and Health department were notified and all recommended that the pt be revaccinated 4 weeks after the invalid dose. pt agreed and future revaccination appt was made. More
2819064 81 F NM 01/02/2025 PNC20
 PFIZER\WYETH
 LG5577
Myalgia, Pain Myalgia, Pain
A few days after receiving the vaccine the patient reported that she experienced an intense muscle p... A few days after receiving the vaccine the patient reported that she experienced an intense muscle pain in her left arm that hasn't gone away instead, intensified whenever she moves her arm. More
2819065 74 M MI 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 XD7Y2
Product preparation issue Product preparation issue
Zoster (Shingles) Administering Vaccines The medical assistant inadvertently administered a 0.5 mL... Zoster (Shingles) Administering Vaccines The medical assistant inadvertently administered a 0.5 mL dose of the Shingrix diluent only. The dose did not contain any antigen powder. The pt and provider and Health department were notified and all recommended that the pt be revaccinated 4 weeks after the invalid dose. pt agreed and future revaccination appt was made. More
2819066 35 F TX 01/02/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event No adverse event
no reaction noted no reaction noted
2819094 U PA 01/02/2025 MMRV
 MERCK & CO. INC.
 Y011214
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE; inadvertently administering a dose of PROQUAD to an adult patient; This spontaneou... No additional AE; inadvertently administering a dose of PROQUAD to an adult patient; This spontaneous report was received from an Other Health Professional and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-DEC-2024, the adult patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (lot #Y011214, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 18-DEC-2025; strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age). It stated the patient had not experienced any symptoms. There was no additional adverse event (AE) or product quality complaint (PQC) was reported, and no additional information was provided. More
2819095 U KS 01/02/2025 PPV
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported. No additional AE/PQC.; an expired product was administered. The product is PN... No symptoms reported. No additional AE/PQC.; an expired product was administered. The product is PNEUMOVAX 23.; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 16-DEC-2024, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection administered for prophylaxis (strength, dose, vaccination scheme, lot#, expiration date, anatomical location and route of administration were not provided) (Expired product administered). No symptoms reported. No additional adverse event was reported. Lot # is being requested and will be submitted if received. More
2819096 14 F NY 01/02/2025 HPV9
 MERCK & CO. INC.
Injection site mass, Injection site pain Injection site mass, Injection site pain
painful lump at injection site that developed 5 weeks after injection; painful lump at injection sit... painful lump at injection site that developed 5 weeks after injection; painful lump at injection site that developed 5 weeks after injection; This spontaneous report was received from a nurse and refers to a 14-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-NOV-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date in December 2024 (also reported as 5 weeks after injection- discrepancy), the patient experienced painful lump at injection site. At the time of reporting, the outcome of the events was not known. The action taken with suspect vaccine was not applicable. The causal relationship between events and suspect vaccine was not provided. Lot # is being requested and will be submitted if received. More
2819097 2 M TX 01/02/2025 HEPA
 MERCK & CO. INC.
 X017317
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported / No additional AE details provided / The patient is fine and is not havin... No additional AE reported / No additional AE details provided / The patient is fine and is not having any problems; a 2 year old male patient was inadvertently given a Vaqta vaccine on 24Dec2024 thad had expired on 13Dec2024; This spontaneous report has been received from a healthcare worker, referring to a 2-year-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided. On 24-DEC-2024, the patient was inadvertently vaccinated with expired hepatitis A vaccine, inactivated (VAQTA), lot# X017317, expiry date 13-DEC-2024, for prophylaxis (dose, route of administration and anatomical location were not provided) (expired product administered). The patient was fine and did not have any problems. No additional adverse events were reported (no adverse event). More
2819098 17 U 01/02/2025 HEP
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; Hepatitis B vaccine that expired on 14-DEC-2024 and the patient got it on 23-DEC-2... No adverse event; Hepatitis B vaccine that expired on 14-DEC-2024 and the patient got it on 23-DEC-2024; This spontaneous report was received from a registered nurse referring to a 17-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications. On 23-DEC-2024, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, that expired on 14-DEC-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided). There was no adverse event. More
2819099 30 M 01/02/2025 RAB
RAB
RAB
RAB
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Alanine aminotransferase increased, Aspartate aminotransferase increased, Bile d... Alanine aminotransferase increased, Aspartate aminotransferase increased, Bile duct stenosis, Bile duct stent insertion, Bile duct stent removal; Biliary tract dilation procedure, Bilirubin conjugated increased, Biopsy bile duct normal, Biopsy liver abnormal, Blood bilirubin increased; Endoscopic retrograde cholangiopancreatography abnormal, Endoscopic ultrasound abnormal, Fatigue, Hepatitis cholestatic, Jaundice; Laboratory test normal, Lymphadenopathy, Magnetic resonance cholangiopancreatography, Magnetic resonance imaging abnormal, Rash More
biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination seri... biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination series; cholestatic hepatitis; rash; fatigue; jaundice; reactive periportal lymphadenopathy following rabies vaccination series; Introduction: Biliary strictures can be a challenging diagnosis. Work-up includes basic lab work, abdominal imaging, and even invasive procedures such as endoscopic retrograde cholangiopancreatography (ERCP). Although up to 30% of strictures are benign, the majority are malignant in the form of pancreatic adenocarcinoma and cholangiocarcinoma. As a result, a multidisciplinary approach is vital to differentiate between the 2. Case Description/Methods: A 30-year-old man with no past medical history presented with a rash, fatigue, and jaundice for 1 week. Of note, the patient was exposed to a bat in his home that had tested positive for rabies. He had subsequently completed the 3 vaccine series 5 days prior to arrival. Denied alcohol use, drug use, recent travel, new medications/supplements, or high-risk sexual behavior. On arrival, aspartate aminotransferase 165, alanine transaminase 372, total bilirubin 9.2, and direct bilirubin 6.6. Serological and infectious work-up unrevealing. Magnetic resonance cholangiopancreatography showed focal narrowing of common hepatic duct. ERCP/endoscopic ultrasound showed reactive periportal lymphadenopathy causing compression of common hepatic duct. The stricture was dilated and the patient received 2 biliary stents in left and right hepatic duct. Subsequent liver biopsy consistent with cholestatic hepatitis. Surgical pathology following stent removal negative for malignancy. Liver function tests normalized on outpatient follow-up. Discussion: The exact incidence of biliary strictures is unknown. In individuals with accompanying obstructive jaundice, the stricture should be considered malignant unless proven otherwise. Common etiologies of benign biliary strictures include iatrogenic (post-procedure), chronic pancreatitis, and primary sclerosing cholangitis. Rarely in the literature is reactive lymphadenopathy a cause of obstruction. This case highlights the importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis. Initial information received on 30-Dec-2024 via Other Health Care Professional regarding an unsolicited valid serious case issued from a literature article: This case involves a 30-year-old male patient who experienced reactive periportal lymphadenopathy, biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination series (bile duct stenosis) and cholestatic hepatitis while receiving vaccine Rabies Vaccine (Latency: unknown). The patient's past medical treatment(s), vaccination(s) and family history were not provided. Patient with no past medical history. On an unknown date, the patient was exposed to a bat in his home that had tested positive for rabies. He had subsequently completed the 3-vaccine series of Rabies Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site 5 days prior to arrival. Denied alcohol use, drug use, recent travel, new medications/supplements, or high-risk sexual behavior. On an unknown date, the patient presented with a rash, fatigue, and jaundice for 1 week. On arrival, aspartate aminotransferase 165, alanine transaminase 372, total bilirubin 9.2, and direct bilirubin 6.6. Serological and infectious work-up unrevealing. Magnetic resonance cholangiopancreatography showed focal narrowing of common hepatic duct. ERCP/endoscopic ultrasound showed reactive periportal lymphadenopathy (lymphadenopathy) causing compression of common hepatic duct. The stricture was dilated and the patient received 2 biliary stents in left and right hepatic duct. Subsequent liver biopsy consistent with cholestatic hepatitis (hepatitis cholestatic). Surgical pathology following stent removal negative for malignancy. Liver function tests normalized on outpatient follow-up. Author stated that: Biliary strictures can be a challenging diagnosis. Work-up includes basic lab work, abdominal imaging, and even invasive procedures such as endoscopic retrograde cholangiopancreatography (ERCP). Although up to 30% of strictures are benign, the majority are malignant in the form of pancreatic adenocarcinoma and cholangiocarcinoma. As a result, a multidisciplinary approach is vital to differentiate between the 2. The exact incidence of biliary strictures is unknown. In individuals with accompanying obstructive jaundice, the stricture should be considered malignant unless proven otherwise. Common etiologies of benign biliary strictures include iatrogenic (post-procedure), chronic pancreatitis, and primary sclerosing cholangitis. Rarely in the literature is reactive lymphadenopathy a cause of obstruction. This case highlights the importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis. Seriousness criteria: medically significant for events cholestatic hepatitis and biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination series and non-serious for reactive periportal lymphadenopathy. Action taken: not applicable Corrective treatment: stricture was dilated and the patient received 2 biliary stents in left and right hepatic duct for biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination series; not reported for the events (reactive periportal lymphadenopathy following rabies vaccination series, cholestatic hepatitis). Outcome: Recovering / Resolving for the events Reporter's causality: Related; Sender's Comments: Sanofi company comment on dated 01-JAN-2025: This case involves a 30-year-old male patient who experienced reactive periportal lymphadenopathy, biliary stricture secondary to reactive periportal lymphadenopathy following rabies vaccination series (bile duct stenosis) and cholestatic hepatitis while receiving vaccine Rabies Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely. More
2819100 0.17 M NJ 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure via breast milk, Foetal exposure during pregnancy Exposure via breast milk, Foetal exposure during pregnancy
The patient is breastfeeding the infant; This non-serious case was reported by a consumer via call c... The patient is breastfeeding the infant; This non-serious case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a male infant exposed to Herpes zoster (Shingrix) in utero. The mother received the product for prophylaxis. On 03-DEC-2024, the mother received Shingrix. The infant was diagnosed with vaccine exposure via breast milk (Verbatim: The patient is breastfeeding the infant). The outcome of the vaccine exposure via breast milk was unknown. Pregnancy exposure: Pregnancy Exposure (Shingrix): To mother while nursing See case US2024AMR152842 for details regarding the mother case. Additional Information: GSK Receipt Date: 03-DEC-2024 and 04-DEC-2024 The reporter reported that she was erroneously given Shingrix by her pharmacy, instead of flu vaccine. The was currently breastfeeding. The reporter reported that it was not clarified if the infant was breast fed after receiving Shingrix.; Sender's Comments: US-GSK-US2024AMR152842:Mother case More
2819101 F CA 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Discomfort, Injection site inflammation, Injection site pain, Injection site war... Discomfort, Injection site inflammation, Injection site pain, Injection site warmth More
she felt the medication being injected into her arm because of how she felt the pain of the medicine... she felt the medication being injected into her arm because of how she felt the pain of the medicine going in/injection site soreness; Injection site inflammation; Injection site hot; she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow; she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow; Uncomfortable; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: she felt the medication being injected into her arm because of how she felt the pain of the medicine going in/injection site soreness), injection site inflammation (Verbatim: Injection site inflammation), injection site warmth (Verbatim: Injection site hot), joint inflammation (Verbatim: she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow), pain in elbow (Verbatim: she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow) and discomfort (Verbatim: Uncomfortable). The outcome of the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort were unknown. It was unknown if the reporter considered the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site inflammation, injection site warmth, joint inflammation, pain in elbow and discomfort to be related to Shingrix. Linked case(s) involving the same patient:US2024152156 Additional Information: GSK Receipt Date: 03-DEC-2024 Pharmacist reported that a patient Shingrix who received the vaccine reported that she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow. It's hot, it's not impeding her daily living but it's just uncomfortable. On her 1st dose, she knew that she got it, she felt the medication being injected into her arm because of how she felt (felt the pain of the medicine going in). The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2024152156.; Sender's Comments: US-GSK-US2024152156:same reporter More
2819102 U UT 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
We have a patient who got a shingrix vaccination years ago; This non-serious case was reported by a ... We have a patient who got a shingrix vaccination years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (got a Shingrix vaccination years ago). 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 incomplete course of vaccination (Verbatim: We have a patient who got a shingrix vaccination years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 05-DEC-2024 The reporter reported that they had a patient who got a Shingrix vaccination years ago. It was just the first shot of the two shot series. They were wondering if they should just got the second shot to complete the series or if they should start the series over by doing both shots again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2819104 F 01/02/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; shingles 2 to 3 times a year; This serious case was reported by a con... Suspected vaccination failure; shingles 2 to 3 times a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 2 to 3 times a year). The patient was treated with lysine. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that there was homeopathy for this. Reporter's ex who took the shot now gets shingles 2 to 3 times year. Nothing doctors gave to stop the pain. She used homeopathic remedies and Lysine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2819105 F CA 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Feeling hot, Injection site pain Erythema, Feeling hot, Injection site pain
patient experienced soreness at the injection site; About 3-4 days later, the injected arm (Left) be... patient experienced soreness at the injection site; About 3-4 days later, the injected arm (Left) became red; Arm hotness; The patient feels that she did not get the full dose of the vaccine; The patient feels that the pharmacist who was injecting the vaccine, pulled the needle out too soon; perhaps the pharmacist went under the skin and not into the muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, for tolerance of1 st dose of Shingrix, refer case US2024152154). 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 injection site pain (Verbatim: patient experienced soreness at the injection site), erythema of extremities (Verbatim: About 3-4 days later, the injected arm (Left) became red), extremities hot feeling of (Verbatim: Arm hotness), underdose (Verbatim: The patient feels that she did not get the full dose of the vaccine), wrong technique in product usage process (Verbatim: The patient feels that the pharmacist who was injecting the vaccine, pulled the needle out too soon) and product administered at inappropriate site (Verbatim: perhaps the pharmacist went under the skin and not into the muscle). The outcome of the injection site pain, erythema of extremities, extremities hot feeling of, underdose, wrong technique in product usage process and product administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain, erythema of extremities and extremities hot feeling of to be related to Shingrix. It was unknown if the company considered the injection site pain, erythema of extremities and extremities hot feeling of to be related to Shingrix. Linked case(s) involving the same patient:US2024152154 Additional Information: GSK Receipt Date: 03-DEC-2024 The reporter is a friend of the patient. The reporter did not wish to provide date of birth, or the initials of the patient. The reporter stated that the patient received both doses of Shingrix, the second dose being with in the recommended time frame of the first (2-6 months). After the second dose, the patient experienced soreness at the injection site. About 3-4 days later, the injected arm (Left) became red, and the redness proceeded down the whole left arm. The arm is red and hot. The patient felt that she did not get the full dose of the vaccine (AE - Underdose), because she did not feel the medication going in (like she did with the first dose). The patient felt that the pharmacist who was injecting the vaccine, pulled the needle out too soon and perhaps the pharmacist went under the skin and not into the muscle, which led to underdose, wrong technique in product usage process and product administered at inappropriate site.; Sender's Comments: US-GSK-US2024152154:Original Case : US2024152154 More
2819106 18 M PR 01/02/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB0308
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
received 2 doses and by error 3rd dose of Menveo; received 2 doses and by error 3rd dose of Menveo; ... received 2 doses and by error 3rd dose of Menveo; received 2 doses and by error 3rd dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB0308, expiry date 30-APR-2025) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 02-DEC-2024, the patient received the 3rd dose of Menveo. On 23-OCT-2023, the patient received the 2nd dose of Menveo. On 23-OCT-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: received 2 doses and by error 3rd dose of Menveo). On 02-DEC-2024, the patient experienced extra dose administered (Verbatim: received 2 doses and by error 3rd dose of Menveo). The outcome of the extra dose administered and extra dose administered were unknown. Additional Information: GSK Receipt Date: 03-DEC-2024 The Healthcare professional reported that an 18 year old patient received 2 doses of Menveo last year, for the first dose they did not know date of administration and second dose was given on 23rd October 2023. Additionally, they received another Menveo vaccine this year by error on 2nd December 2024, which led to extra dose administered. Lot number and expiration dates of the 2 prior doses were unknown by caller since they were administered at another facility. More
2819107 F CA 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Malaise Fatigue, Malaise
tiredness/ fatigue; malaise; This non-serious case was reported by a consumer via call center repres... tiredness/ fatigue; malaise; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: tiredness/ fatigue) and malaise (Verbatim: malaise). The outcome of the tiredness and malaise were unknown. It was unknown if the reporter considered the tiredness and malaise to be related to Shingrix. It was unknown if the company considered the tiredness and malaise to be related to Shingrix. Linked case(s) involving the same patient: US2024AMR165825 Additional Information: GSK Receipt Date: 03-DEC-2024 The reporter was a friend of the patient. The reporter did not wish to provide date of birth, or the initials of the patient. The reporter stated that the patient received both doses of Shingrix. After the first dose of shingrix, the patient experienced tiredness, malaise and fatigue. The reporter did not provide consent to follow-up. For tolerance to 2nd dose, refer case US2024AMR165825.; Sender's Comments: US-GSK-US2024AMR165825:2nd dose case More
2819108 F CA 01/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site discomfort, Injection site inflammation, Injection site pain, Inj... Injection site discomfort, Injection site inflammation, Injection site pain, Injection site warmth More
elbow inflamation; Underdose; This non-serious case was reported by a pharmacist via call center rep... elbow inflamation; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 26-NOV-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: elbow inflamation) and underdose (Verbatim: Underdose). The outcome of the wrong technique in drug usage process and underdose were unknown. Linked case(s) involving the same patient: US2024152154, US2024AMR154060 Additional Information: GSK Receipt Date: 03-DEC-2024 The pharmacist stated a patient who received the Shingrix vaccine reported that on her 2nd dose, she had some inflammation and soreness at the injection site. After 4 days, it kind of spread down to her elbow. It was hot, it was not impeding her daily living, but it was just uncomfortable. The pharmacist went on to state that the patient feels in comparison to her first dose that she did not get the full vaccine, she only got a partial dose. On her 1st dose, she knew she got it, she felt the medication being injected into her arm because of how she felt the pain of the medicine going in. The patient did not felt that way the 2nd time around, she felt that she barely received it because she felt like the pharmacist who gave her the immunization did not even give her the full dose, she did not felt the pain at all. As soon as the needle went in, she felt like 2 seconds later, it came back out which led to wrong technique in drug usage process. The patient did not felt leakage or anything like that, the pharmacist just pulled the needle out like very fast. The patient also did not had the date of the first dose, but the 2nd was administered, which was within the 2 to 6 month time frame. More
2819109 U VA 01/02/2025 DTAP
DTAPHEPBIP
DTAPIPV
HIBV
MENB
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS






Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Improper Storage Error; This non-serious case was reported by a nurse via call center representative... Improper Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and Hib (Hiberix) for prophylaxis. On an unknown date, the unspecified number of patients received Bexsero, Menveo, Kinrix, Pediarix, Boostrix, Infanrix and Hiberix. On an unknown date, an unknown time after receiving Bexsero, Menveo, Kinrix, Pediarix, Boostrix, Infanrix and Hiberix, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was unknown. 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: 03-DEC-2024 Nurse reported that requests to stability data for Bexsero, Menveo (1-vial), Kinrix, Pediarix, Boostrix, Infanrix, Hiberix stored at 1 Celsius for 3 hours 33 minutes ,which led to incorrect storage of drug. No prior excursions. No signs of freezing/slushing. Excursion happened on 19th November 2024, potential patient use of vaccines. No signs of freezing/slushing. Excursion happened on 19NOV2024, potential patient use of vaccines. The reporter was consented to follow up. More
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