πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2830136 16 M TX 03/07/2025 HEPA
IPV
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 DN273
X1C891M
48367AA
U8252AA
Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli; Pallor, Unresp... Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli; Pallor, Unresponsive to stimuli More
Pt. arrived at Clinic to receive immunizations for school. He was given 3 vaccines in his left delto... Pt. arrived at Clinic to receive immunizations for school. He was given 3 vaccines in his left deltoid one inch apart (Tdap,MCV4,Polio). He was given Hep A IM in the right deltoid and upon administering the vaccine he had a reaction. His parent was at his side as we tried to arouse him. Patient started turning pale, his head turn to the right side with feet extended. Help was called and Providers came to assist and started talking with patient. I. started talking with parents. Vitals were taken on patient with first set @10:25am BP-115/66 HR-85, O2Sats 96% T-97.7 R-20. Patient started responding to verbal command with color to skin. At 14:27 BP-118/69,P-64, O2sats @100% R-22. Patient transported into jeri chair with assistance. Given some water and a sugar snack. No problems with swallowing. Parents at patient side. Patient communicating and alert @1445 BP-110/71, P-68, O2sats @100%. Mother refused Ambulance service. Unable to finish immunizations on this visit and parent advised to take patient to pediatrician for other immunizations. Mother verbalized understanding. Pt. alert and talking. Monitored for another 45 minutes until end of visit. Pt. ambulated with a steady gait out the clinic. More
2830137 27 F AZ 03/07/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 B0011
UT8468LA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient inadvertently vaccinated with duplicate Fluzone and Moderna vaccines. Patient inadvertently vaccinated with duplicate Fluzone and Moderna vaccines.
2830138 0.08 F MI 03/07/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 EK7DG
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Mother was notified Mother was notified
2830139 18 F OH 03/07/2025 HEPA
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012054
Y007991
Dizziness; Dizziness Dizziness; Dizziness
PATIENT GOT DIZZY AND LIGHT HEADED PATIENT GOT DIZZY AND LIGHT HEADED
2830140 71 F NJ 03/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Abdominal discomfort, Chills, Fatigue, Headache, Myalgia; Pyrexia, Respiratory t... Abdominal discomfort, Chills, Fatigue, Headache, Myalgia; Pyrexia, Respiratory tract congestion More
pt says she developed a fever after getting the vaccine. Next day she started feeling worse. She had... pt says she developed a fever after getting the vaccine. Next day she started feeling worse. She had headache, shivering, congestion, upset stomach, fatigue, muscle pain, and her fever was 101.9. She took day time and night time Nyquil for her symptoms. She continues to have all of these symptoms after seven days but is feeling a little better. Fever still comes and goes. The pain from the shot in the arm lasted about 2 days. She contacted the nurse with her insurance and was told to follow up with doctor or go to an urgent care. She will contact her pharmacy and PCP if needed. More
2830141 4 F VA 03/07/2025 COVID19
 MODERNA
 3043032
Salivary hypersecretion, Trismus Salivary hypersecretion, Trismus
After 3 mins of vaccine application pt. started with uncontrolled movements of lower jar and increas... After 3 mins of vaccine application pt. started with uncontrolled movements of lower jar and increased saliva production. No loss of conscious. No sounds. No other movements. VS in normal limit. Except HR 142. After 30 minutes Pt. is stable. Given instruction to mother to go to PMD if any other changes. More
2830142 71 F CA 03/07/2025 COVID19
 MODERNA
 801260
Injection site reaction Injection site reaction
Patient presented with loss or displacement of Adipose tissue on right arm approximately 3 inches be... Patient presented with loss or displacement of Adipose tissue on right arm approximately 3 inches below injection site. Occurrence within same day as injection on same arm. Displacement not found on opposite arm which appears normal. More
2830143 3 M 03/07/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Kinrix was administered before his 4th birthday due to miscalculation of age. No adverse effects wer... Kinrix was administered before his 4th birthday due to miscalculation of age. No adverse effects were noted. More
2830144 49 M GA 03/07/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LJ5283
L5229
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient was given Prevnar-20 for a second (duplicate) time. The previous PCV-20 was on 5/3/2022. The... Patient was given Prevnar-20 for a second (duplicate) time. The previous PCV-20 was on 5/3/2022. The database did not specify which PCV was administered, and it has the words "Not Valid" next to the shot, leading the pharmacist to believe the patient had not received the vaccine. The patient experienced zero ADRs and has no complaints. More
2830145 62 F IN 03/07/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.



Abdominal discomfort, Dizziness, Erythema, Headache, Pain in extremity; Skin war... Abdominal discomfort, Dizziness, Erythema, Headache, Pain in extremity; Skin warm; Abdominal discomfort, Dizziness, Erythema, Headache, Pain in extremity; Skin warm More
When i woke up i was feeling sore my arm was feeling sore, kinda warm. Once i got up i looked at it,... When i woke up i was feeling sore my arm was feeling sore, kinda warm. Once i got up i looked at it, it was kinda red, I was feeling dizzy and my stomach was kinda icky and i had a slight headache. ( Unclear which type o the vaccines i got ) More
2830146 29 F KY 03/07/2025 RSV
 PFIZER\WYETH
Breech presentation, Caesarean section, Exposure during pregnancy, Premature lab... Breech presentation, Caesarean section, Exposure during pregnancy, Premature labour More
I went into preterm labor about a week after receiving the vaccine. Baby was breached and I had to r... I went into preterm labor about a week after receiving the vaccine. Baby was breached and I had to receive a C-section to deliver the baby. The baby weighed 7lbs 13.2 oz and spent almost two weeks in the Nicu. My due date was January 25. More
βœ“
2830147 0.33 M OH 03/07/2025 FLU3
 SANOFI PASTEUR
 UT8434LA
Crying, Infant irritability, Injection site erythema, Injection site pain, Produ... Crying, Infant irritability, Injection site erythema, Injection site pain, Product administered to patient of inappropriate age More
Patient received influenza vaccine at 4 months of age rather than at 6 months of age, so vaccine was... Patient received influenza vaccine at 4 months of age rather than at 6 months of age, so vaccine was given 2 months too early. Nursing staff spoke with patient's father. Per patient's father, patient had redness and pain at injection site and was cranky/crying more than usual following vaccination. Patient's father reported no other concerns, and patient did not receive any medical treatment. Patient's father also reports that patient is now back to normal. More
2830148 69 M AZ 03/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 mc7hk
Arrhythmia, Chest pain Arrhythmia, Chest pain
chest pain and arrhythmia-like symptoms were reported. Patient reported that they began to feel bett... chest pain and arrhythmia-like symptoms were reported. Patient reported that they began to feel better on the day they reported to the pharmacy, Patient was recommended to take benadryl for any other allergy-like symptoms and told to continue monitoring for exacerbations. More
2830150 15 F GA 03/07/2025 HEPA
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 DN273
U8351CA
Dizziness, Fall, Hypotension, Seizure like phenomena, Syncope; Dizziness, Fall, ... Dizziness, Fall, Hypotension, Seizure like phenomena, Syncope; Dizziness, Fall, Hypotension, Seizure like phenomena, Syncope More
Pt received a hepatitis A and a meningococcal vaccine in the left deltoid at 1:30pm. Approximately 3... Pt received a hepatitis A and a meningococcal vaccine in the left deltoid at 1:30pm. Approximately 30 seconds after administration, she stated "I feel dizzy" and fell over into the chair beside her. Pt experienced a syncopal episode with some convulsion-like behavior. She came to within 30 seconds and was alert and oriented to person, place, and time. Pt had a second episode of similar behavior (syncope/ convulsion) a few seconds after the first. She came to within about 30 seconds. Vital signs showed pt as hypotensive (70's/40's), normal hr, and O2 sats mid to upper 90's. Pt reports she had not eaten anything that day prior to the vaccine. Pt's mom reports that she has experienced a similar episode before during a venipuncture procedure but it "wasn't as bad as this." More
2830151 37 F FL 03/07/2025 COVID19
 PFIZER\BIONTECH
 lp1776
Impaired driving ability, Sluggishness Impaired driving ability, Sluggishness
after administered vaccine, patient said she felt sluggish and scared to drive. patient waited at ... after administered vaccine, patient said she felt sluggish and scared to drive. patient waited at lobby 1 hour still feels same . she wants to report to about the vaccine. now patient said feels better More
2830152 16 F IL 03/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 7KZ9R
Delivery, Exposure during pregnancy, High risk pregnancy, No adverse event Delivery, Exposure during pregnancy, High risk pregnancy, No adverse event
Patient did not exhibit an adverse affect 15 post administration. Patient was a high risk teen preg... Patient did not exhibit an adverse affect 15 post administration. Patient was a high risk teen pregnancy in 2nd Trimister. Patient delivered 11.XX.2024 More
2830153 12 F MA 03/07/2025 HPV9
 MERCK & CO. INC.
No adverse event No adverse event
Patient was VFC eligible and received a private dose of HPV vaccine instead of a state-supplied dose... Patient was VFC eligible and received a private dose of HPV vaccine instead of a state-supplied dose. No adverse reaction. More
2830154 81 F IL 03/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 gx3t4
Injected limb mobility decreased, Pain in extremity Injected limb mobility decreased, Pain in extremity
Patient called to state she received all her shots this day in the same arm (5 total) and afterwards... Patient called to state she received all her shots this day in the same arm (5 total) and afterwards her arm was more sore than normal. She had mobility issues since then and is now going to see the MD. She thinks maybe the shot was given in the wrong place. She is seeing her MD for the pain and mobility issues this week. More
2830155 0.33 M FL 03/07/2025 DTPPVHBHPB
PNC20
RV1
 MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 u7767AA
LK6655
7E9Y2
Rash, Urticaria; Rash, Urticaria; Rash, Urticaria Rash, Urticaria; Rash, Urticaria; Rash, Urticaria
around 3 hours after the vaccines given, mom called the office and stated he had broke out in a ras... around 3 hours after the vaccines given, mom called the office and stated he had broke out in a rash that could be hives on his face only. Mom also noted that they had just walked through polled right right before the rash started. He had been acting normal otherwise, was happy and smiling at mom, and no reported coughing or breathing struggles. Mom was advised to give 2.5mL benadryl and she said she gave it while on the phone. Advised to watch for worsening symptoms, progression of rash, or struggling to breath and to call office back. No further calls received More
2830157 66 F NY 03/07/2025 COVID19
MMR
 PFIZER\BIONTECH
MERCK & CO. INC.
 301308a
unknown
Injection site pruritus, Mouth swelling; Injection site pruritus, Mouth swelling Injection site pruritus, Mouth swelling; Injection site pruritus, Mouth swelling
Itchiness at ejection site of MMR injection. Funny feeling (swelling?) in mouth (but not throat). I ... Itchiness at ejection site of MMR injection. Funny feeling (swelling?) in mouth (but not throat). I did just have a takeout sandwich and brownie. More
2830158 11 M ND 03/07/2025 COVID19
FLU3
HPV9
MNQ
TDAP
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 b0001
79ky5
y008119
u8361aa
m7yy5
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Patient was administered Moderna covid vaccine for ages 12+ . Patient should have had Moderna covid... Patient was administered Moderna covid vaccine for ages 12+ . Patient should have had Moderna covid vaccine for 6 months to 11 years. Patient and family were educated on vaccine, potential side effects, and adverse effects to be aware of and monitor. Talked with mother of patient who states that patient only has a sore arm. no other side effects or concerns at this time. Primary care provider was updated along with supervising staff per protocol. Manufacturer updated and discussed potential side effects. Dose will not be readministered. No change in treatment for this patient. More
2830159 50 F FL 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 52F7M
Asthenia, Burning sensation, Hypoaesthesia, Paraesthesia Asthenia, Burning sensation, Hypoaesthesia, Paraesthesia
weakness or a burning, numbness, or tingling feeling weakness or a burning, numbness, or tingling feeling
2830160 0.17 M GA 03/07/2025 DTAPHEPBIP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
Y003144
LG5577
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
Patient received two courses of 2 month vaccines. The two month vaccines administered were PedvaxHI... Patient received two courses of 2 month vaccines. The two month vaccines administered were PedvaxHIB, Prevnar and Pediarix. All doses were the same lot number on administration on 2/21/25 and 3/5/25. The patient tolerated the vaccines well and did not demonstrates signs or symptoms of a reaction. Patient was discharged from NICU on 3/6/25. More
2830161 9 F CA 03/07/2025 COVID19
FLU3
HEPA
VARCEL
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 3046979
p224h
Y007585
y014182
Eye pruritus, Swelling face, Swelling of eyelid; Eye pruritus, Swelling face, Sw... Eye pruritus, Swelling face, Swelling of eyelid; Eye pruritus, Swelling face, Swelling of eyelid; Eye pruritus, Swelling face, Swelling of eyelid; Eye pruritus, Swelling face, Swelling of eyelid More
Mother reported that adverse symptoms began roughly 3 hours after vaccination. Symptoms began with p... Mother reported that adverse symptoms began roughly 3 hours after vaccination. Symptoms began with pruritic eyes and eyelid swelling. Mom gave eye drops and oral benadryl and tylenol, per the box dosing instructions. 5-10 minutes post-medication, the eyelid swelling was reduced, but not gone. Mom continued to give benadryl and tylenol around the clock as symptoms were not resolved. In the evening, the facial swelling increased but mom denied shortness of breath, rash, or fever. Patient describes swelling as "puffy bunny face." Symptoms were resolved after the first night (ie, no symptoms since 3/4/25). Of note, Mom denied that patient was exposed to any new items. Mom denied any similar occurrence with prior vaccines. Patient was not treated at a medical facility for symptoms. More
2830162 53 M NV 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient received dose 2 of Shingrix before recommended interval of 8 weeks from first dose. Patient ... Patient received dose 2 of Shingrix before recommended interval of 8 weeks from first dose. Patient was not harmed but informed their 2nd dose would be invalid according to CDC guidelines. Patient agreed to come 8 weeks from invalid dose to receive valid second dose of Shringrix. More
2830163 49 F SD 03/07/2025 PNC21
 MERCK & CO. INC.
 Y013009
No adverse event No adverse event
no adverse event no adverse event
2830164 4 F FL 03/07/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Lip swelling, Oral discomfort, Pruritus, Rash Lip swelling, Oral discomfort, Pruritus, Rash
My daughter received the vaccine, and less than 24 hours later, she began experiencing intense itchi... My daughter received the vaccine, and less than 24 hours later, she began experiencing intense itchiness all over her body, including behind her ears and on her back. The next day, the rash was still present on her back, arms, and extremities. While the rash temporarily subsided, the itching persisted. The following Monday, the rash returned, even worse than before. By Wednesday morning, she was dealing with the same issues: itching, a rash, swollen lips, and discomfort in her mouth, and the itching became unbearable. As soon as we noticed her symptoms worsening, we took her to the ER. The ER doctor confirmed that it was an adverse reaction to the vaccine, as there had been no changes in her diet or any other new medications. She was treated with prednisone and Benadryl at the hospital, and we were given a prescription for both medications to continue for five days. More
2830165 13 F CA 03/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 LN0591
946597
Loss of consciousness, Visual impairment; Loss of consciousness, Visual impairme... Loss of consciousness, Visual impairment; Loss of consciousness, Visual impairment More
I administered the covid and flu vaccine and about 1 minute after she was standing Infront of me and... I administered the covid and flu vaccine and about 1 minute after she was standing Infront of me and said she saw red cells and told her to sit down and when she was about to sit mom and I heard a sound and mom and I ran to her and helped her up and checked her blood pressure, she immediately woke up and was ok. More
2830166 40 F CA 03/07/2025 HEP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MD9SL
Z7L7H
Impaired work ability, Pruritus, Rash; Impaired work ability, Pruritus, Rash Impaired work ability, Pruritus, Rash; Impaired work ability, Pruritus, Rash
Per EE, Had an adverse reaction on 03/06/25 @ 1700. Adverse Reaction started on left posterior si... Per EE, Had an adverse reaction on 03/06/25 @ 1700. Adverse Reaction started on left posterior side of her neck and was itchy and bumpy, and continued to her back and arms and woke up this morning 03/07/25 with itchiness all over body. Per EE, spoke to her local pharmacy and they told her to take benadryl and see provider. Per EE, she told them she couldn't because she was coming into work and benadryl will cause her to be unsafe because of drowsiness and she does not have a provider. Advised EE to seek medical attention as well, but she declined at this time. EE states she took an oatmeal bath and applied Desitin to her underarms for itchiness last night, but has not taken any over-the-counter medication for adverse reaction. Per EE, no hx of adverse reaction to vaccinations, however she had a flu shot one time and became ill. Advised EE that if she would like to receive medical attention with workers comp, she will need to fill out forms and we will refer her to Occ Health. Per EE, she spoke to her manager and will take the day off and will self monitor instead of seeking medical attention at this time and will let us know if she needs anything. Per EE, does not have any respiratory issues at this time and will seek medical attention as needed. More
2830167 F PA 03/07/2025 COVID19
FLU3
UNK
 PFIZER\BIONTECH
SANOFI PASTEUR
UNKNOWN MANUFACTURER
 LM2211
U8515EA
Y011819
Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swellin... Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swelling, Pruritus, Skin warm More
an itchy, red, hot, and swollen arm that went down to her elbow; an itchy, red, hot, and swollen arm... an itchy, red, hot, and swollen arm that went down to her elbow; an itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; itchy, red, hot, and swollen arm that went down to her elbow; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2232179. The previous case ID: 2412USA004213. Information has been received from FDA on 11-DEC-2024, regarding an 82-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-OCT-2024, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection (lot #Y011819 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 01-OCT-2025) intramuscularly in the left arm (strength and dose was not provided), tozinameran (PFIZER BIONTECH COVID-19 VACCINE) intramuscularly in the left arm (lot# LM2211, strength, formulation and expiry date were not provided) and influenza vaccine inact split 3v (FLUZONE HIGH DOSE) intramuscularly in the right arm (lot # U8515EA, strength, formulation and expiry date were not provided) all for prophylaxis. On 11-OCT-2024, the patient experienced an itchy, red, hot, and swollen arm that went down to her elbow. The patient called the doctor and they told her to go to urgent care and she was given an antibiotic and steroid to help. She also used cold compresses all weekend to help. She was told if it got worse, she was to go to the emergency room (ER) but that never happened. Outcome of all the events was recovered on an unknown date in 2024. Causality assessment was not provided. This is one of several reports from the same reporter. Executive Summary: Investigation summary for CAPVAXIVE Batch/Lot# Y011819 Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of CAPVAXIVE Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. There have been no additional requests for information or additional testing relating to this Adverse Event. More
2830168 1 M 03/07/2025 FLU3
MMR
PNC20
UNK
 SEQIRUS, INC.
MERCK & CO. INC.
PFIZER\WYETH
UNKNOWN MANUFACTURER
Y008592

Y013073
Pyrexia; Pyrexia; Pyrexia; Pyrexia Pyrexia; Pyrexia; Pyrexia; Pyrexia
still running a fever; he is also cutting a tooth this week; This spontaneous report was received fr... still running a fever; he is also cutting a tooth this week; This spontaneous report was received from a Nurse and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 03-FEB-2025 (also reported as 03-FEB-2024, discrepancy), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), used along with sterile diluent (no details), 1 dosage form, lot #Y013073, expiration date: 29-JUL-2026, for prophylaxis (anatomical location and route of administration were not provided); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), used along with sterile diluent (no details), 1 dosage form, lot #Y008592, expiration date: 30-APR-2026, for prophylaxis (anatomical location and route of administration were not provided); Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), for prophylaxis (dose, lot #, expiration date, anatomical location and route of administration were not reported); and Influenza vaccine inact sAg 3v (FLUCELVAX), for prophylaxis (dose, lot #, expiration date, anatomical location and route of administration were not reported). Starting on an unspecified date in February 2025 (discrepancy, as also provided as 03-FEB-2024 or "10-FEB"), the patient was displaying a fever, which was expected, however as of 07-FEB-2025 (also reported as "today") he was still running a fever (103.3F unmedicated). Tests were also performed by his pediatrician to ensure that he did not have another infection, and all results came back negative. He was also cutting a tooth that week. No further information was available. At the reporting time, the patient had not recovered from the events. The action taken with suspect products was not reported but established as not applicable. The causal relationship between the events and the suspect products were not provided. More
2830169 F WI 03/07/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Antibody test negative; Antibody test negative Antibody test negative; Antibody test negative
Patient is 30 year old female with a history of 2 VARIVAX doses. HCP believes the titers are low but... Patient is 30 year old female with a history of 2 VARIVAX doses. HCP believes the titers are low but is not sure; This spontaneous report was received from a registered nurse regarding a 30-year-old female patient. The patient's medical history, historical drugs, and concomitant therapies were not reported. Her concurrent conditions included a fish allergy. On an unknown date, the patient was vaccinated with the first and second doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (strengths, doses, lot #, expiration dates, anatomical location, and routes of administrations were not reported), both diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection (strengths, doses, lot #, expiration dates, anatomical location, and routes of administrations were not reported), as prophylaxis. The health care professional stated that in an unknown date, believed that her titers were low but was not sure (Antibody test negative). The HCP additionally inquired whether the suspect vaccine contained fish given the patient's allergy, and the medical information request (MIR) she received only discussed fish oil. At the reporting time, the outcome of the event had not been provided. The causal relationship between the event and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) plus sterile diluent (MERCK STERILE DILUENT) was not provided. Lot # is being requested and will be submitted if received. More
2830170 1 OH 03/07/2025 VARCEL
VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Y015101
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional adverse event; HCP called to report a patient received their first does of VARIVAX at ... No additional adverse event; HCP called to report a patient received their first does of VARIVAX at 12 months of age and was administered a second dose just 3 months later at 15- months of age. Caller states no side effects or symptoms have been reported. HCP does not have the l; Information has been received from a Registered Nurse on 12-FEB-2025 regarding to an 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. It was reported that the patient received their first dose of Varicella Virus Vaccine Live (Oka-Merck) at 12 months of age on 03-NOV-2024 (dose, lot #and expiration date was not reported) and it was administered a second dose, reported as just 3 months later at 15- months of age on 03-FEB-2025 (dose: 0.5 milliliter, lot #Y015101, expiration date: 06-SEP-2026) (Inappropriate schedule of product administration) for prophylaxis. It was reported that no side effects or symptoms had been reported. More
2830171 25 F CA 03/07/2025 HPV9
 MERCK & CO. INC.
 X024251
Exposure during pregnancy, No adverse event, Product use issue, Wrong product ad... Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered More
no adverse event; vaccine exposure during pregnancy; Wrong vaccine administered; This spontaneous Pr... no adverse event; vaccine exposure during pregnancy; Wrong vaccine administered; This spontaneous Prospective pregnancy report was received from a Physician and refers to a 35-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. The patient became pregnant with the date of last menstrual period of 20-Jul-2024. The pregnancy due date was estimated as 26-Apr-2025. This pregnancy involved 1 fetus. The pregnancy outcome and fetal outcome were unknown. On 12-Feb-2025, at gestational age 29 weeks and 4 days the patient was accidentaly given Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #X024251, expiration date: 15-May-2026), dose number 1, 0.5 mL (0.5 mL, deltoid), instead of Tetanus, Diphtheria, and Pertussis (TDAP) (Wrong vaccine administered, vaccine exposure during pregnancy). No adverse event was reported. More
2830172 43 F OH 03/07/2025 HPV9
 MERCK & CO. INC.
 Y014059
Blood glucose increased, Condition aggravated, Hyperglycaemia Blood glucose increased, Condition aggravated, Hyperglycaemia
Hyperglycemia; This spontaneous report was received from a Nurse Practitioner regarding a 42-year-ol... Hyperglycemia; This spontaneous report was received from a Nurse Practitioner regarding a 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Insulin dependent diabetes. Historical drugs included Insulin. Concomitant therapies, past drug reactions and allergies were not reported. On 18-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection administered intramuscularly for prophylaxis (dose, vaccination scheme frequency, lot number, expiration date and anatomical site of injection were not reported). It was reported that on that same date, prior to the vaccination, the patient's blood sugar was 80 (units not provided) and approximately two hours after administering the vaccine, after the patient left the office, they called the HCP to report that her blood sugar had spike to 400 (units not provided) (Blood glucose increased). The reporter stated that no medical treatment was needed, and the patient just gave herself a bolus of insulin at home to bring the number down. At the time of the report, the patient was recovering from the event of Blood glucose increased. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Follow up information was received from a nurse practitioner. Concomitant therapy included cabergoline, insulin pump, lexapro, metformin and levonorgestrel (MIRENA). Current conditions included also situsitis. Lot # of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was Y014059, espiry date was 01-NOV-2025, site was right deltoid. The event term was changed to hyperglycemia, it occurred two hours after vaccination. The patient received increased exogenous insulin and it was reported that the event was controlled. In approximately February 2025, the patient recovered from hyperglicemia. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was changed to possibly related.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2256278 , Central date : 2025-02-24 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830173 03/07/2025 MMRV
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration; No adverse event; Information has been received fr... Inappropriate schedule of product administration; No adverse event; Information has been received from Business Partner/CRO on 18-Feb-2025. This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) Child patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (indication, expiration date, and lot # were not reported). On an unknown date, the patient experienced Inappropriate schedule of product administration. On an unknown date, the patient experienced No adverse event. At the reporting time, the outcome of Inappropriate schedule of product administration and No adverse event was unknown. More
2830174 NY 03/07/2025 MMRV
 MERCK & CO. INC.
 Y003880
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No other AE/PQC reported; the office inadvertently administered PROQUAD to a 20 year old patient; Th... No other AE/PQC reported; the office inadvertently administered PROQUAD to a 20 year old patient; This spontaneous report was received from a nurse and refers to a 20-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 07-Jun-2024, the 20-year-old patient (product administered to a patient of inappropriate age) was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection (lot #Y003880, expiration date: 05-Aug-2025) for prophylaxis. No other adverse event was reported. More
2830175 F TX 03/07/2025 MMRV
 MERCK & CO. INC.
 Y009348
Occupational exposure to product, Syringe issue Occupational exposure to product, Syringe issue
vaccine leaked out onto her gloved hand during administration; HCP reports vaccine leaked out onto h... vaccine leaked out onto her gloved hand during administration; HCP reports vaccine leaked out onto her gloved hand during administration.; HCP reports vaccine leaked out onto her gloved hand during administration.; HCP reports vaccine leaked out onto her gloved hand during administration.; This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Feb-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis (lot #Y009348, expiration date: 11-Nov-2025). On 20-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot #1973529, expiration date: 03-Mar-2026 which was estimated to be non-valid) for an unknown indication. On 20-Feb-2025, the patient experienced vaccine leaked out onto her gloved hand during administration (accidental exposure to product, occupational exposure to product, syringe leak and vaccination error). The patient recovered from the events on unknown date. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable. More
2830176 0.17 OH 03/07/2025 DTPPVHBHPB
DTPPVHBHPB
VARCEL
VARCEL
DTPPVHBHPB
DTPPVHBHPB
VARCEL
VARCEL
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.







No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation error; No adverse event, Product preparation issue; No adverse event, Product preparation error; No adverse event, Product preparation issue; No adverse event, Product preparation error; No adverse event, Product preparation issue; No adverse event, Product preparation error More
No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using... No reported signs or symptoms of adverse effects have been reported; VARIVAX was reconstituted using a VAXELIS pre-filled syringe rather than the sterile diluent and administered; This spontaneous report was received from a nurse and refers to a2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis, the vaccine was reconstituted using a diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) pre-filled syringe rather than the sterile diluent (product preparation error) (exact dose, strength, vaccination site, route of administration, lot number and expiration were not reported). No reported signs or symptoms of adverse effects have been reported. Lot # is being requested and will be submitted if received.; More
2830177 11 F ND 03/07/2025 UNK
 UNKNOWN MANUFACTURER
 Y017208
No adverse event, Product storage error No adverse event, Product storage error
no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator f... no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a registered nurse referring to a 11-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included polio vaccine inact 3v (Vero) (IPOL) (lot# Y1A201M), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) (lot# CX4HL), meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO) (lot# LN75D), and hepatitis B vaccine rHBsAg (yeast) (ENGERIX B) (lot# 998J9). On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. The reporter was unaware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to this patient arrived to the facility on 13-JAN-2025, and on 29-JAN-2025, the patient was vaccinated with this second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot# Y017208, expiration date was not reported, but upon internal validation established as 13-APR-2026; strength and dose were not reported) subcutaneously in the left arm for prophylaxis (product storage error) at a public health clinic. No additional adverse event (AE). This is one of several reports received from the same reporter. More
2830178 6 F ND 03/07/2025 UNK
 UNKNOWN MANUFACTURER
 Y013583
Product storage error Product storage error
they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until admin... they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration; This spontaneous report was received from a registered nurse referring to a 6-year-old female patient. The patient's concomitant drugs included Hepatitis a vaccine inact (HAVRIX) and Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX). The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were not reported. On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. The reporter was unaware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration. On 04-DEC-2024, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: Y013583, expiration date: 03-FEB-2026; strength and dose were not reported) subcutaneously in the left arm for prophylaxis (product storage error). This case was received from the same reporter with the case US-009507513-2254349. More
2830179 6 F ND 03/07/2025 UNK
 UNKNOWN MANUFACTURER
 Y013579
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; incorrect product storage; This spontaneous report was received from a registered ... no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Havrix (Hepatitis a vaccine inact), Infanrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid), Flucelvax (Influenza vaccine inact sAg 3v). On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the client was received on 13-JAN-2025 and stored in the refrigerator until administered. On 01-Feb-2025, the patient was vaccineated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013579, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiry dates were not provided). No additional adverse event (AE) (No adverse event). This case was one of several reports received from the same reporter with the case US-009507513-2254349.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/22/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830183 10 M 03/07/2025 MMRV
UNK
 MERCK & CO. INC.
UNKNOWN MANUFACTURER
Y013579
Product storage error; Product storage error Product storage error; Product storage error
improper storage of product in use; This spontaneous report was received from a nurse referring to a... improper storage of product in use; This spontaneous report was received from a nurse referring to a 10-year-old male patient. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 08-Jan-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number Y013579, which has been verified to be valid, expiration date reported and validated as 03-FEB-2026, second dose, subcutaneously, in left thigh. (strength not provided) The administered dose of the vaccine was stored at multiple temperatures with a range from 15 degree Fahrenheit to 46 degree Fahrenheit during an 1848 (unit not provided).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 10/14/2014 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830184 F TX 03/07/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011709
Y011709
Device connection issue, Device leakage, Exposure via eye contact, Exposure via ... Device connection issue, Device leakage, Exposure via eye contact, Exposure via skin contact, No adverse event; Occupational exposure to product More
No adverse event; after she administered the injection and a "few drops" splattered in her... No adverse event; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; This spontaneous report has been received from a nurse, regarding to herself a 25-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On an unknown date in 2024 (reported as few months ago), it was stated that the hub/leur lock on the sterile diluent solution for injection (BAXTER STERILE DILUENT) syringe became loose caused the needle to fell off, usually prior to injection and when they tried to screw the needle on tight, it caused the hub to became loose and detach and this was noticed immediately after removing from the tray, sometimes while attaching the needle, and once during an injection in which the needle was left in one patient (needle issue) (poor quality device used) (device connection issue). On 20-FEB-2025, after the nurse administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection (M-M-R II) injection, 0.5 mL, administered as prophylaxis (Lot No. Y011709 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 02-JUL-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not reported) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) injection, 0.5 mL, (Lot No. 2050911 has been verified to be a valid lot number for [sterile diluent solution for injection], expiration date was reported and upon internal validation established as 11-FEB-2027) (strength and route of administration were not provided) to an unspecified patient an unknown amount of few drops splattered in her face in which she had to flush her face and eyes (exposure via eye contact) (occupational exposure to product) On the same date (20-FEB-2025) the patient recovered from the events of exposure via eye contact and occupational exposure to product. No additional adverse event was provided (no adverse event).; Reporter's Comments: Keywords : More
2830185 OK 03/07/2025 HIBV
PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y006393
Y005465
Y009341
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE reported; VFC immunization coordinator calling to report T/E for PEDVAX HIB , ROTA... No additional AE reported; VFC immunization coordinator calling to report T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered. T/E date was on 2/18/2025 and PEDVAX HIB , ROTATEQ, VAXNEUVANCE were administered on 3/03/2025. Permission was given to contact HCP; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On 03-MAR-2025, the patient was vaccinated with the first doses of haemophilus b conjugate (PEDVAXHIB-LIQUID) suspension for injection, lot # Y006393, expiration date 07-NOV-2026 (exact dose, route of administration and anatomical location were not reported); and 15-valent pneumococcal conjugate vaccine (VAXNEUVANCE) suspension for injection, lot # Y005465, expiration date 08-JAN-2027 (exact dose, route of administration and anatomical location were not reported); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, lot # Y009341, expiration date: 24-NOV-2025, administered orally (exact dose was not reported), all for prophylaxis. The aforementioned doses of vaccines underwent a temperature excursion of 32.0 Fahrenheit (F) degrees for 2 hours and 12 minutes on 18-FEB-2025 (Product storage error). There was no previous temperature excursion. No additional adverse event was reported. More
2830186 OK 03/07/2025 HEPA
HIBV
PNC15
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y008483
Y006393
Y005465
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE cases; VFC immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , ... No additional AE cases; VFC immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , VAXNEUVANCE that was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Feb-2025, a temperature excursion (TE) occurred (temperature: 32.0F; time frame: 2 hours 12 minutes 0 seconds). There was no previous temperature excursion. On 21-Feb-2025, following the TE, the patient was vaccinated with the fourth dose of with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) lot #Y005465, expiration date reported as and upon internal review confirmed to be: 08-Jan-2027 (exact dose and route of administration were not reported), with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y008483, expiration date reported as and upon internal review confirmed to be: 26-Nov-2025 (exact dose and route of administration were not reported), and with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) lot #Y006393, expiration date reported as and upon internal review confirmed to be: 07-Nov-2026 (exact dose and route of administration were not reported) (product storage error). All vaccines were administered for prophylaxis. No additional adverse event (AE) cases were noted (no adverse event). No product quality complaint (PQC) was reported. More
2830187 F 03/07/2025 UNK
 UNKNOWN MANUFACTURER
Menstruation irregular Menstruation irregular
Irregular menstrual cycle; This spontaneous report was received from a consumer and refers to a fema... Irregular menstrual cycle; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) administered for prophylaxis (lot # and expiration, strength, dose number, route, anatomical location of administration and vaccination scheme frequency were not provided). On an unknown date, the patient experienced Irregular menstrual cycle. At the reporting time, the outcome of Irregular menstrual cycle was unknown. The causal relationship between the event of Irregular menstrual cycle and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided. More
2830188 DE 03/07/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X000532
Expired product administered; Expired product administered Expired product administered; Expired product administered
No additional AEs were reported; patient received an expired VARIVAX; This spontaneous report was re... No additional AEs were reported; patient received an expired VARIVAX; This spontaneous report was received from a Medical Assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-MAR-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X000532, expiration date: 04-JAN-2025), 1 dose, as prophylaxis (Expired product administered). More
2830189 F VA 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Aphasia, Dysarthria, Dysphagia, Muscular weakness, Plasmapheresis Aphasia, Dysarthria, Dysphagia, Muscular weakness, Plasmapheresis
Loss of speech; patient was in hospital for speech swallowing gripping weakness progressive; This se... Loss of speech; patient was in hospital for speech swallowing gripping weakness progressive; This serious case was reported by a consumer and described the occurrence of slurred speech in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of dysarthria (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777) and Shingrix with an associated reaction of aphasia (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777). Concurrent medical conditions included miller fisher syndrome. Concomitant products included prednisone. In AUG-2024, the patient received the 2nd dose of Shingrix. On 12-APR-2024, an unknown time after receiving Shingrix, the patient experienced slurred speech (Verbatim: patient was in hospital for speech swallowing gripping weakness progressive) (serious criteria hospitalization). On 02-AUG-2024, the patient experienced speech loss (Verbatim: Loss of speech) (serious criteria hospitalization). Rechallenge with Shingrix was positive. The outcome of the slurred speech and speech loss were not resolved. It was unknown if the reporter considered the slurred speech and speech loss to be related to Shingrix. The company considered the slurred speech and speech loss to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025021777 Additional Information: GSK receipt date: 20-FEB-2025 The reporter reported patient had recived Shingrix vaccine and experienced speech swallowing gripping weakness progressive and loss of speech. The reporter mentioned that dates when patient was in hospital for speech swallowing gripping weakness progressive and loss of speech was unspecified to unspecified. The expiry date of Shingrix was unknown. The reporter reported that other products patient was recived such as prednisone and started in fall 2024 and continues. The reporter mentioned that symptoms started slowly after first immunizations in April 2024 then rapid progression after booster in August 2024 requiring two hospitalizations with ongoing progressive symptoms and now repeating plasmaphoresis and considerdering rituxin infusions.; Sender's Comments: Dysarthria and Aphasia are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025021777:Same patient. secodn dose case. More
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2830190 63 M MO 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Fatigue, Pain, Pyrexia, Somnolence Chills, Fatigue, Pain, Pyrexia, Somnolence
Chills; Fever; Fatigue/slept all day; body aches; This non-serious case was reported by a consumer v... Chills; Fever; Fatigue/slept all day; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation. Concomitant products included methotrexate, prednisone and evolocumab (Repatha). On 25-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 25-FEB-2025, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fever (Verbatim: Fever), fatigue (Verbatim: Fatigue/slept all day) and general body pain (Verbatim: body aches). The patient was treated with paracetamol (Tylenol). The outcome of the chills, fever, fatigue and general body pain were not resolved. It was unknown if the reporter considered the chills, fever, fatigue and general body pain to be related to Shingrix. It was unknown if the company considered the chills, fever, fatigue and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 27-FEB-2025 The patient received the 2nd dose of Shingrix shot at a local pharmacy. The patient states that he was given a list to check of what medications he was taking, Methotrexate (3 tablets a week and ,physician increased to 6 a week (strength not provided) and Prednisone, and they were in the list. He states, still gave the 2nd shot. The patient reports that he was not taking Methotrexate when he received the 1st dose. The patient reports that he has atrial fibrillation and takes medications for the heart. He also reports taking Repatha 140 mcg every morning. The patient did not recall the date of Shingrix 1st dose, but states that he did not experience any side effects with the 1st dose. The patient reports that the side effects of the 2nd dose started that same evening. He reported having chills that last about an hour, and fever of 100.6 when the fever started. The patient reports he was still hot on 26-February-2025. The patient reports had fatigue and states he slept all day. The patient reported body aches as well. The patient took Tylenol every 4 hours. The patient reports about Shingrix 2nd shot, felt like crap and still not feeling better. More
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