๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2861834 10 F CA 09/27/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Incorrect dose administered Incorrect dose administered
Patient did not received an age appropriate COVID -19 vaccine dose. Patient received COVID-19 mRNA ... Patient did not received an age appropriate COVID -19 vaccine dose. Patient received COVID-19 mRNA Pfizer Comirnaty 2025-2026 12yr-adult 30mcg dose. More
2861835 0.5 F CT 09/27/2025 UNK
 UNKNOWN MANUFACTURER
Rash Rash
Rash on back Rash on back
2861836 6 F CA 09/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0738
U8863CA
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Patient was given an non-age appropriate COVID -19 Vaccine dose. Patient was given COVID-19 mRNA, 20... Patient was given an non-age appropriate COVID -19 Vaccine dose. Patient was given COVID-19 mRNA, 2025-2026 12yr-adult Cominraty Pfizer 30mcg dose. More
2861837 11 F CA 09/27/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Incorrect dose administered Incorrect dose administered
Patient received an non-age appropriate dose of COVID-19 vaccine dose. Patient received COVID-10 mRN... Patient received an non-age appropriate dose of COVID-19 vaccine dose. Patient received COVID-10 mRNA, 2025-2026 12yr-adult Pfizer Cominraty 30mcg dose. More
2861838 84 F PA 09/27/2025 COVID19
FLU3
RSV
VARZOS
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3051995
U8855AA
ae435
7523j
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise More
Patient states her right arm is warm, swollen, painful, and red where she received her vaccines. She... Patient states her right arm is warm, swollen, painful, and red where she received her vaccines. She stated she was also seen in the ER the day after her injections for illness unrelated to the vaccines. She is still experiencing warm, swollen, painful and red area but it is not progressing/ getting worse. More
2861839 82 M NV 09/27/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
PATIENT WAS GIVEN DUPLICATE VACCINE. HE WAS GIVEN FLUZONE HD AND MNEXSPIKE (COVID 19) VACCINES DESPI... PATIENT WAS GIVEN DUPLICATE VACCINE. HE WAS GIVEN FLUZONE HD AND MNEXSPIKE (COVID 19) VACCINES DESPITE HAVING ALREADY RECEIVED IT ON 9/9/2025. More
2861840 6 M CA 09/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0738
U8863CA
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Patient received an non-age appropriate dose of COVID-19 vaccine. Patient recived COVID-19 mRNS 2025... Patient received an non-age appropriate dose of COVID-19 vaccine. Patient recived COVID-19 mRNS 2025-2026 12yr-adult Cominraty Pfizer 30mcg dose. More
2861841 14 F PA 09/27/2025 FLU3
 SANOFI PASTEUR
 TFAA2501
Injection site discharge Injection site discharge
Used a 1 inch needle to administer a vaccine to a 14 year old. Needle length seemed appropriate for ... Used a 1 inch needle to administer a vaccine to a 14 year old. Needle length seemed appropriate for patient's size. After administration, a small amount of vaccine leaked out of the injection site. Counseled the patient & guardian, since such a small unknown amount leaked out, the dose was not repeated. More
2861842 51 F 09/27/2025 COVID19
COVID19
 MODERNA
MODERNA
 8146545
8146545
Chills, Fatigue, Headache, Injection site pain, Oedema peripheral; Tenderness Chills, Fatigue, Headache, Injection site pain, Oedema peripheral; Tenderness
pain at the injection site, fatigue, headache, chills, axillary swelling or tenderness. pain at the injection site, fatigue, headache, chills, axillary swelling or tenderness.
2861843 9 M CA 09/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0738
UT8779MA
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Patient received a non-age-appropriate dose of COVID-19 vaccine. Patient received COVID-19 mRNA 2025... Patient received a non-age-appropriate dose of COVID-19 vaccine. Patient received COVID-19 mRNA 2025-2026 12yrs-adult Cominraty pfizer 30mcg dose. More
2861844 51 M KY 09/27/2025 FLU3
 SANOFI PASTEUR
 U8790AA
Injection site discomfort, Injection site erythema, Injection site pruritus, Inj... Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth More
patient received flublok around 11:30 am on 9/25/25, later that evening the patient states the injec... patient received flublok around 11:30 am on 9/25/25, later that evening the patient states the injection site was red, warm to the touch, but overall small in size. The patient came to the pharmacy today, 9/27/25 to show the pharmacist the progression of the reaction. The skin on the right on was very red, hot to the touch, and had grown in size considerably. The redness/rash spread across the arm roughly 6.5 inches in width and 4 inches in height. Patient stated the redness/rash in uncomfortable, hot, and itchy, but not causing serious pain. Denies chills, fever, tingling or numbness of the right arm. Recommended to use topical hydrocortisone for swelling and itching. With permission, pharmacist used a red sharpie to outline the current size of reaction so patient can visualize if redness/rash is getting larger or smaller. Patient will follow up with pharmacist on 9/28/25. More
2861845 21 M CA 09/27/2025 TYP
 BERNA BIOTECH, LTD.
Lymphadenopathy Lymphadenopathy
Patient has developed left posterior cervical chain lymphadenopathy. Painless. No other source of in... Patient has developed left posterior cervical chain lymphadenopathy. Painless. No other source of infection. No other complaints. More
2861846 71 M AZ 09/27/2025 FLU3
 SANOFI PASTEUR
 U8764BB
Injected limb mobility decreased, Injection site pain Injected limb mobility decreased, Injection site pain
Patient stopped by the pharmacy yesterday and expressed his concerned about the pain (4-5 on the sca... Patient stopped by the pharmacy yesterday and expressed his concerned about the pain (4-5 on the scale of 1-10) in the left arm around the area where the Flu vaccine was administered on 09/03/2025. He can not lift his arm completely. I told him to go see the doctor, meanwhile he may take Ibuprofen and do the compressions. More
2861847 10 F 09/27/2025 COVID19
 PFIZER\BIONTECH
 NA0590
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Member received Comirnaty 30 mcg (for 12 years and older), instead of Comirnaty 10 mcg (5-11 years).... Member received Comirnaty 30 mcg (for 12 years and older), instead of Comirnaty 10 mcg (5-11 years). No adverse reaction reported. PCP was notified and will notify the family. More
2861848 38 F AL 09/27/2025 RAB
 SANOFI PASTEUR
 3052669
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
placed needle in patients arm and realized vaccine was still frozen. Removed needle, destroyed vacci... placed needle in patients arm and realized vaccine was still frozen. Removed needle, destroyed vaccine, and administered new thawed vaccine More
2861849 76 F FL 09/27/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8859BA
MA2523
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Left arm became swollen, red, hot, and uncomfortable. Patient says this started 3 days after adminis... Left arm became swollen, red, hot, and uncomfortable. Patient says this started 3 days after administration and as of 9 days after getting the shots she came into the pharmacy to show me her arm. She said the first few days it was just sore (as expected), then on the 3rd day it was about the size of a lemon, then continued to grow to the size of a baseball. As of when she came into the store her arm from her elbow to her shoulder was red, hot, swollen and it hurt. She started a steroid dose pack and today on day 10 it is no longer hot and the swelling and discomfort is better but the redness is still there. More
2861850 7 F CA 09/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0738
UT8779MA
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
Patient received an non age-appropriate COVID 19 vaccine dose. Patient received COVID-19 mRNA 2025-2... Patient received an non age-appropriate COVID 19 vaccine dose. Patient received COVID-19 mRNA 2025-2026 12 yrs-adult Cominraty Pfizer 30mcg dose. More
2861851 76 M TX 09/27/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052549
UT8804AA
Haematoma, Mobility decreased, Myalgia; Haematoma, Mobility decreased, Myalgia Haematoma, Mobility decreased, Myalgia; Haematoma, Mobility decreased, Myalgia
patient experienced severe muscle pains and could not move the arm starting next day. Today patient ... patient experienced severe muscle pains and could not move the arm starting next day. Today patient went to urgent care and they diagnosed it as hematoma More
2861852 64 F FL 09/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Deafness unilateral, Vertigo Deafness unilateral, Vertigo
Patient told me today on 09/27/2025, that 2 days after getting the second dose, she experienced vert... Patient told me today on 09/27/2025, that 2 days after getting the second dose, she experienced vertigo. A week later, she lost her hearing in the right ear, and she still has not recovered. Now she is seeing a doctor for the issue, and she is started therapy next week. More
2861853 5 F CA 09/27/2025 HEP
UNK
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 Y014090
4004245
Injection site discharge, Injection site pain, Injection site swelling; Injectio... Injection site discharge, Injection site pain, Injection site swelling; Injection site discharge, Injection site pain, Injection site swelling More
Injection site had puss and was very sore to touch, large bump under skin. Injection site had puss and was very sore to touch, large bump under skin.
2861854 80 F OR 09/27/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052296
U8764CB
Injection site bruising, Pain, Rotator cuff syndrome; Injection site bruising, P... Injection site bruising, Pain, Rotator cuff syndrome; Injection site bruising, Pain, Rotator cuff syndrome More
Patient came in to pharmacy on 9/27 at 2:30pm stating she had to go to ER overnight for injection si... Patient came in to pharmacy on 9/27 at 2:30pm stating she had to go to ER overnight for injection site reaction of bruise. She was given a norco pain medication from the ER and was wearing a sling. She stated she is in alot of pain and was told it was a rotator cuff injury. She was given 2 shots in the left arm because she had stated the day before during immunization that she has a rotator cuff injury in her right arm. More
2861855 5 M GA 09/27/2025 FLU3
 SANOFI PASTEUR
 u8832ca
Pain in extremity, Product administered to patient of inappropriate age Pain in extremity, Product administered to patient of inappropriate age
Flublok was administered in error to 5 year old patient. Flublok is designated for 9 and over, and t... Flublok was administered in error to 5 year old patient. Flublok is designated for 9 and over, and therefore pt was under the age for receiving. Mother reports no side effects other than sore arm. More
2861856 35 F ID 09/27/2025 COVID19
FLU3
HPV9
 MODERNA
SANOFI PASTEUR
MERCK & CO. INC.
 3052730
U8823CA
Y012864
Pain, Product administered at inappropriate site; Pain, Product administered at ... Pain, Product administered at inappropriate site; Pain, Product administered at inappropriate site; Pain, Product administered at inappropriate site More
Patient called pharmacy stating she felt the immunizations were given too high. Pharmacy was unable ... Patient called pharmacy stating she felt the immunizations were given too high. Pharmacy was unable to verify location of administration. Patient stated she might go to the ER if the pain got worse. Pharmacist encouraged her to be seen by a healthcare provider if that was the case and to also take tylenol and ibuprofen to help with any pain. More
2861857 73 M KY 09/27/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 u8764db
u8764db
Blister, Diarrhoea, Pain, Skin warm, Tenderness; Throat irritation Blister, Diarrhoea, Pain, Skin warm, Tenderness; Throat irritation
Pt stated the morning after his vaccine, he started having water filled blisters on right side of ne... Pt stated the morning after his vaccine, he started having water filled blisters on right side of neck/ear area. Stated they were painful and sensitive to touch. They followed the path all around his face to the other side and were still visible 9/27/25. They were not itchy. He also stated he felt "warm" in his neck area. His throat was raw feeling as well. Had some episodes of diarrhea. Did not seek medical treatment with any provider. Self treated with benadryl. Pt has had the Fluzone Hd every year since 2021 without any ill effects. More
2861858 54 F CA 09/27/2025 COVID19
PNC20
TDAP
VARZOS
 PFIZER\BIONTECH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MY9550
MA2502
94KG2
3EG9B
Chills, Cough, Dyspnoea, Heart rate decreased, Nausea; Chills, Cough, Dyspnoea, ... Chills, Cough, Dyspnoea, Heart rate decreased, Nausea; Chills, Cough, Dyspnoea, Heart rate decreased, Nausea; Chills, Cough, Dyspnoea, Heart rate decreased, Nausea; Chills, Cough, Dyspnoea, Heart rate decreased, Nausea More
Patient's relative called the pharmacy to inform us that the patient began to experience signif... Patient's relative called the pharmacy to inform us that the patient began to experience significant adverse effects 2 to 4 hours after vaccination. These effects included nausea, chills, cough, shortness of breath, and low heart rate. The patient was subsequently hospitalized. These were all the details provided at the time of communication. More
โœ“
2861859 55 F 09/27/2025 COVID19
 MODERNA
Injection site pain, Injection site rash, Pyrexia, Rash erythematous, Urticaria Injection site pain, Injection site rash, Pyrexia, Rash erythematous, Urticaria
Fever, soreness at site of injection started later that day. Next day, red rash 6 inches circle arou... Fever, soreness at site of injection started later that day. Next day, red rash 6 inches circle around injection site. On Two days after, hives across arms and torso, especially bad on chest and diaphragm More
2861860 29 M MA 09/27/2025 COVID19
 MODERNA
 8146670
Wrong product administered Wrong product administered
I visited the pharmacy Friday 9/26 at 6:30pm and asked the pharmacist if they had the updated Novava... I visited the pharmacy Friday 9/26 at 6:30pm and asked the pharmacist if they had the updated Novavax vaccine. They told me yes. I asked for an appointment for the Novavax vaccine as soon as possible because this vaccine has longer protection, less side effects, and is effective against all COVID-19 strains and variants as opposed to the m-RNA vaccines of Moderna and Pfizer which provide protection for half as long and have worse side effects. It is a protein subunit vaccine which clinicial research shows has benefits over the other 2 COVID shots. I was sick for several days after my Moderna shot previously and wanted the Novavax shot. Today, 9/27, I showed up and asked the pharmacy technician "Just to confirm, I'm getting Novavax right?" and he replied "Yes." Once the Nurse helped me, I saw a box on the counter and it said "2025-2026" on it. I asked the Nurse again "Is that Novavax?" and she said "Yes." When I got home, my vaccine record from pharmacy said I had received the Spike Vax created by Moderna. Pharmacy has violated my rights because they did not have my consent for the Moderna vaccine, only the Novavax vaccine. I called pharmacy and let them know of their error. They told me they are conducting an investigation and that in their system, I was scheduled for a Moderna Vaccine. The policies and procedures of pharmacy were insufficient to prevent this misttake from happening. This mistake also happened in 2024, and I had to correct the pharmacist that she was about to give me a non- Novavax shot. More
2861861 60 M AZ 09/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 MY9550
406986
Dizziness, Dyspnoea; Dizziness, Dyspnoea Dizziness, Dyspnoea; Dizziness, Dyspnoea
After receiving both vaccines patient got up to leave vaccination room, he said he felt light headed... After receiving both vaccines patient got up to leave vaccination room, he said he felt light headed and his wife helped him back to his chair, then he started to have shortness of breath progressing to he couldn't breath and possibly starting to seizure, I administered 1 dose of Epinephrine 0.3mg/0.3ml in auto injector, which relieved his respiratory distress. While I was doing this the technician called 911. Paramedics arrived took over his care and took him to the hospital. More
2861862 64 F WA 09/27/2025 FLU3
 SANOFI PASTEUR
 TFAA2531
Wrong technique in product usage process Wrong technique in product usage process
8/5" needle was used to vaccinate the patient instead of 1" needles. The vaccine was given... 8/5" needle was used to vaccinate the patient instead of 1" needles. The vaccine was given using IM administration techniques such as 90 degrees angle. More
2861559 VA 09/26/2025 VARCEL
 MERCK & CO. INC.
 Z008195
No adverse event, Product storage error No adverse event, Product storage error
Medical Assistant calling to report administering PROQUAD and VARIVAX after experiencing a temperatu... Medical Assistant calling to report administering PROQUAD and VARIVAX after experiencing a temperature excursion; No additional AE; This spontaneous report was received from an unspecified healthcare professional and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (Hollister-Stier STERILE DILUENT) . On an unknown date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Powder and solvent for solution for injection (lot #Z008195, expiration date: 30-Apr-2027) for Prophylaxis (Route, and anatomical location were not reported) after experiencing a temperature excursion. The temperature was -13.4 C, for a timeframe of 9 hours and 32 minutes. There was a previous temperature excursion of -12.9๏ฟฝC for 2 hours 22 minutes (Product storage error). No additional Adverse event was reported. More
2861560 VA 09/26/2025 VARCEL
 MERCK & CO. INC.
 Z008197
No adverse event, Product storage error No adverse event, Product storage error
calling to report administering PROQUAD and VARIVAX after experiencing a temperature excursion; No a... calling to report administering PROQUAD and VARIVAX after experiencing a temperature excursion; No additional AE; This spontaneous report has been received from an Other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot number Z008197, expiration date 30-APR-2027) with sterile diluent, both as prophylaxis (dose, route of administration, anatomical site of injection). The administered dose wase stored at a temperature of -13.4 degrees Celsius (C) during a time frame of 9 hours and 32 minutes (product storage error). There was a previous temperature excursion reported as -12.9 C for 2 hours and 22 minutes. No additional side effects were reported in the patients. More
2861561 4 M AZ 09/26/2025 VARCEL
 MERCK & CO. INC.
 Y013347
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Freezer Temperature out of range; This spontaneous report was received from a medi... No additional AE; Freezer Temperature out of range; This spontaneous report was received from a medical Assistant and refers to a 4-year-old male patient who weighted 6lbs, 6.3oz at birth. He had no siblings. The patient had not pre-existed physician diagnosed with allergies, birth defects nor medical conditions. He had no illness at the time of vaccination and had not previous vaccines. Concomitant therapies were not reported. On 21-Jul-2025, the freezer where de vaccine was storage, went out of range to 6.3F for 45 minutes. There was a previous temperature excursion of 6๏ฟฝF to 14๏ฟฝF for 0 Hours 45 Minutes 0 Seconds; 14๏ฟฝF to 46๏ฟฝF (14.5F) for 0 Hours 15 Minutes 0 Seconds. The temperature excursion was reading from a digital data logger. On 22-Jul-2025, the patient was vaccinated with the inappropriate storage vaccine, it was his second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013347, expiration date: 02-Aug-2026), administered by Subcutaneous route in Left Thigh as prophylaxis. The vaccine was reconstituted with a sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The vaccine was administered by a trained healthcare professional at private doctor's office/hospital with public funds. No additional adverse events (AE). This is one of several cases form the same source. More
2861578 36 F CA 09/26/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LL8396
LL8396
Diarrhoea, Dyspnoea, Exposure during pregnancy, Flatulence, Headache; Injection ... Diarrhoea, Dyspnoea, Exposure during pregnancy, Flatulence, Headache; Injection site reaction, Injection site swelling, Urticaria More
33 weeks 6 days pregnant at time of vaccination Sept 23. Headache began evening of vaccination Sept ... 33 weeks 6 days pregnant at time of vaccination Sept 23. Headache began evening of vaccination Sept 23, persisted overnight until the early afternoon of the following day Sept 24. Some respiratory discomfort Sept 24 - utilized albuterol inhaler (2 sequential puffs within a few minutes). Diarrhea and gas awoke me the following night about 4am Sept 25 ( resolved by late morning 9am Sept 25). Noticed welt / swelling at injection site evening of Sept 25 9p. More
2861589 F MI 09/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; she had shingles in Aug/2024; This serious case was reported by a co... Suspected vaccination failure; she had shingles in Aug/2024; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2023, the patient received Shingrix. On an unknown date, the patient received Shingrix. In AUG-2024, between 1 and 2 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she had shingles in Aug/2024). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 Reporter stated that patient took Shingrix vaccine in 2019, and still experienced shingles multiple times after being vaccinated. Per the patient the last shingles infection she had was in March 2023. No additional information provided. Patient called to provide updated information regarding the shingrix vaccine and also last occurrence of shingles. Patient stated she had the shingrix vaccine in July 2023. She stated she had shingles in Aug 2024. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, between 1 and 2 years after receiving Shingrix, in a 68-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2861590 F 09/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had it twice once years ago). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 15-SEP-2025 The reporter reported that it was no joke, it hurt, burned and itched all at the same time. Nothing really helped until it was over. The reporter had it twice once years ago and one about 7 years ago after the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2861591 50 M MI 09/26/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 ey57a
Wrong technique in product usage process Wrong technique in product usage process
it was administered using an IM technique, but a SC needle length was used; This non-serious case wa... it was administered using an IM technique, but a SC needle length was used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect needle gauge used in a 50-year-old male patient who received HAV (Havrix) (batch number ey57a, expiry date 03-OCT-2026) for prophylaxis. On 28-AUG-2025, the patient received Havrix. On 28-AUG-2025, an unknown time after receiving Havrix, the patient experienced incorrect needle gauge used (Verbatim: it was administered using an IM technique, but a SC needle length was used). The outcome of the incorrect needle gauge used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-AUG-2025 Reporter stated that they had a vaccination that was inappropriately administered. It was administered using an intramuscular IM technique, but a subcutaneous SC needle length was used. The Vaccine Administration Facility was the same as Primary Reporter. Healthcare professional reported that they used a 5/8 needle, instead of a 1 inch needle. More
2861592 IN 09/26/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Pharmacist that reports a patient came to receive a late second dose; This non-serious case was repo... Pharmacist that reports a patient came to receive a late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (first dose was received in Feb-2025). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: Pharmacist that reports a patient came to receive a late second dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-SEP-2025 Pharmacist reported that a patient came to receive a late second dose (first dose was administered on February Twenty twenty-five). Pharmacist had enquired about the scheduling advise. More
2861594 55 F TX 09/26/2025 FLU3
 SEQIRUS, INC.
 407251
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event observed or reported by patient. Wrong vaccine for age group was administered. No adverse event observed or reported by patient. Wrong vaccine for age group was administered.
2861595 0.5 F AL 09/26/2025 HIBV
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 35FA4
Z010141
Rash, Rash macular, Respiratory tract congestion, Stertor; Rash, Rash macular, R... Rash, Rash macular, Respiratory tract congestion, Stertor; Rash, Rash macular, Respiratory tract congestion, Stertor More
About 15 min after leaving office, family came back. States that patient developed a rash and sounde... About 15 min after leaving office, family came back. States that patient developed a rash and sounded congested. Dr stated that patient had faint stertor noises upon arrival. By time of my exam a few minutes later, patient had very faint macular rash on scalp. No other new rash noted on body. No respiratory symptoms noted. Mom has pictures of rash that was more prominent on face/head, but not noted elsewhere. Offered continued observation and dose of antihistamine, but family declined since she was better. Feel okay to get these vaccines in future. May premed with benadryl or zyrtec prior to shot. Will complete VAERS report. More
2861635 M 09/26/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
spent several days in hospital after RSV shot; This serious case was reported by a consumer via inte... spent several days in hospital after RSV shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced hospitalization (Verbatim: spent several days in hospital after RSV shot) (serious criteria hospitalization). The outcome of the hospitalization was resolved. It was unknown if the reporter considered the hospitalization to be related to RSV vaccine. The company considered the hospitalization to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 19-SEP-2025 This case was reported by the patient's sibling via interactive digital media. The reporter's brother spent several days in hospital after his RSV shot. It was made from Hamster Ovaries, red meat. The reporter wondered how many others nearly died because some of these vaccines were made with red meat, and Covid or flu shots and their risk was greater if they take them than it was to get the disease.; Sender's Comments: A case of Hospitalisation, unknown time after receiving RSV vaccine, in a male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
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2861636 4 M AL 09/26/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Expired product administered Expired product administered
Expired vaccine used/kinrix expired used; This non-serious case was reported by a other health profe... Expired vaccine used/kinrix expired used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. On 05-SEP-2025, the patient received Kinrix (intramuscular). On 05-SEP-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine used/kinrix expired used). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 The medical assistant reported that an expired Kinrix was administered which led to expired vaccine use. More
2861637 F NY 09/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4ZS72
Erythema, Feeling hot, Hypersensitivity, Swelling Erythema, Feeling hot, Hypersensitivity, Swelling
swelling, redness, warmth; redness; warmth; Likely allergic reaction; This non-serious case was rep... swelling, redness, warmth; redness; warmth; Likely allergic reaction; This non-serious case was reported by a other health professional and described the occurrence of swelling in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ZS72, expiry date 26-APR-2027) for prophylaxis. On 09-SEP-2025, the patient received Shingrix (intramuscular) .5 ml. On 09-SEP-2025, less than a day after receiving Shingrix, the patient experienced swelling (Verbatim: swelling, redness, warmth), erythema (Verbatim: redness), feeling of warmth (Verbatim: warmth) and allergic reaction (Verbatim: Likely allergic reaction). The outcome of the swelling, erythema, feeling of warmth and allergic reaction were not resolved. It was unknown if the reporter considered the swelling, erythema, feeling of warmth and allergic reaction to be related to Shingrix. It was unknown if the company considered the swelling, erythema, feeling of warmth and allergic reaction to be related to Shingrix. More
2861638 IL 09/26/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
Boostrix reached maximum temperature of (62.6F) for 6 hours 23 minutes and 0 seconds; This non-serio... Boostrix reached maximum temperature of (62.6F) for 6 hours 23 minutes and 0 seconds; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. The patient received Boostrix. After receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix reached maximum temperature of (62.6F) for 6 hours 23 minutes and 0 seconds). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 27-AUG-2025 The reporter (nurse) mentioned that the patient was administered with the Boostrix and Prevnar 20 that reached a maximum temperature. More
2861639 M IN 09/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Inappropriate schedule of product administration; Herpes zoster, ... Herpes zoster, Inappropriate schedule of product administration; Herpes zoster, Inappropriate schedule of product administration More
Outbreak of Shingles; second dose of Shingrix, received in March 2025; This non-serious case was rep... Outbreak of Shingles; second dose of Shingrix, received in March 2025; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included live herpes zoster vaccine (received the live herpes zoster vaccine in 2016). In MAR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix and after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of Shingrix, received in March 2025). On an unknown date, the patient experienced shingles (Verbatim: Outbreak of Shingles). The outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-SEP-2025 After receiving the first dose of Shingrix in 2025 patient had an outbreak of shingles in 2025 and was advised to receive a second dose of Shingrix, patient received a second dose in MAR-2025. Patient stated that he needs another Shingrix by 28-SEP-2025 (6 months from previous) to get maximum efficacy. More
2861640 09/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Hypoaesthesia Herpes zoster, Hypoaesthesia
had it on right side of my face also; right side nose, lip, and cheek still numb; This non-serious c... had it on right side of my face also; right side nose, lip, and cheek still numb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had it on right side of my face also) and numbness facial (Verbatim: right side nose, lip, and cheek still numb). The outcome of the shingles and numbness facial were not reported. It was unknown if the reporter considered the shingles and numbness facial to be related to Shingles vaccine. It was unknown if the company considered the shingles and numbness facial to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient only had 1 Shingles vaccine and going to take other one. The patient had it (shingles) on right side of face also. The patient right side nose, lip, and cheek still numb since DEC 2025. More
2861641 20 F CA 09/26/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 TX77L
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Infanrix given to a patient, instead of Boostrix; Infanrix given to a 20-year-old patient; This non-... Infanrix given to a patient, instead of Boostrix; Infanrix given to a 20-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old female patient who received DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 21-AUG-2025, the patient received Infanrix. The patient did not receive Boostrix. On 21-AUG-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix given to a patient, instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infanrix given to a 20-year-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-AUG-2025 Nurse reported that Infanrix was given to a patient, instead of Boostrix. The vaccine administration facility was the same as primary reporter. More
2861642 1.5 M NJ 09/26/2025 UNK
 UNKNOWN MANUFACTURER
 FH4YR
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
patient did not get the full dose of Flulaval because he moved his arm while receiving the shot; Thi... patient did not get the full dose of Flulaval because he moved his arm while receiving the shot; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 18-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number FH4YR, expiry date 02-JUN-2026) for prophylaxis. On 29-AUG-2025, the patient received the 1st dose of FluLaval 2025-2026 season. On 29-AUG-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced accidental underdose (Verbatim: patient did not get the full dose of Flulaval because he moved his arm while receiving the shot). The outcome of the accidental underdose was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 29-AUG-2025 A medical assistant called to get guidance after a patient did not get the full dose of Flulaval because he moved his arm while receiving the shot. The reporter wanted to know if the shot was valid. More
2861643 VA 09/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This no... 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 Reporter called to report a temperature excursion involving Shingrix vaccines. The reporter stated that the vaccines were exposed to a temperature of 32.8?degree C for 93 hours, with no prior excursions reported. During the call, the healthcare professional inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117352:same reporter, different patient US-GSK-US2025117358:same reporter US-GSK-US2025117361:same reporter US-GSK-US2025117367:same reporter, different patient US-GSK-US2025117365:same reporter US-GSK-US2025117362:same reporter More
2861644 TX 09/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 mg5s9
Product preparation issue Product preparation issue
they only gave the adjuvant vial; they only gave the adjuvant vial; This non-serious case was report... they only gave the adjuvant vial; they only gave the adjuvant vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number mg5s9, expiry date 30-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: they only gave the adjuvant vial) and inappropriate dose of vaccine administered (Verbatim: they only gave the adjuvant vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 12-SEP-2025 The pharmacist reported that they used only one vial of the Shingrix on a patient and asked what they need to do. Also stated that they used the green vial and not the brown, they only gave the adjuvant. More
2861645 09/26/2025 COVID19
 MODERNA
Arthralgia, Body temperature, Pain in extremity, Pyrexia Arthralgia, Body temperature, Pain in extremity, Pyrexia
After the 1st dose I had slight arm pain/after the 2nd dose arm pain; after the 2nd dose arm pain, w... After the 1st dose I had slight arm pain/after the 2nd dose arm pain; after the 2nd dose arm pain, wrist; fever up to 38.5 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the 1st dose I had slight arm pain/after the 2nd dose arm pain), ARTHRALGIA (after the 2nd dose arm pain, wrist) and PYREXIA (fever up to 38.5 degrees) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After the 1st dose I had slight arm pain/after the 2nd dose arm pain), ARTHRALGIA (after the 2nd dose arm pain, wrist) and PYREXIA (fever up to 38.5 degrees). At the time of the report, PAIN IN EXTREMITY (After the 1st dose I had slight arm pain/after the 2nd dose arm pain), ARTHRALGIA (after the 2nd dose arm pain, wrist) and PYREXIA (fever up to 38.5 degrees) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fever upto 38.5 degrees. No concomitant medications were reported. It was reported that the patient not found any other emails or pages where they could contact the pharmacovigilance department to report side effects. After the first dose, the patient experienced slight arm pain. After the second dose, patient had arm pain, wrist pain, and a fever up to 38.5 degrees. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Upon internal review on 18-Sep-2025, significant correction was performed to update case type to valid from invalid, added suspect product second dose regimen and events (fever and wrist pain). Also, It was identified that the information in cases MOD-2021-298294 and MOD-2021-298283 are pertaining to the same patient and same product. Hence, all information from the case MOD-2021-298294 was added and merged with the retained case MOD-2021-298283. The case MOD-2021-298294 will be deleted from the safety database. On 18-Dec-2023: Upon internal review on 18-Dec-2023, non-significant correction was performed to update country of incidence, reporter country, patient country, country in which event occurred for all events and suspect product was re-selected (drug authorization country and obtain drug country updated). More
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