🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2844266 66 F FL 06/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
DUPLICATE VACCINE. PATIENT RECEIVED BOOSTRIX 07/25/2024 DUPLICATE VACCINE. PATIENT RECEIVED BOOSTRIX 07/25/2024
2844267 50 M 06/08/2025 PNC21
PNC21
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y013009
Y013009
JS3S4
JS3S4
Confusional state, Euphoric mood, Hand-eye coordination impaired, Loss of person... Confusional state, Euphoric mood, Hand-eye coordination impaired, Loss of personal independence in daily activities, Muscular weakness; Panic reaction; Confusional state, Euphoric mood, Hand-eye coordination impaired, Loss of personal independence in daily activities, Muscular weakness; Panic reaction More
After receiving PCV21 and Shingrix at the same time, starting later that day or next day - felt ... After receiving PCV21 and Shingrix at the same time, starting later that day or next day - felt 'loopy' and confused for 3 days - panicky, disassociating, dropping things, poor hand-eye coordination - needed help being fed. More
2844268 67 F MN 06/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Injection site bruising, Injection site erythema, Injection site irritation, Inj... Injection site bruising, Injection site erythema, Injection site irritation, Injection site swelling More
Patient reported redness, swelling, and bruising at the injection site. Symptoms started the day aft... Patient reported redness, swelling, and bruising at the injection site. Symptoms started the day after receiving the injection. Injection site was still swollen and red 4 days later. Injection site was not warm to the touch or looked very irritated when seen today. More
2844269 61 F MD 06/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 pj353
Chills, Injection site erythema, Injection site swelling, Pyrexia Chills, Injection site erythema, Injection site swelling, Pyrexia
slight swelling, redness on the injection site. But patient has blistering rash on both arms. She sa... slight swelling, redness on the injection site. But patient has blistering rash on both arms. She said the day she got the shot, she started having fever and chills from about 8pm that day More
2844270 70 F NC 06/08/2025 PNC21
 MERCK & CO. INC.
 Y019158
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Patient reported severe arm/shoulder pain that prompted a visit to the emergency room. Patient reported severe arm/shoulder pain that prompted a visit to the emergency room.
2844271 42 M VA 06/08/2025 ANTH
 EMERGENT BIOSOLUTIONS
 300217a
Erythema, Induration, Pruritus, Skin warm Erythema, Induration, Pruritus, Skin warm
Localized erythema, induration, increased warmth, and pruritus. No medical intervention. Localized erythema, induration, increased warmth, and pruritus. No medical intervention.
2844272 43 F WV 06/08/2025 COVID19
TDAP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 md3414
pd324
Syncope; Syncope Syncope; Syncope
Patient had a syncope episode after receiving the vaccines. Patient 911 was contacted and the patien... Patient had a syncope episode after receiving the vaccines. Patient 911 was contacted and the patient was transported to the hospital. More
✓
2844273 52 F TX 06/08/2025 TDAP
TDAP
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5S945
5S945
295S7
295S7
Arthralgia, Neck pain, Pain, Paralysis, Peripheral coldness; Raynaud's phen... Arthralgia, Neck pain, Pain, Paralysis, Peripheral coldness; Raynaud's phenomenon; Arthralgia, Neck pain, Pain, Paralysis, Peripheral coldness; Raynaud's phenomenon More
Paralysis in neck, sharp shooting pains in neck, aches all over body. Saw chiropractor, didn't ... Paralysis in neck, sharp shooting pains in neck, aches all over body. Saw chiropractor, didn't help, couldn't get into doctors. Couldn't get in hospital for treatment be. Eventually regained movement. Severe pain lasted 48 hrs. Slowly reduced in severity over a period of several months. A month or so later, developed Reynauds disease, causing severe cold feelings in toes and fingers when room temperature dropped below about 72 degrees, also developed severed arthritis like pain in knees, hips, ankles. It's hard to know if this is from the TDAP/Shingles Vaccine combination, or the COVID vaccines I had the previous month. More
✓
2844277 71 M NY 06/08/2025 COVID19
 MODERNA
Dizziness, Vertigo Dizziness, Vertigo
Dizziness vertigo Dizziness vertigo
2844278 76 M CA 06/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ME6072
ME6072
Back pain, Muscle injury, Neck pain, Pain in extremity, Product administered at ... Back pain, Muscle injury, Neck pain, Pain in extremity, Product administered at inappropriate site; Skeletal injury More
Shortly after vaccine administration, patient began experiencing severe upper arm, neck and back pai... Shortly after vaccine administration, patient began experiencing severe upper arm, neck and back pain on a scale of 8 out of 10. Pharmacist (redacted name) confirmed administration was too high up on arm and probably adversely impacted either deltoid muscle or bone. Patient saw PCP on 05/23/2025 and again on 06/12/2025 to discuss ongoing severe pain. PCP also confirmed injury was either to deltoid muscle or bone due to improper vaccine administration too high up on arm. Vaccine site was 2 fingers below top of shoulder. Pain continues at level 8 out of 10. More
✓
2844279 57 F CA 06/08/2025 COVID19
 PFIZER\BIONTECH
 EW0187
Sensitive skin Sensitive skin
progressively worsening/intensifying skin sensitivity to visible light progressively worsening/intensifying skin sensitivity to visible light
2844280 83 M AL 06/08/2025 RSV
 PFIZER\WYETH
 HY1813
Extra dose administered Extra dose administered
none reported none reported
2844281 56 F TX 06/08/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
pain at site of injection following administeration, erythyma at injection site 24 hours post admini... pain at site of injection following administeration, erythyma at injection site 24 hours post administration with continued growth in circumference 4 days post administeration -- site of erythma without reduction in size to date More
2844233 4 F PA 06/07/2025 DTAPIPV
 SANOFI PASTEUR
 U7838AA
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
patients had injection site reaction that was red; injection site reaction that was swollen; injecti... patients had injection site reaction that was red; injection site reaction that was swollen; injection site reaction that was hot to touch; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who had injection site reaction that was red, swollen and was hot to touch after receiving Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine live (ENDERS-EDMONSTON), Mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Immunisation. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 HYBRID AC pertussis/IPV (VERO) vaccine Suspension for injection (lot U7838AA and expiry date- 25-Jul-2027) strength-unknown via intramuscular route in the left deltoid for Immunization. On an unknown date the patient developed injection site reaction that was red, swollen, and hot to touch (vaccination site erythema), (vaccination site swelling) and (vaccination site warmth) (latency: unknown). Reportedly- 3 separate patients that had reaction with specific lot number. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2844234 0.33 M WA 06/07/2025 IPV
 SANOFI PASTEUR
 W1C831M
Product storage error Product storage error
administered vaccine that had temperature excursion Max/low temperature reached: Maximum 10 C, durat... administered vaccine that had temperature excursion Max/low temperature reached: Maximum 10 C, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 4 months old male patient who administered IPV (VERO) [IPOL] that had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jun-2025, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C831M, expiry date: 21-Nov-2025, strength: standard and frequency: once) via unknown route in unknown administration site for immunization and had temperature excursion max/low temperature reached: maximum 10 celsius, duration between 15 minutes to 2 hours and staff noticed it at around 4:00 m in the morning with no reported adverse event (poor quality product administered) (Latency: same day). Reportedly, Human error was No. Reason: Fridge just gave out and they had to replace it. Product was administered post excursion. Extended stability data did not cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844235 F GA 06/07/2025 RAB
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
imovax was told to take her booster shot on Day 7 and 21 but she took it on Day 9 with no reported a... imovax was told to take her booster shot on Day 7 and 21 but she took it on Day 9 with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves an unknown age female patient who was on RABIES (HDC) VACCINE [IMOVAX RABIES] was told to take her booster shot on day 7 and 21 but she took it on day 9 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a Booster dose of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization was told to take her booster shot on day 7 and 21 but she took it on day 9 with no reported adverse event (inappropriate schedule of product administration) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844245 12 M WA 06/07/2025 FLU3
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8518DA
U8193AA
Gastrooesophageal reflux disease, Injection site erythema, Injection site swelli... Gastrooesophageal reflux disease, Injection site erythema, Injection site swelling, Injection site urticaria; Gastrooesophageal reflux disease, Injection site erythema, Injection site swelling, Injection site urticaria More
Developed significant redness and swelling of right upper arm following vaccination, has had recurre... Developed significant redness and swelling of right upper arm following vaccination, has had recurrent urticaria localized to vaccine site on right upper arm as often as daily to weekly since October 2024. More
2844246 61 M FL 06/07/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 018B21A
939905
037B21A
Coronary arterial stent insertion, Coronary artery thrombosis, Laboratory test, ... Coronary arterial stent insertion, Coronary artery thrombosis, Laboratory test, Myocardial infarction; Coronary arterial stent insertion, Coronary artery thrombosis, Laboratory test, Myocardial infarction; Coronary arterial stent insertion, Coronary artery thrombosis, Laboratory test, Myocardial infarction More
February 14th 2025 had a blood clot heart attack had to have a stent put in February 14th 2025 had a blood clot heart attack had to have a stent put in
✓ ✓ ✓
2844247 50 M ND 06/07/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Burning sensation, Immediate post-injection reaction, Injection site pain, Muscu... Burning sensation, Immediate post-injection reaction, Injection site pain, Muscular weakness, Shoulder injury related to vaccine administration; X-ray abnormal More
routine wellness visit with vaccinations with simultaneous vaccine administration by two people: on... routine wellness visit with vaccinations with simultaneous vaccine administration by two people: one in left arm without difficulty but right upper arm vaccination administration with immediate pain and burning from shoulder into top of hand. Within 3 hours the right arm pain progressed to a 10 on a scale of 0-10 including weakness and overall disability. More
2844248 3 M NY 06/07/2025 MMR
 MERCK & CO. INC.
 yo19905
Culture, Hypophagia, Oropharyngeal pain, Streptococcus test negative, Urticaria Culture, Hypophagia, Oropharyngeal pain, Streptococcus test negative, Urticaria
+ hives on lower back and upper buttocks and L posterior shoulder, decreased po intake ? sore throat... + hives on lower back and upper buttocks and L posterior shoulder, decreased po intake ? sore throat. Rapid strep in office negative. RVP 7 pending. No hx of prior hives. Mom with chronic urticaria following covid 19 vaccination and very hesitant to give child vaccines. Mom's urticaria progressed to anaphylaxis symptoms and required ER visit and she subsequently carries an Epipen. More
2844249 5 M FL 06/07/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y020300
Ear swelling, Erythema, Peripheral swelling, Swelling face; Ear swelling, Erythe... Ear swelling, Erythema, Peripheral swelling, Swelling face; Ear swelling, Erythema, Peripheral swelling, Swelling face More
Facial swelling, ear lob swelling, and erythema to the lateral aspect of the right arm. 2" x 2&... Facial swelling, ear lob swelling, and erythema to the lateral aspect of the right arm. 2" x 2" erythematous firm swelling on the left arm at the sight of the immunization. Diphenhydramine and Prednisolone administered in the clinic. Facial swelling and erythema significantly improved. Patient discharged home and advised to follow up with PCP in 2 days. Advised to call 911 or seek care at the ER for worsening symptoms. More
2844250 51 F FL 06/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Rash, Rash macular Rash, Rash macular
BLOTCHY NECK RASH PER PT BLOTCHY NECK RASH PER PT
2844251 5 M FL 06/07/2025 PPV
 MERCK & CO. INC.
 X022827
Nasal congestion, Swelling of eyelid Nasal congestion, Swelling of eyelid
Patient presented to the walk-in clinic with bilateral eye swelling (eyes swollen shut) and nasal co... Patient presented to the walk-in clinic with bilateral eye swelling (eyes swollen shut) and nasal congestion. Keeping his head covered in a blanket and reluctant to talk to parents. Oral Prednisolone and Diphenhydramine was administered in the clinic. Nasal congestion improved and he was able to start opening his eyes. Patient was discharged home on Prednisolone and Benadryl and advised to follow up with PCP in 2 days. Parents where advised to call 911 or take the child straight to the ER for worsening symptoms. More
2844252 72 F KY 06/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 35A77
Dizziness, Dyspnoea, Hypopnoea, Loss of consciousness, Malaise Dizziness, Dyspnoea, Hypopnoea, Loss of consciousness, Malaise
Patient was administered the vaccine and as soon as she got the shot she complained of not feeling w... Patient was administered the vaccine and as soon as she got the shot she complained of not feeling well. Shortly, she complained feeling dizzy and could not breath. Emergency services were alerted 911 was called. Pharmacist checked the patient and she was breathing very shallow with no sign of consciousness. Pharmacist determined that Epinephrine was warranted and administered Epinephrine. Patient gained consciousness within few minutes and the EMS arrived and checked her. We followed up with the patient the next day and she said she was doing fine. She had to go back to ER on Friday night and they observed her for 3 hours, her BP was high and they did not find anything significant to hospitalize her. More
2844253 38 F IL 06/07/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 56G74
Expired product administered Expired product administered
Received vaccine after expiration. Expired 5/24/25 Received vaccine after expiration. Expired 5/24/25
2844254 48 F OH 06/07/2025 TDAP
 SANOFI PASTEUR
Injection site pain, Injection site swelling, Mobility decreased Injection site pain, Injection site swelling, Mobility decreased
PATIENT REPORTED THAT SHE HAD SEVERE PAIN AT THE SITE AND HAD COMPROMISED RANGE OF MOTION, SWELLING ... PATIENT REPORTED THAT SHE HAD SEVERE PAIN AT THE SITE AND HAD COMPROMISED RANGE OF MOTION, SWELLING AT SITE WITH PIMP-LIKE CHARACTERISTICS More
2844255 52 F NC 06/07/2025 PNC21
 MERCK & CO. INC.
 Z005765
Erythema, Pain, Swelling Erythema, Pain, Swelling
local reaction: redness swelling ( size of a tangerine) and pain. treated symptomatically ( over the... local reaction: redness swelling ( size of a tangerine) and pain. treated symptomatically ( over the counter pain meds, ice, monitoring) More
2844256 73 F 06/07/2025 PNC21
 MERCK & CO. INC.
Injection site pain, Pyrexia, Rash, Swelling Injection site pain, Pyrexia, Rash, Swelling
Swelling, Rash, Fever and soreness injection site Swelling, Rash, Fever and soreness injection site
2844257 4 F OR 06/07/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Quadracel (Dtap-IPV combination) was given in Left upper Thigh to patient on 6/5/25. This is the pat... Quadracel (Dtap-IPV combination) was given in Left upper Thigh to patient on 6/5/25. This is the patients 5th dose of Dtap and 4th dose of IPV. Patient went home with no complaints of swelling, redness a=immediately after vaccine was given. Mom noticed Redness and swelling spreading toward the inner thigh on 6/6/25 around 10 AM and drew a mark around the area to keep track of the swelling and redness. Mom reports that when patient woke up this morning 6/7/25 at 7:30 AM there was a much larger amount of swelling than the morning before on 6/6 which prompted her to call the officeand request an appointment. Mom came into the office at 10:30 to be seen with physicians assistant who saw the patient and asked for a consult with another in house provider. Both physicians decided that it did not look like typical cellulitis as the redness was not spreading bilaterally from the vaccine administration sight and was instead spreading toward her inner thigh from the vaccine administration sight. Patient was given a 10ml dose of cetirizine in clinic to see if that would help the redness and swelling to go down. Patient was monitored for an hour after dose was given and there was no change in the reaction sight. Providers decided to prescribe patient cephalexin 2 times daily for 7 days to be on the safe side in the case that it is cellulitis. More
2844258 28 M TX 06/07/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 045B21A
045B21A
045B21A
045B21A
Dyspepsia, Endoscopy upper gastrointestinal tract abnormal, Eructation, Gastriti... Dyspepsia, Endoscopy upper gastrointestinal tract abnormal, Eructation, Gastritis, Malaise; Myositis, Oesophagitis; Dyspepsia, Endoscopy upper gastrointestinal tract abnormal, Eructation, Gastritis, Malaise; Myositis, Oesophagitis More
Developed inflammation in the stomach and esophagus in October 2023 after being sick. Still believe ... Developed inflammation in the stomach and esophagus in October 2023 after being sick. Still believe to have it to this day due to daily indigestion and burping. I also believe to have inflammation in my muscles, especially in the neck and shoulder area. More
2844259 72 M MI 06/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
Got shingles Got shingles
2844260 67 F AL 06/07/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y019158
3273H
Injection site erythema, Injection site inflammation, Injection site pain, Injec... Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pain; Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pain More
Patient states that 1 week after vaccination, shingrix vaccine is swollen, red/inflamed, and painful... Patient states that 1 week after vaccination, shingrix vaccine is swollen, red/inflamed, and painful with reaction radiating down to elbow More
2844261 37 M KS 06/07/2025 PPV
 MERCK & CO. INC.
Arthralgia, Erythema, Skin warm, Swelling, X-ray Arthralgia, Erythema, Skin warm, Swelling, X-ray
Swelling, red, heat in arm 5-6 days after injection. 3-4 weeks after injection, severe joint pain i... Swelling, red, heat in arm 5-6 days after injection. 3-4 weeks after injection, severe joint pain in feet, knees, some fingers, and left elbow. More
2844262 68 M WA 06/07/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Arthralgia, Pain, Sleep disorder Arthralgia, Pain, Sleep disorder
Sore shoulder for over 10 days - waking up in middle of the night, can't comfortably raise left... Sore shoulder for over 10 days - waking up in middle of the night, can't comfortably raise left arm more than shoulder height. Pain started after vaccine administration, slowly getting better. More
2844263 17 F OH 06/07/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Abdominal distension, Arthralgia, Nausea, Peripheral swelling, Pyrexia; Swelling... Abdominal distension, Arthralgia, Nausea, Peripheral swelling, Pyrexia; Swelling face, Throat irritation More
Joint pain, fever, scratchy throat, swelling of joints, fingers and feet and face., nausea Joint pain, fever, scratchy throat, swelling of joints, fingers and feet and face., nausea
2844288 73 F NY 06/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3273H
3273H
Injection site mass, Injection site pruritus, Oral mucosal eruption, Oral pain, ... Injection site mass, Injection site pruritus, Oral mucosal eruption, Oral pain, Rash; Rash pruritic More
Patient was in to receive her 2nd shingles dose on 6/4/25. Called pharmacy on 6/7/25 to report an it... Patient was in to receive her 2nd shingles dose on 6/4/25. Called pharmacy on 6/7/25 to report an itchy rash on certain parts of her body that started the day after the vaccine. She is reporting allergic type, itchy rash on back of right neck, lower back and left side of mouth. She is also reporting that the roof of her mouth is sore and has to consume soft, non-spicy, non-acidic type foods. She also is reporting 2 bumps a few inches below the injection site that are not painful. she has not had any difficulty breathing, has been using ice and taking benadryl. Patient did not have any reactions to dose 1 of the series More
2844131 IN 06/06/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



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 AE; HCP called and reported a patient who received their first dose of MMR-II and VARI... No additional AE; HCP called and reported a patient who received their first dose of MMR-II and VARIVAX on 08AUG2024 and was inadvertently given a second dose of MMR-II and VARIVAX on 15MAY2025. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 24-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-Aug-2024, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (indication, expiration date, and lot # were not reported) diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) for prophylaxis. On 15-May-2025, the patient received inadvertently the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (indication, expiration date, and lot # were not reported) diluted with sterile diluent (MERCK STERILE DILUENT) (indication, expiration date, and lot # were not reported) (Inappropriate schedule of product administration). No additional adverse event was reported. More
2844133 NM 06/06/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
HCP called to state that the patient has missed their window to receive a second dose of GARDASIL 9 ... HCP called to state that the patient has missed their window to receive a second dose of GARDASIL 9 series according to the outlined schedule in the prescribing information.; No additional AE; This spontaneous report was received from a pharmacist referring to a 25-year-old patient, gender was not provided. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, reported as 1 or 2 years ago, the patient received the first dose of Human Papillomavieus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) injection 0,5 ml, administered for prophylaxis (route of administration, anatomical location, lot number and expiration date was not reported), the reporter mentioned that the patient not received their second dose. (Inappropriate schedule of product administration). There was not adverse event reported. More
2844135 52 F NE 06/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273H
Product preparation issue Product preparation issue
Administration of the liquid portion only; This non-serious case was reported by a nurse via call ce... Administration of the liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis. On 22-MAY-2025, the patient received the 1st dose of Shingrix. On 22-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the liquid portion only). The outcome of the inappropriate preparation of medication was not applicable. Additional Information: GSK Receipt Date: 30-MAY-2025 A nurse administered the Shingrix vaccine incorrectly. She drew up the adjuvant and she administer it without mixing it into the antigen component which led to inappropriate preparation of medication. And when she realized what she did, she attempted to correct the error on her own and she mix the antigen component with sterile saline, then drew that and administer that into a separate limb. A nurse reported that this happened on 22 May 2025 and the patient received both injections on the same day (on different limb). This was the 1st Shingrix dose. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.; Reporter's Comments: Wrong tech used in reconstitution Inappropriate preparation of medication More
2844136 0.25 M WA 06/06/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK167AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
pentacel liquid component was administered, however, not with the ActHIB lyophilized powder with no ... pentacel liquid component was administered, however, not with the ActHIB lyophilized powder with no reported adverse event; first dose of PENTACEL was administered at 3 months instead of 2 months with no reported AE; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional with a live follow-up together (CSD: 03-Jun-2025). This case involves a 3 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] liquid component was administered, however, not with the ACT-HIB lyophilized powder instead at the age of 2 months with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V for Immunization. On 12-May-2025, the patient received 0.5 ml of dose 1 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with strength- standard (expiry date- 31-Oct-2025 and lot UK167AA) once via intramuscular route in the right thigh for Immunization and liquid component was administered, however, not with the ACTHIB lyophilized powder (single component of a two-component product administered) at the age of 3 months instead of 2 months with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Reportedly, reporter asked if the liquid was a valid dose and what diluent could be used. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844137 M FL 06/06/2025 TDAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
two-day old patient was administered ADACEL last month, with no reported adverse event; Initial info... two-day old patient was administered ADACEL last month, with no reported adverse event; Initial information received on 04-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 days old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] last month, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in May 2025, the 2 days old patient last month received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: standard and frequency: once) (lot number and expiry date not reported) via intramuscular route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, They wanted to know what the possible adverse events are and what the monitoring requirements would be. Treatment: Patient was monitored for reactions. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844138 MA 06/06/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
ACTHIB was prepared with 0.7 ml SW as diluent with no reported adverse event; Initial information re... ACTHIB was prepared with 0.7 ml SW as diluent with no reported adverse event; Initial information received on 04-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who was administered with HIB (PRP/T) Vaccine [ACT-HIB] which was prepared with 0.7 ml SW as diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) for Immunisation and it was prepared with 0.7 ml SW as diluent with no reported adverse event (single component of a two-component product administered). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, they asked for appropriate follow up and any potential side effect. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844147 57 FL 06/06/2025 TD
 SANOFI PASTEUR
Off label use, Skin laceration Off label use, Skin laceration
tenivac prescribed with off label diagnosis laceration without foreign body of other part of head, i... tenivac prescribed with off label diagnosis laceration without foreign body of other part of head, initial encounter (with no reported ae); Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 57 years old and unknown gender patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] prescribed with off label diagnosis laceration without foreign body of other part of head, initial encounter with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult; Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for Laceration without foreign body of other part of head, initial encounter (Skin laceration) with no reported ae (off label use) (unknown latency). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2844165 0.58 IL 06/06/2025 MMR
 MERCK & CO. INC.
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
no other AE; the MMR-II vaccine to a 7 month old patient; This spontaneous report was received from ... no other AE; the MMR-II vaccine to a 7 month old patient; This spontaneous report was received from a health business professional (HBP) and refers to a 7-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-MAY-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered for prophylaxis (strength, dose, route, lot #, and expiration date were not reported) (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). It was reported that the patient would be travelling outside of the country next week, so the patient was back in the office on 04-JUN-2025 to receive Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and Pneumococcal vaccine conj 7v (CRM197) (PREVNAR). The reporter did not provide which "PREVNAR" that the patient would be receiving and did not provide any further information or patient information. No other adverse event was reported. Lot# is being requested and will be submitted if received. More
2844166 F TX 06/06/2025 PNC21
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Antibody test negative; Antibody test negative Antibody test negative; Antibody test negative
she's (physician) not seeing the antibodies she is looking for; This spontaneous report was rec... she's (physician) not seeing the antibodies she is looking for; This spontaneous report was received from a pharmacist on 04-Jun-2025 and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (a long time ago), the patient may be vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (lot # and expiration date were not reported) as prophylaxis (it was stated that the reporter was uncertain as the patient may have never received it). In April 2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # and expiration date were not reported) as prophylaxis. The physician wanted the patient to receive Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) because the physician not seeing the antibodies she was looking for (Antibody test negative). The reporter inquired about dosing interval between the two vaccines. At the reporting time, the outcome of the event was unknown. The action taken with the vaccines was not applicable. The causal relationship between the event and both of the vaccines not provided. Batch/lot number is being requested and will be submitted if received. More
2844167 CA 06/06/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 T016159
T034630
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
HCP called as she was looking over documentation and realized that the patient may have received 2 d... HCP called as she was looking over documentation and realized that the patient may have received 2 doses of PNEUMOVAX 23 about 6 months apart (please see below). The HCP was unable to confirm if this was a simple documentation error or if the patient; No additional AE/No PQC.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 02-Sep-2021, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), lot #T016159 which has been verified to be valid, expiration date: 28-Feb-2022, administered at a dose of 0.5 milliters, for prophylaxis (route of administration and anatomical site of injection were not reported). On 02-Mar-2022, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), lot # T034630 which has been verified to be valid, expiration date: 22-Jun-2022, administered at a dose of 0.5 milliters, for prophylaxis (route of administration and anatomical site of injection not reported). The reporter was looking over documentation and realized that the patient may have received 2 doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) about 6 months apart (Extra dose administered). The reporter was unable to confirm if this was a simple documentation error or if the patient actually received two doses. The reason behind the second dose in question was unknown. No additional information and no additional adverse event were reported at the time (no adverse event). More
2844168 06/06/2025 COVID19
 MODERNA
Body temperature, Pyrexia Body temperature, Pyrexia
After my previous dose last December, I had a fever of 101�F, which has been a consistent reaction... After my previous dose last December, I had a fever of 101�F, which has been a consistent reaction for me after Moderna vaccines in the past; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After my previous dose last December, I had a fever of 101�F, which has been a consistent reaction for me after Moderna vaccines in the past) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (After my previous dose last December, I had a fever of 101�F, which has been a consistent reaction for me after Moderna vaccines in the past). At the time of the report, PYREXIA (After my previous dose last December, I had a fever of 101�F, which has been a consistent reaction for me after Moderna vaccines in the past) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101degree Farenheit. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that patient received last dose of Moderna vaccine on last December and she experienced fever of 101-degree Fahrenheit, which had been a consistent reaction for the patient after Moderna vaccines in the past. It was reported that patient recently received Spikevax 2024-2025 PFS vaccine and patient doesn't experience any fever at all. Patient was just wondering since the "DIS" date was quite a while ago (Aug-2024), could that affect the vaccine's effectiveness. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. This case was linked to MOD-2025-787102 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2025: Live follow-up received contains non-significant information and reference number added. More
2844170 06/06/2025 COVID19
 MODERNA
Body temperature, Pyrexia Body temperature, Pyrexia
After my previous dose last December, I had a fever of 101�F; This spontaneous case was reported b... After my previous dose last December, I had a fever of 101�F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After my previous dose last December, I had a fever of 101�F) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In December 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (After my previous dose last December, I had a fever of 101�F). At the time of the report, PYREXIA (After my previous dose last December, I had a fever of 101�F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: I had a fever of 101�F. Concomitant medication use information was not provided by reporter. It was reported that, in Dec-2024 patient received vaccine and experienced fever of 101-degree Fahrenheit, which was consistent reaction after Moderna vaccines in the past. Patient recently received another dose of Spikevax 2024-2025 PFS vaccine (lot 3043333) and did not experience any fever at all at this time. Patient was just wondering since the "DIS" date was quite a while ago (Aug-2024), could that affect the vaccine's effectiveness. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-787103 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2025: Live follow-up received which contains non-significant information, reference number added. More
2844171 66 F 06/06/2025 COVID19
 MODERNA
 039A20A
B-cell lymphoma B-cell lymphoma
Low grade B cell non-Hodgkin's lymphoma; This spontaneous case was reported by a consumer and d... Low grade B cell non-Hodgkin's lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A20A, 027A21A, 058E21A and 065K21A) for COVID-19 prophylaxis. Concurrent medical conditions included Gaucher's disease, Hypertension and Obesity. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 15-Jul-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) (seriousness criterion medically significant). At the time of the report, B-CELL LYMPHOMA (Low grade B cell non-Hodgkin's lymphoma) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Moderna COVID-19 Vaccine Dose 5 with lot AU3918E taken on 7-Nov-2023 and Dose 6 lot number 3042388 taken on 08-Oct-2024. The patient was diagnosed with low grade B cell non-Hodgkin's lymphoma in Jul-2023 after receiving the Moderna COVID-19 vaccine. She also had an incurable, lysosomal storage disorder genetic (Gaucher's) disease in which she had a Medi port that she took treatment, and an enzyme replacement therapy every other week to stay alive. She also had hypertension and was obese, all which was confirmed to be pre-existing prior to receiving the COVID-19 vaccines.; Reporter's Comments: Due to lack of biological plausibility (and long latency), the causality of the events was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
📋 Privacy Policy & Data Disclaimer