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
2831949 17 F NE 03/18/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 dd72h
dd72h
C-reactive protein normal, Dysuria, Escherichia test positive, Haematuria, Pyelo... C-reactive protein normal, Dysuria, Escherichia test positive, Haematuria, Pyelonephritis; White blood cell count increased More
within 72hrs dysuria and blood in urine, dx'd with pyelonephritis. within 72hrs dysuria and blood in urine, dx'd with pyelonephritis.
2831950 9 F OH 03/18/2025 HPV9
 MERCK & CO. INC.
Diarrhoea, Vomiting Diarrhoea, Vomiting
child was administered the Gardasil vaccine as ordered by Dr. no problems in the office. at 1:30 A... child was administered the Gardasil vaccine as ordered by Dr. no problems in the office. at 1:30 AM, child started having vomiting, multiple times during the night, and diarrhea once. More
2831951 49 F SC 03/18/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 393341
lg5575
Injection site erythema, Pain in extremity; Injection site erythema, Pain in ext... Injection site erythema, Pain in extremity; Injection site erythema, Pain in extremity More
Patient experienced severe arm pain and red ring on skin around the injection sites. Patient experienced severe arm pain and red ring on skin around the injection sites.
2831952 63 F IN 03/18/2025 PNC20
 PFIZER\WYETH
 LK6651
Injection site erythema, Injection site swelling, Pruritus Injection site erythema, Injection site swelling, Pruritus
Swelling to area of injection, red raised spots the size a a quarter from shoulder to elbow. R arm w... Swelling to area of injection, red raised spots the size a a quarter from shoulder to elbow. R arm was achy. Lasted from 2/26/25 thru 2/31/25 More
2831953 16 M MI 03/18/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 2014790
B4J4B
U8370AA
Hyperhidrosis, Musculoskeletal stiffness, Pallor, Tinnitus, Vision blurred; Hype... Hyperhidrosis, Musculoskeletal stiffness, Pallor, Tinnitus, Vision blurred; Hyperhidrosis, Musculoskeletal stiffness, Pallor, Tinnitus, Vision blurred; Hyperhidrosis, Musculoskeletal stiffness, Pallor, Tinnitus, Vision blurred More
Possible vasovagal syncope episode lasting about 5 seconds. Brief period of resident becoming pale, ... Possible vasovagal syncope episode lasting about 5 seconds. Brief period of resident becoming pale, diaphoretic, ears ringing, blurry vision. Resident laid back in the chair he was sitting in, legs extended, and was then stiff. Eyes open. He was able to follow commands. He sat up and consumed apple juice and had a snack. Cold pack placed on the back of his neck. Monitored x 15 mins in Nurses station. Reported he was well and feeling better and returned to his pod. More
2831955 NJ 03/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
used without the active vaccine component; used without the active vaccine component; This non-serio... used without the active vaccine component; used without the active vaccine component; 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) 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: used without the active vaccine component) and inappropriate dose of vaccine administered (Verbatim: used without the active vaccine component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 13-MAR-2025 The reporter need to ask about Shingrix vaccine and how to obtain extra diluent for the vaccine. A pharmacy that stocks this vaccine and one was inadvertently used without the active vaccine component. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2831956 0.33 M NC 03/18/2025 MENB
 PFIZER\WYETH
 HJ1516
Pyrexia, Vomiting, Wrong product administered Pyrexia, Vomiting, Wrong product administered
Patient was administered a dose of Trumenba in error, patient was supposed to get a dose of PCV20 in... Patient was administered a dose of Trumenba in error, patient was supposed to get a dose of PCV20 instead. Family counseled by provider, patients parent reported today 3/18/2025 patient had a fever and vomited once since administration. No treatment indicated for administration error. More
2831957 14 M TX 03/18/2025 HPV9
 MERCK & CO. INC.
 Y007193
Dyspnoea, Pyrexia, Sensitive skin Dyspnoea, Pyrexia, Sensitive skin
Patient mother reports the patient had a fever and shortness of breathe following the vaccine the ne... Patient mother reports the patient had a fever and shortness of breathe following the vaccine the next day. She also stated that the patients skin was sensitive. More
2831958 21 F 03/18/2025 HPV9
 MERCK & CO. INC.
Extra dose administered, No adverse event Extra dose administered, No adverse event
3rd does given when not recommended by guidelines since first 2 doses were given prior to age 14. No... 3rd does given when not recommended by guidelines since first 2 doses were given prior to age 14. No side effects reported. More
2831959 73 M TN 03/18/2025 FLU3
FLU3
RSV
RSV
 SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 388493
388493
P24D3
P24D3
Amnesia, Computerised tomogram normal, Confusional state, Decreased appetite, Fa... Amnesia, Computerised tomogram normal, Confusional state, Decreased appetite, Fatigue; Peripheral swelling, Road traffic accident, Somnolence, Thirst decreased, Ultrasound Doppler normal; Amnesia, Computerised tomogram normal, Confusional state, Decreased appetite, Fatigue; Peripheral swelling, Road traffic accident, Somnolence, Thirst decreased, Ultrasound Doppler normal More
Pt reports receiving a flu shot at the office and an RSV vaccine at pharmacy last Friday. By Saturda... Pt reports receiving a flu shot at the office and an RSV vaccine at pharmacy last Friday. By Saturday, he experienced extreme fatigue and memory loss. As a truck driver, he struggled with a routine delivery. Sleeping excessively at multiple stops and side-swiping a truck due to confusion. He lost track of time, mistakenly believing he would be home Sunday night when it was already Monday. He also did not eat or drink anything during this period. He suspects a reaction to the vaccines. Additionally, he developed swelling in his right leg and went to ER, where CT scan and US were normal. He was given a Rocephin shot and prescribed cephalexin. He denies current memory issues. More
2831960 61 F AL 03/18/2025 FLU3
HEPAB
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 UT8415KA
M4B34
Rash, Rash pruritic; Rash, Rash pruritic Rash, Rash pruritic; Rash, Rash pruritic
Rash developed on stomach, left side of neck, and left wrist. The rash did cause itching. Patient sa... Rash developed on stomach, left side of neck, and left wrist. The rash did cause itching. Patient said she applied a cream and the rash cleared on neck and stomach. However, the wrist still has appearance of a rash. Patient stated she thinks the rash is taking a little longer to clear on her wrist due to the watch she is wearing More
2831961 68 M MO 03/18/2025 PNC21
 MERCK & CO. INC.
 Y013009
Chills, Hyperhidrosis Chills, Hyperhidrosis
Extreme/uncontrollable chills that resolved after 1.5 hour nap. Woke up with "soaked" she... Extreme/uncontrollable chills that resolved after 1.5 hour nap. Woke up with "soaked" sheets More
2831962 3 F ID 03/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product preparation issue Product preparation issue
incorrect dilution incorrect dilution
2831963 36 M NY 03/18/2025 COVID19
 MODERNA
Dyspnoea, Feeling of body temperature change, Malaise Dyspnoea, Feeling of body temperature change, Malaise
About 1-2 hours after injection I began to feel unwell. I felt cold and hot. It has been difficult t... About 1-2 hours after injection I began to feel unwell. I felt cold and hot. It has been difficult to breathe since getting the injection. It?s taken about 2 months to recover. More
2831964 63 M GA 03/18/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8735
ER8735
EW0165
EW0165
FL3197
FL3197
Balance disorder, Electroneuromyography, Magnetic resonance imaging head, Magnet... Balance disorder, Electroneuromyography, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nerve injury; Paralysis, Peripheral nerve injury, Spinal cord oedema, Spinal operation; Balance disorder, Electroneuromyography, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nerve injury; Paralysis, Peripheral nerve injury, Spinal cord oedema, Spinal operation; Balance disorder, Electroneuromyography, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Nerve injury; Paralysis, Peripheral nerve injury, Spinal cord oedema, Spinal operation More
Paralyzed hips on down both sides, neurological damage in spine and legs especially. Neurological s... Paralyzed hips on down both sides, neurological damage in spine and legs especially. Neurological swelling of spine and neurological death of some leg nerves. Had to have spinal operation to help with swelling of nerves. Still having nerve damage in penis and anus also legs. More
โœ“ โœ“
2831965 53 M NC 03/18/2025 PNC21
 MERCK & CO. INC.
Diarrhoea, Pain, Vomiting Diarrhoea, Pain, Vomiting
Painful all the body for 3 days. Threw up . Diarrhea all nights are days. Painful all the body for 3 days. Threw up . Diarrhea all nights are days.
2831966 51 F CT 03/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Chills, Fatigue, Headache, Injection site discolouration, Injection site erythem... Chills, Fatigue, Headache, Injection site discolouration, Injection site erythema; Injection site swelling, Pain in extremity More
Redness and swelling around injection site, fatigue, chills, headache, arm soreness. On Day 4, the r... Redness and swelling around injection site, fatigue, chills, headache, arm soreness. On Day 4, the redness around the injection site has now turned black and blue. More
2831967 17 F GA 03/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 2G3S9
Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Pai... Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Pain in extremity, Skin warm More
Arm became stiff and sore day after vaccination. Over the following days area became warm to touch ... Arm became stiff and sore day after vaccination. Over the following days area became warm to touch and developed redness, itching at site. More
2831968 4 F CA 03/18/2025 MMR
 MERCK & CO. INC.
 Y011637
Lethargy, Swelling face Lethargy, Swelling face
Facial swelling, lethargy within 10 mins of administration - Given epinephrine injection and 911 ca... Facial swelling, lethargy within 10 mins of administration - Given epinephrine injection and 911 called More
โœ“
2831969 03/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
shingles; This non-serious case was reported by a consumer via interactive digital media and describ... shingles; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine, then had shingles a few weeks later. More
2831970 21 F WI 03/18/2025 MMRV
 MERCK & CO. INC.
 Y014437
Off label use, Product administered to patient of inappropriate age Off label use, Product administered to patient of inappropriate age
21 year old female was administered MMRV (ProQuad Merck) off label - patient notified and did not ha... 21 year old female was administered MMRV (ProQuad Merck) off label - patient notified and did not have any questions. Registry is accurate. More
2831971 62 F KY 03/18/2025 PNC20
 PFIZER\WYETH
 LX4482
Injection site erythema Injection site erythema
Redness around injection site, treated with ibuprofen/warm compress Redness around injection site, treated with ibuprofen/warm compress
2831972 65 M CA 03/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Asthenia, Fibrin D dimer, Haemoptysis, Headache; Productive cough, P... Arthralgia, Asthenia, Fibrin D dimer, Haemoptysis, Headache; Productive cough, Pulmonary pain More
Excruciating pains in all my joints including my jaws, lungs pain and eliminating fleggms with bloo... Excruciating pains in all my joints including my jaws, lungs pain and eliminating fleggms with blood clogs, headache, total weakness; I can't open a bottle of water. More
โœ“ โœ“
2831973 51 M CA 03/18/2025 MMR
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7HG2A
7HG2A
Arthralgia, Feeling hot, Gout, Joint stiffness, Lacrimation increased; Rash, Ras... Arthralgia, Feeling hot, Gout, Joint stiffness, Lacrimation increased; Rash, Rash morbilliform More
Beginning around 3/12/2025, about 13-14 days after receiving the vaccine and expecting its side-effe... Beginning around 3/12/2025, about 13-14 days after receiving the vaccine and expecting its side-effects to be concluded, I developed a mild warm feeling in the skin of my chest, arms, stomach. This all occurred with ZERO flu-like symptoms except for watery eyes. I was not feeling like I was truly ill, just hot and temperature tests revealed my internal temp was normal. Over the course of that day, a measles like rash appeared on my chest with some extending above the neck line but not to the face. I also began to experience arthritis like joint pain. As the days went on, the rash spread downward to my stomach, flank, back, thighs, arms, calves and even to my ankles. The joint pain (mild in nature) continued. After nearly 5 days, the rash on the chest began to fade and has been fading in the order it appeared. Now, on 3/18/2025, a full 6 days after the rash appeared, most of it has disappeared with a little left on the legs and some here and there. However, my left index finger has joint pain in the morning like it has stiffened up (arthritis like) and some gout, both of which have eased over the course of the day today 3/18/2025. Overall, the side-effects appear to be fading today. I am marking "recovered" below because I believe I have recovered. More
2831974 63 M VT 03/18/2025 MMR
 MERCK & CO. INC.
 4013131
Asthenia, Dizziness, Flushing Asthenia, Dizziness, Flushing
Pt c.o. heart rate at 130, extremely dizzy, feeling flush and weak. Sent patient to the ER. Pt c.o. heart rate at 130, extremely dizzy, feeling flush and weak. Sent patient to the ER.
2831975 22 F MO 03/18/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 z27pb
Syncope Syncope
Patient sat down in waiting area after vaccine. The technician went out to hand the patient a reque... Patient sat down in waiting area after vaccine. The technician went out to hand the patient a requested copy of administration report and fainted for a few seconds while seated in chair. Patient refused ambulance and states seated for 20-30 minutes and drank some water and had a friend pick her up. More
2831976 1 F MI 03/18/2025 MMRV
 MERCK & CO. INC.
 Y019176
Wrong product administered Wrong product administered
inadvertently gave an MMRV instead of MMR, where it is located in fridge I grabbed what i thought wa... inadvertently gave an MMRV instead of MMR, where it is located in fridge I grabbed what i thought was MMR, prepared it for administration and did not verify with second check prior to administering More
2831977 1 F MI 03/18/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019176
Y007176
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
inadvertently gave MMRV instead of MMR, where it is located in the freezer I grabbed what i thought ... inadvertently gave MMRV instead of MMR, where it is located in the freezer I grabbed what i thought was MMR from the bin, prepared it for administration and did not verify with a second check prior to giving it to child More
2831979 64 M RI 03/18/2025 PNC20
 PFIZER\WYETH
 unkown
Pruritus, Rash, Urticaria Pruritus, Rash, Urticaria
Patient received PCV20 vaccine on 03/16/2025 at Pharmacy. went hone and 2-3 hours later was covered... Patient received PCV20 vaccine on 03/16/2025 at Pharmacy. went hone and 2-3 hours later was covered in hives. Pt apt on 03/18/25 at Community Health Center for rash from vaccine. Pt showed picture left arm, back and stomach. positive for pruritic, no lip edema, no tongue edema, Pt applied topical Benadryl. Rash resolved. Called pharmacy unable to get lot number of PCV20 vaccine More
2831980 16 F TN 03/18/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
 LL0637
LL0637
Asthenia, Crying, Dizziness, Gait disturbance, Nausea; Urticaria Asthenia, Crying, Dizziness, Gait disturbance, Nausea; Urticaria
dizziness, weakness, hives on arm, nausea, crying, approx 2-3 hours after shot, hives resolved spont... dizziness, weakness, hives on arm, nausea, crying, approx 2-3 hours after shot, hives resolved spontaneously within 1 hour, able to ambulate but initially with assistance, no emesis, vital signs at office FU within normal limits, supportive care treatment only, More
2831981 17 F KS 03/18/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 x004375
5AR2D
U7632BA
Heart rate increased, Hypertension, Loss of consciousness, Postural orthostatic ... Heart rate increased, Hypertension, Loss of consciousness, Postural orthostatic tachycardia syndrome; Heart rate increased, Hypertension, Loss of consciousness, Postural orthostatic tachycardia syndrome; Heart rate increased, Hypertension, Loss of consciousness, Postural orthostatic tachycardia syndrome More
Started having symptoms of POTS that same month. First saw her PCP in September 2023 for POTS. Event... Started having symptoms of POTS that same month. First saw her PCP in September 2023 for POTS. Eventually diagnosed 1 month ago by a cardiologist. High blood pressure problems, high pulse at times, blacking out events. Is on a beta blocker currently for treatment. Patient reported this diagnoses at appointment today and this RN was questioning her about her POTs symptoms and realized they started about the same time. Deferred 3rd dose of HPV and 2nd dose of Bexero today per this RN collaborating with primary care provider. More
2831982 23 F VA 03/18/2025 PNC20
 PFIZER\WYETH
 LX2497
No adverse event No adverse event
There was no adverse effect. There was no adverse effect.
2831983 4 M CA 03/18/2025 COVID19
 MODERNA
 3044211
Urticaria Urticaria
Got hives, the interesting part is that his brother got the same vaccine, same day, same pharmacy an... Got hives, the interesting part is that his brother got the same vaccine, same day, same pharmacy and also got hives, which struck me as uncommon. Was given at Pharmacy More
2831984 64 F CO 03/18/2025 PNC20
 PFIZER\WYETH
 LX2497
Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Pt was administrated PCV20 vaccine on 03/11/2025 and had blood draw as well, arm was warm slightly s... Pt was administrated PCV20 vaccine on 03/11/2025 and had blood draw as well, arm was warm slightly swollen and caused achiness after vaccine. On Sunday 03/17/2025 arm was itchy pt noticed some red patchy areas. More
2831985 F NC 03/18/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose accelerated dosing/ diid not receive; This non-serious case was reported by a pharmaci... Late 2nd dose accelerated dosing/ diid not receive; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose accelerated dosing/ diid not receive). 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: 04-MAR-2025 Pharmacist called and reported that they had a patient who received a Twinrix dose on 10-Feb-2025 from batch number 429JJ with expiry date 01-APR-2026, she was going to be traveling to an area where it was a high or intermedia endemic for hepatitis. And so she had intentionally meant to do the accelerated dosing, however, reporter thought she got confused about when she received the doses, so she got one 10-Feb-2025, which was 22 days ago, today (on the day of reporting) she was going to get the 2nd one but it looks like she should receive the 2nd one about 2 weeks ago, 7 days after the 1st dose, and then she would receive the 3rd one today. So, reporter was wondering about, she would be traveling in June, so he/she was if it was possible for her, since she got the 1st dose in 10-Feb-2025, if she got her 2nd dose today, could she been getting a 3rd dose in you know 2 weeks to have accelerated dosing or not . During the call the reporter mentioned it seems this was the 1st Twinrix scheme dose for the patient, and, they did not have any records about the patient being immunocompromised. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to an incomplete course of vaccination. More
2831986 CO 03/18/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix given intramuscularly, instead subcutaneous; This non-serious case was reported by a pharmac... Priorix given intramuscularly, instead subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix given intramuscularly, instead subcutaneous). The outcome of the subcutaneous injection formulation administered by other route 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-MAR-2025 The registered pharmacist reported that a pharmacist stated to them that they had a Priorix given intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route The reporter was just wondering does it need to be readministered or was still effective. More
2831987 NY 03/18/2025 DTAP
FLU4
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Product storage error; Product storage error; Product storage error Product storage error; Product storage error; Product storage error
Administration after temperature excursion; This non-serious case was reported by a nurse via call c... Administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis. On an unknown date, the patient received Boostrix, Infanrix and FluLaval Tetra. On an unknown date, an unknown time after receiving Boostrix, Infanrix and FluLaval Tetra, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug 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: 11-MAR-2025 A licensed practical nurse reported temperature excursions for Boostrix, Infanrix and Flulaval. Healthcare professional mentioned that these excursions occurred since 12th September 2024 until 28th February 2025. During the call, healthcare professional mentioned that probably a couple of these vaccines were used which led to incorrect storage of drug. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments: US-GSK-US2023167156:same reporter More
2831988 F NY 03/18/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Antibody test, Therapy non-responder Antibody test, Therapy non-responder
low titers/didn't have a response; This non-serious case was reported by a other health profess... low titers/didn't have a response; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 48-year-old female patient who received MMR (Priorix) for prophylaxis. Concomitant products included aciclovir sodium (Acyclovir). On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: low titers/didn't have a response). The outcome of the therapy non-responder 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: 11-MAR-2025 Reporter stated that a patient who was currently on Acyclovir had gotten a dose of Priorix back in 2020 no exact date shared, and did not have a response, reporter mentioned that this patient had a titer test and showed low titers. More
2831989 F NC 03/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Product storage error Product storage error
received a dose of Bexsero after a temperature excursion of 68 ๏ฟฝF to 72 ๏ฟฝF for 15 hours.; This n... received a dose of Bexsero after a temperature excursion of 68 ๏ฟฝF to 72 ๏ฟฝF for 15 hours.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 24-year-old female patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: received a dose of Bexsero after a temperature excursion of 68 ๏ฟฝF to 72 ๏ฟฝF for 15 hours.). The outcome of the incorrect storage of drug 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: 12-MAR-2025 The pharmacist reported that they administered Bexsero to a patient after a temperature excursion and Bexsero vaccine was exposed to 68 degree Fahrenit to 72 degree Fahrenit for 15 hours, which led to incorrect storage of drug. The reporter asked do they have extended stability data for this vaccine. More
2831990 16 F VA 03/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 PZ75H
Expired product administered Expired product administered
Administration of expired dose; This non-serious case was reported by a nurse via call center repres... Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number PZ75H, expiry date 28-FEB-2025) for prophylaxis. On 04-MAR-2025, the patient received Menveo. On 04-MAR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 12-MAR-2025 Licensed practical nurse mentioned that administered a dose of Menveo 1 vial to a patient on 04th March 2025 and the dose expired on 28th February 2025 which led to expired vaccine use. Wanted to know if they should repeat the dose? More
2831991 F MD 03/18/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Inappropriate Reconstitution Technique/only administered the diluent; Inappropriate Reconstitution T... Inappropriate Reconstitution Technique/only administered the diluent; Inappropriate Reconstitution Technique/only administered the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) for prophylaxis. On 11-MAR-2025, the patient received Priorix. On 11-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/only administered the diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/only administered the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 12-MAR-2025 The pharmacist reported that a patient who was only administered the diluent component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2831992 NJ 03/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a physician via call cent... suspected vaccination failure; shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and 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 unknown and the outcome of the shingles was not reported. 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: 12-MAR-2025 The reporter stated that she had a patient who received 2 doses of Shingrix and still got a severe case of shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2831993 F CA 03/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Ocular discomfort, Swelling face Erythema, Ocular discomfort, Swelling face
Swelling on her face; Red cheeks; Pressure on the left eye; This non-serious case was reported by a ... Swelling on her face; Red cheeks; Pressure on the left eye; This non-serious case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced facial swelling (Verbatim: Swelling on her face), red face (Verbatim: Red cheeks) and sensation of pressure in eye (Verbatim: Pressure on the left eye). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the facial swelling, red face and sensation of pressure in eye were resolved (duration 12 hrs). It was unknown if the reporter considered the facial swelling, red face and sensation of pressure in eye to be related to Shingrix. It was unknown if the company considered the facial swelling, red face and sensation of pressure in eye to be related to Shingrix. Additional Information: GSK Receipt Date: 14-MAR-2025 The reporter reported that he/she had a patient, after her 1st shot, she got swelling on her face, red cheeks and pressure on her left eye, which only lasted 12 hours, and she took Benadryl. Could she get the 2nd dose or not. More
2831994 03/18/2025 COVID19
 JANSSEN
Radiculitis brachial Radiculitis brachial
Severe Brachial neuritis; This spontaneous report received from a patient concerned a patient of uns... Severe Brachial neuritis; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Received via J and J managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 09-Oct-2021, additional dosage information included: dose number in series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. The patient left arm/ hand remained at 50 percent function since 5 days post Janssen covid vaccine. On an unspecified date, the patient experienced severe brachial neuritis. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of severe brachial neuritis was not reported. This report was serious (other medically important condition).; Sender's Comments: V0; brachial neuritis; The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
2831995 79 M 03/18/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Acute macular neuroretinopathy, Angiogram retina, Blood immunoglobulin G, Blood ... Acute macular neuroretinopathy, Angiogram retina, Blood immunoglobulin G, Blood immunoglobulin M, Condition aggravated; Fluorescence angiogram, Fundus autofluorescence, Imaging procedure, Laboratory test, Optical coherence tomography; Paracentesis eye, Plasminogen, Retinogram, Visual acuity tests More
Acute Macular Neuroretinopathy; the event exacerbated by mRNA COVID-19 booster vaccination; This lit... Acute Macular Neuroretinopathy; the event exacerbated by mRNA COVID-19 booster vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included COVID-19. Concurrent medical conditions included Arthritis, Hypertension, Occipital neuralgia, Neuropathy, Basal cell carcinoma and Herpes labialis (intermittent). Concomitant products included Aciclovir (Acyclovir) for Herpes labialis, Felodipine, Gabapentin, Hydroxyzine hydrochloride (Hydroxyzine HCL) and Triamcinolone acetonide for an unknown indication. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) (seriousness criterion medically significant). The patient was treated with Prednisone (oral use) at an unspecified dose and frequency; Triamcinolone acetonide (Kenalog) (ophthalmic) at an unspecified dose and frequency and Valaciclovir hydrochloride (Valacyclovir) (oral use) for Herpes labialis, at an unspecified dose and frequency. At the time of the report, ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram retina: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: demonstrated temporal deep retinal/RPE hyperfluorescence and staining; there was no evidence of disc leakage/staining and no evidence of retinal vasculitis.. On an unknown date, Blood immunoglobulin G: High for HSV-1 and VZV. On an unknown date, Blood immunoglobulin M: Normal. On an unknown date, Fluorescence angiogram: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: ICG angiography was unrevealing without choroidal vascular abnormalities.. On an unknown date, Fundus autofluorescence: OD: consistent with a diagnosis of acute macular neuroretinopathy. and OD: demonstrated hyperautofluorescence of the central and temporal macula. On an unknown date, Imaging procedure: OD: demonstrated hyporeflectance temporal to the fovea OD. 2 weeks after initial presentation OCT showed paracentral disruption of the ellipsoid zone (EZ) and interdigitation zone (IZ) disruption and infrared imaging demonstrates hyporeflectance temporal to the fovea., 4 months after presentation infrared imaging showed increased size and prominence of the hyporeflectivity now involving the fovea. and 8 months after presentation, 1 week post third vaccine, infrared imaging revealed increased size and prominence of the hyporeflectivity.. On an unknown date, Laboratory test: Laboratory evaluation for infection, autoimmune, or inflammatory systemic origin was normal.. On an unknown date, Optical coherence tomography: Optical coherence tomography (OCT) of macula OD demonstrated hyporeflectance of the photoreceptor layer, ellipsoid zone (EZ) attenuation, and outer nuclear layer (ONL) thinning. Consistent with a diagnosis of acute macular neuroretinopathy. OCT OS was normal., Four months after presentation, OCT macula was unchanged and infrared OCT OD demonstrated an increase in size and prominence of the hyporeflectivity now involving the fovea. OCT showed decreased EZ and IZ disruption with mild outer nuclear layer thinning., 8 months after presentation, OCT shows unchanged mild EZ and IZ disruption with increased outer nuclear layer (ONL) thinning., 9 months following presentation, revealed marked increase of infrared imaging hyporeflectance and OCT EZ and IZ attenuation and continued ONL thinning OD and 15 months following presentation, demonstrated decreased areas of EZ and IZ disruption but with persistent EZ/IZ temporal attenuation and substantial ONL thinning and decreased infrared imaging hyporeflectance of the temporal macula. On an unknown date, Paracentesis eye: (Negative) Aqueous paracentesis was negative for HSV, HZV and other viruses. On an unknown date, Plasminogen: (Negative) T.PA testing was negative ruling out syphilic outer retinitis and acute syphilitic placoid retinitis.. On an unknown date, Retinogram: Fundus examination was normal OU, color photography consistent with a diagnosis of acute macular neuroretinopathy. and Ultra wide-field color photography OD revealed faint darkening of the deep retina/RPE region corresponding to the area of infrared OCT hyporeflectance.. On an unknown date, Visual acuity tests: 20/30 OU and 20/25 OD, 15 months after presentation. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered ACUTE MACULAR NEURORETINOPATHY (Acute Macular Neuroretinopathy) and CONDITION AGGRAVATED (the event exacerbated by mRNA COVID-19 booster vaccination) to be related. It was reported that patient denied travel and drug use. Patient developed a central scotoma OD two weeks after his second vaccination of the Moderna COVID-19 mRNA vaccine. There was no change in symptoms OD after oral prednisone and subtenons kenalog were prescribed by an outside ophthalmologist. Four months after presentation, examination was unchanged with persistent symptoms. Eight months after presentation the patient received his third vaccination of Moderna COVID-19 mRNA vaccine. One week after this third vaccination, the patient reported worsening of symptoms OD. Nine months after initial symptoms and 1 month after the third vaccine, the patient presented to clinic. Given the history of herpes labialis and the high viral IG titers the patient was switched from acyclovir to valacyclovir orally. Valacyclovir was stopped and a diagnosis of AMN was made. With observation and no treatment, 15 months after presentation and 5 months after the third vaccine, symptoms improved.; Reporter's Comments: Taking into consideration plausible temporal relationship and that the patient's condition even worsened after third vaccination, the causality cannot be excluded and the event is assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report. More
2831996 03/18/2025 COVID19
 MODERNA
COVID-19, Coronary artery occlusion, Ophthalmoplegia, SARS-CoV-2 test COVID-19, Coronary artery occlusion, Ophthalmoplegia, SARS-CoV-2 test
coronary artery occlusion; internuclear ophthalmoplegia; Covid-19 spike protein levels from 3385 arb... coronary artery occlusion; internuclear ophthalmoplegia; Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml; This spontaneous case was reported by a non-health professional and describes the occurrence of CORONARY ARTERY OCCLUSION (coronary artery occlusion) and OPHTHALMOPLEGIA (internuclear ophthalmoplegia) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONARY ARTERY OCCLUSION (coronary artery occlusion) (seriousness criterion medically significant), OPHTHALMOPLEGIA (internuclear ophthalmoplegia) (seriousness criterion medically significant) and COVID-19 (Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml). The patient was treated with Ivermectin at a dose of more than 4 months. At the time of the report, CORONARY ARTERY OCCLUSION (coronary artery occlusion), OPHTHALMOPLEGIA (internuclear ophthalmoplegia) and COVID-19 (Covid-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: 3385 arbitrary unit per millilitre and 2699 arbitrary unit per millilitre. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not reported. It was reported that, patient had coronary artery occlusion and internuclear ophthalmoplegia after administration of Moderna COVID-19 mRNA vaccine. Administration of Ivermectin for more than four months led to notable improvements in the patient's symptoms, with a documented reduction in COVID-19 spike protein levels from 3385 arbitrary units per milliliter (AU/ml) at presentation to 2699 AU/ml. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2025: Live non-significant follow-up was received. Reference ID was added.; Reporter's Comments: Concurrent COVID-19 might be a confounder given that Coronary artery occlusion and Ophthalmoplegia are complications that have been observed in patients who experienced this infection. The benefit-risk relationship of the product is not affected by this report. More
2831997 M 03/18/2025 COVID19
 MODERNA
Asthenia, Gait inability, Immunisation reaction, Migraine Asthenia, Gait inability, Immunisation reaction, Migraine
Couldn't even walk around the room; He had no energy; he had such severe light sensitivity, he ... Couldn't even walk around the room; He had no energy; he had such severe light sensitivity, he can't even be outside, anytime light hits his eyes it creates a horrible migraine/ if any light hits his eyes, it creates a blinding pain; very rare and strange side effect; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT INABILITY (Couldn't even walk around the room), ASTHENIA (He had no energy), MIGRAINE (he had such severe light sensitivity, he can't even be outside, anytime light hits his eyes it creates a horrible migraine/ if any light hits his eyes, it creates a blinding pain) and IMMUNISATION REACTION (very rare and strange side effect) in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't even walk around the room), ASTHENIA (He had no energy), MIGRAINE (he had such severe light sensitivity, he can't even be outside, anytime light hits his eyes it creates a horrible migraine/ if any light hits his eyes, it creates a blinding pain) and IMMUNISATION REACTION (very rare and strange side effect). At the time of the report, GAIT INABILITY (Couldn't even walk around the room), ASTHENIA (He had no energy), MIGRAINE (he had such severe light sensitivity, he can't even be outside, anytime light hits his eyes it creates a horrible migraine/ if any light hits his eyes, it creates a blinding pain) and IMMUNISATION REACTION (very rare and strange side effect) had not resolved. No concomitant medication was reported. Reporter stated patient received the Moderna vaccine, he got the first one and thought he got the second one. And the first one he said, he had the worst days, 5 days of every single symptom that they listed, he couldn't even walk around the room, it was that bad, he had no energy. So, he was really hit hard the first time and then second time when he got a booster, then he developed a very rare and strange adverse side effect, that it was like a few years ago, he still had it. He probably never going to be normal again. Patient had such severe light sensitivity, that he couldn't be even outside, anytime light hits his eyes it created a horrible migraine. He didn't even had migraines before this. His doctor thought it was an adverse, very rare, side effect, but knew everything he took could give side effects. So, patient couldn't get any vaccines, reporter thought he couldn't even be able to take the Novavax. It was pretty devastating what he went through, and he had always had a little yellow light in the house, if any light hits his eyes, it created a blinding pain. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783231 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783231:Patient 2 of 3(Reporter's son) More
2831998 F 03/18/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue; This spo... Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for Drug use for unknown indication: Penicillin, erythromycin and Sulfa. Past adverse reactions to the above products included Allergy with Penicillin, Sulfa and erythromycin. Concurrent medical conditions included GERD, Sleep apnea, Depression, Penicillin allergy, Drug allergy (Allergy to sulfa) and Allergy to antibiotic (Allergy to erythromycin). On 08-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and first dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 20-Feb-2025, the patient experienced COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue). At the time of the report, COVID-19 (Covid started 2/20/25. Symptoms: headache, sore throat, muscle aches, ear ache and fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2025, SARS-CoV-2 test: Positive. On 28-Feb-2025, SARS-CoV-2 test: Negative. On 10-Mar-2025, SARS-CoV-2 test: Positive. Covid began on 20-Feb-2025, presenting symptoms such as headache, sore throat, muscle aches, ear pain, and fatigue. The initial symptoms were noted on 23-Feb-2025 and resolved by 26-Feb-2025. A test was conducted on 28-Feb-2025. A rebound case of Covid emerged on 9-Mar-2025, with a positive test result on 10-Mar-2025, accompanied by symptoms including fatigue, headache, muscle pain, and fever. No concomitant medication was reported. No treatment medication was reported. Reporter did not allow further contact More
2832001 83 F IN 03/18/2025 COVID19
COVID19
COVID19
COVID19-2
COVID19-2
COVID19-2
FLUX
FLUX
FLUX
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER








Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Fall; Tooth fracture, X-... Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Fall; Tooth fracture, X-ray; Antibody test positive, Arthralgia, Condition aggravated, Dizziness, Dyspnoea; Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Fall; Tooth fracture, X-ray; Antibody test positive, Arthralgia, Condition aggravated, Dizziness, Dyspnoea; Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Fall; Tooth fracture, X-ray; Antibody test positive, Arthralgia, Condition aggravated, Dizziness, Dyspnoea More
shortness of breath; dizzy; fallen; cracked one of my teeth; This is a spontaneous report received f... shortness of breath; dizzy; fallen; cracked one of my teeth; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Flu shot, for Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy"; FALL (non-serious), outcome "not recovered", described as "fallen"; TOOTH FRACTURE (non-serious), outcome "unknown", described as "cracked one of my teeth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, dizziness, fall, tooth fracture. Additional information: The caller initially wanted to check if people report side effects with the vaccine. She mentioned had taken the Pfizer Covid-19 vaccine, her fourth shot, a few weeks ago. Since then she had been experiencing shortness of breath. She mentioned she has already been checked out by the doctor, had electrocardiogram and x-rays but no one can explain what she is experiencing. She stated that ruined her life. Caller was asking if other patients have experienced Shortness of Breath and Dizziness following the Pfizer covid vaccine. Caller stated, she have had every test known to man, ever since I had the 4th shot she have had short breath, she had a fall (caller clarified), when she got Short of breath she got dizzy, she had fallen, she cracked one of her teeth, she had to have a crown put on. In the shower, and when she wash her hair, the weight of the water makes me feel like I am going to fall down, any kind of pressure and any kind of weight, water, or vacuuming, she got dizzy and she had fallen that way too. She did not want to blame Pfizer, but she just wanted to find out what was going on with me. The doctors could not find any thing. She was still having that issue. The last shot was 11 04 2023, (04Nov2023), and it was her second booster. Its ruined her life, she was relatively healthy, she had an echo cardiogram, and checked to see, she wanted to go through testing to see if there was any other reason why she was short of breath. All she know was her life was over with. Has anyone else had that experience with shortness of breath and dizziness? The caller stated, She had been to doctors, they checked her lungs, tested her heart. Caller stated, she's had echo, ecg, and x-rays. She have tried albuterol a dilator, nothing helped her. The only thing she was wondering if Pfizer had any suggestions on how to fix that because she know it was from the vaccine. she didn't have this until the 4th vaccine, she had the two vaccines and this was the second booster, her life was over. She was a type A personality and she could not move because she could not breath. Her doctor's tell her she was healthy, tests did not show anything, but you can't treat something if you can't find the problem. Her doctor told her, her father has the same problem, but they did not have enough information to treat her. She had done the nebulizer, the albuterol only burned her throat, it's frustrating being a type A personality and can't do anything. She wish she would die. No additional AE created for albuterol, caller stated she used it in a nebulizer. (last lot exp. of L-Wyeth product (Tablets) divested to Stada Pharmaceuticals was 12/2001). Response: Provided response from attached document, referred to HCP. Caller disconnected before survey could be offered and before this agent could respond to her comment, She wish she would die. She was complaining about shortness of breath. So, she mentioned that she got the COVID-19 vaccine a weeks ago and then it was the 4th shot. After that she has been experiencing shortness of breath. She has been checked out by the doctor, got ECG and X-rays but no one can explain why she is experiencing this one. That is the only info I have." When paraphrased the concern, consumer stated, "All they tell me is they do not know how to treat long-term COVID. That is all I get. I have had echocardiogram; I have had my heart checked. I have had X-rays. But if I even wash my hair, I cannot breathe, I have fallen broken a tooth. I mean, I get so dizzy and short of breath, and I guess, what I want to know is, does anyone else complain of shortness of breath with the Pfizer Vaccine (COVID-19 Vaccine)?" Consumer stated, "And my last shot (COVID-19 Vaccine) was '11/4/23' (further date not clarified)." Age at the time of event: Consumer stated, "Well, it was in 23 so I would have been 2 years younger. I had all kinds of test, and normally I am healthy person. I do not have heart problems. No one can explain, all the doctors I have seen what is wrong with me. I am not trying to blame Pfizer. I am just wanting to see if other people have reported the same thing, and do they have any advice for me? Because my life is hell right now." Consumer was informed that Pfizer medical information is the concerned department for this query. Consumer stated, "I understand that." In response to probe further: Consumer stated, "Yes." When again probed for the age at the time of event: Consumer stated, "Okay, my birthday, well, two years before, I am 84. So, I would have been, I was born in 1940 and this was in 23, so I would have been about, what two years younger." When probed for COVID-19 Vaccine LOT#, NDC#, UPC# and Expiration date: Consumer stated, "Yeah, I do. I do not know if it's a G, it is not written very well but, I do not know if it is a G, or does it always start with a letter because the other one started with a letter. This is the fourth vaccine. It looks like, I do not know, do they all start with a letter? It looks like G15342, and it was done on '11/04/23' looks like a G but then again it could be '1915342' it is written in, it is not very legible '11/04/23' is when I had the shot." When probed for the expiration date: Consumer stated, "All it has got is a date '11/04/23' on here, so if that is the expiration date." When clarified that the LOT#, NDC#, UPC# and Expiration date is not available: Consumer stated, "No, it just says, it says a date. It has got, it is my fourth vaccine (Pfizer COVID-19 Vaccine), and it said Pfizer Bivalent, I do not know whether that is a G or '1915' the numbers are '15342' and it has got, you know, where the date goes, it is got '11/04/23' (date not clarified)." When probed for the time, dose, route of administration and the site of administration: Consumer stated, "Well, I am right-handed so, it would have been administered it in the left arm, as far as I know. I mean, I do not, it is back two years ago, it was done in the left arm. It was a 4th shot (Pfizer COVID-19 Vaccine)." When probed for the time and date of administration as: Consumer stated, "This is November 11th month so the November the 4th." Time of vaccination: Consumer stated, "No, I do not remember the time." When probed if any vaccine was administered on the same day, consumer stated, "No, just that vaccine. I had a shot, I mean, I had a flu shot (Unspecified Flu Shot) but that was like three weeks before. So, it was not with any other shot." Name of flu shot that was administered three weeks before COVID-19 vaccine: Consumer stated, "No, it was a higher dose, the one that they gave to senior people. The higher dose shot but that was on 11th, I did not 'want' it in at the same time." Concomitant Products and other medical conditions: Consumer stated, "No, that is the problem I am not. I have been so long doctors, I have been to my doctor, all she told me was her father had the same thing. I mean, I do not want anything from Pfizer. I just want to know what is wrong with me. I mean, my life is over because I cannot do anything. If I wash my hair, I am absolutely feeling like I am going to pass out. It is I am short of breath, and I never had this until I had this shot. I just want to know if Pfizer have any suggestion for me?" Lab work: Consumer stated, "No because all I, but I have had every test done known to man and it cannot find out what is wrong with me. They thought maybe it was asthma, but it is not asthma because I am not congested. I have used inhalers, I have used sprays, nothing helped me." Treatment: Consumer stated, "No, because I mean, they cannot find the problem. All they told me is that if it is long term COVID, they do not know how to treat me." Name of inhaler and spray that did not helped: Consumer stated, "Albuterol, is that the bronchodilator?" LOT of Albuterol: Consumer stated, "No, I do not have them on me right now, no." Consumer added, "But the only problem is I cannot take them because they burn my throat. I do not want to be, I am not a medicine taker, I don't like medicine unless I know absolutely that would help me, but I have Asthma as a child, and I know it's not asthma. You are congested with asthma. I am not congestive. My dad was a doctor, and he treated me for asthma, but I hope 'that is correct' but this is not asthma. This is something else and I have her, she just was wondering if Pfizer have any suggestion for her?" More
2832003 57 F TX 03/18/2025 PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LJ5281
LJ5281
LJ528
LJ528
Injection site erythema, Injection site induration, Injection site pain, Injecti... Injection site erythema, Injection site induration, Injection site pain, Injection site warmth; Skin warm; Injection site erythema, Injection site induration, Injection site pain, Injection site warmth; Skin warm More
slightly indurated; warm to the touch; soreness she experienced was at the injection site; red mark ... slightly indurated; warm to the touch; soreness she experienced was at the injection site; red mark on the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 57-year-old female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Mar2025 as dose 1, single (Lot number: LJ5281, Expiration Date: 30Mar2026) at the age of 57 years, in arm for immunisation. The patient's relevant medical history included: "allergy to sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2025, outcome "unknown", described as "red mark on the injection site"; VACCINATION SITE PAIN (non-serious) with onset 13Mar2025, outcome "recovered" (13Mar2025), described as "soreness she experienced was at the injection site "; VACCINATION SITE INDURATION (non-serious), outcome "unknown", described as "slightly indurated"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "warm to the touch". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site induration, vaccination site warmth. Additional information: She has no additional medical conditions to provide and states she is a pretty healthy person. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine or within 4 weeks prior to the first administration of the suspect vaccine. Caller had a reaction after receiving the Prevnar 20 vaccine. The caller would like to inquire if Prevnar 20 contains sulfa because she is allergic to it and she had a reaction after receiving the vaccine. The patient read over every document prior to that and she did not see any mention of sulfa in the product and she had the pharmacist double check and he did not see anything and saw no interaction with the medications she takes. She got the injection and a for couple days she was sore and yesterday (13Mar2025) she noticed a quarter or a half dollar sized red mark on the injection site and kind of dismissed it and her initial thought was that she slept on something and this morning she got up and it is like if you cup your hand on your arm and is that size and it is red, slightly indurated and warm to the touch. Clarified the soreness she experienced was at the injection site and it began on 13Mar2025 and the soreness resolved after the 1st day like the norm after getting an injection. The red mark on her arm is now larger and it is the size of putting your hand over the arm and she does not know how to describe it. She is hoping the Benadryl is going to help and at the moment she took some Benadryl to see if that will calm it down. Right at the moment, she is trying Benadryl because this morning (14Mar2025) it got worse so she is trying Benadryl to see if that counteracts what is going on as she was not expecting any of this. More
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