🏥 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 💀 🏥 🚑 ♿ ⚠️
2788210 33 F NC 09/03/2024 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 97N55
Exposure during pregnancy, Product use issue; Delivery, Exposure during pregnanc... Exposure during pregnancy, Product use issue; Delivery, Exposure during pregnancy, Haemorrhage in pregnancy, Product use issue More
This patient was 32 weeks and 5 days when she received the Arevxy RSV vaccine that is not currently ... This patient was 32 weeks and 5 days when she received the Arevxy RSV vaccine that is not currently approved for use during pregnancy. She is currently 33 weeks and 6 days. Patient was made aware and plans to report to Pediatrician as well. More
2828476 M ME 02/26/2025 COVID19
 PFIZER\BIONTECH
Atrial fibrillation, Cardiac failure congestive, Inappropriate schedule of produ... Atrial fibrillation, Cardiac failure congestive, Inappropriate schedule of product administration More
Congestive heart failure; atrial fibrillation; dose 1 administred on 21Feb2021; dose 2 administered ... Congestive heart failure; atrial fibrillation; dose 1 administred on 21Feb2021; dose 2 administered on 04Mar2021 for COVID-19 vaccination; This is a solicited report received from a Consumer or other non HCP. Other Case identifier(s): 846809 (Novo Nordisk Pharmaceuticals Inc. Mfr. Report#), S 20210902206 (Novo Nordisk Pharmaceuticals Inc.), IN20250215380 (Novo Nordisk Pharmaceuticals Inc.). An adult male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; insulin degludec (TRESIBA FLEXTOUCH), first regimen since 2020) and second regimen (Lot number: PZFAE39, Expiration Date: 30Jun2026) at 25 iU, all subcutaneous for diabetes mellitus. The patient's relevant medical history included: "Diabetes Mellitus" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, inrtamuscular), administration date: 21Feb2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2021, outcome "unknown", described as "dose 1 administred on 21Feb2021; dose 2 administered on 04Mar2021 for COVID-19 vaccination"; CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant) with onset 07Apr2021, outcome "not recovered", described as "Congestive heart failure"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 07Apr2021, outcome "unknown". The patient was hospitalized for cardiac failure congestive, atrial fibrillation (start date: 07Apr2021). The action taken for insulin degludec was unknown. Therapeutic measures were taken as a result of cardiac failure congestive, atrial fibrillation. Clinical course: A consumer reported that on 18May2021, as treatment, the patient underwent pacemaker. On an unspecified date, as further treatment, the patient was hospitalized, underwent atrial fibrillation ablation, and was placed on a breathing machine due to complications of congestive heart failure during surgery. After the surgery, the patient went home on oxygen therapy. The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty. The reporter's causality for Tresiba FlexTouch U200 with the events congestive heart failure and atrial fibrillation was unlikely. The Company's causality for Tresiba FlexTouch U200 with the events congestive heart failure and atrial fibrillation was unlikely. Reporter Comment: Alternative etiology: The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty. Company comment: Cardiac failure congestive and atrial fibrillation are assessed as unlisted events according to (redacted) current reference safety information (CCDS) on Tresiba FlexTouch. Information on patient's relevant medical history of coronary disease or other cardiac disease, action taken to Tresiba, associated risk factors (immobilization. reduced cardiac output, surgery, trauma, malignant diseases, infections, dehydration, hypertensive episodes, previous thrombo-embolic events), results from clinical and laboratory investigations performed are not available for further medical assessment. However, the co-suspect, Comirnaty is considered as confounding factor in the case. Congestive cardiac failure could be secondary to atrial fibrillation in the case. Considering the pharmacological profile of the suspect drug and available information, congestive cardiac failure and atrial fibrillation are assessed to be unlikely related to Tresiba FlexTouch. This single case report is not considered to change the current knowledge of the safety profile of Tresiba Flex Touch. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reporter's Comments: Alternative etiology: The reporter felt that the congestive heart failure and atrial fibrillation were related to therapy with Comirnaty.; Sender's Comments: The events cardiac failure congestive, and atrial fibrillation are conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient such as diabetes mellitus and/or concomitant medication of INSULIN DEGLUDEC. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2828477 F 02/26/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
She just got really sick from getting the Pfizer a couple of times; This is a spontaneous report rec... She just got really sick from getting the Pfizer a couple of times; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00069 (Novavax). An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She just got really sick from getting the Pfizer a couple of times". Additional Information: Caller was asked if she was immunocompromised or previously vaccinated against COVID-19 and if she was over 65 years old. Caller added she just got really sick from getting the Pfizer a couple of times so she did not know if this was a better alternative in the future to get this vaccine, like the hepatitis A, B, they have the same type of you know, the flu shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828484 M 02/26/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 SJ1614
SJ1614
Anxiety, Burning sensation, Cough, Dyskinesia, Electric shock sensation; Magneti... Anxiety, Burning sensation, Cough, Dyskinesia, Electric shock sensation; Magnetic resonance imaging, Pain, Paralysis, Seizure, Stress More
paralyzed from the waist down; my leg started thumping like rabbit from the cartoon the little rabbi... paralyzed from the waist down; my leg started thumping like rabbit from the cartoon the little rabbit that goes really fast/ my leg convulsion thing; intensely hot like it was burning like on fire when the MRI started to go down his leg; a lot of stress; a lot of mental anguish; cough; pain; his left leg/ it is not exactly muscle spasm is more of an electric surge running on his leg; his leg is jerking; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 1, single (Lot number: SJ1614) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset 2022, outcome "unknown", described as "his left leg/ it is not exactly muscle spasm is more of an electric surge running on his leg"; DYSKINESIA (non-serious) with onset 2022, outcome "unknown", described as "his leg is jerking"; PAIN (non-serious) with onset 2022, outcome "unknown"; PARALYSIS (medically significant), outcome "unknown", described as "paralyzed from the waist down"; SEIZURE (medically significant), outcome "unknown", described as "my leg started thumping like rabbit from the cartoon the little rabbit that goes really fast/ my leg convulsion thing"; BURNING SENSATION (non-serious), outcome "unknown", described as "intensely hot like it was burning like on fire when the MRI started to go down his leg"; STRESS (non-serious), outcome "unknown", described as "a lot of stress"; ANXIETY (non-serious), outcome "unknown", described as "a lot of mental anguish"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results. Clinical details: He said he is in pain. He is trying to figure out he is having side effect. It is his left leg and with his left leg he is having it is not exactly muscle spasm is more of an electric surge running on his leg. It only happens at specific times which is making it even stranger to him. He has videos of it and it has happened on multiple occasions usually when trying to meditate or going to go inside himself be very calm and still, because he thinks bodies vibrate on or can vibrate on different through frequency energy and vibration when are trying to align this 3 trying to ascend into spirit his leg is like when he gets a tense unit, he assumes, so it's like putting the pads on legs and send electric surges to the leg so this is happening all by itself. He is not using electricity or anything like that on the leg , his leg is jerking and he has had this problem since 2022, and he is really trying to get to the bottom and the only thing he keeps coming back to is the Pfizer shot and he only got one shot and this was back on 07Feb2022, and he is trying to figure out why this is happening. He went to get an MRI during this and when he went to get it and went into the MRI because he did the research on this. When he got in the MRI his leg when intensely hot like it was burning like on fire when the MRI started to go down his leg. So due to the magnet in it and the low frequency that they emit his leg started thumping like rabbit from Name withheld the little rabbit that goes really fast so that's what his leg started doing when the MRI was going through his leg and on top started to burn like it is on fire. The only thing that he could think of was that he was unknowingly injected with nanotechnology and he knows Pfizer deals with nanobots (as reported). He has done his research and this is the only conclusion he has come to, and he can not figure it out cause it is causing him a lot of stress causing a lot of mental anguish. It is really starting to piss him of, and he does not know what else to do about it is there a possibility there could be nanobots on the vaccine. It has been like this the past 3 years he is trying to figure out what he can do. He is paralyzed from the waist down and he has never had this happen to him until he went to get the Pfizer shot, once he got this Pfizer shot this is when it started happening and then when he started doing research on it about the MRI and everything. When he got into his MRI machine his leg got fire hot his leg convulsion thing that was his conclusion with that. It is only happening in his left leg and it is not happening anywhere else in his body and he is pretty sure it would not just only be happening in his left leg. It was also reported that the patient is not using anything that could cause this, and leg is jerking since 2022. This is for Comirnaty Vaccine. For the bottom of the cough it keeps coming back to the Pfizer shot, the Comirnaty that he got on 07Feb2022. He is trying to figure out why this is happening. His leg starting going thumbing like rabbit from the cartoon. More
2828485 71 F GA 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Pt given Arexvy a 2nd time, previously administered 8/23/2023 Pt given Arexvy a 2nd time, previously administered 8/23/2023
2828486 64 F FL 02/26/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN9581 ,EP7534
EN9581 ,EP7534
Arthralgia, Loss of personal independence in daily activities, Mobility decrease... Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Musculoskeletal disorder; Tenderness More
unberabl;e pain shoulder . couldnt move my arm for month. sensetive to the lightest tpuch evoke shar... unberabl;e pain shoulder . couldnt move my arm for month. sensetive to the lightest tpuch evoke sharp pain. my arm was as paraloized,stuck. couldnt move,couldnt use, couldnt dress, . i went to my doctor to get help. i was reffered to the physical therapy, 3 times a week. supreme pai in the therapy. chiropracot, needle treatment. till today my left arm is weak. More
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2828487 71 F WI 02/26/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 ae435
7zm65
Infection; Infection Infection; Infection
a customer come in claiming she got an infection in her left arm after she received two vaccinations... a customer come in claiming she got an infection in her left arm after she received two vaccinations from our pharmacy on Wednesday, Feb 19 at approximately noon. On Saturday, Feb 22 she sought medical attention to an urgent care facility for the infection she claimed she had gotten. Today Feb 23rd at 2:50pm she came into the store and stated she wanted it to be reported and brought in the medical paperwork she received. More
2828488 26 M UT 02/26/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 GH9694
GH9694
GH9694
GH9694
GH9694
Abdominal distension, Aldolase increased, Aspartate aminotransferase increased, ... Abdominal distension, Aldolase increased, Aspartate aminotransferase increased, Biopsy muscle abnormal, Blood creatine phosphokinase increased; Blood lactate dehydrogenase increased, Blood test abnormal, Chest pain, Discomfort, Fatigue; Gastrointestinal pain, Lactate pyruvate ratio abnormal, Magnetic resonance imaging abnormal, Migraine, Muscle fatigue; Myoglobin blood increased, Neuralgia, Oedema, Pain, Palpitations; Rhabdomyolysis More
I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for r... I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain. More
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2828489 64 F WI 02/26/2025 FLU3
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient came in for an influenza vaccine and had a caregiver that filled out the Vaccine Administrat... Patient came in for an influenza vaccine and had a caregiver that filled out the Vaccine Administration Record form. In the Date of Birth section they wrote the correct DOB of 8/XX/60, but in the Age section they wrote 65. The high dose influenza vaccine was run through the system due to the error on the form. Patient was then administered the high dose flu shot. The DOB/age discrepancy was noted shortly after patient and caregiver left. Caregiver was contacted and made aware of the situation and what to monitor concerning potential side effects. Staff was educated on error prevention. More
2828498 70 M NY 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 JS3S4
Herpes zoster Herpes zoster
At vaccination patient had said he had shingles history. Patient returned to pharmacy said he got sh... At vaccination patient had said he had shingles history. Patient returned to pharmacy said he got shingles from the vaccine he received. Patient was presribed valacyclovir and gabapentin for treatment. More
2828499 65 F OH 02/26/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6204
EN6204
EN6204
EW0158
EW0158
EW0158
Abdominal X-ray, Allergy to metals, Blood test, Colonoscopy abnormal, Constipati... Abdominal X-ray, Allergy to metals, Blood test, Colonoscopy abnormal, Constipation; Diarrhoea, Dizziness, Endoscopy abnormal, Gastrointestinal inflammation, Heart rate abnormal; Magnetic resonance imaging abdominal abnormal, Nerve injury, Postural orthostatic tachycardia syndrome, Stool analysis; Abdominal X-ray, Allergy to metals, Blood test, Colonoscopy abnormal, Constipation; Diarrhoea, Dizziness, Endoscopy abnormal, Gastrointestinal inflammation, Heart rate abnormal; Magnetic resonance imaging abdominal abnormal, Nerve injury, Postural orthostatic tachycardia syndrome, Stool analysis More
Developed severe diarrhea that Imodium and prescription anti-diarrheal had no impact. I had multiple... Developed severe diarrhea that Imodium and prescription anti-diarrheal had no impact. I had multiple tests that could not determine what caused it. I reacted as if all food had gluten in it. Even the low fodmap diet didn't help. In July 2022 I had an endoscopy and colonoscopy. I had inflammation thru whole digestive system. Diarrhea ended in Dec 2022 after taking Rabeprazole and severe constipation started. I also started having light-headedness and dizzy spells in June 2021. In May 2022 I was diagnosed with POTS. Since my Vagus nerve damaged in 2016, I could not feel my heart rate issues. I bought a smartwatch and found out that my heart rate varied from 30 bpm to low 200s. More
2828500 61 M GA 02/26/2025 RSV
 PFIZER\WYETH
 LH4511
Fatigue Fatigue
Feeling tired after 2-3 hours of vaccine administration Feeling tired after 2-3 hours of vaccine administration
2828501 73 F RI 02/26/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8252AA
U8252AA
Arthralgia, Feeling abnormal, Intervertebral disc space narrowing, Neck pain, Pa... Arthralgia, Feeling abnormal, Intervertebral disc space narrowing, Neck pain, Pain; Pain in extremity, Spinal X-ray abnormal, Spinal osteoarthritis, X-ray limb More
Patient presented 02/21/2025 for office visit and described the event. No report of the event was re... Patient presented 02/21/2025 for office visit and described the event. No report of the event was reported to our clinic prior to this date. Patient reported: - Experienced pain in the left shoulder after receiving a vaccine on November 27, 2023. - Pain began the same day as the vaccine administration. - Pain intensifies with arm movement, particularly when raising the arm or doing hair. Pain located in shoulder (deltoid region), and feelings a "weird feeling" radiate down arm over lateral arm and forearm with certain movements - She notes that the pain sometimes starts radiates from the mid left side of her neck and radiates neck down the left arm. More
2828502 71 M UT 02/26/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM2215
U8515CA
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
None reported, but this dose of Fluzone HD was second dose of the season, he received first dose 08/... None reported, but this dose of Fluzone HD was second dose of the season, he received first dose 08/24/2024. More
2828503 65 F UT 02/26/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM2211
U8515CA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
None reported, Fluzone HD dose given 10/05/2024 was second dose of 2024-25 version, first dose of Fl... None reported, Fluzone HD dose given 10/05/2024 was second dose of 2024-25 version, first dose of Flublok was given 08/24/2024. More
2828504 65 F AL 02/26/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8081561
ut84j4aa
Acne, Pustule; Acne, Pustule Acne, Pustule; Acne, Pustule
patient state about a week after injection a pimple came up and popped and pus came out. just has no... patient state about a week after injection a pimple came up and popped and pus came out. just has not healed in the meantime. just reported to me on 2/26/25 More
2828505 67 M WA 02/26/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FF2588
FF2588
FF2588
Amnesia, Anxiety, Asthma, Condition aggravated, Confusional state; Dizziness, Dy... Amnesia, Anxiety, Asthma, Condition aggravated, Confusional state; Dizziness, Dyspnoea, Inflammation, Insulin resistance, Tremor; Wheezing More
Shortness of breath, wheezing, dizziness, anxiety, shaky , tremors, confusion, memory loss, increase... Shortness of breath, wheezing, dizziness, anxiety, shaky , tremors, confusion, memory loss, increased insulin resistance, inflammation, frequent asthma attacks. More
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2828506 11 F CA 02/26/2025 VARCEL
 MERCK & CO. INC.
 Y007637
Vomiting Vomiting
Vomiting 1 hour after 2x with no fever Vomiting 1 hour after 2x with no fever
2828507 75 F CA 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 245M94
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Redness around vaccination injection site. Patient was complaining that injection site hurts on 2/25... Redness around vaccination injection site. Patient was complaining that injection site hurts on 2/25/2025. Per personnel, arm is getting better on 2/26/2025. Ice was applied and arm was elevated. More
2828508 65 F VA 02/26/2025 UNK
 UNKNOWN MANUFACTURER
Unevaluable event Unevaluable event
ER ER
2828509 70 F FL 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Areflexia, CSF protein increased, Immunoglobulin therapy, Muscular weakness, Par... Areflexia, CSF protein increased, Immunoglobulin therapy, Muscular weakness, Paralysis More
Patient experienced lower extremity weakness starting Tuesday 2/18/25 which progressed to full paral... Patient experienced lower extremity weakness starting Tuesday 2/18/25 which progressed to full paralysis on Friday 2/21/25. Patient had no reflexes upon presentation at ER and underwent lumbar puncture. She received IGG with improvement in symptoms and no worsening or further paralysis. More
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2828510 62 F WA 02/26/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FF2588
FF2588
Arthritis, Asthenia, Chest discomfort, Dizziness, Dyspnoea; Wheezing Arthritis, Asthenia, Chest discomfort, Dizziness, Dyspnoea; Wheezing
Shortness of breath, tightness in chest came in shortly after the dose of Pfizer vaccine. Weakness a... Shortness of breath, tightness in chest came in shortly after the dose of Pfizer vaccine. Weakness and increased inflammation in joints, dizziness, wheezing are all symptoms I experienced since having the series of the Pfizer vaccine. More
✓
2828511 30 M TX 02/26/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 028L20A
028L20A
028L20A
Abdominal pain, Blood alkaline phosphatase increased, COVID-19, Computerised tom... Abdominal pain, Blood alkaline phosphatase increased, COVID-19, Computerised tomogram abdomen normal, Malaise; Nausea, Primary biliary cholangitis, Scan with contrast normal, Smooth muscle antibody positive, Transaminases increased; Vomiting More
The following events are before any COVID19 infection: first 48H after the vaccine administration, d... The following events are before any COVID19 infection: first 48H after the vaccine administration, developed malaise, 72H after vaccine administration started with severe abdominal pain, nausea and vomiting, that prompted ED visit. More
✓
2828512 66 F NV 02/26/2025 COVID19
COVID19
 MODERNA
MODERNA
 unknown
unknown
Appendicitis perforated, Blood test, Computerised tomogram, Intra-abdominal flui... Appendicitis perforated, Blood test, Computerised tomogram, Intra-abdominal fluid collection, Magnetic resonance imaging; Pernicious anaemia, Tumour marker test More
1. Pernicious Anemia onset 4 months after 1 Moderna dose mRNA Covid. Treatment has been B-12 injecti... 1. Pernicious Anemia onset 4 months after 1 Moderna dose mRNA Covid. Treatment has been B-12 injections 2x/month. Outcome is injections and monitoring for life. 2. Burst Appendix 2 years after Covid 19 Modern with mucin in abdomen. Treatment is HPEC surgery was recommended but refused; MRI, CT, blood tests for tumor markers, MRI again, monitoring for life. More
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2828513 18 M CA 02/26/2025 COVID19
 MODERNA
Lymphadenitis, Lymphadenopathy, SARS-CoV-2 test negative Lymphadenitis, Lymphadenopathy, SARS-CoV-2 test negative
Enlarged/inflamed lymph nodes, persist today, years later. Never had a positive covid test even thou... Enlarged/inflamed lymph nodes, persist today, years later. Never had a positive covid test even though I took them whenever me or someone in my family was symptomatic. My reason for including this is: it seems to me to be from the vaccine not ?long covid? or anything other than the vaccine. More
✓
2828514 26 F KS 02/26/2025 COVID19
 MODERNA
Caesarean section, Exposure during pregnancy, Foetal hypokinesia, Foetal monitor... Caesarean section, Exposure during pregnancy, Foetal hypokinesia, Foetal monitoring More
Received first dose of moderna covid vaccine from pharmacy while 36 weeks pregnant. No side effects ... Received first dose of moderna covid vaccine from pharmacy while 36 weeks pregnant. No side effects other than a sore arm. Received the second dose of moderna covid vaccine from pharmacy at 38 weeks pregnant, after/at 5 pm on 10/21/21. That evening, I Noticed the fetus/ infant stopped moving. Admitted to labor and delivery triage the next morning to monitor fetal vitals. Due to decreased fetal movement, the infant was delivered via emergency c-section on the same day, 10/xx/24. The original delivery date was 11/1/2021. Baby was considered full term at 38 weeks, weighing 6 lbs 2 oz. More
✓
2827940 F TX 02/25/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Vulval cancer; Vulval cancer Vulval cancer; Vulval cancer
the HCP believes she is in the "initial stages of vulvar cancer; the patient has had problems; ... the HCP believes she is in the "initial stages of vulvar cancer; the patient has had problems; This spontaneous report was received from a physician via company representative and refers to a 34-year-old female patient. The patient's medical history included vulvectomy, sexual debut in 2005, and had a child in 2008. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unspecified date in 2009, the patient completed the vaccine series with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, dose, frequency, lot #, and expiration date were not reported) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot #, and expiration date were not reported) for prophylaxis (reporter stated she believed, however was unable to confirm which vaccine the patient received). Since 2016, the patient had had problems. No additional details were provided regarding those problems. The patient was seen on 13-FEB-2025, the healthcare provided (HCP) believed she was in the "initial stages of vulvar cancer." No additional details provided. At the reporting time, the outcome of the events was unknown. The causal relationship between the events, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown. Lot # is being requested and will be submitted if received. Upon internal review, the event of vulvar cancer was determined to be medically significant. More
2827941 69 M NJ 02/25/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Rash pruritic, Rash vesicular; Rash, Rash pruritic; Rash pruritic, Rash vesicula... Rash pruritic, Rash vesicular; Rash, Rash pruritic; Rash pruritic, Rash vesicular; Rash, Rash pruritic More
itchy rash like chicken pox or mosquito bites; This non-serious case was reported by a consumer via ... itchy rash like chicken pox or mosquito bites; This non-serious case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included COVID-19 vaccine and Influenza vaccine (Flu vaccine VII). On 20-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: itchy rash like chicken pox or mosquito bites). The outcome of the varicella-like rash was resolving. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. It was unknown if the company considered the varicella-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received his first dose of Shingrix in his left arm on 20-JAN-2025, and reported that 24 hours after receiving the vaccine, he got a very itchy rash like chicken pox or mosquito bites, in one area of his lower back, just at the top of his touche. The patient reported that rash was much less itchy on 27-JAN-2025 and was almost gone. The patient did not have any lot, expiry, NDC information to provide. The patient reported that he received a Covid vaccine and a high dose Flu vaccine about 3 or 4 weeks ago (Unknown Products Information) (Pre existing Shingrix). More
2827942 M FL 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Seizure, Viral infection Seizure, Viral infection
seizures; This spontaneous serious safety report with reference number 02742982 (Interaction number ... seizures; This spontaneous serious safety report with reference number 02742982 (Interaction number 02742981) was received by a partner on 27-JAN-2025 and forwarded on 28-JAN-2025 from a health care professional. A 6-month-old male patient had been vaccinated with unknown dose of Vaxelis (batch number not provided), on an unknown date for prophylaxis. No medical history was provided. No concomitant vaccinations were reported. On an unknown date, the patient experienced seizures after recently having been administered a dose of Vaxelis. The provider reported that the infant was hospitalized, and it was determined that he had a virus. She also stated that the infant recovered and went on to receive additional immunizations. The event was recovered/resolved. Action taken with Vaxelis was unknown. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "seizures". It was reported that the patient had a virus (alternative causality). Further information is expected. COMPANY COMMENT: Seizure is assessed as serious due to causing hospitalization. Seizure is listed for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to causing hospitalization. Seizure is listed for Vaxelis as per the Reference Safety Information. Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related. This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis. More
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2827943 MO 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7907AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
a dose of VAXELIS was given to a 5 year old patient.; This non-serious spontaneous safety report wit... a dose of VAXELIS was given to a 5 year old patient.; This non-serious spontaneous safety report with reference number: 02729137 (interaction number: 02729135 ) was received by MSD, on 03-JAN-2025 and forwarded to agency on 03-JAN-2025 from a medical assistant. Due to the nature of the event, the causality between the event "a dose of VAXELIS was given to a 5 year old patient" and Vaxelis was not applicable. Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 5 years. No further information is expected. More
2827944 F TX 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 u792188
Product storage error Product storage error
HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient.; Th... HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient.; This non-serious spontaneous safety report, with reference number 02731387 (interaction number: 02731358), was received by partner on 07-JAN-2025 and forwarded to UBC on 08-JAN-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient' and Vaxelis was not applicable. Further information is expected. More
2827945 F LA 02/25/2025 DTPPVHBHPB
VARCEL
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7921AA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Extra dose administered; an inappropriate use due to medical assistant inadvertently administered VA... Extra dose administered; an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax; This non-serious spontaneous safety report, with reference number 2025SA011036, was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from the physician. Due to the nature of the event, the causality between the events 'an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax, Extra dose administered' and Vaxelis was not applicable. Further information is expected. Significant follow-up was received by partner on 24-JAN-2025 and forwarded to UBC on 24-JAN-2025 from the physician in the United States. The case remained as non-serious, with concomitant vaccinations provided. Due to the nature of the event, the causality between the events 'an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax, Extra dose administered' and Vaxelis was not applicable. Further information is not expected. More
2827946 CA 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Inflammation, Lymphadenitis, Malaise, Pyrexia Inflammation, Lymphadenitis, Malaise, Pyrexia
malaise; Lymphadatitis; high inflammation; high fever; This non-serious spontaneous safety report, w... malaise; Lymphadatitis; high inflammation; high fever; This non-serious spontaneous safety report, with reference number 02733834 (interaction number: 02733830), was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from physician. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'high fever, malaise, lymphadenitis, and high inflammation'. Further information is not expected. Non-significant follow-up information was received via email on 27-JAN-2025, from a physician. The case is maintained as non-serious. Further information is not expected. More
2827947 CA 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Inflammation, Lymphadenitis, Malaise, Pyrexia Inflammation, Lymphadenitis, Malaise, Pyrexia
Malaise; Lymphadenitis; High inflammation; High fever; This non-serious spontaneous safety report, w... Malaise; Lymphadenitis; High inflammation; High fever; This non-serious spontaneous safety report, with reference number 02733835 (interaction number: 02733830), was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from physician. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'high fever, malaise, lymphadatitis, and high inflammation'. Further information is expected. More
2827948 M CO 02/25/2025 DTAP
DTAPIPVHIB
DTPPVHBHPB
HIBV
IPV
MMR
 SANOFI PASTEUR
SANOFI PASTEUR
MSP VACCINE COMPANY
SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER





Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got c... it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL; Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025; Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; This non-serious spontaneous safety report was received by partner on 14-JAN-2025 and forwarded to UBC on 16-JAN-2025 from a healthcare professional. Due to the nature of the event, the causality assessment between Vaxelis and the events were not applicable. Further information is expected. Non-significant follow-up information was received by the partner on 27-JAN-2025 and forwarded to UBC on 29-JAN-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable. Further information is not expected. Significant follow-up information was received by the partner on 27-JAN-2025 and forwarded to UBC on 28-JAN-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable. Further information is not expected. Significant follow-up information was received by the partner on 30-JAN-2025 and forwarded to UBC on 30-JAN-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable. Further information is not expected. More
2827949 UT 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Inappropriate schedule of product administration Inappropriate schedule of product administration
Child received a dose of VAXELIS at 2 months old and another dose at 4 months old. At 6 months old t... Child received a dose of VAXELIS at 2 months old and another dose at 4 months old. At 6 months old the child received the PEDIARIX vaccine; This non-serious spontaneous safety report, with reference number 02737956 (interaction number: 02737889), was received by the partner on 17-JAN-2025 and forwarded to UBC on 17-JAN-2025, from other health professional. Due to the nature of the event, the causality between the event "Child received a dose of VAXELIS at 2 months old and another dose at 4 months old. At 6 months old the child received the PEDIARIX vaccine" and Vaxelis was not applicable. Further information is expected. More
2827950 F FL 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7295AA
Product administered to patient of inappropriate age, Product preparation error Product administered to patient of inappropriate age, Product preparation error
an inappropriate use due to VAXELIS inadvertently given to a patient instead of a Flu Shot; 9-year-o... an inappropriate use due to VAXELIS inadvertently given to a patient instead of a Flu Shot; 9-year-old patient; This non-serious spontaneous, safety report was received by partner, on 31-JAN-2025 and forwarded to UBC on 03-FEB-2025 from a healthcare professional. This case is considered off-label use, due to product use in unapproved population, as the patient is 9 years old. The reporter did not provide an assessment of the causal relationship between Vaxelis and "an inappropriate use due to VAXELIS inadvertently given to a patient instead of a Flu Shot". Further information is expected. More
2827951 M CO 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7899AA
Wrong product administered Wrong product administered
Friday vaccinated 15-month old VAXELIS instead of DAPTACEL Inquiry Comments:; This non-serious spont... Friday vaccinated 15-month old VAXELIS instead of DAPTACEL Inquiry Comments:; This non-serious spontaneous safety report, with reference number 2025SA034914, was received by partner on 03-FEB-2025 and forwarded to UBC on 04-FEB-2025 from other health professional. Due to the nature of the event, the causality between the event 'Friday vaccinated 15-month old VAXELIS instead of DAPTACEL' and Vaxelis was not applicable. Further information is expected. More
2827952 F CO 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received an early dose of VAXELIS and is wondering about potential side effects; This non-se... Patient received an early dose of VAXELIS and is wondering about potential side effects; This non-serious spontaneous safety report, with reference number 2025SA036455, was received by partner on 04-FEB-2025 and forwarded to UBC on 05-FEB-2025 from other health professional. Off-label classification was added due to an early dose of Vaxelis being administered (inappropriate schedule of vaccine). Due to the nature of the event, the causality between the events 'Patient received an early dose of VAXELIS and is wondering about potential side effects' and Vaxelis was not applicable. Further information is expected. More
2827953 F WV 02/25/2025 DTPPVHBHPB
FLU3
 MSP VACCINE COMPANY
SANOFI PASTEUR
UT8419CA
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Was supposed to get VAXELIS but she was administered FLUZONE (pf) instead.; This non-serious spontan... Was supposed to get VAXELIS but she was administered FLUZONE (pf) instead.; This non-serious spontaneous safety report, with reference number 2025SA039561, was received by partner on 07-FEB-2025 and forwarded to agency on 10-FEB-2025 from other health professional. Due to the nature of the event, the causality between the events 'was suppose to get VAXELIS but she was administered FLUZONE (pf) instead' and Vaxelis was not applicable. Further information is not expected. More
2827954 M CA 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
Extra dose administered Extra dose administered
administration of VAXELIS instead of Quadracel; patient receiving extra doses of Hib and hepatitis ... administration of VAXELIS instead of Quadracel; patient receiving extra doses of Hib and hepatitis B antigens.; This non-serious spontaneous safety report, with reference number 2025SA043502 (Inquiry number 02407940), was received by partner on 10-FEB-2025 and forwarded to UBC on 12-FEB-2025 from other health professional. Due to the nature of the events, the causality between the events 'administration of VAXELIS instead of Quadracel' and 'patient receiving extra doses of Hib and hepatitis B antigens.' and Vaxelis was not applicable. Further information is expected. More
2827955 F IL 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 u7921aa
Syringe issue, Underdose Syringe issue, Underdose
Patient didn't receive a complete dose of vaccine.; HCP stated that while administering injecti... Patient didn't receive a complete dose of vaccine.; HCP stated that while administering injection to patient, contents of syringe 'sprayed out everywhere' between luer lock and needle attachment.; This non-serious spontaneous safety report, with reference number 02751876 (interaction number: 02751871), was received by partner on 11-FEB-2025 and forwarded to UBC on 11-FEB-2025 from other health professional. Additional information was received by partner on 12-FEB-2025 and forwarded to UBC on 13-FEB-2025 from other health professional. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'Patient didn't receive a complete dose of vaccine' and 'HCP stated that while administering injection to patient, contents of syringe 'sprayed out everywhere' between luer lock and needle attachment'. Further information is expected. More
2827956 M UT 02/25/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7899AA
X027728
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day; inadvertently administered... administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day; inadvertently administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day; This serious spontaneous safety report with MSD reference number #02752914was received by the partner on 12-FEB-2025 and forwarded to UBC on 13-FEB-2025, from a healthcare professional. Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day" was not applicable. Further information is expected. More
2827957 SC 02/25/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7767AA
Extra dose administered Extra dose administered
patient inadvertently received 2 vaccinations of VAXELIS in the same visit.; This serious spontaneou... patient inadvertently received 2 vaccinations of VAXELIS in the same visit.; This serious spontaneous safety report with MSD reference number #002754092 was received by the partner on 14-FEB-2025 and forwarded to UBC on 14-FEB-2025, from a healthcare professional. Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "patient inadvertently received 2 vaccinations of VAXELIS in the same visit" was not applicable. Further information is expected. More
2827969 54 F WA 02/25/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EL0140
EL1283
Biopsy lymph gland, Diffuse large B-cell lymphoma; Biopsy lymph gland, Diffuse l... Biopsy lymph gland, Diffuse large B-cell lymphoma; Biopsy lymph gland, Diffuse large B-cell lymphoma More
Diffuse Large B cell lymphoma Diffuse Large B cell lymphoma
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2827970 53 F ID 02/25/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 037K20A
037K20A
037K20A
Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Blood immunogl... Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Blood immunoglobulin A, Blood immunoglobulin G, Blood uric acid; C-reactive protein, Complement factor C3, Complement factor C4, Double stranded DNA antibody, HLA marker study; Immunology test, Postmenopausal haemorrhage, Red blood cell sedimentation rate, Rheumatoid arthritis, Rheumatoid factor More
after receiving my COVID vaccine series 2 events happened. One I had vaginal bleeding for 6 weeks, ... after receiving my COVID vaccine series 2 events happened. One I had vaginal bleeding for 6 weeks, post menopausal. The second is that in 2023 I developed Rheumatoid Arthritis. I do not know if there is a link but I think it should be reported. Thanks. More
2827980 78 F LA 02/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pain, Injection site pruritus Injection site erythema, Injection site pain, Injection site pruritus
redness right deltoid injection site; itching right deltoid injection site; soreness right deltoid i... redness right deltoid injection site; itching right deltoid injection site; soreness right deltoid injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 06-FEB-2025, the patient received Arexvy .5 ml. On 06-FEB-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness right deltoid injection site), injection site itching (Verbatim: itching right deltoid injection site) and injection site muscle pain (Verbatim: soreness right deltoid injection site). The outcome of the injection site erythema, injection site itching and injection site muscle pain were not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy. Additional Information: GSK Receipt Date: 14-FEB-2025 The reporter reported there was no other conditions provided. Pharmacy did not provide lot number. More
2827981 M FL 02/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
First Vaccination - Missed Second; This non-serious case was reported by a consumer via call center ... First Vaccination - Missed Second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (on 09-JUL-2024 received 1st dose). On an unknown date, the patient did not receive Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: First Vaccination - Missed Second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 17-FEB-2025 The patient received 1st dose of Shingles vaccine. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination. More
2827983 F 02/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nausea Nausea
Nausea; This non-serious case was reported by a consumer and described the occurrence of nausea in a... Nausea; This non-serious case was reported by a consumer and described the occurrence of nausea in a 55-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy). On 21-FEB-2025, the patient received Shingles vaccine. On 23-FEB-2025, 2 days after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea). The outcome of the nausea was not resolved. It was unknown if the reporter considered the nausea to be related to Shingles vaccine. It was unknown if the company considered the nausea to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-FEB-2025 The patient self-reported this case The patient received Shingles vaccine and experienced nausea and was not treated More
2827984 02/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness Influenza like illness
flu-like symptoms; This non-serious case was reported by a consumer and described the occurrence of ... flu-like symptoms; This non-serious case was reported by a consumer and described the occurrence of influenza-like symptoms 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 influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the influenza-like symptoms was resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported that patient received the Shingrix vaccine and had flu-like symptoms for couple of days. The other was Zostavax but it was supposed to be discontinued. More
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