🏥 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 💀 🏥 🚑 ♿ ⚠️
2830266 40 F MD 03/08/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9H5J5
9H5J5
Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness,... Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Musculoskeletal stiffness; Pain in extremity, Paraesthesia More
Upon injection, a sharp pain was felt in the left arm. A few minutes after the vaccine, left arm beg... Upon injection, a sharp pain was felt in the left arm. A few minutes after the vaccine, left arm began to feel numb, pins and needles. The next day, most of the left arm was numb down through the fingers. Was seen in occupational health clinic on 11/1, advised to go to occupational health provider to be seen. Was seen 11/1 and asked to come back in 1 week. Was seen again the next week with no resolution in symptoms. Referred to orthopedic MD/hand/shoulder specialist .Saw specialist on 11/19/24 who recommended PT for 4-6 weeks and commented he felt the axillary nerve may have been damaged. Completed PT with no significant improvement. Continue to have pain, weakness and stiffness in the left shoulder, arm and hand up until now. More
✓
2830267 11 F MA 03/08/2025 HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Blood test, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, La... Blood test, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Laboratory test; Magnetic resonance imaging, Petit mal epilepsy, Scan with contrast; Blood test, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Laboratory test; Magnetic resonance imaging, Petit mal epilepsy, Scan with contrast; Blood test, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Laboratory test; Magnetic resonance imaging, Petit mal epilepsy, Scan with contrast More
Beginning with absence seizures in 2015 during school which were undiagnosed until presentation of ... Beginning with absence seizures in 2015 during school which were undiagnosed until presentation of grand mal seizures starting in 2017. Patient continues with Generalized Seizures Refractory to Medications. More
✓ ✓
2830268 65 F FL 03/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3BH5K
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Patient complains o f redness and pain in her arm at injection site. Patient complains o f redness and pain in her arm at injection site.
2830269 41 M MS 03/08/2025 COVID19
COVID19
 JANSSEN
JANSSEN

Computerised tomogram neck abnormal, Diagnostic aspiration, Pathology test, Sinu... Computerised tomogram neck abnormal, Diagnostic aspiration, Pathology test, Sinusitis, Thyroid mass; Ultrasound neck More
5+cm abnormal nodule on right thyroid, 5+cm abnormal nodule on right thyroid,
2830270 6 F CO 03/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 4K7JP
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Tdap given to a 6 year old for 3rd dose. Tdap given to a 6 year old for 3rd dose.
2830271 51 M MD 03/08/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 x026328
x026328
y005921
y005921
Arthralgia, Fall, Gait disturbance, Headache, Impaired work ability; Pain, Rotat... Arthralgia, Fall, Gait disturbance, Headache, Impaired work ability; Pain, Rotator cuff repair, Vertigo; Arthralgia, Fall, Gait disturbance, Headache, Impaired work ability; Pain, Rotator cuff repair, Vertigo More
On 3/4/25, patient stated he had vertigo, tipped backwards and fell around 3pm. Also, reported mild ... On 3/4/25, patient stated he had vertigo, tipped backwards and fell around 3pm. Also, reported mild headache (general pressure headache) later in the evening. Vertigo has been continuous but getting better (not to the point of falling). Did not go to work on 3/5/25. Patient had rotated cuff surgery on right arm on 12/10/2024. It is tough to tell if the soreness is injection related or from surgery. Left shoulder is still sore but mild. More
2830272 77 F FL 03/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
Patient reported injection-site symptoms, which included pain /tenderness/swelling/redness / a litt... Patient reported injection-site symptoms, which included pain /tenderness/swelling/redness / a little itchy (comes and goes). Symptoms started the day after injection on 3/4/25. Patient stated she used hydrocortisone the first day and icing off and on since. Itchiness has gone down but other symptoms look about the same / but not worsen since started. More
2830273 63 M MO 03/08/2025 COVID19
 MODERNA
 3044202
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax inste... Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax instead. Pharmacist mistakenly pulled 2 vaccines from the Spikevax box in the freezer instead of the mRsevia. Corrective action has been taken to label bins and separate the vaccines. Both boxes are white and say Moderna. The syringes are the same size and the small font does not aid in identification. This error was also reported to ISMP. The error was discovered one week later after the vaccine inventory count. Patients reported no AE. More
2830274 61 M MO 03/08/2025 COVID19
 MODERNA
 3044202
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax inste... Patient was supposed to receive mResvia, RSV vaccine, but the pharmacist administered Spikevax instead. Pharmacist mistakenly pulled 2 vaccines from the Spikevax box in the freezer instead of the mRsevia. Corrective action has been taken to label bins and separate the vaccines. Both boxes are white and say Moderna. The syringes are the same size and the small font does not aid in identification. This error was also reported to ISMP. The error was discovered one week later after the vaccine inventory count. Patients reported no AE. More
2830275 72 F CO 03/08/2025 PNC21
 MERCK & CO. INC.
 Y019157
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Pt presented to pharmacy 2 days after vaccine was given with red, swollen itchy deltoid. Discussed u... Pt presented to pharmacy 2 days after vaccine was given with red, swollen itchy deltoid. Discussed using OTC treatments to help with symptoms and directed patient to contact pharmacy if not improving. More
2830276 50 F TX 03/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 99Y4J
Injection site erythema, Injection site warmth, Pyrexia Injection site erythema, Injection site warmth, Pyrexia
Redness to the right arm at the inject site with fever and warm to touch per patient , she went to t... Redness to the right arm at the inject site with fever and warm to touch per patient , she went to the ER and got antibiotic , Amoxil 500 mg More
2830277 57 F UT 03/08/2025 COVID19
COVID19
 MODERNA
MODERNA
 025J20-2A
025J20-2A
Brain fog, Dysarthria, Dysgraphia, Essential tremor, Fatigue; Head titubation, L... Brain fog, Dysarthria, Dysgraphia, Essential tremor, Fatigue; Head titubation, Loss of personal independence in daily activities, Tremor More
Shortly after receiving the shots my handwriting became illegible. I lost control when writing and i... Shortly after receiving the shots my handwriting became illegible. I lost control when writing and it progressed to being illegible. My speech then became slurred, and the tremors started. My head started shaking uncontrollably and I was unable to eat or drink without my hands shaking. Simple tasks have become difficult. During a routine check-up, my nurse practitioner noticed and said the word tremor. My days are filled with brain fog and exhaustion. The tremor is progressing day-be-day. There is no cure or treatment. More
✓
2830278 50 F IL 03/08/2025 COVID19
 PFIZER\BIONTECH
 FK9729
Dysphonia Dysphonia
caught Covid-19 in March of 2022 after the virus ran its course my voice was hoarse and I was unabl... caught Covid-19 in March of 2022 after the virus ran its course my voice was hoarse and I was unable to project there was no pain. I have been to my general practitioner and multiple ear nose and throat doctors they can not find any definitive reason for my voice to be hoarse or for me to not be able to project without it sounding like I am out of breath. More
2830279 17 F CA 03/08/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Chest pain, Loss of consciousness, Throat tightness, Urticaria Chest pain, Loss of consciousness, Throat tightness, Urticaria
Patient reports that she began to develop hives/welts to her buttocks bilaterally, left abdomen, and... Patient reports that she began to develop hives/welts to her buttocks bilaterally, left abdomen, and "entire back" at 1800 last night. Patient took a Benadryl capsule at 1900 last night. Patient reports a "brief five second" loss of consciousness at 1243AM on 3/8/25. She reports remembering "passing out" and calling her mother shortly afterwards. Patient reports mild persistent 3/10 throat tightness since 0700 this AM, 3/8/25 and intermittent bilaterally upper chest pain since 0700 this AM. More
2830280 77 M MO 03/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HM9N5
Hypoaesthesia, Injection site erythema, Injection site induration, Injection sit... Hypoaesthesia, Injection site erythema, Injection site induration, Injection site swelling, Paraesthesia More
pt's wife reported he had some redness and swelling at the site of the injection, and that it f... pt's wife reported he had some redness and swelling at the site of the injection, and that it felt hard to the touch. Pt started to have some numbness/tingling in fingers on that arm so decided to go to the ER. They said they thought it was likely an immune response to the vaccine, but gave him cephalexin 500mg to prevent any cellulitis. The numbness had since resolved itself by the time the rx was picked up. It was still red and swollen, but pt had not yet started the cephalexin. More
2830281 22 F CA 03/08/2025 TDAP
 SANOFI PASTEUR
Dizziness Dizziness
pt came to get two vaccines. In about 15 minutes after got the vaccines, pt stated that pt felt dizz... pt came to get two vaccines. In about 15 minutes after got the vaccines, pt stated that pt felt dizzy. More
2830282 25 M CA 03/08/2025 FLU3
 SANOFI PASTEUR
Dizziness Dizziness
pt came to the pharmacy for two vaccines. in about 15-20 minutes after getting the vaccines, pt stat... pt came to the pharmacy for two vaccines. in about 15-20 minutes after getting the vaccines, pt stated that pt felt dizzy More
2830283 25 F TX 03/08/2025 COVID19
 PFIZER\BIONTECH
 LM2224
Chills, Impaired work ability, Pain, Pyrexia, Tachycardia Chills, Impaired work ability, Pain, Pyrexia, Tachycardia
The morning after the vaccine on Feb 6, 2025, I had a fever of 102.2, became tachycardic to 132 bpm,... The morning after the vaccine on Feb 6, 2025, I had a fever of 102.2, became tachycardic to 132 bpm, and had chills (I have time stamped pictures of these and I'm a medical student). I was just lying on the couch and resting so I wasn't straining myself or doing something that would cause my heart rate to spike that much. My legs were also aching like nothing I've ever experienced before and I considered going to the emergency department because I was feeling so horrible. I ultimately just rested the entire day and felt a little better on Feb 7, 2025 so I didn't go to the ER. I've never had a reaction this badly before and I have physicians in my family who said this was not normal and I should report it and not get a COVID vaccine again. This was my 4th dose, and I'd like it to be my final one because I was unable to work the day after I got it. More
2830045 M NY 03/07/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
Pharmacist called to report 25 year old male was administered first dose of GARDASIL 9 in APR2023 an... Pharmacist called to report 25 year old male was administered first dose of GARDASIL 9 in APR2023 and second dose in JUN2023 but has not yet received their third dose.; No adverse event; This spontaneous report has been received from a pharmacist concerns a 25-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided. On an unknown date in April 2023, the patient received first dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) suspension for injection (strength, exact dose, anatomical route of administration, lot number and expiration date were not reported) and second dose in June 2023, but has not yet received their third dose (inappropriate schedule of product administration). No additional adverse event. Additional information is not expected. More
2830047 OK 03/07/2025 PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
 Y005465
Y005878
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE reported; VFC immunization coordinator calling to report T/E for ROTATEQ, and VAXN... No additional AE reported; VFC immunization coordinator calling to report T/E for ROTATEQ, and VAXNEUVANCE that was administered. T/E date was on 2/18/2025 and ROTATEQ and VAXNEUVANCE were administered on 2/25/2025. Permission was given to contact HCP by email. No addition; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-FEB-2025, the patient was vaccinated with the third dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) 0.5 mL Injection, administered as prophylaxis (lot number reported as Y005465, which has been verified as valid, expiration date reported and validated as 08-JAN-2027) (dose, route of administration, and anatomical site of injection were not provided); and with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral suspension, administered orally as prophylaxis (lot number reported as Y005878, which has been verified as valid, expiration date reported and validated as 28-OCT-2025) (strength and dose were not provided). The administered doses were exposed to a temperature excursion of 32 Fahrenheit degrees (F) for 2 hours and 12 minutes (Product storage error). No additional adverse events were reported. More
2830048 53 F NY 03/07/2025 PPV
 MERCK & CO. INC.
 W027449
Expired product administered, No adverse event Expired product administered, No adverse event
The patient did not report any adverse issues or side effects related to the administered dose; A HC... The patient did not report any adverse issues or side effects related to the administered dose; A HCP called to inquire about the validity and potency of an expired dose of PNEUMOVAX 23 (lot: W027449 expiration: 09/25/2024) that was inadvertently administered to a patient on 03/04/2025. The patient did not report any adverse issues or side eff; This spontaneous report was received from a pharmacist and refers to a(n) 53-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Mar-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) injection, at a dose of 0.5 milliliters (mL), lot #W027449; which has been verified to be a valid, expiration date reported and upon internal validation established as 25-Sep-2024 (strength, dose number, route, anatomical site of administration and vaccination scheme frequency were not provided) for prophylaxis (Expired product administered). The vaccine had never been exposed to any temperature excursions. The HCP was provided with a "not supported" outcome per the Post Expiry Memo Vaccines and Biologics Administered. The patient did not report any adverse issues or side effects related to the administered (No adverse event). More
2830049 F UT 03/07/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Asthenia, Back pain, Blood alkaline phosphatase increased, Blood glucose normal,... Asthenia, Back pain, Blood alkaline phosphatase increased, Blood glucose normal, Borrelia test negative; C-reactive protein increased, CSF culture negative, CSF glucose increased, CSF protein increased, CSF red blood cell count positive; CSF white blood cell count increased, Central nervous system leukaemia, Computerised tomogram thorax, Computerised tomogram thorax normal, Electroencephalogram normal; Electromyogram normal, Encephalitis, Gait disturbance, Guillain-Barre syndrome, HIV test negative; Haematocrit decreased, Haemoglobin decreased, Headache, Herpes simplex test negative, Hypoaesthesia; Immunoglobulin therapy, Intervertebral disc degeneration, Intervertebral disc protrusion, Intervertebral disc space narrowing, Lyme disease; Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Mean platelet volume increased, Meningitis, Metastases to meninges; Mobility decreased, Myalgia, Nephrolithiasis, Neurological symptom, Neuropathy peripheral; Paraesthesia, Paraneoplastic syndrome, Protein total normal, Pyrexia, Red blood cell count decreased; Red blood cell sedimentation rate increased, Renal stone removal, SARS-CoV-2 test negative, Spinal deformity, Spinal stenosis; Treponema test negative, Ureteral stent insertion More
atypical GBS; Lymphomatous meningitis; Lyme disease; Paraneoplastic syndrome; Meningoencephalitis; C... atypical GBS; Lymphomatous meningitis; Lyme disease; Paraneoplastic syndrome; Meningoencephalitis; CNS leukemia; Progressive neuropathy; This serious case was reported in a literature article and described the occurrence of neuropathy in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference. The patient's past medical history included percutaneous nephrolithotomy (11 days post-vaccination) and ureteral stent insertion (11 days post-vaccination). Concurrent medical conditions included tobacco user, hypertension, hypothyroidism, insomnia, postmenopausal bleeding, urinary calculus, urinary retention, renal stone (weighing 2.3 g), drug allergy (Sulfa, Amoxicillin, Altenelol, Zestril, Trazadone.), pharyngitis and sulfonamide allergy. Concomitant products included losartan, levothyroxine, amlodipine besilate (Norvasc) and cyanocobalamin-tannin complex (B12). On 07-JUL-2022, the patient received Shingrix. On 19-JUL-2022, 12 days after receiving Shingrix, the patient experienced neuropathy (Verbatim: Progressive neuropathy) (serious criteria hospitalization, disability and GSK medically significant). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: atypical GBS) (serious criteria hospitalization, disability and GSK medically significant), lymphomatous meningitis (Verbatim: Lymphomatous meningitis) (serious criteria hospitalization and GSK medically significant), lyme disease (Verbatim: Lyme disease) (serious criteria hospitalization and GSK medically significant), paraneoplastic syndrome (Verbatim: Paraneoplastic syndrome) (serious criteria hospitalization and GSK medically significant), meningoencephalitis (Verbatim: Meningoencephalitis) (serious criteria hospitalization and GSK medically significant) and central nervous system leukemia (Verbatim: CNS leukemia) (serious criteria hospitalization). The patient was treated with doxycycline, meropenem, dexamethasone, vancomycin, immunoglobulins nos (Immunoglobulin I.V) and ceftriaxone sodium (Rocephin). The outcome of the neuropathy, guillain barre syndrome, lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia were resolving. The reporter considered the neuropathy, guillain barre syndrome, lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia to be probably related to Shingrix. The company considered the neuropathy and guillain barre syndrome to be related to Shingrix. The company considered the lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia to be unrelated to Shingrix. Additional Information: GSK Receipt date 26-Feb-25 Author reported a 64-year-old woman with a previous medical history significant for tobacco usage, hypertension, hypothyroidism, insomnia, post-menopausal bleeding, urinary calculus, and urinary retention presented with a series of symptoms following Shingrix vaccine administration eleven days post-vaccination. The initial presentation of symptoms included bilateral paresthesia through her wrists, arms, and lower extremities, as well as headaches, fevers, and muscle aches in her hips and back. The patient received no other medications or vaccinations during the visit in which she received the Shingrix vaccine. Eleven days post-vaccination, the patient presented to her primary care provider's office with paresthesia spreading bilaterally through the wrists, arms, and lower body with increasing progression for about 3 to 4 days. The patient reported new-onset headaches, fever, and muscle aches in her hips and back. An at-home COVID-19 test was negative, and no upper respiratory symptoms were reported. A history and physical examination performed by her primary care provider found pharyngitis and cephalgia. The working diagnosis was Lyme disease or another tick-borne illness causing meningoencephalitis, which was reported to the patient. The patient reported no known tick or insect bites, though she reported it was difficult to be sure. General lab work and a Lyme/tick panel were ordered. The patient was prescribed doxycycline to be taken twice daily for 21 days. Her Lyme and tick panels both came back negative. Within hours of her primary care office visit, the patient presented to the emergency department with fevers, numbness, tingling in her body, and a shuffling, stiff gait. A lumbar puncture showed a white cell count of 452, subsequently leading to treatment for suspected meningitis with meropenem, dexamethasone, and vancomycin. The patient was then admitted to the hospital 12 days post-vaccination due to her rapidly progressive neurological symptoms. Upon admission, her MRI results were as follows: unremarkable for brain pathology, multilevel disc disease with mild spinal canal stenosis of C4-C7, posterior disc bulge at T7-T8 with flattening of the ventral thecal sac and deformity of the ventral spinal cord, and moderate neural foraminal narrowing of L4-S1. The MRI showed no concerns associated with cord signaling in any region. A chest CT with contrast showed that there was no evidence of an intrathoracic malignancy as a contributing factor for her ascending weakness. The EEG showed a normal awake state record, no definite spikes or paroxysms of significance, and no significant epileptiform activities. No electrographic seizures were recorded. No significant focal or lateralizing abnormalities were seen. Even with the patient's leg shaking, no significant EEG abnormalities were recorded. Thirteen days post-vaccination, a second MRI without contrast was performed to assess her progressive lower extremity weakness. The MRI found no indications of flow limiting stenosis or occlusion of proximal intracranial arteries. An electromyogram of the right upper and bilateral lower extremities came back normal, with the electrodiagnostic evaluation revealing no findings suggestive of cervical radiculopathy, brachial plexopathy, lumbosacral radiculopathy/plexopathy, other peripheral mono/polyneuropathy, or any myopathic process affecting the right upper and bilateral lower extremities. The working diagnosis for this patient remained broad, but included Lyme disease with atypical presentation, atypical GBS, primary lymphomatous meningitis, CNS leukemia, or a paraneoplastic syndrome. An infectious disease consultation ordered syphilis, HIV, and HSV tests, which all came back negative. Neurology was consulted and started the patient on IVIG and Rocephin. Her neuropathy showed improvement with the initiation of IVIG and Rocephin. Fourteen days post-vaccination, the patient was entered into evaluation for physical therapy with the goal of ambulating independently on level surfaces, as her neurological symptoms had significantly impacted her mobility. Twice daily physical therapy was performed with the plan to discharge her to a skilled rehabilitation facility when ready. Her physical therapy treatments continued for 16 days. During this visit, a large calcium oxalate kidney stone weighing 2.3 g was also diagnosed. The patient underwent percutaneous nephrolithotomy with ureteral stent placement 11 days post-vaccination. The kidney stone was reported to be incidental and unlikely to be related to her chief complaint on presentation. Upon discharge 17 days post-vaccination, the confirmed diagnosis was never determined for the presenting symptoms of fever, numbness, tingling, and paresthesia, though it was eventually presumed to be a neurological event stemming from the Shingrix vaccination by her providers due to her response to IVIG. The patient reported improvement, albeit minimal, with continuing numbness, tingling, and weakness. Continued improvement was reported to her primary care provider, extending all the way to 74 days post-vaccination, but numbness in her feet and groin persisted, as seen in the complete timeline of symptoms and treatments. At present, the patient reports that her symptoms have nearly (but not completely) subsided, with occasional numbness in her feet and groin. She reports frustration concerning her perceived delay in treatment as well as the lack of an eventual diagnosis. Her case was reported to VAERS in the hope that it can increase patient and provider vigilance. The patient's inconclusive diagnosis remains due to incomplete testing as well as the broad differential upon admission that did not include rare adverse events, leaving the patient unsure of how to proceed medically. These lingering questions can persist for patients and providers, leaving all parties involved to speculate based on the circumstances. With continued patient and provider education, author remained hopeful that both parties involved utilize resources, such as VAERS, in order to consider rare, but serious events. Although a conclusive diagnosis was not reached for this patient, a presumed diagnosis of an adverse neurological event, such as GBS, following vaccine administration was eventually reached. Her symptom onset at 11 days post-vaccination was consistent with the pathophysiology surrounding GBS. She also was taking no other medications and received no other vaccines at the time. Her CSF studies were inconsistent with a typical GBS but failed to produce any microbial growth indicating infection. In addition, it was less likely that an infection would continue to produce neurologic symptoms as far as 74 days after an event. Lastly, her improvement was seen with the initiation of IVIG, not with the initial treatment regimen that included coverage for meningitis with meropenem and vancomycin. Confounding factors, such as an infection, may have been present, but author believed the likely source of this patient's prolonged neuropathy to be related to her Shingrix vaccination. The treatment with (and outcome after using) IVIG suggests a grade 4 serious adverse event (SAE) from the Shingrix vaccine in this patient. Author hypothesize that some sort of immune cross-reactivity may have led to her neurological symptoms, although a number of factors could be involved in her symptomatology. The Q2-S1 molecule found in the AS01 adjuvant may be a culprit for the cross-reactivity noted in this case. Author reported a probable serious adverse event associated with the Shingrix vaccine. A confirmed diagnosis was never reached, with a working diagnosis that was eventually ruled out. The prevalence of neuropathy associated with Shingrix was low, however not unheard of, as a black box warning for GBS included on the label. Author advocated for the continued awareness of serious neuropathy after Shingrix vaccination to allow for improved patient care and peace of mind, with the goal of educating both patients and providers about this rare event in order to improve awareness, destigmatize efficacious vaccines, and increase surveillance regarding long-term or delayed side effects following vaccinations. This article is not available for regulatory reporting purpose due to copyright restrictions.; Sender's Comments: Metastases to meninges, Lyme disease, Paraneoplastic syndrome, Encephalitis and Central nervous system leukaemia are unlisted events which are considered unrelated to GSK vaccine Shingrix. Neuropathy peripheral is an unlisted event which, due to the following criteria (strong temporal association, Guillain-Barre syndrome ) is considered related to GSK vaccine Shingrix. Guillain-Barre syndrome is a listed event which is considered related to GSK vaccine Shingrix. More
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2830050 03/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I receive shingles twice, even with a shingles shot; This serious cas... Suspected vaccination failure; I receive shingles twice, even with a shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I receive shingles twice, even with a shingles shot). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient received shingles twice, even with a shingles shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2830051 03/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; My doctor has had patients get shingles from the vaccine; This seriou... Suspected vaccination failure; My doctor has had patients get shingles from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My doctor has had patients get shingles from the vaccine). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 27-FEB-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her doctor had patients get shingles from the vaccine. The reporter stated that if you recognized a rash or spots and take care of it quickly you would not had a problem. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2830052 03/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspeceted vaccination failure; generally have recurrent outbreaks every; This serious case was repo... Suspeceted vaccination failure; generally have recurrent outbreaks every; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: generally have recurrent outbreaks every). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that for what it was worth, the vaccine was worth getting. Unfortunately, despite being vaccinated, the patient generally had recurrent outbreaks every 12-18 months. But thanks to that vaccine, his/her outbreak was very small, about the size of a half dollar. The patient had learned to always have a prescription for valacyclovir on hand so the reporter could start treatment the moment it started. Still painful and not fun but resolves within a few days. The patient could not imagine how bad it would be if the patient had not been vaccinated. This case was considered as suspected vaccination failure as details time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of shingles) is considered unrelated to GSK Shingles vaccine. More
2830064 70 F WA 03/07/2025 UNK
 UNKNOWN MANUFACTURER
 X2233
Underdose Underdose
NONE, LOW DOSE (HALF THE ADULT DOSE) NONE, LOW DOSE (HALF THE ADULT DOSE)
2830075 25 M 03/07/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Fatigue, Injection site rash, Pruritus Chills, Fatigue, Injection site rash, Pruritus
rash at injection site; itching; chill; fatigue; This non-serious case was reported by a consumer vi... rash at injection site; itching; chill; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 25-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on an unknown date) and Twinrix (Patient received second dose on an unknown date). On 24-FEB-2025, the patient received the 3rd dose of Twinrix. On 25-FEB-2025, 1 days after receiving Twinrix, the patient experienced injection site rash (Verbatim: rash at injection site), pruritus (Verbatim: itching), chills (Verbatim: chill) and fatigue (Verbatim: fatigue). On 26-FEB-2025, the outcome of the chills and fatigue were resolved (duration 1 day). The outcome of the injection site rash and pruritus were not resolved. It was unknown if the reporter considered the injection site rash, pruritus, chills and fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site rash, pruritus, chills and fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device. 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: 26-FEB-2025 Patient who stated that from previous ones (Twinrix), he never had any issues but with his last vaccine for Twinrix, he started to develop a rash on his arm, and it was itching, and started having some other symptoms that he was kind of concerned about. Patient had a telehealth that night and he was told that everything was fine and he was okay. He received the vaccine on Monday, 24-FEB-2025, and Tuesday night when he got home around 7, he noticed he had a rash at the injection site (left shoulder), and chills. He stated he felt off throughout the day with fatigue and when asked if the symptoms had resolved, he stated the rash was still there, but the other symptoms were gone in the morning when he woke up. More
2830076 53 F CT 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Inappropriate schedule of product administration, Product preparation issue Inappropriate schedule of product administration, Product preparation issue
Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix... Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient; Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient; Patient received first dose of Shingrix on March 6th 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) and (batch number N77J2, expiry date 23-OCT-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose of shingrix on 06th March 2024). On 03-MAR-2025, the patient received the 2nd dose of Shingrix. On 03-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient), inappropriate dose of vaccine administered (Verbatim: Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient) and drug dose administration interval too long (Verbatim: Patient received first dose of Shingrix on March 6th 2024). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date : 03-MAR-2025 Licensed Practical Nurse explained that they administered just the diluent portion without reconstituting of a Shingrix vaccine to a patient on March 3rd 2025 which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Patient received first dose of Shingrix on March 6th 2024. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2830078 1 F MP 03/07/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse Reaction noted yet. No adverse Reaction noted yet.
2830079 1.08 M CA 03/07/2025 FLU3
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UT8468LA
X026330
Y011712
Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count abnor... Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count abnormal, Rash; Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count abnormal, Rash; Contusion, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count abnormal, Rash More
MMR given 1/29/25; returned to clinic on 2/18/25 for rash and bruising. MD called Hematologist who a... MMR given 1/29/25; returned to clinic on 2/18/25 for rash and bruising. MD called Hematologist who advised transfer to ER to transfer for admission for tx. Pt was seen and dc'd from hospital. He was given a single course of IVIG with iomprovement and stabilization of platelet number More
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2830116 15 M MI 03/07/2025 HPV9
 MERCK & CO. INC.
Fall, Head injury, Presyncope Fall, Head injury, Presyncope
patient had vasovagal event within 5 minutes of vaccine administration. Patient was not sitting, but... patient had vasovagal event within 5 minutes of vaccine administration. Patient was not sitting, but leaning against exam table and slid down table to ground hitting head on ground. No LOC from hitting head. awake immediately and with sitting down for 10-15 minutes recovered without concerns More
2830117 57 F FL 03/07/2025 PNC20
 PFIZER\WYETH
 PAA201729
Chills, Decreased appetite, Pruritus, Pyrexia, Rash Chills, Decreased appetite, Pruritus, Pyrexia, Rash
slight fever, chills, loss of appetite and a big red rash with itch on arm slight fever, chills, loss of appetite and a big red rash with itch on arm
2830118 0.33 F PA 03/07/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
 9D25P
UK113AB
LK6651
Y011481
Body temperature increased, Diarrhoea, Frequent bowel movements; Body temperatur... Body temperature increased, Diarrhoea, Frequent bowel movements; Body temperature increased, Diarrhoea, Frequent bowel movements; Body temperature increased, Diarrhoea, Frequent bowel movements; Body temperature increased, Diarrhoea, Frequent bowel movements More
Mom called on 3/6/2025 with concerns that patient had a temp of 101.7 at 1900 on 3/5/2025. Mom said ... Mom called on 3/6/2025 with concerns that patient had a temp of 101.7 at 1900 on 3/5/2025. Mom said that the temp at 0925 on 3/6/2025 was 100.1. Mom said patient had an increased amount of stools as well. Mom described them as "runny, almost like water." More
2830119 0.58 M MI 03/07/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 DN273
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
N/A given for travel N/A given for travel
2830120 56 M NC 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Injection site pruritus Injection site pruritus
5 minutes after given injection pt states that his arm was itching at injection site. Pt denies any ... 5 minutes after given injection pt states that his arm was itching at injection site. Pt denies any SOB or swelling in face. Site was not red, hot to touch, rash or swelling. Otherwise, pt states that he is feeling fine. Dr. examined pt and took band aid off. Vitals were obtained and pt sat for another 10 mins. Dr. examined pt again. Pt states that itching was gone. Pt instructed of itching comes back, redness or swelling at site, SOB to call our office. Pt verbalized understanding. More
2830121 4 M PA 03/07/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5H95B
Y014305
Injection site erythema, Injection site rash, Injection site swelling; Injection... Injection site erythema, Injection site rash, Injection site swelling; Injection site erythema, Injection site rash, Injection site swelling More
Leg rash at site of injection. Exam shows localized swelling, erythema of U/L LE that appears consis... Leg rash at site of injection. Exam shows localized swelling, erythema of U/L LE that appears consistent with injection site reaction, most likely to Proquad. Recommended conservative measures at this time with ice, analgesics if febrile, and antihistamine for pruritus. More
2830122 31 F AR 03/07/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FF2589
FF2589
FF2589
FC3184
FC3184
FC3184
Biopsy thyroid gland, Biopsy thyroid gland normal, Blood thyroid stimulating hor... Biopsy thyroid gland, Biopsy thyroid gland normal, Blood thyroid stimulating hormone decreased, Computerised tomogram, Poorly differentiated thyroid carcinoma; Radioactive iodine therapy, Thyroid mass, Thyroidectomy, Thyroxine, Ultrasound thyroid abnormal; Whole body scan; Biopsy thyroid gland, Biopsy thyroid gland normal, Blood thyroid stimulating hormone decreased, Computerised tomogram, Poorly differentiated thyroid carcinoma; Radioactive iodine therapy, Thyroid mass, Thyroidectomy, Thyroxine, Ultrasound thyroid abnormal; Whole body scan More
Nodule on thyroid developed and had grown significantly in size by April, lab work was completed and... Nodule on thyroid developed and had grown significantly in size by April, lab work was completed and TSH was 0.69 and T4 was 1.01. Us was done in May and found a 4.7cmx1.7x3.9 nodule on thyroid. FNA biopsy completed by the ENT was negative. Recommendation by ENT based on US presentation and the nodule having continued to grow on repeat US in a short time frame was for removal. Nodule was removed with thyroidectomy and diagnosed as poorly differentiated thyroid carcinoma. Radioactive iodine was performed. Continuous monitoring has been completed by MD for lymph nodes in thyroid bed. More
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2830123 76 M ME 03/07/2025 COVID19
 MODERNA
 8081260
Asthenia Asthenia
Patient reported paralyzing weakness Patient reported paralyzing weakness
2830124 1 M PA 03/07/2025 HEPA
MMR
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH


Generalised tonic-clonic seizure; Generalised tonic-clonic seizure; Generalised ... Generalised tonic-clonic seizure; Generalised tonic-clonic seizure; Generalised tonic-clonic seizure More
Non febrile seizure on 3/1/25 and also on 3/6/25. Both were Tonic clonic seizures lasting 5 minutes ... Non febrile seizure on 3/1/25 and also on 3/6/25. Both were Tonic clonic seizures lasting 5 minutes on 3/1/25 and 7 minutes on 3/6/25. No family history of epilepsy on either maternal or paternal side. More
2830125 14 M TX 03/07/2025 HPV9
 MERCK & CO. INC.
 Y000206
No adverse event No adverse event
Nothing has been said of any signs of adverse. Nothing has been said of any signs of adverse.
2830126 18 F VA 03/07/2025 TDAP
 SANOFI PASTEUR
 U8389AA
Exposure during pregnancy, Foetal monitoring abnormal, Loss of consciousness, Ul... Exposure during pregnancy, Foetal monitoring abnormal, Loss of consciousness, Ultrasound antenatal screen More
Patient was given the TDAP vaccine 0853 - when she went to check out she passed out at the front des... Patient was given the TDAP vaccine 0853 - when she went to check out she passed out at the front desk. Per witnesses, she did not fall straight to floor, pivoted and then went down to side. Vitals WNL - patient take back to room. Patient to go to triage when her mom picks her up. Patient reports good fetal movement. Left clinic at 0946 ambulatory. -OB Triage Discharge Summary Presenting Complaint: Syncopal episode at OB appointment while checking out Presenting time:1000 Discharge Diagnosis:S/P Syncopal episode Discharge time: 11:16 AM HPI: 18 y.o. female G1P0000 at 30w1d who presents to triage with the c/o gentle fall to floor following syncopal episode at OB appointment. Pt does not believe she hit her abdomen. She denies VB or LOF. She reports active fetal movement. States she feels fine Pregnancy Complicated by: Chlamydia on initial labs, TOC positive, retreated 1/29 GBS UTI on initial labs, allergy to PCN and cephalosporin, tx with nitrofurantoin per Up to Date, will need TOC Anatomy - 12/10 - 23% overall, 8%AC for 21w2d, all details visualized, will rpt with MFM or direct to US for poss IUGR, Rpt - 01/02 - 38% overall for 24w4d, 16% AC, rpt as clinically indicated, consider 3rd trim growth. Observational course/ Follow up Examination(s) Pt resting in bed in no acute distress. She reports active FM throughout monitoring/time in triage Fetal monitoring: NST: baseline 130 with moderate variability, present accelerations, NST reactive : yes TOCO: few mild irregular contractions every 10-15 minutes Plan: DC home Kick counts reviewed Reviewed importance of hydration and nutrition Labor precautions given More
2830127 71 F IN 03/07/2025 PNC21
 MERCK & CO. INC.
 y019157
Confusional state, Impaired driving ability Confusional state, Impaired driving ability
Starting wednesday had confusion. placed uncooked food in bed to eat and then didn't eat. Did n... Starting wednesday had confusion. placed uncooked food in bed to eat and then didn't eat. Did not realize until morning. Friends reported when speaking to the patient that they were concerned she was having a stroke. The next day while driving patient got lost despite having gps map guidance open. Was able to make it home ok, but without the gps she would not have. More
2830128 78 F PA 03/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Injection site pain, Injection site swelling, Pain, Pain in extremity Injection site pain, Injection site swelling, Pain, Pain in extremity
The night after the shot my arm was extremely sore but it went away after two days. But my arm at th... The night after the shot my arm was extremely sore but it went away after two days. But my arm at the site became tender and puffy and pain on movement after 8 days. More
2830129 67 M FL 03/07/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse events noted; Patient received Boostrix in 3/6/2025 and Boostrix on 7/29/2024 . No adverse events noted; Patient received Boostrix in 3/6/2025 and Boostrix on 7/29/2024 .
2830130 11 M AZ 03/07/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Z27PB
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse reactions noted. Client inadvertently received 1 cc ( adult dose) of Hepatitis A vaccine.... No adverse reactions noted. Client inadvertently received 1 cc ( adult dose) of Hepatitis A vaccine. 11 year old should have received a 0.5 cc dose of Havrix More
2830131 67 M MD 03/07/2025 COVID19
FLU3
PNC20
TDAP
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
SANOFI PASTEUR



Wrong patient; Wrong patient; Wrong patient; Wrong patient Wrong patient; Wrong patient; Wrong patient; Wrong patient
This RN roomed a patient for PCP visit. Chart opened and confirmed birthday with patient. Patient a... This RN roomed a patient for PCP visit. Chart opened and confirmed birthday with patient. Patient advised due for 4 vaccinations, pt agreed to all 4. This RN went back into patient room, reopened chart and proceeded to give the 4 due vaccinations. Upon speaking to PCP, it was realized that vaccinations were given to incorrect patient. System showed patients being in incorrect rooms (i.e pt in room 27 actually in room 26). Patients also had same first name and same birth year. Patient notified by PCP, and had actually been due for 3 of 4 vaccinations. More
2830132 61 F 03/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Contusion, Erythema, Pruritus Contusion, Erythema, Pruritus
redness, itching, bruise feeling redness, itching, bruise feeling
2830133 34 M SC 03/07/2025 HPV9
 MERCK & CO. INC.
 X024650
Musculoskeletal stiffness, Syncope Musculoskeletal stiffness, Syncope
No contraindications or precautions on screening prior to vaccination. Following administration of v... No contraindications or precautions on screening prior to vaccination. Following administration of vaccine in seated position, client reported feeling lightheaded. Client placed in supine position. This nurse called health department nurse manager to the room. Client appeared to experience syncopal episode with muscle stiffening. Client s legs elevated. Client returned to consciousness within seconds. Vital signs monitored. Client declined emergency medical services contact. Client provided cool water and candy which were tolerated well. Client declined cool cloth or cool pack. Client alert and oriented to person, place, time, and situation. Client denied previous reactions to vaccines in the past. Continued to monitor client with stable vital signs in supine, sitting, and standing positions. Regional medical director notified. Client encouraged to follow up with personal medical provider. Client voiced understanding. Client encouraged to notify providers of reaction following receipt of vaccine prior to any future injections or procedures. Client voiced understanding. Client informed that per regional medical director client cannot receive any further doses of HPV vaccine from clinics. Client voiced understanding. Vital signs stable. Client ambulatory with steady gait without assistance. No symptoms present at time of discharge from clinic. Regional immunization program manager notified. More
2830134 0.5 M CO 03/07/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Patient as vaccinated on 02/13/2025 and vaccine were drawn up by another MA named and I gave the pat... Patient as vaccinated on 02/13/2025 and vaccine were drawn up by another MA named and I gave the patient his vaccine and had them verify by an RN named. I was informed at my eval on 03/05 that the vaccines for a 6-month-old child only received the sterile saline used to mix with the hib vaccine meaning he has not been vaccinated for Hib and will need to return to the clinic to be re-vaccinated. I call the mother and notify her of the situation, and to see if the patient had any vaccine reaction, or she had any questions? Mother of the patient stated we are all human and make mistake and no symptoms and that the patient is doing fine and will come into the clinic to be revaccinated again. More
2830135 79 F FL 03/07/2025 HEPAB
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 m4b34
lk6650
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient was given two Prevnar 20 vaccines which is over the maximum number of doses that should be g... Patient was given two Prevnar 20 vaccines which is over the maximum number of doses that should be given for this vaccine. The first was given on 04/25/24 and second was given on 03/06/25. More
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