๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2856191 1 F CO 08/31/2025 HEPA
HEPA
HEPA
HEPA
HEPA
HEPA
HEPA
HEPA
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
MMR
MMR
MMR
MMR
MMR
MMR
MMR
MMR
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.







































Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Bloo... Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal; CSF protein normal, CSF white blood cell count negative, Chest X-ray normal, Conjunctivitis, Cough; Culture urine negative, Cyanosis, Eosinophil count normal, Fatigue, Gait disturbance; Haemoglobin normal, Hypotension, Lethargy, Liver function test normal, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Mobility decreased, Neutrophilia, Platelet count normal, Procalcitonin increased; Pyrexia, Scan with contrast normal, Transcranial electrical motor evoked potential monitoring, Tremor, Unresponsive to stimuli; Urine analysis normal, Vomiting; Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal; CSF protein normal, CSF white blood cell count negative, Chest X-ray normal, Conjunctivitis, Cough; Culture urine negative, Cyanosis, Eosinophil count normal, Fatigue, Gait disturbance; Haemoglobin normal, Hypotension, Lethargy, Liver function test normal, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Mobility decreased, Neutrophilia, Platelet count normal, Procalcitonin increased; Pyrexia, Scan with contrast normal, Transcranial electrical motor evoked potential monitoring, Tremor, Unresponsive to stimuli; Urine analysis normal, Vomiting; Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal; CSF protein normal, CSF white blood cell count negative, Chest X-ray normal, Conjunctivitis, Cough; Culture urine negative, Cyanosis, Eosinophil count normal, Fatigue, Gait disturbance; Haemoglobin normal, Hypotension, Lethargy, Liver function test normal, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Mobility decreased, Neutrophilia, Platelet count normal, Procalcitonin increased; Pyrexia, Scan with contrast normal, Transcranial electrical motor evoked potential monitoring, Tremor, Unresponsive to stimuli; Urine analysis normal, Vomiting; Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal; CSF protein normal, CSF white blood cell count negative, Chest X-ray normal, Conjunctivitis, Cough; Culture urine negative, Cyanosis, Eosinophil count normal, Fatigue, Gait disturbance; Haemoglobin normal, Hypotension, Lethargy, Liver function test normal, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Mobility decreased, Neutrophilia, Platelet count normal, Procalcitonin increased; Pyrexia, Scan with contrast normal, Transcranial electrical motor evoked potential monitoring, Tremor, Unresponsive to stimuli; Urine analysis normal, Vomiting; Adenovirus test positive, Asthenia, Balance disorder, Blood albumin normal, Blood creatine phosphokinase normal; Blood creatinine normal, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal; CSF protein normal, CSF white blood cell count negative, Chest X-ray normal, Conjunctivitis, Cough; Culture urine negative, Cyanosis, Eosinophil count normal, Fatigue, Gait disturbance; Haemoglobin normal, Hypotension, Lethargy, Liver function test normal, Magnetic resonance imaging head normal; Magnetic resonance imaging spinal normal, Mobility decreased, Neutrophilia, Platelet count normal, Procalcitonin increased; Pyrexia, Scan with contrast normal, Transcranial electrical motor evoked potential monitoring, Tremor, Unresponsive to stimuli; Urine analysis normal, Vomiting More
Monday PM after vaccines lethargic with fever to 104 Tmax rectally and conjunctivitis. Tuesday ongoi... Monday PM after vaccines lethargic with fever to 104 Tmax rectally and conjunctivitis. Tuesday ongoing fever with unbalanced walking low energy and tired and clingy. Wednesday fatigue progressive with not wanting to walk or move. Has been walking for past 1-2 months. Did have one episode spitting up/emesis. Also developed whole body shakiness that started with one arm and one leg and progressed to whole body shaking. No turning blue, was unresponsive during episode, and parents could not stop the shaking. Poor balance continued. Would not walk or crawl and balance continued to worsen. Thursday ongoing fever with purple hands and feet prompting hospital evaluation. ROS: cough. Denies rhinorrhea, diarrhea, extremity swelling, rash, LAD. Endorse possibly bright pink swollen lips. Since hospitalization, febrile Tmax 40.3C. Hypotensive on arrival, otherwise age appropriate VS. Low flow NC. Labs have shown normal Cr, normal LFTs, normal CK, normal albumin, elevated PCT, neutrophilic predominant leukocytosis, normal hgb, normal plts, nml AEC, CSF profile without pleocytosis normal glucose and protein, elevated but DT CRP, clear UA without pyuria. ID work up has included negative urine culture, blood cultures, CSF culture, MEP. Positive RPP for adenovirus. Imaging shows clear CXR and normal MRI brain and spine with contrast. Ataxia resolved and improving fatigue. Thought to have had possible transient ataxia and febrile seizures from vaccinations. More
โœ“
2856192 34 F TN 08/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 pk9c5
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Patient is pregnant and this vaccine isn't indicated for pregnant women. Patient is pregnant and this vaccine isn't indicated for pregnant women.
2856193 50 F VA 08/31/2025 DTAP
FLU3
PNC20
VARZOS
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 u8618aa
tfaa2501
ln4932
3t74x
Dizziness, Feeling abnormal, Syncope; Dizziness, Feeling abnormal, Syncope; Dizz... Dizziness, Feeling abnormal, Syncope; Dizziness, Feeling abnormal, Syncope; Dizziness, Feeling abnormal, Syncope; Dizziness, Feeling abnormal, Syncope More
Patient reported having severe needle-anxiety prior to administration of immunizations. Patient did ... Patient reported having severe needle-anxiety prior to administration of immunizations. Patient did well during administration, but after reported feeling a bit lightheaded. Patient then fainted. Was out for about 10 seconds. Still felt "a little off," but was alert and oriented. Patient was back to her normal self after 10 to 15 minutes post-fainting episode. More
2856194 38 F TX 08/31/2025 FLU3
 SEQIRUS, INC.
 406986
Contusion, Pain, Swelling Contusion, Pain, Swelling
Patient states she experienced bruising, swelling, and pain. Patient states she experienced bruising, swelling, and pain.
2856195 53 F MO 08/31/2025 PNC21
TDAP
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z003579
H4K3S
55KB9
Axillary pain, Erythema, Injection site pain, Skin warm; Axillary pain, Erythema... Axillary pain, Erythema, Injection site pain, Skin warm; Axillary pain, Erythema, Injection site pain, Skin warm; Axillary pain, Erythema, Injection site pain, Skin warm More
Patient received the vaccine on 8/26/25. She received the Capvaxive and Boostrix in the left deltoid... Patient received the vaccine on 8/26/25. She received the Capvaxive and Boostrix in the left deltoid IM and she came in on Sunday 8/31/25 at 1:15 pm. Her left arm is extremely red and warm to the touch and she is experiencing left arm pain around the injection site and she said under her arm as well, in her armpit area. She has taken benadryl, zyrtec, ibuprofen and iced the area. She has also used benadryl gel topically. I recommended some Xyzal, which is non-drowsy and then we got them a reusable ice pack and ace bandage wrap to put on it. We also marked the red area with sharpie to determine if the size/swelling of the area is improving or getting worse. If not better tomorrow on 9/1/25, I recommend seeing a physician and getting prescribed and antibiotic. More
2856197 65 M OH 08/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 354T3
Injected limb mobility decreased, Pain in extremity, Product administered at ina... Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site More
Patient presented to pharmacy for prescriptions approx. beginning of June 2025 and was asked about h... Patient presented to pharmacy for prescriptions approx. beginning of June 2025 and was asked about his second shingles vaccine. He stated that he had had severe pain in his left arm following the first injection that left his arm unable to move for 2+ days. He stated he still had limited range of motion at that time. When asked where he received the shot, he indicated the upper shoulder, near the bone. I advised him to see medical treatment for his condition, and that his shot may have been given too high on the arm. Follow-up: Patient presented to pharmacy 8/31/25 still c/o arm pain and limited ROM. He stated he has received the 2nd shot from another pharmacy without issue, and the pharmacist told him his arm injury was likely due to inproper administration. More
2856198 57 F FL 08/31/2025 COVID19
 PFIZER\BIONTECH
Polymyalgia rheumatica Polymyalgia rheumatica
STRONG PMR kicked in after the 3 vaccine. Lasted almost 2 years before receding STRONG PMR kicked in after the 3 vaccine. Lasted almost 2 years before receding
2856199 89 M CA 08/31/2025 VARCEL
 MERCK & CO. INC.
 Y015100
Muscular weakness, Pain in extremity Muscular weakness, Pain in extremity
Patient complains of pain in arm and also hand ( 2 fingers) and that he does not have a good grip. H... Patient complains of pain in arm and also hand ( 2 fingers) and that he does not have a good grip. He states that the pain is in the right arm and hand and started after the Varivax vaccine was administered on 5/31/25. The pain has not subsided since the vaccine. He has been using pain gels like Bengay OTC and also hot pack. More
2856220 0.75 F OH 08/31/2025 DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
 U7899AA
U7899AA
Abdominal discomfort, Decreased activity, Endoscopy, Speech disorder, Strabismus... Abdominal discomfort, Decreased activity, Endoscopy, Speech disorder, Strabismus; Stridor, Swallow study, X-ray with contrast upper gastrointestinal tract More
Child became less vocal. Did not start to become vocal again until April/May of 2025. Child became l... Child became less vocal. Did not start to become vocal again until April/May of 2025. Child became less active for about 2-3 months. Child experienced increase in stomach discomfort for about 1.5 - 2 months. Child developed strabismus/intermittent exotropia within 3-4 days of vaccines and is still currently an issue. Child developed intermittent stridor 8 days after receiving vaccines and continued to be an issue for about 2 months. More
โœ“
2856151 44 M PA 08/30/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Unevaluable event; Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event; Unevaluable event
44 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report ... 44 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report received from the authors above and refers to a(n) 44-year-old male patient. The patient's medical history included Solid organ transplant at his 39 years old. The patient's concurrent conditions included chronic immunosuppression. Concomitant therapies were not reported. On an unknown date (reported as 4 years after the transplant), the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (manufacturer unknown), Injection, a 3 doses scheme (administration route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). This is one of 4 same literature reports. A copy of the published article is attached as further documentation of the patient's experience. More
2856152 78 M PA 08/30/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report... 63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report received from the authors above and refers to a(n) 78-year-old male patient. The patient's medical history included Solid organ transplant at his 69 years old. The patient's concurrent conditions included chronic immunosuppression. Concomitant therapies were not reported. On an unknown date (reported as 4 years after the transplant), the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (manufacturer unknown), Injection, a 2 doses scheme (administration route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). This is one of 4 same literature reports. A copy of the published article is attached as further documentation of the patient's experience. More
2856153 63 M PA 08/30/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report... 63 year old male vaccinated with Nonavalent HPV vaccine; Literature Article: This literature report received from the authors above and refers to a(n) 63-year-old male patient. The patient's medical history included Solid organ transplant at his 61 years old. The patient's concurrent conditions included chronic immunosuppression. Concomitant therapies were not reported. On an unknown date (reported as 1 year after the transplant), the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (manufacturer unknown), Injection, a 2 doses scheme (administration route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). This is one of 4 same literature reports. A copy of the published article is attached as further documentation of the patient's experience. More
2856154 F VA 08/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization complete), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient stated that her doctor prescribed the Paxlovid for her she got COVID. The patient had all the Pfizer COVID Shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2856155 M 08/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago; h... has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago; has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago; This is a spontaneous report received from a Physician from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrosis" (unspecified if ongoing); "pulmonary hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 8 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago". Clinical course: Reporter stated that he is a "very high-risk patient", since he has "pulmonary fibrosis and pulmonary hypertension" and also mentioned that he has had "all 9 COVID-19 vaccines from Pfizer", but that, despite that, he contracted the COVID-19 infection 2 months ago. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago".; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the event vaccination failure (COVID-19). This case will be reassessed upon receipt of additional information. More
2856156 F 08/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
she has Covid; she has Covid; This is a spontaneous report received from a Consumer or other non HCP... she has Covid; she has Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she has Covid"; COVID-19 (medically significant), outcome "unknown", described as "she has Covid ". Clinical course: patient stated she has Covid and was prescribed Paxlovid and she has taken all of the Covid shots and done everything. Caller confirms the Covid vaccines were Pfizer. Patient states when she got to the Pharmacy they told her it was going to be (withheld) 1700 and she is a disabled vet so they told her to call Pfizer for help. No follow-up attempts are possible. More
2856157 F FL 08/30/2025 COVID19
 PFIZER\BIONTECH
Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
COVID after Pfizer COVID vaccines/tested positive; COVID after Pfizer COVID vaccines/tested positive... COVID after Pfizer COVID vaccines/tested positive; COVID after Pfizer COVID vaccines/tested positive; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID vaccines/tested positive". The event "covid after pfizer covid vaccines/tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 104; SARS-CoV-2 test: (27Aug2025) positive. Clinical course: During an inbound call for financial assistance, The patient informed that she has COVID. So, the doctor prescribed her the Paxlovid. She was tested positive today (27Aug2025)." The patient informed that she just didn't feel like going online, and like her fever was like 104 and she can barely keep her eyes open. She was tired. The patient informed that they had Pfizer COVID vaccines, they didn't get them last year (2024), they didn't get them this year (2025).; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500104330 same reporter/product/events, different patient; More
2856158 M FL 08/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID after Pfizer COVID Vaccine/tested positive today; COVID after Pfizer COVID Vaccine/tested posi... COVID after Pfizer COVID Vaccine/tested positive today; COVID after Pfizer COVID Vaccine/tested positive today; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Aug2025, outcome "unknown" and all described as "COVID after Pfizer COVID Vaccine/tested positive today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2025) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The reporter stated that she and her husband both had COVID. So, the doctor prescribed them Paxlovid. The reporter's husband (patient) actually on a transplant list. So, the patient needs this medicine, they both need it, because they both tested positive today." Reporter stated, they had Pfizer COVID vaccines. They didn't get them last year, they didn't get them this year yet cause it's so early. Reporter stated "he (patient) gets the retirement benefit because he can claim that at 62."He was supposed to go in on 02Sep2025 to start his, for his transplant for his heart. Because he's got COVID, they have to put him as a status 7, wait 14 days, but if they don't have medicine, they need to get it out of his system, then they have to retest again, to make sure they're negative. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500104329 Same reporter, same vaccine and event, different patient; More
2856159 M SC 08/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or... diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Oct2024 (unspecified if ongoing), notes: Took Paxlovid. It occurred ten months ago from 27Aug2025. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for Covid-19 immunisation. He had Pfizer shots. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Aug2025, outcome "unknown" and all described as "diagnosed with COVID". Clinical course: The patient was diagnosed with COVID in the morning (27Aug2025). He was trying to purchase PAXLOVID that his doctor prescribed. The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up. More
2856168 50 F MI 08/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site reaction, Injection site swelling, Injec... Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria More
Reaction at injection site, redness and welting with swelling with warmth that has extended around u... Reaction at injection site, redness and welting with swelling with warmth that has extended around upper arm and down to elbow area More
2856169 48 M OK 08/30/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 011AZ21A
011AZ21A
011AZ21A
011AZ1A
011AZ1A
011AZ1A
Adrenal mass, Atrial fibrillation, Blood thyroid stimulating hormone, Cox-Maze p... Adrenal mass, Atrial fibrillation, Blood thyroid stimulating hormone, Cox-Maze procedure, Differential white blood cell count; Full blood count, Hepatitis C antibody, Lipids, Metabolic function test, Platelet count; Prostatic specific antigen, Shoulder operation, Thyroid cancer, Thyroidectomy; Adrenal mass, Atrial fibrillation, Blood thyroid stimulating hormone, Cox-Maze procedure, Differential white blood cell count; Full blood count, Hepatitis C antibody, Lipids, Metabolic function test, Platelet count; Prostatic specific antigen, Shoulder operation, Thyroid cancer, Thyroidectomy More
Forced to get the Vax to have an elective surgery on my RT shoulder to remove a bone spur. Got the s... Forced to get the Vax to have an elective surgery on my RT shoulder to remove a bone spur. Got the shot and went in for pre-op testing to be told I am now in Afib.11mths and a double Maze Ablation later I was no longer in Afib and got the surgery. Since then I have been diagnosed with Thyroid cancer had my left half of thyroid removed and have a growing mass on my adrenal gland that also will need to be removed. More
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2856170 73 F 08/30/2025 FLU3
 SANOFI PASTEUR
 UT8781AA
Swelling, Swelling face, Swelling of eyelid Swelling, Swelling face, Swelling of eyelid
swelling of eyelids, undereyes, cheeks swelling of eyelids, undereyes, cheeks
2856171 69 M 08/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received 2 doses of Arexvy; Once in august 2023 and once in august 2025. Patient is so far n... Patient received 2 doses of Arexvy; Once in august 2023 and once in august 2025. Patient is so far not experiencing any side effects. More
2856172 55 F CT 08/30/2025 COVID19
 MODERNA
Erythromelalgia, Psoriatic arthropathy Erythromelalgia, Psoriatic arthropathy
Erythromelalgia, psoriatic arthritis Erythromelalgia, psoriatic arthritis
2856173 65 F 08/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 BG5J4
Erythema Erythema
patient stated on 8/30 that she has red reaction on arm and is spreading patient stated on 8/30 that she has red reaction on arm and is spreading
2856174 11 M MI 08/30/2025 FLU3
 SEQIRUS, INC.
 406984
Hyperhidrosis, Nausea, Somnolence, Vomiting Hyperhidrosis, Nausea, Somnolence, Vomiting
sleepiness, sweeting, nausea and vomiting sleepiness, sweeting, nausea and vomiting
2856175 56 F 08/30/2025 FLU3
 SANOFI PASTEUR
 u8790aa
Genital rash, Hypersensitivity, Skin irritation, Urticaria Genital rash, Hypersensitivity, Skin irritation, Urticaria
rash in genital area; hives and irritation; provider told pt it was an allergic reaction likely due ... rash in genital area; hives and irritation; provider told pt it was an allergic reaction likely due to vaccine; cleared up after 2-3 days More
2856176 72 M NJ 08/30/2025 FLU3
HEPAB
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8764DB
324BY
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
None stated. None stated.
2856177 49 F NH 08/30/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 3F7A5
Eye swelling, Lip swelling, Swelling face Eye swelling, Lip swelling, Swelling face
pt called the next day (8/30/25) and said her eyes and cheeks were swollen...and lip ws a tiny bit s... pt called the next day (8/30/25) and said her eyes and cheeks were swollen...and lip ws a tiny bit swollen and then improved. She woke up at around 6am and noticed it. She said it has gotten a little bit better when she called me at 11:09am from when she woke up and saw it. She said she was feeling fine. Pt asked about taking allegra. I told her it would be good to take an antihistamine in case it was an allergy. She did say she has an epi-pen for bee stings in case. I told her to contact her md's on call provider for any further information and to monitor if any worsening to call 911 if mouth/throat tingly or swelling and if she ends up needing to use her epi-pen. More
2856178 69 F FL 08/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 552wgfv9y4
Extra dose administered Extra dose administered
Patient recieved RSV arexvy vaccine twice in lifetime, once in november 2023, and again in August 20... Patient recieved RSV arexvy vaccine twice in lifetime, once in november 2023, and again in August 2025 More
2856179 80 F AR 08/30/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 946064
946064
Abdominal distension, Chest pain, Dizziness, Headache, Limb discomfort; Peripher... Abdominal distension, Chest pain, Dizziness, Headache, Limb discomfort; Peripheral swelling, Spinal pain More
heaviness in legs, swelling in stomach and legs, spine pain ,headache, chest pain, dizziness heaviness in legs, swelling in stomach and legs, spine pain ,headache, chest pain, dizziness
2856180 33 M NC 08/30/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 041A21A
041A21A
Condition aggravated, General physical health deterioration, Hepatic failure, In... Condition aggravated, General physical health deterioration, Hepatic failure, Inflammation, Influenza; Musculoskeletal disorder, Thyroid disorder More
CHRONIC FLU SYMPTOMS date of the shot . Ever since that day . My health has rapidly declined , I no ... CHRONIC FLU SYMPTOMS date of the shot . Ever since that day . My health has rapidly declined , I no longer can use my hands cause my body wont heal from the inflammation. My liver is slowly failing and my thyroid is being effected. CHECK MEDICAL RECORDS ( more diagnoses to come ) More
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2856020 F NJ 08/29/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Colposcopy, Human papilloma virus test positive, Inappropriate schedule of produ... Colposcopy, Human papilloma virus test positive, Inappropriate schedule of product administration; Colposcopy, Human papilloma virus test positive, Inappropriate schedule of product administration; Colposcopy, Human papilloma virus test positive, Inappropriate schedule of product administration More
patient has tested positive for HPV; irst dose of GARDASIL 9 in 2019, their second in 2024 and their... patient has tested positive for HPV; irst dose of GARDASIL 9 in 2019, their second in 2024 and their third 6 months later; This spontaneous report was received from a Physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2019, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), then in 2024 she received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), and 6 months later, she received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (Inappropriate schedule of vaccine administration). No lot # and expiration date were not reported for any dose, all administered by Unknown route for human papilloma virus (HPV). On an unknown date, HPV test showed Positive. Patient has had a colposcopy; however results were unknown at time of report. At the reporting time, the outcome of the event was unknown. The causal relationship between the event of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) was not reported. Batch/Lot number is being requested and will be submitted if received. More
2856036 NJ 08/29/2025 HEP
 MERCK & CO. INC.
 Y014323
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No additional AEs were reported; Nurse reported that a patient received first dose of RECOMBIVAX on ... No additional AEs were reported; Nurse reported that a patient received first dose of RECOMBIVAX on 2/5/2025 and the patient is in the office to received the second dose today. The patient did not receive the second dose yet; This spontaneous report was received from an other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. 05-FEB-2025, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), lot #Y014323, expiration date reported as 12-Feb-2027 (strength, dose, route of administration and anatomical location of vaccine) for Prophylaxis. 12-AUG-2025, Nurse reported that a patient went to the office to receive the second dose today. The patient did not receive the second dose yet. The patient experienced No additional adverse event (AEs) were reported. More
2856037 26 F IN 08/29/2025 PPV
 MERCK & CO. INC.
 X022827
Inflammation, Mobility decreased, Pain in extremity Inflammation, Mobility decreased, Pain in extremity
Movement disorder; Pain in extremity; Peripheral swelling; This spontaneous report was received from... Movement disorder; Pain in extremity; Peripheral swelling; This spontaneous report was received from a consumer or other non-health professional and refers to a 26-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 12-Aug-2025, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) at a dose of 0.5 mL (0.5mL / once), administered by Intramuscular route, lot number X022827 and expiration date of 14-Aug-2025 for prophylaxis. On 13-Aug-2025, the patient experienced pain from shoulder to hand and the inability to move their arm all with inflammation from the elbow to the shoulder with severe pain (pain in extremity, movement disorder and peripheral swelling). The patient sought for medical attention and received as a treatment ice packs, alternate Ibuprofen and paracetamol (TYLENOL) every 3-4 hours and prescribed a prednisone taper for 3-days. At the reporting time, the patient was recovering from the events. The causal relationship between the events and vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. This is one of four reports received from the same reporter. More
2856038 45 F WI 08/29/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.








Androgenetic alopecia, Dysphonia, Formication, Hair texture abnormal, Inflammati... Androgenetic alopecia, Dysphonia, Formication, Hair texture abnormal, Inflammation; Lid sulcus deepened, Malaise, Pain in extremity, Pain of skin, Pruritus; Swelling, Swelling face; Androgenetic alopecia, Dysphonia, Formication, Hair texture abnormal, Inflammation; Lid sulcus deepened, Malaise, Pain in extremity, Pain of skin, Pruritus; Swelling, Swelling face; Androgenetic alopecia, Dysphonia, Formication, Hair texture abnormal, Inflammation; Lid sulcus deepened, Malaise, Pain in extremity, Pain of skin, Pruritus; Swelling, Swelling face More
alopecia/bald spot/autoimmune injury/hair loss; extreme and unusual pain in her arm; swollen face an... alopecia/bald spot/autoimmune injury/hair loss; extreme and unusual pain in her arm; swollen face and neck; swollen face and neck; eyes receded into her face; voice changed; felt as if something is crawling in her hair/itchiness on her scalp; he texture of her hair completely changed; inflammation; occasional pain in her scalp; Information has been received from a lawyer referring to a 45-year-old female patient regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, at 45 years old, the patient received 3 doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, route, lot#, and expiration date were not reported). The patient agreed to receive the vaccine after being convinced that the vaccine was very safe, that the vaccine prevented cancer. The patient relied upon the company's ubiquitous representations concerning the safety and efficacy of the vaccine, in consenting to her vaccination. The patient's health care provider recommended that she receive the Gardasil vaccine, which was touted as a safe and effective vaccine for preventing cervical cancer. Upon information and belief, the patient's doctor read and relied upon information from the company, through its labeling and/or marketing, that the vaccine was safe and effective. In light of the patient's doctor's recommendations, as well as the company's relentless marketing and advertising messages, to which the patient had been exposed concerning the safety and efficacy of the vaccine, the patient consented to being injected with the vaccine. After receiving the second Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine, the patient experienced extreme and unusual pain in her arm and called the office immediately. The nurse that administered the vaccine said that this Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine was a "rough shot" and advised she would experience pain for three weeks. The following day, the patient woke up to a swollen face and neck. The patient's eyes receded into her face and her voice changed from swelling in her neck. In between the second and third Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine, the patient went to the emergency room three times for facial swelling. The doctors could not diagnose her, but she was prescribed water pills and blood pressure medication to decrease her swelling. The patient visited her primary care provider once a month for the swelling and still received no answers or diagnosis to these symptoms. The patient became ill within two days after receiving the last Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) shot. She developed a bald spot, and the texture of her hair completely changed. Thereafter, the patient visited a specialist and was diagnosed with alopecia. The patient had to cut off all her hair, purchased costly hair products, and over the counter supplements to counteract her hair loss and inflammation. She still suffered from occasional pain in her scalp and felt as if something is crawling in her hair. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: facial and neck swelling, hair loss, and pain and itchiness on her scalp. Following her vaccinations, the patient's confidence has been deeply shaken because of the physical changes she had experienced following her vaccinations. Based upon her chronic and severe post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, the patient has been diagnosed with various medical conditions, including but not limited to, alopecia. The patient contended that her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to, alopecia, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and the vaccine's manufacturing defects, the patient has suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The patient also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of her vaccine-induced injuries, the patient had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. The outcome of the events was not recovered. The causality between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was considered to be related. The lawyer considered the events to be disability. More
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2856039 2.5 F KY 08/29/2025 DTAPIPV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 3RT93
HR3650
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
2 year old patient was due for her 15 month shots. She received a 4 year old DTAP-IPV instead of a D... 2 year old patient was due for her 15 month shots. She received a 4 year old DTAP-IPV instead of a DTAP/IPV/HIB for 6 wks - 4 years. More
2856064 MO 08/29/2025 MMRV
 MERCK & CO. INC.
 Y003883
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; patient was inadvertently administered an expired dose of PROQUAD; This spontaneou... no adverse event; patient was inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 06-Aug-2025, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin)(PROQUAD), Injection (lot #Y003883, expiration date: 05-Aug-2025) 0.5 mL dose for prophylaxis. No additional adverse event was reported. This is one of several cases received from the same reporter. More
2856065 16 NJ 08/29/2025 HEPA
 MERCK & CO. INC.
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No symptoms reported; an adult dose of VAQTA on 07AUG2025 to a 16 year old patient.; This spontaneou... No symptoms reported; an adult dose of VAQTA on 07AUG2025 to a 16 year old patient.; This spontaneous report was received from a physician and refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccines included 1st dose of hepatitis a vaccine, inactivated (VAQTA), administered on 18-DEC-2024. On 07-AUG-2025, the patient was vaccinated with 2nd dose of hepatitis a vaccine, inactivated (VAQTA) suspension for injection, reported as an adult dose, administered for prophylaxis (exact dose, route of administration, anatomical location, lot# and expiry date were not reported) (overdose). No additional adverse event was reported. Lot# is being requested and will be submitted if received. More
2856066 13 F IL 08/29/2025 HPV4
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient had a dose of GARDASIL in JUN2014, and is a 24 year old female and wants to get the GARDASIL... Patient had a dose of GARDASIL in JUN2014, and is a 24 year old female and wants to get the GARDASIL 9. She received the first dose at age 13. Pharmacist wasn't sure still whether to do a 2 or 3 dose schedule as it was a long interval of time since; No additional AE; This spontaneous report was received from a pharmacist and refers to a 24-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. In June 2014 at the age of 13 years, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (Unknown by Reporter/one dose), (lot # and expiration date were not reported), for prophylaxis. Currently, the patient wanted to get the GARDASIL 9. The pharmacist was not sure still whether to do a 2 or 3 dose schedule as it was a long interval of time since the 1st dose and had concerns and was unsure (inappropriate schedule of product administration). No additional AE reported (no adverse event). More
2856067 5 M 08/29/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Abdominal pain, Extra dose administered, Incorrect route of product administrati... Abdominal pain, Extra dose administered, Incorrect route of product administration, Injection site pain; Abdominal pain, Extra dose administered, Incorrect route of product administration, Injection site pain More
belly hurts; pediatric nurse gave child a third dose of VARIVAX; achy muscle in thigh; achy muscle i... belly hurts; pediatric nurse gave child a third dose of VARIVAX; achy muscle in thigh; achy muscle in thigh; This spontaneous report was received from a consumer and refers to a 5-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included allergy to amoxicillin. Concomitant therapies were not reported. In April 2025, the patient had received a 2nd dose Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (strength, dose, anatomical site, route, lot # and expiration date were not reported) for 5-year check up as Varicella Vaccine. On 19-Aug-2025, pediatric nurse gave the patient a third dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) administered by Intravenous (IV) route (strength, dose, anatomical site, lot # and expiration date were not reported) for Varicella Vaccine (Inappropriate dose of vaccine administered). On the same day, the patient said their belly hurts, achy muscle in thigh where they received the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). The patient didn't seek medical attention. No lab diagnostic/study was performed. No was treatment was given for the events. No other symptoms reported. No additional adverse event (AE)/no product quality complaints (PQC). At the reporting time, the patient was recovering from belly hurts and achy muscle in thigh. The outcome of Inappropriate dose of vaccine administered was unknown. The causal relationship between suspect vaccine and the events of belly hurts and achy muscle was not provided. Batch/Lot number is being requested and will be submitted if received. More
2856069 F 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Skin discolouration, Skin warm, Swelling face Skin discolouration, Skin warm, Swelling face
Warm to the touch; black and blue; Swollen face/the lower left side of her face / chin (jowl area) w... Warm to the touch; black and blue; Swollen face/the lower left side of her face / chin (jowl area) was a little swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included dermal filler injection (had filler placed in the chin area about 1 year ago) and trigger finger release (had hand surgery (trigger finger surgery) last Tuesday (5 August 2025) in which she was given Propofol and Versed). Previously administered products included Shingrix with an associated reaction of swelling face (received first dose on an unknown date and had a little swelling on her face). On 08-AUG-2025, the patient received the 2nd dose of Shingrix. On 11-AUG-2025, 3 days after receiving Shingrix, the patient experienced facial swelling (Verbatim: Swollen face/the lower left side of her face / chin (jowl area) was a little swollen). On 12-AUG-2025, the patient experienced skin warm (Verbatim: Warm to the touch) and skin discoloration (Verbatim: black and blue). The outcome of the facial swelling, skin warm and skin discoloration were not resolved. It was unknown if the reporter considered the facial swelling, skin warm and skin discoloration to be related to Shingrix. It was unknown if the company considered the facial swelling, skin warm and skin discoloration to be related to Shingrix. Additional Information: GSK receipt date: 12-AUG-2025 The patient had the second dose of Shingrix and one day prior to the reporting date, the patient had the lower left side of her face/chin (jowl area) was a little swollen and was more swollen on the day of reporting. 4 days after vaccination, the patient was looking a little black and blue and was warm to the touch. There was no discomfort, and the patient did not feel unwell. This report was filed with limited information. The patient disconnected the call prior to gathering further details or clarification. The consumer did not wish to provide any contact information. More
2856070 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness, Malaise Influenza like illness, Malaise
very sick; Flu type reaction; This non-serious case was reported by a consumer via interactive digit... very sick; Flu type reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: very sick) and influenza-like symptoms (Verbatim: Flu type reaction). The outcome of the sickness and influenza-like symptoms were not reported. It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the sickness and influenza-like symptoms to be related to Shingrix. Additional Information: GSK receipt date: 05-AUG-2025 The patient had a 3-day flu like reaction and was very much sick. The patient won't take the second dose. More
2856071 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I got the first dose of Shingrix vaccine 2 years ago and forgot to get the 2nd dose; This non-seriou... I got the first dose of Shingrix vaccine 2 years ago and forgot to get the 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient had 1st dose 2 years ago). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I got the first dose of Shingrix vaccine 2 years ago and forgot to get the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date:12-AUG-2025 Patient got the first dose of Shingrix vaccine 2 years ago and forgot to get the 2nd dose. Asked if they need to start over with the first dose again. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2856072 08/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: Shingles). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-AUG-2025 This case was reported by a patient via interactive digital media Patient had the shot and still got shingles. 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 completion of primary vaccine schedule, TTO of an event and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine. More
2856073 08/29/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Feeling abnormal, Herpes zoster Feeling abnormal, Herpes zoster
triggered the shingles outbreak; This non-serious case was reported by a consumer via interactive di... triggered the shingles outbreak; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 72-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Previously administered products included Shingrix (had taken a shingles vaccine last year, never no shingles). On an unknown date, the patient received RSV vaccine. On an unknown date, less than 9 months after receiving RSV vaccine, the patient experienced shingles (Verbatim: triggered the shingles outbreak). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to RSV vaccine. It was unknown if the company considered the shingles to be related to RSV vaccine. Additional Information: GSK Receipt Date: 16-AUG-2025 This case was reported by a patient via interactive digital media. The patient took the RSV vaccine this year (in 2025) and it triggered the shingles outbreak. The patient ended up in the emergency room, isolated from other patients and it was the most miserable two months of patient's life. Vaccines for the patient were done. The patient said that please research before taking any vaccines. More
2856074 M 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
COVID-19, Malaise, Pyrexia COVID-19, Malaise, Pyrexia
Unrelated to the Shingrix dose the patient developed COVID in December 2020.; The first dose make hi... Unrelated to the Shingrix dose the patient developed COVID in December 2020.; The first dose make him feel unwell; high fever for about 3 days.; This non-serious case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included prostatic disorder. In SEP-2020, the patient received the 1st dose of Shingrix. In DEC-2020, between 2 and 4 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: Unrelated to the Shingrix dose the patient developed COVID in December 2020.). On an unknown date, the patient experienced feeling unwell (Verbatim: The first dose make him feel unwell) and fever (Verbatim: high fever for about 3 days.). The outcome of the feeling unwell and fever were resolved (duration 3 days) and the outcome of the covid-19 was not reported. The reporter considered the feeling unwell and fever to be related to Shingrix. The reporter considered the covid-19 to be unrelated to Shingrix. The company considered the feeling unwell and fever to be related to Shingrix. The company considered the covid-19 to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025AMR108260 Additional Information: GSK Receipt Date: 20-AUG-2025 Patient took dose 1 of Shingrix in September of 2020. The first dose make him feel unwell with a high fever for about 3 days. Unrelated to the Shingrix dose the patient developed COVID in December 2020.; Sender's Comments: GSK-US2025AMR108260: More
2856075 F CA 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site vesicles Injection site vesicles
she had a circle of blisters around the injection site.; This non-serious case was reported by a con... she had a circle of blisters around the injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid 19 vaccine with an associated reaction of erythema and Shingrix with an associated reaction of blister (For tolerance of first dose refer case US2025105095). Concurrent medical conditions included allergy to vaccine and food allergy (allergic to specific foods allergic to turkey, trout, soul fish and pumpkin). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site blisters (Verbatim: she had a circle of blisters around the injection site.). The outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to Shingrix. It was unknown if the company considered the injection site blisters to be related to Shingrix. Linked case(s) involving the same patient: US2025105095 Additional Information: GSK Receipt Date: 14-AUG-2025 The patient had the complete series of Shingrix administered in the later months of 2019. The second dose of Shingrix she had a circle of blisters around the injection site. The consumer stated she was immune to chickenpox and never had a case, however, she had been exposed several times personally with family and professionally with patients. The consumer stated she had a chickenpox titer done (date not disclosed) and the range was 150 or 160. Consumer stated she presently takes enzymes, D3 and K2 for a reaction she had after Covid vaccination (date not disclosed.) She stated her allergic reaction consists of arm getting huge, red, hot and swollen. Stabbing feeling in heart and ears that goes down her neck. Consumer stated she will report to manufacturer of Covid vaccine.; Sender's Comments: US-GSK-US2025105095:SAME REPORTER DIFFERENT PATIENT More
2856076 08/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
yes I got it a second time and had even gotten the shot 2 years ago/ I got the vaccine in 2023 and h... yes I got it a second time and had even gotten the shot 2 years ago/ I got the vaccine in 2023 and had shingles for the first time 1990 and now again; had shingles for the first time 1990 and now again; 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. The patient's past medical history included shingles (had shingles for the first time 1990). On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: yes I got it a second time and had even gotten the shot 2 years ago/ I got the vaccine in 2023 and had shingles for the first time 1990 and now again) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles for the first time 1990 and now again). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-AUG-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine in 2023 and had shingles for the first time 1990 and now again. 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, regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2856077 08/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Paraesthesia, Vaccination failure Herpes zoster, Paraesthesia, Vaccination failure
Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via in... Suspected vaccination failure; got the shingles; 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. In JUL-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the shingles in July 2024, had previously been vaccinated and because of that showed very few spots on the left arm, although the left arm did tingle and it was lasted about three weeks, but it was almost unnoticeable. The patient was grateful because had been vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 completion of primary vaccine schedule, TTO of an event and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine. More
2856078 FL 08/29/2025 DTAP
DTAPHEPBIP
DTAPIPV
HEP
HEPA
MENB
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS






Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Maladministration of vaccines after a temperature excursion; This non-serious case was reported by a... Maladministration of vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Pediarix, Engerix B, Kinrix, Infanrix, Havrix, Menveo and Bexsero. On an unknown date, an unknown time after receiving Pediarix, Engerix B, Kinrix, Infanrix, Havrix, Menveo and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Maladministration of vaccines after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-JUL-2025 Medical Assistant reported that Pediarix, Rotarix pre filled version, Engerix-B, Kinrix, Infanrix, Havrix, Menveo one dose vial presentation and Bexsero vaccines were exposed to a minimum temperature of 31.53 degrees Fahrenheit and were below the recommended range for a maximum cumulative time of 2 hours and 45 minutes on 28-June-2025. In-house extended stability data does not supports the stability of Pediarix, Engerix-B, Kinrix, Infanrix, Havrix, Menveo one dose vial and Bexsero, which led incorrect storage of drug. In-house extended stability data supports the stability of Rotarix pre filled presentation and its listed expiration date still applies. The healthcare provider requires additional time to collect any relevant patient information related to the administration of these vaccines following exposure to freezing temperatures. The reporter consented to follow up. More
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