🏥 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 💀 🏥 🚑 ♿ ⚠️
2852825 16 F MI 08/05/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
 z007667
HP9987
U8438AA
Dizziness, Flushing, Nausea; Dizziness, Flushing, Nausea; Dizziness, Flushing, N... Dizziness, Flushing, Nausea; Dizziness, Flushing, Nausea; Dizziness, Flushing, Nausea More
sudden onset dizziness, flushing and nausea. plan to rest, drink fluids and zofran PRN for nausea. sudden onset dizziness, flushing and nausea. plan to rest, drink fluids and zofran PRN for nausea.
2852826 64 F IL 08/05/2025 PNC20
 PFIZER\WYETH
Injection site rash, Tenderness Injection site rash, Tenderness
pt states that she has tenderness on her right arm and several days later developed a rash at the in... pt states that she has tenderness on her right arm and several days later developed a rash at the injection site and surrounding areas. She let her physician know and was told to apply ice to her arm and to contact them if it didn't go away. More
2852827 3 F DC 08/05/2025 HIBV
PNC20
 MERCK & CO. INC.
PFIZER\WYETH
 Y005454
LN4929
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received extra unnecessary doses of both listed vaccines. Patient was 12 months of age when ... Patient received extra unnecessary doses of both listed vaccines. Patient was 12 months of age when dose 3 of PCV20 was given. Patient received 4 age appropriate doses of HiB prior to 5th dose. Administration sites were not alternated when vaccines were given. More
2852828 19 F MI 08/05/2025 HPV9
 MERCK & CO. INC.
 z005469
Injection site pain, Mobility decreased, Pain, Postural orthostatic tachycardia ... Injection site pain, Mobility decreased, Pain, Postural orthostatic tachycardia syndrome More
pain with injection. Worsened over the following 1.5 weeks. pain with ROM, limited ROM. pain with injection. Worsened over the following 1.5 weeks. pain with ROM, limited ROM.
2852829 57 F 08/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Patient erroneously given Engerix-B as second dose, instead of the required Twinrix. Patient had to ... Patient erroneously given Engerix-B as second dose, instead of the required Twinrix. Patient had to advocate for herself to find a solution, with provider initially unwilling to remedy the situation. GlaxoSmithKline did not provide online information about remedying this situation. More
2852830 16 F MD 08/05/2025 MNP
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 LW8911
U8573AA
Pallor, Pyrexia, Tremor, Vomiting; Pallor, Pyrexia, Tremor, Vomiting Pallor, Pyrexia, Tremor, Vomiting; Pallor, Pyrexia, Tremor, Vomiting
Approximately 12 hrs after vaccination, patient presented with shaking, pallor, emesis x 1, fever 10... Approximately 12 hrs after vaccination, patient presented with shaking, pallor, emesis x 1, fever 101.9 orally More
2852831 4 M CA 08/05/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
4L454
Z007210
Z007210
Injection site erythema, Injection site inflammation, Injection site pain, Injec... Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling; Injection site warmth, Skin tightness; Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling; Injection site warmth, Skin tightness More
Patient developed redness, swelling and pain to left arm injection site the day after vaccination. ... Patient developed redness, swelling and pain to left arm injection site the day after vaccination. arm redness and swelling extended form shoulder area down to elbow. skin was tense and warm to the touch. Dr prescribed Zyrtec x 7 days. additional advice given, apply cold compress ( ice pack) to help decrease inflammation and pain. Patient was re-evaluated on 8/4/25. Symptoms improved, localized redness and slight swelling to left deltoid area. More
2852832 64 M IA 08/05/2025 COVID19
 MODERNA
 3043159
Death Death
resident passed away resident passed away
✓
2852833 1.75 M OK 08/05/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009782
Y009782
C-reactive protein, Full blood count, Metabolic function test, Peripheral swelli... C-reactive protein, Full blood count, Metabolic function test, Peripheral swelling, Procalcitonin; Rash, Respiratory viral panel, Streptococcus test, Urine analysis More
rash and foot swelling rash and foot swelling
2852834 1 M CA 08/05/2025 HEPA
HPV9
MMR
PNC15
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 H3N97
Z002903
Y017528
Y016880
Z004246
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; 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
Patient came in for their 12 months well child and was given the Gardasil vaccine instead of the HIB... Patient came in for their 12 months well child and was given the Gardasil vaccine instead of the HIB vaccine. More
2852835 59 M AZ 08/05/2025 RSV
RSV
UNK
UNK
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Don?t knows
Don?t knows
Abdominal pain upper, Blood test, Computerised tomogram, Malaise, Rash; Urticari... Abdominal pain upper, Blood test, Computerised tomogram, Malaise, Rash; Urticaria; Abdominal pain upper, Blood test, Computerised tomogram, Malaise, Rash; Urticaria More
The day after I had the vaccines injected into me I woke up not feeling very good and my stomach hur... The day after I had the vaccines injected into me I woke up not feeling very good and my stomach hurting, later in the day I broke out in hives or rash which it?s really bad. I was in bed for two days and went to the ER three days after the injection More
2852836 7 F MI 08/05/2025 HEPA
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y015027
Z003883
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
PATIENT AGE WAS 7 AND KINRIX IS TO BE USED ONLY UP TO AGE 6 BUT NO NEED TO REPEAT PATIENT AGE WAS 7 AND KINRIX IS TO BE USED ONLY UP TO AGE 6 BUT NO NEED TO REPEAT
2852837 62 F NE 08/05/2025 MMR
 MERCK & CO. INC.
 Y020516
Injection site erythema, Injection site induration, Injection site pain Injection site erythema, Injection site induration, Injection site pain
Pain noticed less than 12 hours after vaccine. Patient did not palpate the site until 10 days after ... Pain noticed less than 12 hours after vaccine. Patient did not palpate the site until 10 days after the vaccine administration date to discover hard, reddened area (oval shaped approx 2.5 cm by 4.5 cm) at injection site, pain/soreness at site continued since vaccine administration. Treatments included ice packs and warm packs, but no change in symptoms. Medical evaluation arranged 8/5/25. More
2852838 44 M IL 08/05/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
7/29/25 at 1200pm patient received his 3rd Twinrix vaccine. Administered into right deltoid with a 2... 7/29/25 at 1200pm patient received his 3rd Twinrix vaccine. Administered into right deltoid with a 25G x1 inch safety hypodermic needle. As this RN was pushing in vaccine, employee stated it was painful compared to the other 2 doses. Complained of continued pain while in health center. Employee given Ibuprofen 200 mg (2 tablets) at 1207pm. Advised to keep arm moving. Denied any numbness or tingling. Employee stated he had minimal discomfort and left department at 1218pm. 8/5/25 1339 employee came back into health center complaining of right arm pain. "I can raise my arm to about shoulder height, then I have to push through the pain. And it gets stiff, and I have to work it out to loosen it up." Reports taking Ibuprofen 200 mg x3 tabs twice a day. Denies any pain into shoulder or down into bicep/arm. Recommended alternate ice/heat, alternate Tylenol/Ibuprofen and follow package direction. More
2852839 38 F FL 08/05/2025 HPV9
 MERCK & CO. INC.
 Y013712
Muscle mass, Tenderness Muscle mass, Tenderness
PT STATE SHE FEELS BUMP INSIDE OF HER MUSCLES. IT HURTS TO RUB IN PT STATE SHE FEELS BUMP INSIDE OF HER MUSCLES. IT HURTS TO RUB IN
2852840 0.5 M NC 08/05/2025 PNC20
 PFIZER\WYETH
 LP4946
Product container issue Product container issue
the vial of the glass breaking while we were giving the vaccine; the vial of the glass breaking whil... the vial of the glass breaking while we were giving the vaccine; the vial of the glass breaking while we were giving the vaccine; administered to the patient; This is a spontaneous report received from a Consumer or other non HCP. A 6-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2025 as dose number unknown, single (Lot number: LP4946, Expiration Date: Aug2026) at the age of 6 months intramuscular, in left vastus lateral. for immunisation, Device Lot Number: LP4946, Device Expiration Date: Aug2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine"; POOR QUALITY DEVICE USED (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine; administered to the patient". Additional information: Reporter stated that medication issue they had this morning(31Jul2025) of a vial breaking while giving a vaccine. Packaging sealed and intact. It was administered to the patient and the patient got the full vaccine. Lab working (Past 2 week) was Unknown. The "lab was no" but reporter was not sure. Causality for "the vial of the glass breaking while we were giving the vaccine" and "the vial of the glass breaking while we were giving the vaccine; administered to the patient" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2852841 18 F NH 08/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Arthralgia, Asthenia, Back pain, Pain, X-ray limb normal Arthralgia, Asthenia, Back pain, Pain, X-ray limb normal
Patient was seen in the office 7/10 with left shoulder pain that extended to her left upper back an... Patient was seen in the office 7/10 with left shoulder pain that extended to her left upper back and the connecting part of her right shoulder. Difficulty lifting her arm due the severity of the pain. The patient also has weakness in her shoulder but maintains normal hand strength and finger mobility without paresthesia. The injection site had no swelling, redness or bruising. She was given home care remedies. The patient reached out on 7/18 stating that she still had limited range of motion and pain. Home remedies recommended. b On 7/24 the patient called back because she was still experiencing pain in her shoulder. Pedi recommended physical therapy (PT) but the PT dept was unable to get patient in soon. We scheduled the patient to be seen in the office 7/25- Xray ordered prior to visit. Follow up appt scheduled in orthopaedics. Patient seen in ortho 7/28 and counseled on a SIRVA etiology and was provided the education materials for next steps. More
2852842 4 F TX 08/05/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
Swollen thigh with redness. Treatment provided in the emergency room. Parent was advised to alterna... Swollen thigh with redness. Treatment provided in the emergency room. Parent was advised to alternate Tylenol and Motrin and apply compress as needed. More
2852843 4 M MD 08/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 YN2X2
Injection site pain, Injection site swelling, Injection site warmth Injection site pain, Injection site swelling, Injection site warmth
Left deltoid swollen, hot to the touch with pain started 10 o'clock this morning. Tylenol given... Left deltoid swollen, hot to the touch with pain started 10 o'clock this morning. Tylenol given at 10AM. Denies vomiting More
2852844 9 M WA 08/05/2025 HPV9
 MERCK & CO. INC.
 Z002580
Dizziness, Musculoskeletal stiffness, Tremor Dizziness, Musculoskeletal stiffness, Tremor
Patient received vaccine in left deltoid, then became stiff with noted shaking. Dad was able to lea... Patient received vaccine in left deltoid, then became stiff with noted shaking. Dad was able to lean him back and hold him. This lasted approximately 10 seconds, at which point he laid down on the bed, then started asking what happened. He was noted to be oriented to person, placed, and time. He did have some dizziness when rechecked at 5 minutes. On recheck at 15 minutes after event, after he had drank ~12 oz of water, he was no longer dizzy. A mini neuro exam was performed and was normal. He was noted to ambulate well without concerns More
2852845 16 M CT 08/05/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 ES49H
U8193AA
Pruritus, Rash; Pruritus, Rash Pruritus, Rash; Pruritus, Rash
Whole body rash with itching lasting for 3 days Whole body rash with itching lasting for 3 days
2852846 16 F MD 08/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Dyspnoea, Loss of consciousness, Mobility decreased Dyspnoea, Loss of consciousness, Mobility decreased
12+ hours after receiving the vaccine patient reported that she began to feel like she couldn't... 12+ hours after receiving the vaccine patient reported that she began to feel like she couldn't move, also felt like she was having trouble breathing. Father states she lost consciousness briefly. Symptoms resolved, then the following day, 8/5/25 around 3:00pm patient stated she began feeling like she couldn't move her arms and legs. More
2852847 24 M PA 08/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 DL4YY
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse event noted. Menveo was administered instead of Bexsero No adverse event noted. Menveo was administered instead of Bexsero
2852848 4 M KS 08/05/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8383AB
Z008500
Injection site reaction, Rash erythematous, Rash macular; Injection site reactio... Injection site reaction, Rash erythematous, Rash macular; Injection site reaction, Rash erythematous, Rash macular More
Patient's mother reports patient began developing rash on 8.01.25 in late afternoon hours. &quo... Patient's mother reports patient began developing rash on 8.01.25 in late afternoon hours. "Large and blotchy, red" rash that covered both arms and legs bilat. The rash was itchy in nature. The patient was administered Children's Benadryl 12.5 mg po on Friday evening the 1st and mid-Saturday, 8.02 received a second dose of Benadryl. Patient's mother called and reported reaction today, 8.05. Mother reports rash is dissipating but is "faintly" visible. No other adverse reactions noted. More
2852849 12 F AL 08/05/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U85088A
7KD5B
Dizziness; Dizziness Dizziness; Dizziness
5 minutes after administering vaccines, patient reported feeling a little light headed, cool cloth ... 5 minutes after administering vaccines, patient reported feeling a little light headed, cool cloth provided, BP checked 122/72, O2 Saturation was 98 %, HR 64/min. She reported feeling better after 5 mins, able to communicate with her mother and staff. She was also given small amount of sprite. More
2852850 17 F ME 08/05/2025 MNQ
 SANOFI PASTEUR
 U8558BA
Anxiety, Asthenopia, Balance disorder, Dizziness, Mydriasis Anxiety, Asthenopia, Balance disorder, Dizziness, Mydriasis
Patient presented as anxious/dizzy. Her pupils were dilated. We administered Benadryl and she drank ... Patient presented as anxious/dizzy. Her pupils were dilated. We administered Benadryl and she drank a small cup of water. Her mom is a nurse and was with her for the vaccine. Patient was able to walk out on her own but her eyelids were heavy and she was slightly unsteady on her feet. Mom brought her out to the car to sit in the air conditioning for a bit before going home. Mom called us at 1:26pm on 8/5/25 with an update that she was feeling much better and back to normal. More
2852851 57 F NC 08/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 944942
Erythema, Fatigue, Pruritus, Vomiting Erythema, Fatigue, Pruritus, Vomiting
Within a few hours of vaccine administration patient reported redness and itching all over her body ... Within a few hours of vaccine administration patient reported redness and itching all over her body along with vomiting and fatigue, "feels like I've been run over by a truck." Upon questioning, patient reported some labored breathing, but self-attributed to the strain of vomiting and fatigue. Patient reported afebrile upon questioning. More
2852852 21 F 08/05/2025 HEP
HPV9
MMR
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 945663
Y007197
Y07528
Z002625
Dyskinesia, Electrocardiogram normal, Loss of consciousness, Musculoskeletal sti... Dyskinesia, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Pallor; Dyskinesia, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Pallor; Dyskinesia, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Pallor; Dyskinesia, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness, Pallor More
Patient was screened for vaccine eligibility; on VAR she had selected "no" for all questio... Patient was screened for vaccine eligibility; on VAR she had selected "no" for all questions. Patient had no questions or concerns as she has been fine with all vaccines prior. Started with immunizations on left arm, administered MMR and Heplisav-B and the patient had no issues at this time. Then proceeded with giving the remaining 2 immunizations on the right arm. Administered the Varicella first on the right arm and patient was still fine then proceeded with the Gardasil on the right arm as well. Almost immediately after Gardasil administration patient went pale, went unconscious and jerked back, muscles went stiff with some jerking motions. More
2852853 11 M MI 08/05/2025 HPV9
 MERCK & CO. INC.
 Y017907
Refusal of vaccination, Wrong product administered Refusal of vaccination, Wrong product administered
This vaccine was declined and received a phone call 4 days later letting us know they accidentally g... This vaccine was declined and received a phone call 4 days later letting us know they accidentally gave him the hpv vaccine instead of tetanus vaccine. More
2852854 13 M TX 08/05/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8438AA
4CA28C1
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Tdap and Menquadfi given off schedule. Last dose of Tdap was 05/15/23. Last dose of MenQuadfi was ... Tdap and Menquadfi given off schedule. Last dose of Tdap was 05/15/23. Last dose of MenQuadfi was 07/25/2024. More
2852855 17 F IN 08/05/2025 YF
 SANOFI PASTEUR
 UK137AA
Product preparation error Product preparation error
There were 2 boxes of diluent next to each other. Unfortunately, the pharmacist saw the bigger box ... There were 2 boxes of diluent next to each other. Unfortunately, the pharmacist saw the bigger box of STERILE WATER and not the small YF diluent box. Pharmacist giving the vaccine for the first time used the sterile water diluent. the error was detected when there was more YF diluent remaining than vaccine. Patient parents were called no adverse reaction along with sanofi. Despite recommendations from manufacturer patient did not want to be revaccinated after the trip. More
2852856 0.5 M AR 08/05/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7767AA
Injection site mass, Injection site swelling Injection site mass, Injection site swelling
Swelling and hard knot at injection site. Pediatrician discussed anti inflammatory measures and taki... Swelling and hard knot at injection site. Pediatrician discussed anti inflammatory measures and taking ibuprofen every 6 hrs for 3 days then as needed. Also, taking Benadryl morning and night for 3 days and then as needed. Given arthus reaction handout. More
2852857 F 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria:... COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: [ICH-Unidentifiable patient]. Upon receipt of follow-up information on (24Jul2025), this case now contains all required information to be considered valid. This is a literature report. A 26-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 3 (booster), single and on 27Mar2023 as dose 4 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "dysfunctional uterine bleeding" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "Attention-deficit hyperactivity disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia; LEVONORGESTREL taken for contraception; TESTOSTERONE taken for hypogonadism; BUSPIRONE taken for anxiety; SERTRALINE taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "recovered" (14Apr2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: There is not a reasonable possibility that the reported event covid-19 was related to the suspect product event most likely due to patient underlying contributory factors.,Linked Report(s) : US-PFIZER INC-PV202500078537 Same article, drug, event and different patient; More
2852858 NY 08/05/2025 PNC20
 PFIZER\WYETH
Product container issue Product container issue
this vaccine broke as we were like administering it basically and the tip just came off where you wo... this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.". Additional information: The reporter stated, all the liquid was still in the vaccine. The vaccine was not administered to any patient, as they got another dose and we used that to administer the dose. The reporter considered "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Product Quality Group provided investigational results on 01Aug2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2852859 F 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria:... COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 24Jul2025, this case now contains all required information to be considered valid. This is a literature report. A 40-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 4 (booster), single and on 30Mar2023 as dose 5 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chronic low back pain" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "gastroesophageal reflux disease" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "Migraine without aura" (unspecified if ongoing); "Nausea associated with migraines" (unspecified if ongoing); "Peripheral sensory neuropathy" (unspecified if ongoing); "Muscle pain" (unspecified if ongoing); "Headache" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease; PROCHLORPERAZINE taken for anxiety; SUMATRIPTAN taken for migraine without aura; CLONAZEPAM taken for depression; INTRAUTERINE CONTRACEPTIVE DEVICE taken for contraception; DESVENLAFAXINE taken for depression; GABAPENTIN taken for depression; EPTINEZUMAB taken for migraine without aura, headache; PARACETAMOL taken for myalgia; NAPROXEN taken for myalgia; BREXPIPRAZOLE taken for depression. Past drug history included: Bactrim, reaction(s): "bactrim allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Apr2023, outcome "recovered" (01May2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event covid-19 based on the known safety profile and temporal association.,Linked Report(s) : US-PFIZER INC-202500156631 Same article, drug, event and different patient; More
2852861 0.17 F DE 08/05/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK174AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
pentacel vaccine, but was only given the hib portion of the vaccine, which was reconstituted with st... pentacel vaccine, but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event; pentacel vaccine, but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event; Initial information received on 31-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old female patient who was administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)],but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Pneumococcal vaccine conj 20v (CRM197)); and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 21-Jul-2025, the patient received 0.5 ml (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection(lot UK174AB, expiry date 21-Mar-2026, strength standard and frequency once) via intramuscular route in the left lateralis for Immunisation but was only given the hib portion of the vaccine, which was reconstituted with sterile water with no reported adverse event (product preparation error), (single component of a two-component product administered) (latency same day). Reportedly, patient started Pentacel vaccine, but was only given the HIB portion of the vaccine, which was reconstituted with sterile water. She was asking if they can continue the vaccine by giving the missing portion or if it needs to be restarted. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852862 M KY 08/05/2025 HEP
TDAP
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
U8274AA
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
adacel was administered to a newborn instead of hepatitis b with no reported adverse event; adacel w... adacel was administered to a newborn instead of hepatitis b with no reported adverse event; adacel was administered to a newborn instead of hepatitis b with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 1 day old male patient who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to a newborn instead of Hepatitis B Vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Aug-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (Lot U8274AA, expiry date 31-Aug-2026, strength standard and frequency once) via intramuscular route in unknown administration site for Immunisation and it was administered to a newborn instead of Hepatitis B Vaccine with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852863 1 M MD 08/05/2025 IPV
 SANOFI PASTEUR
 WIC831M
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion reached 5 hours and 38 minutes at 33.6f + 48 minutes at 46.8fproduct/s: opened... temperature excursion reached 5 hours and 38 minutes at 33.6f + 48 minutes at 46.8fproduct/s: opened ipol with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered to temperature excursed opened -IPV (Vero) [IPOL] which reached 5 hours and 38 minutes at 33.6F+ 48 minutes at 46.8F, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Apr-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot WIC831M, expiry date 30-NOV-2025, strength standard and frequency once) via intramuscular route in unknown administration site for Immunization and temperature excursion reached 5 hours and 38 minutes at 33.6f + 48 minutes at 46.8fproduct/s: opened ipol with no reported adverse event (product storage error). Reportedly, they had an opened an IPOL and since it was a multidose vial, they were not aware that there has been an excursion prior to it being administered. She wanted to know what the consequences would be and what should be done.Physician said they were not aware what the exact reason for the excursion is, stating the door may have been left opened. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852864 GA 08/05/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
patients who may have received a dose of ipol from an opened multi-dose vial that had undergone the ... patients who may have received a dose of ipol from an opened multi-dose vial that had undergone the excursions with no reported ae; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] from an opened multi-dose vial that had undergone the excursions with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 0.5ml of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization from an opened multi-dose vial that had undergone the excursions with no reported ae (poor quality product administered). Reportedly-Human error was not involved; Stability data does not cover the excursion; Previous excursion was there. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852869 5 M MI 08/05/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5H773
Expired product administered Expired product administered
Expired dose; This non-serious case was reported by a nurse via call center representative and desc... Expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 28-JUL-2025, the patient received Infanrix. On 28-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose). The outcome of the expired vaccine used 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: 28-JUL-2025 A Nurse Practitioner mentioned he did not realize that he gave a Infanrix vaccine that was a little bit past the expiration date which led to expired vaccine used. More
2852871 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; I contracted covi... I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I contracted covid 4 times, I stopped taking vaccines as it was not protecting me". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852872 M 08/05/2025 COVID19
 PFIZER\BIONTECH
Depressed mood, Feeling abnormal Depressed mood, Feeling abnormal
About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really d... About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad; Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 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: DEPRESSED MOOD (non-serious), outcome "unknown", described as " About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me". Additional information patient went to get the vaccine (Pfizer COVID-19 Vaccine) about like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed and I think they are related. Consumer stated, Ever since I, this is very related to the vaccine. So, I told you ever since I got the vaccine (Pfizer COVID-19 Vaccine), I have been a little sad but along or soon I also kind of feel like I have hamster and for some reason I had it (hamster) for years and he's just been a really pet of mine and I loved them but I got this vaccine shot for COVID about two weeks ago and ever since then I can't stop thinking about putting this hamster in my butt hole, so weird, I don't know have you had any report about that or I might be the only one? I felt like getting my hamster doing that and it's been bothering me, and I feel like it has to do with the vaccine (Pfizer COVID-19 Vaccine) Consumer stated, I am sorry, I have 'pauperism autism' (further not clarified). So, some times I say retracted things. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2852873 F 08/05/2025 MNP
 PFIZER\WYETH
Headache, Pain in extremity Headache, Pain in extremity
having like under other arm she did not get injection, she felt heavy on her other arm; sore arm; Ha... having like under other arm she did not get injection, she felt heavy on her other arm; sore arm; Having headache everyday; This is a spontaneous report received from a Consumer or other non HCP. A female patient received meningococcal group abcwy vaccine (PENBRAYA), in Jul2025 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jul2025, outcome "unknown", described as "Having headache everyday"; LIMB DISCOMFORT (non-serious) with onset Jul2025, outcome "recovered" (2025), described as "having like under other arm she did not get injection, she felt heavy on her other arm"; PAIN IN EXTREMITY (non-serious) with onset Jul2025, outcome "unknown", described as "sore arm". Additional information: The reporter stated, "Yes, my daughter get a vaccine for Penbraya the meningitidis vaccine like a week ago and then she had, at the beginning the first two days sore arm which is normal and then while she took the vaccine, she was on her menstrual period too, right and then she started having like under other arm she did not get injection, she felt heavy on her other arm and then for one or two days and it went away but after her period was over and like Sunday, on Sunday last week after that she started having headache every day. So, I was wondering is this related to the Penbraya vaccine or?" When paraphrased the above concern: Reporter stated, "Last Wednesday and then she was having sore arm under that she got the shot and then the first two days and then next two days she started having the other arm feeling heavy." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2852874 M 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP. A mal... got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP. 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 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 "got covid". The clinical course was reported as follows: The patient was diagnosed with COVID-19 and he found a pack of nirmatrelvir;ritonavir (PAXLOVID) dates Sep2022 and he also got Pfizer COVID-19 vaccines shot twice before but still got COVID-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2852875 F VA 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; I've always... I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; This is a spontaneous report received from a Consumer or other non HCP,. A 79-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 included: "Cataracts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated, "The doctor just prescribed Paxlovid for me. I got COVID. I can't afford the medicine, Paxlovid. I have cataracts, and I am old. Well, I do want to say that I do like the Pfizer medication program. I've always used the Pfizer shots, and all that stuff, I can appreciate this." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852876 81 F FL 08/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
she had the vaccine 6 times, and the last one being in October, and this is the first time having CO... she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; This is a spontaneous report received from a Consumer or other non HCP. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID". The events "she had the vaccine 6 times, and the last one being in october, and this is the first time having covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was vaccinated 6 times against COVID, counting the recommended boosters. The last one was on 15Oct2024 and it would be one year since the last COVID vaccination. It was the patient's first time having COVID. Doctor ordered a prescription at a pharmacy and was told that she would be given a voucher for Paxlovid. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852877 59 M MD 08/05/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 N35N9
N35N9
N35N9
N35N9
Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, As... Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Asthenia, Blood creatine phosphokinase MB increased; C-reactive protein, Full blood count, Malaise, Metabolic function test, Muscle spasms; Musculoskeletal stiffness, Neck pain, Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor; Urine analysis More
Sick/Ill, Neck pain/stiffness, shoulder pain/stiffness, reoccurring fevers, other joint pain, genera... Sick/Ill, Neck pain/stiffness, shoulder pain/stiffness, reoccurring fevers, other joint pain, generalized weakness, and muscle spasms. Symptoms are daily a day or two after vaccination. More
2852878 4 F UT 08/05/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42Y93
y019530
Injection site dryness, Injection site pain, Injection site swelling; Injection ... Injection site dryness, Injection site pain, Injection site swelling; Injection site dryness, Injection site pain, Injection site swelling More
Swelling and tenderness at injection site. Swelling was significant enough to dry the skin out, but ... Swelling and tenderness at injection site. Swelling was significant enough to dry the skin out, but is almost completely cleared after a week (Aug 5th 2025) More
2852879 54 F 08/05/2025 PNC21
 MERCK & CO. INC.
 Z006076
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Patient had arm swelling around the injection site and around the upper arm that took almost a week ... Patient had arm swelling around the injection site and around the upper arm that took almost a week to improve . Patient also had redness to upper arm that continued to be bright red for 3-4 days. More
2852880 60 F 08/05/2025 PNC21
 MERCK & CO. INC.
 Z006076
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
Patient had bright red reaction around administration site that spread up the upper arm and down to ... Patient had bright red reaction around administration site that spread up the upper arm and down to the elbow. Redness continued even with use of ice and hydrocortisone cream. Is still red and itchy More
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