🏥 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 💀 🏥 🚑 ♿ ⚠️
2849425 78 F FL 07/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EK225
EK225
Back pain, Condition aggravated, Gait inability, Injection site pain, Injection ... Back pain, Condition aggravated, Gait inability, Injection site pain, Injection site swelling; Injection site warmth, Pain in extremity, Sciatica, Vaccine positive rechallenge More
Back pain; excruciating sciatica pain; Leg pain; I can't even walk due to the pain; Injection s... Back pain; excruciating sciatica pain; Leg pain; I can't even walk due to the pain; Injection site pain; Injection site warmth; Injection site swelling; I can't even walk due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225, expiry date 03-OCT-2027) for prophylaxis. Concurrent medical conditions included sciatic nerve injury. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), gabapentin and ibuprofen sodium (Ibuprofen). On 27-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling), pain (Verbatim: I can't even walk due to the pain) and unable to walk (Verbatim: I can't even walk due to the pain). On 28-JUN-2025, the patient experienced back pain (Verbatim: Back pain), sciatica aggravated (Verbatim: excruciating sciatica pain) and leg pain (Verbatim: Leg pain). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, pain, back pain, sciatica aggravated, leg pain and unable to walk to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR082131 Additional Information: GSK Receipt Date: 30-JUN-2025 The reporter was the patient. The patient reports that she received the 2nd dose of Shingrix vaccine at a local pharmacy and were administered in the left arm. The patient reports that she has sciatic nerve issues and gets treatment with a chiropractor and her condition was under control. The patient states she had just left the chiropractor office when she went to get the 2nd dose of Shingrix. The patient reports that on Saturday June 28th 2025 in the morning she had excruciating sciatica pain on her back and right leg. The patient reports with the 1st dose she had pain and swollen of the injection site. She reports that with the second dose she has the same but also it was warm. The patient reports could not even walk due to the pain. The patient reports she has applied ice and has taken Ibuprofen for the pain. No additional event was reported.; Sender's Comments: US-GSK-US2025AMR082131:Same patient/Dose 1 More
2849426 07/11/2025 RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Cough, Dyspnoea, Fatigue, Paranasal sinus hypersecretion, Respiratory syncytial ... Cough, Dyspnoea, Fatigue, Paranasal sinus hypersecretion, Respiratory syncytial virus infection; Vaccination failure More
Cough; Sinus drainage; Hard time getting my breath; fatigued; Suspected vaccination failure; RSV; Th... Cough; Sinus drainage; Hard time getting my breath; fatigued; Suspected vaccination failure; RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included asthma. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). On an unknown date, the patient experienced cough (Verbatim: Cough), postnasal drip (Verbatim: Sinus drainage), difficulty breathing (Verbatim: Hard time getting my breath) and fatigue (Verbatim: fatigued). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue were not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, cough, postnasal drip, difficulty breathing and fatigue to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-JUN-2025 The patient had the RSV vaccine after the first of the year and about one month ago the patient was pretty sure about got respiratory syncytial virus infection because everyone around seemed to have it. The patient have asthma and still coughing and lots of sinus drainage. Hard time getting breath and so fatigued. At first thought it was really bad allergies but got worse. Still hoping anyway now would be back to normal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection 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 details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine. More
2849427 07/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles on face and near my eye; This serious case was reported by a... Suspected vaccination failure; shingles on face and near my eye; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUL-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on face and near my eye). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-JUL-2025 This case was reported by a patient via interactive digital media. Patient finished the two shot series in late spring and was diagnosed this week with shingles, stated that I'm sitting here in July with shingles on my face and near my eye. Patient was questioning the value of the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2849428 07/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Burning sensation, Crying, Erythema, Headache, Pain; Peripheral swelling, Skin w... Burning sensation, Crying, Erythema, Headache, Pain; Peripheral swelling, Skin warm, Swelling More
headaches; pain; swelling; arm was extremely swollen; heat/arm hot; itching; arm red; arm burning; C... headaches; pain; swelling; arm was extremely swollen; heat/arm hot; itching; arm red; arm burning; Crying; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On 05-JUL-2025, less than a week after receiving Shingles vaccine, the patient experienced crying (Verbatim: Crying). On an unknown date, the patient experienced headache (Verbatim: headaches), pain (Verbatim: pain), swelling (Verbatim: swelling), swelling arm (Verbatim: arm was extremely swollen), extremities hot feeling of (Verbatim: heat/arm hot), pruritus (Verbatim: itching), erythema of extremities (Verbatim: arm red) and burning sensation (Verbatim: arm burning). The outcome of the headache, swelling, extremities hot feeling of and pruritus were not resolved and the outcome of the pain was resolved and the outcome of the swelling arm, erythema of extremities, burning sensation and crying were not reported. It was unknown if the reporter considered the headache, pain, swelling, swelling arm, extremities hot feeling of, pruritus, erythema of extremities, burning sensation and crying to be related to Shingles vaccine. It was unknown if the company considered the headache, pain, swelling, swelling arm, extremities hot feeling of, pruritus, erythema of extremities, burning sensation and crying to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-JUL-2025 and 06-JUL-2025 The case was received from the patient via interactive digital media. The patient had first shingles vaccine six days ago and on the day of reporting the first time he/she was not in pain. The patient's arm was extremely swollen, hot, red and burning. One day before the reporting, it itched and burned so bad he/she was crying. The patient still struggling with headaches, pain, swelling, heat and itching. Praying tomorrow would be a better day. It's got to be better than shingles but it's not good and was not a baby. The patient did not think he/she would get the second vaccine. More
2849429 07/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Infection, Varicella Infection, Varicella
still had breakthrough chicken pox; This non-serious case was reported by a consumer via interactive... still had breakthrough chicken pox; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox 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 chickenpox (Verbatim: still had breakthrough chicken pox). The outcome of the chickenpox was not reported. It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine. It was unknown if the company considered the chickenpox to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shots and still had breakthrough chicken pox. More
2849430 71 M VA 07/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
he got the 3rd one; This non-serious case was reported by a pharmacist via call center representativ... he got the 3rd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose of vaccine on 23rd February 1999) and Havrix (received 2nd dose of vaccine on 12th October1999). On 01-OCT-2024, the patient received the 3rd dose of Havrix. On 01-OCT-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: he got the 3rd one). The outcome of the extra dose administered 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-JUN-2025 Pharmacist just need to check and saw if this patient needs another vaccination. Patient had 2 (doses) in 1999, an another one (dose) last year, was typically a 2-shot series. But patient got the 3rd one which led to extra dose administered. Pharmacist questioned that if he needs a 4th dose. More
2849431 F MS 07/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 2N795
Incorrect route of product administration Incorrect route of product administration
Intramuscular Administration of Priorix (Inappropriate Route of Administration); This non-serious ca... Intramuscular Administration of Priorix (Inappropriate Route of Administration); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 64-year-old female patient who received MMR (Priorix) (batch number 2N795, expiry date 13-SEP-2026) for prophylaxis. On 01-JUL-2025, the patient received the 1st dose of Priorix (intramuscular). On 01-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular Administration of Priorix (Inappropriate Route of Administration)). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-JUL-2025 The pharmacist called to ask for information/advise about the administration of Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administered by other route. Vaccination date, vaccine detail and patient demographics were obtained in this call (only no patient initials provided from the Pharmacist end). No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2849432 F MO 07/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 LB93L
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
4 month old female patient received a dose of Menveo 1 vial presentation.; This non-serious case was... 4 month old female patient received a dose of Menveo 1 vial presentation.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L, expiry date 30-JUN-2025) for prophylaxis. On 30-JUN-2025, the patient received the 1st dose of Menveo. On 30-JUN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old female patient received a dose of Menveo 1 vial presentation.). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 02-JUL-2025 The charge nurse called to ask if a 4 months old female patient received the 1-vial presentation of Menveo on 30th June 2025 which led to inappropriate age at vaccine administration. The reporter asked was there anything specific to do next. The reporter also asked that did they continue with the 2-vial to complete the series. More
2849433 0.75 M KY 07/11/2025 PNC20
 PFIZER\WYETH
Lethargy, Syncope Lethargy, Syncope
Prolonged Syncope; The baby was lethargic; The initial case was missing the following minimum criter... Prolonged Syncope; The baby was lethargic; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 08Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from medical information team. A 9-month-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) at the age of 9 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant, life threatening), outcome "unknown", described as "Prolonged Syncope"; LETHARGY (life threatening), outcome "unknown", described as "The baby was lethargic". Clinical course: The pediatrician called regarding a 9-month baby, healthy, no allergies (referred a "perfectly fine") who was administered PCV 20. The pediatrician initially reported that the baby almost died right after giving the vaccine in their office and that they almost lost the baby. She mentioned that this is so very serious. This vaccine is causing problems and lots of reactions. She does not know if she should give this vaccine anymore. On 08Jul2025, the same pediatrician reported that the baby had a reaction that is not outlined in the PI. As soon as PCV 20 was administered, the baby went to sleep almost immediately, they thought they had lost him. They tried to wake him up, took about half an hour to know what's going on. The baby was lethargic, almost called the Emergency Services. The pediatrician stated that this is not normal. It was an instant reaction to the vaccine. The pediatrician is aware that the PI reported drowsiness, however she would referred it as Prolonged Syncope. The pediatrician also reported that she has seen other local reactions (redness, 1-inch knots that take 2-4 weeks) that she didn't see with PCV 13. The pediatrician wanted to know if she should continue to give the vaccine and if there are any more reports. The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the events syncope and lethargy with PREVNAR 20 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
✓
2849434 F 07/11/2025 COVID19
 PFIZER\BIONTECH
Death, Thrombosis Death, Thrombosis
Died in sleep; started getting blood clots; This is a spontaneous report received from a Consumer or... Died in sleep; started getting blood clots; This is a spontaneous report received from a Consumer or other non HCP. A 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. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died in sleep"; THROMBOSIS (medically significant), outcome "unknown", described as "started getting blood clots". The patient date of death was unknown. Reported cause of death: "Died in sleep". It was not reported if an autopsy was performed. Clinical course: The patient got the vaccine for COVID-19 from Pfizer. The patient started getting blood clots and she died in her sleep. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Died in sleep More
✓
2849435 F 07/11/2025 COVID19
 PFIZER\BIONTECH
Body temperature, COVID-19 pneumonia, Drug ineffective Body temperature, COVID-19 pneumonia, Drug ineffective
gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlov... gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid; gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid; This is a spontaneous report received from a Consumer or other non HCP. A 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: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "unknown" and all described as "gets pneumonia from getting sick/fever of 102/getting financial assistance for the medication Paxlovid". The patient underwent the following laboratory tests and procedures: Body temperature: 102. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia. The patient did state that they had Pfizer, she said it was the booster shot while on the line about getting financial assistance for the medication Paxlovid. She did state that she gets pneumonia from getting sick, that she has that as well and she has a fever of 102. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849436 64 F SC 07/11/2025 PNC20
 PFIZER\WYETH
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Redness at the injection site and swollen; Redness at the injection site and swollen; This is a spon... Redness at the injection site and swollen; Redness at the injection site and swollen; This is a spontaneous report received from a Physician from a sales representative. A 64-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Jul2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 02Jul2025, outcome "not recovered" and all described as "Redness at the injection site and swollen". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849437 59 F SC 07/11/2025 PNC20
 PFIZER\WYETH
Injection site pain, Mobility decreased Injection site pain, Mobility decreased
Pain at the injection where she has lost full movement of moving her arm all the way up and down; Pa... Pain at the injection where she has lost full movement of moving her arm all the way up and down; Pain at the injection where she has lost full movement of moving her arm all the way up and down; This is a spontaneous report received from an Other HCP from a sales representative. A 59-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), INJECTED LIMB MOBILITY DECREASED (non-serious) all with onset Jul2025, latency 2 weeks after the suspect product(s) administration, outcome "not recovered" and all described as "Pain at the injection where she has lost full movement of moving her arm all the way up and down". Therapeutic measures were not taken as a result of vaccination site pain, injected limb mobility decreased. Additional information: The patient didn't receive any other vaccines on the same date as the vaccine reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine reported. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. Pain at the injection where the patient has lost full movement of moving her arm all the way up and down. This was 2 weeks later from vaccine administered. The reporter classified the event as non-serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849438 73 F NJ 07/11/2025 PNC20
 PFIZER\WYETH
Pain in extremity Pain in extremity
pain in both legs for 3 plus weeks; This is a spontaneous report received from a Physician from a sa... pain in both legs for 3 plus weeks; This is a spontaneous report received from a Physician from a sales representative. A 73-year-old female patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 17Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jun2025, outcome "recovering", described as "pain in both legs for 3 plus weeks". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received. More
2849439 M VA 07/11/2025 PNC20
 PFIZER\WYETH
 HP73b4
Immunisation reaction, Swelling Immunisation reaction, Swelling
he swelled up like a balloon; bad Allergic Reaction to a Pfizer (Flu) Vaccine; The initial case was ... he swelled up like a balloon; bad Allergic Reaction to a Pfizer (Flu) Vaccine; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on (09Jul2025) , this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID: 005570. A 90-year-old male patient received pneumococcal 20 val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HP73b4). The patient's relevant medical history included: "Deaf" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome unknown, described as "he swelled up like a balloon" HYPERSENSITIVITY (non-serious), outcome "unknown", described as bad Allergic Reaction to a Pfizer (Flu) Vaccine. Additional information: The patient stated he was 90 years old and deaf. He had a bad reaction and got the questionnaire all filled out and is trying to find out an email he can send the completed form back to Pfizer. He needed an email to send this 7 page completed form. He was in a nursing home, and it has Pfizer all over the envelope and he is not sure they will release this to the mail man. Is there a customer relations email to send this to. The nursing home gave him this and he swelled up like a balloon and he thinks they tried to take him out. He put down everything he could. 3 months later they told him it was a pneumonia shot, told him the HP73b4. He is trying to get Pfizer interested in this crazy thing. He has trouble getting 7 page completed questionnaire in mail to reach us. wanted to back up with email. Gave him a mystery chemical and they wouldn't tell him what it was until 3 months later and gave this number. There was no consent form, and it was all underhanded and not properly handled. Can this call handler talk to head of privacy branch and come up with an email. He tried to get this in the mail, but he really needs an email to send as backup. This is for proper purpose. It was a Pfizer product they started with and something happened to it, they did something and did not think Pfizer is responsible. He blew up like a balloon for 2 weeks. He has had 200 shots in his life and had a military career and was in 3rd world countries and never had a reaction in his life. They tried to take him out and he wanted to get the information to Pfizer. The patient stated he was a lawyer and federal judge. He is very hard of hearing so if we send him an email address he can have this taken care of in 5 minutes. Clarifies he was hard of hearing before the shot; it had nothing to do with Pfizer at all. Email works because he can read but over telephone, he is unreliable. PSCC Communication: Informed caller his request would be filed and that call handler does not have an email to provide. More
2849440 07/11/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
I don't trust it because I was very sick after taking vaccines.; This is a spontaneous report r... I don't trust it because I was very sick after taking vaccines.; 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: ILLNESS (non-serious), outcome "unknown", described as "I don't trust it because I was very sick after taking vaccines.". Additional information: Causality reported as not known. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849441 F TN 07/11/2025 RAB
RAB
RAB
RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR



Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus,... Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus, Tremor; Chest pain, Decreased appetite, Hallucination, Insomnia, Palpitations; Tinnitus, Tremor More
insomnia; hallucinations; anorexia; heart palpitation/heart palpitations, shaking really bad; shakin... insomnia; hallucinations; anorexia; heart palpitation/heart palpitations, shaking really bad; shaking really bad, like bad tremors; tinnitus/ringing in the ears and stuff like that; chest pain/chest was having a lot of pain in it; Initial information received on 08-Jul-2025 regarding an unsolicited valid serious case received from a nurse. This case involves Adult female patient who experienced insomnia, hallucinations, anorexia, chest pain/chest was having a lot of pain in it, heart palpitation/heart palpitations, shaking really bad, tremors and tinnitus/ringing in the ears and stuff like that while receiving vaccines Rabavert and Rabies (HDC) Vaccine[Imovax Rabies]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Mar-2025 the patient received (2 doses) one of 0 mg of suspect Rabies (HDC) Vaccine, Powder and solvent for suspension for injection frequency: once, via intramuscular route and other one unknown dose of suspect Rabies vaccine inact (chick embryo) not produced by Sanofi Pasteur, unknown formulation, via unknown route, both with (lot number, expiry date and strength not reported) via unknown route in unknown administration site for vaccination. Information on the batch number could not be requested corresponding to the one at time of event occurrence On an unknown date In Mar-2025 the patient had insomnia, hallucinations (hallucination), anorexia (decreased appetite), chest pain/chest was having a lot of pain in it (chest pain), heart palpitation/heart palpitations, shaking really bad (palpitations), tremors (tremor) and tinnitus/ringing in the ears and stuff like that (tinnitus) (latency: few days approximately following the first dose of both the suspects). Reportedly, patient received 2 doses of the rabies vaccination one which is RabAvert and then another one through Imovax. She had pretty bad reaction to we're not sure which one it was because she got, and have to figure out what order they went in but not sure which one it was. Action taken was not applicable for all the events for both the suspects It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria: Medically significant for the event hallucination and hospitalized for all the events. No follow-up is possible as Reporter cannot be contacted by Sanofi; Sender's Comments: Sanofi company comment dated 10-Jul-2025: This case involves Adult female patient who experienced insomnia, hallucinations, anorexia, chest pain/chest was having a lot of pain in it, heart palpitation/heart palpitations, shaking really bad, tremors and tinnitus/ringing in the ears and stuff like that while receiving vaccines Rabavert and Rabies (HDC) Vaccine[Imovax Rabies]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
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2849442 5 07/11/2025 DTAPIPV
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient 5 years old who was administered Quadracel (in error) 1 year after receiving a dose of Quadr... Patient 5 years old who was administered Quadracel (in error) 1 year after receiving a dose of Quadracel with no adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old and unknown gender patient who was administered Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] (in error) 1 year after receiving a dose of quadracel with no 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 an unknown dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunsation) 1 year after receiving a dose of quadracel with no adverse event (extra dose administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. 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
2849443 TN 07/11/2025 YF
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
2-family members received a booster dos of YF-vax prior to the 10- year interval, with no reported a... 2-family members received a booster dos of YF-vax prior to the 10- year interval, with no reported adverse event; Initial information received on 09-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Child patient with unknown gender who received a booster dos of Yellow Fever Vaccine - US [YF-VAX] prior to the 10- year interval, with no reported 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 Booster dose of suspect Yellow Fever Vaccine - US, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization and 2-family members received a booster dos of yf-vax prior to the 10- year interval, with no reported adverse event (inappropriate schedule of product administration). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, she was asking if there were any precautions they need to take for this situation. 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.; Sender's Comments: US-SA-2025SA194542: More
2849444 PA 07/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
Product preparation issue Product preparation issue
only the ACTHIB component of PENTACEL was administered with no reported adverse event; Initial infor... only the ACTHIB component of PENTACEL was administered with no reported adverse event; Initial information received on 09-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who ronly eceived the Act-Hib component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported 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 only the Act-Hib component suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, (Unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization with no reported adverse event (single component of a two-component product administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, Nurse verified that they administered powdered part with sterile water diluent. She reported that and would now like to know what to do with the DTAP component. 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
2849445 17 F OH 07/11/2025 MENB
 PFIZER\WYETH
 HP9988
Fatigue, Loss of consciousness, Malaise, Vomiting Fatigue, Loss of consciousness, Malaise, Vomiting
Grandmother called in today 7/11/25 and reported that yesterday around 5:30 client had passed out on... Grandmother called in today 7/11/25 and reported that yesterday around 5:30 client had passed out on a car ride. She received her second dose of Trumenba around 2:30 on 7/10/25. Grandmother reports they were driving down the highway and client reported she didn't feel good and then she passed out on the grandmother's arm. Grandmother reports she called the clients name and no response. States the episode didn't last very long and she came too. Her eyes were open and continued to complain of not feeling well. Report they went to get her something to drink and she then vomited x1. After emesis continued to complain of being tired and not feeling good. Reports client is fine today and no complaints. More
2849446 55 F IA 07/11/2025 COVID19
 JANSSEN
 201a21a
Death Death
Resident passed away on 7/10/2025 Resident passed away on 7/10/2025
✓
2849447 0.5 M MI 07/11/2025 DTAPHEPBIP
HEP
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 4L544
32M5G
LK6653
Y018378
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No advance effect reported or observed, patient accidently received 2 hepatitis B vaccines. One hepa... No advance effect reported or observed, patient accidently received 2 hepatitis B vaccines. One hepatitis B vaccine and Pediarix which also contains hepatitis B component. More
2849448 1 M AL 07/11/2025 MMR
 MERCK & CO. INC.
 Y008289
Rash Rash
rash on stomach, back, & forehead small red bumps not bothersome low grade temp 100.0 day prior ... rash on stomach, back, & forehead small red bumps not bothersome low grade temp 100.0 day prior to pediatrician visit on 7/11/25 normal temp in office, no treatment. More
2849449 39 M 07/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL8982
EL8982
EN6201
EN6201
FF2590
FF2590
Chills, Diarrhoea, Discomfort, Facial pain, Haemorrhage; Impaired work ability, ... Chills, Diarrhoea, Discomfort, Facial pain, Haemorrhage; Impaired work ability, Pruritus, Rash, Skin burning sensation, Vomiting; Chills, Diarrhoea, Discomfort, Facial pain, Haemorrhage; Impaired work ability, Pruritus, Rash, Skin burning sensation, Vomiting; Chills, Diarrhoea, Discomfort, Facial pain, Haemorrhage; Impaired work ability, Pruritus, Rash, Skin burning sensation, Vomiting More
with first shot missed three days of work for chills, shivering, throwing up, diarrhea . After 2nd s... with first shot missed three days of work for chills, shivering, throwing up, diarrhea . After 2nd shot missed 5 days of work for the same symptoms and about a week after second shot patient's face started breaking out and it is still going and no doctor new what to do till now. it itches it bleeds it burns it hurts in addition to that it makes patient feel uncomfortable and insecure and he guarantee he lost his job for it even though he cant prove it. In summery this adverse reaction changes patient's life. He fills up work applications and when they look at his face they don't give him the job- sad. More
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2849450 14 F TX 07/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 343DD
Inappropriate schedule of product administration, Wrong patient Inappropriate schedule of product administration, Wrong patient
A vaccine intended for the patient?s sibling was mistakenly administered to the patient. The patient... A vaccine intended for the patient?s sibling was mistakenly administered to the patient. The patient stood up to receive the vaccine, and the nurse administered it without confirming the correct recipient. The patient?s vaccination history shows the last Menveo dose was given on 9/16/2022 at 12 years of age. According to the vaccine?s package insert, the patient was not yet due for another dose. Indication per package insert: Booster Vaccination: A single booster dose of MENVEO may be administered to individuals aged 15 through 55 years who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a meningococcal . Note: The patient did not have any specific adverse events, treatment, and/or outcomes due to this. More
2849451 0.92 M 07/11/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y008592
Y014181
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
None None
2849452 38 M MI 07/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42d7a
Underdose Underdose
Patient was given a pediatric dose of Hepatitis B vaccine instead of an adult Hepatitis B vaccine. Patient was given a pediatric dose of Hepatitis B vaccine instead of an adult Hepatitis B vaccine.
2849454 13 M CA 07/11/2025 DTAP
HEP
HEPA
HPV9
MNQ
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 9PT2F
7NX57
H3N97
Z002580
XL223
Y017062
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; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Gave patient vaccine, and tolerated well. Gave patient vaccine, and tolerated well.
2849455 60 F MD 07/11/2025 PNC20
 PFIZER\WYETH
Pain in extremity, Paraesthesia Pain in extremity, Paraesthesia
PATIENT COMPLAINED OF PAIN IN RIGHT ARM THAT IS DESCRIBED AS CONTINOUS TINGLING WITH PAIN WITH NO RE... PATIENT COMPLAINED OF PAIN IN RIGHT ARM THAT IS DESCRIBED AS CONTINOUS TINGLING WITH PAIN WITH NO RELIEF. SYMPTOMS START APPROXIMATELY 2 MONTHS AFTER RECEVING VACCINE. PATIENT FOLLOWED UP WITH PROVIDER WHO COMPLETED ASSESMENT WITH SCAN WHICH PROVED INCONCLUSIVE. PROVIDER INQUIRRED ABOUT VACCINE HISTORY IN WHICH PREVNAR 20 WAS THE LAST VACCINE ADMINISTERED TO PATIENT. More
2849456 13 F NC 07/11/2025 HPV9
 MERCK & CO. INC.
Dysmenorrhoea, Polymenorrhoea Dysmenorrhoea, Polymenorrhoea
Period started 2 weeks early after having regular periods for 12 months. Period is accompanied by se... Period started 2 weeks early after having regular periods for 12 months. Period is accompanied by severe debilitating cramps and child has never had cramps since starting menstruatio More
2849457 18 F 07/11/2025 MENB
MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH


Abdominal pain, Chills, Dry mouth, Headache, Heart rate increased; Hyperhidrosis... Abdominal pain, Chills, Dry mouth, Headache, Heart rate increased; Hyperhidrosis, Insomnia, Nausea, Oropharyngeal pain, Pyrexia; Rash, Restlessness, Vomiting More
Patient started experiencing the following symptoms after receiving the vaccine. These symptoms incl... Patient started experiencing the following symptoms after receiving the vaccine. These symptoms included fever, chills, sweats, elevated heart rate, nausea, sore throat, headache, abdominal pain, vomiting, rash on chest, loss of appetite, dry mouth, sore throat, restlessness, insomnia and headache. More
2849459 74 F FL 07/11/2025 TDAP
 SANOFI PASTEUR
 u8353AA
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Patient became red , hot, swollen and painful at the injection site. The day after talking the vacci... Patient became red , hot, swollen and painful at the injection site. The day after talking the vaccine More
2849460 0.33 M OR 07/11/2025 RV5
 MERCK & CO. INC.
 X028882
Expired product administered, No adverse event Expired product administered, No adverse event
No reaction the Vaccine expired 3 days prior of the day given No reaction the Vaccine expired 3 days prior of the day given
2849461 M KS 07/11/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7NX57
7NX57
7NX57
Blood gases normal, Brief resolved unexplained event, Chest X-ray normal, Cyanos... Blood gases normal, Brief resolved unexplained event, Chest X-ray normal, Cyanosis, Echocardiogram normal; Electrocardiogram normal, Hiccups, Oxygen saturation decreased, Poor feeding infant, Poor weight gain neonatal; Sleep apnoea syndrome, Sleep study abnormal, Ultrasound head normal, Ultrasound kidney abnormal, Urogram More
I (mother of patient) had a perfectly healthy pregnancy and we left labor and delivery with a perfec... I (mother of patient) had a perfectly healthy pregnancy and we left labor and delivery with a perfectly healthy baby (minus kidneys due to my high fluid). I even called medical records and got his records from L&D sent over to me to confirm this. Everything was pointing to a perfectly healthy baby, I delivered patient. We gave him the eye ointment & vitamin K vaccine on May 6. I held off on the hep B vaccine because I wanted to read up on it before giving it to him blindly. We ended up agreeing and having them administer the hep B vaccination on May 7. We checked out May 8, where he weighed 6 lbs 15 oz. We stayed one night at home, but then rushed to the ER on May 9 at 9:15 pm because he had a violent episode of the hiccups and the area around his mouth turned blue. His oxygen saturation levels were 78/79 upon arrival, but then he was able to self resolve most of the time. We stayed for the week, where we kept hearing that what happened was a BRUE , which meant it was an unexplained event. As the week went on, his oxygen saturation levels started to have events where he would sit around 80-85? they eventually diagnosed with sleep apnea on the very last day. We checked out of hospital around 6 pm on May 13. I took him immediately to my pediatrician on May 14. Patient was STILL 6 lbs 15 oz over a week after leaving labor and delivery. The doctors at hospital were saying my milk supply was drowning him. They had me pump for 10 minutes, then attempt to breastfeed. He would go boob to boob for over an hour. I wasn t allowed to give him a bottle of breast milk - I was told breast is best and to keep going. Hospital chalked it up to him having a feeding issue. Upon leaving the hospital, my husband and I gave him a few bottles of breast milk at home because it just didn t feel right to me. May 16 (so two days after our appointment at the pediatrician), we went back to the pediatrician and he had already popped back up to 7 lbs 9 oz. I have come to the conclusion that he never had a feeding issue, he just wasn t eating enough and also dehydrated, causing his oxygen saturations levels to dip more as the week went on. An outpatient Occupational Therapist that we had to see for his feeding issues mentioned this being a possibility because he was immediately discharged from OT for not having a feeding issue at all. This all made me dig even more because it just hasn t sat right with me.. I see the second round of hep B coming up - and see a rare side effect of the hep B vaccination is apnea and asphyxiation 48 to 72 hours post injection. This perfectly times up with when we checked into the emergency room, which now leads me to believe that (especially when this was initially a BRUE ) patient had the rare reaction to that hep B vaccine, which initially got us admitted. I think the feeding issue causing his saturation to be so low is what kept us there for so long. I brought this up to his sleep doctor who said that the weight gain is most likely what caused the sleep apnea episodes and all of this to spiral. I just can t see how this wouldn t explain it when we left L&D with a perfectly healthy baby with normal respiration according to his records. I know it s an absolutely crazy thought but also maybe so crazy that it was overlooked? No one asked me about his timeline of any vaccinations or anything when we were at hospital so I don t think this was ever explored as a possibility of what got us admitted, and being underfed just led to more problems. More
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2849462 35 F TX 07/11/2025 HEPAB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
H4279
Asthenia, Cold sweat, Dizziness, Loss of consciousness, Muscular weakness; Asthe... Asthenia, Cold sweat, Dizziness, Loss of consciousness, Muscular weakness; Asthenia, Cold sweat, Dizziness, Loss of consciousness, Muscular weakness More
After giving both vaccines patient had continued to sit in the chair. Asked if she was ok and she sa... After giving both vaccines patient had continued to sit in the chair. Asked if she was ok and she said she feels weak/dizzy. Asked she had eaten anything today and she said no, offered water and she said yes. Gave her a bottle of water and asked to take small sips and just relax and focus on breathing. She took a sip of water and shortly after, she lost grip of the bottle and dropped the bottle. 911 was called. Continued to talk to her and she seemed to be responding nodding her head and taking deep breaths. Then she appeared to have lost conscious for a few seconds and started responding again. She said she's better now but have cold sweats. She sat for a few more minutes and had gotten up to leave the pharmacy when paramedics came. Paramedics checked on her vital and cleared her to go. More
2849463 38 M VA 07/11/2025 HEP
IPV
MMR
TD
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 945663
Y1A201M
Y008592
U8492AA
Y014181
Arthralgia, Discomfort; Arthralgia, Discomfort; Arthralgia, Discomfort; Arthralg... Arthralgia, Discomfort; Arthralgia, Discomfort; Arthralgia, Discomfort; Arthralgia, Discomfort; Arthralgia, Discomfort More
The patient reported experiencing a constant aching and heavy sensation in the left shoulder blade a... The patient reported experiencing a constant aching and heavy sensation in the left shoulder blade area since receiving vaccines on June 30, 2025. They did not seek medical attention for this concern, believing the sensation was a normal reaction after vaccination. The patient stated that they have not experienced any headaches, dizziness, fainting, or swelling of the tongue, lips, or throat. Additionally, the patient mentioned, "I work for X, and I use my back because I change tires, batteries, and provide gas." More
2849464 66 M OK 07/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Antinuclear antibody, Antinuclear antibody positive, Autoimmune disorder, Dizzin... Antinuclear antibody, Antinuclear antibody positive, Autoimmune disorder, Dizziness, Dyspnoea; Laboratory test abnormal, Pyrexia, Rash More
Rash fevers shortness of breath dizzines auto immune disorder Rash fevers shortness of breath dizzines auto immune disorder
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2849465 41 F AZ 07/11/2025 VARCEL
 MERCK & CO. INC.
 Y019318
Injection site pain, Neck pain, Pain, Pain in extremity Injection site pain, Neck pain, Pain, Pain in extremity
Pain radiating from location of vaccine up to/through neck and down through arm since vaccine given ... Pain radiating from location of vaccine up to/through neck and down through arm since vaccine given 1 month ago. More
2849466 4 M WI 07/11/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Z003311
Cough, Crying, Malaise, Oropharyngeal pain; Cough, Crying, Malaise, Oropharyngea... Cough, Crying, Malaise, Oropharyngeal pain; Cough, Crying, Malaise, Oropharyngeal pain More
Patient received Kinrix and Proquad at 0920 and left clinic. At approx. 0930 dad returned to front d... Patient received Kinrix and Proquad at 0920 and left clinic. At approx. 0930 dad returned to front desk stating patient did not feel well. Patient had cough and complained of throat pain. Patient was crying. Dr asked to come in an assess patient. Patient's O2 sat was 92% on room air. B/P was 90/60, HR was 154. Dr listened to breath sounds and assessed throat. No swelling noted. Patient's father advised to take patient to ER which is next door to the clinic. In ER patient received Epinephrine, decadron, benadryl, and pepcid. Patient discharged home and advised to follow up with allergy specialist. More
2849467 1.33 F AL 07/11/2025 DTAP
IPV
 SANOFI PASTEUR
SANOFI PASTEUR
 3CA51C1
W1C831M
Injection site mass, Injection site rash; Injection site mass, Injection site ra... Injection site mass, Injection site rash; Injection site mass, Injection site rash More
Pt came in to receive vaccine, after administering vaccine, a knot came up. One of our nurses checke... Pt came in to receive vaccine, after administering vaccine, a knot came up. One of our nurses checked it and let mom know if it got worse to call us. Mom brought pt back in next day and there was a rash that appeared and covered the entire right thigh. The doctor called hospital for guidance, pt was given an antibiotic and is coming in today 7/11/25 for the rash to be measured to make sure its not getting larger. More
2849468 1 F WI 07/11/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 M52GG
Y005366
LX4484
Crying, Inappropriate schedule of product administration; Crying, Inappropriate ... Crying, Inappropriate schedule of product administration; Crying, Inappropriate schedule of product administration; Crying, Inappropriate schedule of product administration More
Patient received Infanrix dose too early. Patient's mom contacted the clinic around 1646 in the... Patient received Infanrix dose too early. Patient's mom contacted the clinic around 1646 in the afternoon stating that patient was non-stop crying throughout the day and was not able to settle down after receiving vaccines. Patient was at daycare after the immunizations and was told that the patient was basically inconsolable all afternoon, daycare was able to calm her down slightly by turning on the TV. Patient was heard crying in the background during the call. She was given protocol recommendations and patient's mom states that she would rather give patient ibuprofen to see if she settles down and mother stated that she would take the patient in if she was not able to settle down. More
2849469 11 F IL 07/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 z007847
9x7cd
EB499
Syncope, Tremor; Syncope, Tremor; Syncope, Tremor Syncope, Tremor; Syncope, Tremor; Syncope, Tremor
Per MD Mom reported 5 mins patient fainted for 4-5 seconds and then begin to shake. MD and medical ... Per MD Mom reported 5 mins patient fainted for 4-5 seconds and then begin to shake. MD and medical staff immediatly call. Vitals take , water , ice packs and graham crackers Mom stated that patient hadn't eaten at all and was nervous about the shots. Md assessed patient . Patient remembered everything before and after this happened, and was back to baseline within a few minutes. MD Continue to monitor patient in the office for the next 20 minutes, and provided warning signs and ED precautions. Also placed referral for neurologist out of extra precaution due to episode of shaking More
2849470 25 M WI 07/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9M2R7
Wrong patient Wrong patient
Due to patient misidentification, was administered a Menveo that was intended for another patient. D... Due to patient misidentification, was administered a Menveo that was intended for another patient. Dr immediately explained the error, discussed possible side effects and adverse reactions. Patient was understanding and stated no further concerns. More
2849471 10 M TN 07/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3CA30C1
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Vaccine given at wrong interval. Needed 6 months between doses 2-3. TDAP was given 4 months early. ... Vaccine given at wrong interval. Needed 6 months between doses 2-3. TDAP was given 4 months early. No adverse reaction noted, just early interval. More
2849472 80 F FL 07/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 52BDB7K40M
Inappropriate schedule of product administration Inappropriate schedule of product administration
PATIENT RECEIVED TWO BOOSTRIX SHOTS 5 MONTHS APART PATIENT RECEIVED TWO BOOSTRIX SHOTS 5 MONTHS APART
2849473 4 F 07/11/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
Patient given unnecessary additional Hep A dose. Patient given unnecessary additional Hep A dose.
2849474 12 M MI 07/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
PATIENT WAS GIVEN KINRIX AND DIDN'T HAVE A ADVERSE REACTION PATIENT WAS GIVEN KINRIX AND DIDN'T HAVE A ADVERSE REACTION
2849475 66 M MA 07/11/2025 UNK
 UNKNOWN MANUFACTURER
Neurological symptom Neurological symptom
neurological symptoms neurological symptoms
2849476 1.25 F CO 07/11/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Vaccine was given to 15 month old instead of Hep A as a mistake. Vaccine was given to 15 month old instead of Hep A as a mistake.
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