๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2855932 21 F OR 08/28/2025 COVID19
COVID19
HPV9
HPV9
TTOX
TTOX
MODERNA
MODERNA
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER






Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Ras... Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash; Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash; Fatigue, Headache, Hypertension, Mast cell activation syndrome, Photophobia; Rash More
She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic; high blood pressure; sensitiv... She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic; high blood pressure; sensitivity to light; headaches; fatigue; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) in a 21-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for HPV vaccine and Tetanus vaccine toxoid (Tetanus vaccine) for an unknown indication. The patient's past medical history included Raynaud's disease (Two different times, once in middle school and once in high school, the patient was diagnosed with Raynaud's Disease. Fingers were painful, difficulty opening bottles. Some days were better than others, but no comparison to how she was prior to receiving the three shots). On 13-May-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form, dose of HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) (unknown route) 1 dosage form and dose of Tetanus vaccine toxoid (Tetanus vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic) (seriousness criterion medically significant), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes). At the time of the report, MAST CELL ACTIVATION SYNDROME (She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic), HYPERTENSION (high blood pressure), PHOTOPHOBIA (sensitivity to light), HEADACHE (headaches), FATIGUE (fatigue) and RASH (rashes) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient did not have any known allergies. The patient had adverse effect impacts for more than a year due to taking Gardasil 9. She received the Gardasil 9 vaccine, a Moderna vaccine shot and a Tetanus shot. Ever since receiving the shots, she had been a shell of herself. The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. She had been to numerous doctors at the clinic while in college. The patient wanted to know if it was safe to administer the Gardasil 9 along with the Covid and Tetanus shots, and asked about how to know for sure that which vaccine was causing the issues. She was trying to find out which vaccine had caused the issues. Patient had undergone bloodwork, ziopatch test for heart monitoring and Gold Standard Potts Diagnosis tests and results were not reported. Treatment medication was not reported.; Reporter's Comments: Co-suspect products HPV vaccine VLP rL1 9v, Tetanus vaccine and past medical history of Raynaud's disease are confounders for the events. The benefit -risk relationship of product is not affected by this report. More
2855933 69 F 08/28/2025 COVID19
MODERNA
3031894
Arthralgia, COVID-19, Triple negative breast cancer Arthralgia, COVID-19, Triple negative breast cancer
she also got COVID around 6 months after her breast cancer surgery; after each COVID vaccine her shi... she also got COVID around 6 months after her breast cancer surgery; after each COVID vaccine her shins and joints ache for 8-10 hours; fast growing triple negative breast cancer (40%); This spontaneous case was reported by a consumer and describes the occurrence of TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3031894 and 204H23-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Jul-2024, received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. In July 2024, the patient experienced TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (she also got COVID around 6 months after her breast cancer surgery) (seriousness criterion medically significant) and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, TRIPLE NEGATIVE BREAST CANCER (fast growing triple negative breast cancer (40%)) and COVID-19 (she also got COVID around 6 months after her breast cancer surgery) outcome was unknown and ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. The patient was diagnosed with fast growing triple negative breast cancer (40%) in Jul-2024. It took one year and a half to become large enough to find and they found it early. They started chemo two weeks after they found it. She reported that triple negative was the deadliest form of breast cancer, so her team jumped on it and did a really good job. Over the past year she had been done with 2 rounds of chemotherapy and a full round of radiation and reported that she did not have an immune system. She was told by her cancer specialist to hurry, and she got a COVID shot for her immune system. She also got COVID around 6 months after her breast cancer surgery. Her breast cancer surgery was in Jul-2024. She reported that she was sick, but Moderna saved her life. If she hadn't had that vaccine, even if she would have Pfizer, the percentage was much lower. She blamed Moderna for saving her life. She reported that that after each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. She was 3 months out of radiation and did not have her first check-up. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-788868, MOD-2025-788869 (Patient Link).; Reporter's Comments: Concurrent medical condition Lupus syndrome is a confounder for arthralgia event. Due to lack of biological plausibility, the causality of the event Triple negative breast cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2855934 84 F OH 08/28/2025 COVID19
MODERNA

Fatigue, SARS-CoV-2 test Fatigue, SARS-CoV-2 test
extra tired now; This spontaneous case was reported by a consumer and describes the occurrence of FA... extra tired now; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extra tired now) in an 84-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) on 04-Feb-2021, Moderna covid-19 vaccine (Dose 2) on 04-Mar-2021, Moderna covid-19 vaccine (Dose 3) on 29-Oct-2021, Spikevax (Dose 4) on 03-May-2022 and Spikevax XBB.1.5 (Dose 5) on 13-Oct-2023. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine, Spikevax and Spikevax XBB.1.5. Family history included Heart disease, unspecified (Patient had a hereditary condition which both parents also had, and they both required aortic valve replacements). Concurrent medical conditions included Cancer and Heart disease, unspecified (had hereditary condition). On 17-Sep-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extra tired now). At the time of the report, FATIGUE (extra tired now) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medications were reported. The patient was tested positive for Covid prior to receiving any Covid vaccine and no hospitalization was required. She was a cancer patient and was very active. She had received all Moderna Covid-19 vaccines/boosters with no problems and stated that, she had been very happy with Moderna. However, she would require a TAVAR aortic valve replacement scheduled for 16-Sep-2025. She had been requiring surgery for the last year. She was currently on bed rest in preparation for surgery and stated that, she was just extra tired now. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2855935 M 08/28/2025 COVID19
MODERNA

Blood immunoglobulin E, Burning sensation, Histamine level, Pruritus Blood immunoglobulin E, Burning sensation, Histamine level, Pruritus
developed severe itching; developed burning sensations on my forearms; This spontaneous case was rep... developed severe itching; developed burning sensations on my forearms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-May-2021, the patient experienced PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms). At the time of the report, PRURITUS (developed severe itching) and BURNING SENSATION (developed burning sensations on my forearms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin E: elevated. On an unknown date, Histamine level: elevated. Concomitant medication was not reported. It was reported that patient had concern about a health issue which he experienced following his COVID-19 vaccination. Despite seeing numerous healthcare professionals, the cause of these symptoms was unclear. The symptoms had been persistent, and he had undergone various tests, which had revealed elevated IgE and histamine levels. However, a definitive diagnosis or cause had not been identified. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2855936 F SC 08/28/2025 COVID19
PFIZER\BIONTECH

COVID-19, Drug ineffective COVID-19, Drug ineffective
really hurting too. There's this like stabbing in my throat feeling and I've had it before... really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 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), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated, "(inaudible) really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before. I've gotten the booster every year." Later while searching for the patients account she added, "I have my Pfizer booster every year I wasn't due for it yet, I had it in at the end of Sep of last year (2024) so obviously (inaudible)." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2855937 84 M CO 08/28/2025 COVID19
PFIZER\BIONTECH

COVID-19, Drug ineffective COVID-19, Drug ineffective
came down with the COVID/still picked up this variant; came down with the COVID/still picked up this... came down with the COVID/still picked up this variant; came down with the COVID/still picked up this variant; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:. An 84-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "came down with the COVID/still picked up this variant". Clinical course: During an inbound call for financial assistance, the patient, (name withheld), stated, "I wish I had applied for my Part D at the start, but I'm 84, I'm not sure I can get it." When (name withheld) was asked if he had any further questions, an unknown person, who joined the call, stated, "I have a question. When I came down, I came down with the COVID first, and (name withheld) came down a day later. But I applied and I got-I got the pills for free, especially when you're sick and your brain doesn't work right anymore." After explaining the differences between the different programs offered, (name withheld) stated, "I think that-that you've helped us as much as you can, and it looks like we have to go through the government first and then go from there. But by that time, hopefully I will be over COVID." After explaining to (name withheld) that he is not eligible for the program initially, (name withheld) asked, "So, I do, or I don't?" The unknown person then answered, "You don't, but you're retired, so I don't know what they're going by because you just retired this year." Later in the call, the unknown person stated, "It's bad enough having COVID without being penalized, you know. And I must tell you that we have always kept our Pfizer vaccines up. We had our last one in Jun, but we still picked up this variant, whatever it is, and, anyway, they've always-the vaccines have always been very successful. My mother's 99, and she was living with us until a few months ago, so we were careful, but she's not with us now." At the end of the call, the unknown person stated, "Okay, I'm going to give this information to a neighbor since we have COVID and we're quarantined. So a neighbor be able to pick this up for us, I guess." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2855938 08/28/2025 MENB
PFIZER\WYETH

Malaise Malaise
feeling sick after the first dose; This is a spontaneous report received from a Pharmacist from medi... feeling sick after the first dose; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), in Mar2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2024, outcome "unknown", described as "feeling sick after the first dose". Additional information: The pharmacist reported that I have a patient that requires the Trumenba two dose series. Patient initially received first dose March of 2024 but reported feeling sick after the first dose so did not follow-up for 2nd dose 6 months later. Patient is now interested in completing the series. Does the patient need to restart the series or can they just receive one more dose?. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received. More
2855939 08/28/2025 PNC20
PFIZER\WYETH

Drug ineffective, Pneumonia Drug ineffective, Pneumonia
has been continuing to get pneumonia; has been continuing to get pneumonia; This is a spontaneous re... has been continuing to get pneumonia; has been continuing to get pneumonia; This is a spontaneous report received from a Pharmacist from medical information team. 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "has been continuing to get pneumonia". Clinical course: Reporter like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. He also would like to know what is the level of efficacy of Prevnar 20 in preventing recurrent pneumonia (ex: he has a patient that had pneumonia, received Prevnar 20, and has been continuing to get pneumonia). Provider was asking if we had any information on the following questions: what is the rate of incidence of illness in the 9 serotypes found in PCV21 and not found in Prevnar 20. Wants to know that rate of incidence of illness in the serotypes found in Prevnar 20 vs. serotypes in PCV 21. 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.; Sender's Comments: The efficacy of a product varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product pneumococcal 20-val conj vac to the reported event 'has been continuing to get pneumonia' cannot be ruled out. More
2855940 F 08/28/2025 COVID19
PFIZER\BIONTECH

Cerebrovascular accident Cerebrovascular accident
stroke; This is a spontaneous report received from a Consumer or other non HCP. A female patient re... stroke; 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 included: "alzheimer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Premarin, reaction(s): "Stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2855941 M 08/28/2025 PNC20
PFIZER\WYETH

Pain in extremity Pain in extremity
pain in arm after vaccination; This is a spontaneous report received from a Consumer or other non HC... pain in arm after vaccination; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A male patient 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm after vaccination". It was unknown if therapeutic measures were taken as a result of pain in extremity. Additional information: Patient reported pain in arm after vaccination. It was unknown if the patient received any other vaccines on the same date as the suspected vaccine. It was unknown if the patient received any other vaccines within 4 weeks prior to the suspected vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. 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
2855942 F 08/28/2025 COVID19
PFIZER\BIONTECH

Drug ineffective, Suspected COVID-19 Drug ineffective, Suspected COVID-19
there is a chance that I could have had covid, I had a kind of fluish period of time; there is a cha... there is a chance that I could have had covid, I had a kind of fluish period of time; there is a chance that I could have had covid, I had a kind of fluish period of time; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "there is a chance that I could have had covid, I had a kind of fluish period of time". Clinical course: per caller she was thinking that she need another booster, and that they could give her a titer blood test to see if she still had immunity against a covid virus. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2855943 M NY 08/28/2025 COVID19
PFIZER\BIONTECH

Metastasis Metastasis
metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales ... metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales representative. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metastatic Prostate Cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; manufacturer unknown), for Covid-19 immunisation. The following information was reported: METASTASIS (life threatening, medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "metastasis of prostate cancer.". Therapeutic measures were taken as a result of metastasis. Clinical course: Dr. reported about a month after he received his 3rd Pfizer Covid vaccine, he had metastasis of prostate cancer. Dr. considered the event resulted in life threatening illness (immediate risk of death from the event). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event metastasis and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2855944 F 08/28/2025 COVID19
PFIZER\BIONTECH

Chills Chills
had some chills and other side effects; This is a spontaneous report received from a Consumer or oth... had some chills and other side effects; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult 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: CHILLS (non-serious), outcome "unknown", described as "had some chills and other side effects". Additional information: Patient heard yesterday on social media information from an anti-vaccine cardiologist (couldn't remember his name) that all covid vaccine were being cancelled and taken off the market. Patient was very upset, frustrated by this administration making decisions that effect millions of people. You don't announce things by social media. Patient was so angry that these people who have no medical or science background are making these decision. Patient had mostly the Moderna vaccine and had headaches, chills and felt kinda crummy but it was nothing comparted to if got covid. Patient got her first Pfizer covid vaccine in July and had some chills and other side effects. She did not want toprovide any more information as she did not want to give any information that anyone could use against the vaccine. Patient was very grateful for the vaccines and has never gotten covid and Patient would be traumatized if the vaccines were taken away. Patient had fewer side effects than she did with the Moderna vaccine. Patient did not want to speak with safety or give her name or age just that she is an adult (> 18 years) female. More
2855945 CO 08/28/2025 COVID19
PFIZER\BIONTECH

COVID-19, Drug ineffective COVID-19, Drug ineffective
I came down with the COVID; I came down with the COVID; This is a spontaneous report and received fr... I came down with the COVID; I came down with the COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I came down with the COVID". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2855946 CT 08/28/2025 DTAPIPVHIB
SANOFI PASTEUR
UK232AB
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More
inappropriate use due to patient not receiving a full dose with no reported adverse event; Initial i... inappropriate use due to patient not receiving a full dose with no reported adverse event; Initial information received on 22-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who did not receive full dose 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 did not receive a full dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK232AB, expiry date 31-Aug-2026, strength not reported) via unknown route in unknown administration site for Immunisation, with no reported adverse event (incorrect dose administered) (latency same day). Reportedly, nurse stated that they had patient that was administered with Pentacel but the patient moved and was not able to get the full dose. Nurse was not sure of if the patient was able to get at least half the dose but the needle punctured the patient's skin. 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
2855947 20 F CO 08/28/2025 MENB
MENB
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
47KS7
47KS7
Injected limb mobility decreased, Injection site pain, Injection site reaction, ... Injected limb mobility decreased, Injection site pain, Injection site reaction, Myalgia, Pain; Pyrexia, Rash, Rash papular More
Fever x 1 day within 24 hours of administration. Fine papular rash of face and chest x 2 days after ... Fever x 1 day within 24 hours of administration. Fine papular rash of face and chest x 2 days after vaccine. Left upper arm pain and limited ROM of shoulder x 1 week after vaccine administration. Seen in office on 8/19 for this concern. Patient concerned for possible bursitis. Limited ROM secondary to pain (limited lateral extension of left arm past 90 degrees, limited internal and external rotation due to pain. No swelling or redness on exam. Pain to palpation of deltoid. Treated with NSAIDs and prednisone taper 20mg BID x 5 days and 20mg daily x 5 days. Pain resolved within 48 hours of treatment. No ongoing concerns. More
2855948 2 F NC 08/28/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
hep A
Unevaluable event Unevaluable event
My supervisor spoke with Communical disease nurse about what steps to take, spoke with mother of ch... My supervisor spoke with Communical disease nurse about what steps to take, spoke with mother of child and she was fine with the event that took place. More
2855950 31 M NC 08/28/2025 COVID19
COVID19
MODERNA
MODERNA
045AZ1A
0Z6BZ1A
Arthralgia, Blood test normal, Rheumatoid factor negative; Arthralgia, Blood tes... Arthralgia, Blood test normal, Rheumatoid factor negative; Arthralgia, Blood test normal, Rheumatoid factor negative More
Joint pain in hands that never fully went away. Within 1-2 weeks of the vaccine my hands suddenly fe... Joint pain in hands that never fully went away. Within 1-2 weeks of the vaccine my hands suddenly felt like I was 80 years old, it gradually got better but it never went away. The same thing happened after boosters. It's been 4 1/2 years and hands still hurt. More
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2855951 5 M MD 08/28/2025 MMRV
MERCK & CO. INC.
Y018154
Extra dose administered Extra dose administered
Member received a third dose of MMR. Reported to doctor of the day. No further treatment or actions ... Member received a third dose of MMR. Reported to doctor of the day. No further treatment or actions required other than to notify member's parent of extra dose given. Member's mother given information and verbalized understanding of event. More
2855952 14 M SD 08/28/2025 IPV
MMR
MNQ
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
w1b511,
x026404
u8574aa
Disorientation, Immediate post-injection reaction, Loss of consciousness; Disori... Disorientation, Immediate post-injection reaction, Loss of consciousness; Disorientation, Immediate post-injection reaction, Loss of consciousness; Disorientation, Immediate post-injection reaction, Loss of consciousness More
child passed out immediately after injection of 3rd vaccine. noted that child looked at vaccine whil... child passed out immediately after injection of 3rd vaccine. noted that child looked at vaccine while being given, even after being told multiple times to look the other way, immediately after he slumped forward in chair and was noted to have fainted. was lowered to the ground by nurse and his lower legs were placed on nearby chair. within 1 minute he was conscious again, though disorientated. nurse and patients mother provided comfort and reminded him where he was and what happened. after approximately 5 minutes he was assisted to a sitting position on the floor and "scooted" over to a nearby desk that he could lean on while sitting, where he remained for the rest of the family's appointment (approximately 40 minutes). after that time he was assisted to stand, he denies dizziness, nausea, weakness or any other symptoms at that time and left the office with his family with no help. nurse checked back with mom later that day, approximately 5 hours after incident and she reported Jayden was feeling well and had no other symptoms at that time. More
2855953 51 F NC 08/28/2025 PNC20
PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
LN4930
LN4930
LN4930
Headache, Hypertension, Influenza virus test negative, Injection site cellulitis... Headache, Hypertension, Influenza virus test negative, Injection site cellulitis, Injection site erythema; Injection site pain, Injection site swelling, Pain in extremity, Pruritus, Pyrexia; SARS-CoV-2 test negative, Streptococcus test negative, Viral infection More
Patient received a Prevnar 20 vaccine on 8/19/25 from Pharmacy. She stated that throughout the day ... Patient received a Prevnar 20 vaccine on 8/19/25 from Pharmacy. She stated that throughout the day and the next day she started to developed a fever, headaches, high blood pressure and pain in her arm. She was rushed to Hospital via EMS on 8/20/25 and was discharged the same day. While at the ED a flu, strep and covid testing was completed and they all resulted negative. She was discharged with a diagnosis of Viral Syndrome. Patient then contacted our facility on 8/25/25 stating that she is still having a lot of pain in her arm where the vaccine was administered and that its red and swollen and painful to the touch in addition to itching to her chest and left leg. Patient was treated at urgent care for cellulitis of the left upper arm with a Kenalog and ketorolac injection, a 10 day course of Amoxicillin, Ibuprofen for pain and a LUE US was ordered to rule out Thrombophlebitis and DVT. A follow-up call was conducted by this writer and patient reports feeling a lot better, the pain has decreased and the redness is slowly going away. More
2855954 58 M GA 08/28/2025 PNC21
MERCK & CO. INC.
Z006076
Computerised tomogram, Malaise, Pain in extremity, Peripheral swelling, X-ray li... Computerised tomogram, Malaise, Pain in extremity, Peripheral swelling, X-ray limb More
pain in arm with swelling and malaise for 1 month pain in arm with swelling and malaise for 1 month
2855955 85 F OH 08/28/2025 FLU3
PNC20
SANOFI PASTEUR
PFIZER\WYETH
U8764BB
LN4932
Swelling face; Swelling face Swelling face; Swelling face
Patient reported being given Prevnar 20 Syringe and Fluzone HD Trivalent 2025-26 PFS around 3:30 pm ... Patient reported being given Prevnar 20 Syringe and Fluzone HD Trivalent 2025-26 PFS around 3:30 pm on 8/27/25. Around 4:30 pm on 8/27/25, patient noticed left side of face swollen. Her friend noticed this as well and commented about the facial swelling to the patient. Patient reported taking Lisinopril 20mg in the evening after the facial swelling had already started. Patient stated she went straight to bed after taking Lisinopril 20mg so she is uncertain if that medication affected any of the swelling. Patient did not take anything for the facial swelling. The patient did not call her doctor to report the facial swelling. Patient reports today on 8/28/25 that the swelling is gone. I notified her physician and the store pharmacist on 8/28/25. More
2855956 1 M NC 08/28/2025 HEPA
HIBV
MMRV
PNC20
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
L4EA4
Y020467
Y016874
LK6653
Z005456
Extra dose administered, Rash; Extra dose administered, Rash; Extra dose adminis... Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash; Extra dose administered, Rash More
Whole body rash started a few days after vaccination where patient received double dose of varicella... Whole body rash started a few days after vaccination where patient received double dose of varicella. More
2855957 0.17 M MO 08/28/2025 UNK
UNKNOWN MANUFACTURER
U8383AB
Extra dose administered, No adverse event, Wrong product administered Extra dose administered, No adverse event, Wrong product administered
Patient received Pentacel and Rotavirus that day. Patient received Quadracel that day as well inste... Patient received Pentacel and Rotavirus that day. Patient received Quadracel that day as well instead of receiving Vaxneuvance (PCV 15) that day. So pt was double dosed with Dtap & IPV essentially. No side effects reported to the office. Parents did return with patient on 8/20 to receive PCV15 and did not report any adverse reactions. We did want to report the error More
2855958 67 F 08/28/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
7523j
Arthralgia, Neck pain, Pain in jaw Arthralgia, Neck pain, Pain in jaw
patient felt pain up her shoulder, neck and jaw patient felt pain up her shoulder, neck and jaw
2855959 12 F MI 08/28/2025 MENB
NOVARTIS VACCINES AND DIAGNOSTICS
K7JY3
No adverse event, Wrong product administered No adverse event, Wrong product administered
Given Bexsero when should have been given Menveo, no side effects Given Bexsero when should have been given Menveo, no side effects
2855960 5 M TX 08/28/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS

Injection site erythema, Injection site pain, Injection site pruritus Injection site erythema, Injection site pain, Injection site pruritus
Redness, itching, soreness around injection site, started two days after administration per parent. Redness, itching, soreness around injection site, started two days after administration per parent.
2855961 4 M CA 08/28/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
4L454
Crying, Injection site erythema, Injection site swelling, Injection site vesicle... Crying, Injection site erythema, Injection site swelling, Injection site vesicles, Pain More
Patient received Kinrix for his 5th Dtap and 4th IPV. His mother took him to the ER on 08/23/2025 du... Patient received Kinrix for his 5th Dtap and 4th IPV. His mother took him to the ER on 08/23/2025 due to his right thigh being red, swollen and having a small area that was blistered with complaints of pain and crying. ER doctor gave 25mg Benadryl and 365.5mg ibuprofen and prescribed Benadryl 25mg PO BID PRN at discharge. ER doctor stated there were no signs of cellulitis or infection and to follow up with PCP. Patient presented to clinic with mother on 08/27/2025 for follow up as directed. No swelling, redness or blistering at visit. Patient per provider was back to baseline. More
2855962 11 F MI 08/28/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
JF7DM
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none none
2855963 48 F NC 08/28/2025 FLU3
SANOFI PASTEUR
u8790aa
Dyspnoea, Palpitations, Paraesthesia, Paraesthesia oral Dyspnoea, Palpitations, Paraesthesia, Paraesthesia oral
Heart racing, difficulty breathing, tingling in lips and limbs - pt took benadryl and went to ER; st... Heart racing, difficulty breathing, tingling in lips and limbs - pt took benadryl and went to ER; still experiencing some tingling today 8/28/25 More
2855964 3 M WA 08/28/2025 TDAP
SANOFI PASTEUR
U8274AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient does not meet minimum age requirement for vaccine. Patient does not meet minimum age requirement for vaccine.
2855965 77 F SC 08/28/2025 PNC21
PNC21
MERCK & CO. INC.
MERCK & CO. INC.
Y011819
Y011819
Bone pain, Injection site erythema, Injection site induration, Injection site in... Bone pain, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain; Injection site warmth More
Patient noted that vaccine was painful at the time of administration. Shortly after administration, ... Patient noted that vaccine was painful at the time of administration. Shortly after administration, the injection site was red and hard to the touch. It got worse overnight and she developed a hard, red, inflamed area about 4 inches long underneath her deltoid to just above her elbow that wrapped the entire circumference of her arm. She reported that it was hot, red and hard to the touch. She also noted "bone pain" that extended from the top of her arm, into her elbow and down to her fingertips. The injection site pain dissipated, but the pain underneath her deltoid and in her bones worsened. She has full range of motion in her shoulder muscle, but has aching internally in her arm More
2855966 6 M OH 08/28/2025 DTAPIPV
HEP
HEPA
MMRV
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
42Y93
4D333
DN273
Y014306
Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperacti... Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder; Abnormal behaviour, Adjustment disorder, Aggression, Attention deficit hyperactivity disorder More
Since the shots he started acting out, yelling kicking, throwing things, threatening people, hitting... Since the shots he started acting out, yelling kicking, throwing things, threatening people, hitting people. He did not act like this before the shots. Since then the diaognosed him with ADHD and adjustment disorder but I dont believe them. I believe my son has been injured by this round of shots. More
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2855967 12 M WA 08/28/2025 HEPA
HPV9
MNQ
TDAP
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
42DM9
Y012864
U8508AA
U8252AA
Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive... Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli; Blood pressure orthostatic increased, Posture abnormal, Presyncope, Unresponsive to stimuli More
After receiving the fourth vaccine (meningococcal) patient appeared to have a vasovagal response (he... After receiving the fourth vaccine (meningococcal) patient appeared to have a vasovagal response (head nodding, unresponsive) for 5-10 seconds. More
2855968 0.5 M OH 08/28/2025 DTPPVHBHPB
PNC20
RV1
MSP VACCINE COMPANY
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
U7969AA
LX2498

Injection site reaction, Rash macular; Injection site reaction, Rash macular; In... Injection site reaction, Rash macular; Injection site reaction, Rash macular; Injection site reaction, Rash macular More
MSP Vaccine Company Vaxelis in left thigh, Prevnar 20 in right thigh and rotavirus (Rotatix) oral.Ab... MSP Vaccine Company Vaxelis in left thigh, Prevnar 20 in right thigh and rotavirus (Rotatix) oral.About one hour later, developed a lacey and blotchy bilateral lower leg rash. No urticaria, respiratory or GI symptoms. Has remained stable, happy and began to fade by the time seen virtually 5 hours later. More
2855969 57 F TN 08/28/2025 COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
EN5318
EN5318
EN5318
Arthralgia, Asthenia, Dysstasia, Fatigue, Hypoaesthesia; Laboratory test, Magnet... Arthralgia, Asthenia, Dysstasia, Fatigue, Hypoaesthesia; Laboratory test, Magnetic resonance imaging, Muscular weakness, Myelitis transverse, Pain in extremity; Plasmapheresis, Wheelchair user More
pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She w... pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She was very weak. At work she had a sharp pain that went from her hip and went down her right leg. She immediately sat down. She had to called the ambulance because she couldn't stand up. She was taken to Hospital ER. She couldn't feel it when they lifted her right leg. She was admitted and was there for over 2 weeks. She was diagnosed with Transverse myelitis that affected both legs and lower part of her body. She is currently wheelchair bound and disabled. Had to go to (withheld name) rehab after being discharged. She is currently being treated by a neurologist Dr. at the MS clinic. More
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2855970 66 F FL 08/28/2025 FLU3
FLU3
SANOFI PASTEUR
SANOFI PASTEUR
UT8794BA
UT8794BA
Dizziness, Fatigue, Feeling cold, Muscular weakness, Pyrexia; Vomiting Dizziness, Fatigue, Feeling cold, Muscular weakness, Pyrexia; Vomiting
I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and ... I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and then all of the sudden i was freezing and i couldn't get warm. Then i got tired, fever, throwing up, dizzy. My legs are very weak. More
2855971 50 F AZ 08/28/2025 FLU3
HEP
PNC21
VARZOS
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
U8790AA
945664
Z003579
945664
Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site... Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia; Dizziness, Injection site erythema, Pruritus, Pyrexia More
Patient came back 2 days later after 4 vaccines. Right arm had redness from muscle area down arm to... Patient came back 2 days later after 4 vaccines. Right arm had redness from muscle area down arm to just above elbow, had itching around arm and chest. Said they had fever, light headedness. Pt wanted to make sure they could take something will take Tylenol or ibuprofen, antihistamine for the itching, ice the area and follow up with PCP if needed More
2855972 18 M UT 08/28/2025 RAB
NOVARTIS VACCINES AND DIAGNOSTICS
FDP00720
Bell's palsy, Facial paralysis Bell's palsy, Facial paralysis
Pt woke up day after vaccination with left sided facial paralysis. No other neurologic symptoms. H... Pt woke up day after vaccination with left sided facial paralysis. No other neurologic symptoms. He was treated for Bell's Palsy with prednisone and Valacyclovir by another health professional More
2855973 76 M OH 08/28/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
AE435
Injection site pain, Limb discomfort Injection site pain, Limb discomfort
patient notified pharmacy on 8/28/25 that he has had soreness and pain he described as "a needl... patient notified pharmacy on 8/28/25 that he has had soreness and pain he described as "a needle stuck in my arm" ever since receiving the vaccine on 8/21/25 - he stated he has full range of motion and no redness, bruising, or feeling of warmth at the injection site. More
2855974 9 M PA 08/28/2025 TDAP
SANOFI PASTEUR

Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt was given Adacel at the of 9. Per Provider who saw him 8/2025, When reviewing his vaccinations, I... Pt was given Adacel at the of 9. Per Provider who saw him 8/2025, When reviewing his vaccinations, I found he was incorrectly given Tdap at age 9 in 2023. Per package insert, Adacel is not indicated until age 10. I did order another Tdap at time of physical as it is recommended to have Tdap at proper age. More
2855975 4 M MI 08/28/2025 DTAPIPV
MMR
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
42y93
y011484
y011018
Injection site reaction; Injection site reaction; Injection site reaction Injection site reaction; Injection site reaction; Injection site reaction
possible site reaction, possible site reaction,
2855976 4 M GA 08/28/2025 HPV9
MERCK & CO. INC.
Z004534
Wrong product administered Wrong product administered
Administration Error-Incorrect vaccine given, HPV administered instead of HepA Administration Error-Incorrect vaccine given, HPV administered instead of HepA
2855977 76 F OK 08/28/2025 PNC21
PNC21
MERCK & CO. INC.
MERCK & CO. INC.
z003579
z003579
Diarrhoea, Erythema, Headache, Injection site pain, Injection site swelling; Pai... Diarrhoea, Erythema, Headache, Injection site pain, Injection site swelling; Pain in extremity, Skin warm, Somnolence More
Patient had a really sore arm following the vaccination, swelling and pain at the injection site tha... Patient had a really sore arm following the vaccination, swelling and pain at the injection site that traveled from her shoulder down to her elbow. She also experienced drowsiness, headache, diarrhea, and red skin. The arm was red and hot to the touch for 3 days. Her doctor recommended she try benadryl and she also applied ice to the swelling. patient is feeling better after the 3 days following vaccination. More
2855978 61 M TX 08/28/2025 PNC21
MERCK & CO. INC.

Chills, Feeling cold, Headache, Pain in extremity, Speech disorder Chills, Feeling cold, Headache, Pain in extremity, Speech disorder
I received Capvaxive 21. I had previously received Pneumovax 23 on 06/30/2002. I received the inject... I received Capvaxive 21. I had previously received Pneumovax 23 on 06/30/2002. I received the injection at about 7:30 am and only had a sore arm for most of the day. At about 9:30 pm, I started feeling a dull headache, and wondered if it might be low blood sugar. I drank about two mouthfuls of cold chocolate milk and had a sudden, very strong wave of chills run through my entire body, and was immediately freezing, shivering, and having trouble speaking. I had to sleep under heavy covers using a heating pad that night, and was very cold every time I woke up during the night. By the next morning, the chills were gone and I was left with only a sore arm again. I've never had an adverse reaction to a vaccination before, including flu, shingles, covid, cholera, hepatitis A, hepatitis B, MMR, meningococcal, Tdap, typhoid, and yellow fever. More
2855979 11 M TX 08/28/2025 MNQ
TDAP
SANOFI PASTEUR
SANOFI PASTEUR
U8169AB
U8274AA
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Patient developed itching of right arm with swelling and redness. Patient developed itching of right arm with swelling and redness.
2855980 7 F VA 08/28/2025 PNC20
PFIZER\WYETH
LP4947
Erythema, Inflammation Erythema, Inflammation
ERYTHEMA AND INFLAMMATION ERYTHEMA AND INFLAMMATION
2855981 10 M CA 08/28/2025 COVID19
MODERNA
3046979
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the... Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the 6 months- 11 years old. Provider was notified and stated that there is no adverse reaction and that it is still FDA approved. Parent was notified and was explained that the child will be okay. More
2855982 1 F LA 08/28/2025 MMRV
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
Z009474
Z003766
Extra dose administered, Wrong product administered; Extra dose administered, Wr... Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered More
PROQUAD WAS GIVEN AT THE SAME TIME AS VARICELLA. IT WAS ONLY SUPPOSED TO BE MMR AND VARICELLA (SEPER... PROQUAD WAS GIVEN AT THE SAME TIME AS VARICELLA. IT WAS ONLY SUPPOSED TO BE MMR AND VARICELLA (SEPERATE) More