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
2829812 M NJ 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945656
Extra dose administered Extra dose administered
Two Dose Series Completed, and Received A Third Dose; 1st Dose Given in Nov-2024, 2nd Dose given in ... Two Dose Series Completed, and Received A Third Dose; 1st Dose Given in Nov-2024, 2nd Dose given in Jan-2025; Initial report received on 12-Feb-2025. A pharmacist reported that a 25-year-old male received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two months after the first and received a third dose of HEPLISAV-B. No medical history or concomitant medications were reported. On 20-Nov-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945656, expiration date 24-Jan-2027, NDC# 43528-003-01) intramuscularly in the left arm. On 23-Jan-2025, 64 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945659, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the left arm. On 11-Feb-2025, 19 days after receiving dose 2 of HEPLISAV-B, the patient received dose 3 of a hepatitis B vaccine [HEPLISAV-B (lot # 945659, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the right arm. This was the third dose of HEPLISAV-B. No adverse effects were reported to any of the 3 doses the patient received. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2829813 F OH 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Exposure during pregnancy Exposure during pregnancy
Pregnant and Received Heplisav-B; Initial report received on 12-Feb-2025. A pharmacist reported tha... Pregnant and Received Heplisav-B; Initial report received on 12-Feb-2025. A pharmacist reported that a female (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant. No medical history or concomitant medications were reported. On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route and site not available)]. The patient was pregnant. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829814 M 03/05/2025 COVID19
 UNKNOWN MANUFACTURER
Fatigue, Initial insomnia Fatigue, Initial insomnia
extreme tiredness/like he was zapped; He can never fall asleep; This is a spontaneous report receive... extreme tiredness/like he was zapped; He can never fall asleep; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), in Oct2024 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: Comirnaty (DOSE 1, SINGLE; Lot number: unknown), administration date: 2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 2, SINGLE; Lot number: unknown), administration date: 2021, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 5 (BOOSTER), SINGLE; Lot number: unknown), administration date: 2023, for Covid-19 Immunization, reaction(s): "No adverse event". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness/like he was zapped"; INITIAL INSOMNIA (non-serious), outcome "unknown", described as "He can never fall asleep". Additional information: Patient stated that when the covid broke out, they gathered everybody and said that you must get these vaccines. The first couple of years, they got two each year, and the last couple of years, he just has been getting one. He started getting extremely tired in the afternoon, he doesn't know if that was from Pfizer covid-19 vaccine, or he was getting old. He had 6 of the covid-19 vaccines. He would get up in the morning and do his normal stuff and around lunch time, it would seem like he was zapped. He can never fall asleep, but he had to lay down and rest for a while. It has been going on for couple of weeks and he doesn't know what was going on. He was going to see his heart doctor. Per patient, he got his last vaccine last fall in October. First couple of years, they got couple of them a year and then that tapered off so that would have been 4, then in 2023 and 2024 he just got one. He thinks he might have gotten 6 of them and the last one was October 2024. Later, the patient stated that the last one they gave him may have been Moderna. He did not specify the last one to the pharmacy which one he wanted but until then everything was Pfizer. He wanted to continue with Pfizer but that last one may have been different. He got that one in October and he never had any problems until a couple of weeks ago. He was querying if he did not have any problems right away, it probably does not have anything to do with the Pfizer vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2829815 F 03/05/2025 COVID19
 PFIZER\BIONTECH
Ear swelling, Hypoacusis Ear swelling, Hypoacusis
complete hell as her ears have swelled up 3 times the size; couldn't hear; This is a spontaneou... complete hell as her ears have swelled up 3 times the size; couldn't hear; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose number unknown, 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: EAR SWELLING (non-serious), outcome "unknown", described as "complete hell as her ears have swelled up 3 times the size"; HYPOACUSIS (non-serious), outcome "unknown", described as "couldn't hear". Additional Information: Caller stated that she took Comirnaty last November and had "used Moderna all of the way through, and she will ever again use a Pfizer product. She has been through complete hell as her ears have swelled up 3 times the size, she couldn't hear, and she was home alone. It was the perfect storm. This is what happenings to human beings, had she known it had a horrific rash, because that's hard to find and you can't really find out anything, it's just a little thing that says you might get hives or rash, it doesn't say how long it's going to last." Caller stated that she is on the 8th day and is asking how much longer will the rash last?. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2829816 03/05/2025 PNC20
 PFIZER\WYETH
Syringe issue Syringe issue
vials somethings cracked and broken; The initial case was missing the following minimum criteria: [s... vials somethings cracked and broken; The initial case was missing the following minimum criteria: [specify criteria adverse event. Upon receipt of follow-up information on [19Feb2025], this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "vials somethings cracked and broken". Additional information: It was stated, "I'm a Pfizer vaccine sales representative I'm calling because I have an office that received Prevanar 20 and one of the pens, vials somethings cracked and broken and I spoke with the doctor and he said all of the vaccine Is still intact inside but there's something that's cracked and he tried to explain to me and I said is it still something that you can administer and he said he would have to use another needle so I said let me get medical on because I was told by customer service that the medical department needs to make a decision on weather they can use it or not." The reporter considered "vials somethings cracked and broken" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "vials somethings cracked and broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2829817 M TN 03/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a C... tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". Clinical course: the reporter stated, the patient (her husband) tested positive for COVID, and he received the "Pfizer shot." The doctor prescribed nirmatrelvir and ritonavir (PAXLOVID)." The reporter also stated that the patient received "some cough medicine." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. More
2829818 03/05/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH



Dizziness, Frostbite, Nerve conduction studies, Pain, Pain in extremity; Pyrexia... Dizziness, Frostbite, Nerve conduction studies, Pain, Pain in extremity; Pyrexia; Dizziness, Frostbite, Nerve conduction studies, Pain, Pain in extremity; Pyrexia More
Back of hand feels like pins and needles like coming out of frostbite, when this first happened with... Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst; Painful hands; Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; Dizziness; Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-782572 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single) intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FROSTBITE (non-serious), outcome "not recovered", described as "Back of hand feels like pins and needles like coming out of frostbite, when this first happened with the very first vaccine hand felt so cold and they hurst"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Painful hands"; PAIN (non-serious), outcome "unknown", described as "Aches/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing"; DIZZINESS (non-serious), outcome "not recovered"; PYREXIA (non-serious), outcome "unknown", described as "Fever/usually have fever and aches but the fever and aches go awaybut the hand adverse event is and has been ongoing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of frostbite, pain in extremity, pain, dizziness, pyrexia. Additional Information: Concomitant medication use information was not provided by reporter. Patient had no concomitant disease or risk factor. Patient developed adverse event after the first vaccination with covid vaccines. So far patient had received 8 vaccines, most of them were Moderna but a couple were Pfizer. Patient had already consulted to doctor, and he advised to use vitamin b, but it gave no results. As per patient it was sure the events were caused by the covid vaccine. The patient was treated with Vitamin b complex (Vitamin b) at an unspecified dose and frequency. At the time of the report, the events frostbite, pain in extremity and dizziness had not resolved; pain and pyrexia outcome was unknown Batch/lot number is not provided, and it cannot be obtained. More
2829819 74 M TX 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 94SE2
Feeling abnormal, Heart rate increased Feeling abnormal, Heart rate increased
Patient states that on the same day after the shot and for at least two weeks following that he suff... Patient states that on the same day after the shot and for at least two weeks following that he suffered from a general state of feeling "bad" and that his resting heart rate was elevated above normal. He states that after about two weeks that feeling and the heart rate went back to normal. Patient doesn't wish to get the second dose of the vaccine because he is worried that the same thing will happen again More
2829820 4 F TX 03/05/2025 MMRV
 MERCK & CO. INC.
 Y012343
Injection site pruritus, Injection site urticaria Injection site pruritus, Injection site urticaria
whelp on shot area, itchy whelp on shot area, itchy
2829821 12 F OR 03/05/2025 IPV
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 Y1A201M
3CA22C1
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Dose of Tdap given 1 month too early. Misread catch-up chart in standing orders and thought she need... Dose of Tdap given 1 month too early. Misread catch-up chart in standing orders and thought she needed one more dose after this one, based on previous vaccination history. More
2829822 51 F AZ 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 BP74J
Injection site erythema Injection site erythema
Patient presented to the pharmacy in the evening on 2/24 reporting that she experienced redness belo... Patient presented to the pharmacy in the evening on 2/24 reporting that she experienced redness below the injection site the day after administration (2/19) that progressed to swelling and heat the following day (2/20). She reports these adverse effects improved through the weekend, but she developed a painful, red, itchy, swollen, warm to the touch, almost bruised area the following Monday (2/24) even farther down the arm from the injection site (a bit above the elbow). She wanted to know if what she was experiencing was typical following Shingrix administration. Pharmacy advised patient to reach out to her doctor for assessment and for advisement on second dose administration given the length of time involved in the incident and the fact that the patient's symptoms improved and then quickly worsened days later. Pharmacy advised patient that symptoms could potentially be attributed to a delayed sensitivity/mild allergic reaction to the vaccine and that if symptoms worsened (spreading rash, hives, swelling of the face, difficulty breathing, etc.) she should seek immediate medical attention. Pharmacy followed up with patient by phone on 2/26. Patient reported that she had some mild, lingering itchiness in the area, but that the rash and bruising were gone. Patient further reported that while she had contacted her doctor, they never got back to her and she sought no other medical attention for the issue. Pharmacy advised patient to still follow up with her doctor on second dose advisement. More
2829823 67 F FL 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 e3xt9
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient has not reported any side effects or issues. When running reports for last months shots, I n... Patient has not reported any side effects or issues. When running reports for last months shots, I noticed that this patient received a 3rd dose in Feb 6th of Shingrix and guidelines only recommend 2 doses More
2829824 65 F AZ 03/05/2025 PPV
PPV
PPV
PPV
PPV
PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.






Angioedema, Arthralgia, Brain fog, Burning sensation, Chest discomfort; Deafness... Angioedema, Arthralgia, Brain fog, Burning sensation, Chest discomfort; Deafness, Dizziness, Eye irritation, Eye movement disorder, Eye swelling; Facial paralysis, Flushing, Headache, Hypoacusis, Immediate post-injection reaction; Inflammation, Injected limb mobility decreased, Lymphadenopathy, Neuromyopathy, Neuropathy peripheral; Pain in extremity, Palpitations, Paraesthesia, Pharyngeal swelling, Skin burning sensation; Skin disorder, Swelling, Swelling face, Swelling of eyelid, Swollen tongue; Tinnitus, Trismus, Vision blurred More
Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye ... Immediate Reaction Post-Vaccination: The patient experienced brain flush, unilateral facial and eye burning with blurred vision (caused her to have to get a new prescription) with muscular incoordination of the eyes (8 days post vaccine) with facial drooping, R facial and eye swelling, within 10 minutes of receiving the pneumococcal vaccine. Jaw dropping started 2-3 hours after the vaccine (unable to close her mouth), the tongue was swollen, throat was swollen and all the lymph nodes in the neck were enlarged, and later the angioedema worsened to the point the eyes were swollen to halfway and the nose was swollen to shift. Was having chest pressure and palpitations, headaches by 3:40 PM and lost the hearing as well around that time. Buzzing muffled sound (like someone vacuuming behind her.) The L side of her body was also swollen and inflamed after the vaccine. With severe burning searing pain in the R arm started 8:15 PM last x 2 weeks, then waxed and waned x 2 weeks, then started being able to be use the arm in the next month. Aching pain in the B shoulders. Then B arms with neuropathy 72 hours (tip of the shoulders into the hands buzzing, burning, tingling pain) which progressed and lasted x 2 weeks. Cognition was decreased with brain fog x 2 weeks. The facial swelling went through to 20 d later Still is experiencing facial flushing. 9 days after with some possible skin reaction with back swelling to the point of shininess that lasted 4 days. More
โœ“
2829825 41 F CA 03/05/2025 HEP
HEP
MMR
MMR
TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 T5D73
T5D73
Y000225
Y000225
3RE73
3RE73
Amnesia, Depressed level of consciousness, Discomfort, Dizziness, Headache; Imme... Amnesia, Depressed level of consciousness, Discomfort, Dizziness, Headache; Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli; Amnesia, Depressed level of consciousness, Discomfort, Dizziness, Headache; Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli; Amnesia, Depressed level of consciousness, Discomfort, Dizziness, Headache; Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli More
On 03/04/2025 requested to be vaccinated for an immigration process (Hepatitis B, TDAP, MMR, Varicel... On 03/04/2025 requested to be vaccinated for an immigration process (Hepatitis B, TDAP, MMR, Varicella, Flu). Pre-screen assessment of immunization completed. Client denied any allergy or significant medical history. At 9:02am RN administered Hepatitis B dose#1 and TDAP dose #2 both to the left deltoid, MMR dose #2 Left Arm. Immediately following the MMR vaccine client complained of discomfort and light headedness. At 9:03 am client became pale and complained of dizziness. RN paused the vaccination. At 9:04am client experienced decreased consciousness and began to slide out of the chair. She was immediately assisted to semi-fowler's position in a reclining chair. RN requested additional assistance from another staff RN and PHN, who helped with client transfer and the recording of vital signs and referred to policy for syncope event. At 9:05 am blood pressure:70/40, pulse 46, SpO2 sat 99%, temperature -97.2. Client was unresponsive for about 30 seconds with opened eyes. At 9:07 am client complains of slight headache and asked what happened. Vital signs were taken as follows: 9:14am- blood pressure 78/48, pulse 49, SpO2 sat 99%, temperature 97.7. At 9:18am client stated she felt a little dizzy, blood pressure 65/39, pulse 49, SpO2 sat 99%, temperature 97.6; At 9:20am client's skin color back to normal, speech normal, blood pressure 82/48, P52, spO2 sat 99%, temperature 7.8; 9:27 blood pressure 100/67, p58, SpO2 sat 99%, client denied dizziness. Client was offered to stop vaccination and postpone till next visit, client responded that she feels much better and insist to continue vaccination. Client was offered cup of coffee with sugar per her request. Client is alert and oriented to person, place and time. At 9:36 am RN administered Flu vaccine to the right deltoid, client tolerated well; 9:38am Varicella vaccine was administered right arm by RN, client tolerated well, blood pressure 105/72, P54. At 9:41am client independently transitioned to standing position, no evidence of rebound symptoms, vital signs: blood pressure 106/73, P59, spO2 sat 99%, temperature 97.8. RN provided instruction to follow up with medical provider or seeking urgent/emergency services if symptoms return. Client confirmed and agreed. Client was strongly encouraged to call a family member for a ride, client refused to call. At 9:55 am client, denied further symptoms, was alert and oriented to person place and time and in no apparent distress and ambulated without assistance out of the clinic. The phone number of the clinic was given to the client, and she was encouraged to call back on arrival to home. At 10:25am RN received a phone call from the client that she arrived safely and denied recurrent symptoms or any distress. As a response to this event, the team will conduct a review and drill of response to syncope event in the clinic per policy. More
2829844 12 M VA 03/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 LX494
Extra dose administered, No adverse event Extra dose administered, No adverse event
TDAP was given in 06/08/2023 Patient was 11 yrs old, another dose of TDAP was given today patient is... TDAP was given in 06/08/2023 Patient was 11 yrs old, another dose of TDAP was given today patient is 13 yrs old. No adverse reactions observed, patient is stable. More
2829845 1 M TX 03/05/2025 HEPA
MMR
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 DN273
Y008290
LG5578
Y014868
No adverse event; No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event; No adverse event
Patient no have a reaction, symptom, sing. Patient no have a reaction, symptom, sing.
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2829846 30 M CA 03/05/2025 PNC20
 PFIZER\WYETH
 LK6651
Unevaluable event Unevaluable event
none none
2829847 53 F OK 03/05/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 XN575
333SK
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient was set to receive a shingles vaccine alongside her Tdap but inadvertently was administered ... Patient was set to receive a shingles vaccine alongside her Tdap but inadvertently was administered two Tdap vaccines. Patient did not report any adverse events at time of error or for 15 minutes after error. I aim to follow up with the patient and she assured me she would contact me with any adverse events. More
2829848 76 M NV 03/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4Bn95
Unevaluable event Unevaluable event
I did a clinic for this facility Country Club. Patient came in asking for RSV. I explained to him th... I did a clinic for this facility Country Club. Patient came in asking for RSV. I explained to him that this only a one dose vaccine and if he had this before. He said no, his first time. More
2829849 31 F OH 03/05/2025 COVID19
COVID19
 MODERNA
MODERNA

Altered state of consciousness, Amenorrhoea, Breast enlargement, Euphoric mood, ... Altered state of consciousness, Amenorrhoea, Breast enlargement, Euphoric mood, Fatigue; Mobility decreased, Pyrexia, Weight increased More
Within 24 hours of receiving an mRNA shot, i an altered state of consciousness for about 24 hours, f... Within 24 hours of receiving an mRNA shot, i an altered state of consciousness for about 24 hours, fever of 104, euphoria, could not get out of bed. Then I did not menstruate for 4 months and gained 40 pounds. Rapid breast growth. Physicians could not find a hormonal imbalance. Very not been able to lose weight on a GLP-1, has ongoing fatigue. More
2829850 0.33 F OH 03/05/2025 RV5
 MERCK & CO. INC.
 Y009341
Colectomy, Enema administration, Intussusception, Laparotomy Colectomy, Enema administration, Intussusception, Laparotomy
Patient had long segment ileocolonic intussusception and pneumatic reduction was unsuccessful so pat... Patient had long segment ileocolonic intussusception and pneumatic reduction was unsuccessful so patient required laparoscopy that was converted to exploratory laparotomy with R hemicolectomy More
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2829851 67 F TN 03/05/2025 PNC20
 PFIZER\WYETH
 lj5281
Fatigue Fatigue
fatigue fatigue
2829852 72 F CA 03/05/2025 RSV
 PFIZER\WYETH
 LN5491
Deep vein thrombosis, Ultrasound Doppler abnormal Deep vein thrombosis, Ultrasound Doppler abnormal
Patient diagnosed with right deep vein thrombosis on 2/20/25 Patient diagnosed with right deep vein thrombosis on 2/20/25
2829172 60 F 03/04/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Cough, Headache, Nasal congestion, Oropharyngeal pain Cough, Headache, Nasal congestion, Oropharyngeal pain
woke up with a stuffy nose; Cough; Headache; she had a sore throat; This non-serious case was report... woke up with a stuffy nose; Cough; Headache; she had a sore throat; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 60-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 24-FEB-2025, the patient received the 1st dose of Shingles vaccine (intramuscular, left arm). On 24-FEB-2025, less than a day after receiving Shingles vaccine, the patient experienced sore throat (Verbatim: she had a sore throat). On 25-FEB-2025, the patient experienced nasal stuffiness (Verbatim: woke up with a stuffy nose), cough (Verbatim: Cough) and headache (Verbatim: Headache). On 25-FEB-2025, the outcome of the sore throat was resolved. The outcome of the nasal stuffiness, cough and headache were not resolved. It was unknown if the reporter considered the sore throat, nasal stuffiness, cough and headache to be related to Shingles vaccine. It was unknown if the company considered the sore throat, nasal stuffiness, cough and headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter stated that she received Shingrix the day before reporting. She stated last night she had a sore throat but had gone away. At the time of reporting, she woke up with a stuffy nose, cough and headache that she had not recovered from yet. More
2829173 CA 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
A patient received the first Shingrix dose on 7/27/2021 and never received his second dose; This non... A patient received the first Shingrix dose on 7/27/2021 and never received his second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 27-JUL-2021). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: A patient received the first Shingrix dose on 7/27/2021 and never received his second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 22-FEB-2025 and 24-FEB-2025 A patient received the first Shingrix dose on 27-JUL-2021 and never received his second dose. If he were to get one now would he have to start the series over or would this count as his second dose. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. More
2829174 F FL 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Ankle fracture, Cardiac failure, Condition aggravated, Incomplete course of vacc... Ankle fracture, Cardiac failure, Condition aggravated, Incomplete course of vaccination, Myocardial infarction More
Heart failure; Heart attack; Broken ankle; This serious case was reported by a consumer via call cen... Heart failure; Heart attack; Broken ankle; This serious case was reported by a consumer via call center representative and described the occurrence of cardiac failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type i diabetes mellitus (Diabetes type 1 (diagnosed prior the administration of Shingrix)) and cardiac failure (Heart failures before and after the first dose of Shingrix). On 10-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac failure (Verbatim: Heart failure) (serious criteria GSK medically significant), heart attack (Verbatim: Heart attack) (serious criteria GSK medically significant) and ankle fracture (Verbatim: Broken ankle). The outcome of the cardiac failure, heart attack and ankle fracture were unknown. The reporter considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix. The company considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 24-FEB-2025 A member of the public call to asked if she could receive directly the second dose of Shingrix after she had the first one on 10th April 2024, or if she should restart the first dose to finally get that second. She mentioned to be diagnosed with diabetes type I before having the first dose, but also to have had a broken ankle, a heart attack and a heart failure were unrelated to the vaccine administration, since the first dose was given to date. Patient had heart attack, heart failure, broken ankle after Shingrix first dose.; Sender's Comments: Cardiac failure and Myocardial infarction are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
2829175 NY 03/04/2025 PNC20
 PFIZER\WYETH
 LJ5280
Device connection issue Device connection issue
the adaptor is damaged or broken when trying to administer it; the adaptor is damaged or broken when... the adaptor is damaged or broken when trying to administer it; the adaptor is damaged or broken when trying to administer it; This is a spontaneous report received from an Other HCP from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LJ5280, Expiration Date: 30Apr2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE CONNECTION ISSUE (non-serious), outcome "unknown" and all described as "the adaptor is damaged or broken when trying to administer it". The reporter considered "the adaptor is damaged or broken when trying to administer it" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "the adaptor is damaged or broken when trying to administer it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: the reporter was unable to administer PREVNAR 20 to the patient and it looked like the adaptor was damaged or broken when trying to administer it. Reporter stated that it was only one dose. NDC reported as "00052000-01". More
2829176 0.08 03/04/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Accidental use in 1mo year old patient with no reported adverse event; Initial information received ... Accidental use in 1mo year old patient with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 1 month old and unknown gender patient who received with no reported adverse event while receiving vaccine influenza USP trival A-B subvirion NO preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 26-Feb-2025, the patient received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection lot number not reported via intramuscular route in unknown administration site for Influenza vaccination (Influenza immunisation) (product administered to patient of inappropriate age) (Latency same day) Information on the batch number could not be requested corresponding to the one at time of event occurrence. 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
2829177 60 OH 03/04/2025 IPV
 SANOFI PASTEUR
No adverse event, Off label use No adverse event, Off label use
intentional off label prescription by hcp: imovax prescribed with off label diagnosis other specifie... intentional off label prescription by hcp: imovax prescribed with off label diagnosis other specified personal risk factors, not elsewhere classified with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 60-year-old and unknown gender patient and had intentional off label prescription by hcp (healthcare professional): IPV (VERO) [Imovax] prescribed with off label diagnosis other specified personal risk factors, not elsewhere classified 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, intentional off label prescription by HCP: suspect IPV (VERO) Suspension for injection 1 ml twice (expiry date, lot number not reported) via intramuscular route in unknown administration site prescribed with off label diagnosis Other specified personal risk factors, not elsewhere classified (Disease risk factor) with no reported adverse event (off label use) (latency: on same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Action taken was not applicable. More
2829178 0.5 M NH 03/04/2025 HIBV
 SANOFI PASTEUR
 UK169AC
No adverse event, Product preparation issue No adverse event, Product preparation issue
a six month-old boy received the diluent only, instead of the intended ACT- HIB vaccine and not the ... a six month-old boy received the diluent only, instead of the intended ACT- HIB vaccine and not the powder portion of the vaccine with no reported adverse event; Initial information received on regarding an unsolicited valid non-serious case received from a other health professional along with live follow up both are processed together on 25-Feb-2025. This case involves a 6 months old male patient to whom had received the diluent only, instead of the intended HIB (PRP/T) Vaccine [ACT-HIB] and not the powder portion of the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 20-Feb-2025, the patient received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, lot UK169AC and expiry date: 28-Feb-2026) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) and received the diluent only, instead of the intended act-hib vaccine and not the powder portion of the vaccine with no reported adverse event (product preparation error) (latency: same day). Reportedly: "She states that they are in the practice of removing the little tiny square label which used to have both the lot number and expiration date printed on it, and putting it on a piece of paper for documentation/ record keeping. But now the vaccine label has a tiny piece of paper which doesn't include the expiration date, so they have to take the whole label off and when that is done, the two vials for the vaccine look basically the same, aside from some red writing. So the new labels do not work with their tracking protocol. She feels that there should be some better safeguards. She states that ACT-HIB is the only vaccine that they still use that utilizes this kind of system for 2-component vaccines. She mentions one manufacturer that uses an elastic-tab that keeps the two components hooked together, which she states is a really great feature. She reports that Merck now puts their diluent in a pre-filled syringe, packaged with the vaccine needing reconstitution." Action taken; 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
2829179 1 M CO 03/04/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
They gave it to the child 1 week early with no reported adverse event; Initial information received ... They gave it to the child 1 week early with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] 1 week early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN, hepatitis A vaccine (hepatitis A) for Immunisation and HIB vaccine (HIB vaccine), all for Immunisation. On 25-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection once with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the right thigh for Immunization 1 week early with no reported adverse event (inappropriate schedule of product administration) (Latency same day). Action taken was not applicable. Reportedly, they gave it to the child 1 week early and she seeking for recommendations and what adverse reaction to watch for. 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
2829180 0.67 F MN 03/04/2025 FLU3
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
administered a booster dose of fluzone np to a 9-month-old earlier than scheduled with no reported a... administered a booster dose of fluzone np to a 9-month-old earlier than scheduled with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old female patient who was administered a booster dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] earlier than scheduled with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. . On 29-Jan-2025 patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date and lot not reported) via unknown route in unknown administration site for Influenza. On 11-Feb-2025, the patient received an unknown booster dose 2 of influenza USP TRIVAL A-B subvirion no preservative vaccine (expiry date- 30-JUN-2025 and lot U8465BA) via unknown route in unknown administration sit for Influenza earlier than scheduled with no reported adverse event (inappropriate schedule of product administration) (latency- same day). Information on the batch number for dose 1 was requested corresponding to the one at time of event occurrence. 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
2829181 31 M CO 03/04/2025 YF
 SANOFI PASTEUR
 UK134AA
No adverse event, Product preparation error No adverse event, Product preparation error
YF-VAX was reconstituted with sterile water and administered to a patient with no reported adverse e... YF-VAX was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 31 years old male patient who received YELLOW FEVER VACCINE - [YF-VAX] was reconstituted with sterile water and administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and TYPHOID VACCINE (TYPHOID VACCINE) both for Immunisation. On 31-Jan-2025, the patient received 0.5 ml of suspect YELLOW FEVER VACCINE - Solution for injection (lot UK134AA and expiry 30-Nov-2025) (strength: unknown) was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency same day) via subcutaneous route in the left arm for immunization. Reportedly:- Nurse explains that he was doing inventory and he noticed that there was 1 extra saline diluent for YF-VAX, and so he has reason to believe that YF-VAX was administered to the patient with sterile water. He states that they will be in contact with the patient. He asks if YF-VAX reconstituted with sterile water would have provided any protection for the patient. 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
2829182 FL 03/04/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
four patients received pentacel that was not suitable for use due to the excursion with no reported ... four patients received pentacel that was not suitable for use due to the excursion with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves 4 patients of unknown demographics who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] that was not suitable for use due to the excursion 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 in February 2025, the patients received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (expiry date, lot number not reported) via unknown route in unknown administration site for Immunization that was not suitable for use due to the excursion with no reported adverse event (poor quality product administered) (latency: on same day).Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. Reportedly, there was a power outage with the unknown result of a lowering of the temperature. It happened on 12Feb2025. Max/low temperature reached: 31.4๏ฟฝF (<0๏ฟฝC) Duration: 41 minutes. Previous Excursion: NO, Human error: NO, Administered post-excursion: YES for pentacel (4 patients). 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
2829183 4 M IN 03/04/2025 DTAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
4yr old patient was given adacel instead of daptacel with no reported adverse event; Initial informa... 4yr old patient was given adacel instead of daptacel with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient was given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On an unknown date, 4 year old patient was given adacel (Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine ) instead of daptacel (Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine ) with no reported adverse event (wrong product administered) (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly "This was to be his fifth dose on Daptacel schedule. " 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
2829195 M 03/04/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Inappropriate schedule of product administration, Vaccination fai... Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Vaccination failure More
Suspected vaccination failure; Shingles; 2n dose received late; This serious case was reported by a ... Suspected vaccination failure; Shingles; 2n dose received late; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (stable for 17 years), cholesterol and blood pressure. Concomitant products included atorvastatin calcium (Statin). On 14-AUG-2023, the patient received the 2nd dose of Shingrix. On 14-JUL-2022, the patient received the 1st dose of Shingrix. On 14-AUG-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2n dose received late). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-FEB-2025 The patient reported 3 years after Shingrix vaccination sequence got shingles. The patient was wondering if there was value in repeating the dosage sequence more frequently given, decrease in immune functioning with the chronic lymphocytic leukemia along with age. The patient received 2nd dose at longer time interval then recommended, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2829196 F CA 03/04/2025 HEPA
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 T5727
KH2BD
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
extra dose given to the same patient) for PRIORIX and HAVRIX; This non-serious case was reported by ... extra dose given to the same patient) for PRIORIX and HAVRIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 3-year-old female patient who received HAV (Havrix) (batch number T5727, expiry date 06-MAY-2026) for prophylaxis. Co-suspect products included MMR (Priorix) (batch number KH2BD, expiry date 01-JAN-2026) for prophylaxis. On 29-JAN-2025, the patient received Havrix and Priorix. On 29-JAN-2025, an unknown time after receiving Havrix and Priorix, the patient experienced extra dose administered (Verbatim: extra dose given to the same patient) for PRIORIX and HAVRIX). 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: 28-FEB-2025 The health care professional reported that a patient received extra dose for Priorix and Havrix, which led to extra dose administered. More
2829198 62 F ME 03/04/2025 PNC20
 PFIZER\WYETH
Injection site pain, Mobility decreased, Pain in extremity Injection site pain, Mobility decreased, Pain in extremity
Sore arm, limited range of motion of arm and shoulder where injection site is. Sore arm, limited range of motion of arm and shoulder where injection site is.
2829204 03/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; ended up getting shingles; This serious case was reported by a consum... Suspected vaccination failure; ended up getting shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: ended up getting shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-FEB-2025 The case was received from the patient via interactive digital media. The reporter had several friends took the shingles vaccination and they ended up getting them. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2829205 MA 03/04/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 3L339
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 14-year-old patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. On 25-FEB-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-FEB-2025 The patient was administered one Bexsero vaccine the day before reporting, after a below temperature excursion happened on February 7th, 2025, which led to incorrect storage of vaccine. The reporter was not aware of the excursion and reported it until at the time of reporting. the reporter was not sure if he/she could provide patient's personal information. The conditions of the excursion were temperature, 0.44 degree C for 36 minutes. The reporter consented to follow up. More
2829209 31 F CO 03/04/2025 TDAP
 SANOFI PASTEUR
 U8352AA
Arthralgia, Skin warm Arthralgia, Skin warm
Pt had local reaction 1 week warmth and her left shoulder hurt. Pt was started on cephalexin for pos... Pt had local reaction 1 week warmth and her left shoulder hurt. Pt was started on cephalexin for possible cellulitis. More
2829210 11 M NY 03/04/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Y013712
U8369BA
Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More
Local reaction including pain and redness surrounding injection sites Local reaction including pain and redness surrounding injection sites
2829211 63 M WV 03/04/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Bronchiectasis, Bronchoscopy, Chest tube insertion, Pneumonia, Thoracotomy; Bron... Bronchiectasis, Bronchoscopy, Chest tube insertion, Pneumonia, Thoracotomy; Bronchiectasis, Bronchoscopy, Chest tube insertion, Pneumonia, Thoracotomy More
onset of Bronchiectasis in Late 2022. None smoker ever. multiple lung infections, Hospital stays, Br... onset of Bronchiectasis in Late 2022. None smoker ever. multiple lung infections, Hospital stays, Bronchoscopy's and a Thoracotomy with chest tubes for infection. Ongoing symptoms still. More
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2829217 M 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
Patient took entire course of Vivotif without refrigerating; Patient took entire course of Vivotif w... Patient took entire course of Vivotif without refrigerating; Patient took entire course of Vivotif without refrigerating; Case reference number US-BN-2024-001945 is a spontaneous case report initially received from other health care professional via Med Communication (reference number: USBAV24-1146) on 24-May-2024 and concerns male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 17-May-2024, Vivotif vaccine was dispensed. As reported, patient was not aware that Vivotif should been kept in the fridge (explicitly coded as 'product storage error'). On unspecified dates, patient took entire course of Vivotif (brand name: unknown) without refrigerating, at unknown dose, route, or site of administration for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age was not aware that Vivotif should been kept in the fridge which is considered as product storage error, and took entire course of Vivotif without refrigerating, at unknown dose, route, or site of administration for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. More
2829218 M VA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004007
Oropharyngeal pain, Pharyngitis streptococcal, Streptococcus test positive Oropharyngeal pain, Pharyngitis streptococcal, Streptococcus test positive
Patient started developing sore throat, positive on streptococcus (strep throat); Case reference num... Patient started developing sore throat, positive on streptococcus (strep throat); Case reference number US-BN-2024-001979 is a spontaneous case report initially received from nurse via Med Communication (reference number: USBAV23-1233) on 03-Jun-2024 and concerns 18-year-old male patient. The patient's relevant medical history and concomitant medications were not provided. On 28-May-2024, the patient was vaccinated with first dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally, for typhoid immunization (immunization of adults and children against disease caused by Salmonella typhi). On 30-May-2024, two days after the first dose, the patient was vaccinated with second dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally. On 01-Jun-2024, reported as Saturday, two days after the second dose, the patient was vaccinated with third dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally. On the same day, patient started developing sore throat. On 02-Jun-2024, reported as yesterday on Sunday, patient throat was positive on streptococcus (strep throat) *and received antibiotics (brand name: unknown) as treatment for the event.* *On the same day, the patient recovered from the event 'Streptococcal sore throat'.* The reporter assessed the event 'Streptococcal sore throat' as non-serious, *and not related to Vivotif.* Additional information received on 03-Jun-2024 from Med Communication included additional reporter information, date of administration for three doses of Vivotif, patient information, events 'Streptococcal sore throat' added. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received form the reporter on 16-Jul-2024: New information included patient initials, Vivotif dosage information, event seriousness, intensity, stop date, treatment and updated outcome and causal relationship to Vivotif for the event of 'Streptococcal sore throat'.; Reporter's Comments: An 18-year-old male patient developing sore throat on the same day he was vaccinated with third dose of Vivotif vaccine. On the next day the patient was positive on streptococcus (strep throat). Pharyngitis streptococcal is unlisted and unexpected according to CCDS v8 and USPI for Vivotif. The outcome was resolved. The patient's relevant medical history and concomitant medications were not provided. Causality is conservatively assessed as related. The case is non-serious.; Sender's Comments: An 18-year-old male patient developing sore throat on the same day he was vaccinated with third dose of Vivotif vaccine. On the next day the patient was positive on streptococcus (strep throat). Pharyngitis streptococcal is unlisted and unexpected according to CCDS v8 and USPI for Vivotif. The outcome was resolved. The patient's relevant medical history and concomitant medications were not provided. Causality is conservatively assessed as related. The case is non-serious. More
2829257 AZ 03/04/2025 HPV9
 MERCK & CO. INC.
 Y000206
No adverse event, Syringe issue No adverse event, Syringe issue
No additional AE; leaking; syringe popped out; patient received partial dose of GARDASIL 9; This spo... No additional AE; leaking; syringe popped out; patient received partial dose of GARDASIL 9; This spontaneous report was received from a Physician via a company representative and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Feb-2025, the patient was vaccinated with partial dose (about half dose) (Accidental underdose) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y000206, expiration date: 23-Sep-2026, dose number 1) for prophylaxis. During the vaccination, the syringe popped out (Device connection issue) and about half of it leaked out (Device leakage). The reporter confirmed syringe was not cracked or broken and needle was locked in place at time of vaccination and only leak was at the syringe hub/luer lock. The vaccine was not available for retrieval as it was discarded. No additional adverse event (no adverse event). More
2829258 F TX 03/04/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site pain, Injection site reaction, Injection... Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pruritus More
injection site reaction: developed extreme itching; aching at injection site; injection site reactio... injection site reaction: developed extreme itching; aching at injection site; injection site reaction: developed swelling; injection site reaction: developed redness; This spontaneous report was received from a physician and refers to an 88-year-old female patient. The patient's concomitant medication included "flue shot". No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided. On 03-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, intramuscularly in unspecified arm (dose, lot #, expiration date and site of administration was not reported) for prophylaxis. On the same day, she experienced injection site reaction described as aching and then developed swelling, redness, and extreme itching. It was reported that the patient sought medical attention, however no details was reported. She was using cool, wet compress at the site, however no treatment was given. On an unknown date in February 2025, the patient recovered from the pain at the vaccination site. The outcome of the rest of the events was reported as not recovered. The causality assessment was not provided. More
2829259 NY 03/04/2025 MMRV
 MERCK & CO. INC.
 W024967
Expired product administered Expired product administered
no additional AE/No PQC; patient received an expired dose of PROQUAD; This invalid spontaneous repor... no additional AE/No PQC; patient received an expired dose of PROQUAD; This invalid spontaneous report was received from an other health professional (nurse) and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction/allergies were not reported. On 26-MAR-2024, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose unknown, lot #W024967, expiration date: 05-FEB-2024 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered) and with sterile diluent (BAXTER Sterile Diluent) (dose, lot #, expiration date, route of administration and indication were not reported). No symptoms or side effects were reported (also reported as "no AE/no PQC"). This case is invalid due to lack of patient identifiers. More
2829260 KY 03/04/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Medical Assistant calling with a report of an adverse event regarding improperly s... No adverse event; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided. Medical Assistant stated that the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was involved in multiple temperature excursions beginning on 05-DEC-2024, and the product was administered to the patient involved on 06-DEC-2024, with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015108 who had been verified to be a valid lot number, expiration date: 06-SEP-2026) 0.5 mL / Two dose series), for prophylaxis; and sterile diluent (BAXTER STERILE DILUENT) (improper storage of product in use). No additional adverse event. More
2829261 SC 03/04/2025 HPV9
 MERCK & CO. INC.
 W028573
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; GARDASIL-9 expired on 1/6/2025 and was administered on 2/11/2025; This spontaneous... No additional AE; GARDASIL-9 expired on 1/6/2025 and was administered on 2/11/2025; This spontaneous report was received from an Office Manager and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 11-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W028573, expiration date: 06-JAN-2025) for prophylaxis (strength, formulation, dose, and route of administration were not provided) (Expired product administered). No additional AE. More
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