🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2813911 55 F NM 12/05/2024 FLU3
UNK
 SEQIRUS, INC.
UNKNOWN MANUFACTURER
 AW3225B
AW3225B
Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash ... Injection site rash, Injection site swelling, Injection site warmth, Rash, Rash erythematous; Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous, Skin warm More
Rash and swelling on injection site L deltoid, rash was red and hot, went half way down upper arm. V... Rash and swelling on injection site L deltoid, rash was red and hot, went half way down upper arm. Very sore and swollen, felt like there was a ball in arm. Last 4 days. More
2813840 71 F SC 12/04/2024 COVID19
COVID19
FLU3
FLU3
RSV
RSV
COVID19
COVID19
RSV
RSV
UNK
UNK
 NOVAVAX
NOVAVAX
SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 jirj22i041pqlnm
jirj22i041pqlnm
33t4pab0b1
33t4pab0b1
5h1gy99say
5h1gy99say
JIRJ22I041PQLNM
JIRJ22I041PQLNM
5H1GY99SAY
5H1GY99SAY
33T4PAB0B1
33T4PAB0B1
Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personal... Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Positive airway pressure therapy, Vomiting; Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Positive airway pressure therapy, Vomiting; Blood test, Feeling abnormal, Injection site bruising, Malaise, Nausea; Personality change, Positive airway pressure therapy, Vomiting; Feeling abnormal, Injection site bruising, Malaise, Nausea, Personality change; Vomiting; Feeling abnormal, Injection site bruising, Malaise, Nausea, Personality change; Vomiting; Feeling abnormal, Injection site bruising, Malaise, Nausea, Personality change; Vomiting More
patient received three vaccines, rsv and covid in left arm and flu in the right arm. day 1 patient w... patient received three vaccines, rsv and covid in left arm and flu in the right arm. day 1 patient was fine, by day 3 patient had developed a bruise where rsv shot was given, and began to feel nausea and " out of it". Vomited once, and experienced nausea. over the course of ten days patient's "persona" began to decline. Her husband decided to take her to the hospital after several days of feeling terrible. they have been trying blood tests to try to figure out what has been going on, with no clear diagnosis. patient has been in hospital since Saturday or Sunday at this point. They are suspecting possible carbon monoxide excess per husband as they have patient on a cpap machine. she has been feeling less nauseated, although she is still in hospital under medical care. The bruise has turned to a purple at this point. More
✓
2822594 73 M FL 01/23/2025 PNC20
 PFIZER\WYETH
 LG5579
Extra dose administered Extra dose administered
There was not an actual event. Patient received 2 doses of Prevnar20 within 1.5 years of each other.... There was not an actual event. Patient received 2 doses of Prevnar20 within 1.5 years of each other. We were not aware that he had gotten a Prevnar20 shot on 5/26/2023 and patient had requested to get same shot on 1/17/2025. More
2822612 3 F NV 01/23/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Pain, Peripheral swelling Erythema, Pain, Peripheral swelling
Pain for over 24 hours followed by large red swelling covering over half her thigh Pain for over 24 hours followed by large red swelling covering over half her thigh
2822145 F 01/22/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Autoimmune thyroiditis, Impaired work ability, Memory impairment, Psoriasis; Aut... Autoimmune thyroiditis, Impaired work ability, Memory impairment, Psoriasis; Autoimmune thyroiditis, Impaired work ability, Memory impairment, Psoriasis More
Hashimoto's thyroiditis; her memory recall has not been good since the HPV vaccine; Psoriasis; ... Hashimoto's thyroiditis; her memory recall has not been good since the HPV vaccine; Psoriasis; health issues; Patient was not able to confirm if the vaccine she received was the GARDASIL or GARDASIL 9; This spontaneous report was received from a female patient of unknown age concerning herself. Patient did not have pertinent medical history or concurrent conditions. Concomitant medications included vitamin C. On an unknown date (also reported as a while ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as HPV vaccine) route of administration reported as injection, for prevention (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) (product origin unknown). On an unknown date, the patient's memory recall and was not good since HPV vaccination. After the vaccination the patient experienced psoriasis and Hashimoto's thyroiditis. She went to a natural doctor and was being treated with some of the treatment that involved circulation with vitamin C and an unknown product. The patient mentioned that her life crippled and cannot advance in her career due to her health issues. At the time of this report, the patient had not recovered from the events. The causal relationship between the vaccine and the events was not provided. Upon internal review, Hashimoto's thyroiditis was determined to be a medically significant event. More
2822146 F SD 01/22/2025 PNC20
 PFIZER\WYETH
Fatigue, Pyrexia Fatigue, Pyrexia
fatigue; fever; This is a spontaneous report received from a Pharmacist. An 89-year-old female pati... fatigue; fever; This is a spontaneous report received from a Pharmacist. An 89-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "depression" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CHF" (unspecified if ongoing); "CAD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; ASCORBIC ACID; ASPIRIN (E.C.); CETIRIZINE; VIT D3; DULOXETINE; FUROSEMIDE; LACTOBACILLUS ACIDOPHILUS; LEVOTHYROXINE; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; OLOPATADINE; OMEGA 3 FISH OIL [FISH OIL]; OMEPRAZOLE; POLYETHYLENE GLYCOL COMPOUND; KCL oral; ROPINIROLE; ROSUVASTATIN; TROSPIUM. Past drug history included: No, reaction(s): "Hypersensitivity". The following information was reported: FATIGUE (non-serious) with onset 15Jan2025, outcome "recovered" (15Jan2025); PYREXIA (non-serious) with onset 15Jan2025, outcome "recovered" (15Jan2025), described as "fever". Therapeutic measures were taken as a result of fatigue, pyrexia. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2822148 F 01/22/2025 PNC20
 PFIZER\WYETH
Injection site reaction, Injection site warmth, Rash erythematous Injection site reaction, Injection site warmth, Rash erythematous
rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is ... rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; rash at the injection site/it is red and it is warm; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2025 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: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Jan2025, outcome "unknown" and all described as "rash at the injection site/it is red and it is warm". Additional information: The patient was calling "today" (17Jan2025) about the Prevnar 20 vaccine and she stated she had this shot exactly one week ago "today" (Jan2025). she had a rash at the injection site, it was red and it was warm but it did not hurt or anything and she just wanted to call to find out if the rash was normal. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2822149 1 F TX 01/22/2025 HIBV
 SANOFI PASTEUR
 UJ992AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
This situation is pre-assessed as a medication error/an inappropriate use due to ACT-HIB was reconst... This situation is pre-assessed as a medication error/an inappropriate use due to ACT-HIB was reconstituted with sterile water. with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves, this situation is pre-assessed as a medication error/an inappropriate use due to a 1 year old female patient received HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); RSV Vaccine and Pneumococcal Vaccine CONJ for Immunization. On 09-Jan-2025, this situation is pre-assessed as a medication error/an inappropriate use due to the patient received 0.25 ml to 2 ml (once) dose of suspect (standard) HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ992AA, expiry date: 28-Feb-2025) (unknown strength) via intramuscular route in left thigh for Immunization that was reconstituted with sterile water with no reported adverse event (product preparation error) (latency-same day). Reportedly, Medical assistant reported that she used sterile water instead. She asks if the dose is still valid or do they need to re-administer the dose. 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
2822150 U LA 01/22/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK043AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
administration of only the liquid DTAP-IPV portion of PENTACEL, the dose administered did not includ... administration of only the liquid DTAP-IPV portion of PENTACEL, the dose administered did not include the ACTHIB portion with no reported adverse event; Initial information received on 14-Jan-2025 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves, the unknown age and gender patient who was administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel], the dose administered did not include the ACT HIB portion with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient administration of only the liquid DTAP-IPV portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot UK043AA, expiry date: 31-Aug-2025), the dose administered did not include the ACT HIB portion with no reported adverse event (single component of a two-component product administered) (unknown latency). Reportedly, Caller did not have specific details or patient specific information available at the time of the call. No other details were available in regards to this situation. 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
2822152 91 F MO 01/22/2025 FLU3
 SANOFI PASTEUR
 U8527AA
Arthralgia, Insomnia, Pain in extremity, Rash Arthralgia, Insomnia, Pain in extremity, Rash
bumps; can not sleep at night; pain from shoulder to hand on same side as FLUZONE HD injection site;... bumps; can not sleep at night; pain from shoulder to hand on same side as FLUZONE HD injection site; Initial information received on 15-Jan-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 91 years old female patient who experienced bumps, can not sleep at night and pain from shoulder to hand on same side after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (expiry date: 30-Jun-2025 and lot U8527AA) via unknown route in unknown administration site as immunization. On an unknown date in 2024 the patient developed bumps (swelling), can not sleep at night (sleep disorder) and pain from shoulder to hand on same side as fluzone hd injection site (pain in extremity) (latency: few days approximately). Action taken: not applicable. It was not reported if the patient received a corrective treatment for all events. At time of reporting, the outcome was Unknown for all events. More
2822153 U FL 01/22/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
they have an opened vial that has been left outside for 12 hours , with no reported adverse event; I... they have an opened vial that has been left outside for 12 hours , with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited non-valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient and reporter stated that they have an opened IPV (VERO) [IPOL] vial that has been left outside for 12 hours, with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the suspect opened IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) for immunisation, vial that has been left outside for 12 hours, with no reported adverse event (product storage error). Pharmacist called to ask regarding multidose vials of IPOL. They wanted to know what the expiration date was for punctured vials. They said that they have an opened vial that has been left outside for 12 hours that they were going to dispose of anyway and wanted the information for reference. Pharmacist declined to report about the aforementioned IPOL. They were asking because they could not agree with their partner if they should be disposing these vials by the expiration date or after 28 days. 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
2822154 U IN 01/22/2025 HIBV
 SANOFI PASTEUR
 uk007ab
Expired product administered, No adverse event Expired product administered, No adverse event
patient was given expired dose of vaccine with no reported adverse event; Initial information receiv... patient was given expired dose of vaccine with no reported adverse event; Initial information received on 16-Jan-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and unknown gender patient who was given expired dose of HIB (PRP/T) Vaccine [ACT-HIB] vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Jan-2025, the patient received an expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- uk007ab and expiry- 01-Dec-2024) via unknown route in unknown administration site for immunization (dose, strength: not provided) with no reported adverse event (expired product administered) (latency- same day). 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
2822168 0.33 M 01/22/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
MMR
MMR
MMR
PNC13
PNC13
PNC13
RV1
RV1
RV1
UNK
UNK
UNK
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status ... Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal; Chills, Febrile convulsion, Hyporesponsive to stimuli, Hypotonia, Mental status changes; Posture abnormal, Pyrexia, Somnolence, Staring, Tachycardia; Urine abnormality, Urine analysis normal More
Febrile Seizure; This 13-month-old male subject was enrolled in a study. The subject received the 4t... Febrile Seizure; This 13-month-old male subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 12-SEP-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-MAR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 08-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 12-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 12-SEP-2019, for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) for prophylaxis and Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 01-NOV-2019, 50 days after receiving Bexsero vs Placebo, M-M-R II and Varivax and 238 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed severe - grade 3 febrile seizure (Verbatim: Febrile Seizure). Serious criteria included clinically significant/intervention required. The subject was treated with ibuprofen (Children'S Ibuprofen) and paracetamol (Tylenol Infant). The outcome of febrile seizure was resolved on 01-NOV-2019. Relevant Tests: On 02Nov2019, Urine culture was performed. Findings showed "mixed organisms are present indicating probable contamination or colonization not related to infection". On 02Nov2019, Urinalysis was performed. Results showed "cloudy" appearance-normal would be "clear". All other tests were within normal units for the urinalysis.. Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature- 01-NOV-2019 102.2 degree F and in NOV-2019 38.8 degree C. The investigator considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II and Varivax. GSK Receipt Date: 05-NOV-2019 Thirteen month old who was brought to the Emergency Department for an episode of altered mental status. The child was noted to be playful and active in the morning of 01Nov2019 by his grandmother. He was picked up by Mom after her work and Mom noted that the child "went limp", staring off into space with eyes open, head flopped back and extremities went limp". Mom noted "no eye movements or convulsions of extremities. No urinary incontinence. No apnea or cyanosis. He was limp for about two minutes then was very sleepy/hard to engage or arouse for some forty to sixty minutes". Parents noted later the child shivering and having intermittent chills. In the Emergency Department the child had a temperature of 38.8 degree C and pulse of 185. A urine analysis and urine culture were ordered, and obtained the following day on 02Nov2019. The child was given PO Motrin in the Emergency Department on 01Nov2019. The child was discharged on 01Nov2019 to home with a diagnosis of Febrile Seizure. Before discharge he was afebrile, adequately hydrating. The tachycardia was likely related to his fevers. Teaching was discussed regarding antifebrile medications as well as aggressive oral rehydration. The child was discharged in good condition on 01Nov2019. The child continued on around the clock Motrin and Tylenol alternating each medication until 03Nov2019. He was seen for follow-up on 02Nov2019. And was noted that the fever was "likely viral source". The child had no symptoms of pneumonia, or evidence of urinary tract infection. Spoke to Mom on 04Nov2019, per Mom "He's back to normal, no fevers, doing well". Addendum: Mom reported the duration of the seizure to be approximately 2 minutes (17:30). she also reported that the child's uncle had one febrile seizure when he was a boy. This child was born full term, had a normal delivery with no infections, trauma or complications. Hi APGARS were 8 at 1 minute after birth and 9 at 5 minutes after birth. He was diagnosed with a "Simple febrile seizure". He had no post history of hypotonic, hyporesponsive episodes or absence seizures. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The Seizure was Witnessed by parents or relatives. Date of first Seizure was 1/Nov/2019 and Time of first Seizure was 17:30. Body temperature (fever) at the time of generalized convulsive seizure was 102.2 degrees Fahrenheit. Duration of seizure in minutes (approximately) was 2 minutes. Number of generalized convulsive seizures was 1. There was no past history of similar events. There was familial history of similar events but the event was not already reported. Type of Seizure was Febrile Seizure with fever, Subject's mom reported her brother had one febrile seizure. Diagnostic certainty level was Level 1; Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Follow up information received on 15-JAN-2025 Summary of changes: General narrative comments updated. The start date and time of event febrile seizure was 1-NOV-2019 17:30 Upon internal review case was updated on 21-JAN-2025 Co-suspect vaccines DTPa-HBV-IPV, Hiberix,,MMR II, Varivax start date updated.; Sender's Comments: A case of Febrile convulsion, 50 days after receiving 4th dose of Bexsero vs Placebo, 1st dose of M-M-R II and Varivax and Prevnar 13, 238 days after receiving 3rd dose of DTPa-HBV-IPV vaccine and Hiberix and 298 days after Rotarix liquid formulation, in a 13-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (family h/o febrile seizure and multiple concomitant vaccines). More
2822169 0.33 F 01/22/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
HIBV
MMR
MMR
MMR
MMR
PNC13
PNC13
PNC13
PNC13
RV1
RV1
RV1
RV1
UNK
UNK
UNK
UNK
VARCEL
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
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Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia... Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing; Ataxia, Chest X-ray normal, Computerised tomogram head normal, Cough, Dyskinesia; Febrile convulsion, Influenza, Influenza A virus test positive, Middle ear effusion, Postictal state; Pyrexia, Respiratory tract congestion, Somnolence, Tremor, Tympanic membrane hyperaemia; Unresponsive to stimuli, Use of accessory respiratory muscles, Vomiting, Wheezing More
Complex Febrile Convulsions; Influenza A; This 15-month-old female subject was enrolled in a study ... Complex Febrile Convulsions; Influenza A; This 15-month-old female subject was enrolled in a study The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 18-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 15-FEB-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 18-OCT-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 18-OCT-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 18-OCT-2019, for prophylaxis. Concurrent medical conditions included reactive airways disease. On 08-JAN-2020, 82 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 257 days after receiving DTPa-HBV-IPV and Hiberix and 327 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 influenza a virus infection (Verbatim: Influenza A). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 complex febrile convulsion (Verbatim: Complex Febrile Convulsions) on 13-JAN-2020 with serious criteria of hospitalization. The subject was treated with oxygen, budesonide, salbutamol (Albuterol), sodium chloride, paracetamol (Tylenol), oseltamivir phosphate (Tamiflu) and lorazepam (Ativan). The outcome of influenza a virus infection was resolved on 18-JAN-2020. The outcome(s) of the additional event(s) included complex febrile convulsion (resolved on 13-JAN-2020). Relevant Tests: On 13-JAN-2020 Chest X-Ray No acute cardiopulmonary findings On 14-JAN-2020 CT (Computerised tomogram) Head; No acute pathology seen on the brain On 14-JAN-2020 Influneza Virus A RNA; Positive.. The investigator considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. The company considered that there was no reasonable possibility that the influenza a virus infection and complex febrile convulsion may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Linked case(s) involving the same subject: US2020029362 GSK Receipt Date: 18-FEB-2020 15 Month girl with history of Reactive Airway Disease and family history of febrile seizures, transferred from ED (emergency department) for 2 complex seizures in 24hrs, found to be influenza A positive. Prior to seizure, subject had cough, congestion and fevers. First seizure occurred 13JAN2020 at daycare, she became unresponsive and had jerking arm movements, followed by emesis and groggy post ictal period with full return to baseline. In the ED (emergency department) had a second seizure approximately 8 minutes in duration requiring Ativan with R arm shaking and unresponsiveness. Febrile to 102.5, labs and head CT normal. Transferred to hospital for further management. During her admission she had no further seizure activity. Neurological exams improved throughout the day on 14JAN2020, early in the day she was drowsy and ataxic, likely due to Ativan administration. No signs of encephalopathy. No further fevers. Further imaging and lumbar puncture deferred secondary to reassuring improvement of neurologic exam and return to baseline per parents. On the day of discharge she developed mild wheezing and intermittent subcostal retractions consistent with her known reactive airway disease symptoms. Exam improved significantly after normal albuterol dose. Subject started on Tamiflu, would continue 5 day course BID. On day of discharge, bilateral tympanic membranes were mild erythematous and had copious earwax, but no bulging, purulent or serous fluid behind tympanic membrane was visualized. Subject admitted to hospital on 13JAN2020 and discharged on 15JAN2020. This child did not experience any infections, trauma or complications at birth. The child's APGARS were 9 at 1 minute after and 9 at 5 minutes after birth. No seizures were experienced by this child prior to occurrence. Follow-up information received on 12th May 2022 this follow-up was consider as non-significant. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The seizure was witnessed by study personnel or other health care professional. The date of first seizure was 13/Jan/2020 and time of first seizure was 17:30. Fever at the time or immediately before generalized convulsive seizure: 102.5 degrees Fahrenheit. Duration of seizure in minutes (approximately): 6 minutes. Number of generalized convulsive seizures: 2. No past history of similar events. Familial history of similar events: Yes, but the event was not already reported. Type of Seizure: Febrile seizure. Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. Summary of changes: No new information updated. Follow up information was received on 08-AUG-2024 The subject was received D5 Nacl 0.9% as treatment dose 40 ml/hr, CO via Intravenous on 14-JAN-2020 for complex febrile convulsions The subject was received D5-Nacl 0.9% with KCL as treatment dose 40 ml/hr, CO via Intravenous from 14-JAN-2020 to 15-JAN-2020 for complex febrile convulsions. Summary of changes: Event complex Febrile Convulsions seriousness criteria GSK Medically Significant removed, treatment medication Ativan unit updated from mg to ml, Tylenol frequency updated from Once only to Once daily and narrative updated. Follow up information was received on 14-JAN-2025 Summary of changes: General narrative comments and unit update for oxygen.; Sender's Comments: A case of Influenza and Febrile convulsion 82 days after receiving 4th doses of Bexsero vs Placebo and Prevnar 13, 1st doses of M-M-R II and Varivax, 257 days after receiving 3rd doses of DTPa-HBV-IPV and Hiberix, and 327 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 15-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausability (for Bexsero vs Placebo, Rotarix lyophilized formulation, M-M-R II, Varivax and Prevnar 13) and alternative etiology (Influenza A positive) and alternative risk factors (h/o Reactive Airway Disease, family history of febrile seizures and fever contributed by underlying infection). US-GLAXOSMITHKLINE-US2020029362: More
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2822170 0.33 M 01/22/2025 DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
MMR
MMR
PNC13
PNC13
RV1
RV1
UNK
UNK
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
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Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss... Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure; Blood electrolytes, Blood magnesium increased, Full blood count, Hypotonia, Loss of consciousness; Lymphocyte percentage increased, Seizure More
Single Seizure Unspecified Type; This 21-month-old male subject was enrolled in a blinded study. The... Single Seizure Unspecified Type; This 21-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 04-FEB-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 16-OCT-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 16-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 05-JUL-2020, 263 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 436 days after receiving DTPa-HBV-IPV and Hiberix and 517 days after receiving Rotarix lyophilized formulation, the subject developed mild - grade 1 seizure (Verbatim: Single Seizure Unspecified Type). Serious criteria included clinically significant/intervention required. The outcome of seizure was resolved on 05-JUL-2020. Diagnostic results (reference ranges are provided in parenthesis if available): Blood magnesium- 05-JUL-2020 2.4 mg/dL, (1.70-2.30). Body temperature- 05-JUL-2020 98.3 (taken orally). Lymphocyte count- 05-JUL-2020 78.0 percent, (20.00-70.00). The investigator considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. Other possible cause(s) of the seizure included DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE. The company considered that there was no reasonable possibility that the seizure may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. 05JUL2020 mother was trying to put subject down to nap, he was crawling to the edge of their bed, but did not fall, and then suddenly went limb. Mom flipped him over, eyes were fluttering, body was limp, lasted about 3 minutes. Did not stop breathing, did not turn blue, did not wet himself. Mom called EMS. The subject regained his strength and Baseline status. He has been doing well recently with no recent illness. No head trauma recently. No family history of epilepsy. Subject was discharged home in stable condition after being observed in Emergency Department for 3 hours. No medications were given. The only procedure done was lab draw for complete blood count (CBC) and Electrolytes. Labs were normal except for Magnesium 2.4 mg/dL (normal range 1.7-2.3 mg/dL) and lymphocytosis ith lymphocytes at 78 percent (normal range 20-70 percent). No other treatments were done. No family history of epilepsy. No previous history of seizures documented in medical record. Loss of consciousness reported. Event occurred more than 48hrs after last vaccination (15NOV2019), so hypotonic hyporesponsive episode excluded. No birth complications reported. No fever. The seizure was witnessed by study parents or relatives. The date of first seizure was 5/Jul/2020 and time of first seizure was unknown. No fever at the time or immediately before generalized convulsive seizure. Duration of seizure in minutes (approximately): 3 minutes. Number of generalized convulsive seizures: 1. No past history of similar events. Familial history of similar events. Type of Seizure: Single Seizure, unspecified type. Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. No Familial history of similar events. Investigator reported SAE term as Single Seizure Unspecified Type. On 28May2021, the SAE Single Seizure Unspecified Type was marked as Other AESI by the Investigator. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 14-Jan-2025. Summary of changes: General narrative updated. Upon internal review the case was updated on 20-Jan-2025. Route of administration was corrected for Rotarix lyophilized formulation, M-M-R II and Varivax. Anatomical location added for Bexsero vs Placebo, Prevnar 13, Hiberix, M-M-R II, Varivax, device causality updated as unknown.; Sender's Comments: A case of Seizure, 263 days after receiving the 4th dose of Bexsero vs Placebo and Prevnar 13, 1 st dose of M-M-R II and Varivax, 436 days after receiving 3rd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, and Hiberix, 517 days after receiving 2nd dose of Rotarix vaccine oral applicator device, co-administered with PCV and routine vaccines, in a 21-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. More
2822171 M 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Lymphadenopathy Lymphadenopathy
Swollen lymph nodes; This non-serious case was reported by a consumer via patient support programs a... Swollen lymph nodes; This non-serious case was reported by a consumer via patient support programs and described the occurrence of swollen lymph nodes in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 19-DEC-2024, the patient received Shingrix. On 20-DEC-2024, 1 days after receiving Shingrix, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph nodes). The outcome of the swollen lymph nodes was not resolved. It was unknown if the reporter considered the swollen lymph nodes to be related to Shingrix. It was unknown if the company considered the swollen lymph nodes to be related to Shingrix. Additional Information: GSK Receipt Date: 23-DEC-2024 The patient self-reported this case for himself. The patient experienced swollen lymph nodes which was ongoing. The patient did not receive other products. No symptoms were treated. More
2822172 0.42 M NE 01/22/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Inappropriate schedule of product administration Inappropriate schedule of product administration
The Kinrix was the 2nd in the series; Kinrix was administered to a 5 month old; This non-serious cas... The Kinrix was the 2nd in the series; Kinrix was administered to a 5 month old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Concomitant products included Pediarix. On 15-NOV-2024, the patient received the 2nd dose of Kinrix. On 15-NOV-2024, an unknown time after receiving Kinrix and an unknown time after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: The Kinrix was the 2nd in the series) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 5 month old). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown. 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-DEC-2024 Nurse reported that Kinrix was administered to a 5 month old on November 15, 2024. Patient has had no issues. 1st dose of Pediarix on August 23, 2024. The Kinrix was the 2nd in the series which led to Inappropriate schedule of vaccine administered and Inappropriate age at vaccine administration. More
2822173 F MD 01/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
A pregnant woman on her 3rd trimester received a dose of Arexvy.; A pregnant woman on her 3rd trimes... A pregnant woman on her 3rd trimester received a dose of Arexvy.; A pregnant woman on her 3rd trimester received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy.) and drug use in unapproved population (Verbatim: A pregnant woman on her 3rd trimester received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist reported that they administered a dose of Arexvy to a pregnant woman which led to drug use in unapproved population. The patient was on her 3rd trimester of pregnancy and she was in her mid 30's of age. The pharmacist asked safety information about this. More
2822174 0.67 F ME 01/22/2025 DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
X9EP5
Cough, Cyanosis, Decreased appetite, Injection site erythema, Injection site swe... Cough, Cyanosis, Decreased appetite, Injection site erythema, Injection site swelling; Respiratory tract congestion More
Within 24 hours: decreased feeding, within 48 hours, cough/congestion, within 72 hours, peripheral c... Within 24 hours: decreased feeding, within 48 hours, cough/congestion, within 72 hours, peripheral cyanosis of bilateral lower extremities and injection site swelling/redness. More
2822175 M CO 01/22/2025 HPV9
 MERCK & CO. INC.
 Y008843
Pityriasis rosea, Rash, Rash pruritic Pityriasis rosea, Rash, Rash pruritic
Itchy Rash on back, chest & abdomen consistent with pityriasis rosea (Herald lesion on (R) shou... Itchy Rash on back, chest & abdomen consistent with pityriasis rosea (Herald lesion on (R) shoulder blade) More
2822239 83 F IN 01/22/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
354m3
Abdominal pain, Abdominal tenderness, Acute kidney injury, Alanine aminotransfer... Abdominal pain, Abdominal tenderness, Acute kidney injury, Alanine aminotransferase normal, Anaemia; Anion gap, Ascites, Aspartate aminotransferase increased, Basophil count decreased, Basophil percentage decreased; Bilirubin conjugated decreased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased; Blood chloride decreased, Blood creatinine increased, Blood glucose normal, Blood lactic acid increased, Blood magnesium normal; Blood potassium increased, Blood sodium decreased, Blood urea increased, Carbon dioxide normal, Colitis; Computerised tomogram abdomen abnormal, Condition aggravated, Creatinine renal clearance decreased, Dehydration, Diarrhoea; Eosinophil count decreased, Eosinophil percentage decreased, Gastrointestinal wall thickening, Gastrooesophageal reflux disease, Glomerular filtration rate decreased; Haematocrit decreased, Haemoglobin decreased, Hyperlipidaemia, Hyponatraemia, Influenza A virus test negative; Influenza B virus test, Influenza virus test negative, Leukocytosis, Lipase normal, Lymphocyte count decreased; Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal; Monocyte count normal, Monocyte percentage, Nephrolithiasis, Neutrophil count increased, Neutrophil percentage increased; Normocytic anaemia, Platelet count normal, Pollakiuria, Protein total decreased, Red blood cell count decreased; Red cell distribution width increased, SARS-CoV-2 test negative, Tachycardia, White blood cell count increased More
Document Type: History and Physical Document Subject: History & Physical Note Performed By: ... Document Type: History and Physical Document Subject: History & Physical Note Performed By: MD on January 20, 2025 13:46 Verified By: MD on January 20, 2025 13:46 Encounter Info: Hospital, Inpatient, 01/20/25 - * Final Report * Chief Complaint Diarrhea History of Present Illness/Subjective Patient is an 83 year old woman who presents to the ER w/ diarrhea and abd pain for the last 3 days. Patient endorses watery diarrhea, no blood. She has also had abd pain and increased urinary frequency. She denies any fever. Upon arrival to the ER she was tachycardic and afebrile. BP was 91/60. Labs were notable for a WBC count of 12. Hgb was 11. Na was 129 and Cr was 2.6. CT abd/pelvis showed e/o colitis. Lactate was 2.3 but repeat was normal. Patient was given fluids and admitted to the medicine service for further management. Review of Systems With the exception of that noted in the HPI all systems were reviewed and were negative. Physical Exam/Objective Vitals & Measurements most recent past 24 hours Constitutional: No acute distress, well-nourished Eyes: no scleral icterus ENMT: Moist oral mucosa Respiratory: CTAB Cardiovascular: Regular rate and rhythm, no MGR Gastrointestinal: non-distended, tender to palpation Musculoskeletal: intact ROM Integumentary: no rashes Neurologic: no focal deficits Psychiatric: Cooperative, appropriate mood and affect Assessment/Plan 1. Colitis K52.9 -Unclear cause -GIP panel -GI consult -Zosyn 2. AKI (acute kidney injury) N17.9 -Pre-renal in nature -LR at 100cc/hr -PVR urine -Renally dose meds 3. Dehydration E86.0 -Fluids as above 4. Hyponatremia E87.1 -The patient presents with a electrolyte imbalance including hypo-osmolality and hyponatremia. Continue to trend serial analysis as appropriate with replenishment of electrolyte imbalance as required for stabilization. -Hypovolemic -Fluids as above 5. Anemia D64.9 -The patient presents with anemia chronic and normocytic due to other chronic disease at present is stable. Continue to trend serial analysis as appropriate with nutritional or blood product supplementation as required. 6. Leukocytosis D72.829 -Non-specific finding -Likely due to colitis 7. GERD (gastroesophageal reflux disease) K21.9 -Continue PPI 8. Hyperlipidemia E78.5 -Continue statin Code Status Full Code Chronic Problem List Acute respiratory failure Anemia Cervical radiculopathy CKD (chronic kidney disease), stage II COPD (chronic obstructive pulmonary disease) COPD bronchitis COVID DDD (degenerative disc disease), cervical DDD (degenerative disc disease), lumbar GERD (gastroesophageal reflux disease) Goiter Hematuria History of peptic ulcer Hyperlipidemia Hypoalbuminemia Long term use of drug Lumbar radiculopathy Lung nodule Osteoarthritis Osteopenia PE (pulmonary thromboembolism) Pneumonia Postmenopausal Reactive thrombocytosis Smoking Thrombocytosis UTI (urinary tract infection) Procedure/Surgical History ?Back surgery (07/17/2024) ?colonoscopy (05/15/2014) ?small bowel capsule (04/29/2014) ?egd (04/24/2014) ?back surgery (05/2010) ?abdominal laparotomy multiple times ?c-section ?cataract removal with lens implants ?goiter removed from neck ?hysterectomy ?lumbar surgery ?rotator cuff repair right shoulder Surgical History Internal 06/17/2024 Spine Fusion Posterior Lumbar (Postr) MD 04/02/2018 Spine Fusion Posterior Lumbar MD 03/07/2016 Lumbar Laminectomy (Left) MD Medications Home Medications (10) Active albuterol 2.5 mg/3 mL (0.083%) inhalation solution 2.5 mg = 3 mL, PRN, Neb Inhal, Q6H, COPD atorvastatin 20 mg oral tablet 20 mg = 1 Tablet, Orally, QHS DME (Vendor) Oxygen See DME Order Details or printed requisition for more information., This is a print requisition order, cannot be ePrescribed. DULOXetine 30 mg oral delayed release capsule 30 mg = 1 Capsule, Orally, Daily, TAKE 1 CAPSULE BY MOUTH DAILY gabapentin 100 mg oral capsule 100 mg = 1 Capsule, Orally, 4 Times Daily hydroxyurea 500 mg oral capsule 1 Capsule, Orally, Daily Magic Potion oral solution 5 mL, Orally, 4 Times Daily, Swish and Spit montelukast 10 mg oral tablet 10 mg = 1 Tablet, Orally, Daily OXYcodone-acetaminophen 7.5 mg-325 mg oral tablet 1 Tablet, PRN, Orally, Q4H pantoprazole 40 mg oral delayed release tablet 40 mg = 1 Tablet, Orally, Daily Active Scheduled Inpatient Medications Sodium Chloride 0.9% 500 mL IV Continuous 42 mL/hr Days 1, 8 One-Time Medications Given 01/19/25 00:00:00 TO 01/20/25 13:41:14 None Reported PRN Medications (0600 - 0559) from 01/19 - 01/20 None Reported Allergies Eggs (Blisters) No Known Medication Allergies Social History Alcohol Denies Electronic Cigarette/Vaping E-Cigarette Use Never. Home/Environment Lives with Spouse, 35YR OLD GRANDSON. Nutrition/Health Diet: Regular. Substance Abuse Denies Tobacco Tobacco Use: Former smoker, quit more than 30 days ago. Started age 16.0 Years. Stopped age 83 Years. Family History Breast cancer: Mother. Cancer of colon: Daughter. Diabetes mellitus type 2: Mother. Heart attack..: Mother. Prostate cancer..: Father. Deceased Family Member(s) Relationship: Mother, Age: Unknown, Cause: DM, CA of breast, heart Relationship: Father, Age: Unknown, Cause: Bladder CA, Prostate CA then to Bone Lab Results All Labs Last 24 hours (No Micro or Pathology) Hematology: WBC: 12 k/cumm High (01/20/25 08:08:00) RBC: 3.24 million/cumm Low (01/20/25 08:08:00) Hgb: 11.8 GM/dL Low (01/20/25 08:08:00) Hct: 35.6 % (01/20/25 08:08:00) MCV: 110 fL High (01/20/25 08:08:00) MCH: 36.5 pg High (01/20/25 08:08:00) MCHC: 33.2 GM/dL (01/20/25 08:08:00) RDW: 24.1 % High (01/20/25 08:08:00) Platelet: 212 k/cumm (01/20/25 08:08:00) MPV: 8.5 fL (01/20/25 08:08:00) Neutrophils %: 94 % (01/20/25 08:08:00) Lymphocytes %: 3 % (01/20/25 08:08:00) Monocytes %: 3 % (01/20/25 08:08:00) Eosinophils %: 0 % (01/20/25 08:08:00) Basophils %: 0 % (01/20/25 08:08:00) Absolute Neutrophil: 11.3 k/cumm High (01/20/25 08:08:00) Absolute Lymphocyte: 0.4 k/cumm Low (01/20/25 08:08:00) Absolute Monocyte: 0.4 k/cumm (01/20/25 08:08:00) Absolute Eosinophil: 0 k/cumm (01/20/25 08:08:00) Absolute Basophil: 0 k/cumm (01/20/25 08:08:00) Chemistry: Sodium SerPl QN: 129 mmol/L Low (01/20/25 08:08:00) Potassium SerPl QN: 5.5 mmol/L (01/20/25 08:08:00) Chloride SerPl QN: 95 mmol/L Low (01/20/25 08:08:00) Carbon Dioxide SerPl QN: 25 mmol/L (01/20/25 08:08:00) Anion Gap: 9 mmol/L (01/20/25 08:08:00) BUN SerPl QN: 60 mg/dL High (01/20/25 08:08:00) Creatinine SerPl QN: 2.63 mg/dL High (01/20/25 08:08:00) Estimated GFR (CKD-EPI, no race): 18 mL/min/1.73m2 Low (01/20/25 08:08:00) Estimated CRCL (CG): 9 mL/min Low (01/20/25 08:08:00) Glucose SerPl QN: 175 mg/dL High (01/20/25 08:08:00) Calcium Total SerPl QN: 7.4 mg/dL Low (01/20/25 08:08:00) Alkaline Phos SerPl QN: 92 Units/L (01/20/25 08:08:00) ALT SerPl QN: 15 Units/L (01/20/25 08:08:00) AST SerPl QN: 47 Units/L High (01/20/25 08:08:00) Bilirubin Direct SerPl QN: <0.1 (01/20/25 08:08:00) Bilirubin Total SerPl QN: 0.6 mg/dL (01/20/25 08:08:00) Total Protein SerPl QN: 5.1 GM/dL Low (01/20/25 08:08:00) Albumin SerPl QN: 2.5 GM/dL Low (01/20/25 08:08:00) Magnesium SerPl QN: 1.8 mg/dL (01/20/25 08:08:00) Lipase SerPl QN: 4 Units/L Low (01/20/25 08:08:00) Lactate Venous Pl QN: 1.4 mmol/L (01/20/25 11:09:00) All Other Labs: COVID 19 Specimen Source: Nasal (01/20/25 08:29:00) Coronavirus SARS-CoV2 Rapid: Not Detected (01/20/25 08:29:00) Micro - Last 7 days Rapid Influenza Method: PCR - Liat (01/20/25 08:29:00) Rapid Influenza A PCR: Not Detected (01/20/25 08:29:00) Rapid Influenza B PCR: Not Detected (01/20/25 08:29:00) Diagnostics Radiology Results - Last 24 hours Across Visits 01/20/2025 09:17 - CT Abd/Pelvis W/O IV Contrast IMPRESSION: 1. Status post cholecystectomy and hysterectomy and probablyprevious hiatal hernia repair.2. Mild ascites.3. Bilateral nonobstructing nephrolithiasis.4. Diffuse wall thickening of the colon and rectum consistent withcolitis. Signature Line Electronically Signed on 01/20/25 13:46 ________________________________________________________ MD More
✓
2822240 0.5 F FL 01/22/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product storage error Product storage error
none, vaccine was administered past the 10 week EAU expiration date. none, vaccine was administered past the 10 week EAU expiration date.
2822241 12 F PR 01/22/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y007193
U8113BA
CX4HL
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L... Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness More
SUDDEN AND TEMPORARY LOSS OF CONSCIOUSNESS, DIZZINESS SUDDEN AND TEMPORARY LOSS OF CONSCIOUSNESS, DIZZINESS
2822243 80 F FL 01/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, No adverse event Extra dose administered, No adverse event
There were no adverse reactions to this vaccination. The patient got 2 vaccinations instead of on... There were no adverse reactions to this vaccination. The patient got 2 vaccinations instead of one More
2822244 0.17 F FL 01/22/2025 DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
HEP
HEP
HEP
PNC15
PNC15
PNC15
RV5
RV5
RV5
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
HEP
HEP
HEP
PNC15
PNC15
PNC15
RV5
RV5
RV5
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UK109AA
UK109AA
UK109AA
4D333
4D333
4D333
Y002963
Y002963
Y002963
Y005907
Y005907
Y005907
UK109AA
UK109AA
UK109AA
4D333
4D333
4D333
Y002963
Y002963
Y002963
Y005907
Y005907
Y005907
Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticari... Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria; Crying, Erythema, Infant irritability, Joint swelling, Rash; Skin warm, Urticaria; Crying, Infant irritability, Rash, Urticaria More
MOC REPORTS THAT PATIENT HAD A FEVER (99.6 F) ON WEDNESDAY , 1/1/2025. SHE GAVE THE PATIENT INFANT... MOC REPORTS THAT PATIENT HAD A FEVER (99.6 F) ON WEDNESDAY , 1/1/2025. SHE GAVE THE PATIENT INFANT TYLENOL EVERY 4 HOURS FOR 3 DOSES UNTIL THERE IS WAS NO MORE FEVER. ON THURSDAY, 1/2/2025, MOC REPORTS THAT PATIENT WAS DOING BETTER. ON FRIDAY, 1/3/2025, MOC TOOK PATIENT TO THE PRIMARY PROVIDER TO GET VACCINES. ON SATURDAY, 1/4/2025, MOC NOTICED THAT PATIENT BECAME VERY FUSSY AND CRIED A LOT, HOWEVER, SHE WAS CONSOLABLE. ON SUNDAY, 1/5/2025, IN THE MORNING MOC REPORTS THAT PATIENT WAS STILL FUSSY, BUT NOW HAD A RASH ON HER. IT WAS ON BOTH ELBOWS, LEFT PINKIE AND MIDDLE FINGER, RIGHT RING FINGER AND LEFT FOOT AND KNEE WERE RED, HOT AND SWOLLEN. PARENTS TOOK PATINENT TO THE ER FOR FURTHER EVALUATION. MOC REPORTS THAT SHE TOLD THEM THAT PATIENT HAD SHOTS A COUPLE OF DAYS AGO. ER DIAGNOSED PATIENT WITH URTICARIA AND WAS PRESCRIBED PRENISOLONE 15MG/5ML SOLUTION - IN A STEP DOWN REGIMEN FOR 6 DAYS. MOC RPORTS THAT SHE WAS ADVISED TO FOLLOW-UP WITH PATIENT'S PRIMARY PROVIDER. WHEN SHE WENT PATIENT WAS REFERRED TO AN ALLERGIST FOR FURTHER EVALUATION. More
2822245 72 M MO 01/22/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5A4H7
5A4H7
5A4H7
Arthralgia, Asthenia, Bradykinesia, Chills, Dizziness; Feeling abnormal, Headach... Arthralgia, Asthenia, Bradykinesia, Chills, Dizziness; Feeling abnormal, Headache, Heart rate increased, Nausea, Pain in extremity; Tinnitus More
Per patient: I came in Friday 01/17/2025 for my second shot almost exactly 3 months from the first ... Per patient: I came in Friday 01/17/2025 for my second shot almost exactly 3 months from the first shot which I also received the Flu shot for veterans over 65 had absolutely no reaction to these but the shot I received Friday 01/17/2024 time was approximately 16:15 pm I had extreme negative reaction accelerated heart above 100 moving slowly extreme head pain, nausea, extreme, ringing of ears, aches and pains joint, legs, arms, un controlled shivering, very dizzy, no elevated temperature absolutely miserable Friday, Saturday, Sunday general weakness of complete body, some relief Monday and today 01/21/2025 More
2822246 43 F ID 01/22/2025 FLU3
 SEQIRUS, INC.
 391417
No adverse event No adverse event
No known adverse reaction. No known adverse reaction.
2822247 38 M 01/22/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 3042648
3042648
3042648
Arthralgia, Asthenia, Chills, Fatigue, Headache; Lacrimation increased, Malaise,... Arthralgia, Asthenia, Chills, Fatigue, Headache; Lacrimation increased, Malaise, Myalgia, Onychalgia, Pain; Pyrexia, Somnolence More
Muscle pain, joint pain, malaise, weakness, chills, fever, headache, watery eyes, pain in hair and n... Muscle pain, joint pain, malaise, weakness, chills, fever, headache, watery eyes, pain in hair and nails, sleepiness, tiredness. More
2822248 12 F MI 01/22/2025 MENB
 PFIZER\WYETH
 GX1463
Unevaluable event Unevaluable event
N/A N/A
2822249 56 F RI 01/22/2025 PNC20
 PFIZER\WYETH
 HN2630
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Patient reports localized swelling, redness and tenderness at injection site that she first noticed ... Patient reports localized swelling, redness and tenderness at injection site that she first noticed the morning after her injection. Patient first reported the symptoms to the clinic on 1/22/25. At this time the symptoms have improved. More
2822250 52 M WA 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Insomnia Insomnia
Insomnia for night after injection. Insomnia for night after injection.
2822251 6 M CO 01/22/2025 TDAP
 SANOFI PASTEUR
 3CA22C1
No adverse event, Wrong product administered No adverse event, Wrong product administered
Tdap (adacel) 3CA22C1 0.5 mL was given on 12/18/24 to client. Client was 6 years old when dose was g... Tdap (adacel) 3CA22C1 0.5 mL was given on 12/18/24 to client. Client was 6 years old when dose was given. Error was discovered on 01/16/25 when RN had patient again and discovered that wrong vaccine was given. RN notified nurse manager of error and per review of CDC and immunize.org as well as standing orders no harm could come of giving this dose. RN started correct series with Dtap on 1/16/25 and educated client and FOC of client of error and new plan for restarting Dtap series. FOC and client stated understanding and were okay with plan going forward More
2822252 11 F DE 01/22/2025 HPV9
HPV9
FLU3
FLU3
HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y007322
Y007322
U8523da
U8523da
Y007322
Y007322
U8369BA
U8369BA
U8325aa
U8325aa
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Patient already received dose 1 and 2 at ages 9 and 10 respectively. 3rd dose given at 11 incorrectl... Patient already received dose 1 and 2 at ages 9 and 10 respectively. 3rd dose given at 11 incorrectly. More
2822253 70 M WI 01/22/2025 COVID19
 MODERNA
 3043823
Product storage error Product storage error
Patient given vaccine 1/22/25, Use by date for vaccine was 1/21/2025 Patient given vaccine 1/22/25, Use by date for vaccine was 1/21/2025
2822254 50 M PA 01/22/2025 HPV9
HPV9
RSV
RSV
 MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X026926
X026926
7L3ST
7L3ST
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Wrong product administered; No adverse event, Product administered to patient of inappropriate age; No adverse event, Wrong product administered More
Pt was order to be given HPV by provider. Age limit for HPV is 45 and pt is currently 50 years old. ... Pt was order to be given HPV by provider. Age limit for HPV is 45 and pt is currently 50 years old. No adverse effects noted at this time. More
2822256 17 F CO 01/22/2025 HPV9
 MERCK & CO. INC.
 Y012864
Exposure during pregnancy Exposure during pregnancy
Client came in to receive REV vaccine per prescription from provider and following guidance for preg... Client came in to receive REV vaccine per prescription from provider and following guidance for pregnancy during RSV season. Per review of chart RN noticed Flu, COVID and HPV were available to give. RN did not review standing order for HPV at time of vaccination and due to being newer was not thinking about the fact that HPV is not recommended during pregnancy. RN did report to manager after reflecting on vaccines given yesterday on 1/22/2025. Per review of Ask the experts at immunize.org and CDC guidance for HPV vaccination during pregnancy no action is required however due to standing order VAERS is required to be submitted. More
2822257 80 M MN 01/22/2025 COVID19
 PFIZER\BIONTECH
Musculoskeletal disorder, Urinary incontinence Musculoskeletal disorder, Urinary incontinence
Loss of control of legs and urine - lasting about 2 hours. Loss of control of legs and urine - lasting about 2 hours.
2822259 3 F CA 01/22/2025 DTAPIPV
FLU3
HEP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 D947X
FJ47R

2YS34
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Kinrix given to a 3 year old Kinrix given to a 3 year old
2822260 36 F OH 01/22/2025 COVID19
 JANSSEN
 204A21A
Eczema, Embolic stroke, Multisystem inflammatory syndrome in adults Eczema, Embolic stroke, Multisystem inflammatory syndrome in adults
1 week after vaccination I developed full body eczema. Now treated by a dermatologist. Now 3 years l... 1 week after vaccination I developed full body eczema. Now treated by a dermatologist. Now 3 years later I had an embolic stroke at 39 years old likely from multisystem inflammatory syndrome. More
✓ ✓
2822261 10 F MI 01/22/2025 MNQ
 SANOFI PASTEUR
 U8369AA
No adverse event No adverse event
no adverse effects noted no adverse effects noted
2822262 50 F CO 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 58160082311
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria More
Large area redness, swelling, itching, hives, starting five days after injection as baseball-diamete... Large area redness, swelling, itching, hives, starting five days after injection as baseball-diameter area around injection site and traveling down left arm. Some itching relief with topical Cortizone-10 but redness and hives persisted. Some response to Benadryl, but merely temporary; redness/itching continued to spread down the arm for 2 days. Consistent Benadryl use for 6 days showed a response and reaction has abated. Still monitoring for recurrence. More
2822263 63 M FL 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 y009430
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received 3 doses of MMR vaccine instead of 2. Patient has not reported any adverse events at... Patient received 3 doses of MMR vaccine instead of 2. Patient has not reported any adverse events at this time. More
2822264 30 F OH 01/22/2025 COVID19
 MODERNA
 8080797
Injection site pain Injection site pain
Patient received second dose of Moderna 2024-2025 vaccine outside of ACIP protocol (not having immun... Patient received second dose of Moderna 2024-2025 vaccine outside of ACIP protocol (not having immunocompromised state). Patient did not report any S/Es outside of soreness at the injection site. More
2822265 18 F WV 01/22/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
Hepatitis B antibody negative, Incorrect dose administered Hepatitis B antibody negative, Incorrect dose administered
Pt had received Hep B series as an infant, recently had titers drawn that showed no immunity. An ad... Pt had received Hep B series as an infant, recently had titers drawn that showed no immunity. An adult Hep B was administered inadvertently instead of a pediatric dose. More
2822266 48 M GA 01/22/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8015AA
U8015AA
Chills, Dizziness, Headache, Malaise, Pain; Pyrexia Chills, Dizziness, Headache, Malaise, Pain; Pyrexia
Donor reports fever of 101.8 F, Chills, body aches, malaise, dizziness and severe headache. Admits t... Donor reports fever of 101.8 F, Chills, body aches, malaise, dizziness and severe headache. Admits to self admin of Ibuprofen x3. Reports S/S persisted x4 days. More
2822267 53 F FL 01/22/2025 HEPAB
TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 58160-0842-52
58160-0815-52
58160-0823-11
Axillary pain, Pain, Pain in extremity; Axillary pain, Pain, Pain in extremity; ... Axillary pain, Pain, Pain in extremity; Axillary pain, Pain, Pain in extremity; Axillary pain, Pain, Pain in extremity More
Shingrix vaccine given on left arm, feel underarm pain running down to elbow. Pain intensifies when... Shingrix vaccine given on left arm, feel underarm pain running down to elbow. Pain intensifies when lifting left arm up. More
2822268 65 F FL 01/22/2025 PNC20
 PFIZER\WYETH
 LC5482
Extra dose administered, No adverse event Extra dose administered, No adverse event
Prevnar 20 only approved as a single one time dose. Patient received one dose on 03/11/2023, and ano... Prevnar 20 only approved as a single one time dose. Patient received one dose on 03/11/2023, and another on 01/21/2025. Patient hasn't reported any side effects but dose was given outside series recommendation. More
2822270 F VA 01/22/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 34MF9
Wrong product administered Wrong product administered
Patient was due 15 month old immunizations. Dtap/IPV was ordered and given rather than DTAP/Hib Patient was due 15 month old immunizations. Dtap/IPV was ordered and given rather than DTAP/Hib
2822271 18 F CA 01/22/2025 COVID19
HEPA
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 LP1776
4T93R
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
This report is to provide notification of a medication error only. The 18 y/o client was inadvertent... This report is to provide notification of a medication error only. The 18 y/o client was inadvertently given Havrix vaccine indicated for adults 19 years old ad above. The patient did not experience any adverse effects. The client was monitored post vaccination, without consequence, and notified of the error. More
2822272 1 F 01/22/2025 VARCEL
 MERCK & CO. INC.
 X00100
Expired product administered, No adverse event Expired product administered, No adverse event
Varicella immunization expired on 1/9/25 and given in error to patient on 1/14/25. No adverse reacti... Varicella immunization expired on 1/9/25 and given in error to patient on 1/14/25. No adverse reactions noted. More
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