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
2844545 M GA 06/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 md3414
md3414
Chills, Fatigue, Headache, Injection site erythema, Injection site swelling; Mya... Chills, Fatigue, Headache, Injection site erythema, Injection site swelling; Myalgia, Nausea, Pyrexia, Vomiting More
Muscle spasms / chest pain Muscle spasms / chest pain
2844546 73 F GA 06/10/2025 COVID19
 PFIZER\BIONTECH
 md3414
Cheilitis, Eye swelling, Rash Cheilitis, Eye swelling, Rash
Swollen eye, rash on lips and hips Swollen eye, rash on lips and hips
2844547 0.58 M MT 06/10/2025 DTPPVHBHPB
HEPA
MMR
PNC20
RV1
 MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U7801BA
C24B9
X026404
HR3650
2032349
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
patient had no adverse reactions, hep A shot was given too early patient had no adverse reactions, hep A shot was given too early
2844548 51 F 06/10/2025 PNC20
 PFIZER\WYETH
 LX4482
Extra dose administered Extra dose administered
Patient received PREVNAR 20 on 3/13/23 and on 6/4/25. Based on ACIP guidelines patient was not indic... Patient received PREVNAR 20 on 3/13/23 and on 6/4/25. Based on ACIP guidelines patient was not indicated for the second dose of PREVANR 20. More
2844549 70 F 06/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 kr75k
Extra dose administered, No adverse event Extra dose administered, No adverse event
vaccine not documented in database from 2024. Pharmacist reviewed file and patient came in requestin... vaccine not documented in database from 2024. Pharmacist reviewed file and patient came in requesting vaccine. Since there was no record in database pharmacist administered. Patient reported no adverse effects More
2844550 78 F AZ 06/10/2025 RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 00069-2465-10
00069-2465-10
00069-2465-10
Asthenia, Blood test, Chills, Craniofacial fracture, Dysstasia; Electrocardiogra... Asthenia, Blood test, Chills, Craniofacial fracture, Dysstasia; Electrocardiogram, Fall, Haemorrhage, Internal haemorrhage, Magnetic resonance imaging neck; Sepsis, Skin laceration More
Got chill on right side of body around 8:30 pm night of vaccination. Fell on 3/6/2025 @ 4:30am, cou... Got chill on right side of body around 8:30 pm night of vaccination. Fell on 3/6/2025 @ 4:30am, could not get up, bleeding in several locations, gash on head, broke bridge of nose. Laid on floor till 10:30am when friends came and called 911. Taken to hospital; had internal bleeding and sepsis. Released from hospital on 3/11. Paid out-of-pocket for very expensive 24/7 care for 5+ weeks. Still working to build strength and stamina More
โœ“
2845054 0.17 F FL 06/10/2025 DTAPHEPBIP
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 9D25P
Y017360
Crying, Injection site erythema, Injection site swelling; Crying, Injection site... Crying, Injection site erythema, Injection site swelling; Crying, Injection site erythema, Injection site swelling More
The patient had continuous, inconsolable crying for 3hr after vaccination. It was accompanied by a l... The patient had continuous, inconsolable crying for 3hr after vaccination. It was accompanied by a local reaction consisting of redness & swelling at the injection site. More
2844275 MT 06/09/2025 MMRV
 MERCK & CO. INC.
 Y010930
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported.; HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product... No symptoms reported.; HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product experienced a temperature excursion on 19MAY2025.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-MAY-2025, a temperature excursion occurred at a temperature of 10.5 Fahrenheit during a time frame of 1 hour. On 23-May-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, lot #Y010930; which has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal validation establish as 14-DEC-2025 and with the sterile diluent (BAXTER STERILE DILUENT) 0.5 mL, lot #1950636; which has been verified to be valid, expiration date reported and upon internal validation establish as 22-JAN-2026, 0.5 mL, both administered for prophylaxis (dose number, vaccination site scheme, route and anatomical site of administration were not provided) (Product storage error). No previous temperature excursion. No symptoms reported (No adverse event). More
2844276 CO 06/09/2025 MEN
 UNKNOWN MANUFACTURER
Extra dose administered Extra dose administered
Patient given a 3rd dose of meningococcal by mistake last week, with no reported adverse event; Init... Patient given a 3rd dose of meningococcal by mistake last week, with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non healthcare professional). This case involves a patient with unknown age and gender patient who was given a 3rd dose of Meningococcal Vaccine by mistake last week, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose (dose 3) of suspect Meningococcal Vaccine produced by unknown manufacturer (lot number, expiry date and formulation not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and received 3rd dose by mistake last week, with no reported adverse event (inappropriate schedule of product administration) (latency same day). Reportedly, they did speak with the dad a few days ago and did report it and as per him. patient was feeling fine. Was there anything I need to do. 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
2844282 4 M MO 06/09/2025 DTAPIPV
IPV
MMRV
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.



Injection site reaction, Injection site swelling; Injection site reaction, Injec... Injection site reaction, Injection site swelling; Injection site reaction, Injection site swelling; Injection site reaction, Injection site swelling; Injection site reaction, Injection site swelling More
Extreme swelling and redness of arm. Started Saturday. Increasingly got worse. Extreme swelling and redness of arm. Started Saturday. Increasingly got worse.
2844283 13 M CA 06/09/2025 HPV9
 MERCK & CO. INC.
 1965079
Craniofacial fracture, Fracture reduction, Syncope Craniofacial fracture, Fracture reduction, Syncope
The patient was sitting on the patient table/bed for the vaccine, as per protocol for pediatric pati... The patient was sitting on the patient table/bed for the vaccine, as per protocol for pediatric patients for the nurse to get a good landmark of the upper arm to administer the vaccine. Vasovagal syncope occurred seconds (within the minute) after the vaccine was administered. The exact time reported under patient information may not be accurate, but it was definitely within the minute after the vaccine was administered. The patient fell off the patient table/bed after the vasovagal syncope and broke his nose. He quickly regained conscious after the fall. He had visits with the ENT doctor and required "closed reduction of nasal fracture" on 6/18/24. The patient did not return to our clinic after the vaccine, so I am not aware of any longterm outcomes. More
2844284 82 F HI 06/09/2025 COVID19
 MODERNA
 3043391
Fatigue, Genital herpes, Stomatitis Fatigue, Genital herpes, Stomatitis
Extreme fatigue and malaise began 05/10/25 and is ongoing. Mouth sores from 06/01/25 to 06/07/25. ... Extreme fatigue and malaise began 05/10/25 and is ongoing. Mouth sores from 06/01/25 to 06/07/25. Multiple outbreaks of genital herpes continuously without a day's break from 05/25 to 06/08/25 and ongoing. Outbreaks were in 5 different locations. I have had herpes for 50 years and this is the worst continuous outbreak since my very first one 50 years ago. More
2844287 27 MO 06/09/2025 RAB
 SANOFI PASTEUR
Malocclusion, Off label use Malocclusion, Off label use
intentional off label prescription by hcp: imovax is prescribed with off label diagnosis open bite o... intentional off label prescription by hcp: imovax is prescribed with off label diagnosis open bite of unspecified upper arm, initial encounter with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 27 years old and unknown gender patient was prescribed IPV (Vero) [movax] with off label diagnosis open bite of unspecified upper arm, initial encounter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed 1ML dose of suspect IPV (Vero) (once) Powder for Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for open bite of unspecified upper arm, initial encounter [bite] (off label use). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, Imovax was prescribed with off label diagnosis code S41.159A Open bite of unspecified upper arm. Action taken was not applicable. No follow-up is possible as Reporter cannot be contacted by Sanofi More
2844290 12 M TN 06/09/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8494AA
U8232AA
Blood glucose normal, Heart rate decreased, Pallor, Vertigo; Blood glucose norma... Blood glucose normal, Heart rate decreased, Pallor, Vertigo; Blood glucose normal, Heart rate decreased, Pallor, Vertigo More
Low HR-42 O2-100% BP 86/52 - 5 min post vaccine admin. Pallor Vertigo Low HR-42 O2-100% BP 86/52 - 5 min post vaccine admin. Pallor Vertigo
2844321 M AZ 06/09/2025 HEPA
 MERCK & CO. INC.
 X026485
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; Customer called and reported that a dose of VAXTA expired on 5/11/2025 and was adm... No adverse event; Customer called and reported that a dose of VAXTA expired on 5/11/2025 and was administered on 5/15/2025. No temperature excursions through date of administration. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from an Other health professional and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X026485, expiration date: 11-May-2025) 1 mL for prophylaxis (Expired product administered). There were no temperature excursions through date of administration. No additional AE was reported (No adverse event). More
2844322 4 F MN 06/09/2025 DTAP
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Gait disturbance, Injection site erythema, Injection site swelling; Gait disturb... Gait disturbance, Injection site erythema, Injection site swelling; Gait disturbance, Injection site erythema, Injection site swelling More
swelling; getting red/red rash; Limping; This spontaneous report was received from a Consumer or oth... swelling; getting red/red rash; Limping; This spontaneous report was received from a Consumer or other non health professional via Sanofi and refers to a 4-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Dupixent (Dupilumab). Concomitant therapies were not reported. On 16-Apr-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dose, lot # and expiration date were not reported) reconstituted with sterile diluent (DSM STERILE DILUENT), (lot # and expiration date were not reported). On 16-Apr-2025, the patient started therapy with Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (lot # and expiration date were not reported). On 16-Apr-2025, the patient experienced Limping and continued limping on 17-Apr-2025. On 18-Apr-2025, the patient experienced swelling. On 18-Apr-2025, patient's leg started swelling and getting red. Caregiver said there was swelling and a red rash near patient's inner thigh and knee area on her left leg. Caregiver said one of the immunizations was administered into patient's upper outer thigh on the left leg, but she could not confirm if it was the DTaP or MMR administered into that leg. At the reporting time, the patient had not recovered from Limping, swelling and getting red/red rash. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. The action taken with Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid). The causal relationship between the event of Limping and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of swelling and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was unknown/not reported/not provided. The causal relationship between the event of Limping and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of swelling and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and sterile diluent was unknown/not reported/not provided. The causal relationship between the event of Limping and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided. The causal relationship between the event of getting red/red rash and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided. The causal relationship between the event of swelling and Dtap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) was unknown/not reported/not provided. More
2844323 F MD 06/09/2025 PNC21
 MERCK & CO. INC.
Headache, Mobility decreased Headache, Mobility decreased
immobility; Merk Employee calling on behalf of HCP to report an AE for CAPVAXIVE. HCP reported that... immobility; Merk Employee calling on behalf of HCP to report an AE for CAPVAXIVE. HCP reported that the their pharmacy administered a dose of CAPVAXIVE, and following the administration, the patient developed a "severe headache and immobility." HCP also reporte; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered intramuscularly (IM) (lot # and expiration date were not reported) for Streptococcus pneumoniae prophylaxis. On an unknown date in May 2025 (reported as sometime last weekend), following the administration, the patient developed a severe headache and immobility. HCP also reported that the patient had to be taken to the emergency room following the administration. No other symptoms or side effects were reported. The outcome of the events was not reported. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of immobility was determined to be medically significant. Lot# is being requested and will be submitted if received. More
2844324 IN 06/09/2025 VARCEL
 MERCK & CO. INC.
 X011424
Expired product administered Expired product administered
No additional AE; administration of expired VARIVAX to a patient; Information has been received from... No additional AE; administration of expired VARIVAX to a patient; Information has been received from Business Partner/CRO on 06-Jun-2025. This spontaneous report was received from a/an Physician Assistant and refers to a(n) 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 06-Jun-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #X011424, expiration date: 19-Apr-2025). On 06-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of prophylaxis. On 06-Jun-2025, the patient experienced administration of expired VARIVAX to a patient. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of administration of expired VARIVAX to a patient and No additional AE was unknown. The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. More
2844325 51 F NY 06/09/2025 COVID19
 MODERNA
Audiogram, Autoimmune inner ear disease, Condition aggravated, Deafness unilater... Audiogram, Autoimmune inner ear disease, Condition aggravated, Deafness unilateral More
worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss; worsening of autoimm... worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss; worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss; Unilateral hearing loss; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) in a 51-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Autoimmune inner ear disease. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) (seriousness criterion medically significant), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) (seriousness criterion medically significant) and DEAFNESS UNILATERAL (Unilateral hearing loss) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Audiogram: prior audiograms were available to confirm the acute change in hearing that was temporally related to COVID-19 exposure and audiometric confirmation of an asymmetric hearing loss. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered AUTOIMMUNE INNER EAR DISEASE (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss), CONDITION AGGRAVATED (worsening of autoimmune inner ear disease (AIED)/ asymmetric flat hearing loss) and DEAFNESS UNILATERAL (Unilateral hearing loss) to be related. Concomitant medications were not reported. The patient had asymmetric flat hearing loss post vaccination. The hearing loss was related to vaccine. The patient had previous hearing decline unrelated to vaccine. There was no hearing recovery with steroids. Reported that immune-mediated hearing loss (IMHL) patients (comprised of autoimmune inner ear disease (AIED) and sudden sensorineural hearing loss (SSNHL)) may be at higher risk for hearing loss following Coronavirus disease (COVID-19) infection and/or vaccination. This study compared inflammatory cytokine expression in response to SARS-CoV2 spike protein between two groups of patients with IMHL: IMHL patients that temporally demonstrated worsening SNHL following COVID vaccination or infection as compared to IMHL patients with worsening SNHL unrelated to COVID exposure: (IMHL-COVID (?+)) (n?=?11) (IMHL-COVID (-)) (n?=?10). Two groups, treated isolated PBMCs with increasing amounts of SARS-CoV-2 spike protein and compared responses to stimulation with positive and negative controls. IMHL-COVID (+) group is further broken down into 6 patients with AIED that experienced prior hearing declines over a several year period prior to COVID-19 exposure and 5 patients with SSNHL temporally related to COVID-19 exposure with no prior history of acute hearing loss. Patients were enrolled at the time of their office visit reporting a decline in hearing, and blood was collected if audiometric confirmation of an asymmetric hearing loss was obtained. All patients were queried as to COVID-19 exposure, COVID-19 vaccination history, and hearing health history of IMHL which included prior diagnoses of SSNHL, AIED or Meniere's Disease. The hearing losses all occurred between 2021 and 2023. All patients had PBMC harvested immediately prior to the institution of corticosteroid therapy. The time interval between the index event of perceived loss and clinical evaluation and enrollment was highly variable, from 1 day to several months, however the perceived hearing change had to have occurred within a two-week period following infection/vaccination to be considered for enrollment. Informed consent was provided by all enrolled patients prior to entering a subject into the study. Peripheral Blood Mononuclear Cells (PBMC) from IMHL-COVID (?+) patients had increased expression and release of both IL-1๏ฟฝ and IL-6 in response to spike protein as compared to IMHL-COVID (-) patients. However, when the IMHL-COVID (?+) group was broken down into AIED patients compared to SSNHL, it became apparent that the greatest responses were from the AIED patients. When reporter broke down the COVID (?+) group to infection versus vaccination, the immune responses in the infection group (N?=?3 AIED, 1 SSNHL) were stronger. SARS-CoV-2 spike protein at 12 ๏ฟฝg/ml concentration showed robust release of IL-6 in infection group (around sixfold) when compared to the vaccination group. SARS-CoV-2 spike protein showed dose-dependent release of IL-1Ra in both groups. Spike protein at 12 ๏ฟฝg/ml concentration showed much greater release of IL-1Ra in infection group when compared to the vaccination group This study concluded that COVID-19 exposure with reported changes in hearing sensitivity in IMHL patients resulted in pro-inflammatory responses in response to spike protein. The inflammatory responses were greatest in AIED patients, and greater following infection rather than vaccination. This case was linked to US-MODERNATX, INC.-MOD-2025-786805 (E2B Linked Report).; Reporter's Comments: Patients underlying condition of Autoimmune inner ear disease is a risk factor for the events. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786805:61-Year-old Female patient (Same Report) More
2844326 06/09/2025 COVID19
 MODERNA
COVID-19 COVID-19
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient had a problem with the vaccine. Patient never had the Pfizer vaccine but had Moderna. Patient was asking about Paxlovid, medication taken after COVID. No treatment medication was reported. Reporter did not allow further contact More
2844327 0.17 M OH 06/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Wrong product administered Wrong product administered
PER DOCUMENTATION OF REPORTER, THE INCORRECT VACCINE WAS O RDERED AND WAS ADMINISTERED TO PATIENT. ... PER DOCUMENTATION OF REPORTER, THE INCORRECT VACCINE WAS O RDERED AND WAS ADMINISTERED TO PATIENT. WERE NOTIFIED OF MISTAKE. More
2844328 12 M MI 06/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
No adverse event, Wrong product administered No adverse event, Wrong product administered
Incorrect vaccine given. No immediate adverse reaction or symptoms. Incorrect vaccine given. No immediate adverse reaction or symptoms.
2844329 1 M MI 06/09/2025 HEPA
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014585
Z002990
Erythema multiforme; Erythema multiforme Erythema multiforme; Erythema multiforme
Erythema multiforme Erythema multiforme
2844330 59 F NC 06/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5T42
Burning sensation, Pain, Paraesthesia, Urticaria Burning sensation, Pain, Paraesthesia, Urticaria
About an hour or so after vaccination, I felt burning stings on my left shoulder, down my trunk left... About an hour or so after vaccination, I felt burning stings on my left shoulder, down my trunk left side and then across my back. It was an experience similar to being bitten by fire ants. Large welts came up like insect bites across all those referenced sites. I removed clothing and showered in case it was insects. Needle prick sensation and welts continued for about 90 minutes. I took 2 antihistamine tablets and some tylenol which helped. 2 days later, those welts are still visible and remain a little itchy. Antihistamines continue to help. More
2844331 67 M VA 06/09/2025 PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH







Blood test, Pneumonia; Atrial fibrillation, Blood pressure decreased, Blood test... Blood test, Pneumonia; Atrial fibrillation, Blood pressure decreased, Blood test, Cerumen impaction, Deafness bilateral; Drug ineffective, Ejection fraction decreased, Impaired work ability, Intensive care, Pneumonia; Weight decreased; Blood test, Pneumonia; Atrial fibrillation, Blood pressure decreased, Blood test, Cerumen impaction, Deafness bilateral; Drug ineffective, Ejection fraction decreased, Impaired work ability, Intensive care, Pneumonia; Weight decreased More
Vaccinated on 4/24/2025 - diagnosis with pneumonia on 5/26/2025 - hospital stay from 5/25/25 until 6... Vaccinated on 4/24/2025 - diagnosis with pneumonia on 5/26/2025 - hospital stay from 5/25/25 until 6/6/25. More
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2844332 66 F IN 06/09/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness More
right arm redness, warmth, swelling on 6/8/25, mild intermittent pain right upper arm, tender and st... right arm redness, warmth, swelling on 6/8/25, mild intermittent pain right upper arm, tender and stiff, treatment: ice back on/off, can take ibuprofen or tylenol, follow up in 4-5 days is needed More
2844333 63 F FL 06/09/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 4KF75
Expired product administered Expired product administered
Patient was given an expired vaccine- patient reports no issues Patient was given an expired vaccine- patient reports no issues
2844334 0.5 M IL 06/09/2025 MMR
 MERCK & CO. INC.
 Y019108
Blood glucose, Brief resolved unexplained event, Electrocardiogram, Febrile conv... Blood glucose, Brief resolved unexplained event, Electrocardiogram, Febrile convulsion, Laboratory test More
Patient seen in the ER after presumed febrile seizure and BRUE on 6/5/25. Patient seen in the ER after presumed febrile seizure and BRUE on 6/5/25.
2844335 70 F GA 06/09/2025 TD
TD
 SANOFI PASTEUR
SANOFI PASTEUR

Abdominal distension, Injection site erythema, Injection site pain, Injection si... Abdominal distension, Injection site erythema, Injection site pain, Injection site scab, Injection site swelling; Injection site warmth More
Large swelling at injection site. Redness and hot to touch. Day 2 swelling was size of golf ball and... Large swelling at injection site. Redness and hot to touch. Day 2 swelling was size of golf ball and very tender. Day three swelling was the size of an orange and redness had spread around the shoulder to midway to elbow. Today 6/9/25 swelling down to size of a quarter and still red. Also sight of injection has scabs around injection sight. More
2844336 51 F TN 06/09/2025 PNC20
TDAP
VARZOS
 PFIZER\WYETH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 LC5485
U8115AA
E754F
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
BEGAN HAVING REDNESS AND SWELLING AT SHOT SITE THAT BEGAN TO GET VERY HOT AND SWELL TO PAST HER ELBO... BEGAN HAVING REDNESS AND SWELLING AT SHOT SITE THAT BEGAN TO GET VERY HOT AND SWELL TO PAST HER ELBOW DESPITE ICE PACKS, BENADRYL AND OTHER COMFORT MEASURES. NOW CLAIMS TO HAVE SWELLING AND TIGHTNESS TO HER RIGHT JAW. CALLED HER PCP TODAY AND AM AWAITING A CALL BACK FOR FURTHER TREATMENT DECISIONS More
2844337 74 F NC 06/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 pj353
Fatigue, Injection site erythema, Injection site pain, Injection site swelling, ... Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Night sweats More
Patient started to notice her skin felt hot, and also was sore. She kept a long sleeve shirt on and ... Patient started to notice her skin felt hot, and also was sore. She kept a long sleeve shirt on and didnt think much about it. She stated on sunday am she put a short sleeve shirt on. That is when she discovered a red, raised, hot to the touch rash on the same arm the vaccine was given. It was under the injection site. it went down 4 inches and was 2.5 inches wide, located medial to inner arm. When she woke up the night after the vaccine she did experience night sweats, and felt fatigue with a sore arm. More
2844338 1.33 F MA 06/09/2025 HIBV
 SANOFI PASTEUR
 UK210AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
Given the diluent without the actual medication mixed, no adverse reaction Given the diluent without the actual medication mixed, no adverse reaction
2844339 35 F CO 06/09/2025 UNK
 UNKNOWN MANUFACTURER
Confusional state, Dizziness, Headache, Lethargy, Myalgia Confusional state, Dizziness, Headache, Lethargy, Myalgia
Headache, dizziness, muscle aches, confusion, lethargic Headache, dizziness, muscle aches, confusion, lethargic
2844340 11 F NC 06/09/2025 HPV9
HPV9
HPV9
MNQ
MNQ
MNQ
TDAP
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y012508
Y012508
Y012508
U8375AB
U8375AB
U8375AB
U8274AA
U8274AA
U8274AA
Blood glucose normal, Fall, Flushing, Head injury, Headache; Heart rate decrease... Blood glucose normal, Fall, Flushing, Head injury, Headache; Heart rate decreased, Hyperhidrosis, Nystagmus, Seizure, Subdural haematoma; Subdural haematoma evacuation, Vomiting projectile; Blood glucose normal, Fall, Flushing, Head injury, Headache; Heart rate decreased, Hyperhidrosis, Nystagmus, Seizure, Subdural haematoma; Subdural haematoma evacuation, Vomiting projectile; Blood glucose normal, Fall, Flushing, Head injury, Headache; Heart rate decreased, Hyperhidrosis, Nystagmus, Seizure, Subdural haematoma; Subdural haematoma evacuation, Vomiting projectile More
Patient had possible seizure activity after vaccine administration. The incident happened after pati... Patient had possible seizure activity after vaccine administration. The incident happened after patient exited the room. She fell and hit the floor. Medic was called right away. Patient believed to have hit her head, but unwitnessed fall. Immediately patient began moving arms and legs in a rhythmic motion with nystamus. Patient positioned onto her side and patient placed on heart rate and spo2 monitor. SP02 at 100, but heart rate decreased to low 50-60s. Patient had convulsion like movements lasting approximately 2 minutes. During this time, patient SP02 remained 100 but heart rate decreased to 50-60s bpm. At end of two minutes, patient stopped making repetitive movements and patient began trying to get up and saying her head hurt. Patient was diaphoretic with flushed cheeks. We kept patient on floor and continued watching her movements and VS. Blood glucose taken during event and it was 104mg/DL. During this time patient was able to answer where she was, her name, she stuck out her tongue, pupils were equal, round,and reactive, patient wiggled fingers and toes. Upon arrival of medic, report given then when they attempted to place cervical collar on patient, she projectile vomited. Once collar was secured, patient placed on stretcher and given versed by medic. Last VS taken in office SP02 99% and HR 62. Mom left with medic for Transporation to Hospital More
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2844341 0.33 F TN 06/09/2025 RV5
 MERCK & CO. INC.
 2124039
Intussusception, Ultrasound scan, Vomiting Intussusception, Ultrasound scan, Vomiting
Pt started vomiting 05/30/2025. Diagnosed with intussusception on 05/31/2025 at ER Pt started vomiting 05/30/2025. Diagnosed with intussusception on 05/31/2025 at ER
2844342 5 M OH 06/09/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8493AA
3CA22C1
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
PATIENT WAS SUPPOSED TO RECEIVE THEIR DTAP AND IPV VACCINE. PATIENT WAS ACCIDENTALLY GIVE TDAP AND ... PATIENT WAS SUPPOSED TO RECEIVE THEIR DTAP AND IPV VACCINE. PATIENT WAS ACCIDENTALLY GIVE TDAP AND MCV4 VACCINE INSTEAD. More
2844343 0.33 M NY 06/09/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 77J49
77J49
77J49
Dyspnoea, Feeling cold, Injection site erythema, Injection site swelling, Lethar... Dyspnoea, Feeling cold, Injection site erythema, Injection site swelling, Lethargy; Moaning, Pain, Pallor, Pyrexia, Screaming; Vomiting More
Body cold, fever in head, pale skin, injection area was swollen, temperature 103 at hospital, blood ... Body cold, fever in head, pale skin, injection area was swollen, temperature 103 at hospital, blood pressure 240BPM, panting, redness and swelling at the injection site, screaming in pain at times and moaning and lethargic at other times, vomiting. At hospital his vitals were checked, they administered a tylenol suppository then motrin to reduce the fever, fever broke shortly after being breast fed More
2844344 56 M KS 06/09/2025 COVID19
COVID19
 MODERNA
MODERNA

Cerebrovascular accident; Cerebrovascular accident Cerebrovascular accident; Cerebrovascular accident
Stroke august 2021 and december 2021 Stroke august 2021 and december 2021
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2844345 62 F CO 06/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Erythema Erythema
Patient arm was red on sunday and went to urgent care. They thought it was possibly cellulitis and g... Patient arm was red on sunday and went to urgent care. They thought it was possibly cellulitis and gave her an antibiotic. More
2844346 16 F NC 06/09/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
DD72H
Burning sensation, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Para... Burning sensation, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia; Tenderness More
Significant left arm pain and numbness. S/P Meningitis B vaccine 5 days ago. Exquisite pain to palp... Significant left arm pain and numbness. S/P Meningitis B vaccine 5 days ago. Exquisite pain to palpation. Radial distribution neuropathy with burning, numbness, and tingling. Cold compress and tylenol without improvement - r/o post vaccine rhabdo More
2844347 64 F SC 06/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 2ME34
Underdose Underdose
Patient came in for Hep B vaccine was signed out and review by other medical staff, under dosage err... Patient came in for Hep B vaccine was signed out and review by other medical staff, under dosage error was not capture until it was being documented, proper medical staff was made aware on the incident, patient was notified, patient verbalized understanding the error that had accrued and understood that she was not in any harm base on her labs results. More
2844348 17 M AZ 06/09/2025 HEPA
HPV9
MENB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 A3XZK
Y007191
TH9NR
3RE73
Syncope; Syncope; Syncope; Syncope Syncope; Syncope; Syncope; Syncope
Pt waited 15 minutes, pt experienced a syncope episode while giving the vaccines, pt was given a jui... Pt waited 15 minutes, pt experienced a syncope episode while giving the vaccines, pt was given a juice. Pt monitored for 15 minutes, Pt had no reaction after that. Pt and guardians informed to hold off remaining vaccines for another day in-clinic. Pt guardians stated that pt has a hx of syncope with blood draws after syncope episode occurred and after consent was given. Vaccine verified by LPN. More
2844349 1.25 M MD 06/09/2025 EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
EBZR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
LP4946
Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test... Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test negative, Injection site erythema; Injection site pain, Injection site scab, Irritability, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Body temperature increased, Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test negative; Injection site erythema, Injection site pain, Injection site reaction, Injection site scab, Irritability; Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test negative, Injection site erythema; Injection site pain, Injection site scab, Irritability, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative; Body temperature increased, Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test negative; Injection site erythema, Injection site pain, Injection site reaction, Injection site scab, Irritability; Respiratory syncytial virus test negative, SARS-CoV-2 test negative More
Parents noted fussiness a few hours after the vaccine was given on 6/4/2025. Patient was fussy. He f... Parents noted fussiness a few hours after the vaccine was given on 6/4/2025. Patient was fussy. He felt warm and had a temp 102-104 by temporal thermometer. Patient got a bath and Motrin. His right thigh was red and swollen and tender the evening of 6/4/25. On 6/5/2025 Patient was seen in our office at approximately 3:30pm and patient was walking, had decreased po intake that day, no rash and seemed to be improving. Site coloration was bluish-red; minimally tender over of 2cmx1cm on right lateral thigh with central 1-mm diameter scab. This overlies firm muscle of about 4x3cm. He has FROM and walked well. No bleeding, no other rash. Parent did take patient to the ER on 6/5/2025 approximately 9pm for complaint of a fever. ER gave Acetaminophen and patient responded and was discharged. More
2844350 81 F NC 06/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y4TL
Injection site erythema, Injection site pain, Injection site swelling, Limb inju... Injection site erythema, Injection site pain, Injection site swelling, Limb injury More
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- More
2844351 72 F PA 06/09/2025 COVID19
 MODERNA
 3043334
Fatigue, Lethargy Fatigue, Lethargy
Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient stated she gets tired after receiv... Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient stated she gets tired after receiving vaccines at times bit was not specific as to which More
2844353 69 F TX 06/09/2025 COVID19
 MODERNA
 3042558
Asthma, COVID-19, Condition aggravated, Dyspnoea Asthma, COVID-19, Condition aggravated, Dyspnoea
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: COVID-19/Asthma Flare-Severe, Additional ... Systemic: Allergic: Difficulty Breathing-Severe, Systemic: COVID-19/Asthma Flare-Severe, Additional Details: Patient had COVID-19 and an Asthma Flare which required steroids and antibiotics More
2844354 68 F CA 06/09/2025 COVID19
 MODERNA
 8080799
Malaise Malaise
Systemic: Patient says she always gets sick every time she gets a COVID vaccine. Patient did not ela... Systemic: Patient says she always gets sick every time she gets a COVID vaccine. Patient did not elaborate on symptoms.-Medium, Additional Details: Patient says she always gets sick every time she gets a COVID vaccine. Patient did not elaborate on symptoms. More
2844355 79 M MD 06/09/2025 COVID19
 MODERNA
 3042560
Injection site pain Injection site pain
Site: Pain at Injection Site-Mild, Additional Details: Patient stated that every time he has gotten ... Site: Pain at Injection Site-Mild, Additional Details: Patient stated that every time he has gotten a covid vaccination he has experienced soreness at the site of injection that has resolved in a few days. He indicated that the intensity and duration has decreased with every vaccine. More
2844356 75 M MD 06/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NY749
Influenza like illness, Pyrexia Influenza like illness, Pyrexia
Systemic: Fever-Mild, Additional Details: Patient stated that after his 1st dose of the shingrix, he... Systemic: Fever-Mild, Additional Details: Patient stated that after his 1st dose of the shingrix, he felt like he had the flu for 1 day More
2844357 68 M IN 06/09/2025 COVID19
 MODERNA
 3043153
Chills, Feeling abnormal, Influenza like illness, Pain, Pyrexia Chills, Feeling abnormal, Influenza like illness, Pain, Pyrexia
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional... Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: AE reported by wife. Reported fever, feeling miserable, achiness, and flu-like feeling for 24 hours after vaccine and then resolved More
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