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
2837134 69 M GA 04/21/2025 COVID19
 PFIZER\BIONTECH
 lp1780
Injection site bruising, Injection site pain Injection site bruising, Injection site pain
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium
2837135 41 F OH 04/21/2025 HEP
HPV9
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.

Arthralgia, Injected limb mobility decreased, Pain in extremity, Spinal pain; Ar... Arthralgia, Injected limb mobility decreased, Pain in extremity, Spinal pain; Arthralgia, Injected limb mobility decreased, Pain in extremity, Spinal pain More
Received vaccines on 02/21/25. Patient reported left shoulder/arm pain and decreased ROM in left arm... Received vaccines on 02/21/25. Patient reported left shoulder/arm pain and decreased ROM in left arm to facility staff on 3/5/25. Also pain in left back, hip and thigh. MD ordered prednisone. Pt reported steroids help but still has pain in lower spine and shoulder as of 3/25/25. Prednisone reordered on 4/8/25. More
2837136 39 M WI 04/21/2025 HEP
MMR
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
 945664
Y015022
Loss of consciousness, Pallor, Underdose, Unresponsive to stimuli; Loss of consc... Loss of consciousness, Pallor, Underdose, Unresponsive to stimuli; Loss of consciousness, Pallor, Underdose, Unresponsive to stimuli More
Heplisav vaccine was administered into left deltoid. A few minutes passed as immunizer prepared seco... Heplisav vaccine was administered into left deltoid. A few minutes passed as immunizer prepared second vaccine. Administration of MMR vaccine into left arm (subcutaneous) was initiated and patient became pale and then unresponsive for a few seconds. Needle was withdrawn before entire dose administered. Patient appeared to lose consciousness for a few seconds (<10). When patient was able to respond to immunizer, he was assisted to elevate his feet and remain seated. Pharmacist provided a cool cloth for patient's face and neck. Patient was full coherent and reported that he felt fine and that this had happened before when he was much younger. Pharmacist remained with patient for about 5 minutes before he was allowed to move to waiting area for further observation. Patient remained at pharmacy for about 20 additional minutes with no additional symptoms. More
2837138 73 F MA 04/21/2025 PNC15
 MERCK & CO. INC.
Injection site oedema, Injection site reaction, Local reaction, Oedema periphera... Injection site oedema, Injection site reaction, Local reaction, Oedema peripheral More
severe local reaction :approx 8 x 20 cm , noted below injection site and circling upper left arm. ... severe local reaction :approx 8 x 20 cm , noted below injection site and circling upper left arm. edema of upper and lower left arm More
2837139 42 F NC 04/21/2025 HEPA
 MERCK & CO. INC.
Underdose Underdose
Patient given pediatric dose of Hep A Patient given pediatric dose of Hep A
2837140 43 F AK 04/21/2025 FLU3
FLU3
HEP
HEP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8518DA
U8518DA
944914
944914
X449Y
X449Y
Contusion, Injection site bruising, Injection site discolouration, Injection sit... Contusion, Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling; Iron deficiency anaemia; Contusion, Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling; Iron deficiency anaemia; Contusion, Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling; Iron deficiency anaemia More
Onset of pain, swelling and bruising 24 hours after Tdap given on L arm. Swelling and bruising still... Onset of pain, swelling and bruising 24 hours after Tdap given on L arm. Swelling and bruising still present on 4/9/25, area measured at 3 cm x 2 cm. Slight swelling and discoloration still present on 4/21/25. Onset of bruising 24 hours after Flu and Hep B given on R arm, no swelling or pain. Bruising still present on 4/9/25, measured at 2 cm x 2 cm. Discoloration still present on 4/21/25. Bruising at L forearm PPD site with same time line as immunizations. More
2837141 14 F ID 04/21/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y007197
Y007197
U8375AA
U8375AA
U8252AA
U8252AA
Apnoea, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity,... Apnoea, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity, Pallor; Unresponsive to stimuli; Apnoea, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity, Pallor; Unresponsive to stimuli; Apnoea, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity, Pallor; Unresponsive to stimuli More
Patient received immunization, all questions were answered. Patient was assisted to a chair by her m... Patient received immunization, all questions were answered. Patient was assisted to a chair by her mom to wait the suggested 15 minutes in the clinic immediately following the shots. She requested water and the nurse stepped out of the room to get the water. Within 5 seconds patients mom yelled for help. Nurse returned to the room immediately and found patient unconscious, pale, entire body rigid, hands clenched into fists and not breathing. Nurse yelled patients name, shook her head and shoulders and lightly tapped cheeks for response. Patient did not respond and nurse yelled for the CSR at the front desk to call "Dr." over the intercom (page for medical emergency). 6-7 personnel responded from within the building to the call and by this time patient was awake and responsive. Patient was unresponsive for approximately a total of 15-20 seconds. Patient was helped to the exam table. Patient was able to confirm, date, place and her name; her color returned, and she was given orange juice. Vital signs were 76/43, pulse 44, respirations 12 at 10:16am. Provider,FNP-BC, APRN, came into the room to assess patient and obtain hx from patient's mom. After the visit, patient and mom were given the following instructions: Do not leave patient unattended, especially in places like the shower, for the next 48 hours and to seek medical attention for headache or another episode and to report this event to her pediatrician. Mom stated she understood. Vital Signs at 10:23 99/64, pulse 56 and respirations 12. Patient left with her mom at 10:42. Nurse left a message on phone number listed on the consent Friday 4/18/25 and Monday 4/21/25 to have mom call back to give update on her daughter. No returned phone call has been received. More
2837142 66 F SC 04/21/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y011819
3334Y
Injection site reaction, Rash erythematous, Rash pruritic; Injection site reacti... Injection site reaction, Rash erythematous, Rash pruritic; Injection site reaction, Rash erythematous, Rash pruritic More
Patient reported today at routine doctor's appointment. S/s: right arm localized injection site... Patient reported today at routine doctor's appointment. S/s: right arm localized injection site, red itchy rash More
2837143 76 M AZ 04/21/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 MD3414
MD3414
Pruritus; Pruritus, Skin disorder; Pruritus; Pruritus, Skin disorder Pruritus; Pruritus, Skin disorder; Pruritus; Pruritus, Skin disorder
After 7 hours from the administered vaccine Patient noticed he has an itchy 4 small dots size of a q... After 7 hours from the administered vaccine Patient noticed he has an itchy 4 small dots size of a quarter on his left forearm (forming letter J).He said it must have been an allergic reaction/ rash from the covid shot. Patient said he is applying an OTC diphenhydramine cream and today, 04/21/2025 it's a size of a penny, More
2837144 1.25 M PA 04/21/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y015995
Y019319
Pyrexia, Rash, Rash erythematous, Rash papular; Pyrexia, Rash, Rash erythematous... Pyrexia, Rash, Rash erythematous, Rash papular; Pyrexia, Rash, Rash erythematous, Rash papular More
Rash - pink, raised rash from head to toe, fever Rash - pink, raised rash from head to toe, fever
2837145 16 M MN 04/21/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 HD2729
U8370AA
Headache, Hypoaesthesia, Migraine, Nausea; Headache, Hypoaesthesia, Migraine, Na... Headache, Hypoaesthesia, Migraine, Nausea; Headache, Hypoaesthesia, Migraine, Nausea More
1-2 hours later patient began complaining of an extreme headache and feeling numb. He is nauseous bu... 1-2 hours later patient began complaining of an extreme headache and feeling numb. He is nauseous but has not vomited. Has a history of migraines but states this is worse than any migraine he has had. Has not had a migraine in a couple of years per family report. More
2837146 69 M TN 04/21/2025 COVID19
 PFIZER\BIONTECH
 lp1780
Expired product administered Expired product administered
vacine expired 2 days prior 4/19/2025 vacine expired 2 days prior 4/19/2025
2837147 70 F WI 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L5P2
Erythema, Lymphadenopathy, Peripheral swelling, Rash, Rash pruritic Erythema, Lymphadenopathy, Peripheral swelling, Rash, Rash pruritic
developed small red, raised dot on arm over next couple days, progressed into patchy and itchy rash ... developed small red, raised dot on arm over next couple days, progressed into patchy and itchy rash down entire arm, some swelling of local lymph nodes. Improved with Benadryl but not yet resolved (as of ~6 days post vaccination) More
2837148 66 F FL 04/21/2025 PNC20
 PFIZER\WYETH
 LC1281
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Redness around the injection site; pain to the touch Redness around the injection site; pain to the touch
2837149 F MD 04/21/2025 DTAP
HIBV
PNC20
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
PFIZER\WYETH


Paralysis; Paralysis; Paralysis Paralysis; Paralysis; Paralysis
she had like a type of palsy; This is a spontaneous report received from an Other HCP from medical i... she had like a type of palsy; This is a spontaneous report received from an Other HCP from medical information team. A 15-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in thigh for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), as dose number unknown, single) for immunisation; hib vaccine conj (tet tox) (ACT HIB), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "she had like a type of palsy". The patient underwent the following laboratory tests and procedures: Specialist consultation: allergist think there was an egg or animal, notes: component that could have caused the episode. It was unknown if therapeutic measures were taken as a result of paralysis. Reporter was unable to clarify palsy further to include location on body. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event palsy was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
2837150 F CO 04/21/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Stillbirth Exposure during pregnancy, Stillbirth
Delivered a stillborn baby at 37 weeks; This is a spontaneous report received from a Nurse. A 35-ye... Delivered a stillborn baby at 37 weeks; This is a spontaneous report received from a Nurse. A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing). The patient was 37 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: STILLBIRTH (medically significant) with onset Mar2025, outcome "unknown", described as "Delivered a stillborn baby at 37 weeks". The pregnancy resulted in still birth. This was the patient's second pregnancy. The reporter stated that a friend of hers received the RSV vaccine and delivered a stillborn baby about a month ago. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event stillbirth and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500078577 mother/ baby case; More
2837151 37 M 04/21/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Myelin oligodendrocyte glycoprotein antibody-associated disease, Visual acuity t... Myelin oligodendrocyte glycoprotein antibody-associated disease, Visual acuity tests; Myelin oligodendrocyte glycoprotein antibody-associated disease, Visual acuity tests More
diagnosed with MOGAD; This is a spontaneous report received from a Consumer or other non HCP. A 38-... diagnosed with MOGAD; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Feb2025 as dose number unknown, single) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (prolonged hospitalization, disability) with onset 07Apr2025, outcome "not recovered", described as "diagnosed with MOGAD". The patient prolonged hospitalization for myelin oligodendrocyte glycoprotein antibody-associated disease (hospitalization duration: 10 day(s)). The patient underwent the following laboratory tests and procedures: Visual acuity tests: (13Apr2025) like 85, notes: His vision was much better. Therapeutic measures were taken as a result of myelin oligodendrocyte glycoprotein antibody-associated disease. The clinical course was reported as follows: The patient was diagnosed with Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The exact cause was not fully understood but the neurologist thought it may have been triggered by the flu vaccine and covid booster. As a symptom of MOGAD, the patient had optic neuritis which was inflammation in the optic nerve and it was causing some vision loss, eye pain, and headache. He lost vision in his left eye (his right eye was not great either) and had headaches and eye pain. He got seven rounds of steroids (last one on 02Apr2025) to help reduce the inflammation and it was really helping. He started having headaches and eye pain again this week and he lost vision in his right eye fully on 09Apr2025. He went to get steroids on 12Apr2025 to help with inflammation. His vision was much better at like 85% on 13Apr2025. Still in hospital and receiving steroids, rounds of plasmapheresis and inebilizumab-cdon. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
โœ“ โœ“
2837152 04/21/2025 COVID19
 PFIZER\BIONTECH
Loss of consciousness, Syncope Loss of consciousness, Syncope
Fainting; passing out; This is a spontaneous report received from a Consumer or other non HCP. A pa... Fainting; passing out; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passing out". Clinical course: Reporter wanted to know if fainting or like passing out, is a long-term effect of the Pfizer vaccination after receiving the vaccine a couple of years ago. Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question. When probed to clarify if reporter is having the side effects after the vaccine, reporter stated, "Well not myself but someone close to me and I was just wondering I am not 'going in or' anything, I do not have the 'fax', but I was just wondering if it could be connected with the Pfizer." was reporting for someone else No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837153 F 04/21/2025 COVID19
 PFIZER\BIONTECH
Inappropriate sinus tachycardia, Postural orthostatic tachycardia syndrome, Sync... Inappropriate sinus tachycardia, Postural orthostatic tachycardia syndrome, Syncope More
Fainting; POTS; inappropriate sinus tachycardia; This is a spontaneous report received from a Consum... Fainting; POTS; inappropriate sinus tachycardia; This is a spontaneous report received from a Consumer or other non HCP. A 23-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Concomitant vaccines and prior vaccinations within 4 weeks were none. The following information was reported: SYNCOPE (disability), outcome "not recovered", described as "Fainting"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability), outcome "not recovered", described as "POTS"; INAPPROPRIATE SINUS TACHYCARDIA (disability), outcome "not recovered". The clinical course was reported as follows: The patient experienced fainting, and was diagnosed with postural orthostatic tachycardia syndrome (POTS) and inappropriate sinus tachycardia after receiving vaccine. She had been healthy prior to this. The patient took medication to treat the events. Therapeutic measures were taken as a result of syncope, postural orthostatic tachycardia syndrome, inappropriate sinus tachycardia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
โœ“
2837154 M NV 04/21/2025 COVID19
 PFIZER\BIONTECH
Cerebrovascular accident, Cognitive disorder Cerebrovascular accident, Cognitive disorder
suffered a stroke; permanent cognitive problems; This is a spontaneous report received from a Consum... suffered a stroke; permanent cognitive problems; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "suffered a stroke"; COGNITIVE DISORDER (disability), outcome "not recovered", described as "permanent cognitive problems". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
โœ“
2837156 F ME 04/21/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LP1776
UT8485MA
Chills, Dissociation, Hallucination, Headache, Tremor; Chills, Dissociation, Hal... Chills, Dissociation, Hallucination, Headache, Tremor; Chills, Dissociation, Hallucination, Headache, Tremor More
mild hallucinations; disassociation/not being fully aware of where she was; an extreme headache has ... mild hallucinations; disassociation/not being fully aware of where she was; an extreme headache has settled that has lasted since 09Apr2025; chills; shakes; This is a spontaneous report received from a Consumer or other non HCP. A 45-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Apr2025 at 15:00 as dose 1, single (Lot number: LP1776), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 08Apr2025 as dose 1, single (Lot number: UT8485MA), in left arm for immunisation. The patient's relevant medical history included: "Just occasional heartburn" (unspecified if ongoing). Concomitant medication(s) included: HEPLISAV B taken for immunisation, on 01Apr2025 as dose 2, single; TDAP taken for immunisation, on 01Apr2025 as dose 1, single; TYPHOID VACCINE POLYSACCH VI taken for immunisation, on 01Apr2025 as dose 1, single; VITAMIN D NOS, start date: 26Mar2025; SIMPESSE, start date: 27Mar2025; OMEPRAZOLE, start date: 04Apr2024. Vaccination history included: Heplisav b (Dose 1), for Immunization. The following information was reported: CHILLS (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025); TREMOR (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025), described as "shakes"; HEADACHE (non-serious) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "an extreme headache has settled that has lasted since 09Apr2025"; DISSOCIATION (non-serious) with onset 09Apr2025 at 13:00, outcome "recovered" (Apr2025), described as "disassociation/not being fully aware of where she was"; HALLUCINATION (medically significant) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "mild hallucinations". The events "mild hallucinations", "disassociation/not being fully aware of where she was" and "an extreme headache has settled that has lasted since 09apr2025" required emergency room visit. Therapeutic measures were taken as a result of hallucination, dissociation, headache. Clinical details: The next morning after taking the two vaccines, she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 09Apr2025. She was having mild hallucinations the first couple days, not being fully aware of where she was. Went to urgent care, they prescribed Fioricet, which has stopped the disassociation, but has not touched the actual headache. The patient had none known allergies. More
2837157 54 F TX 04/21/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 33036BD
33036BD
33036BD
33036BD
COVID-19, Drug ineffective; Arthralgia, Meniscus injury, Muscle disorder, Myalgi... COVID-19, Drug ineffective; Arthralgia, Meniscus injury, Muscle disorder, Myalgia, Rheumatoid arthritis; COVID-19, Drug ineffective; Arthralgia, Meniscus injury, Muscle disorder, Myalgia, Rheumatoid arthritis More
got the covid virus around Dec2022; got the covid virus around Dec2022; This is a spontaneous report... got the covid virus around Dec2022; got the covid virus around Dec2022; This is a spontaneous report received from a Consumer or other non HCP. A 55--old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8736), in left arm, on 06May2021 as dose 2, single (Lot number: ER8736), in left arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "got the covid virus around Dec2022". Clinical course: Got covid virus after her second shoulder surgery, which is probably around Christmas time after her second shoulder surgery, got the COVID virus around Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500081919 Same patient and product; different dose and events; More
2837160 F NV 04/21/2025 COVID19
 PFIZER\BIONTECH
Death Death
died; This is a spontaneous report received from a Consumer or other non HCP. A female patient rece... died; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: died More
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2837176 60 M NY 04/21/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
Anxiety, Autophony, Blood pressure fluctuation, Chills, Dysphonia; Hypoaesthesia... Anxiety, Autophony, Blood pressure fluctuation, Chills, Dysphonia; Hypoaesthesia, Muscular weakness, Nerve conduction studies normal, Pain in extremity, Paraesthesia; Scan, Sensory disturbance, Trismus More
Blood pressure fluctuation; chattering in jaw; sensation of a hair being on his face; voice has chan... Blood pressure fluctuation; chattering in jaw; sensation of a hair being on his face; voice has changed; inner shivering; can hear myself talking; weakness in both legs; Numbness in leg/left toes numb/bottom falls asleep; pins and needles in legs and feet; Anxiety; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included covid-19 (received 3 COVID-19 vaccinations and states he did test positive for COVID (date not provided.)). Previously administered products included COVID-19 vaccine (on an unknown date received). On 08-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 10-MAR-2025, 2 days after receiving Shingrix, the patient experienced numbness in leg (Verbatim: Numbness in leg/left toes numb/bottom falls asleep), pins and needles (Verbatim: pins and needles in legs and feet) and anxiety (Verbatim: Anxiety). On 11-MAR-2025, the patient experienced lower extremities weakness of (Verbatim: weakness in both legs), jaw movements disturbance (Verbatim: chattering in jaw), sensory disturbance (Verbatim: sensation of a hair being on his face), voice alteration (Verbatim: voice has changed), shivering (Verbatim: inner shivering) and autophony (Verbatim: can hear myself talking). On an unknown date, the patient experienced blood pressure fluctuation (Verbatim: Blood pressure fluctuation). The outcome of the numbness in leg, pins and needles, anxiety, lower extremities weakness of, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony were not resolved and the outcome of the blood pressure fluctuation was unknown. It was unknown if the reporter considered the numbness in leg, pins and needles, anxiety, lower extremities weakness of, blood pressure fluctuation, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony to be related to Shingrix. It was unknown if the company considered the numbness in leg, pins and needles, anxiety, lower extremities weakness of, blood pressure fluctuation, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony to be related to Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The patient had dose of Shingrix and two days after receiving the vaccine his left leg felt numb and was tingling. On the third day the sensation of numbness and tingling was present in both legs. He began to experience muscle weakness and pain in both legs. The patient reports he was experiencing a chatter in his jaw, inner shivering, he can hear himself talking, he has the sensation a hair was on his face, his voice has changed (which he states might be due to the anxiety that he was now feeling,) states his bottom falls asleep and describes this a as feeling that have been driving too long. States when drive too long bottom, legs and feet might feel numb. States normally were able to walk around and that sensation goes away, however, the sensation of numbness, tingling and pain has not gone away no matter how long he attempts to walk it off. At the time of the call the patient states his left toes were numb. The patient states he has reported this to the vaccinating pharmacist at he scheduled an appointment with his primary care provider. He had an appointment with Cardiology and four appointments with Neurology. The neurologist did examination and conducted nerve tests and ruled out Guillain-Barre Syndrome. The patient states he was referred to the hospital where he had scans done and he was released. Diagnosis/comments/what images were taken from scans not provided. The patient was very concerned because he received Shingrix approximately one month ago from reporting date and the adverse events experienced have not resolved. The patient states he did not receive any other vaccination along with Shingrix vaccine. The patient states neurologist prescribed Gabapentin for symptoms of numbness, tingling and pain (dose/frequency not provided) but the patient states he has not taken the medication. The patient was concerned he would present with a case of Guillain-Barre Syndrome and was very anxious about his adverse events not resolving. This case was linked with case US2025041543 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025041543:Same reporter 1 of 2 More
2837177 F 04/21/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test; CO... COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test; COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test More
Interchange of vaccine products; COVID/we were both positive; COVID/we were both positive; This is a... Interchange of vaccine products; COVID/we were both positive; COVID/we were both positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Feb2024, outcome "unknown" and all described as "COVID/we were both positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: The reporter and her husband got a box (Paxlovid) about a year and a half ago because they were going on vacation and then they didn't use it. Her husband brought COVID home from the gym on Friday (16Feb2024) and on Saturday (17Feb2024), patient started to feel sick. Yesterday (19Feb2024), the they took the test and they were both positive so they shared the beginning of the first box (Paxlovid). The area was supposed to have really high covid at time of report. The patient and her husband had all the vaccines, every single one of them. She didn't have any reaction to Pfizer. The last one was Moderna: it was the only one she had a reaction to. It wasn't terrible, patient woke up feeling like she was hit by a truck, everything aches and that was it (Moderna). The patient added "I mean it's not like the worst reaction I have ever had to anything which was much worse than a little sore arm." Amendment: This follow up report is being submitted to amend previously reported information: reporter contact information added, suspect vaccine name was updated from BNT162B2 NOS to BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)).; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500039883 Same reporter, product, and event; different patient; More
2837178 04/21/2025 COVID19
 PFIZER\BIONTECH
Asthma Asthma
a single person with severe asthma experienced worsening symptoms; The initial case was missing the ... a single person with severe asthma experienced worsening symptoms; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 15Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "a single person with severe asthma experienced worsening symptoms". Additional information: In a 2021 case study, a single person with severe asthma experienced worsening symptoms following the second dose of the Pfizer-BioNTech vaccine. However, researchers were not able to definitively establish a cause-and-effect relationship and were unable to draw conclusions based on a single case study. More research is necessary to determine whether any relationship exists. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837179 M CA 04/21/2025 COVID19
 PFIZER\BIONTECH
General physical health deterioration General physical health deterioration
health dwindling/ health is worse; This is a spontaneous report received from a Consumer or other no... health dwindling/ health is worse; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "health dwindling/ health is worse". Therapeutic measures were not taken as a result of general physical health deterioration. Additional information: The patient was calling about the first dose and second dose of the COVID vaccine. He is just curious since he got the first dose in 2020 or 2021. Then he got the second dose right after that from clinic. Confirms both doses were the Pfizer COVID vaccine which he received from clinic. States it is still three years later and he is still trying to decide what was in the vaccine. With his body he was a very healthy individual before the vaccine, and after had a large downslide with his health after the second dose. He did not really have time or economic stability to confront the situation. Basically wanted to know what was in in the vaccine and why his health dwindled after the second dose. He was asking what can be derived about this, he was just looking for information. When querying medical conditions states he was smoking. He was overworked. Treatment: No. He was able to work through it but his body did not like whatever the vaccine was. When querying when his health started dwindling, clarifies that he felt this pretty immediately within two weeks after the first dose. Then he got the second dose thinking it was just the vaccine doing its job. Outcome: health is worse since got the vaccine, he is referring to both doses. He does not know if its coincidental. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500081832 Same patient/product/event; different dose; More
2837180 M 04/21/2025 COVID19
 PFIZER\BIONTECH
General physical health deterioration General physical health deterioration
health dwindling/ health is worse/ had a large downslide with his health; This is a spontaneous repo... health dwindling/ health is worse/ had a large downslide with his health; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Sep2021, for COVID-19 immunisation. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "health dwindling/ health is worse/ had a large downslide with his health". Additional information: Patient was calling about the first dose and second dose of the covid vaccine. He is just curious since he got the first dose in 2020 or 2021. Then he got the second dose right after that from clinic. Confirms both doses were the Pfizer covid vaccine which he received from clinic. States it is still three years later and he is still trying to decide what was in the vaccine. With his body he was a very healthy individual before the vaccine, and after had a large downslide with his health after the second dose. He did not really have time or economic stability to confront the situation. Basically wants to know what it is in the vaccine and why his health dwindled after the second dose. He is asking what can be derived about this, he is just looking for information. Declined to provide address. States he can be followed up with via phone. He has heard two scenarios with his position, clarifies that he heard that the first dose had mu metal in it and then also heard that the second dose may have formaldehyde in it which is an embalming fluid, asking if this is true. He is not sure where his vaccine card is. When querying when his health started dwindling, clarifies that he felt this pretty immediately within two weeks after the first dose. Then he got the second dose thinking it was just the vaccine doing its job. Outcome: health is worse since got the vaccine, he is referring to both doses. He does not know if its coincidental. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2837182 0.33 F MO 04/21/2025 DTAPIPV
DTAPIPVHIB
 SANOFI PASTEUR
SANOFI PASTEUR
 U7931AB
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
she gave the wrong medication to a 4-month old patient/patient received QUADRACEL and a HIB vaccine,... she gave the wrong medication to a 4-month old patient/patient received QUADRACEL and a HIB vaccine, but the patient was supposed to receive PENTACEL, with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 4 months old female patient to whom received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] and a hib vaccine, instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine (Hib) Rotavirus vaccine and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 09-Apr-2025, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 09-Nov-2025 and lot U7931AB) via intramuscular route in the left vastus lateralis as immunization instead of Pentacel with no reported adverse event (wrong product administered) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2837183 8 F WA 04/21/2025 IPV
 SANOFI PASTEUR
 X1C891M
No adverse event, Product storage error No adverse event, Product storage error
Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30 minutes and administered with no adve... Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30 minutes and administered with no adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 years old female patient who received IPV (VERO) [IPOL] that exposed to max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine for Immunisation. On 10-Apr-2025, the patient received Dose 3 of 0.5 ml of suspect IPV (VERO) Suspension for injection of standard strength once with lot X1C891M and expiry date 31-Oct-2026 via intramuscular route in the right deltoid for Immunisation. 04-Apr-2025, the suspect IPV (VERO) exposed to max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes and administered with no adverse event (product storage error) (unknown latency) Reportedly, Human error involved. No previous excursion. Extended stability data did not cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 02490903: US-SA-2025SA113179: US-SA-2025SA113172:Master case More
2837184 19 F WA 04/21/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
Temperature excursion/temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC for 30 minutes with no reported adve... Temperature excursion/temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC for 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to master case US-SA-2025SA112035. This case involves a 19 years old female patient who was administered Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] after temperature excursion/temperature reached: 8.5 ๏ฟฝc (Degree Celsius) to 8.8 ๏ฟฝc for 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Nurse called to report a temperature excursion that occurred on 04-Apr-2025. On 14-Apr-2025, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion Vaccine Suspension for injection (lot U8442BA, Expiry: 20-Jun-2025) (Strength: Standard) via intramuscular route in the left deltoid as Influenza immunization that had temperature excursion/temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc for 30 minutes with no reported adverse event (product storage error). Human error: yes Reportedly, No adverse events were noted. There was no previous excursion and extended stability data does not cover the excursion. Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA112035:Master case More
2837185 22 F WA 04/21/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
product administered after excursion with no adverse event; Temperature excursion/temperature reache... product administered after excursion with no adverse event; Temperature excursion/temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC with 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA112035 This case involves a 22 years old female patient to whom INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] product administered after excursion with no adverse event and temperature excursion/temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc with 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-APR-2025 temperature excursion/temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc with 30 minutes with no reported adverse event (product storage error). On 15-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE dose 0.5 ml 1x(once) Suspension for injection (strength standard) lot U8442BA Expiry date-20-Jun-2025 via intramuscular route in the left deltoid for Influenza immunization, product administered after excursion with no adverse event (poor quality product administered) (latency same day). Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA112035: US-SA-2025SA113170: US-SA-2025SA113835: US-SA-2025SA113257: US-SA-2025SA113846: US-SA-2025SA113850: US-SA-2025SA114290: More
2837186 36 F WA 04/21/2025 FLU3
 SANOFI PASTEUR
 U8442BA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion: negative disposition with human error max/low temperature reached: 8.5 ๏ฟฝc t... temperature excursion: negative disposition with human error max/low temperature reached: 8.5 ๏ฟฝc to 8.8, duration: 30 minutes with no reported adverse event; Fluzone was administered to patient post excursion with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA112035, US-SA-2025SA113179, US-SA-2025SA113850. This case involves a 36 years old female patient who was exposed to temperature excursion: negative disposition with human error max/low temperature reached: 8.5 ๏ฟฝc to 8.8, duration: 30 minutes with no reported adverse event and influenza usp trival a-b subvirion vaccine [Fluzone] was administered to patient post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received 0.5 ml dose of suspect influenza usp trival a-b subvirion vaccine Suspension for injection lstrength- standard) (lot U8442BA and expiry date- 20-JUN-2025) via intramuscular route in the right deltoid for Influenza (Influenza immunization) and temperature excursion: negative disposition with human error max/low temperature reached: 8.5 ๏ฟฝc to 8.8, duration: 30 minutes with no reported adverse event (product storage error) and fluzone was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency- same day). Treatment: None given. No adverse events were reported Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113850: US-SA-2025SA113376: US-SA-2025SA113846: US-SA-2025SA113257: US-SA-2025SA113835: US-SA-2025SA113170: US-SA-2025SA113172: US-SA-2025SA112035: US-SA-2025SA113257: More
2837187 1.25 F NY 04/21/2025 HIBV
 SANOFI PASTEUR
 UK025AA
Expired product administered, No adverse event Expired product administered, No adverse event
administered act-hib to a 15-month-old patient and it was already expired on 31mar2025 with no repor... administered act-hib to a 15-month-old patient and it was already expired on 31mar2025 with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient for whom HIB (PRP/T) vaccine [ACT-HIB], administered already expired on 31-Mar-2025 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 hepatitis a vaccine and pneumococcal vaccine both for Immunisation. On 17-Apr-2025, the patient received an unknown dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UK025AA with expiry date 31-MAR-2025) via intramuscular route in the thigh NOS (Not Otherwise Specified) for Immunization, administered already expired on 31-Mar-2025 with no reported adverse event (expired product administered). 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
2837188 OH 04/21/2025 HIBV
 SANOFI PASTEUR
 UK025AA
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to administration of expired vaccine with no reported adverse event; Initial i... inappropriate use due to administration of expired vaccine with no reported adverse event; Initial information received on 18-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient to whom received administration of expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On ana unknown date In 2025, the patient received a expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: unknown, expired date: 31-Mar-2025 and lot UK025AA via unknown route in unknown administration site as immunization with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2837189 KY 04/21/2025 HIBV
 SANOFI PASTEUR
 UK010AA
Expired product administered, No adverse event Expired product administered, No adverse event
Expired ACT-HIB vaccine was administered to a patient with no reported adverse event; Initial inform... Expired ACT-HIB vaccine was administered to a patient with no reported adverse event; Initial information received on 18-Apr-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and unknown gender patient to whom expired HIB (PRP/T) Vaccine [ACT-HIB] was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient received unknown expired dose of suspect HIB (PRP/T) VACCINE (lot- UK010AA and expiry date- 28-Feb-2025) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency- same day). Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2837190 50 F NC 04/21/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y013009
MG5S9
Erythema, Injection site pain, Pyrexia, Skin warm, Swelling; Erythema, Injection... Erythema, Injection site pain, Pyrexia, Skin warm, Swelling; Erythema, Injection site pain, Pyrexia, Skin warm, Swelling More
PATIENT STATED SHE STILL HAD FEVER, SWELLING, REDNESS, AND ARM HOT TO TOUCH POST 72 HOURS VACCINATIO... PATIENT STATED SHE STILL HAD FEVER, SWELLING, REDNESS, AND ARM HOT TO TOUCH POST 72 HOURS VACCINATION. PATIENT WAS ADVISED TO CONTINUE OTC TYLENOL, IBUPROFEN AND ALSO ADVISED TO ADD COLD COMPRESS AND START OTC ANTIHISTAMINE LIKE BENADRYL OR CLARITIN. PATIENT WAS FOLLOWING UP WITH PCP TODAY SINCE THE PAIN AT THE INJECTION SITE WAS NOT GOING AWAY AND THE REDNESS AND SWELLING WAS NOT EITHER AND BECAUSE ARM WAS STILL HOT TO THE TOUCH. More
2837191 77 F OH 04/21/2025 COVID19
 PFIZER\BIONTECH
Burning sensation, Rosacea Burning sensation, Rosacea
Roseacea on cheeks burning sensation (like sunburn but I am wearing sunblock). Slight temperatures 9... Roseacea on cheeks burning sensation (like sunburn but I am wearing sunblock). Slight temperatures 98.9. No other illness symptoms More
2837192 69 F WA 04/21/2025 PNC21
 MERCK & CO. INC.
 y011819
Inflammation, Pruritus Inflammation, Pruritus
after 5 days of getting vaccine, she had inflammation of they arm and itching, lasting over 2 weeks after 5 days of getting vaccine, she had inflammation of they arm and itching, lasting over 2 weeks
2837199 77 F FL 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Extra dose administered Extra dose administered
PATIENT RECIEVED 3 DOSES OF SHINGRIX VACCINE ON 09/14/2023,11/27/2023 AND 02/07/2025 PATIENT RECIEVED 3 DOSES OF SHINGRIX VACCINE ON 09/14/2023,11/27/2023 AND 02/07/2025
2837200 73 M FL 04/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 N77J2
Extra dose administered Extra dose administered
Patient received 3 doses of Shingrix vaccines 09/14/2023,11/27/2023 and 02/074/2025 Patient received 3 doses of Shingrix vaccines 09/14/2023,11/27/2023 and 02/074/2025
2837201 54 F NC 04/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Pyrexia, Rash, Swelling, Type III immune complex mediated reaction, Urticaria Pyrexia, Rash, Swelling, Type III immune complex mediated reaction, Urticaria
Arthus Reaction including Fever. Treatment in Urgent Care with OTC medication for Fever. Decadron in... Arthus Reaction including Fever. Treatment in Urgent Care with OTC medication for Fever. Decadron injection for rash/hives/swelling with the following recommendations: You were seen today for a probable reaction to the Tdap vaccine you received last week. You were given a steroid injection in the clinic and prescribed an oral steroid to take daily. Take the medication exactly as directed and be sure to finish the full course, even if your symptoms start to improve. You should also take Benadryl around the clock for the next two days. After that, you may take over-the-counter Benadryl as needed. To help your skin heal, place cool, wet cloths on the affected areas. Avoid scratching, as this can worsen the irritation or cause an infection. Try not to rub or put pressure on the rash. Stay away from soaps, perfumes, dyes, or any products with added fragrances, as these can further irritate the skin. Use lukewarm water when bathing, as hot water can dry out your skin and make the rash worse. We will report this reaction to the Vaccine Adverse Event Reporting System (VAERS) on your behalf. Keep your scheduled appointment with your primary care provider tomorrow. You should also follow up again after you complete the steroid treatment to make sure all of your symptoms have resolved. More
2837202 13 F CA 04/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 f5l5e
Expired product administered Expired product administered
expired vaccine administered expired vaccine administered
2837204 0.83 M KS 04/21/2025 MMRV
 MERCK & CO. INC.
 Y0191773
Injection site pain, Product administered to patient of inappropriate age, Pyrex... Injection site pain, Product administered to patient of inappropriate age, Pyrexia More
This child was given the MMRV at 10 months instead of waiting until a year. There were no adverse re... This child was given the MMRV at 10 months instead of waiting until a year. There were no adverse reactions. Had normal reaction of low grade fever and soreness at the injection site. No other s/s per parent. Merck Co to be contacted 4/22/2025. More
2837205 62 F OR 04/21/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LG5579
99HE4
Pruritus, Rash, Swelling of eyelid; Pruritus, Rash, Swelling of eyelid Pruritus, Rash, Swelling of eyelid; Pruritus, Rash, Swelling of eyelid
3 days after receiving vaccine, patient developed a rash on her forehead. The rash progressively g... 3 days after receiving vaccine, patient developed a rash on her forehead. The rash progressively got bigger and dry. Her left eye swollen shut. Daughter reported the reaction and stated that the patient has not reported to the doctor and is trying to wait it out. Patient had been taking Benadryl 4-5 days ago and applied OTC Hydrocortisone on the rash for the itchiness. More
2836912 31 F CO 04/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9L944
9L944
Brain fog, Chills, Dizziness, Fatigue, Injection site erythema; Injection site p... Brain fog, Chills, Dizziness, Fatigue, Injection site erythema; Injection site pruritus, Injection site swelling, Pain, Pain in jaw, Pyrexia More
Dizziness, body aches, sudden jolts of pain in jaw, fatigue, brain fog, chills, fever, local swellin... Dizziness, body aches, sudden jolts of pain in jaw, fatigue, brain fog, chills, fever, local swelling/redness/inching at injx site. Started 2 hours after injx, still ongoing though improving as of 4/19 More
2836913 5 F WA 04/20/2025 MMR
 MERCK & CO. INC.
Headache, Lethargy Headache, Lethargy
All day headache and lethargy All day headache and lethargy
2836914 77 F MA 04/20/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Injection site bruising, Injection site haemorrhage Injection site bruising, Injection site haemorrhage
MD OFFICE CALLED PHARMACY TO INFORM PHARMCY THAT PATIENT'S SISTER CALLED MD OFFICE ON 4/16/25 A... MD OFFICE CALLED PHARMACY TO INFORM PHARMCY THAT PATIENT'S SISTER CALLED MD OFFICE ON 4/16/25 AND STATED PATIENT RECEIVED VACCINE ON 4/10/25 AND THE SITE WAS BLEEDING AND BRUISED. 4/16/25 MD STATED UNCERTAIN HOW LONG OR HOW MUCH BLED BUT BLEEDING HAS ALREADY STOPPED ON 4/16/25 More
2836915 81 M VA 04/20/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 3043823
3043823
3043823
Blood test, Chest X-ray, Computerised tomogram head, Computerised tomogram neck,... Blood test, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Disorientation; Electrocardiogram, Gait disturbance, Inflammation, Magnetic resonance imaging, Middle insomnia; Pyrexia, Urine analysis More
103 fever followed by middle of the night awakening with prolonged disorientation and a stiff gait. ... 103 fever followed by middle of the night awakening with prolonged disorientation and a stiff gait. At 3am, he believed it was morning (despite it still being dark outside) and got dressed to go run errands. Wife called 911 and he was taken to Hospital Center and admitted for stroke protocol. After CT scan and MRI confirmed no evidence of stroke, he was discharged and told the disorientation and gait issues were the likely result of an inflammatory response to the Moderna vaccine received the day prior. Prior COVID vaccines resulted in fever and body aches but no similar disorientation and gait issues. More
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2836916 0.33 M MI 04/20/2025 DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
PNC15
PNC15
RV5
RV5
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
PNC15
PNC15
RV5
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 B532G
B532G
3A2KF
3A2KF
Y010032
Y010032
2052020
2052020
B532G
B532G
3A2KF
3A2KF
Y010032
Y010032
2052020
2052020
Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arr... Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation; Cardiac arrest, Resuscitation; Cardiac arrest, Death, Resuscitation More
Cardiac arrest at home while sleeping. Ultimately achieved return of circulation in the ED after 30+... Cardiac arrest at home while sleeping. Ultimately achieved return of circulation in the ED after 30+ minutes of CPR. Concern for myocarditis as a potential cause of cardiac arrest. More
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