πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2862879 64 F SC 10/02/2025 FLU3
 SANOFI PASTEUR
 U8823BA
Feeding disorder, Impaired work ability, Malaise Feeding disorder, Impaired work ability, Malaise
Became extremely sick. I had to report to my job of my absenteeism. Could not eat or drink any flui... Became extremely sick. I had to report to my job of my absenteeism. Could not eat or drink any fluids. More
2862880 71 M NC 10/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 B5NJ9
Extra dose administered Extra dose administered
Patient received second dose of AREXVY on 10/02/2025 at Pharmacy. Patient received the first dose of... Patient received second dose of AREXVY on 10/02/2025 at Pharmacy. Patient received the first dose of AREXVY was given on 10/25/2023 at Pharmacy. CDC guidelines recommend one dose of RSV vaccine per lifetime. More
2862881 57 F IN 10/02/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.
 406995
Z007870
Injection site erythema, Injection site pruritus, Injection site swelling, Pain ... Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity; Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity More
Patient received Flucelvax and Capvaxive vaccines one inch apart in left arm. Patient had significan... Patient received Flucelvax and Capvaxive vaccines one inch apart in left arm. Patient had significant soreness in that arm and developed swelling, redness, and itching at the injection site and under her arm the next day. Patient says ibuprofen helps relieve the pain. More
2862882 82 F VA 10/02/2025 COVID19
 MODERNA
 3053253
Wrong product administered Wrong product administered
Pt received Spikevax 6mo-11 years instead of Spikevax 12+. Pt received Spikevax 6mo-11 years instead of Spikevax 12+.
2862884 65 F GA 10/02/2025 PNC21
 MERCK & CO. INC.
 Z009861
Injection site erythema, Injection site induration, Injection site pain Injection site erythema, Injection site induration, Injection site pain
Redness, pain/tenderness, and 3.5 cm induration at site of vaccine administration in RIGHT arm. Red... Redness, pain/tenderness, and 3.5 cm induration at site of vaccine administration in RIGHT arm. Redness and induration lasted for 5+ days. Pt received an influenza vaccine in LEFT arm on the same day by the same nurse and is not having any problems with the left arm. More
2862885 14 F CA 10/02/2025 MNQ
 SANOFI PASTEUR
 U8574AA
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient was accidentally given a MCV4 Menquadfi vaccine too early. Pt had no reaction but is submitt... Patient was accidentally given a MCV4 Menquadfi vaccine too early. Pt had no reaction but is submitting this report just in case she happens to get a reaction due for giving early. More
2862888 79 F GA 10/02/2025 FLU3
 SANOFI PASTEUR
 UT8781AA
Deafness unilateral, Nausea, Sensory disturbance, Tinnitus, Vomiting Deafness unilateral, Nausea, Sensory disturbance, Tinnitus, Vomiting
Loss of hearing in left ear, ringing in left ear, vibration in left ear when talking. Severe nausea... Loss of hearing in left ear, ringing in left ear, vibration in left ear when talking. Severe nausea and vomiting. More
2862889 72 F MD 10/02/2025 COVID19
 MODERNA
 3052155
Asthenia, Chills, Pyrexia Asthenia, Chills, Pyrexia
PT DESCRIBED SEVERE FEVER, CHILLS, WEAKNESS. SHE DESCRIBED IT AS THE WORST SHE'S FELT IN A LONG... PT DESCRIBED SEVERE FEVER, CHILLS, WEAKNESS. SHE DESCRIBED IT AS THE WORST SHE'S FELT IN A LONG TIME. SHE REQUESTED FOR ME TO REPORT. More
2862891 66 F MN 10/02/2025 FLU3
 SANOFI PASTEUR
 u8830ba
Contusion, Mobility decreased, Pain in extremity Contusion, Mobility decreased, Pain in extremity
Patient called two days after her vaccine saying her arm was bruised and it was very sore. Pharmacis... Patient called two days after her vaccine saying her arm was bruised and it was very sore. Pharmacist recommended she try tylenol or ibuprofen and to ice the area. Patient denied any redness, hot to the touch, or fever. Patient came back two weeks later and still has a sore arm and can't lift it. Went to provider on 10/2/25 and provider gave diclofenac gel. More
2862892 32 F AZ 10/02/2025 FLU3
 SANOFI PASTEUR
 u8832ba
Mobility decreased, Musculoskeletal discomfort, Product administered at inapprop... Mobility decreased, Musculoskeletal discomfort, Product administered at inappropriate site, Shoulder injury related to vaccine administration More
The Flu Vaccine was given to high in the arm, into the shoulder causing SIRVA. Patient started to h... The Flu Vaccine was given to high in the arm, into the shoulder causing SIRVA. Patient started to have discomfort and losing range of motion. She went to Doctor office and they told her she got SIRVA from the vaccine being administered to high up on the arm and into the shoulder More
2862893 16 F TX 10/02/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Anxiety, Balance disorder, Face injury, Fall, Feeling hot; Head discomfort, Head... Anxiety, Balance disorder, Face injury, Fall, Feeling hot; Head discomfort, Headache, Muscular weakness, Pallor, Palpitations; Paraesthesia, Syncope, Vision blurred More
After leaving the exam room, while standing at the front desk her arms felt warm and tingly, startin... After leaving the exam room, while standing at the front desk her arms felt warm and tingly, starting to lose feeling of legs and arms, heart was racing, onset of anxiety, felt like start of panic attack, vision went blurry, head felt heavy, losing balance, hit the wall, tried to gain control but unable to, hit her chin on the counter going down, tried to get up and hit her head on the counter, fainted and collapsed, very pale, white ring around her lips. Nurse used alcohol swabs for her to smell. Helped her get up to lay down. Mom and nurse walked her to room. Trying to breathe normally to calm down, back of head warm and in pain, layed for about 7 minutes to try to recoup, Left the doctors office and mom drove home. More
2862894 3 F NJ 10/02/2025 DTAP
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 YB7N7
MA2505
Rash; Rash Rash; Rash
Rash Rash
2862895 65 F AL 10/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 FAC3
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient had already gotten shot twice the two years prior (this was their third dose). Pt did not ex... Patient had already gotten shot twice the two years prior (this was their third dose). Pt did not experience any side effects any of the extra times. Was counseled this is a once in a lifetime, not yearly vaccine. More
2862900 17 PA 10/02/2025 FLU3
HPV9
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 40255
Y019459
U8574AA
Dyspnoea; Dyspnoea; Dyspnoea Dyspnoea; Dyspnoea; Dyspnoea
< 15 min after administration of vaccines patient was discharged and mom returned to report pt wi... < 15 min after administration of vaccines patient was discharged and mom returned to report pt with dyspnea. Mom went out to get patient No wheeze auscultated no other organ systems sensation of throat closure per patient no lesion. treated with Albuterol patient after receiving Albuterol suggestive for additional symptoms. More
2862422 M 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Arthralgia, Headache, Injection site erythema, Nausea, Pain Arthralgia, Headache, Injection site erythema, Nausea, Pain
Joint pain; Body ache; nausea; headache; patch of redness at the site; This non-serious case was rep... Joint pain; Body ache; nausea; headache; patch of redness at the site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced joint pain (Verbatim: Joint pain), general body pain (Verbatim: Body ache), nausea (Verbatim: nausea), headache (Verbatim: headache) and injection site erythema (Verbatim: patch of redness at the site). The outcome of the joint pain, general body pain, nausea, headache and injection site erythema were resolved (duration 48 hrs). It was unknown if the reporter considered the joint pain, general body pain, nausea, headache and injection site erythema to be related to Shingrix. It was unknown if the company considered the joint pain, general body pain, nausea, headache and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The reporter stated be sure to plan on taking the day after getting the second shingles shot off. The patient was down all day with body, joint aches, nausea, headache. The patient had 5-inch patch of redness at the site. The next day of vaccination, 48 hours later, patient was fine. More
2862424 77 M IL 10/01/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Pruritus, Urticaria COVID-19, Drug ineffective, Pruritus, Urticaria
he developed hives; itching from the top of his head to his feet; Right now they are currently diagn... he developed hives; itching from the top of his head to his feet; Right now they are currently diagnosed with Covid after taking the Covid-19 Vaccine on 09Sep2025; Right now they are currently diagnosed with Covid after taking the Covid-19 Vaccine on 09Sep2025; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 77-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 09Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2025, outcome "unknown" and all described as "Right now they are currently diagnosed with Covid after taking the Covid-19 Vaccine on 09Sep2025"; URTICARIA (non-serious) with onset 12Sep2025, outcome "recovering", described as "he developed hives"; PRURITUS (non-serious) with onset 12Sep2025, outcome "not recovered", described as "itching from the top of his head to his feet". Therapeutic measures were taken as a result of covid-19, drug ineffective, urticaria, pruritus. Clinical course:Caller stated her husband had received the covid vaccine on 09Sep and he developed hives and itching from the top of his head to his feet. He had gone to urgent care twice and the dermatologist gave him a Medrol dose pack and it did nothing. Another doctor gave him a shot of prednisone and higher doses of prednisone and while the hives are going away, the itching has not stopped. What can they do for the itching. She stated she had covid from her shot and she doesn't want to give it to him on top of the itching, reported that they were sent to urgent care 3 times yesterday for hives and itching.Hives and itching: Started on 12Sep2025. Hives are better, but the itching has not stopped. He keeps going back to the urgent care to get more treatment and they said that he can not have any more prednisone and he is afraid it will get out his system and the hives will come back. Caller reported that they just got prescription for Prednisone and it is not helping. She doesn't know if there is a antidote for this. The urgent care said that the hives and itching were from the covid vaccine. More
2862425 10/01/2025 COVID19
 PFIZER\BIONTECH
Rash Rash
Today her face is beet red; This is a spontaneous report received from a Consumer or other non HCP f... Today her face is beet red; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cortisone knee injection, start date: 23Sep2025. The following information was reported: RASH (non-serious) with onset 25Sep2025, outcome "unknown", described as "Today her face is beet red". Additional information: The patient stated she got the Pfizer covid vaccine day before reporting day and the day before that she got a cortisone knee injection. On reporting day her face was beet red and she wondered if there was an interaction between the vaccine and the cortisone. Asked if a beet red face had been reported with the covid shot. Response as Spoke from attached consumer document was: "Non-severe allergic reactions such as rash, itching, hives, or swelling of the face" but could not assess if that was what she was experiencing. Referred to HCP for evaluation. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2862426 FL 10/01/2025 COVID19
 PFIZER\BIONTECH
Rash, Reaction to excipient Rash, Reaction to excipient
Rash after Comirnaty; agents contain polyethylene glycol; Rash after Comirnaty; agents contain polye... Rash after Comirnaty; agents contain polyethylene glycol; Rash after Comirnaty; agents contain polyethylene glycol; This is a spontaneous report received from a nurse from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: REACTION TO EXCIPIENT (non-serious), RASH (non-serious), outcome "unknown" and all described as "Rash after Comirnaty; agents contain polyethylene glycol". Additional Information: The nurse was asking information the company has regarding cross allergy between Paxlovid and Comirnaty. The patient has rash after Comirnaty and EMR flagged Paxlovid for cross allergy because both agents contain polyethylene glycol. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862427 71 F NC 10/01/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Blood thyroid stimulating hormone, COVID-19, Thyroxine, Tri-iodothyronine, Vacci... Blood thyroid stimulating hormone, COVID-19, Thyroxine, Tri-iodothyronine, Vaccination failure More
had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID; had a v... had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID; had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID; This is a spontaneous report received from a Pharmacist. A 71-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Sep2025 as dose 1, 0.3 ml, single (Lot number: MY9550) at the age of 71 years intramuscular, in left deltoid for covid-19 immunisation. The time of vaccination was at the end of the day, 4 or 5 in the afternoon, pm, eastern time. The vaccination facility in a clinic and not administered in a military facility. The patient got it through their physician assistant or nurse practitioner through their emergent care program. The patient's relevant medical history included: "hypertension/high blood pressure" (ongoing), notes: date of diagnosis for hypertension was 42 that was like 30 years ago; "hypothyroid" (ongoing), notes: date of diagnosis for hypothyroid was 42 that was like 30 years ago. Concomitant medication(s) included: INFLUENZA HA VACCINE PF taken for immunisation, on 08Sep2025 as dose 1, 0.5 ml, single; SYNTHROID taken for hypothyroidism (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing). The patient also took other concomitant therapy. Vaccination history included: comirnaty, 2024-2025 (dose 1, 0.3 ml, batch/lot number LN0590, left arm and IM injection, it was fifth or sixth time, had it twice a year), administration date: 15Mar2025, when the patient was 70-year-old, for COVID-19 Immunization; Bnt162b2 (dose 1), administration date: 2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization; Bnt162b2 (dose 2), administration date: 2021, when the patient was 67 years old, for COVID-19 immunization. The patient did not received other vaccine within 4 weeks. The patient adverse event after previous vaccination was no. The patient was not allergic to any vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2025, outcome "not recovered" and all described as "had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (08Sep2025) everything looks good, the values are good, notes: done every 3 months; Thyroxine: (08Sep2025) everything looks good, the values are good, notes: done every 3 months; Tri-iodothyronine: (08Sep2025) everything looks good, the values are good, notes: done every 3 months. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient was diagnosed today (26Sep2025) and still suffering from COVID. The patient informed that it worsened a little. The patient treatment was no. The patient was trying to get Paxlovid from Pfizer but she cannot get it. The patient informed that there were no adverse event required hospitalization.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/ vaccination failure (COVID-19) with the suspect product BNT162B2 OMICRON (LP.8.1) cannot be fully excluded. More
2862428 10/01/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Hyperhidrosis; Hyperhidrosis Hyperhidrosis; Hyperhidrosis
sweating; This is a spontaneous report received from a Consumer or other non HCP. Other Case identif... sweating; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789451 (moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as 1 df, single intramuscular for covid-19 prophylaxis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid vaccine (last dose), administration date: 2023, for COVID-19 immunisation, reaction(s): "Sweating". The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating". Additional information: The patient always had excessive problems, like getting the vaccine. The last dose of the Moderna COVID vaccine was received probably in 2023. Sweating occurred after the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2862429 FL 10/01/2025 COVID19
 PFIZER\BIONTECH
Peripheral swelling, Urticaria Peripheral swelling, Urticaria
Hives all over my body; Feet were so swollen; This is a spontaneous report received from a Consumer ... Hives all over my body; Feet were so swollen; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 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: PERIPHERAL SWELLING (non-serious) with onset 25Sep2025, outcome "not recovered", described as "Feet were so swollen"; URTICARIA (non-serious) with onset 25Sep2025, outcome "not recovered", described as "Hives all over my body". Therapeutic measures were taken as a result of urticaria, peripheral swelling. Additional information: the patient got the Covid vaccine on Wednesday, September 24, 2025. On Thursday the 25th, the patient developed hives all over the body and the feet were so swollen that the patient had to go to the hospital. The patient thought it's a reaction to the vaccine since it's a live virus. The patient was prescribed Prednisone, but on Saturday, September 27, 2025, the patient was still the same. The patient reported she/he can send photos. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862455 67 PA 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Frequent bowel movements, Injection site erythema, Myalgia Fatigue, Frequent bowel movements, Injection site erythema, Myalgia
Muscle pain; Tiredness; Something more unusual than I felt with a vaccine; Injection site redness; F... Muscle pain; Tiredness; Something more unusual than I felt with a vaccine; Injection site redness; Frequent bowel movements/ more frequent bathroom trips; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-SEP-2025, the patient received the 1st dose of Shingrix. On 02-SEP-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site redness) and frequent bowel movements (Verbatim: Frequent bowel movements/ more frequent bathroom trips). On an unknown date, the patient experienced muscle pain (Verbatim: Muscle pain), tiredness (Verbatim: Tiredness) and feeling abnormal (Verbatim: Something more unusual than I felt with a vaccine). The outcome of the injection site erythema and frequent bowel movements were not resolved and the outcome of the muscle pain, tiredness and feeling abnormal were not reported. It was unknown if the reporter considered the injection site erythema, frequent bowel movements, muscle pain, tiredness and feeling abnormal to be related to Shingrix. It was unknown if the company considered the injection site erythema, frequent bowel movements, muscle pain, tiredness and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 04-SEP-2025 The reporter stated that the patient experienced redness at injection site and frequent bowel movements. The reporter also stated that the patient had the common side effects of Shingrix vaccine and experienced muscle pain, tiredness, more frequent bathroom trips, something more unusual the patient felt with vaccine. More
2862456 66 M TX 10/01/2025 FLU3
MNQ
 SEQIRUS, INC.
SANOFI PASTEUR
 AX55904A
U8562AA
Injection site induration, Injection site swelling, Injection site warmth, Malai... Injection site induration, Injection site swelling, Injection site warmth, Malaise, Pain in extremity; Injection site induration, Injection site swelling, Injection site warmth, Malaise, Pain in extremity More
S: PATIENT REPORTS THAT HE HAS NOT BEEN FEELING WEEL AND THAT HIS REIGHT ARM IS SORE FROM MENINGITIS... S: PATIENT REPORTS THAT HE HAS NOT BEEN FEELING WEEL AND THAT HIS REIGHT ARM IS SORE FROM MENINGITIS VACCINE HE RECEIVED YESTERDAY, DENIES SHORTNESS OF BREATH OR CHEST TIGHTNESS O: PATIENT NOTED WITH HARDNESS AND WRMTH AT INJECTION SITE TO RIGHT ARM WITH LOCALIZED SWELLING, RESPIRATIONS REGULAR AND UNLABORED LUNGS CLEAR O2 SAT 98% RA A: NO SIGHNS OF RESPIRATORY DISTRESS, LOCALIZED SWELLING AND WARMTH AT INJECTION SITE Plan is as follows: CONSULTED WITH PA 1. BENEADRYL INJECTION 50MG IM GIVEN RIGHT GLUTEAL 2. PATIENT RELEASTED WITH INSTRUACTION TO RETURN TO MEDICAL FOR SHORTNESS OF BREATH, CHEST TIGHGTNESS, FACIAL SWELLING, PATIENT VERABLIZED UNDERSTANDING More
2862507 78 F LA 10/01/2025 PPV
 MERCK & CO. INC.
Dyspnoea, Gait inability, Memory impairment Dyspnoea, Gait inability, Memory impairment
not able to walk; Trouble breathing; Had problems remembering things; This spontaneous report was re... not able to walk; Trouble breathing; Had problems remembering things; This spontaneous report was received from a Consumer and refers to a 79-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Pulmonary arterial hypertension, Allergy to Latex, Allergy to penicillin) and Interstitial lung disease. Concomitant therapies included mirabegron (MYRBETRIQ), venlafaxine hydrochloride, empagliflozin (JARDIANCE), insulin glargine (BASAGLAR KWIKPEN), cinacalcet hydrochloride, allopurinol, aspirin, losartan potassium, trospium chloride, albuterol sulfate, levothyroxine sodium, calcitriol, venlafaxine hydrochloride (EFFEXOR), citalopram hydrobromide, oxygen, omeprazole, polycarbophil calcium (FIBER), hydrozyxine hydrochloride, amlodipine besylate, furosemide and bimatoprost (LUMIGAN). On 29-Jan-2024, the patient started therapy with Treprostinil (TYVASO DPI) Inhalation powder 16 ug, administered four times a day (qid) by Respiratory (inhalation) route (lot # and expiration date were not reported), as treatment for Secondary pulmonary arterial hypertension and interstitial pulmonary disease, unspecified (Pulmonary arterial hypertension). On 17-Jul-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX) (lot #, expiration date, strength, dose number, route of administration, anatomical location not provided) as immunization. On 18-Jul-2025, the patient experienced to be not able to walk and had Trouble breathing; therefore, she was hospitalized due to these events. She also had problems remembering things, and it was stated that she had been downhill since the shot. The patient was hospitalized for about a week and on an unspecified date in July 2025, she was discharged. At the reporting time, the patient was recovering from the problems remembering things and not being able to walk (also reported as she was now doing better), and the outcome of Trouble breathing was unknown. The action taken with Treprostinil (TYVASO DPI) regarding the events was unknown. The reporter all the events to be possibly related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX). Causality assessment between the events and Treprostinil (TYVASO DPI) was not reported.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : withheld , Index date : 2025-09-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : UNT-2025-027733 , Central date : 2025-09-21 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
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2862508 F TX 10/01/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Atrial fibrillation, Back pain, Cardioversion, Herpes zoster, Skin lesion; Spina... Atrial fibrillation, Back pain, Cardioversion, Herpes zoster, Skin lesion; Spinal operation, Transient ischaemic attack, Urinary tract infection, Vaccination failure; Atrial fibrillation, Back pain, Cardioversion, Herpes zoster, Skin lesion; Spinal operation, Transient ischaemic attack, Urinary tract infection, Vaccination failure More
she had atrial fibrillation; she had a TIA and was admitted to the hospital; developed back pain/ ha... she had atrial fibrillation; she had a TIA and was admitted to the hospital; developed back pain/ had back surgery for the back pain and was hospitalized overnight; A little over a year ago, she developed shingles under her breast; Suspected vaccination failure; had frequent UTIs this year; About five weeks ago she developed shingles; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles twice, pre-vaccination). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In DEC-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced back pain (Verbatim: developed back pain/ had back surgery for the back pain and was hospitalized overnight) (serious criteria hospitalization). On 27-MAR-2025, the patient experienced atrial fibrillation (Verbatim: she had atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On 30-APR-2025, the patient experienced transient ischemic attack (Verbatim: she had a TIA and was admitted to the hospital) (serious criteria hospitalization and GSK medically significant). In AUG-2025, the patient experienced shingles (Verbatim: About five weeks ago she developed shingles). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: A little over a year ago, she developed shingles under her breast) and recurrent urinary tract infection (Verbatim: had frequent UTIs this year). The patient was treated with gabapentin and prednisone. In MAR-2025, the outcome of the atrial fibrillation was resolved. On 30-APR-2025, the outcome of the transient ischemic attack was resolved. The outcome of the vaccination failure and shingles were not reported and the outcome of the back pain was unknown and the outcome of the shingles was resolving and the outcome of the recurrent urinary tract infection was not resolved. It was unknown if the reporter considered the atrial fibrillation, transient ischemic attack, vaccination failure, back pain, shingles, shingles and recurrent urinary tract infection to be related to Shingrix and Shingrix. The company considered the atrial fibrillation, transient ischemic attack, vaccination failure and back pain to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles and recurrent urinary tract infection to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 The patient self-reported this case for herself. The patient received the two Shingrix doses as soon as they were available. The first was in 2017 and the second two months later. A little over a year ago (from the date of reporting), she developed shingles under her breast that she describes as mild adverse event. She self-treated with an unknown ointment. She developed back pain and on 19-DEC-2024 received injections in her back to treat the pain. She had frequented urinary tract infections this year in 2025 On 27-MAR-2025, she had atrial fibrillation and had her heart shocked back into rhythm and was hospitalized. On 28-APR-2025, she had back surgery for the back pain and was hospitalized overnight until 29-APR-2025. Two days later, on 30-APR-2025, she had a TIA (transient ischemic attack) and was admitted to the hospital for three days until 03-MAY-2025. About five weeks ago (from the date of reporting), she developed shingles that she describes as severe. The lesions were on her left from middle of abdomen to her back. She saw the physician that day and was treated with an unknown antiviral pill, gabapentin 100mg and prednisone 10mg. The shingles case was improving. Nothing else was reported. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and a request for this information has been made.; Sender's Comments: A case of Back pain, Atrial fibrillation, Transient ischaemic attack and Vaccination failure, an unknown time after receiving Shingrix, in a 78-year-old female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
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2862509 F NJ 10/01/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 XX33P
Pyrexia, Wrong product administered Pyrexia, Wrong product administered
had a fever; she requested the wrong vaccine, and wanted her daughter to receive Menveo; This non-se... had a fever; she requested the wrong vaccine, and wanted her daughter to receive Menveo; This non-serious case was reported by the other health professional via call center representative and described the occurrence of fever in an adult female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 28-AUG-2025, the patient received Bexsero. The patient did not receive Menveo. On 28-AUG-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: she requested the wrong vaccine, and wanted her daughter to receive Menveo). On an unknown date, the patient experienced fever (Verbatim: had a fever). The outcome of the fever was resolved and the outcome of the wrong vaccine administered was not applicable. It was unknown if the reporter considered the fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:05-SEP-2025 The reporter was a Certified Pharmacy Technician calling to report that a female patient between the ages of 18-21 years of age received Bexsero on 28-AUG-2025 and had a fever. The reporter had no further information to provide other than the mother of the patient made it seem like the fever had come and gone. The patient received Bexsero as per the request of the mother of the patient to the pharmacy for the patient going off to college. The mother returned to the pharmacy several days ago and told the pharmacy that she requested the wrong vaccine and wanted her daughter to receive Menveo (no further information was provided as to why the mother felt like it was the wrong vaccine, which led to Wrong vaccine administered. The pharmacy had not administered Menveo at the time of the call. The reporter did not have the location or route of administration. The pharmacist at the pharmacy location did report the fever through VAERS. More
2862510 M OH 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Drug ineffective, Herpes zoster, Pain Drug ineffective, Herpes zoster, Pain
Pain; broke out in shingles/ lack of drug effect; This non-serious case was reported by a pharmacist... Pain; broke out in shingles/ lack of drug effect; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cancer (type not disclosed), chemotherapy (last chem treatment in JUL-2024) and pancreatectomy. Concurrent medical conditions included asplenia. On 28-AUG-2025, the patient received the 1st dose of Shingrix. On 31-AUG-2025, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: broke out in shingles/ lack of drug effect). On an unknown date, the patient experienced pain (Verbatim: Pain). The patient was treated with valaciclovir hydrochloride (Valtrex) and hydrocodone bitartrate;paracetamol (Norco). The outcome of the shingles and pain were not resolved. It was unknown if the reporter considered the shingles and pain to be related to Shingrix. It was unknown if the company considered the shingles and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The reporter was healthcare professional (HCP) calling on behalf of a consumer (patient) who received the first dose of Shingrix and broke out in shingles (lack of drug effect) which was ongoing. HCP stated shingles outbreak located on his side on the left. Consumer prescribed Valtrex for shingles and Norco for pain consumer was experiencing (dose/frequency unknown) in 2025. HCP stated she was calling to report on her day off from work, so she was unable to provide specific information. No further information was obtained/provided. More
2862512 10/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Headache, Malaise, Mobility decreased, Myalgia Headache, Malaise, Mobility decreased, Myalgia
felt very lousy; Headache; entire body muscle aching; Bedridden for10 hours; This non-serious case w... felt very lousy; Headache; entire body muscle aching; Bedridden for10 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, 12 hrs after receiving Arexvy, the patient experienced feeling bad (Verbatim: felt very lousy), headache (Verbatim: Headache), generalized muscle aches (Verbatim: entire body muscle aching) and bedridden (Verbatim: Bedridden for10 hours). The patient was treated with paracetamol (Tylenol). The outcome of the feeling bad, headache and generalized muscle aches were resolved and the outcome of the bedridden was resolved (duration 10 hrs). It was unknown if the reporter considered the feeling bad, headache, generalized muscle aches and bedridden to be related to Arexvy. It was unknown if the company considered the feeling bad, headache, generalized muscle aches and bedridden to be related to Arexvy. Additional Information: GSK Receipt Date: 03-SEP-2025 The reporter reported that it was easy to get the vaccine , however the patient felt very lousy 12 hours later. The patient experienced headache and entire body muscle aching and was bedridden for 10 hours. It was all good now and patient took Ibprophen and Tylenol. More
2862513 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
I used two of the diluents for Shingrix but not the antigen; I used two of the diluents for Shingrix... I used two of the diluents for Shingrix but not the antigen; I used two of the diluents for Shingrix but not the antigen; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: I used two of the diluents for Shingrix but not the antigen) and inappropriate dose of vaccine administered (Verbatim: I used two of the diluents for Shingrix but not the antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 The patient used two of the diluents for Shingrix but not the antigen which led to inappropriate preparation of medication and inappropriate dose of vaccine administered and wondered how do they just order the two diluents? More
2862514 10/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Cough, Headache, Rhinorrhoea Cough, Headache, Rhinorrhoea
coughing; Runny nose; headache; This non-serious case was reported by a consumer via interactive dig... coughing; Runny nose; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, several days after receiving Arexvy, the patient experienced cough (Verbatim: coughing), runny nose (Verbatim: Runny nose) and headache (Verbatim: headache). The outcome of the cough, runny nose and headache were resolving. It was unknown if the reporter considered the cough, runny nose and headache to be related to Arexvy. It was unknown if the company considered the cough, runny nose and headache to be related to Arexvy. Additional Information: GSK Receipt Date: 24-SEP-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she got RSV vaccine (Arexvy) and a few days later experienced coughing, runny nose, headache and no fever. The patient reported he/she was getting better. The batch number was not provided, and we are unable to contact the reporter. More
2862516 M 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
had arm soreness at the site; This non-serious case was reported by a consumer via interactive digit... had arm soreness at the site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: had arm soreness at the site). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 24-SEP-2025 This case is linked with case US2025AMR124367, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR124367:same reporter More
2862518 10/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingrix vaccine is what caused my shingles; This serious case was re... Suspected vaccination failure; Shingrix vaccine is what caused my shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingrix vaccine is what caused my shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 26-SEP-2025 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2862520 0.67 F CT 10/01/2025 RVX
 UNKNOWN MANUFACTURER
 7E9Y2
Extra dose administered, Product administered to patient of inappropriate age Extra dose administered, Product administered to patient of inappropriate age
an 8-month patient had received a dose of Rotarix; 3rd dose administered; This non-serious case was ... an 8-month patient had received a dose of Rotarix; 3rd dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received Rotavirus vaccine (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis. Previously administered products included Rotarix (received 2 doses on an unknown date). On 15-SEP-2025, the patient received the 3rd dose of Rotavirus vaccine. On 15-SEP-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8-month patient had received a dose of Rotarix) and extra dose administered (Verbatim: 3rd dose administered). The outcome of the inappropriate age at vaccine administration and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2862521 10/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
received an expired dose of Arexvy vaccine last Thursday; This non-serious case was reported by a nu... received an expired dose of Arexvy vaccine last Thursday; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 20-AUG-2025) for prophylaxis. On 18-SEP-2025, the patient received Arexvy. On 18-SEP-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: received an expired dose of Arexvy vaccine last Thursday). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 23-SEP-2025 A nurse reported that a patient received an expired dose of Arexvy vaccine. The nurse asked if the patient should be revaccinated. More
2862522 CA 10/01/2025 COVID19
 MODERNA
Anxiety Anxiety
almost died from the Moderna vaccine; This spontaneous case was reported by a consumer and describes... almost died from the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (almost died from the Moderna vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included PEG allergy. 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 ANXIETY (almost died from the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, ANXIETY (almost died from the Moderna vaccine) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient was just trying to find Novavax vaccine and was having a heck of a time trying to find it and the others had PEG in it, so the patient could not use them. No treatment medication was reported.; Reporter's Comments: Company Comment: PatientοΏ½s medical history of allergy could be a contributing factor for the event. The benefit-risk relationship of product is not affected by this report. More
2862523 10/01/2025 COVID19
 MODERNA
Gait disturbance, Immunisation reaction Gait disturbance, Immunisation reaction
A friend who had the Moderna, who use the Moderna and have the same symptoms; Some of them, they can... A friend who had the Moderna, who use the Moderna and have the same symptoms; Some of them, they cannot walk; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (A friend who had the Moderna, who use the Moderna and have the same symptoms) and GAIT DISTURBANCE (Some of them, they cannot walk) 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 IMMUNISATION REACTION (A friend who had the Moderna, who use the Moderna and have the same symptoms) and GAIT DISTURBANCE (Some of them, they cannot walk). At the time of the report, IMMUNISATION REACTION (A friend who had the Moderna, who use the Moderna and have the same symptoms) and GAIT DISTURBANCE (Some of them, they cannot walk) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789631 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789631:Patient's case More
2862524 31 F MA 10/01/2025 COVID19
 MODERNA
Headache, Maternal exposure during pregnancy, Pain in extremity, Toothache Headache, Maternal exposure during pregnancy, Pain in extremity, Toothache
teeth hurting; arm soreness; headache; Drug exposure during pregnancy; This case was received via an... teeth hurting; arm soreness; headache; Drug exposure during pregnancy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2025 and was forwarded to Moderna on 23-Sep-2025. This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Sep-2025, the patient experienced TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. On 21-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. At the time of the report, TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. The patient did not experience any additional symptoms/events.; Reporter's Comments: The events of PAIN IN EXTREMITY, HEADACHE and TOOTHACHE were assessed as related due to temporal association and known safety profile of Spikevax. The benefit-risk relationship of product is not affected by this report. More
2862525 F 10/01/2025 COVID19
 MODERNA
Anxiety, Underdose, Wrong technique in product usage process Anxiety, Underdose, Wrong technique in product usage process
she is feeling "unsafe because she doesn't feel protected/she's scared; 0.2ml dose&qu... she is feeling "unsafe because she doesn't feel protected/she's scared; 0.2ml dose". HCP added that "there's a small volume of air and so we push up on the plunger just to get rid of the air bubble; 0.2ml dose". HCP added "there's a small volume of air and so we push up on plunger just to get rid of air bubble/doesn't know how much she's receive; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (she is feeling "unsafe because she doesn't feel protected/she's scared), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (0.2ml dose". HCP added that "there's a small volume of air and so we push up on the plunger just to get rid of the air bubble) and UNDERDOSE (0.2ml dose". HCP added "there's a small volume of air and so we push up on plunger just to get rid of air bubble/doesn't know how much she's receive) in an elderly female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 22-Sep-2025, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (0.2ml dose". HCP added that "there's a small volume of air and so we push up on the plunger just to get rid of the air bubble) and UNDERDOSE (0.2ml dose". HCP added "there's a small volume of air and so we push up on plunger just to get rid of air bubble/doesn't know how much she's receive). On an unknown date, the patient experienced ANXIETY (she is feeling "unsafe because she doesn't feel protected/she's scared). At the time of the report, ANXIETY (she is feeling "unsafe because she doesn't feel protected/she's scared), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (0.2ml dose". HCP added that "there's a small volume of air and so we push up on the plunger just to get rid of the air bubble) and UNDERDOSE (0.2ml dose". HCP added "there's a small volume of air and so we push up on plunger just to get rid of air bubble/doesn't know how much she's receive) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. It was stated that the patient was over 75 years of age. Concomitant medication was not reported. HCP administered the vaccine to this patient, and the patient had reached out to the store saying that she was feeling unsafe because she didn't feel protected. She was in a situation where she didn't know how much she had received. The HCP stated that the patient stated she was sure that when the HCP was ejecting an air bubble/priming the vaccine, the patient saw a stream of liquid and she was not confident that she received the 0.2ml dose. HCP added that there was a small volume of air and so push up on the plunger just to get rid of the air bubble that was something they did with every injection, the patient was looking and saw a full-on like stream of liquid. HCP stated it to be one of the challenges with this vaccine. HCP also stated that the patient was thinking she might have received next to nothing but then she didn't feel confident enough to get another dose because she was scared. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2862526 69 M MD 10/01/2025 COVID19
 MODERNA
 3052154
Headache, Nausea Headache, Nausea
headache; little bit of nausea; This spontaneous case was reported by a consumer and describes the o... headache; little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (little bit of nausea) in a 69-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052154) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 25-Aug-2025. Past adverse reactions to the above products included No adverse effect with INFLUENZA VACCINE. Concurrent medical conditions included Heart disorder (heart issues). Concomitant products included Ibuprofen (Advil) for an unknown indication. On 24-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 25-Sep-2025, the patient experienced HEADACHE (headache) and NAUSEA (little bit of nausea). On 25-Sep-2025, HEADACHE (headache) and NAUSEA (little bit of nausea) had resolved. The patient had a headache and a little bit of nausea. These were dissipated within 24 hours. The patient did not experience any additional symptoms or events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There was no lab data or results available. The treatment medication was not reported by the reporter. More
2862527 F 10/01/2025 COVID19
 MODERNA
Body temperature, Headache, Myalgia, Palpitations, Pyrexia Body temperature, Headache, Myalgia, Palpitations, Pyrexia
palpitations; body aches; fever of 101; headaches; This spontaneous case was reported by a consumer ... palpitations; body aches; fever of 101; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever of 101) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 27-Sep-2025, the patient experienced PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever of 101) and HEADACHE (headaches). At the time of the report, PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever of 101) and HEADACHE (headaches) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2025, Body temperature: 101. The concomitant medication was not reported by the reporter. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2862528 10/01/2025 UNK
 UNKNOWN MANUFACTURER
COVID-19, Drug ineffective COVID-19, Drug ineffective
I had my Covid shot and booster but Why I got Covid. Why?; I had my Covid shot and booster but Why I... I had my Covid shot and booster but Why I got Covid. Why?; I had my Covid shot and booster but Why I got Covid. Why?; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (BNT162B2 OMICRON (LP.8.1)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had my Covid shot and booster but Why I got Covid. Why?". More
2862529 44 F WI 10/01/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 80777-0112-96
70461-0655-03
Erythema, Pruritus, Swelling, Tenderness, Urticaria; Erythema, Pruritus, Swellin... Erythema, Pruritus, Swelling, Tenderness, Urticaria; Erythema, Pruritus, Swelling, Tenderness, Urticaria More
Large red, raised, warm oblong welt approx 1.5" x 3". Low grade itch from site all the ti... Large red, raised, warm oblong welt approx 1.5" x 3". Low grade itch from site all the time, discomfort increases if any pressure is applied, even by light clothing. More
2862530 75 F GA 10/01/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Abdominal pain, Arrhythmia, Arthralgia, Atrial fibrillation, Body temperature; E... Abdominal pain, Arrhythmia, Arthralgia, Atrial fibrillation, Body temperature; Electrocardiogram, Gastrointestinal pain, Headache, Myalgia, Pain; Pyrexia More
atrial fibrillation with rapid ventricular response; heart dysrhythmia; abdomen hurt; Fever; her gut... atrial fibrillation with rapid ventricular response; heart dysrhythmia; abdomen hurt; Fever; her guts hurt bad; The muscle aches and joints and everything hurt severely including her head; The muscle aches and joints and everything hurt severely including her head; muscle aches; ache/hurts all over/hurt severely; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 at 09:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in right upeer arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation", start date: Apr2014 (unspecified if ongoing); "had long covid twice" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE oral taken for atrial fibrillation. Vaccination history included: Bnt162b2 (dose number unknown, Last year she had a horrible time too with side effects when she got the Pfizer covid vaccine), administration date: 2024, for Covid-19 immunization, reaction(s): "side effects". The following information was reported: ARTHRALGIA (non-serious), HEADACHE (non-serious) all with onset 24Sep2025, outcome "recovering" and all described as "The muscle aches and joints and everything hurt severely including her head"; PAIN (non-serious) with onset 24Sep2025, outcome "recovering", described as "ache/hurts all over/hurt severely"; MYALGIA (non-serious) with onset 24Sep2025, outcome "recovering", described as "muscle aches"; PYREXIA (non-serious) with onset 25Sep2025, outcome "unknown", described as "Fever"; ABDOMINAL PAIN (non-serious) with onset 25Sep2025, outcome "recovered", described as "abdomen hurt"; ATRIAL FIBRILLATION (medically significant) with onset 25Sep2025, outcome "recovered" (25Sep2025); ARRHYTHMIA (medically significant) with onset 25Sep2025, outcome "recovered" (25Sep2025), described as "heart dysrhythmia"; GASTROINTESTINAL PAIN (non-serious) with onset 25Sep2025, outcome "recovered", described as "her guts hurt bad". Therapeutic measures were taken as a result of atrial fibrillation, arrhythmia. Therapeutic measures were not taken as a result of myalgia, pain, abdominal pain, pyrexia, arthralgia, headache, gastrointestinal pain. Clinical course: She got Comirnaty 12 plus on Wednesday 24Sep2025 around 9am and she had rather serious side effects within 12 hours. She kept going about her day and started to ache and ache and ached and ached until she could barely stand, she hurts all over, she hurt badly. This started on Wednesday two days ago. She is still not all better and has improved but slowly. The muscle aches and joints and everything hurt severely including her head. She was not back to herself yet. She declined any and then stated it hurt worse and worse. About 2:30 in the morning on 25Sep2025 she started with atrial fibrillation, heart dysrhythmia. She took an antidysrhythmic called Flecainide. She had a maintenance dose of Flecainide and she had dose that she takes of Flecainide when she has atrial fibrillation. Her Flecainide maintenance dose was 100mg tablet in the morning and half of a 100mg tablet at night (to equal 50mg at night) by mouth. At 2:30 in the morning when she had the dysrhythmia and atrial fibrillation she took 200mg more of Flecainide. She took a total of 250mg of Flecainide within just a few hours of each other and she took the Flecainide along with diltiazem extended release (ER) 180mg capsule. She had a Kardia device which she stated was an electrocardiogram device that was showing atrial fibrillation at 2:30 in the morning and RVR which she states stands for rapid ventricular response. The dysrhythmia and atrial fibrillation stopped some time before 9 am on 25Sep2025. She experienced something else which is her guts hurt bad, and her abdomen hurt all day yesterday (25Sep2025). she got a fever of 100.3 that lasted for hours which was during the middle of the night around 1am, 2am, 3 am on 25Sep2025 and her fever kept going for hours. She was wondering if she should not have the covid vaccine in the future and if the benefits outnumber or outweigh the risks. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862531 12 M NH 10/01/2025 FLU3
HPV9
 SANOFI PASTEUR
MERCK & CO. INC.
 UT8792MA
Y015599
Syncope; Syncope Syncope; Syncope
Patient had syncopal spell within a few minutes after vaccine administration. He recovered within 2... Patient had syncopal spell within a few minutes after vaccine administration. He recovered within 20 minutes and was able to leave the office by his own power More
2862532 86 F SC 10/01/2025 FLU3
 SANOFI PASTEUR
 UT8820CA
Nausea, Peripheral swelling, Rash, Skin warm Nausea, Peripheral swelling, Rash, Skin warm
The day after receiving the vaccine, the patient's arm started to swell. Subsequently, the swe... The day after receiving the vaccine, the patient's arm started to swell. Subsequently, the swelling got worse with the addition of a rash, warmth in the area, and complaining of nausea. Her daughter began giving her Benadryl and Tylenol and made her an appointment with her primary care doctor this week. More
2862533 53 M CO 10/01/2025 COVID19
 JANSSEN
Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Par... Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Parkinson's disease, Tremor More
At unknown date, I experienced a minor stroke that has resulted in a right arm tremor that has been ... At unknown date, I experienced a minor stroke that has resulted in a right arm tremor that has been diagnosed as "early onset Parkinson's More
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2862535 17 F OH 10/01/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR

Injection site erythema, Injection site oedema, Injection site pain; Injection s... Injection site erythema, Injection site oedema, Injection site pain; Injection site erythema, Injection site oedema, Injection site pain More
Erythema, edema, and pain of the left deltoid Erythema, edema, and pain of the left deltoid
2862536 10 M MI 10/01/2025 COVID19
 MODERNA
 3052736
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event occurred. Pharmacist discovered after vaccination that mNEXspike is only indicated ... No adverse event occurred. Pharmacist discovered after vaccination that mNEXspike is only indicated for 12+. More
2862538 72 F MI 10/01/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 407254
407254
Blood pressure increased, Discomfort, Dyspnoea, Erythema, Head discomfort; Muscl... Blood pressure increased, Discomfort, Dyspnoea, Erythema, Head discomfort; Muscle spasms More
Client provided Fluad at her desk while sitting at 1016. At 1018, client stood up and yelled the nam... Client provided Fluad at her desk while sitting at 1016. At 1018, client stood up and yelled the name of a coworker. Client was grabbing her neck, face beet red, and appeared to have a difficult time breathing. Client c/o "back spasms". A staff member stated 911 should be called and client stated "No". Client sat back in chair, staff instructed client to take slow deep breaths. Client stated she felt like she was "bloating up" with pressure in head and neck. Client's normal color slowly returned and back to baseline 1035. Client calm, A&Ox4. Client at that time denied any spasms, pressure, or symptoms. BP was elevated and remained elevated. Of note, client has received Fluad every season for the last 3 years. She denies any history of a vaccine reaction or allergic reaction. More
2862539 13 M AR 10/01/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0173
EW0173
EW0173
FC3183
FC3183
FC3183
Atrial fibrillation, Cardiac ablation, Chest tube insertion, Computerised tomogr... Atrial fibrillation, Cardiac ablation, Chest tube insertion, Computerised tomogram, Echocardiogram; Electrocardiogram, Genetic testing, Heart rate increased, Magnetic resonance imaging heart, Myocarditis; Pneumothorax spontaneous, X-ray; Atrial fibrillation, Cardiac ablation, Chest tube insertion, Computerised tomogram, Echocardiogram; Electrocardiogram, Genetic testing, Heart rate increased, Magnetic resonance imaging heart, Myocarditis; Pneumothorax spontaneous, X-ray More
May 2024- rapid heart rate, Dec 2024-ablation for atrial fibrillation, Aug 2025-myocarditis, Sep 202... May 2024- rapid heart rate, Dec 2024-ablation for atrial fibrillation, Aug 2025-myocarditis, Sep 2025-spontaneous pneumothorax More
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