🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2846715 14 F CA 06/20/2025 HPV9
 MERCK & CO. INC.
 Y008843
Urticaria Urticaria
Hives that started 2 hours after the vaccine was given and are expaning to the rest of the body, pru... Hives that started 2 hours after the vaccine was given and are expaning to the rest of the body, pruritic, she was prescribed cetirizine, Hydrocortisone 1% topical as needed and benadryl as needed More
2846716 52 M MA 06/20/2025 COVID19
 PFIZER\BIONTECH
 md3414
Muscular weakness, Pain in extremity Muscular weakness, Pain in extremity
The vaccination administration itself went well but then the patient reported he had a lot of arm pa... The vaccination administration itself went well but then the patient reported he had a lot of arm pain and loss of arm strength. He reported this to us at the pharmacy on 6/18/2025. At this time we found out the patient had already gone to his doctor and received prednisone for his reaction but he did not report much relief on 6/202/2025 when he finally called me back to discuss. More
2846717 75 F NH 06/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 57dd5
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
no adverse event noted, patient is doing well reports no soreness. Injection was given IM vs approve... no adverse event noted, patient is doing well reports no soreness. Injection was given IM vs approved SQ route More
2846718 69 F NY 06/20/2025 PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 2004301
2004301
2004301
2004301
2004301
2004301
2004301
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headac... Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headache; Injection site pain, Pain, Protein urine present, Pyrexia, Pyuria; Urine abnormality, White blood cells urine positive; Acute kidney injury, Back pain, Bacterial test positive, Blood creatinine normal, Blood urine present; Chromaturia, Condition aggravated, Haematuria, Headache, Injection site pain; Pain, Protein urine present, Pyrexia, Pyuria, Urinary squamous epithelial cells increased; Urine abnormality, White blood cells urine positive; Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headache; Injection site pain, Pain, Protein urine present, Pyrexia, Pyuria; Urine abnormality, White blood cells urine positive; Acute kidney injury, Back pain, Bacterial test positive, Blood creatinine normal, Blood urine present; Chromaturia, Condition aggravated, Haematuria, Headache, Injection site pain; Pain, Protein urine present, Pyrexia, Pyuria, Urinary squamous epithelial cells increased; Urine abnormality, White blood cells urine positive More
Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuri... Fever (high as 102.3F), body aches, headache, injection site soreness and gross hematuria with pyuria and AKI. More
2846719 5 TN 06/20/2025 DTAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 5kr3r
3ca30c1
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
TDAP vaccine was inadvertently administered instead of DTAP.No adverse reactions noted.DTAP vaccine ... TDAP vaccine was inadvertently administered instead of DTAP.No adverse reactions noted.DTAP vaccine administered as indicated in clinic same day no adverse reactions to either vaccine More
2846720 17 F MD 06/20/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 B4J4B
Injection site swelling Injection site swelling
Arm swelling on the site of injection left deltoid; treatment: apply cold compress, maintain hygiene... Arm swelling on the site of injection left deltoid; treatment: apply cold compress, maintain hygiene, Tylenol PRN q4h for pain, advised to return if no improvement. More
2846721 16 M 06/20/2025 MENB
MENB
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
 LW8910
LW8910
U8494AA
U8494AA
Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pall... Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pallor; Visual impairment; Dizziness, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pallor; Visual impairment More
Patient received his first Trumenba at his well visit today. Shortly after receiving is vaccine he s... Patient received his first Trumenba at his well visit today. Shortly after receiving is vaccine he said he felt dizzy and like he was going to faint. He became pale, diaphoretic, complained of changes to his vision and then lost consciousness and became very stiff. He was laid on exam table by parent, and two nurses. MD notified and came to bedside to assess. BP/HR obtained. Patient came to without intervention after a couple of minutes. After he regained consciousness, he was given a popsicle, granola bar, and water. He was repositioned to recheck blood pressure when sitting and again became nauseated and feeling faint. He was laid back down on exam table with legs elevated. After several minutes he was able to sit on the edge of the table and BP was reassessed and was normal with normal HR. He denied any feelings of nausea or visual changes/feelings of being faint. He was then able to leave the exam room and office in the care of his mother. More
2846722 40 F MD 06/20/2025 TDAP
TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8353BA
U8353BA
U8353BA
U8353BA
Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, E... Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered; Exposure during pregnancy, Extra dose administered More
Pt is 37w pregnant. She was accidentally scheduled on the RN schedule for fetal monitoring and label... Pt is 37w pregnant. She was accidentally scheduled on the RN schedule for fetal monitoring and labeled as a 28 week pregnant patient. A tdap was given to the pt this day, as routinely done with 28 week appts. After further discussion, the patient and I were confused on dates while scheduling follow-up pregnancy appts, at which time she realized she was not 28 weeks and we together realized she is 37 weeks. She said she was confused as well and when double checking the immunization record, it was then discovered that she had already had her 28 week appt and tdap vaccine on April 11, 2025. More
2846723 11 M AZ 06/20/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 9X7CD
KR75K
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
pt had injection in office. Two days after injection mother called in stating the pt had a read area... pt had injection in office. Two days after injection mother called in stating the pt had a read area around injection site. Mother brought pt in for nurse visit. Injection site was red, warm to the touch, raised. Symptoms contained to R upper arm. PCP assessed area and informed pt to take OTC allergy medication, can use OTC anti-itch cream and continue to monitor area. More
2846724 51 F MI 06/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5A4XG
Erythema, Immediate post-injection reaction, Induration, Injection site vesicles... Erythema, Immediate post-injection reaction, Induration, Injection site vesicles, Skin warm More
The patient states that her arm became red as soon as she received the vaccine and was hot. It has ... The patient states that her arm became red as soon as she received the vaccine and was hot. It has been 2 weeks since her vaccination and her arm is still red, hard, and starting to blister at the injection site. More
2846726 4 F TX 06/20/2025 DTAPIPV
HEPA
MMRV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 U8209CB
J4K4X
Y017512
Crying, Hypotonia, Pallor, Unresponsive to stimuli; Crying, Hypotonia, Pallor, U... Crying, Hypotonia, Pallor, Unresponsive to stimuli; Crying, Hypotonia, Pallor, Unresponsive to stimuli; Crying, Hypotonia, Pallor, Unresponsive to stimuli More
The client, sitting on her mom s lap talking approximately five minutes after receiving vaccinations... The client, sitting on her mom s lap talking approximately five minutes after receiving vaccinations, suddenly became limp, unresponsive to verbal stimuli and color to face was ashen. Client was gently lowered to the floor lying on her back. Sternal rubs were done, and the client responded by opening her eyes and crying for her mother. Client was transferred on to a mat, feet elevated above her heart and a cool compress was applied to her forehead and neck. Once the client was able to answer questions appropriately and sit upright without any assistance, she was given orange juice which she took several sips without any problems. Client monitored for 30 minutes after adverse. No further adverse issues were noted and no complaints were voiced. Color with pink. Mother instructed to 1. notify client s primary care physician of adverse reaction to vaccines and follow up with primary care physician or go to the ER for any adverse changes in condition 2. Make sure client eats something soon as she leaves the clinic 3. with future vaccinations make sure healthcare provider is aware of possible adverse reaction. Mom verbalized understanding to instructions and felt comfortable with taking child home. Client is alert, oriented x3 and able to walk on her own without any issues. More
2846740 F 06/20/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y019158
EK225
Erythema, Pain in extremity, Skin warm; Erythema, Pain in extremity, Skin warm Erythema, Pain in extremity, Skin warm; Erythema, Pain in extremity, Skin warm
red, hot painful arm; red, hot painful arm; red, hot painful arm; Information has been received from... red, hot painful arm; red, hot painful arm; red, hot painful arm; Information has been received from the Food and Drug Administration (FDA) (agency number 2836907-1). This spontaneous report refers to a 65-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Apr-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), lot #Y019158, expiration date: 20-May-2026, administered by intramuscular route in the left arm for prophylaxis; and with Shingrix (Varicella zoster vaccine rgE (CHO)), lot #EK225, administered by intramuscular route (indication and expiration date were not reported). On 17-Apr-2025, the patient experienced red, hot painful arm (Skin warm, Pain in extremity, Erythema). On an unspecified date the patient recovered from the event of red, hot painful arm. The causal relationship between the events and the suspect therapies was not provided. More
2846741 F MO 06/20/2025 MMR
 MERCK & CO. INC.
Antibody test negative Antibody test negative
the patient developed an Alpha-Gal allergy at an unknown point in time; but it is not showing when t... the patient developed an Alpha-Gal allergy at an unknown point in time; but it is not showing when they ran titers; This spontaneous report was received from a Nurse and refers to an 60-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Prednisone allergy, Penicillin allergy, and Alpha-Gal allergy. Historical drugs included Prednisone (Prednisone), and Penicillin (Penicillin nos). Concomitant therapies were not reported. On an unknown date, it was stated that the patient was vaccinated with the series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection 0.5 mL, administered as prophylaxis (Lot Numbers, expiration dates, dose numbers, exact dose quantity volumes, routes and anatomical locations of administrations and vaccination scheme frequencies were not provided); that were reconstituted with sterile diluent (Lot No, expiration date and indication were not provided). On an unknown date, the patient developed an alpha-Gal allergy (food allergy) and also it was stated that she received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMR II) series (dates unknown) but it is not showing when they ran titers (antibody test negative) At the reporting time, the outcome of both events was not provided. The causal relationship between the both events with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the sterile diluent was not provided. More
2846742 55 M TX 06/20/2025 PNC21
 MERCK & CO. INC.
Pyrexia Pyrexia
fever; This spontaneous report was received from non-health proffesional and refers to 55-year-old m... fever; This spontaneous report was received from non-health proffesional and refers to 55-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included Environmenta allergies (pollen). Concomitant therapies were not reported. On 17-Jun-2025 at 08:40, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection, (dose, lot # and expiration date were not reported) as routine vaccination. On 17-Jun-2025 at 23:00, the patient experienced fever. It lasted through the night. The patient took 2 - 350 mg acetaminophen on 18-JUN-2025 at 2:00 am. The patient was fine on 18-JUN-2025 at 11:00. The patient recovered from the event of fever on 18-Jun-2025 at 11:00. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the event of fever and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received. More
2846743 74 F PA 06/20/2025 COVID19
COVID19
 MODERNA
MODERNA

Back pain, Chest pain, Fatigue, Heart rate, Immunisation reaction; Inappropriate... Back pain, Chest pain, Fatigue, Heart rate, Immunisation reaction; Inappropriate schedule of product administration, Neck pain, Respiratory failure, Sensory loss, Swelling More
Couldn't feel her legs when attempting to walk; Swelling in her left neck; Neck pain; Pain in h... Couldn't feel her legs when attempting to walk; Swelling in her left neck; Neck pain; Pain in her upper back; Chest pain; Fatigue/Didn't feel well and went to bed; Received the 1st shot 3 weeks before; Respiratory failure; Mild Side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), FATIGUE (Fatigue/Didn't feel well and went to bed) and RESPIRATORY FAILURE (Respiratory failure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus and Blood pressure high. Concomitant products included Metformin for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In May 2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and IMMUNISATION REACTION (Mild Side effects). On 26-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st shot 3 weeks before). On 27-May-2021, the patient experienced FATIGUE (Fatigue/Didn't feel well and went to bed) (seriousness criterion death). On 28-May-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death). 28-May-2021, the patient experienced SENSORY LOSS (Couldn't feel her legs when attempting to walk), SWELLING (Swelling in her left neck), NECK PAIN (Neck pain) and BACK PAIN (Pain in her upper back). The patient died on 29-May-2021. The reported cause of death was Chest pain, Fatigue and Respiratory failure. It is unknown if an autopsy was performed. At the time of death, SENSORY LOSS (Couldn't feel her legs when attempting to walk), SWELLING (Swelling in her left neck), NECK PAIN (Neck pain), BACK PAIN (Pain in her upper back), IMMUNISATION REACTION (Mild Side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 1st shot 3 weeks before) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Heart rate: no pulse. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient experienced mild side effects after the first shot. The patient's husband called her 1 hour before she passed on 29-May-2021. She was bedridden on 26-May-2021 and also on Thursday, 27-May-2021. By 28-May-2021, she was complaining of chest pain, left neck pain and swelling in her left neck and pain in her upper back. On 29-May-2021, patient's husband found her not responding, her eyes were not moving, and she had passed away. They called the medics and by the time they arrived, she had no pulse. The reporter stated that she was in fair health, but later when asked if she wasn't taking any medications, the reporter reported that he didn't know, but she was diabetic and had high blood pressure. He stated they had called her physician but had not received a call back. He did not know which arm the patient received the injection but knew that it was in the muscle of her upper arm. The patient was taking medication for diabetes. She had a severe reaction to the vaccine. The reporter was assuming that she died of a blood clot. On her death certificate, it stated that she died of natural causes, which the reporter felt to be untrue. It had been 4 years now since the patient died. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787078, US-MODERNATX, INC.-MOD-2021-237262 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon receipt of follow-up information on 10-Jun-2025; it was determined during case processing that the case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) is a duplicate of the already existing case MOD-2021-226627 (US-MODERNATX, INC.-MOD-2021-226627). Therefore, all information from case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) was added and merged with the retained case MOD-2021-226627 (US-MODERNATX, INC.-MOD-2021-226627). Hence, the duplicate case MOD-2021-229276 (US-MODERNATX, INC.-MOD-2021-229276) will be nullified and deleted from the safety database. Significant follow-up received in which suspect product first dose administration date was added, new events added, event outcome for the event of Inappropriate schedule of vaccine administered was updated, case narrative was updated and from subordinate duplicate case new reference number was added. On 11-Jun-2025: Live follow up received contains no new information.; Reporter's Comments: Company comment: The medical history of Diabetes mellitus and Blood pressure high remains as confounders. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787078:Case for multiple Patient (unknown) US-MODERNATX, INC.-MOD-2021-237262:Case for male patient (T-P); Reported Cause(s) of Death: Chest pain; Fatigue; Respiratory failure More
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2846744 M 06/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Death Death
My friend's son just died from taking a shingles/He passed away last week from the syndrome; Th... My friend's son just died from taking a shingles/He passed away last week from the syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: My friend's son just died from taking a shingles/He passed away last week from the syndrome) (serious criteria death and GSK medically significant). The patient died in JUN-2025. The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to Shingles vaccine. The company considered the unknown cause of death to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported his/her friend's son just died from taking a shingles shot. He passed away last week from the syndrome that it sent him into.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine; Reported Cause(s) of Death: Unknown cause of death More
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2846745 65 M WA 06/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Arthralgia, Lip swelling, Oral herpes, Tenderness Arthralgia, Lip swelling, Oral herpes, Tenderness
lip swelling; cold sore on his lower lip; shoulder was sore from the injection/tenderness in shoulde... lip swelling; cold sore on his lower lip; shoulder was sore from the injection/tenderness in shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis. The patient's past medical history included cold sores (had cold sores all his life). Previously administered products included multi vitamin and loratadine (allergy pill). On 29-MAY-2025, the patient received the 1st dose of Shingrix (left arm). On 30-MAY-2025, 1 days after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: shoulder was sore from the injection/tenderness in shoulder). On 04-JUN-2025, the patient experienced cold sores lip (Verbatim: cold sore on his lower lip). On 06-JUN-2025, the patient experienced lip swelling (Verbatim: lip swelling). The patient was treated with docosanol. The outcome of the shoulder soreness was resolved and the outcome of the cold sores lip and lip swelling were not resolved. The reporter considered the shoulder soreness to be related to Shingrix. It was unknown if the reporter considered the cold sores lip and lip swelling to be related to Shingrix. The company considered the shoulder soreness to be related to Shingrix. It was unknown if the company considered the cold sores lip and lip swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JUN-2025 Patient received his first dose of Shingrix in his left arm on 29-MAY-2025 from his Physician, and reports that starting on 30-MAY-2025, his shoulder was sore from the injection. The patient reported that he felt mild tenderness in his shoulder for the next day or two (no specific dates provided) that was 0.5 on a scale of 1 to 10. The patient reported that on 4-JUN-2025, he developed a cold sore on his lower lip, but he has had cold sores all his life. The patient used Over the Counter Docosanol Cream on the cold sore from 4-JUN-2025 through 6-JUN-2025, and the cold sore was diminishing. The patient reported that on the evening on 6-JUN-2025, through the morning of 7-JUN-2025, the cold sore spread to the right side of his lower lip and swelled up enormously. The patient reported that his lip was three times the normal size and he could not put his teeth together, the swelling went down by half over the next 24 hours, and on 10-JUN-2025, the swelling has gone down by half again. The patient stated he has never had an outbreak like this in his entire life and the patient did not know if the vaccine was given as an IM injection. The patient reported that he takes a Multi Vitamin and over the counter allergy pill, Loratadine, but did not take concurrently with Shingrix. More
2846746 F NJ 06/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via... Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2022). In MAR-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). In MAR-2025, the outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 11-JUN-2025 The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule. More
2846747 06/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
Took shingle shots it hurt patient; This non-serious case was reported by a consumer via interactive... Took shingle shots it hurt patient; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Took shingle shots it hurt patient). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR076144 Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she took second shingles shot and it hurt patient but will get over it as having shingles was horrible and it was worth taking the shots.; Sender's Comments: US-GSK-US2025AMR076144:1 st dose More
2846748 06/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
That second shingles shot did me in sick; This non-serious case was reported by a consumer via inter... That second shingles shot did me in sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: That second shingles shot did me in sick). The outcome of the sickness was not reported. The reporter considered the sickness to be related to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a consumer via interactive digital media. The second shingles shot did him/her sick. More
2846749 06/20/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; am dealing shingles now from my spine around the right to my navel; T... Suspected vaccination failure; am dealing shingles now from my spine around the right to my navel; 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 (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: am dealing shingles now from my spine around the right to my navel). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-JUN-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the shots two years ago and dealing with shingles now from spine around the right to navel. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2846750 06/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Erythema, Injection site swelling Erythema, Injection site swelling
swelling on my arm; redness on my arm; This non-serious case was reported by a consumer via interact... swelling on my arm; redness on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 13-JUN-2025, the patient received the 2nd dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: swelling on my arm) and erythema of extremities (Verbatim: redness on my arm). The outcome of the swelling arm and erythema of extremities were not reported. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingles vaccine. It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUN-2025 The patient self-reported this case for himself/herself. The patient had his/her 2nd Shingles vaccination shot yesterday (day before reporting). The patient had swelling and redness on his/her arm. More
2846751 F NJ 06/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Circumstance or information capable of leading to medication error, Extra dose a... Circumstance or information capable of leading to medication error, Extra dose administered More
second dose of Boostrix will be administered today; second dose of Boostrix will be administered tod... second dose of Boostrix will be administered today; second dose of Boostrix will be administered today June 10, 2025; A female patient received the first dose of Boostrix on April 24, 2025 and is intended to get the second dose on June 10, 2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 37-year-old female patient who did not receive DTPa (Reduced antigen) (Boostrix) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix). The patient did not receive Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: second dose of Boostrix will be administered today), extra dose administered (Verbatim: second dose of Boostrix will be administered today June 10, 2025) and drug prescribing error (Verbatim: A female patient received the first dose of Boostrix on April 24, 2025 and is intended to get the second dose on June 10, 2025.). The outcome of the circumstance or information capable of leading to medication error, extra dose administered and drug prescribing error 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. Additional Information: GSK receipt date: 10-JUN-2025 On 10/ June/2025 a pharmacist called to ask two questions for two different patients: The first patient is a female and received Boostrix on April 24, 2025. Physician prescribed a 3 dose series of Boostrix which led to drug prescribing error and because the patient never had Boostrix before. The second dose of Boostrix will be administered today June 10, 2025, and 3rd dose will be administered 6 months later, this led to circumstance or information capable of leading to medication error and extra dose administered. Is there any information of primary series of Boostrix for unvaccinated adults. More
2846752 M TX 06/20/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 T5D73
UNK
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
inadvertent administration of 1st dose; inadvertent administration of 2nd dose; This non-serious cas... inadvertent administration of 1st dose; inadvertent administration of 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received HBV (Engerix B) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 24-JAN-2025, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 1st dose of Engerix B. On 24-JAN-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of 2nd dose). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of 1st dose). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable. Additional Information: GSK receipt date: 13-JUN-2025 Other HCP reported that the inadvertent administration of two adult doses to a 17-year-old male patient, which led to inappropriate age at vaccine administration. He wanted to know how to proceed, and if the same vaccine could be used or a vaccine change is needed for completing the third dose. Second dose was administered on 24 January 2025, and third dose is scheduled as for 24 June 2025. More
2846753 F MS 06/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
a patient that was accidentally given 2 shingrix shots in one day (in January); This non-serious cas... a patient that was accidentally given 2 shingrix shots in one day (in January); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JAN-2025, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced accidental overdose (Verbatim: a patient that was accidentally given 2 shingrix shots in one day (in January)). The outcome of the accidental overdose was not applicable. Additional Information: GSK Receipt Date: 17-JUN-2025 Pharmacist had a patient that was accidentally given 2 Shingrix shots in one day (in January) which led to accidental overdose Pharmacist questioned that did you had any data on whether she should receive another shot after 60 days or was she complete. Pharmacist could share some of the patient information, but pharmacist did not have the vaccine information. More
2846754 F 06/20/2025 COVID19
 MODERNA
Macular degeneration, Retinal haemorrhage Macular degeneration, Retinal haemorrhage
retinal hemorrhage; macular degeneration; This spontaneous case was reported by a consumer and descr... retinal hemorrhage; macular degeneration; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (retinal hemorrhage) and MACULAR DEGENERATION (macular degeneration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 29-Nov-2021, the patient experienced RETINAL HAEMORRHAGE (retinal hemorrhage) (seriousness criteria disability and medically significant) and MACULAR DEGENERATION (macular degeneration) (seriousness criteria disability and medically significant). The patient was treated with Aflibercept (Eylea hd) at an unspecified dose and frequency and Aflibercept (Eylea) at an unspecified dose and frequency. At the time of the report, RETINAL HAEMORRHAGE (retinal hemorrhage) and MACULAR DEGENERATION (macular degeneration) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications were reported. On 29-Nov-2021, patient experienced temporary blurry vision, so patient did not think too much about it. Patient was busy during holidays and had minor symptoms. The blurry vision recurred on 25-Dec-2021 during a drive and worsened upon arrival. Patient made an appointment with an ophthalmologist and was told she had a retinal hemorrhage and macular degeneration. Ophthalmologist sent patient to a retinal specialist who began eye injections. patient received injections every month eventually getting to every 12 weeks. patient did not associate this problem with the vaccine until almost 2 years later when patient had lunch with a friend, and she mentioned she also had these same issues and her doctor told her it was from the Moderna vaccine. It was reported that they had both eye exams shortly before receiving the vaccine. Her friend had an exam 1 month before and patient had her eye exam 5 months before and both had not any of these issues and both had 1st symptoms approximately 2 weeks after injections and did think this was a coincidence. Patient mentioned that this has been a very inconvenient experience and reported that she would probably need to be receive this treatment for life. She had to drive 3 hours each way to visit the retinal specialist and patient received the Eylea HD at the university but she went to another Doctor at winter there was only given the Eylea and it was not as effective. Patient needed the injections more often. She stated that it was too expensive to get the Eylea HD. Also, patient was told she could no longer legally drive until her vision improved. It was mentioned that she felt like Moderna was responsible for her issue as they were not given any warning regarding eye problem when the vaccine was made available, and it was Moderna responsibility to report those side effects to the public. This case was linked to US-MODERNATX, INC.-MOD-2025-787620 (E2B Linked Report).; Reporter's Comments: Based on information provided, the causality cannot be excluded and both events are assessed as related to the suspect product. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787620:Patient 2 More
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2846755 65 F ME 06/20/2025 COVID19
 PFIZER\BIONTECH
Computerised tomogram, Salivary gland disorder, Sinus disorder, Ultrasound scan Computerised tomogram, Salivary gland disorder, Sinus disorder, Ultrasound scan
Has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a sali... Has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder; Sinus issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. Past drug history included: Botox injections, notes: Had the day before she had the vaccine but, has been having those for years. The following information was reported: SALIVARY GLAND DISORDER (non-serious) with onset 14Oct2024, outcome "not recovered", described as "Has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder"; SINUS DISORDER (non-serious) with onset 14Oct2024, outcome "not recovered", described as "Sinus issues". The events "has been experiencing symptoms since the week after getting the vaccine/diagnosed with having a salivary gland disorder" and "sinus issues" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of salivary gland disorder. Therapeutic measures were not taken as a result of sinus disorder. Additional Context: Reporter not sure of exact name but, calling regarding Covid vaccine she had in Oct2024. Further clarified, referring to Pfizer Covid vaccine. Has been experiencing symptoms since the week after getting the vaccine. None of her physicians have been able to diagnose what it is and what it isn't. They are aware she had vaccine, just spoke to CDC, filed report, wanted to report through Pfizer as well. When clarifying symptoms that caller has been experiencing, she states, she has been diagnosed with having a salivary gland disorder. Had Covid vaccine 08Oct2024, the symptoms began after 7 days. Clarified, the specific symptoms she experienced, that lead to being diagnosed with having a salivary gland disorder, are xerostomia and hypersalivation, which is excess salivation, even though, xerostomia means dry mouth. Xerostomia, Hypersalivation: Outcome of events: Have stayed the same, 24/7, with no change. Treatment: No, they don't have any treatment for her. They have given her a few medications not tolerable, did not help in any way. Further clarified, was just that one dose Covid vaccine, which she had on 08Oct2024. Has other medical conditions. Had Botox injections the day before she had the vaccine but, has been having those for years. Test results: Has had extensive testing, lab tests, CT scan, ultrasound. Drove 8 hours to (redacted), to see specialist, a salivary gland expert. Was something they cannot diagnose or, what is causing the problem. They have no way to prove diagnosis of anything. Clarified, she is referring to diagnosis of salivary gland disorder. It just started over night, was not slow or progressive. One night she was fine then, next day, had this problem. Did have regular flu shot. When clarifying if same date as Covid vaccine, 08Oct2024, caller states, she is not 100 percent sure, thinks it might have been. She knew they were not combined, was 2 separate injections. No AE required a visit to the Emergency Room. AE require a visit to a Physician's Office? Has seen many doctors and specialists, Nurse Practitioners, pulmonologist; cannot even keep track. Not allergic to any previous vaccination, medications, food or other products. Patient had sinus issues started same day as the salivary symptoms. she is still experiencing now, coincide with the other conditions, also has it 24/7. Has no previous history of sinus problems. Outcome of event: Has stayed about the same. Treatment: No prescription medicines. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2846756 M AR 06/20/2025 PNC20
 PFIZER\WYETH
Pneumonia, Pneumothorax Pneumonia, Pneumothorax
Pneumonia; Pneumothorax; A hole in the lung; This is a spontaneous report received from a Physician.... Pneumonia; Pneumothorax; A hole in the lung; This is a spontaneous report received from a Physician. A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown"; PNEUMOTHORAX (medically significant), 48 hrs after the suspect product(s) administration, outcome "unknown", described as "Pneumothorax; A hole in the lung". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event pneumonia and pneumothorax based on the known safety profile 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
2846757 F 06/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood pressure measurement, Death, Dizziness, Dyspnoea, Fatigue; Hypertension, L... Blood pressure measurement, Death, Dizziness, Dyspnoea, Fatigue; Hypertension, Lung neoplasm malignant More
developed high blood pressure; dizziness; shortness of breath; persistent tiredness; who has since p... developed high blood pressure; dizziness; shortness of breath; persistent tiredness; who has since passed away; lung cancer; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: LUNG NEOPLASM MALIGNANT (disability, life threatening) with onset 2023, 9 months after the suspect product(s) administration, outcome "not recovered", described as "lung cancer"; DEATH (death), outcome "fatal", described as "who has since passed away"; HYPERTENSION (disability, life threatening), outcome "not recovered", described as "developed high blood pressure"; DIZZINESS (disability, life threatening), outcome "not recovered"; DYSPNOEA (disability, life threatening), outcome "not recovered", described as "shortness of breath"; FATIGUE (disability, life threatening), outcome "not recovered", described as "persistent tiredness". Clinical course: The patient had passed away. Soon after taking the Covid vaccine booster (Pfizer), she developed high blood pressure that had never been seen in her lifetime. She experienced dizziness and shortness of breath. This led to reduced activity level and persistent tiredness. 9 months after the vaccine, she was detected with lung cancer even though all her previous assessments were clean. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were not taken as a result of death, lung neoplasm malignant, hypertension, dizziness, dyspnoea, fatigue. 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, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Reported Cause(s) of Death: who has since passed away More
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2846758 M WA 06/20/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
came down with COVID two weeks ago; came down with COVID two weeks ago; This is a spontaneous report... came down with COVID two weeks ago; came down with COVID two weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 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: Paxlovid for COVID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2025, outcome "unknown" and all described as "came down with COVID two weeks ago". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient's wife stated "My husband came down with COVID two weeks ago and the doctor provided or prescribed Paxlovid because he's got an upcoming surgery. When asked when the medication was picked up, patient's wife stated, "29May, just last month, so just over 2 weeks ago." "we were in such shock, but it was like 'Oh, we have to do this so he can have his surgery'." "When it's COVID you're just in a hurry to get the medication on the Paxlovid cause he had a upcoming heart procedure"...and we're spoiled, cause we all got it, my family, like a year or so ago (that was like almost 2 years ago), and the Paxlovid was free...it's kind of like a fast reaction, well we got to get this." When asked if Paxlovid was previously taken for COVID, patient's wife replied, "Yes, yes, and then we've had all our vacc-Pfizer, we get the Pfizer vaccinations regularly. We got it in Jan, just this year..." Later she said, "Thankfully I didn't get it I kept testing". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2846759 66 M MI 06/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0164
EW0164
Blood cholesterol, Blood triglycerides, Cardiac sarcoidosis, High density lipopr... Blood cholesterol, Blood triglycerides, Cardiac sarcoidosis, High density lipoprotein, Investigation; SARS-CoV-2 antibody test, SARS-CoV-2 test More
sarcoidosis of the heart; This is a spontaneous report received from a Consumer or other non HCP. A... sarcoidosis of the heart; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0164) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing); "congestive heart failure", start date: 2013 (ongoing); "hypertension" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "blood clots" (unspecified if ongoing); "anxiety " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number:EW0150), administration date: 12Apr2021, when the patient was 66-year-old, for covid-19 immunisation. The following information was reported: CARDIAC SARCOIDOSIS (medically significant) with onset 2023, outcome "unknown", described as "sarcoidosis of the heart". Clinical course: Medical History and Heart Condition Summary: In 2013, his daughter observed the patient was visibly unwell during a visit. At the hospital, doctors diagnosed him with congestive heart failure. The patient was hospitalized for nearly one month. Since that time, the patient had been under the care of Dr. (name withheld), MD, for ongoing heart-related issues. In 2020, during the height of the COVID-19 pandemic, the patient contracted the virus from his daughter, a nurse. The patient was severely ill and bedridden for over two months and home confinement, and caused long-term complications, including loss of taste and smell. His symptoms included intense body pain, complete loss of taste and smell extreme fatigue, weight loss, and inability to eat anything but soup and crackers. The patient suffered from brain fog, confusion, and prolonged physical weakness. After becoming sick, the patient experienced many of the same symptoms (name withheld) suffered, including pain, fatigue, and loss of taste and smell. In addition, the patient experienced serious complications, including blood clots. This all occurred while the patient was already coping with multiple serious chronic conditions, including congestive heart failure, hypertension, enlarged prostate, arthritis, and vertigo, details: long-standing congestive heart failure, hypertension, and other chronic illnesses. The patient was-and remain-the very type of high-risk individual claimed the Pfizer vaccine was designed to protect. Since recovering, the patient had not felt the same. His physical stamina was reduced, and the patient continued to experience ongoing anxiety and medical issues. These changes had affected every part of his life - his personal relationships, his mental health, and his sense of safety in the world. The patient continued to live with these fears and had not returned to the emotional and physical stability the patient had before the pandemic. After recovery, the patient followed the public health guidance issued and received two doses of Pfizer-BioNTech vaccine. However, his health worsened significantly. In 2023, ongoing health symptoms led to additional cardiac testing at (hospital name), the patient was diagnosed with cardiac sarcoidosis, a rare and serious inflammatory disease now requiring long-term steroid therapy (prednisone) and ongoing medical management. This was in addition to his previous congestive heart failure, hypertension, and other chronic illnesses. As of 2024, the patient was being treated with prednisone to control inflammation in his heart. These cardiac conditions-particularly sarcoidosis-did not exist prior to his COVID-19 infection and vaccination. The patient's current health status was directly worsened by exposure to COVID-19 and the withheld promoted Pfizer-BioNTech vaccine. Lab test: SARS-CoV-2 IgG, Result: SARS-CoV-2 IgG antibody (COVID-19), Value: Positive, comment: A positive result suggests previous exposure to SARS-CoV-2 (COVID-19) and is evidence of immunological responsiveness to the virus. A serological test result should always be interpreted together with clinical history and other results such as direct viral detection of SARS-CoV-2 (COVID-19). The performance characteristics of this test were determined by (name) laboratory. The test has been cleared by Food and Drug Administration under an Emergency Use Authorization. Lipid Panel: Result: Cholesterol: comment: 200-239 mg/dL borderline high. More than 240 mg/dL high; Value: 198; Ref Range: 70-199 mg/dL. Result: Triglycerides: comment: 150-199mg/dL borderline high. 200-499 mg/dL High. More than, equal to 500 mg/dL high; Value: 50; Ref Range: 0-149 mg/dL. Results: HDL Cholesterol; Value: 43; Ref range: 40-90 mg/dL. Current allergies included: Bactrim. Current Medications: aspirin, 81 mg; carvedilol, 25 mg; diclofenac sodium, 1 %; docusate sodium. 100 mg; furosemide, 40 mg; lidocaine, 4 %; meclizine, 25 mg; Narcan, 4 mg/actuation; nitroglycerin, 0.4 mg; omeprazole, 40 mg; tamsulosin, 0.4 mg; Entresto, 24-26 mg, BID (twice a day); finasteride, 5 mg. QD (once a day); oxycodone-acetaminophen, 10-325 mg. Every 4-6 hours as; naproxen, 500 mg BID; gabapentin. 400 me. TID (three times a day); Tab-A-Vite, 400 mcg QD; Rosuvastatin 10 mg. QD; ergocalciferol (vitamin 02) 1.250 mcg (50.000 unit) BIW (twice a week; bisacodyl, 5 mg; prednisone 20 mg; cyclobenzaprine 10 mg; paroxetine HCL 20 mg; amlodipine. 5 mg QD. More
2846760 79 M 06/20/2025 COVID19
 PFIZER\BIONTECH
Cardiac valve disease, Pyrexia Cardiac valve disease, Pyrexia
heart valve replacement surgery; fever; PROGRAM NAME NOT AVAILABLE This is a solicited report recei... heart valve replacement surgery; fever; PROGRAM NAME NOT AVAILABLE This is a solicited report received from a Consumer or other non HCP from License Party, Program ID: NOT AVAILABLE. A 79-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), on 07Nov2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; dupilumab (DUPILUMAB), since 21Oct2022 (ongoing)) at 300 mg (300 mg qow), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing). Concomitant medications included Nitroglycerin; Metoprolol; Rosuvastatin; Vitamins nos (Multivitamin): Tacrolimus monohydrate (Protopic): Aspirin: Allopurinol: Lisinopril: Hydrocodone; and Clobetasol. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The course of the events was as follows: On 21Oct2022, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300mg/2mI) at a dose of 300 mg QOW subcutaneously for Atopic dermatitis. On 07Nov2023. the patient received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (with an unknown strength, route, batch number and expiration date) for Prophylactic vaccination. On 07Nov2023 the patient developed a non-serious event "experiencing a fever after receiving the covid 19 vaccine booster" (pyrexia) (latency: 1 year 17 days) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. The patient developed a non-serious event 'heart valve replacement surgery' on 02JUN2025" (cardiac valve disease) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. Action taken with DUPILUMAB (DUPIXENT) was continued for both the events. Action taken with COVID-19 VACCINE was not applicable for both the events. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Reporter causality: Unassessable for dupilumab and Related to covid-19 vaccine for pyrexia and Unassessable for cardiac valve disease for dupilumab and not reported to covid-19 vaccine. The reporter considered "fever" related to BNT162b2. The reporter's assessment of the causal relationship of "heart valve replacement surgery" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY is under agreement with BIONTECH SE.; Sender's Comments: Based on known drug safety profile, and close temporal association the event pyrexia is assessed as related to the suspect drug BNT162B2. 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. Based on known mechanism of action of the drugs, the event cardiac valve disease is assessed as not related to the suspect drug, and more likely a pre-existing cardiac valve condition unspecified in the medical history as evidenced by the patient's intake of concomitant medications such as nitroglycerin, metoprolol, and rosuvastatin which are usually given to delay that progression of a heart valve disease of decrease the workload of the heart due to the valvular heart disease. Also, the age of the patient may be a contributory factor in the development a cardiac valve disease. More
2846761 24 KS 06/20/2025 UNK
 UNKNOWN MANUFACTURER
Animal bite, No adverse event, Off label use Animal bite, No adverse event, Off label use
patient who was prescribed Imovax with off label diagnosis Bitten by cat, initial encounter with no ... patient who was prescribed Imovax with off label diagnosis Bitten by cat, initial encounter with no reported AE; Initial information received on 16-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 24 years old and unknown gender patient who was prescribed IPV (VERO) [IMOVAX] with off label diagnosis bitten by cat, initial encounter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patient was prescribed unknown dose of suspect IPV (VERO) with off label diagnosis for Bitten by cat, initial encounter (Animal bite) (formulation: suspension for injection) (lot number, strength and expiry date not reported) with no reported adverse event (off label use) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. More
2846772 06/20/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Arthritis, Injection site cellulitis, Injection site rash, Joint swe... Arthralgia, Arthritis, Injection site cellulitis, Injection site rash, Joint swelling; Rheumatoid arthritis More
acute rheumatoid arthritis in R. thumb; rash extending 5 inches from injection site; rash turned int... acute rheumatoid arthritis in R. thumb; rash extending 5 inches from injection site; rash turned into cellulitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced rheumatoid arthritis (Verbatim: acute rheumatoid arthritis in R. thumb) (serious criteria GSK medically significant), injection site rash (Verbatim: rash extending 5 inches from injection site) and injection site cellulitis (Verbatim: rash turned into cellulitis). The outcome of the rheumatoid arthritis, injection site rash and injection site cellulitis were not reported. It was unknown if the reporter considered the rheumatoid arthritis, injection site rash and injection site cellulitis to be related to Arexvy. The company considered the rheumatoid arthritis to be unrelated to Arexvy. It was unknown if the company considered the injection site rash and injection site cellulitis to be related to Arexvy. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had rash extended 5 inches from injection site which appeared about 12 hours after Arexvy injection. Also, joint swelling, inflamed and extremely painful acute rheumatoid arthritis in right thumb. Then on day 5 and 6, rash turned into cellulitis.; Sender's Comments: Rheumatoid arthritis is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
2846773 F 06/20/2025 PNC13
 PFIZER\WYETH
Pneumonia, Vaccination failure Pneumonia, Vaccination failure
Vaccine was not effective; pneumonia; This is a spontaneous report received from an Other HCP. A fe... Vaccine was not effective; pneumonia; This is a spontaneous report received from an Other HCP. A female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), outcome "recovering", described as "Vaccine was not effective"; PNEUMONIA (hospitalization), outcome "recovering". The patient was hospitalized for drug ineffective, pneumonia (hospitalization duration: 10 day(s)). It was unknown if therapeutic measures were taken as a result of drug ineffective, pneumonia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (pneumonia) with the suspect product PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be fully excluded. More
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2846774 1.25 F MI 06/20/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK043AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
administering only the liquid component of Pentacel, with no reported adverse event; Initial informa... administering only the liquid component of Pentacel, with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] administering only the liquid component of pentacel, 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 Pneumococcal vaccine conj 7v (CRM197) (Prevnar). On 16-Jun-2025, the patient received the liquid component of dose 4 (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection with Strength = standard (lot UK043AA with expiry date 31-AUG-2025) via intramuscular route in the thigh nos for Immunization; with no reported adverse event (single component of a two-component product administered) (latency: same day). 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
2846775 TX 06/20/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK225AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
given the PENTACEL but without the HIB component with no reported adverse event; Initial information... given the PENTACEL but without the HIB component with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient gives the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) but without the hib component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine with unknown formulation and strength (lot UK225AB with expiry date 31-JUL-2026) via unknown route in unknown administration site for Immunization; without the hib component with no reported adverse event (poor quality product administered) (unknown latency). Reportedly: The staff member may have used a sterile diluent. Caller verified that the liquid component was not 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
2846776 62 F OH 06/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
red, warm area on right arm more down towards the elbow on the front of the arm, not as the site of ... red, warm area on right arm more down towards the elbow on the front of the arm, not as the site of injection, told patient to use ice pack and take tylenol/ibuprofen More
2846779 67 F 06/20/2025 PNC21
 MERCK & CO. INC.
Erythema, Mobility decreased Erythema, Mobility decreased
Patient reports numbness in the right shoulder area and decreased movement in the right shoulder are... Patient reports numbness in the right shoulder area and decreased movement in the right shoulder area. Patient gets all routine vaccinations at this location and symptoms began following the Capvaxive vaccine 4 months ago. More
2846780 1.58 M CA 06/20/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 MMR
CVP-X021118
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Patient had already received MMR and VZV given separately at visit 1/9/25. It was not my custom to ... Patient had already received MMR and VZV given separately at visit 1/9/25. It was not my custom to give these vaccines until 18 months. Therefore child got 2 doses approx 3 months apart. I sent an inquiry to CDC-INFO and received a response that although early, these shots would be valid and the child would therefore not need boosters at age 4 years. More
2846781 34 F CA 06/20/2025 TDAP
 SANOFI PASTEUR
Circumstance or information capable of leading to medication error, Exposure dur... Circumstance or information capable of leading to medication error, Exposure during pregnancy More
I am currently 29 weeks pregnant. Estimated date of delivery 9/5/25. On 6/20/25, around 5:20 pm, I... I am currently 29 weeks pregnant. Estimated date of delivery 9/5/25. On 6/20/25, around 5:20 pm, I had a scheduled Tdap vaccine. The pharmacist who administered the vaccine greeted me with blue gloves already on. With those same gloves, he open 2 doors so we can enter the storage room where he set up to administered the vaccine. Before administering the vaccine, he still had the gloves on, he pulled out his personal phone, touched it and said "I thought someone was calling me". He then put his personal phone away. Still with the blue gloves, he open the alcohol wipe, wiped the area were he was going to administered the vaccine, he opened the bandaid and put it on his right thigh, he administered the Tdap and some liquid spilled on my arm. When he was done administering the vaccine, he grabbed a cotton ball, wiped the spill liquid from my arm and dabbed where he administered the vaccine. He then pulled out the bandaid from his right thigh and put it on my arm and he said "all done". More
2846782 78 F WA 06/20/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Arthralgia, Ear pain, Hypoaesthesia, Pain in extremity, Palpitations Arthralgia, Ear pain, Hypoaesthesia, Pain in extremity, Palpitations
6/18/25: PT GOT VACCINE ON 6/13/25 DETAILS FRIDAY NIGHT: HEART POUNDING IN THE MIDDLE OF THE NIGHT, ... 6/18/25: PT GOT VACCINE ON 6/13/25 DETAILS FRIDAY NIGHT: HEART POUNDING IN THE MIDDLE OF THE NIGHT, ELBOW PAIN NEXT DAY, RIGHT LEG NUMB SATURDAY NIGHT-- > BETTER NEXT 2 DAYS, SHARP PINCHING BEHINHD RIGHT EAR FOR3 TO 4 DAYS-- > GOES AWAY 6/17/25, ---- > RIGHT LEG STILL HURT, MILD ELBOWS PAIN ; 6/20/25 FOLLOW UP, PT RIGHT LEG STILL HURT-- > SHE HAD APPT WITH EHR DOCTOR ON 6/19/25. SHE SAID DOCTOR TOLD HER SHE MAY NEED TO DO XRAY IN THE NEXT 2 WEEKS AND MAYBE SURGERY More
2846830 1.5 M MA 06/20/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Product storage error Product storage error
None reported- Symptoms COVID vaccine given over 10 weeks after thawed and storage. None reported- Symptoms COVID vaccine given over 10 weeks after thawed and storage.
2846831 77 F OH 06/20/2025 PNC21
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z004302
9JT45
Injection site erythema, Injection site pain, Injection site warmth, Muscle spas... Injection site erythema, Injection site pain, Injection site warmth, Muscle spasms; Injection site erythema, Injection site pain, Injection site warmth, Muscle spasms More
The night she had vaccine she experienced body spasms that lasted 24 hours, pain, redness, warmth, @... The night she had vaccine she experienced body spasms that lasted 24 hours, pain, redness, warmth, @ injection site. The patient had never had a reaction to an injection. At todays visit, no futher spasm, still having, redness & warmth @ injection site. Left arm More
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2846515 VA 06/19/2025 DTPPVHBHPB
RVX
 MSP VACCINE COMPANY
UNKNOWN MANUFACTURER

No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a tem... No additional AE; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 28MAY2025.; This spontaneous report was received from a Nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 28-May-2025, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis (strength, Lot No, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided), also with an improperly stored dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) (indication, strength, Lot No, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); after a temperature excursion of 1.4 degree Celsius (C) during a time frame of 18 minutes that occurred (on 07-May-2025) (product storage error). No previous temperature excursions were reported. No additional adverse events or PQC were provided (no adverse event). More
2846527 M NY 06/19/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Colonoscopy, Fall, Glaucoma, Memory impairment, Mobility decreased; Neoplasm mal... Colonoscopy, Fall, Glaucoma, Memory impairment, Mobility decreased; Neoplasm malignant, Parkinson's disease More
diagnosed with Parkinson's Disease; Glaucoma; Form of cancer; Fall; could not get up; This seri... diagnosed with Parkinson's Disease; Glaucoma; Form of cancer; Fall; could not get up; This serious case was reported by a consumer via call center representative and described the occurrence of parkinson's disease in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart disorder (Heart trouble is unspecified). 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 parkinson's disease (Verbatim: diagnosed with Parkinson's Disease) (serious criteria GSK medically significant), glaucoma (Verbatim: Glaucoma) (serious criteria GSK medically significant), cancer (Verbatim: Form of cancer) (serious criteria GSK medically significant), fall (Verbatim: Fall) and mobility decreased (Verbatim: could not get up). The outcome of the parkinson's disease, glaucoma, cancer and fall were unknown and the outcome of the mobility decreased was not reported. It was unknown if the reporter considered the parkinson's disease, glaucoma, cancer, fall and mobility decreased to be related to Shingrix. The company considered the parkinson's disease, glaucoma and cancer to be unrelated to Shingrix. It was unknown if the company considered the fall and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient. The patient received both doses of Shingrix vaccine several years ago. In 2023 or 2024, the patient was diagnosed with Parkinson's opposes disease. The patient stated that he had trouble with his memory, it was unclear how long the patient was just diagnosed with glaucoma, and was currently using eye drops to treat this. The patient recently had a colonoscopy and was told that it was possible that he might have a form of cancer. The patient reported that he had fallen 6 times in which he could not get up. The patient had limited contact information for the healthcare professional.; Sender's Comments: Parkinson's disease, Glaucoma and Neoplasm malignant are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
2846528 F MO 06/19/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 7975C
Incorrect route of product administration Incorrect route of product administration
intramuscular versus subcutaneous administration of PRIORIX.; This non-serious case was reported by ... intramuscular versus subcutaneous administration of PRIORIX.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 7975C, expiry date 01-MAR-2027) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular use). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular versus subcutaneous administration of PRIORIX.). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 11-JUN-2025 Bachelor of Science in Nursing called to ask, are there any safety concerns regarding the intramuscular versus subcutaneous administration of Priorix which led to incorrect route of product administration. Vaccine details and patient demographics were obtained in this call. No vaccination was confirmed from the Bachelor of Science in Nursing's end. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2846529 68 F CA 06/19/2025 COVID19
COVID19
 MODERNA
MODERNA

Chills, Hyperhidrosis, Nausea, Pain, Pain in extremity; Pyrexia, Vomiting Chills, Hyperhidrosis, Nausea, Pain, Pain in extremity; Pyrexia, Vomiting
sweats; sore arm; Fever; chills; nausea/ vomiting; nausea/ vomiting; aches; This spontaneous case wa... sweats; sore arm; Fever; chills; nausea/ vomiting; nausea/ vomiting; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 13-Jun-2025, the patient experienced PAIN (aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting) was resolving. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. More
2846531 34 F NY 06/19/2025 FLU3
 SEQIRUS, INC.
 946639
Asthma, Hypersensitivity, Hypoxia, Pulmonary function test Asthma, Hypersensitivity, Hypoxia, Pulmonary function test
Shortly after this vaccine (within the week) , the patient had to be put on an inhaler again after 2... Shortly after this vaccine (within the week) , the patient had to be put on an inhaler again after 25 years and placed on steroids. This was the first time in 25 years the patient had a respiratory attack. The patients immune system has been hyper reactive since, easily having respiratory/asthma attacks triggered, despite being put on steroids multiple times. This patient has not had a medical condition prior to this in the time period mentioned above before this vaccine was administered. Recently, she has been really close to calling EMS due to this repository attacks causing hypoxia. All the above is what is promoting this VAERS report, as many adverse effects by these vaccines are underreported. More
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2846542 06/19/2025 FLUN4
 MEDIMMUNE VACCINES, INC.
Influenza Influenza
Around 2010, FLM was administered to the child who studying abroad, and the patient developed influe... Around 2010, FLM was administered to the child who studying abroad, and the patient developed influenza; A spontaneous report has been received from a other health professional via License Partner. The report concerns a patient of unknown gender (age not provided). No medical history was reported. No concomitant products were reported. The patient started treatment with Flumist Quadrivalent (flumist, influenza virus vaccine polyvalent, q/laiv) UNK, on an unknown date for vaccination. No malfunction has been reported for the Accuspray Single Dose device. On an unknown date, the patient experienced around 2010, flm was administered to the child who studying abroad, and the patient developed influenza (preferred term: Influenza). The outcome of the event(s) of around 2010, flm was administered to the child who studying abroad, and the patient developed influenza was unknown. The event was considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): around 2010, flm was administered to the child who studying abroad, and the patient developed influenza. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): around 2010, flm was administered to the child who studying abroad, and the patient developed influenza. Report received by AstraZeneca via License Partner on 12-JUN-25. Device Information: Combination Product Report: Yes Product As Reported: Flumist Quadrivalent Brand Name: FLUMIST QUADRIVALENT Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No More
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