🏥 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 💀 🏥 🚑 ♿ ⚠️
2853381 76 F TN 08/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 JB27A
Extra dose administered, Fatigue, Somnolence Extra dose administered, Fatigue, Somnolence
PATIENT ALREADY HAD 1 SHOT IN JUNE 2024. VACCINE ADMINISTERED ON 08/07/25 WAS INAPPROPRIATE AS ONLY ... PATIENT ALREADY HAD 1 SHOT IN JUNE 2024. VACCINE ADMINISTERED ON 08/07/25 WAS INAPPROPRIATE AS ONLY ONE DOSE IS RECOMENDED. PATIENT WAS INFORMED ABOUT THE ERROR AND ASKED ABOUT ANY ADVERSE EVENT SHE CAME ACROSS. SHE MENTIONED THAT THE FEES TIRED AND SLEEPY. More
2853382 50 F NE 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
Patient noticed redness to her left deltoid area on 8/7/25. On 8/8/25, exam of the left deltoid sho... Patient noticed redness to her left deltoid area on 8/7/25. On 8/8/25, exam of the left deltoid shows erythematous raised area measuring 6 cm x 9 cm. It is sore to palpation, and feels warm to touch. . More
2853383 1 M MT 08/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 JF7DM
Injection site warmth Injection site warmth
Today (7 days after vaccination) mom noticed a flesh-colored welt at the vaccine site on right thigh... Today (7 days after vaccination) mom noticed a flesh-colored welt at the vaccine site on right thigh. Denies previous reaction with last DTaP's. Denies redness. Denies fevers. Denies drainage. Welt is approximately half dollar size. No other vaccinations were given, just the DTaP on 8/1/25. More
2853384 36 F MS 08/08/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 U8122AA
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Patient's mother called clinic on 8/7/25 at 849am and reported that patient was having severe p... Patient's mother called clinic on 8/7/25 at 849am and reported that patient was having severe pain in left arm and shoulder area. Patient's mother states she cannot move her shoulder. Nurse asked to speak with patient and mother said patient was sleeping. Patient had TDaP vaccine on 7/31/25. Nurse instructed mother to have patient see PCP or go to urgent care facility. Patient's mother verbalized understanding of these recommendations. Nurse called patient on 8/8/25 and patient reports pain is slightly better and wants to wait until Monday 8/11/25 to see a physician. Nurse instructed patient, again, to seek out PCP or urgent care immediately. More
2853385 49 M OR 08/08/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Patient came in for 2nd dose of Monkey pox after the 28 day minimal acceptable spacing. Nurse admini... Patient came in for 2nd dose of Monkey pox after the 28 day minimal acceptable spacing. Nurse administered the 2nd dose IM into the left deltoid, instead of subcutaneous. The error was realized very quickly. This nurse asked the patient to stay in the room while investigating the potential side effects of wrong route. Informed the patient that he may experience more systemic or localized reaction. He reported a small lump after the last injection that went away within 1 week. He was alert and oriented. No signs or symptoms of adverse reaction in clinic. He agrees to notify the health department of any issue that arise in the next few days. This nurse will be calling him Monday. More
2853386 12 F NM 08/08/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8375AA
CX4HL
Dizziness, Feeling hot, Hypotonia, Pallor, Presyncope; Dizziness, Feeling hot, H... Dizziness, Feeling hot, Hypotonia, Pallor, Presyncope; Dizziness, Feeling hot, Hypotonia, Pallor, Presyncope More
Patient had a vasovagal response after the second vaccine injection (MenQuadfi). She turned pale and... Patient had a vasovagal response after the second vaccine injection (MenQuadfi). She turned pale and started to slump to the left. She was laid in a reclining position, and her legs and feet were elevated. She came around less than 15 seconds later. She stated that she was dreaming about elephants. She asked how long she was sleeping. She stated that she felt warm on her face. She was given a small cup of water. Vital signs completed: BP right arm 97/78, Pulse 85, RR 14, O2 98%. Mom stated that she did eat prior to coming to the clinic for her appointment. Patient is a tall and thin adolescent, and she stated that she has had episodes of light headedness when standing up from a seated position in the past. RN observed client for 15 minutes after event to make sure she was safe to leave with mother. More
2853387 82 F FL 08/08/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8764BB
LX4482
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient was given two doses of Prevnar 20. One was given on 02/14/2025 and the other on 08/06/2025. ... Patient was given two doses of Prevnar 20. One was given on 02/14/2025 and the other on 08/06/2025. No adverse symptoms were reported by patient. More
2853388 4 M UT 08/08/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Emotional distress, Injection site bruising, Injection site erythema, Injection ... Emotional distress, Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule; Injection site pain, Injection site urticaria, Injection site warmth More
Large, hard red bruise on side of left thigh where shot was administered. It grew for 72 hours. It w... Large, hard red bruise on side of left thigh where shot was administered. It grew for 72 hours. It was almost as large as his entire thigh! It became softer after 48 hours. But, continues to grow in size, even at 4 days after. It has developed large red hives on the border of his bruise. This nodule is much larger than 2 inches in diameter in all directions. It is hot to the touch. It cause him great pain and distress. More
2853389 1.33 M CA 08/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 Y7JC3
Erythema, Pyrexia, Swelling Erythema, Pyrexia, Swelling
SWELLING, FERVER , REDNESS FACE LEGS SWELLING, FERVER , REDNESS FACE LEGS
2853390 24 F VA 08/08/2025 COVID19
 MODERNA
Chest pain, Pain, Vaccination site urticaria Chest pain, Pain, Vaccination site urticaria
Body aches and pains; Chest pain within 48 hours. A 5/10 on pain. Tightness; raised warm welt at inj... Body aches and pains; Chest pain within 48 hours. A 5/10 on pain. Tightness; raised warm welt at injection site within 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) in a 24-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Aug-2025, the patient experienced PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours). At the time of the report, PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had body aches and pains, raised warm welt at injection site within 24 hours, chest pain within 48 hours, A 5/10 on pain, and tightness. It was unknown if she experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. There were no lab data/results available. Treatment medication was not reported. More
2853391 F CA 08/08/2025 COVID19
 UNKNOWN MANUFACTURER
Breakthrough COVID-19, Polymerase chain reaction Breakthrough COVID-19, Polymerase chain reaction
Got Covid about 9 months after getting Novavax, last August 2024; This non-serious initial spontaneo... Got Covid about 9 months after getting Novavax, last August 2024; This non-serious initial spontaneous report was reported by a Physician via contact center (MI No. NOV25-00560) and concerns a 69-year-old Female who experienced "GOT COVID ABOUT 9 MONTHS AFTER GETTING NOVAVAX, LAST AUGUST 2024" on an unspecified date in August 2024 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on an unknown day. At the time of the report, the outcome of the Breakthrough COVID-19 was Unknown.; Sender's Comments: This 69-year-old Female experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Breakthrough COVID-19 was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 is considered Possible. More
2853392 57 M TX 08/08/2025 COVID19
 PFIZER\BIONTECH
 SENG6198
Back pain, Insomnia, Pain Back pain, Insomnia, Pain
Upper Back pain; excruciating pain; unable to sleep consistently through the night; This is a sponta... Upper Back pain; excruciating pain; unable to sleep consistently through the night; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 at 12:30 as dose 3, single (Lot number: SENG6198) at the age of 57 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Hypersensitivity". The following information was reported: BACK PAIN (non-serious), outcome "recovering", described as "Upper Back pain"; PAIN (non-serious), outcome "recovering", described as "excruciating pain"; INSOMNIA (non-serious), outcome "recovering", described as "unable to sleep consistently through the night". Additional information: the pain starts on the right side of his ribs. More
2853393 CA 08/08/2025 PNC20
 PFIZER\WYETH
 LN4930
Erythema, Swelling, Tenderness Erythema, Swelling, Tenderness
large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder ... large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500159686 same drug/events, different patient;US-PFIZER INC-202500159687 same drug/events, different patient; More
2853394 CA 08/08/2025 PNC20
 PFIZER\WYETH
 LN4930
Erythema, Swelling, Tenderness Erythema, Swelling, Tenderness
large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder ... large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500159687 same drug/events, different patient;US-PFIZER INC-202500159685 same drug/events, different patient; More
2853395 CA 08/08/2025 PNC20
 PFIZER\WYETH
 LN4930
Erythema, Swelling, Tenderness Erythema, Swelling, Tenderness
large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder ... large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500159685 same drug/events, different patient;US-PFIZER INC-202500159686 same drug/events, different patient; More
2853396 F AZ 08/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a C... tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Aug2025, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2853397 F 08/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Herpes simplex, Pyrexia, Vomiting COVID-19, Drug ineffective, Herpes simplex, Pyrexia, Vomiting
diagnosed with COVID-19; diagnosed with COVID-19; broke out with "herpes simplex" virus al... diagnosed with COVID-19; diagnosed with COVID-19; broke out with "herpes simplex" virus all over her face; fever; threw up; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series completed), for covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "broke out with "herpes simplex" virus all over her face"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "threw up". Clinical course: Caller is a consumer, calling to report AE after receiving COVID-19 booster shots. After receiving booster shots she broke out with herpes simplex virus all over her face, had a fever, threw up and was diagnosed with COVID-19. Needs patient assistance for Paxlovid. Patients have government funded insurance. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853398 08/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Their Covid shot failed; Their Covid shot failed; This is a spontaneous report received from a Consu... Their Covid shot failed; Their Covid shot failed; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Their Covid shot failed". Clinical course: The reporter stated that Pfizer's Covid shot failed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853399 73 F 08/08/2025 UNK
UNK
UNK
MMR
MMR
MMR
RVX
RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER








Condition aggravated, Eczema, Injection site pain, Injection site reaction, Myal... Condition aggravated, Eczema, Injection site pain, Injection site reaction, Myalgia; Pain; Vaccine interaction; Condition aggravated, Eczema, Injection site pain, Injection site reaction, Myalgia; Pain; Vaccine interaction; Condition aggravated, Eczema, Injection site pain, Injection site reaction, Myalgia; Pain; Vaccine interaction More
experiencing myalgias during the evenings about 5 pm in her right hip and her elbow; reports an inje... experiencing myalgias during the evenings about 5 pm in her right hip and her elbow; reports an injection site reaction; experienced pain when the injection started and was startled and relaxed lhe pressure, causing the medicalion to pool under skin; experienced pain when the injection started and was startled and relaxed lhe pressure, causing the medicalion to pool under skin; worsening of eczema on her scalp; drug-vaccine interaction dupixent; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025SA039251 (Sanofi). A 73-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 09Jul2025 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 09Jul2025 as booster, single; dupilumab (DUPIXENT), (ongoing) at 300 mg (300 mg qow (every other week)), subcutaneous for chronic obstructive pulmonary disease. The patient's relevant medical history included: "eczema" (ongoing); "hip injury" (unspecified if ongoing); "lupus" (unspecified if ongoing); "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Mmr vaccine, for immunization. The following information was reported: DRUG INTERACTION (non-serious) with onset 09Jul2025, outcome "unknown", described as "drug-vaccine interaction dupixent"; MYALGIA (non-serious), outcome "unknown", described as "experiencing myalgias during the evenings about 5 pm in her right hip and her elbow"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "reports an injection site reaction"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious), outcome "unknown" and all described as "experienced pain when the injection started and was startled and relaxed lhe pressure, causing the medicalion to pool under skin"; ECZEMA (non-serious), outcome "unknown", described as "worsening of eczema on her scalp". The action taken for dupilumab was dosage not changed. Additional information: She got an RSV and MMR booster vaccine yesterday at her local pharmacy. Today, took her dose of Dupixent. Advised if both inactivated the Dupixent can still reduce her vaccine immune response and there their efficacy. The bigger concern would be if the MMR one is a live virus to where she can actually catch the virus from it. It was reported that the patient experiencing myalgias during the evening about 5pm in her right hip and her elbow following the first dose intake of dupilumab. It was also reported that patient developed a nonserious got live vaccine mmr booster following the first dose intake of dupilumab and following the administration of RSV vaccine and same day latency following administration of MMR. Patient got live vaccine mmr bosster directly linked to the contraindicated drug administered. Batch/lot number is not provided, and it cannot be obtained. More
2853400 F NC 08/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 35-year-old female pat... COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. During an inbound call for financial assistance, the patient wanted to know what she has to do to try to lower the cost of COVID-19 medicine, because she currently has COVID. The patient got COVID and got to take a break from work. The patient remembers when this stuff was free. The patient had nirmatrelvir/ritonavir (PAXLOVID) before for COVID. Per patient, it didn't feel like this time. The patient was sicker than she was last time. But the patient had a couple shots and boosters, but then she hadn't had it in a long time. The patient had been in the patient assistance program before. The patient inquired if she could go take that COVID shot. More
2853401 08/08/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
Perhaps too effective because it made me feel horrible; This is a spontaneous report received from a... Perhaps too effective because it made me feel horrible; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Perhaps too effective because it made me feel horrible". Additional information: Patient reported that yes, the covid shot was incredibly effective. Perhaps too effective because it made me feel horrible. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853402 F IL 08/08/2025 RSV
 PFIZER\WYETH
Nervous system disorder, Respiratory failure Nervous system disorder, Respiratory failure
respiratory failure; neurological distress; This is a spontaneous report received from a Consumer or... respiratory failure; neurological distress; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY FAILURE (hospitalization, medically significant), 30 days after the suspect product(s) administration, outcome "unknown"; NERVOUS SYSTEM DISORDER (hospitalization), 30 days after the suspect product(s) administration, outcome "unknown", described as "neurological distress". No prior symptoms or diagnosis before the vaccine. Patient has been in the hospital/long term care (LTC) for over 100 days. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
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2853404 81 M 08/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 f4ac3
Arthralgia, Extra dose administered, Fatigue Arthralgia, Extra dose administered, Fatigue
Reporting a duplication of vaccination. The patient previously received the vaccine in 2023 but the ... Reporting a duplication of vaccination. The patient previously received the vaccine in 2023 but the record wasn't reported in the state vaccine registry and the patient didn't remember having done so. This came to light today via a system report indicating the duplication in dose. Patient reports sore shoulder and fatigue the day after, but feels well today. More
2853405 67 F 08/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 f4ac3
Extra dose administered Extra dose administered
I haven't been able to get in touch with this patient yet. I will update once I am able to spea... I haven't been able to get in touch with this patient yet. I will update once I am able to speak with her to detail whether she had any adverse reactions or not. It came to our attention after the fact that this was a duplication of the RSV vaccine. She had indicated that she hadn't yet received it and there was no record in our state immunization registry. After the fact we received a report from our Rx processing software indicating that it was duplicated. More
2853406 56 M OR 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Pain, Tinnitus Pain, Tinnitus
The vaccine was administered on August 1, 2025 around 13:30. Around 19:00 I started to experience wh... The vaccine was administered on August 1, 2025 around 13:30. Around 19:00 I started to experience whole body aches and tinnitus. The body aches were gone within 24 hours. The tinnitus has been continuing (for 5+ days as of this time) with no sign of improvement. No subjective hearing loss. Tinnitus is worse in the L ear than the right ear and it is a high pitched buzz More
2853407 11 F ID 08/08/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y012864
DL4YY
9JT4S
Injection site erythema, Injection site rash, Injection site swelling, Injection... Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth; Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth; Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth More
Parent called on August 8, 2025 and reported an adverse event. Patient experienced injection site s... Parent called on August 8, 2025 and reported an adverse event. Patient experienced injection site swelling, redness, hot to touch and visible rash on the right arm only until August 3, 2025 2 days after immunization was administered. Parents watched site at home. More
2853414 11 M CA 08/08/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8558AA
PG3RP
Adverse reaction; Adverse reaction Adverse reaction; Adverse reaction
topical adverse reaction topical adverse reaction
2853415 62 M FL 08/08/2025 PNC21
 MERCK & CO. INC.
 Y013009
Erythema, Peripheral swelling, Pyrexia, Skin warm Erythema, Peripheral swelling, Pyrexia, Skin warm
Patient developed fever, red swollen and warm to touch arm from approx 1/2 bicep down to hand day fo... Patient developed fever, red swollen and warm to touch arm from approx 1/2 bicep down to hand day following vaccine administration. Patient advised to take ibuprofen/tylenol and even topical diclofenac to combat by primary dr. Condition did not improve so saw Primary Dr. on Day 4 after vaccine More
2853416 75 M CA 08/08/2025 UNK
 UNKNOWN MANUFACTURER
Headache, Listless Headache, Listless
listless, headache, listless, headache,
2853417 4 F CA 08/08/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Crying, Decreased appetite, Erythema, Headache, Lethargy; Pyrexia, Rash Crying, Decreased appetite, Erythema, Headache, Lethargy; Pyrexia, Rash
My daughter had a high fever of 104 for 8 days with a full dose of Tylenol and ibuprofen I couldn?t... My daughter had a high fever of 104 for 8 days with a full dose of Tylenol and ibuprofen I couldn?t get the fever to go down. She was extremely lethargic, had no appetite, crying with a bad headache. She then broke out for five days head to toe in red dots all over her body and her skin turned red. I have pictures, dates and times. I called my doctor multiple times worried that this reaction was too much for her heart. More
2853418 18 F ID 08/08/2025 MNQ
 SANOFI PASTEUR
 U8494AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient didn't have a reaction to the vaccination. Patient didn't have a reaction to the vaccination.
2853419 45 F MN 08/08/2025 HPV9
 MERCK & CO. INC.
Muscle spasms Muscle spasms
Muscle spasm Muscle spasm
2853420 72 M FL 08/08/2025 PNC20
 PFIZER\WYETH
 lp4947
Injection site pain, Injection site swelling, Injection site warmth Injection site pain, Injection site swelling, Injection site warmth
Patient experienced a lot of pain, warmth, swelling underneath the deltoid. No itching. Pharmacist w... Patient experienced a lot of pain, warmth, swelling underneath the deltoid. No itching. Pharmacist was able to spot the injection site correctly in the deltoid when reported. More
2853421 66 F HI 08/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 XA53Y
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
redness, warmth, and tenderness to site 4" below injection site about 2 days after injection. ... redness, warmth, and tenderness to site 4" below injection site about 2 days after injection. pt.given ice pack for area. pt.not concerned and does not worry about reaction More
2853422 71 M NC 08/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient received Arexvy on 9/11/2023 but no one entered it into Immunization Registry. We were p... The patient received Arexvy on 9/11/2023 but no one entered it into Immunization Registry. We were performing an employee vaccine clinic and was working off immunization registry to identify what vaccines were due. Immunization registry indicated patient was due for RSV. We administered vaccine. We were notified from our corporate office that patient already received vaccine in 2023. Patient was not experiencing any side effects but wanted to report the double dose. More
2853423 4 F OR 08/08/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U7908AA
Y017513
Gait disturbance, Injection site erythema, Injection site swelling, Loss of pers... Gait disturbance, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities; Gait disturbance, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities More
Patient is a 4-year-old female who received DTaP/IPV and MMRV vaccines on 8/07/25. Within 24 hours,... Patient is a 4-year-old female who received DTaP/IPV and MMRV vaccines on 8/07/25. Within 24 hours, mother reported increased swelling in the leg extending down toward the knee. No redness noted near the DTaP/IPV injection site. The MMRV injection site is erythematous but redness has not spread. Motrin given at 11:00 am with no additional medications. Patient has been icing the area with minimal relief. She is visibly limping and avoiding climbing activities but remains alert and interactive. Mother denies fever, body aches, chills, fatigue, lethargy, rash, hives, or decreased appetite. Patient is able to bend the knee without difficulty. Swelling and erythema remain localized, and supportive measures continue. More
2853424 80 CA 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75D3A
Injection site erythema, Injection site pruritus, Injection site warmth Injection site erythema, Injection site pruritus, Injection site warmth
Patient presented with redness around injection site on left arm. Warm to touch and states it was it... Patient presented with redness around injection site on left arm. Warm to touch and states it was itchy. More
2853425 16 M WA 08/08/2025 IPV
MENB
MNQ
 SANOFI PASTEUR
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Y1A201M
49M9N
DL4YY
Arthralgia, Bursitis, Mobility decreased, Shoulder injury related to vaccine adm... Arthralgia, Bursitis, Mobility decreased, Shoulder injury related to vaccine administration, Ultrasound joint; Arthralgia, Bursitis, Mobility decreased, Shoulder injury related to vaccine administration, Ultrasound joint; Arthralgia, Bursitis, Mobility decreased, Shoulder injury related to vaccine administration, Ultrasound joint More
Received above vaccines on 7/29/2025. Mom called clinic 7/31, reported pt. having significant left s... Received above vaccines on 7/29/2025. Mom called clinic 7/31, reported pt. having significant left shoulder pain with reduced range of motion. Seen / examined by physician 8/1/2025: Noted to have significant global left shoulder pain and reduced range of motion. No injection sites were identified on 8/1. Physician suspected SIRVA. Ordered Ultrasound left shoulder; pt. treated with prednisone and over counter NSAID. More
2853083 CA 08/07/2025 MEN
MMR
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
Y017527
No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More
HBP calling on behalf of the HCP to report an AE with the MMR II vaccine. HBP reported that a patien... HBP calling on behalf of the HCP to report an AE with the MMR II vaccine. HBP reported that a patient was inadvertently administered a dose of the MMR II vaccine that was reconstituted with the MENQUADFI vaccine. HBP did not report any side effects o; HBP calling on behalf of the HCP to report an AE with the MMR II vaccine. HBP reported that a patient was inadvertently administered a dose of the MMR II vaccine that was reconstituted with the MENQUADFI vaccine. HBP did not report any side effects o; HBP calling on behalf of the HCP to report an AE with the MMR II vaccine. HBP reported that a patient was inadvertently administered a dose of the MMR II vaccine that was reconstituted with the MENQUADFI vaccine. HBP did not report any side effects o; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-AUG-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (valid lot number Y017527, expiration date: 21-OCT-2026) for prophylaxis. The patient was inadvertently administered a dose of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine that was reconstituted with the Meningococcal vaccine A/C/Y/W conj (tet tox)) (MENQUADFI) vaccine (lot number and expiration date were not reported) for prophylaxis. The reporter did not report any side effects or adverse events associated with the administration (accidental exposure to product, vaccine coadministration, product preparation error). At the reporting time, the outcome of the event vaccine coadministration was not provided. The causal relationship between the event vaccine coadministration the suspect vaccines was not reported. More
2853084 GA 08/07/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Z003883
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
HBP confirmed the patient involved did not experience any medical concerns or symptoms after the adm... HBP confirmed the patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored VARIVAX; HBP calling with a report of a report of an adverse event regarding an improperly stored and administered dose of VARIVAX. HBP stated that the VARIVAX was exposed to multiple temperature excursions beginning in May 2025 and stated that a dose of the; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 06-Jun-2025, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (oka-merck) (VARIVAX) 0.5 mL (dose frequency reported as two dose series) administered as prophylaxis (Lot No. Z003883 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck], expiration date reported and upon internal validation established as 03-Feb-2027) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date and indication were not provided) (Product storage error). Additionally, it was stated that the previous mention vaccine was exposed to multiple temperature excursions beginning in (May 2025). The patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored varicella virus vaccine live (oka-merck) (VARIVAX). No additional adverse event (No adverse event). More
2853085 M TX 08/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
adjuvant was only administered; adjuvant was only administered; This non-serious case was reported b... adjuvant was only administered; adjuvant was only administered; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-JUL-2025, the patient received Shingrix (unknown deltoid). On 30-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant was only administered) and inappropriate dose of vaccine administered (Verbatim: adjuvant was only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-JUL-2025 The physician reported that the patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2853086 08/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Yesterday I was diagnosed with shingles; This serious case was report... Suspected vaccination failure; Yesterday I was diagnosed with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On 28-JUL-2025, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Yesterday I was diagnosed with shingles). 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JUL-2025 This case was reported by a patient via interactive digital media. The patient had Shingrix vaccine in 2019. The day before the date of this report (yesterday) the patient was diagnosed with shingles. It was reported as the patient was surprised. The doctor had told that Shingrix is 95 percent effective and the patient was the 5 percent. The severity of shingles should be less. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2853087 TX 08/07/2025 PNC13
 PFIZER\WYETH
Dyspnoea, Heart rate decreased Dyspnoea, Heart rate decreased
shortness of breath; low heart rate; This is a spontaneous report received from an Other HCP. Other ... shortness of breath; low heart rate; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 02842711 (Merck). An infant patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jul2020 as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immunocompromised with immunodeficiency" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), administration date: 2019, for Immunization; Prevnar 13 (DOSE 2, SINGLE), administration date: Jan2020, for Immunization. The following information was reported: HEART RATE DECREASED (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "low heart rate"; DYSPNOEA (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Heart rate: (2020) low. Clinical course: HCP called and stated a patient had received PREVNAR 20 shortness of breath, low heart rate, and the "almost called code blue" and had it in 2020, and the patient was a child and still growing, now looking to see if they could receive pneumovax23. Had 1 dose in 2019, and then 2 doses in Jan2020 and Jul2020. Patient had PREVNAR 20 at a different clinic. Patient received those doses at 1 year old or less. Patient was immunocompromised with immunodeficiency and asthma. Reporter was asking what ingredients are in PNEUMOVAX23. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: As there is limited and conflicting information in the case provided, the causal association between the events dyspnoea, and heart rate decreased; and the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
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2853102 08/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dermatomyositis, Immediate post-injection reaction Dermatomyositis, Immediate post-injection reaction
dermatomyositis; This serious case was reported by a consumer via interactive digital media and desc... dermatomyositis; This serious case was reported by a consumer via interactive digital media and described the occurrence of dermatomyositis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced dermatomyositis (Verbatim: dermatomyositis) (serious criteria GSK medically significant). The outcome of the dermatomyositis was not reported. It was unknown if the reporter considered the dermatomyositis to be related to Shingles vaccine. The company considered the dermatomyositis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 25-JUL-2025 This case was reported by a patient via interactive digital media. The patient had a shingles shot and got dermatomyositis an autoimmune disease shortly after it's like lupus.; Sender's Comments: A case of Dermatomyositis, immediately after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2853103 08/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema Injection site erythema
my arm to be kind of pink at the injection site; This non-serious case was reported by a consumer vi... my arm to be kind of pink at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: my arm to be kind of pink at the injection site). The outcome of the injection site erythema was not reported. It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine. It was unknown if the company considered the injection site erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-JUL-2025 Reporter questioned that was it normal for his/her arm to be kind of pink at the injection site four days after the shot. More
2853104 08/07/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; people that have taken the vaccine got shingles anyway; This serious ... Suspected vaccination failure; people that have taken the vaccine got shingles anyway; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: people that have taken the vaccine got shingles anyway). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by a patient via interactive digital media. The doctor recommended the vaccine but the passed on it because all the people that have taken the vaccine got shingles anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853105 F WV 08/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Inappropriate schedule of product administration, Vaccination fai... Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Vaccination failure More
had a case of shingles after getting Shingrix; had a case of shingles after getting Shingrix; 2nd do... had a case of shingles after getting Shingrix; had a case of shingles after getting Shingrix; 2nd dose in Oct 2022; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In OCT-2022, the patient received the 2nd dose of Shingrix. In FEB-2022, the patient received the 1st dose of Shingrix. In OCT-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose in Oct 2022). On an unknown date, the patient experienced vaccination failure (Verbatim: had a case of shingles after getting Shingrix) (serious criteria GSK medically significant) and shingles (Verbatim: had a case of shingles after getting Shingrix). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-JUL-2025 The reporter stated that the patient experienced case of shingles after getting Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. This case is one of the three linked cases reported by the same reporter.; 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 vaccine Shingrix. US-GSK-US2025098394:same reporter, Different patient US-GSK-US2025098302:same reporter, Different patient More
2853106 4 M AZ 08/07/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Y019464
Injection site erythema, Injection site induration; Injection site erythema, Inj... Injection site erythema, Injection site induration; Injection site erythema, Injection site induration More
Redness & hardness in injection site (Left arm) Redness & hardness in injection site (Left arm)
2853107 CA 08/07/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00722
Injury associated with device Injury associated with device
Describe Event, Problem, or Product Use Error: There has been an increase of incident of needlestick... Describe Event, Problem, or Product Use Error: There has been an increase of incident of needlestick injuries within our nursing staff involving the compounding of the rabies vaccine. The kit that is provided by the manufacturer includes 2 needles and the syringe to reconstitute and administer the drug. There currently is a lack of recommendation on how to exchange the needles without the need of recapping used needles. The recapping of used needle poses a high risk to needlestick injuries and therefore should be avoided when possible. More
2853108 25 F MI 08/07/2025 VARCEL
 MERCK & CO. INC.
 Z005456
Inappropriate schedule of product administration Inappropriate schedule of product administration
gave 2nd dose of VAR too soon, within one week of 1st dose. gave 2nd dose of VAR too soon, within one week of 1st dose.
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