๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2849477 10 F MA 07/11/2025 HPV9
 MERCK & CO. INC.
 y012921
Abdominal pain upper, Vomiting Abdominal pain upper, Vomiting
Post vaccine admin, pt was given water and instructed to lay down per caution. A few minutes later p... Post vaccine admin, pt was given water and instructed to lay down per caution. A few minutes later pt c/o "stomach hurting" and vomitted shortly after. Vitals obtained and were normal. More
2849478 73 M IA 07/11/2025 PNC20
 PFIZER\WYETH
 LW1951
Inappropriate schedule of product administration Inappropriate schedule of product administration
Pneumovax 23 given in 01/2021 but was not logged into the immunization registry. Patient was seen b... Pneumovax 23 given in 01/2021 but was not logged into the immunization registry. Patient was seen by his provider on 6/18/25 and they recommended him to receive Prevnar 20 that day. They sent him to the pharmacy and it was administered 6 months early. Patient was called and informed of the early administration and has no concerns. More
2849479 37 F SC 07/11/2025 COVID19
 MODERNA
 023m20a
Anaphylactic reaction, Headache, Pyrexia, Rash Anaphylactic reaction, Headache, Pyrexia, Rash
Following vaccination, a full-body rash developed as well as a fever > 100 F, headache, and event... Following vaccination, a full-body rash developed as well as a fever > 100 F, headache, and eventually anaphylaxis requiring hospitalization. More
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2849480 78 F MI 07/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was given a Hep B booster when she was offered and thought she was receiving a PCV20 which s... Patient was given a Hep B booster when she was offered and thought she was receiving a PCV20 which she was due for. Patient reported no adverse reaction when informed she received the wrong vaccine. More
2849481 4 M FL 07/11/2025 DTAPIPV
HEP
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
7NX57
Z007579
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti... Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Patient came in the office on 7/11/2025 at 3:04pm with with redness, pain and swelling of upper ar... Patient came in the office on 7/11/2025 at 3:04pm with with redness, pain and swelling of upper arm on right arm around injection site. no fevers. Warm to touch. Diagnosed with cellulitis of other sites. Outlined effected area . Clindamycin Pediatric Solution, Reconstituted, Oral 75 mg/5 mL prescribed. Advised If worsens beyond outlined border refer to ED. Patient to follow-up in 3 days. More
2849486 LA 07/11/2025 COVID19
COVID19
COVID19
COVID19
FLUX
FLUX
FLUX
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER







Anxiety, Asthma, Cardiac failure, Cardiac failure congestive, Depression; Dilate... Anxiety, Asthma, Cardiac failure, Cardiac failure congestive, Depression; Dilated cardiomyopathy, Drug intolerance, Hypercholesterolaemia, Hypotension, Inability to afford medication; Medication error, Metabolic function test, Pain, Restless legs syndrome, Seasonal allergy; Vitamin D deficiency; Anxiety, Asthma, Cardiac failure, Cardiac failure congestive, Depression; Dilated cardiomyopathy, Drug intolerance, Hypercholesterolaemia, Hypotension, Inability to afford medication; Medication error, Metabolic function test, Pain, Restless legs syndrome, Seasonal allergy; Vitamin D deficiency More
Chronic congestive heart failure; unspecified heart failure type (HCC)(HCC); Dilated cardiomyopathy;... Chronic congestive heart failure; unspecified heart failure type (HCC)(HCC); Dilated cardiomyopathy; unable to tolerate betablocker; she is unable to afford given her financial situation; in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4; Anxiety; Depression/ Mild episode of recurrent major depressive disorder (HCC); Mild intermittent asthma without complication; Comprehensive metabolic panel (Resulted 4/16/2025, Abnormal); Encounter for long-term (current) use of medications 279.899; hypotension; RLS (restless legs syndrome); hypercholesterolemia; seasonal Allergies; Vit D Deficiency; A solicited report has been received from a physician in Patient Support Program. The report concerns a female adult patient (age 61 years, height 173 cm, weight 107 kg). The patient's past and current medical history included age related cataract in both eyes (started 04-FEB-2024), diverticulitis (started 04-FEB-2024), hematochezia (started 04-FEB-2024) and rheumatoid arthritis (dates not reported).Family history included hypertension and kidney disorder. No concomitant products were reported. The patient started treatment with Farxiga (dapagliflozin) UNK, Oral use, on an unknown date and with Influenza Vaccine (flumist, influenza virus vaccine polyvalent, q/laiv), on an unknown date. On an unknown date, the patient experienced she is unable to afford given her financial situation (preferred term: Inability to afford medication), chronic congestive heart failure (preferred term: Cardiac failure congestive), unable to tolerate betablocker (preferred term: Drug intolerance), hypotension (preferred term: Hypotension), dilated cardiomyopathy (preferred term: Dilated cardiomyopathy), unspecified heart failure type (hcc)(hcc) (preferred term: Cardiac failure), encounter for long-term (current) use of medications 279.899 (preferred term: Medication error), comprehensive metabolic panel (resulted 4/16/2025, abnormal) (preferred term: Metabolic function test), mild intermittent asthma without complication (preferred term: Asthma), hypercholesterolemia (preferred term: Hypercholesterolaemia), rls (restless legs syndrome) (preferred term: Restless legs syndrome), vit d deficiency (preferred term: Vitamin D deficiency), depression/ mild episode of recurrent major depressive disorder (hcc) (preferred term: Depression), anxiety (preferred term: Anxiety), seasonal allergies (preferred term: Seasonal allergy) and in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4 (preferred term: Pain). The report described a medication error for Farxiga. The reported term was encounter for long-term (current) use of medications 279.899 (preferred term: Medication error). It is unknown if any action was taken with Farxiga (dapagliflozin). The outcome of the event(s) of anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency was unknown. The following event(s) were considered serious due to medically significant:unspecified heart failure type (hcc)(hcc), chronic congestive heart failure and dilated cardiomyopathy. The following events were considered non-serious:anxiety, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker and vit d deficiency. The reporter did not assess causality for anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): unable to tolerate betablocker. The company physician did not consider that there was a reasonable possibility of a causal relationship between Farxiga and the following event(s): unable to tolerate betablocker. The company physician considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Farxiga and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unspecified heart failure type (hcc)(hcc) and vit d deficiency. The company physician considered that there was a reasonable possibility of a causal relationship between Influenza Vaccine and the following event(s): anxiety, chronic congestive heart failure, comprehensive metabolic panel (resulted 4/16/2025, abnormal), depression/ mild episode of recurrent major depressive disorder (hcc), dilated cardiomyopathy, encounter for long-term (current) use of medications 279.899, hypercholesterolemia, hypotension, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, mild intermittent asthma without complication, rls (restless legs syndrome), seasonal allergies, she is unable to afford given her financial situation, unable to tolerate betablocker, unspecified heart failure type (hcc)(hcc) and vit d deficiency. Device Information: Combination Product Report: Yes Product As Reported: Influenza Vaccine Brand Name: INFLUENZA VACCINE Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Summary of follow-up of information received by AstraZeneca on 25-APR-2025 from solicited source: patient's past and current medical history (age related cataract in both eyes (started 04-FEB-2024), diverticulitis (started 04-FEB-2024), hematochezia (started 04-FEB-2024) and rheumatoid arthritis (dates not reported), Family history (hypertension and kidney disorder) was added. Added new events of she is unable to afford given her financial situation, in the last 4 weeks how much bodily pain have you had on a scale of 1-1 0? 4, Anxiety, Depression, Mild intermittent asthma without complication, Comprehensive metabolic panel, Encounter for long-term (current) use of medications 279.899, Hypotension, RLS (restless legs syndrome), hypercholesterolemia, seasonal Allergies, Vit D Deficiency. Narrative updated.; Sender's Comments: Cardiac failure congestive, cardiac failure and dilated cardiomyopathy are not listed in the company core data sheet of dapagliflozin. Due to limited information on final outcome of event, start date of suspect drug, circumstances and details surrounding the event, event onset date, concomitant medications, possible risk factors, relevant medical history, treatment undertaken, clinical course, detailed etiologic and diagnostic workup the evaluation did not find evidence to exclude a reasonable possibility of a causal relationship between event and the suspect drug. More
2849487 07/11/2025 HPVX
 UNKNOWN MANUFACTURER
 UNK
Paralysis Paralysis
paralyzed; This serious case was reported by a consumer and described the occurrence of paralysis in... paralyzed; This serious case was reported by a consumer and described the occurrence of paralysis in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received HPV vaccine. On an unknown date, an unknown time after receiving HPV vaccine, the patient experienced paralysis (Verbatim: paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported. It was unknown if the reporter considered the paralysis to be related to HPV vaccine. The company considered the paralysis to be unrelated to HPV vaccine. Additional Information: GSK receipt date: 03-JUL-2025 The reporter heard about a person who was paralyzed by HPV shot; Sender's Comments: A case of Paralysis, an unknown date after receiving HPV vaccine, patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR084861:Same reporter More
2849488 40 M TX 07/11/2025 HPV9
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y010656
75DBA
Mobility decreased; Mobility decreased Mobility decreased; Mobility decreased
cannot move arm cannot move arm
2849489 12 F AZ 07/11/2025 HPV9
 MERCK & CO. INC.
 Y013469
Dizziness, Immediate post-injection reaction, Syncope Dizziness, Immediate post-injection reaction, Syncope
Patient immediately felt lightheaded after vaccine. She walked to checkout after a few minutes and f... Patient immediately felt lightheaded after vaccine. She walked to checkout after a few minutes and fainted. We had patient sit for about 20 minutes gave her water, crackers, and a popsicle. We checked her BP. She stated she felt better and mother agreed to go home. More
2849496 16 F MN 07/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Arthralgia, Injected limb mobility decreased, Pain in extremity Arthralgia, Injected limb mobility decreased, Pain in extremity
Left arm and shoulder pain, left shoulder limited range of motion. Ongoing pain since the vaccine wa... Left arm and shoulder pain, left shoulder limited range of motion. Ongoing pain since the vaccine was given in left upper deltoid and shoulder region More
2849497 78 F 07/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 kr75k
Extra dose administered Extra dose administered
patient received booster dose outside of cdc guidelines; she received 1 dose boostrix 03/26/25 and ... patient received booster dose outside of cdc guidelines; she received 1 dose boostrix 03/26/25 and received another dose 7/9/25 More
2849498 51 F CA 07/11/2025 PNC21
 MERCK & CO. INC.
 Y019158
Breast pain, Lymph node pain, Pain in extremity Breast pain, Lymph node pain, Pain in extremity
PT came into the pharmacy on 07/10/25, and stated that she had a lot of pain in the arm, which trave... PT came into the pharmacy on 07/10/25, and stated that she had a lot of pain in the arm, which travelled to the lymph nodes and breast. At this point, she was feeling much better, but she also reported it to her doctor. More
2849499 27 F CA 07/11/2025 HEPAB
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
4N222
Injection site pain, Product preparation issue; Injection site pain, Product pre... Injection site pain, Product preparation issue; Injection site pain, Product preparation issue More
patient came in requesting MMR vaccine. Pharmacist gave patient vaccine on left arm. Patient stated ... patient came in requesting MMR vaccine. Pharmacist gave patient vaccine on left arm. Patient stated it was extremely painful. Upon further investigation, it was discovered that forgot to mix the diluent with the vaccine and patient only got the sterile water for injection. Pharmacist called patient and apologized, patient came back at 6pm and pharmacist apologized again and showed her how the mistake happened and mixed the vaccine correctly and gave her the MMR vaccine on the right arm. More
2849500 65 F CA 07/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Joint stiffness, Musculoskeletal stiffness, Urticaria Joint stiffness, Musculoskeletal stiffness, Urticaria
Patient states they got hives on palms of both hands and joint/neck stiffness the day after vaccinat... Patient states they got hives on palms of both hands and joint/neck stiffness the day after vaccination. Patient mentioned she was given Triamcinolone cream by doctor. Hives has been healing and limited on palms as of today. More
2849501 17 M MO 07/11/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 LN75D
LN75D
Blindness, Cold sweat, Disorientation, Loss of consciousness, Mydriasis; Pallor Blindness, Cold sweat, Disorientation, Loss of consciousness, Mydriasis; Pallor
Right after the vaccination, patient felt disoriented and lost consciousness briefly for about 3 tim... Right after the vaccination, patient felt disoriented and lost consciousness briefly for about 3 times. When patient came back, he had dilated pupils claiming he couldn't see the fingers in front of him, cold sweats all over the body, pale skin. We called 911 and after about 10-15 minutes he started to dialogue normally, cold sweat disappeared slowly, and color came back. EMT check blood pressure (100/58) and examined the patient and okayed to go home with his dad. Patient walked around in the store without problem and left with his dad. More
2849560 4 M NY 07/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Injection site erythema, Injection site induration, Injection site pain, Injecti... Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Scratch More
On 7/10/25 patient was c/o pain in the left leg. Mom reported redness and swelling on the left thigh... On 7/10/25 patient was c/o pain in the left leg. Mom reported redness and swelling on the left thigh where Kinrix was administered. Patient asessed by someone 7/11/25, area red, swollen, raised & hard pictures uploaded scratch visible near injection site. More
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2849561 65 F MN 07/11/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7KD5B
425CR
Rash, Rash pruritic; Rash, Rash pruritic Rash, Rash pruritic; Rash, Rash pruritic
Patient reported 24 hours after getting vaccinated that she developed a large, itchy rash on her bac... Patient reported 24 hours after getting vaccinated that she developed a large, itchy rash on her back. It got bad enough to warrant a trip to urgent care. More
2849562 0.2 M MA 07/11/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U8313AA
U8313AA
LK6653
LK6653
2117047
2117047
Blood glucose normal, Electrocardiogram normal, Haemoglobin normal, Hyporesponsi... Blood glucose normal, Electrocardiogram normal, Haemoglobin normal, Hyporesponsive to stimuli, Pallor; Respiration abnormal; Blood glucose normal, Electrocardiogram normal, Haemoglobin normal, Hyporesponsive to stimuli, Pallor; Respiration abnormal; Blood glucose normal, Electrocardiogram normal, Haemoglobin normal, Hyporesponsive to stimuli, Pallor; Respiration abnormal More
Abnormal breathing, pallor and decreased tone with decreased responsiveness x10 minutes. Brought to ... Abnormal breathing, pallor and decreased tone with decreased responsiveness x10 minutes. Brought to the ED and observed. More
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2849174 07/10/2025 HPV9
 MERCK & CO. INC.
Circumstance or information capable of leading to medication error, Liquid produ... Circumstance or information capable of leading to medication error, Liquid product physical issue, No adverse event More
No additional AE; An Email/Case was received in the Email to case Queue via interaction 02830005 on ... No additional AE; An Email/Case was received in the Email to case Queue via interaction 02830005 on 06/30/2025 at 0457ET containing a question from a consumer sent by a Merck group. GARDASIL 9 was administered on 06/28/2025 so this case i; The solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking; This spontaneous report was received from a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 28-JUN-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. However, the patient, noticed that the nurse administered the vaccine without shaking the vial beforehand. It was reported that the solution appeared clear, whereas the package insert states that the vaccine should be shaken well before use and that it should appear cloudy after shaking. The patient was concerned whether the vaccine was administered correctly and whether it would still be effective under these circumstances and asked on whether the dose needed to be repeated or if any further action was necessary. No additional adverse event reported. Lot # is being requested and will be submitted if received. More
2849175 07/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
I have sourness after the 2nd shingle shot; This non-serious case was reported by a consumer via int... I have sourness after the 2nd shingle shot; 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: I have sourness after the 2nd shingle shot). 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. Additional Information: GSK Receipt Date:01-JUL-2025 This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media. The reporter asked if he/she should take ibuprofen when he/she had sourness after the 2nd shingle shot. More
2849176 07/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I had one shingles vaccination 2 years ago๏ฟฝdo I need to start again and get two more, or just one?... I had one shingles vaccination 2 years ago๏ฟฝdo I need to start again and get two more, or just one?; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (had one shingles vaccination 2 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after not receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I had one shingles vaccination 2 years ago๏ฟฝdo I need to start again and get two more, or just one?). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:01-JUL-2025 This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media. The patient had one shingles vaccination 2 years ago and asked if they need to start again and get two more or just one. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2849177 07/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
I have them now and not an easy case; I have them now and not an easy case; This serious case was re... I have them now and not an easy case; I have them now and not an easy case; 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: I have them now and not an easy case) (serious criteria GSK medically significant) and shingles (Verbatim: I have them now and not an easy case). 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:02-JUL-2025 This case was reported by a patient via interactive digital media. The patient had them (shingles) now and it's not an easy case . The patient had both vaccines. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2849192 CA 07/10/2025 HEPA
 MERCK & CO. INC.
 X023975
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects; patient inadvertently received expired dose of VAQTA; This spontaneous report wa... No adverse effects; patient inadvertently received expired dose of VAQTA; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-Jul-2025, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X023975, expiration date: 18-Apr-2025), administered for prophylaxis (strength, dose, and route were not reported) (Expired product administered). There was no temperature excursion. Dose was supported per post expiry memo. No adverse effects reported. More
2849193 F GA 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 39H2S
Product preparation issue Product preparation issue
accidentally could have administered only the adjuvant portion of Shingrix; accidentally could have ... accidentally could have administered only the adjuvant portion of Shingrix; accidentally could have administered only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally could have administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: accidentally could have administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 A nurse called to report that they might have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. The reporter asked that they do have to revaccinate all the 7 patients involved in this possible administration of the adjuvant only. This is 4 out of 7 linked patients reported by the same reporter.; Sender's Comments: US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient More
2849194 81 F OH 07/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 P7FJ2
Product preparation issue Product preparation issue
adult female patient received Arexvy adjuvant alone without the powder; adult female patient receive... adult female patient received Arexvy adjuvant alone without the powder; adult female patient received Arexvy adjuvant alone without the powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number P7FJ2, expiry date 30-NOV-2025) for prophylaxis. On 28-JUN-2025, the patient received Arexvy. On 28-JUN-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: adult female patient received Arexvy adjuvant alone without the powder) and inappropriate dose of vaccine administered (Verbatim: adult female patient received Arexvy adjuvant alone without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-JUN-2025 Clinical director wanted to see if they need to revaccinate because the patient received Arexvy adjuvant alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. More
2849195 33 F MD 07/10/2025 PNC20
TDAP
 PFIZER\WYETH
SANOFI PASTEUR
 LK6650
3CA30C1
Lip swelling, Peripheral swelling, Rash, Urticaria; Lip swelling, Peripheral swe... Lip swelling, Peripheral swelling, Rash, Urticaria; Lip swelling, Peripheral swelling, Rash, Urticaria More
Client received 2 Vaccines: Tdap 0.5 ml and Prevnar 20 0.5 ml intramuscular injection to left deltoi... Client received 2 Vaccines: Tdap 0.5 ml and Prevnar 20 0.5 ml intramuscular injection to left deltoid on 6/20/25. Client called on 6/23/25 stated at 6:00 PM on 6/20/25, she has hives, rashes all over her face, chest and arms. Client reported rashes were more pronounced on 6/21/25 and 6/22/25. On 6/23/25, her lips and legs started swelling and she called the clinic. Client denies taking any new medication or any new foods, drinks or use of new detergent. Dr. was notified and advised client to Clartin in the day time and Benadryl at night. She was advised to contact her provider or go to Urgent care if her breathing is affected or if symptoms get worse. Client verbalized understanding. Client was called on 6/24/25 regarding symptoms and client reported they had resolved. More
2849198 50 F IL 07/10/2025 PNC20
TDAP
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LN4929
9JT9S
FT95N
Cellulitis, Ear pain, Ear swelling, Pyrexia; Cellulitis, Ear pain, Ear swelling,... Cellulitis, Ear pain, Ear swelling, Pyrexia; Cellulitis, Ear pain, Ear swelling, Pyrexia; Cellulitis, Ear pain, Ear swelling, Pyrexia More
Fever, severe ear pain & swelling. Diagnosed with cellulitis at urgent care. Prescribed doxycycl... Fever, severe ear pain & swelling. Diagnosed with cellulitis at urgent care. Prescribed doxycycline and triamcinolone cream (7/5/25). Office visit 7/7/25 - showed improvement. More
2849199 16 F NM 07/10/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 U8438AA
HP9989
Angioedema; Angioedema Angioedema; Angioedema
facial angioedema pt was given epi pen (prn), steroids & benadryl to help w/swelling. ER note is... facial angioedema pt was given epi pen (prn), steroids & benadryl to help w/swelling. ER note is attached & patients chart has been flagged. More
2849200 17 M CA 07/10/2025 MENB
MNQ
 PFIZER\WYETH
NOVARTIS VACCINES AND DIAGNOSTICS
 HP9987
AMVB064A
Somnolence, Urticaria; Somnolence, Urticaria Somnolence, Urticaria; Somnolence, Urticaria
Parent reports child was more sleepy after the vaccine and >24hrs later developed hives on the tr... Parent reports child was more sleepy after the vaccine and >24hrs later developed hives on the trunk which progressed to thigh. More
2849261 F NC 07/10/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
Y015180
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
Confirmed no symptomatic adverse events at this time; one dose of GARDASIL-9 in the summer of 2024 a... Confirmed no symptomatic adverse events at this time; one dose of GARDASIL-9 in the summer of 2024 and another dose on 27- JUN-2025.; This spontaneous report was received from a nurse concerning a 35-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. The patient received 3 doses of HPV vaccine VLP rL1 4v (yeast) (GARDASIL) as a teenager. On approximately 20-Jun-2024 (reported as "in the summer of 2024"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (route of administration, anatomical location, bath/lot # and expiration date were not reported). On 27-Jun-2025, the patient was vaccinated by a health professional with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, batch/lot #Y015180 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation confirmed as 28-Jan-2027, 0.5 mL (anatomical location and route of administration were not reported) (inappropriate schedule of product administration). Both vaccine doses were administered a prophylaxis Confirmed no symptomatic adverse events at this time (no adverse event.) Batch/lot# is being requested and will be submitted if received. More
2849262 F MA 07/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Antibody test negative Antibody test negative
titer test showed zero immunity again; This non-serious case was reported by a consumer via call cen... titer test showed zero immunity again; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received MMR (Priorix) for prophylaxis. Previously administered products included MMR vaccine (received in 1963) and MMR (received in 1983). Concurrent medical conditions included mast cell activation syndrome (Consumer states she has mast cell activation syndrome and is injected with IgE. Consumer states her last vaccination with IgE was 15 APR 2025). Concomitant products included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr). On 25-APR-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: titer test showed zero immunity again). The outcome of the therapy non-responder 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: 20-JUN-2025 Consumer states she has mast cell activation syndrome and is injected with IgE. Consumer states her last vaccination with IgE was 15 APR 2025 The reporter states that she was vaccinated with an MMR vaccine in 1963 and in 1983 (unknown name and specific dates.) Consumer states she had a titer test for MMR and the results noted zero immunity. The consumer states she was vaccinated again with an MMR vaccine on 27 APR 2025 and titer test showed zero immunity again (lack of effect.) Consumer could not provide the lot number for the vaccine, however, she was able to provide an national drug code number. The national drug code number she provided was for an MMR vaccine manufactured by MERCK SHARP and DOHME. Consumer was unable to verify having received an MMR vaccine manufactured by GSK, however, she states she thought she did receive an MMR vaccine manufactured by GSK. Consumer will follow up with safety to cancel case or call GSK to cancel case if she finds she did not receive MMR vaccine manufactured by GSK. Consumer states she has a lot going on and she may have gotten confused after having had an endoscopy (date not disclosed) and medication associated with that procedure. Consumer also states she will be a participant in a clinical trial for an antiviral (undisclosed diagnosis) starting soon. No further information was provided/obtained. Its not indicated for adults. Consumer calls back to cancel this report. She received an MMR vaccine manufactured by another pharmaceutical company (MSD.) More
2849263 F NC 07/10/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Abdominal pain upper, Blister, Gastrointestinal pain, Rash, Vaccination failure;... Abdominal pain upper, Blister, Gastrointestinal pain, Rash, Vaccination failure; Zoster sine herpete; Abdominal pain upper, Blister, Gastrointestinal pain, Rash, Vaccination failure; Zoster sine herpete More
Suspected vaccination failure; Enteric Shingles internal/ gut pain and stomach pain; rash was locate... Suspected vaccination failure; Enteric Shingles internal/ gut pain and stomach pain; rash was located on the Left side around the waist; the blisters never cracked; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female 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 (intramuscular, left arm) .5 ml and the 1st dose of Shingles vaccine (left arm). 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 clinically significant/intervention required), zoster sine herpete (Verbatim: Enteric Shingles internal/ gut pain and stomach pain), rash (Verbatim: rash was located on the Left side around the waist) and blister (Verbatim: the blisters never cracked). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was resolving and the outcome of the rash was unknown and the outcome of the blister was resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete, rash and blister 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 zoster sine herpete, rash and blister to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 The patient mentioned that she had received both doses of vaccine close to the time it was approved around 2018 She had got them as recommended by the product information in a timely manner (2 to 6 months after the 1st dose) and received the doses at a local pharmacy. The patient stated it was a light case and went to urgent care due to gut pain and stomach pain, and it was really tough. She reported she did not know it was shingles until the rash showed. The doctor stated it was enteric shingles (internal), and it was exceedingly unpleasant. The patient stated she got over it faster because the doctor prescribed Valtrex and after 2 days and was better and took Valtrex for 10 days. Further patient mentioned that the blisters never cracked, so she was never contagious. The patient reported about the rash to be located on the left side around the waist. The patient reported having gut pain at the same spot (internally). 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.; 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's Shingles vaccine (Dose 1 & 2). More
2849264 07/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dyspnoea, Eye swelling, Lacrimation increased Dyspnoea, Eye swelling, Lacrimation increased
Can not breath; my eyes are swollen and teary; my eyes are swollen and teary; This non-serious case ... Can not breath; my eyes are swollen and teary; my eyes are swollen and teary; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: Can not breath), eye swelling (Verbatim: my eyes are swollen and teary) and eyes tearing (Verbatim: my eyes are swollen and teary). The outcome of the difficulty breathing, eye swelling and eyes tearing were not reported. It was unknown if the reporter considered the difficulty breathing, eye swelling and eyes tearing to be related to Arexvy. It was unknown if the company considered the difficulty breathing, eye swelling and eyes tearing to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient reporter after receiving Arexvy vaccine, could not breath, all stuffed op, eyes were swollen and teary. More
2849265 07/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pruritus Injection site pruritus
Itching at injection site; This non-serious case was reported by a consumer via interactive digital ... Itching at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site itching (Verbatim: Itching at injection site). The outcome of the injection site itching was not reported. It was unknown if the reporter considered the injection site itching to be related to Arexvy. It was unknown if the company considered the injection site itching to be related to Arexvy. Additional Information: GSK Receipt Date: 26-JUN-2025 This case was reported by a patient via interactive digital media. The patient received the Arexvy vaccine and experienced itching at the injection site. More
2849266 78 F FL 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via c... Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (expiry date 10-MAR-2027) for prophylaxis. Concurrent medical conditions included sciatica. On 30-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site pain and injection site swelling were not resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site pain and injection site swelling to be related to Shingrix. Linked case(s) involving the same patient: US2025081876 Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case. The patient received her first dose of Shingrix vaccine on 30th April 2025 and reported that she had pain and swollen of the injection site and she did not experience the sciatic pain with the 1st dose. The patient had sciatic nerve issues and got treatment with a chiropractor and her condition was under control and had just left the chiropractor office when she went to get the 2nd dose of Shingrix. This case is linked with US2025081876, reported by same reporter.; Sender's Comments: US-GSK-US2025081876:Same patient/Dose 2 More
2849267 52 M IL 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 77D52
Product preparation issue Product preparation issue
adjuvant was given without being mixed with the active ingredient; adjuvant was given without being ... adjuvant was given without being mixed with the active ingredient; adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 77D52, expiry date 16-SEP-2025) for prophylaxis. On 13-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular). On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 Reporter state that only adjuvant was given without being mixed with the active ingredient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with case US2025061270, reported by the same reporter.; Sender's Comments: US-GSK-US2025061270:Same reporter/Different patient More
2849268 07/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
soreness; This non-serious case was reported by a consumer via call center representative and descri... soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. 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 pain (Verbatim: soreness). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 01-JUL-2025 Patient had some sourness after the 2nd shot and was wondering if they can take an iboprofen. More
2849269 18 F NY 07/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMXB030A
Product preparation issue Product preparation issue
administration of Menveo diluent only to a patient; administration of Menveo diluent only to a patie... administration of Menveo diluent only to a patient; administration of Menveo diluent only to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXB030A, expiry date 31-DEC-2025) for prophylaxis. On 26-JUN-2025, the patient received Menveo. On 26-JUN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of Menveo diluent only to a patient) and inappropriate dose of vaccine administered (Verbatim: administration of Menveo diluent only to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 27-JUN-2025 A registered pharmacist reported that the administration of Menveo diluent only to a patient on 26th June 2025 which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2849270 F 07/10/2025 COVID19
COVID19
 MODERNA
UNKNOWN MANUFACTURER

Hypersensitivity; Hypersensitivity Hypersensitivity; Hypersensitivity
Hypersensitivity rxns; This spontaneous case was reported by a consumer and describes the occurrence... Hypersensitivity rxns; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity rxns) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product COVID-19 vaccine for an unknown indication. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 vaccine (unknown route) 1 dosage form. On an unknown date, received second dose of COVID-19 vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity rxns). At the time of the report, HYPERSENSITIVITY (Hypersensitivity rxns) outcome was unknown. Concomitant medication was not provided. Patient took the vaccine 3.25 year ago. It was reported that the patient had experienced hypersensitivity reactions following her initial two doses and even more so after receiving a Moderna COVID-19 booster. It was told to the pharmacist upon arrival of patient severe reaction to mRNA vaccines was reported. Treatment information was not reported. More
2849271 77 M IA 07/10/2025 COVID19
 MODERNA
 3032233
Death Death
Resident passed away Resident passed away
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2849272 34 F FL 07/10/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Autoimmune disorder, Cardiac ablation, Chest pain, Dyspnoea, Electrocardiogram; ... Autoimmune disorder, Cardiac ablation, Chest pain, Dyspnoea, Electrocardiogram; Granuloma annulare, Inflammation, Magnetic resonance imaging heart, Pericarditis, Presyncope; Rash, Right ventricular enlargement, Ventricular arrhythmia More
Progressive ventricular heart arrhythmia with pre-syncope, chest pain and hardship breathing; follow... Progressive ventricular heart arrhythmia with pre-syncope, chest pain and hardship breathing; followed by pericarditis, enlarged right ventricle; hospitalization after 4 weeks as symptoms progressed; scheduled for heart surgery (catheterization ablation) in October 2021; post-surgery chest pain and vascular inflammation treated with high-dose ibuprofen; followed by undiagnosed autoimmune disorder first noticed as skin rash in January 2022, later diagnosed as granuloma annulare. More
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2849273 18 F CA 07/10/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS



Blood glucose normal, Chills, Cold sweat, Loss of consciousness, Nausea; Pallor,... Blood glucose normal, Chills, Cold sweat, Loss of consciousness, Nausea; Pallor, Vomiting; Blood glucose normal, Chills, Cold sweat, Loss of consciousness, Nausea; Pallor, Vomiting More
Patient passed out within seconds of the two shots. She woke up pale, clammy and nauseous. We waited... Patient passed out within seconds of the two shots. She woke up pale, clammy and nauseous. We waited at the office for another 30 minutes. She threw up on the way home and had chills, but no fever, when we arrived home. More
2849274 68 M FL 07/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient came in yesterday (7/9 at 12pm) to get a TDAP shot so that he could be vaccinated against wh... Patient came in yesterday (7/9 at 12pm) to get a TDAP shot so that he could be vaccinated against whooping cough because he is expecting a new grandchild. Upon typing it up and putting through our DUR system, it went through fine without any DUR flag. Vaccine was administered and patient went about their day. Upon opening the pharmacy this morning (7/10 at 8:55am), I was alerted in my email that this patient was flagged as having a duplicate vaccine and that I was to look into it. Looks like this patient received a TDAP on May 21st of this year. I spoke with the patient, and he did not have any side effects or adverse events. Says he feels perfectly fine and was doing okay and also said he didn't even remember receiving the TDAP vaccine in May. Clinically speaking, a patient can get multiple TDAPs based on vaccination status and injuries that require a TD or TDAP shot, but these were given very close to each other, and the first one was not due to any injury per the patient. More
2849275 7 F MI 07/10/2025 DTAPIPV
HEPA
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
Y018582
Z003309
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; Product administered to patient of inappropriate age More
no known symptoms patient doing fine no known symptoms patient doing fine
2849276 40 F VA 07/10/2025 MMRV
 MERCK & CO. INC.
 Y015355
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
The MMRV vaccine was administered to an adult aged 40. Recommendations state not to administer MMRV ... The MMRV vaccine was administered to an adult aged 40. Recommendations state not to administer MMRV vaccine to anyone aged 12 and up. The patient experienced no adverse events and has been notified. More
2849277 57 M MI 07/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood test, Cardiac monitoring, Computerised tomogram, Dizziness, Dyspnoea; Elec... Blood test, Cardiac monitoring, Computerised tomogram, Dizziness, Dyspnoea; Electrocardiogram, Heart rate increased, Hypoaesthesia More
The 1st dose of the Pfizer Covid 19 vax (April 2021) caused an outbreak of the Shingle virus (Sep 20... The 1st dose of the Pfizer Covid 19 vax (April 2021) caused an outbreak of the Shingle virus (Sep 2021). The 2nd dose of the Pfizer vax (Feb 2022, due to employer mandate) caused 3 separate trips to the ER. The symptoms were super high blood pressure (190/120), rapid heart rate, dizziness, breathing difficulty, numbness in my extremities. More
2849278 17 F KS 07/10/2025 ADEN_4_7
ADEN_4_7
ADEN_4_7
 TEVA PHARMACEUTICALS
TEVA PHARMACEUTICALS
TEVA PHARMACEUTICALS
 ACYW135
ACYW135
ACYW135
Back pain, Eye pain, Fear, Full blood count, Headache; Metabolic function test, ... Back pain, Eye pain, Fear, Full blood count, Headache; Metabolic function test, Mobility decreased, Muscular weakness, Sensory disturbance, Tremor; White blood cell count normal More
Around 1:45 am on 7/9, my daughter started to develop what she described as a "scary headache&q... Around 1:45 am on 7/9, my daughter started to develop what she described as a "scary headache". She couldn't move her head at her neck and felt like she couldn't move at all; she described it as if her neck/back was fused. She was scared to fall asleep because her eyes hurt as well, and she became shaky. Upon taking her to the ER at the advice of her PCP, her mid/low back started to hurt as well. Walking into the ER, she said her legs felt weak. She didn't have a fever. I wasn't worried about Menegitis being a thing, I was more scare of the reaction she was having. Later that evening, around 9:30 pm she said that the back of her head felt swollen, which I felt was odd. More
2849279 5 M NH 07/10/2025 MMRV
 MERCK & CO. INC.
 DILUENT ONLY 19
No adverse event, Product preparation issue No adverse event, Product preparation issue
MEDICAL ASSISTANT ADMINISTERED ONLY THE DILUENT AND NOT THE ANTIGEN ON 2/4/2025. THIS WAS DISCOVERED... MEDICAL ASSISTANT ADMINISTERED ONLY THE DILUENT AND NOT THE ANTIGEN ON 2/4/2025. THIS WAS DISCOVERED RECENTLY, WHEN A SIMILIAR OCCURANCE WAS CAUGHT PRIOR TO ADMINISTRATION INVOLVING ANOTHER PATIENT. UPON FURTHER REVIEW, THE MEDICAL ASSISTANT INDICATED NOT BEING AWARE THE MMRV WAS IN THE FREEZER OR THAT IT NEEDED TO BE DILUTED. THIS PROMPTED THE NURSE TO INVESTIGATE ALL PRIOR MMRV ADMINISTRATIONS AND DISCOVERED THE 2/4/2025 VACCINE ERROR. THE PATIENT HAD NO ADVERSE EFFECTS, THE PROVIDER WAS NOTIFIED, NHIP HAS BEEN NOTIFIED AND IT IS RECOMMENDED THE PATIENT RECEIVE A REPEAT MMRV. PATIENT IS SCHEDULED ON 7/23/2025 FOR REPEAT MMRV. More
2849280 68 F 07/10/2025 PNC20
 PFIZER\WYETH
Extra dose administered Extra dose administered
Patient was given Prevnar 20 vaccine on 7/10/2025. Patient had had already had the Prevnar 20 on 02... Patient was given Prevnar 20 vaccine on 7/10/2025. Patient had had already had the Prevnar 20 on 02/06/2024. Notified the patient's provider. More
2849281 81 F 07/10/2025 UNK
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS

No adverse event, Product prescribing error; No adverse event, Product prescribi... No adverse event, Product prescribing error; No adverse event, Product prescribing error More
Beyfortus ordered by provider and administered by medical assistant in error. Patient should have re... Beyfortus ordered by provider and administered by medical assistant in error. Patient should have received Abrysvo instead. No adverse reactions noted. More
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