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
2856697 44 F OH 09/03/2025 COVID19
 PFIZER\BIONTECH
 EN5318
Gait disturbance, Laboratory test, Memory impairment, Speech disorder Gait disturbance, Laboratory test, Memory impairment, Speech disorder
speech issue, memory issue, and gait issue ( MS like presentation, worked up and not recovering ) speech issue, memory issue, and gait issue ( MS like presentation, worked up and not recovering )
โœ“
2856698 83 F WA 09/03/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT8779KA
MA2505
Incorrect dose administered; Incorrect dose administered Incorrect dose administered; Incorrect dose administered
PATIENT WAS TO RECEIVE HIGH DOSE FLUZONE. THE ORDER WAS INPUTTED AS HIGH DOSE, BUT THE INCORRECT REG... PATIENT WAS TO RECEIVE HIGH DOSE FLUZONE. THE ORDER WAS INPUTTED AS HIGH DOSE, BUT THE INCORRECT REGULAR DOSE FLUZONE WAS CHOSEN BEFORE VACCINATION. More
2856699 51 M 09/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Dizziness, Hyperhidrosis, Tremor, Vision blurred Dizziness, Hyperhidrosis, Tremor, Vision blurred
Patient started sweating profusely, shaking, feeling faint and had blurry vision right after vaccine... Patient started sweating profusely, shaking, feeling faint and had blurry vision right after vaccine. Patient stated extreme fear of needle and also diabetic. Pt had to lie down in the waiting area, was given water and wet cloth to place over forehead. Patient recovered after about 15 minutes More
2856700 56 F MN 09/03/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Muscular weakness, Vertigo Fatigue, Muscular weakness, Vertigo
About 50 mins after i got the vaccine my left leg felt weak and then my left leg began to feel weak,... About 50 mins after i got the vaccine my left leg felt weak and then my left leg began to feel weak, and then it seemed to get worse. When i got home i got bad vertigo. It resolved in about a week, I am still feeling fatigue but don't know if that is from the vaccine. More
2856701 2 M MN 09/03/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y014446
y020518
Z004455
Decreased appetite, Fatigue, Pyrexia, Rash; Decreased appetite, Fatigue, Pyrexia... Decreased appetite, Fatigue, Pyrexia, Rash; Decreased appetite, Fatigue, Pyrexia, Rash; Decreased appetite, Fatigue, Pyrexia, Rash More
non-petechial, non-pruritic papular rash on bilateral arms, palms, legs, chest, and groin, decreased... non-petechial, non-pruritic papular rash on bilateral arms, palms, legs, chest, and groin, decreased appetite, fatigue, fever with TMax 104F More
2856702 1.5 F CT 09/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK341AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
Pt was to receive DTAP, Polio and HIB and only received DTAP-Polio portion of pentacel vaccine. The ... Pt was to receive DTAP, Polio and HIB and only received DTAP-Polio portion of pentacel vaccine. The dtap-polio portion was not mixed with HIB. Provider, parent, nurse lead and RNM all notified. Sanofi, the manufacturer was contacted and states pt will just need to receive HIB. There was no physical reaction/harm to patient. More
2856703 82 F FL 09/03/2025 COVID19
 PFIZER\BIONTECH
 407244
No adverse event No adverse event
THERE WAS NO ADVERSE EFFECT. THIS REPORT IS BEING DONE BECAUSE THE VACCINE WAS ADMINISTERED BEFORE T... THERE WAS NO ADVERSE EFFECT. THIS REPORT IS BEING DONE BECAUSE THE VACCINE WAS ADMINISTERED BEFORE THERE WAS AN APPROVAL FOR THE STATE More
2856704 27 M AK 09/03/2025 COVID19
 JANSSEN
 206A21A
Cardiac arrest, Coronary artery aneurysm, Coronary artery bypass, Coronary arter... Cardiac arrest, Coronary artery aneurysm, Coronary artery bypass, Coronary artery occlusion, Ventricular fibrillation More
Suffered a V fib cardiac arrest Sept 09 2024. Total occlusion of proximal LAD requiring coronary byp... Suffered a V fib cardiac arrest Sept 09 2024. Total occlusion of proximal LAD requiring coronary bypass grafting LIMA to LAD. No family history and was without any known cardiovascular risk factors. Was hospitalized until Sept 24. More
โœ“ โœ“
2856705 M 09/03/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or oth... COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old male patient received BNT162b2 (BNT162B2), in 2020 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) all with onset 2021, outcome "unknown" and all described as "COVID-19 infection". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient's spouse stated that her husband has just been prescribed Paxlovid but patient not able to get it. They wanted more dollars and in the past, patient's had that one, 2 times and there was no payment". After having the Program guidelines explained, stated, she just confused because in the past patient has taken it in 2021 &2023. No, he's being prescribed the same medicine". When offered a transfer to the redacted stated that it might be helpful they both had the Pfizer vaccinations back in 2020. Patient's had the Paxlovid twice and he's gone on to have to have more antibiotics on top of the Paxlovid (inaudible)". There was no confirmation that the Patient currently has Covid. That was implied patient had Covid and Paxlovid previously when the reporter stated, "they both had the Pfizer vaccinations back in 2020. Patient had Paxlovid twice and he's gone on to have to have more antibiotics on top of the Paxlovid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2856706 45 M CA 09/03/2025 PNC20
 PFIZER\WYETH
 LP4947
Injected limb mobility decreased, Injection site pain, Pyrexia Injected limb mobility decreased, Injection site pain, Pyrexia
Acute pain in right deltoid, limited range of motion, and fever. Afebrile now and pain/range of moti... Acute pain in right deltoid, limited range of motion, and fever. Afebrile now and pain/range of motion has improved. More
2856707 17 F TX 09/03/2025 HEPA
HPV9
IPV
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 3255P
Y015560
X1D141M
Z0022625
Vomiting; Vomiting; Vomiting; Vomiting Vomiting; Vomiting; Vomiting; Vomiting
Client vomited. after all vaccine administration and TB Skin Test given. Felt better about 10 minute... Client vomited. after all vaccine administration and TB Skin Test given. Felt better about 10 minutes later. More
2856708 M 09/03/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

COVID-19, Drug ineffective; COVID-19, Drug ineffective COVID-19, Drug ineffective; COVID-19, Drug ineffective
suffered with Covid, with symptoms; suffered with Covid, with symptoms; This is a spontaneous report... suffered with Covid, with symptoms; suffered with Covid, with symptoms; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) all with onset Oct2023, outcome "unknown" and all described as "suffered with Covid, with symptoms". Clinical course: The patient informed that during the Covid pandemic, his wife and himself both received Pfizer's Covid vaccines and boosters. Since Jul of approximately 2023, his wife has suffered the loss of her taste buds. Several medical professionals have suggested that she may have had Covid without symptoms. Later in 2023, approximately Oct, they both suffered with Covid, with symptoms. The loss of her taste buds proceeded her experience with Covid. The patient wanted to know if Pfizer has been notified or experienced any other individuals or groups that have experienced loss of taste with exposure to Pfizer's vaccines and boosters. If yes, what has been the outcome of those experiences and if Pfizer offer any possible cure for the situation his wife was currently experiencing. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received. More
2856709 F TN 09/03/2025 RAB
 SANOFI PASTEUR
Oral herpes Oral herpes
stated that she then was having some issues with cold sores; Initial information received on 28-Aug-... stated that she then was having some issues with cold sores; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age female patient who was having some issues with cold sores after receiving Rabies (HDC) Vaccine [Imovax Rabies]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Aug-2025, the patient received an unknown dose of suspect Rabies (HDC) Vaccine, Powder and solvent for suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for post-exposure prophylaxis vaccines [Immunisation]. Information regarding batch number corresponding to the one at time of event occurrence was requested. On an unknown date in Aug-2025, the patient was having some issues with cold sores (oral herpes) (latency Few days approximately). Reportedly, Reporter freaked out since she took an anti-viral after finishing a vaccine series. Action taken was not applicable. The patient was treated with Valaciclovir Hydrochloride (Valtrex) for Oral herpes. At time of reporting, the outcome was Unknown for the event. More
2856710 M ME 09/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK216AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
report an incident involving pentacel wherein a nurse did not reconstitute the powdered HIB componen... report an incident involving pentacel wherein a nurse did not reconstitute the powdered HIB component with the liquid DTaP-IPV component with no reported adverse event; Initial information received on 29-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient to whom administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] where a nurse did not reconstitute the powdered hib component with the liquid dtap-ipv component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE for Immunisation. On 28-Aug-2025, the patient received a 0.5 ml (dose 1) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: unknown, expiry date: 31-Jul-2027 and lot UK216AB) via intramuscular route in the left vastus lateralis. as immunization, where a nurse did not reconstitute the powdered hib component with the liquid dtap-ipv component with no reported adverse event (single component of a two-component product administered) (latency: same day). Action taken: Not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2856718 NY 09/03/2025 MMRV
 MERCK & CO. INC.
 Z003307
No adverse event, Product storage error No adverse event, Product storage error
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ... No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; This spontaneous report was received from a nurse 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 16-Jul-2025, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 ml, lot # Z003307, expiration date: 21-Jul-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter.; Reporter's Comments: Keywords : MUL More
2856719 NY 09/03/2025 MMRV
 MERCK & CO. INC.
 Z003307
No adverse event, Product storage error No adverse event, Product storage error
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ... No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; This spontaneous report was received from a nurse 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 05-Aug-2025, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 ml, lot # Z003307, expiration date: 21-Jul-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter. More
2856721 M 09/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
drug dose administration interval too long; This non-serious case was reported by a consumer via cal... drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 03-JAN-2025). In AUG-2025, the patient received the 2nd dose of Shingrix. In AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: drug dose administration interval too long). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 29-AUG-2025 The reporter stated that the patient got Shingrix shot 1 on 03-Jan-2025 and Shingrix shot 2 on an unspecified date last week (August 2025). Patient was told by physician that he could get the second dose between 28-FEB-2025 and 30-AUG-2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2856722 09/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Musculoskeletal discomfort Musculoskeletal discomfort
four hours after the injection my shoulder felt like frogged in the arm; This non-serious case was r... four hours after the injection my shoulder felt like frogged in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 08-AUG-2025, the patient received Shingles vaccine. On 08-AUG-2025, 4 hrs after receiving Shingles vaccine, the patient experienced shoulder pain (Verbatim: four hours after the injection my shoulder felt like frogged in the arm). The outcome of the shoulder pain was not reported. It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine. It was unknown if the company considered the shoulder pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-AUG-2025 This case was reported by a patient via interactive digital media. The patient reported he/she got the vaccine last Friday and their shoulder felt like it was broken. The patient stated about four hours after the injection the shoulder felt like someone frogged in the arm. The patient enquired if this was normal. More
2856723 09/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Painful shingles after receiving vaccine; This serious case was repor... Suspected vaccination failure; Painful shingles after receiving vaccine; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (several people with copd). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Painful shingles after receiving vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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:27-AUG-2025 Other Health Professional reported that several people with copd who had said they had extended painful shingles even after getting vaccinated 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 vaccine Shingrix. More
2856724 82 F IL 09/03/2025 COVID19
PNC20
 PFIZER\BIONTECH
PFIZER\WYETH
 MD3414
LJ5283
Fatigue, Incorrect dose administered, Muscular weakness; Fatigue, Incorrect dose... Fatigue, Incorrect dose administered, Muscular weakness; Fatigue, Incorrect dose administered, Muscular weakness More
patient experienced muscle weakness; fatigue; inadvertently received 2 doses of Prevnar 20 and Comir... patient experienced muscle weakness; fatigue; inadvertently received 2 doses of Prevnar 20 and Comirnaty,12 years and up, within 48 hours of each other.; This is a spontaneous report and received from Pharmacists from medical information team. An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15May2025 as dose 2, 0.3 ml single (Lot number: MD3414) at the age of 82 years, in left deltoid for covid-19 immunisation, Device Lot Number: MD3414; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15May2025 as dose 2, single (Lot number: LJ5283) at the age of 82 years, in left deltoid for immunisation, Device Lot Number: LJ5283. The patient's relevant medical history included: "Prediabetes" (ongoing); "Sleep apnea" (ongoing); "Vitamin D deficiency" (ongoing). There were no concomitant medications. Vaccination history included: prevnar 20 (Dose 1, single), administration date: 13May2025, when the patient was 82-year-old, for Immunization; comirnaty (Dose 1, single), administration date: 13May2025, when the patient was 82-year-old, for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 15May2025, outcome "unknown", described as "inadvertently received 2 doses of Prevnar 20 and Comirnaty,12 years and up, within 48 hours of each other."; FATIGUE (non-serious) with onset Jun2025, outcome "not recovered"; MUSCULAR WEAKNESS (non-serious) with onset Jun2025, outcome "not recovered", described as "patient experienced muscle weakness". Therapeutic measures were not taken as a result of fatigue. Additional information: female patient who inadvertently received 2 doses of Prevnar 20 and Comirnaty,12 years and up, within 48 hours of each other. The patient experienced muscle weakness and fatigue in which they are trying to determine if that was related to the vaccine administrations. More
2856725 76 F MO 09/03/2025 PNC20
 PFIZER\WYETH
 LX4482
Cellulitis, Product administered at inappropriate site Cellulitis, Product administered at inappropriate site
cellulitis; Caller thinks the technician administered it too low, a couple of inches above the elbow... cellulitis; Caller thinks the technician administered it too low, a couple of inches above the elbow; This is a spontaneous report received from a Pharmacist from medical information team. A 76-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Aug2025 as dose number unknown, single (Lot number: LX4482, Expiration Date: Feb2026) at the age of 76 years, in left arm for immunisation, Device Lot Number: LX4482, Device Expiration Date: Feb2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (medically significant) with onset 19Aug2025, outcome "unknown", described as "Caller thinks the technician administered it too low, a couple of inches above the elbow"; CELLULITIS (medically significant) with onset 29Aug2025, outcome "unknown". The event "cellulitis" required physician office visit. Therapeutic measures were taken as a result of cellulitis. Clinical course: The patient didn't receive any other vaccines on the same date as the Pfizer vaccine. The patient didn't receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient didn't previously receive the Pfizer suspect vaccine. No allergic to any previous vaccination, medications, food or other products. NDC number of Prevnar 20: 0005-2000-10. Caller mentioned a patient (female, 76 years) developed cellulitis after getting Prevnar 20. Caller thought the technician administered it too low, a couple of inches above the elbow. Caller would like to get more information about the re-vaccination. Reporter later clarified given too low as right above the elbow, it was the left elbow. She does not know if it being given too low went hand and hand with the development of cellulitis. No AE require a visit to the Emergency Room. She went to her primary physician, but does not know specifically what she. Was prescribed an antibiotic that they are dispensing. Causality for "caller thinks the technician administered it too low, a couple of inches above the elbow" and "cellulitis" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). More
2856727 62 M VA 09/03/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got the Comirnaty in early Sep2024 prior to having covid; got the Comirnaty in early Sep2024 prior t... got the Comirnaty in early Sep2024 prior to having covid; got the Comirnaty in early Sep2024 prior to having covid; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown, Expiration Date: Mar2025) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: He had , covid more than once, but the last time was in , Sep2024. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2024, outcome "unknown" and all described as "got the Comirnaty in early Sep2024 prior to having covid". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Caller on the line calling about the medication Comirnaty and reported that he had his last booster in Mar2025. He did get covid, but it was mild and when he caught covid it was last year 2024. He took Paxlovid and it cleared it up. The caller verified the information provided by the transferring agent. HCP: No email to provide. He did not get the Comirnaty vaccines at his doctor's office. He got the vaccine at # or #. He had covid more than once, but the last time was in Sep2024. He got the Comirnaty in early Sep2024 prior to having covid. His last booster was in Mar2025. He got the vaccine and he went on a business trip and must've gotten Covid on the trip and had covid a few days later. Does not have his Vaccination card to provide a NDC, Lot, or expiration date for the Comirnaty vaccines he received. He gets the booster about every 6 months. Testing: He had a physical in late Jun2025 and everything was fine. Blood work and everything was good and came back fine. He has been good about the covid test and took covid test and said his Covid was like a cold. He took Paxlovid and was better and was testing negative within a few days. He took the 5 days of Paxlovid. More
2856728 F MS 09/03/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pain Vaccination site pain
still has problems with her left arm hurting; This is a spontaneous report received from a Consumer ... still has problems with her left arm hurting; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for Primary immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still has problems with her left arm hurting". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500173597 same patient, different dose/event; More
2856729 NY 09/03/2025 FLU4
 SANOFI PASTEUR
Injection site reaction Injection site reaction
caused more injection-site reactions than standard-dose influenza vaccines; Initial information rece... caused more injection-site reactions than standard-dose influenza vaccines; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who had injection-site reactions than standard-dose influenza vaccines after receiving influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received Unknown dose of suspect influenza quadrival A-B HIGh dose HV vaccine (Unknown strength, formulation, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) On an unknown date the patient developed injection-site reactions than standard-dose influenza vaccines (vaccination site reaction) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. It was not reported if the patient received corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2856730 52 M 09/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Loss of consciousness Loss of consciousness
patient passed out after getting a shingles and flu shot (20 min later) but patient had given blood ... patient passed out after getting a shingles and flu shot (20 min later) but patient had given blood at dr office before getting vaccinated More
2856731 53 F NC 09/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Joint swelling, Muscular weakness Arthralgia, Joint swelling, Muscular weakness
Severe pain and swelling all around shoulder. 4 ibuprophen did alleviate the pain. My left arm is ... Severe pain and swelling all around shoulder. 4 ibuprophen did alleviate the pain. My left arm is very weak. Previously during workouts could lift 15 lb weights in each arm while on back to do chest press for multiple sets. Can not even lift a 12 lb weight at all with my left arm in the same position right now. More
2856749 64 F WA 09/03/2025 MMR
 MERCK & CO. INC.
 LN4932
Inappropriate schedule of product administration, Pain in extremity, Sleep disor... Inappropriate schedule of product administration, Pain in extremity, Sleep disorder More
Injection was given 6 months after I received previous Pneumococcal conjugate PCV20 (Prevnar 20) o... Injection was given 6 months after I received previous Pneumococcal conjugate PCV20 (Prevnar 20) on Mar 12, 2025 should be 12 months between vaccinations More
2856750 43 F AZ 09/03/2025 UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 946907
37F34
Y1D03O1
Z008082
Y014094
Pyrexia; Pyrexia; Pyrexia; Pyrexia; Pyrexia Pyrexia; Pyrexia; Pyrexia; Pyrexia; Pyrexia
Pt reported "fever" and body aches 10 minutes after vaccines. (withheld) Interpretor #469... Pt reported "fever" and body aches 10 minutes after vaccines. (withheld) Interpretor #469134 called and patient reported these symptoms. Vital signs: temp = 97.4, BP 107/75, HR 70, 02 = 100% More
2856751 31 F OR 09/03/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Employee is having redness, swelling, and tenderness at the injection site. She reports it is a dela... Employee is having redness, swelling, and tenderness at the injection site. She reports it is a delayed reaction and the redness wrapped around her arm at one point, but has decreased significantly. More
2856752 51 F 09/03/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 58160-842-43
Diarrhoea, Erythema, Headache, Nausea, Peripheral swelling Diarrhoea, Erythema, Headache, Nausea, Peripheral swelling
patient received Tdap on 8/29/25 and developed nausea, diarrhea, headache and upper extremity rednes... patient received Tdap on 8/29/25 and developed nausea, diarrhea, headache and upper extremity redness and swelling the following day. symptoms have persisted More
2856753 64 F TX 09/03/2025 FLU3
VARZOS
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 406983
3E27G
Injection site pain, Injection site swelling; Injection site pain, Injection sit... Injection site pain, Injection site swelling; Injection site pain, Injection site swelling More
-Swollen armpit around the injection site of SHINGRIX on right arm. -Slightly soreness of the area ... -Swollen armpit around the injection site of SHINGRIX on right arm. -Slightly soreness of the area surrounding the injection site. - Swollen are about the size of a tennis ball. More
2856754 1 M MA 09/03/2025 MMRV
PNC20
VARCEL
 MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 Z007853
LX2496
Z008083
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Patient received 2 doses of varicella and received MMRV outside of recommended age. Called patient n... Patient received 2 doses of varicella and received MMRV outside of recommended age. Called patient next day and no adverse events had occurred, child was doing fine. More
2856755 52 F TN 09/03/2025 FLU3
 SANOFI PASTEUR
 U8823AA
Hypoaesthesia Hypoaesthesia
Patient received vaccine around 10:14 AM. At 12:30 PM started with symptoms. At ~ 12:40 daughter cal... Patient received vaccine around 10:14 AM. At 12:30 PM started with symptoms. At ~ 12:40 daughter called and I got the call. She said mom had a vaccine earlier. Now she can't feel anything on her left side of her body or face. Said her body feels "numb" and can't feel anything if she is touched. What do we do she asks? I go through allergies, any problems with vaccines before? Answer is no to everything. I ask daughter to ask mom-did anything feel different about vaccination-answer was no. I asked if mom had any breathing issues-answer was no. I ask the technician that administered the vaccine-anything unusual occur. She said no-her shirt didn't go all the way up, but I was still able to administer in the muscle was her response. More
2856756 39 F 09/03/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Chills, Fatigue, Headache, Influenza like illness, Malaise; Pain, Polymenorrhoea... Chills, Fatigue, Headache, Influenza like illness, Malaise; Pain, Polymenorrhoea, Pyrexia More
Woke up early the morning after the vaccine with flu-like symptoms. Pounding headache, malaise, chil... Woke up early the morning after the vaccine with flu-like symptoms. Pounding headache, malaise, chills, body aches, low grade fever. Symptoms improved with ibuprofen but persisted for about 36 hours. Headaches were daily and lasted 7 days post-vaccination. Fatigue persisted for nearly two weeks. Menstrual cycle after vaccination was 6 days shorter than average. More
2856757 51 F OH 09/03/2025 FLU3
 SEQIRUS, INC.
Swelling Swelling
Swollen area lasting now three weeks after administration Swollen area lasting now three weeks after administration
1868997 17 M PA 09/02/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Autopsy, Death, Myocarditis; Infection, Myocarditis, Pulmonary oedema Autopsy, Death, Myocarditis; Infection, Myocarditis, Pulmonary oedema
Death. Death.
โœ“
2856278 34 M TN 09/02/2025 VARCEL
 MERCK & CO. INC.
 Y006523
No adverse event, Product storage error No adverse event, Product storage error
no additional adverse event was reported; Product storage error; This spontaneous report was receive... no additional adverse event was reported; Product storage error; 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 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) Powder and solvent for solution for injection, (lot #Y006523, expiration date: 25-Mar-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The vaccine was inadvertently stored in the refrigerated before administration (Improper storage of product in use). No additional adverse event was reported. Follow-up information has been received from a nurse regarding a 34-year-old male patient on 11-Aug-2025. On 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y006523, expiration date: 25-Mar-2026), 1 dosage from, total, administered subcutaneously, as prophylaxis. It was reported that an improper transportation of vaccine from pharmacy to clinic with use of refrigerated vaccine transport was used. Additionally improper storage of vaccine in clinic. Placed in refrigerator when storage requirements were kept frozen and only stable for 72 hours in refrigerator. The action that was taken with the suspect vaccine was removed from clinic immediately. The patient did not have adverse reaction. The vaccine was not resumed. The vaccine was not available for returned. The operator of the vaccine was a healthcare professional. More
2856279 2 M CO 09/02/2025 HEPA
 MERCK & CO. INC.
 Y015910
Muscle tightness Muscle tightness
No additional AE; Nurse calling to report an AE for VAQTA. They attempted to administer a dose of VA... No additional AE; Nurse calling to report an AE for VAQTA. They attempted to administer a dose of VAQTA to a 2 year old male patient who "tightened his muscles up" in his thigh so they were not able to administer the vaccine. She states it seemed "like a little had go; She reports difficult administration of all vaccines with this patient; This spontaneous report was received from a Nurse 15-Aug-2025 and refers to a 2-year-old male patient. The patient's concurrent conditions include allergy to Beef, eggshell membrane. concomitant therapies and historical conditions were reported as none. On 15-Aug-2025, the nurse attempted to administer a dose of Hepatitis A Vaccine, inactivated (VAQTA), (lot #Y015910, expiration date: 06-Feb-2026), dose of: 0.5 mL, administered by Intramuscular route for prophylaxis. It was reported that the patient who "tightened his muscles up" in his thigh so they were not able to administer the vaccine. She stated it seemed "like a little had go, but not the entire volume." She stated they attempted a second time with the same vaccine/syringe and only a small amount "if any" was successfully administered(Underdose). She reported difficult administration of all vaccines with this patient (Product use complaint). No laboratory test was performed. No additional adverse event experienced. More
2856280 17 PA 09/02/2025 HEPA
 MERCK & CO. INC.
 Z006542
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
no symptoms; administered an adult dose of VAQTA to a 17 year old patient; This spontaneous report w... no symptoms; administered an adult dose of VAQTA to a 17 year old patient; This spontaneous report was received from an Office Manager and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-Aug-2025, the patient was vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Z006542, expiration date: 20-Oct-2026) 1 mL (Overdose) administered by Unknown route as prophylaxis. The vaccine was administered by a healthcare professional. No additional adverse event or symptoms were reported. More
2856281 09/02/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Fibromyalgia, Herpes zoster, Neuralgia, Vaccination failure; Fibromyalgia, Herpe... Fibromyalgia, Herpes zoster, Neuralgia, Vaccination failure; Fibromyalgia, Herpes zoster, Neuralgia, Vaccination failure More
Suspected vaccination failure; received both shots a few years ago and still get outbreaks; cripplin... Suspected vaccination failure; received both shots a few years ago and still get outbreaks; crippling nerve pain; fibromyalgia; 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. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received both shots a few years ago and still get outbreaks), nerve pain (Verbatim: crippling nerve pain) and fibromyalgia (Verbatim: fibromyalgia). The outcome of the vaccination failure and shingles were not reported and the outcome of the nerve pain and fibromyalgia were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and fibromyalgia 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, nerve pain and fibromyalgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a patient via interactive digital media. The patient received both shots a few years ago and still get outbreaks. The doctor said that it did not stop breakouts in everyone, and the patient was one of the ones it did not stop. It had lessened the duration and severity of the breakout. The patient was given daily antibiotics. The nerve pain was debilitating, and the patient was endlessly frustrated with crippling nerve pain. The patient was told it was fibromyalgia. The patient wondered if it had something also to do with patient's shingles history. This case was considered as suspected vaccination failure as details regarding time to onset 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 Shingles vaccine (doses 1 and 2). More
2856420 65 F AZ 09/02/2025 PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z003579
Z003579
Z003579
Arthralgia, Chills, Dyspnoea, Erythema, Fatigue; Insomnia, Pain in extremity, Pe... Arthralgia, Chills, Dyspnoea, Erythema, Fatigue; Insomnia, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Tenderness More
Reactions started the evening on the day vaccine was administered. Patient experienced fever of 101.... Reactions started the evening on the day vaccine was administered. Patient experienced fever of 101.5 degrees F, chills, shortness of breath, joint soreness, right arm pain, and insomnia. The following day, arm was red, very tender, and swollen Two days later: arm was itchy, redness spread, tenderness increased Three days later: still having intense arm soreness, redness, and swelling, chills, joint aches, fatigue More
2856467 CO 09/02/2025 MMRV
MMRV
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No additional AE; inadvertent administration of PROQUAD to a 13-year-old patient.; inadvertent admin... No additional AE; inadvertent administration of PROQUAD to a 13-year-old patient.; inadvertent administration of PROQUAD to a 13-year-old patient.; This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided. On 22-Aug-2023, the 13-year-old patient was inadvertently vaccinated (Product administered to patient of inappropriate age and Accidental exposure to product) with a first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) STERILE DILUENT (strength, route of administration, site of administration, lot #, and expiration date were not provided); and on 31-JUL-2025, subsequently with a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) STERILE DILUENT (strength, route of administration, site of administration, lot #, and expiration date were not provided); both given as prophylaxis. No additional adverse event reported. Batch/Lot number is being requested and will be submitted if received. More
2856468 61 F FL 09/02/2025 PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y013009
Y013009
Y013009
Arthralgia, Asthenia, Blood test, Chills, Fatigue; Headache, Injection site haem... Arthralgia, Asthenia, Blood test, Chills, Fatigue; Headache, Injection site haemorrhage, Lethargy, Muscle swelling, Myalgia; Pain in extremity, Peripheral swelling, Rash macular, Skin warm, Wrong technique in product usage process More
she feels that the person who administered the CAPVAXIVE "shot so hard and so fast, which may h... she feels that the person who administered the CAPVAXIVE "shot so hard and so fast, which may have caused these side effects; Indication pneumonia; the rash is very warm to the touch; at the injection site, she experienced side effects of bleeding, as well as muscle and joint pain following the administration.; at the injection site, she experienced side effects of bleeding; at the injection site, she experienced side effects of bleeding, as well as muscle and joint pain following the administration.; muscle and joint pain; muscle and joint pain; chills throughout the entire day; very lethargic; fatigued; headaches; muscle on the side of the breast" was experiencing pain, and started to swell; pain and swelling has moved down further on her arm; pain and swelling has moved down further on her arm; red splotches all over".; This spontaneous report was received from a Patient and refers to herself, a 61-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Repatha (Evolocumab), Allegra (Bilastine), and Alvesco (Ciclesonide) (reported as Avesco). On 03-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (valid lot #Y013009, expiration date was not provide but established as: 17-Nov-2025) 0.5 mL administered by Intramuscular route for pneumonia (Product use in unapproved indication) (dose number and anatomical location were not provided). On an unspecified day in August 2025, she experienced side effects at the injection site of bleeding, as well as muscle and joint pain following the administration (vaccination site haemorrhage, vaccination site pain, vaccination site joint pain). The patient reported that on an unspecified day in August 2025 (over the course of the next few days), she experienced side effects of muscle and joint pain, chills throughout the entire day, very lethargic and fatigued, and headaches (myalgia, arthralgia, chills, lethargy, fatigue, headache). She reported that her "muscle on the side of the breast" was experiencing pain, and started to swell (muscle swelling). On an unspecified day in August 2025 (over the last few days), the patient reported that the pain and swelling had moved down further on her arm (pain in extremity, peripheral swelling), and she had developed (reported as had not developed- conflicting information) a rash that has "red splotches all over" (rash macular). Patient reported that the rash was "very warm to the touch" (skin warm). No other symptoms or side effects reported. No specific dates were reported for when patient experienced these symptoms, but patient stated that these have "all occurred over the last few days" (estimated as August 2025). Patient reported that she had "started to get her energy back the last few days, so she felt like she was recovering". The patient reported that she felt that the person who administered the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (on 03-AUG-2025) "shot so hard and so fast, which might have caused these side effects" (wrong technique in product usage process). She also reported that she asked her pharmacist about these side effects, but her pharmacist "tried telling me it was from a bug bite". The patient reported that she was "positive this was not from a bug bite." It was reported that bloodwork was done recently, but result was not provided. At the reporting time, the patient was recovering from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was assessed as not applicable. The causal relationship between the all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) not provided. More
2856469 12 F CO 09/02/2025 HPV9
 MERCK & CO. INC.
 Y015760
No adverse event, Syringe issue No adverse event, Syringe issue
No additional AE; HCP reported 2 issues regarding irregular pressure of GARDASIL 9 syringes when adm... No additional AE; HCP reported 2 issues regarding irregular pressure of GARDASIL 9 syringes when administering to patients. Both products were administered; PQC for GARDASIL 9. Caller stated HCP reported 2 issues regarding irregular pressure of GARDASIL 9 syringes when administering to patients.; This spontaneous report was received from an Other health professional (certified medical assistant [CMA]) and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-AUG-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, valid lot #Y015760, expiration date: 10-FEB-2027, administered for prophylaxis (exact dose, route of administration and anatomical location were not reported). When administering the suspect vaccine, there was an irregular pressure in the human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) syringe (Poor quality device used, Syringe issue). There was no leaking from either the syringe or the vial as a result of the pressure irregularity, and the patient was eventually able to get full dose. It was difficult but possible to push the plunger rod/stopper towards the tip of the syringe. The carton that contained the syringe was not damaged on receipt. No additional adverse event was reported (no adverse event). The suspect vaccine was disposed after vaccines was administered therefore product was not available for retrieval. This is one of two reports received from the same reporter. More
2856470 11 M CO 09/02/2025 HPV9
 MERCK & CO. INC.
 Y015760
No adverse event, Syringe issue No adverse event, Syringe issue
No additional AE; irregular pressure of GARDASIL 9 syringes; regarding irregular pressure of GARDA... No additional AE; irregular pressure of GARDASIL 9 syringes; regarding irregular pressure of GARDASIL 9 syringes when administering to patients; This spontaneous report was received from a medical assistant and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-AUG-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a total dose of 1 dosage form, lot #Y015760, expiration date: 10-FEB-2027, administered for prophylaxis (route of administration and anatomical location were not reported). When administering, there was an irregular pressure in the human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) syringe (Poor quality device used, Syringe issue). There was no leaking from either the syringe or the vial as a result of the pressure irregularity, and the patient was eventually able to get full dose. No additional adverse event was reported. This is one of two reports received from the same reporter. More
2856471 MI 09/02/2025 RVX
 UNKNOWN MANUFACTURER
 2142136
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report... No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Product storage error) (lot #2142136, expiration date: 28-May-2026) 1 dose form administered by Oral route as prophylaxis. It was reported that the vaccine was exposed to a Temperature of 8.8C for 30 minutes; and 8.5C for 15 minutes. There was not previous temperature excursion. No additional adverse events were reported, no further information provided. More
2856472 71 F NY 09/02/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Back pain, Musculoskeletal pain, Nausea, Pain, Pain in extremity; Pruritus, Slee... Back pain, Musculoskeletal pain, Nausea, Pain, Pain in extremity; Pruritus, Sleep disorder, Vaccination site pain More
The last 4 nights the pain is in her right thigh; she experienced itching and full body aches and pa... The last 4 nights the pain is in her right thigh; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; she experienced itching and full body aches and pains, including in her butt and back; immediately experienced injection site pain that lasted 5 days; it makes her nauseous; She also has an oval rash around the injection site; She is struggling during the day though due to a lack of sleep; She is struggling during the day though due to a lack of sleep; This spontaneous report was received from a 71-year-old female patient, referring to herself. The patient's medical history and concomitant therapies were unknown. There were no drug reactions or allergies. On 13-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 168 mcg/ml injection 0.5 mL (lot #, expiration date and vaccination site were not reported) for prophylaxis. On the same day, immediately after the vaccination, the patient experienced vaccination site pain, it lasted 5 days. On 18-Aug-2025, when trying to sleep the patient experienced itching and full body aches and pains, including in her butt and back. Since 25-Aug-2025, the pain was in her right thigh. The patient stated that the pain has the intensity of labor pains, and on scale of 1-10 its a 12, and it makes her nauseous. Every night has been horrible and unbearable, but the pains mostly went away during the day and then got worse at night again. The patient was struggling during the day though due to a lack of sleep. The patient sought medical attention and was given treatment of acetaminophen (Tylenol) and Ibuprofen (Advil). On an unknown date in August 2025, the patient also had an oval rash around the vaccination site. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. At the time of this report, the outcome of vaccination site pain was considered as resolved on 17-Aug-2025. The outcome of other events was not recovered. The causal relationship between the suspect vaccine and all events was not provided. More
2856473 71 F MA 09/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Rash Pruritus, Rash
Rash; Itchy; This non-serious case was reported by a consumer via call center representative and des... Rash; Itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included lyme disease (diagnosed and treated in 1991) and immune disorder (nos) (due to lymes disease). On 28-JUL-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 rash (Verbatim: Rash) and injection site itching (Verbatim: Itchy). The outcome of the injection site rash and injection site itching were not resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix. It was unknown if the company considered the injection site rash and injection site itching to be related to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 The reporter states at the injection site she had a rash that was itchy and this started calming down about 3 days later. The reporter states that last night (of reporting) the rash and itching started coming back. The reporter states the rash and itch was not spreading. More
2856474 F MD 09/02/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 7YS93
Product administered to patient of inappropriate age, Wrong patient received pro... Product administered to patient of inappropriate age, Wrong patient received product More
The vaccine was prepared for different patients, and the vaccines were mixed due to a room change, l... The vaccine was prepared for different patients, and the vaccines were mixed due to a room change, leading to giving the 6-day-old baby the Rotarix orally; received 6-day-old baby the Rotarix orally; This non-serious case was reported by a physician via call center representative and described the occurrence of administered drug to incorrect patient in a 6-day-old female patient who received Rota (Rotarix liquid formulation) (batch number 7YS93, expiry date 15-NOV-2026) for prophylaxis. On 04-AUG-2025, the patient received the 1st dose of Rotarix liquid formulation (oral). On 04-AUG-2025, an unknown time after receiving Rotarix liquid formulation, the patient experienced administered drug to incorrect patient (Verbatim: The vaccine was prepared for different patients, and the vaccines were mixed due to a room change, leading to giving the 6-day-old baby the Rotarix orally) and inappropriate age at vaccine administration (Verbatim: received 6-day-old baby the Rotarix orally). The outcome of the administered drug to incorrect patient and inappropriate age at vaccine administration were not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The vaccines had been prepared for different patients, but they were mixed due to a room change. As a result, a 6-day-old baby was mistakenly given Rotarix orally, which led to Inappropriate age at vaccine administration and Administered drug to incorrect patient. More
2856475 69 F GA 09/02/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4LM9F
Product preparation issue Product preparation issue
Two Arexvy Adjuvants were mixed together and administered to the patient; Two Arexvy Adjuvants were ... Two Arexvy Adjuvants were mixed together and administered to the patient; Two Arexvy Adjuvants were mixed together and administered to the patient; 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 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4LM9F) for prophylaxis. Concomitant products included Pneumococcal vaccine. On 23-JAN-2025, the patient received Arexvy (left arm). On 23-JAN-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Two Arexvy Adjuvants were mixed together and administered to the patient) and inappropriate dose of vaccine administered (Verbatim: Two Arexvy Adjuvants were mixed together and administered to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 06-AUG-2025 The Health Care Professional was the reporter. The reporter stated a patient was vaccinated only with the Arexvy adjuvant into the left arm of the patient on 23 JAN 2025. The HCP reported two Arexvy adjuvants were mixed together and administered to the patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
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