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
2856131 12 F MO 08/29/2025 TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U827AA
U827AA
U827AA
Abdominal pain upper, Dizziness, Dyspnoea, Limb discomfort, Nausea; Pain, Pain i... Abdominal pain upper, Dizziness, Dyspnoea, Limb discomfort, Nausea; Pain, Pain in extremity, Palpitations, Peripheral swelling, Skin warm; Swelling face More
Patient woke up early on 8/21/25 to use the bathroom. She had a very sore arm. felt heavy, dizzy, an... Patient woke up early on 8/21/25 to use the bathroom. She had a very sore arm. felt heavy, dizzy, and had a possible fever. Her arm was hot, swollen. Her mom said she was breathing hard and patient's heart was racing. Her face was also puffy according to her mom. She had nausea and stomach pains. Her mom called their EMT neighbors, they recommended some Benadryl. She took Tylenol as well. On 8/22/25, she no longer had a fever. Her body did ache and appeared swollen according to her mom. Her arm was still swollen and heavy. On 8/25/25 She felt the same as Friday. On 8/27/25 She is back to normal. Her mom gave her a detox tea and put her on the vibration pad and now she is fine. More
2856132 83 F 08/29/2025 PNC20
 PFIZER\WYETH
 LX4484
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
patient called about redness, swelling, and warmth at the injection site patient called about redness, swelling, and warmth at the injection site
2856133 20 F TN 08/29/2025 FLU3
 SANOFI PASTEUR
 u8790aa
Loss of consciousness Loss of consciousness
patient received flu immunization and then went and sat on bench- within 5 minutes she passed out- h... patient received flu immunization and then went and sat on bench- within 5 minutes she passed out- had her lie down and applied cold towels and monitored blood pressure- she came too very quickly More
2856134 4 M 08/29/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Priorix was inadvertently given IM instead of SQ. No adverse reaction. Priorix was inadvertently given IM instead of SQ. No adverse reaction.
2856135 35 F TX 08/29/2025 TDAP
 SANOFI PASTEUR
Cough, Fatigue, Injection site pain, Oropharyngeal pain, Throat irritation Cough, Fatigue, Injection site pain, Oropharyngeal pain, Throat irritation
Pregnancy Delivery date estimated 10/10/25. Following vaccine, severe unusual fatigue and some pain ... Pregnancy Delivery date estimated 10/10/25. Following vaccine, severe unusual fatigue and some pain at the injection site - not unexpected; unusually overheated all day. Next morning, very sore & scratchy throat, constant coughing (not able to be soothed), continued fatigue. Wanted to submit as this is all an unusual condition for me and the throat symptoms are not listed among the possible side effects. More
2856136 12 F FL 08/29/2025 HPV9
 MERCK & CO. INC.
 Z007667
Injection site reaction, Rash, Rash erythematous, Rash papular Injection site reaction, Rash, Rash erythematous, Rash papular
Tolerated admin without issue. Mom called about 2 hours after they left office to describe a rash o... Tolerated admin without issue. Mom called about 2 hours after they left office to describe a rash on the arm of administration that was pink, raised. She submited a photo to the portal for review. Child without cough, wheeze, dizziness, weakness. She noted some on right arm as well. Mom tells me child did put some trash in the dumpster for her before rash, unclear if she got anything on her arms. Mom called to let us know what was happending, esp since she had the vaccine. Reviewed signs and sx of allergic reaction requiring immediate ER eval. None present. Advised to wash area, observe. Mom was going to observe her, have her stay with mom. I called the next day to check on patient. Mom reported rash disappeared within an hour after we spoke, no further issues. Advised mom that I would submit the report to Vaers. Mom aware. More
2856137 55 F NY 08/29/2025 PNC20
 PFIZER\WYETH
 LX4486
Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus,... Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus, Rash More
After PCV 20 on 08/20/2025, patient noticed itchiness and swelling at injection site and also her p... After PCV 20 on 08/20/2025, patient noticed itchiness and swelling at injection site and also her palms b/l. she took claritine/zyrtec and rash on palm resolved but itchiness at injection site did not. Patient returned to PCP on 08/26/2025, the redness was bigger but less swollen. no pain. still very itchy. denies any other symptoms. PCP offered Benadryl and Topical cream, patient declined, will continue to take cetirizine for itchiness. PCP instructed patient to return if worsening symptoms. More
2856138 68 F CA 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Pain in extremity, Pyrexia Pain in extremity, Pyrexia
Fever for about 48 hours. First 24 it got to 102, next 24hrs was a little over 100 degrees. Very so... Fever for about 48 hours. First 24 it got to 102, next 24hrs was a little over 100 degrees. Very sore arm. Tylenol worked fine. More
2856139 23 F FL 08/29/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00600
Arthralgia, Back pain, Hypoaesthesia, Pain, Pain in extremity Arthralgia, Back pain, Hypoaesthesia, Pain, Pain in extremity
Pain in left arm, radiating to the left shoulder and upper back. Reported numbness in left arm with ... Pain in left arm, radiating to the left shoulder and upper back. Reported numbness in left arm with no improvement to Tylenol. More
2856141 VA 08/29/2025 VARCEL
 MERCK & CO. INC.
 Z003767
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; HCP called to report T/E. HCP stated VARIVAX was administered inadvertent... No additional AE reported; HCP called to report T/E. HCP stated VARIVAX was administered inadvertently during T/E. Permission was given to contact HCP for further information. T/E date was on 8/4/2025 , VARIVAX was administered on 8/7/2025. No additional information was provid; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-AUG-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003767, expiration date: 30-Jan-2027), dose number 2, 0.5 mL, administered by unknown route as prophylaxis. The vaccine was administered after being improperly stored (temperature excursion took place on 04-AUG-2025); temperature: -8.5 C, time frame: 2 hour 34 minutes 0 seconds (Product storage error). No additional adverse event reported. The outcome of the event was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not applicable. More
2856142 59 M PA 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L5P2
Inappropriate schedule of product administration Inappropriate schedule of product administration
A male patient received Shingrix in 2020 and the second dose in 2024, now he wants a 3rd dose.; This... A male patient received Shingrix in 2020 and the second dose in 2024, now he wants a 3rd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L5P2, expiry date 27-OCT-2026) for prophylaxis. Previously administered products included Shingrix (1st dose received on 08-DEC-2020, batch number-4Z43X and expiration date 22-FEB-2022). On 11-NOV-2024, the patient received the 2nd dose of Shingrix. On 11-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: A male patient received Shingrix in 2020 and the second dose in 2024, now he wants a 3rd dose.). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient received second dose of Shingrix at longer interval than recommended which led to lengthening of vaccination schedule. At the time of reporting the patient wants a 3rd dose. The reporter asked was this possible, what would be the dosing schedule or the safety information. The reporter consented to follow up. More
2856143 23 F NJ 08/29/2025 FLU3
 SANOFI PASTEUR
 U8790AA
Syncope Syncope
pt fainted, recovered quickly pt fainted, recovered quickly
2856144 64 M CA 08/29/2025 FLU3
 SANOFI PASTEUR
 u8800ca
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none know none know
2856145 0.58 M OR 08/29/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 34MF9
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Administered Dtap-IPV combination vaccine "Kinrix" instead of separate Dtap and IPV immuni... Administered Dtap-IPV combination vaccine "Kinrix" instead of separate Dtap and IPV immunizations. Kinrix intended for 4 years and up; patient is 7 months old. Provider gave verbal okay when MA suggested the combination vaccine, when neither confirmed age range on package. Mother of child was immediately informed in-person of administration error. No adverse events have been noted at the time of making this report. More
2856146 73 M HI 08/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Swelling face Swelling face
He experienced facial swelling on the cheeks after receiving his second shingles vaccine at 9:00 AM.... He experienced facial swelling on the cheeks after receiving his second shingles vaccine at 9:00 AM. The swelling became noticeable around 9:30 AM while driving home and was described as 'really very puffy' by the time he arrived home. In response to the swelling, he took 25 mg of Benadryl, which reduced the swelling to about twenty percent of its original size by the time of the visit. No other symptoms associated with his known peanut allergy, such as hives, lip swelling, or breathing difficulties, were present. More
2856147 58 F LA 08/29/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Arthralgia, Mobility decreased, Muscular weakness, Sleep disorder Arthralgia, Mobility decreased, Muscular weakness, Sleep disorder
PATIENT REPORTED TO PHARMACIST TODAY ON 08/29/2025 THAT SHE HAD PAIN FROM A PREVIOUS VACCINE IN HER ... PATIENT REPORTED TO PHARMACIST TODAY ON 08/29/2025 THAT SHE HAD PAIN FROM A PREVIOUS VACCINE IN HER SHOULDER. SHE SAID IT HAD BEEN A WHILE SINCE THE VACCINE. ONCE DISCUSSED WITH THE PATIENT, IT WAS DETERMINED SHE HAS BEEN HAVING PAIN SINCE 09/26/2024. SHE DENIES MENTIONING IT TO HER PRESCRIBER. SHE DID STATE THAT SHE CANNOT SLEEP ON THAT ARM AND HAS RESTRICTED MOVEMENT AND DIFFICULTY CARRING A GALLON OF MILK IN THAT ARM. More
2856148 11 F AZ 08/29/2025 UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 3N2ND
Z008220
Y1A201M
9YB4G
Y012921
U8494AA
Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope; Crying, ... Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope; Crying, Fall, Head injury, Syncope More
Patient talking to RN, RN finished giving shots and turned around to get bandaids and patient fainte... Patient talking to RN, RN finished giving shots and turned around to get bandaids and patient fainted and fell off chair, to knees and hit head. Cold compress and to forehead and patient started crying. BP WNL, A&O, waited 20 minutes and left. Mother called today but didn't answer or return calls. More
2856160 76 F FL 08/29/2025 PNC20
 PFIZER\WYETH
 LX4482
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient came in to get pneumonia vaccine; however, patient had already received the same vaccine in ... Patient came in to get pneumonia vaccine; however, patient had already received the same vaccine in June 2023. Patient did not experience any adverse event. More
2856161 37 F NJ 08/29/2025 VARCEL
 MERCK & CO. INC.
 Z006737
Injection site cellulitis, Injection site erythema, Injection site inflammation,... Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain More
Patient developed a red spot at injection site and it was sore and inflamed. Patient reported she w... Patient developed a red spot at injection site and it was sore and inflamed. Patient reported she was diagnosed in hospital with cellulitis at the injection site. We filled script from the hospital for Doxycycline More
2856162 56 F TX 08/29/2025 PNC21
 MERCK & CO. INC.
 z004302
Arthralgia, Arthritis, Joint range of motion decreased, Musculoskeletal discomfo... Arthralgia, Arthritis, Joint range of motion decreased, Musculoskeletal discomfort, Pyrexia More
Patient received a vaccine on 08/24/2025 , the next day she had a fever and her shoulder has been so... Patient received a vaccine on 08/24/2025 , the next day she had a fever and her shoulder has been sore since the shot. She says it been inflamed and has had limited mobility of the shoulder since the shot. She has been taking ibuprofen and has helped with the discomfort . Pharmacist advised her to fallow up with her primary care doctor and continue ibuprofen and to take a dose Benadryl as well. Let her know we will reach out to her primary care as well More
2856163 68 F WA 08/29/2025 COVID19
 PFIZER\BIONTECH
 LM222
Myalgia, Periarthritis Myalgia, Periarthritis
patient started having muscle pain after receiving Comirnaty and continued for long time. Now patie... patient started having muscle pain after receiving Comirnaty and continued for long time. Now patient reports that she has frozen shoulder due to vaccine and asked me to report. More
2856164 67 F FL 08/29/2025 COVID19
COVID19
 MODERNA
MODERNA
 018B21A
018B21A
Asthenia, Bursa removal, Magnetic resonance imaging, Surgery, Tendon rupture; Te... Asthenia, Bursa removal, Magnetic resonance imaging, Surgery, Tendon rupture; Tenodesis, X-ray More
Torn tendon, IT band reattach and bersa sac removed. Moderna shot caused soft tissue to weaken. ... Torn tendon, IT band reattach and bersa sac removed. Moderna shot caused soft tissue to weaken. Dr said he has treated numerous patients with lower back and hip issues that had Moderna but not Pfizer More
โœ“
2856165 17 M CO 08/29/2025 HPV9
 MERCK & CO. INC.
 Y015760
Arthralgia, Fall, Lip injury, Loss of consciousness, Mouth injury Arthralgia, Fall, Lip injury, Loss of consciousness, Mouth injury
Patient received Bexsero in the R arm and felt fine then received the Gardasil and passed out out wi... Patient received Bexsero in the R arm and felt fine then received the Gardasil and passed out out within 10 seconds, fell to the floor. Patient was monitored in the office - B/P, given juice and snacks in the office until felt stable - 30 minutes. Patient c/o knees hurting from impact and hit mouth and cut inside of lip. Teeth intact. Pt left office with mom and sibling - laughing and interacting normally. More
2856166 13 F VA 08/29/2025 HPV9
 MERCK & CO. INC.
Injection site induration, Injection site pain, Injection site swelling Injection site induration, Injection site pain, Injection site swelling
Swelling at injection site, in duration and pain Swelling at injection site, in duration and pain
2856167 11 F VA 08/29/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 x024650
amab056a
Balance disorder, Blood pressure decreased, Dizziness, Nausea, Pallor; Balance d... Balance disorder, Blood pressure decreased, Dizziness, Nausea, Pallor; Balance disorder, Blood pressure decreased, Dizziness, Nausea, Pallor More
Pt did not faint and stayed alerted. However she did have low BP, pale look, light headedness, feel... Pt did not faint and stayed alerted. However she did have low BP, pale look, light headedness, feeling unsteady standing/walking. These symptoms lasted for 20-30mins, and improved with time and food. She also stated she felt nauseous for a few mins, but this also resolved with time and food. She was very talkative and more comfortable before leaving with her mom, and her BP had improved. More
2856196 13 F PA 08/29/2025 HPV4
 MERCK & CO. INC.
 Y020588
Incorrect route of product administration, Product administered at inappropriate... Incorrect route of product administration, Product administered at inappropriate site More
Noted that vaccine was given to low in (L) arm. Pt received subcu due to incorrect administration. S... Noted that vaccine was given to low in (L) arm. Pt received subcu due to incorrect administration. Should have been in deltoid. More
2856418 F CA 08/29/2025 HEP
IPV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 N7338
Y1A212M
Rash; Rash Rash; Rash
Rash after 24 hours of vaccine Rash after 24 hours of vaccine
2856419 78 F MO 08/29/2025 FLUX
PNC20
UNK
 UNKNOWN MANUFACTURER
PFIZER\WYETH
UNKNOWN MANUFACTURER
 407242
lx2497
342xp
Peripheral swelling, Pruritus, Skin reaction; Peripheral swelling, Pruritus, Ski... Peripheral swelling, Pruritus, Skin reaction; Peripheral swelling, Pruritus, Skin reaction; Peripheral swelling, Pruritus, Skin reaction More
Left arm became swollen, red, and somewhat itchy. Patient's sister called her PCP and the offic... Left arm became swollen, red, and somewhat itchy. Patient's sister called her PCP and the office said to keep an eye on it for now. Patient said will apply ice and maybe take otc analgesics. More
2855847 OH 08/28/2025 MMR
MMRV
UNK
 MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
 Y019108
Z007853
Extra dose administered, No adverse event, Wrong technique in product usage proc... Extra dose administered, No adverse event, Wrong technique in product usage process; Extra dose administered, No adverse event, Wrong technique in product usage process; Extra dose administered, No adverse event, Wrong technique in product usage process More
Nurse confirmed the patient involved did not experience any medical concerns as a result of this rep... Nurse confirmed the patient involved did not experience any medical concerns as a result of this report; Unknown vaccine product administered; doses of PROQUAD and MMR II were simultaneously reconstituted into separate syringes without any identifier to differentiate the vaccines from one another; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 08-Aug-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), batch/lot #Y019108 has been verified to be a valid batch lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, expiration date reported and upon internal verification confirmed as 18-Nov-2026, 0.5 mL (Two dose series); or Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), batch/lot #Z007853 has been verified to be a valid batch lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal verification confirmed as 19-Oct-2026) 0.5 mL (Two dose series (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccines were diluted with sterile (expiration date and batch/lot # were not reported). It was reported that on that date, the patient reported to the clinic for a routine vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), were simultaneously reconstituted into separate syringes without any identifier to differentiate the vaccines from one another (wrong technique in product usage process). Nurse stated that the patient was administered one syringe, but the staff was uncertain which syringe contained the dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), and which dose contained the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), and was also unsure of which vaccine was administered and which reconstituted vaccine remained unused (unknown vaccine product administered). Nurse confirmed the patient involved did not experience any medical concerns as a result of this report (no adverse event). No additional information was provided. Batch/lot # for sterile diluent is being requested and will be submitted if received. More
2855848 41 FL 08/28/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event, Wrong product administered No adverse event, Wrong product administered
imovax prescribed with off label diagnosis, poisoning by unspecified systemic antibiotic, accidental... imovax prescribed with off label diagnosis, poisoning by unspecified systemic antibiotic, accidental (unintentional), initial encounter with no reported adverse event; Initial information received on 25-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 41 years old and unknown gender patient who was prescribed IPV (Vero) [Imovax] with off label diagnosis for poisoning by unspecified systemic antibiotic, accidental (unintentional), initial encounter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed 1mL dose (twice) of suspect IPV (Vero), Powder for solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for poisoning by unspecified systemic antibiotic, accidental (unintentional), initial encounter with no reported adverse event (off label use). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Action taken was not applicable. More
2855862 08/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Deafness Deafness
could not hear the sound; This serious case was reported by a consumer via interactive digital media... could not hear the sound; This serious case was reported by a consumer via interactive digital media and described the occurrence of deafness in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced deafness (Verbatim: could not hear the sound) (serious criteria GSK medically significant). The outcome of the deafness was not reported. It was unknown if the reporter considered the deafness to be related to Herpes Zoster vaccine. The company considered the deafness to be unrelated to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. Patient could not hearth the sound.; Sender's Comments: A case of Deafness, on an unknown time after receiving Herpes Zoster vaccine, in a 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 More
2855863 F KY 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
I did not have anything more than pain at the injection site with the first dose; This non-serious c... I did not have anything more than pain at the injection site with the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: I did not have anything more than pain at the injection site with the first dose). The outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR107892 Additional Information: GSK Receipt Date: 18-AUG-2025 The patient mentioned she did not have anything more than pain at the injection site with the first dose of Shingrix vaccine For tolerance to second dose refer case US2025AMR107892; Sender's Comments: US-GSK-US2025AMR107892:same patient first dose More
2855864 7 M TX 08/28/2025 HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 74262
MS0416
Erythema; Erythema Erythema; Erythema
Patient received Immunizations on 8/18/25 PCV20 on Right Arm, HIB on Left Arm at night 8/18/25 mothe... Patient received Immunizations on 8/18/25 PCV20 on Right Arm, HIB on Left Arm at night 8/18/25 mother notice a red spot on Right arm and thought it was normal Because he got his shot earlier that morning. More
2855865 90 F MI 08/28/2025 PNC20
 PFIZER\WYETH
 LX4486
Injection site rash Injection site rash
Rash at Injection Site Rash at Injection Site
2855916 CA 08/28/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
Y013565
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE; Caller reported patient received 1st does of GARDASIL 9 on 6/21/2022 and 2nd dose ... No additional AE; Caller reported patient received 1st does of GARDASIL 9 on 6/21/2022 and 2nd dose on 8/1/2025. Product information reflects Lot and expiration date of 2nd dose. No other information provided. No additional AE/PQC reported.; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 21-Jun-2022, the patient started prophylactic therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, administered by unknown route (lot # and expiration date were not reported). On 08-Jan-2025, the patient was vaccinated with the 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y013565, expiration date: 01-Feb-2027), 0.5 mL, administered by intramuscular route for prophylaxis (Inappropriate schedule of product administration). No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect vaccine was not applicable. More
2855917 60 F IN 08/28/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
vaccine on 11-MAR-2019 and 06-AUG-2019; This spontaneous report was received from a physician and re... vaccine on 11-MAR-2019 and 06-AUG-2019; This spontaneous report was received from a physician and refers to a 60-year-old female patient. The patient's concurrent conditions included essential hypertension (benign), hyperlipidemia, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA)/chronic hypercapnic respiratory failure on bilevel positive airway pressure (BipPA) therapy, non-small cell lung cancer (NSCLC) status post stereotactic body radiotherapy (SBRT), coronary artery disease (CAD), dysphagia, gastroesophageal reflux disease (GERD), and esophageal dysmotility. She was an ex-smoker with a history of passive smoking (mother, father, co-workers and husband were smokers). She was oxygen dependent. Her medical history included appendectomy. In 2016, she experienced right supraspinatus tendon tear. The patient's historical vaccinations included influenza vaccine (Quad) PF, influenza (standard dose) trivalent vaccine, influenza (trival) Im preservative free vaccine, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13), pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP). Concomitant vaccines included hepatitis B vaccine (manufacturer unknown). On 11-MAR-2019, the patient was vaccinated with 1st dose of hepatitis a vaccine, inactivated (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). On 06-AUG-2019, the patient was vaccinated with 2nd dose of hepatitis a vaccine, inactivated (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported) (Inappropriate schedule of product administration). This is one of two reports referring to the same patient. Lot# is being requested and will be submitted if received. More
2855918 12 M IN 08/28/2025 PPV
 MERCK & CO. INC.
 Y016291
Injected limb mobility decreased, Injection site erythema, Pyrexia Injected limb mobility decreased, Injection site erythema, Pyrexia
evaluated at the emergency room on 08/17/2025 with a fever of 104F and other unknown symptoms.; eval... evaluated at the emergency room on 08/17/2025 with a fever of 104F and other unknown symptoms.; evaluated at the emergency room on 08/17/2025 with a fever of 104F and other unknown symptoms.; The patients mother called the office this morning, 08/18/2025, and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better.; The patients mother called the office this morning, 08/18/2025, and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better.; This spontaneous report was received from an office manager and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-Aug-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #Y016291 with expiration date reported as and upon internal validation confirmed to be 06-Dec-2026) 0.5mL/once administered intramuscularly in the left arm for Low IG levels ๏ฟฝ vaccination (prophylaxis). On 17-Aug-2025, the patient was evaluated at the emergency room with a fever of 104F and other unknown symptoms (pyrexia; ill-defined disorder). It was reported that the patient sought medical attention and went to the emergency room (ER) over the weekend. On an unspecified date in august 2025, the patient experienced injection site erythema and injected limb mobility decreased. The treatment provided was as followed: cool compresses to left arm, initiated steroid taper, triamcinolone cream and zyrtec twice daily. On 18-Aug-2025 (this morning), the patients mother called the office and reported the redness at the patient's injection site was shrinking and they were able to move their arm a little better. No other details or information were able to be provided during the call. No additional adverse event (AE) and no product quality complaint (PQC) was reported. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as not applicable. At the reporting time, the patient was recovering from the adverse events. The causal relationship between the reported adverse events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as related. It was noted that the reporter called in to report the facility had four patients who reported adverse issues related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). This is one of several reports received from the same reporter.; Reporter's Comments: Keywords : MUL; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02858136-02858116 , CLIC number : , ESTAR number : , IRMS number : 500UW00000jA28KYAS|20082025120015|1284 , Central date : 2025-08-20 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2320678 , MNSC case number : 02858136 , MNSC interaction number : 02858116 , Integration log UniqueID : 500UW00000jA28KYAS|20082025120015|1284 , Service cloud CaseID : 500UW00000jA28KYAS More
2855919 34 F MD 08/28/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.








Abdominal pain, Chest pain, Condition aggravated, Heavy menstrual bleeding, Hype... Abdominal pain, Chest pain, Condition aggravated, Heavy menstrual bleeding, Hypersensitivity; Insomnia, Migraine, Mood swings, Night sweats, Premature menopause; Restlessness, Vomiting; Abdominal pain, Chest pain, Condition aggravated, Heavy menstrual bleeding, Hypersensitivity; Insomnia, Migraine, Mood swings, Night sweats, Premature menopause; Restlessness, Vomiting; Abdominal pain, Chest pain, Condition aggravated, Heavy menstrual bleeding, Hypersensitivity; Insomnia, Migraine, Mood swings, Night sweats, Premature menopause; Restlessness, Vomiting More
premature ovarian failure/severe night sweats/mood swings/difficulty sleeping/restless nights/migrai... premature ovarian failure/severe night sweats/mood swings/difficulty sleeping/restless nights/migraines/early onset menopause/allergies worsen/abdominal cramping/chest pains, a heavy menstrual cycle; autoimmune injuries; vomiting; Plaintiff was 34 years when she received three dosages of Gardasil; Information has been received from a lawyer regarding a case in litigation and referred to a currently adult female patient (pt) (exact age not provided). Her other medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date (at the age of 34 years old), the pt was vaccinated with three dosages of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her health care provider/ doctor with her consent, for prophylaxis (reported as for preventing cervical cancer) (Product administered to patient of inappropriate age). Pt had no symptoms following the first quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. Following the second and third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt began to have severe night sweats, mood swings, restless nights, difficulty sleeping, and migraines. Her allergies worsened. Following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, her doctor suspected premature ovarian failure and had her stop Depo-Provera so he could get accurate testing results as Depo-Provera could mask the symptoms of premature ovarian failure and impact the results. Pt's menstrual period started two weeks prior to stopping Depo-Provera and was ongoing at the time she stopped the shot. After she stopped the Depo-Provera, she had severe abdominal cramping, chest pains, night sweats, migraines that led to vomiting, and a heavy menstrual cycle which lasted for nine weeks steady. Pt's doctor suspected premature ovarian failure, as well as early onset menopause (Premature menopause). Pt contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune injuries (Autoimmune disorder), including but not limited to Premature ovarian failure/premature menopause, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. The outcome of all events (except for Product administered to patient of inappropriate age) was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events (except for Product administered to patient of inappropriate age) to be disabling/incapacitating. More
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2855920 70 M NY 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
Pain injection site; This non-serious case was reported by a consumer via call center representative... Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included coronary artery disease, blood cholesterol increased and hypertension. Concomitant products included atorvastatin calcium (Lipitor) and losartan potassium (Losartan). On 20-AUG-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 20-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site). The outcome of the injection site pain was resolving. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 21-AUG-2025 The reporter is the patient who stated he had arm pain at the injection site right after receiving his second dose of Shingrix and that the pain is still present but is improving. Patient has distended aorta. This case is linked with case US2025107416, reported by the same reporter.; Sender's Comments: US-GSK-US2025107416:same reporter More
2855921 08/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injecti... Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site swelling, Myalgia More
pain at the injection site; redness at the injection site; swelling at the injection site; Muscle pa... pain at the injection site; redness at the injection site; swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 29-JUL-2025, the patient received the 2nd dose of Shingles vaccine. In JUL-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), muscle pain (Verbatim: Muscle pain), tiredness (Verbatim: Tiredness), headache (Verbatim: Headache) and shivering (Verbatim: Shivering). The outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025 This case was reported by a patient via interactive digital media. Patient got the 2nd shingles shot and experienced pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering. Also asked What can they have to feel better. More
2855922 08/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersensitivity, Incomplete course of vaccination Hypersensitivity, Incomplete course of vaccination
allergic muscular reaction; This non-serious case was reported by a consumer via interactive digital... allergic muscular reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. Previously administered products included Medrol. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: allergic muscular reaction). The outcome of the allergic reaction was resolved (duration 2 years). It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. It was unknown if the company considered the allergic reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025, 30-JUL-2025 This case was reported by a patient via interactive digital media. Patient got a Medrol Pack (controlled Prednisone) for the severe itching that disappeared within 2 doses) and a couple of viral antibiotics) especially for Shingles. Also stated that had relief within a few hours, blisters etc. all gone in a couple weeks, then later got 1st Shingle shot and had a huge 2 plus year allergic muscular reaction and stated that he/she will never get the 2nd one or they would be toying with a full-blown Guillain-Barre syndrome muscular and nerve damage non-reversible side effects. More
2855923 08/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oral herpes, Pain of skin, Pruritus, Skin abrasion, Skin ulcer Oral herpes, Pain of skin, Pruritus, Skin abrasion, Skin ulcer
cold sore; Kept getting a sore it itched and painful on his/her shoulder; I'd been scratching i... cold sore; Kept getting a sore it itched and painful on his/her shoulder; I'd been scratching it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (as a child had one chicken pox) and shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced cold sores (Verbatim: cold sore), skin ulcer (Verbatim: Kept getting a sore it itched and painful on his/her shoulder) and scratch (Verbatim: I'd been scratching it). The patient was treated with gabapentin. The outcome of the cold sores, skin ulcer and scratch were not reported. It was unknown if the reporter considered the cold sores, skin ulcer and scratch to be related to Shingles vaccine. It was unknown if the company considered the cold sores, skin ulcer and scratch to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient did get one shot after shingles and further said it gave him/her another (not as severe) round of them. The patient took gabapentin only when he/she had a reaction. Also helps to get in shower and just let it beat in him/her shoulder where pain was worst. The patient also had it once beside one eye. The next visit to eye physician, he was rattling off about that eye when patient told him he/she had a shingle there. He said that explains it. So just because it was beside your eye does not mean it did not affect your eyesight. The patient recently went to a dermatologist because he/she kept getting a sore (it itched and painful on his/her shoulder). The patient thinking was it was skin cancer, but it would heal up but come back again. The physician said it was a cold sore and patient had been scratching it, so he/she had 2 by then. The patient guess some of patients would carry on forever with this disease. More
2855924 08/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
worst pain; This non-serious case was reported by a consumer via interactive digital media and descr... worst pain; 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 (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: worst pain). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 13-AUG-2025 At the time of reporting patient had it and it had to be the worse pain patient ever had in his/her life. More
2855925 08/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccina... Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccination failure More
Suspected vaccination failure; shingles in my right eye again; This serious case was reported by a ... Suspected vaccination failure; shingles in my right eye again; 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 (had shingles on scalp) and ophthalmic herpes zoster (had shingles in right eye, eyelid was affected). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in my right eye again) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. The patient said that his/her physician told him/her once you have had shingles it was in your system, and the shot would not help. The patient had shingles on his/her scalp and in right eye, finally recovered after a few months but his/her eyelid was affected, got the 2 Shingles shots and 2 years later, in his/her right eye again. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of ophthalmic herpes zoster 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). A case of Ophthalmic herpes zoster, 2 years after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2855926 08/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Zoster sine herpet... Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Zoster sine herpete More
Suspected vaccination failure; had it on my eye and 30 days from that, internal, and then on my head... Suspected vaccination failure; had it on my eye and 30 days from that, internal, and then on my head; Internal shingles; Shingles on head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: had it on my eye and 30 days from that, internal, and then on my head) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: Internal shingles) and shingles (Verbatim: Shingles on head). The outcome of the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles were not reported. The reporter considered the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles to be possibly related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the zoster sine herpete and shingles to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that same had it on eye and 30 days from that, internal, and then on head. The reporter was also mentioned that the vaccination be triggered it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. More
2855927 F 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Eye pruritus, Swelling of eyelid Eye pruritus, Swelling of eyelid
swollen shut eyes; itchy eyes; This non-serious case was reported by a consumer and described the oc... swollen shut eyes; itchy eyes; This non-serious case was reported by a consumer and described the occurrence of eye swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 24-JUL-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye swelling (Verbatim: swollen shut eyes) and eye pruritus (Verbatim: itchy eyes). Rechallenge with Shingrix was positive. The outcome of the eye swelling and eye pruritus were not reported. It was unknown if the reporter considered the eye swelling and eye pruritus to be related to Shingrix. It was unknown if the company considered the eye swelling and eye pruritus to be related to Shingrix. Linked case(s) involving the same patient: US2025096594 Additional Information: GSK receipt date: 28-JUL-2025 The patient had itchy and swollen shut eyes after the 2nd shot of Shingrix.; Sender's Comments: US-GSK-US2025096594:Same patient 1st dose More
2855928 F 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
Shingles after 1st dose of Shingrix; This non-serious case was reported by a consumer via interactiv... Shingles after 1st dose of Shingrix; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after 1st dose of Shingrix). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 18-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that one vaccine had worked, while the other had caused people to develop shingles. The reporter reported that his/her mother had gotten shingles from one vaccine but not the other. The effective vaccine was called Shingrix.; Sender's Comments: GSK-US2025AMR107265:Case for other vaccine More
2855929 3 M TX 08/28/2025 DTAP
DTAPHEPBIP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 5KR3R
Inappropriate schedule of product administration, Wrong product administered; In... Inappropriate schedule of product administration, Wrong product administered; Inappropriate schedule of product administration, Wrong product administered; Inappropriate schedule of product administration, Wrong product administered More
Infanrix administered instead of Boostrix; late second dose of Diphtheria, Tetanus and Pertussis vac... Infanrix administered instead of Boostrix; late second dose of Diphtheria, Tetanus and Pertussis vaccine; Potential late second dose of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa (DTPa vaccine) for prophylaxis. Previously administered products included Pediarix (1st dose on 08-APR-2013), DTPa vaccine (1st dose on 03-JAN-2017) and Kinrix (received on 29-OCT-2018, lot number E337X and expiration date-07-November-2020). On 29-JUL-2025, the patient received Infanrix. The patient did not receive Boostrix. On 03-MAY-2016, the patient received the 2nd dose of Pediarix. On 03-JAN-2017, the patient received the 2nd dose of DTPa vaccine. On 03-MAY-2016, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: Potential late second dose of Pediarix). On 03-JAN-2017, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Diphtheria, Tetanus and Pertussis vaccine). On 29-JUL-2025, the patient experienced wrong vaccine administered (Verbatim: Infanrix administered instead of Boostrix). The outcome of the wrong vaccine administered, drug dose administration interval too long and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-JUL-2025 Medical Assistant mentioned that a patient received Infanrix instead of Boostrix which led wrong vaccine administered. The patient received Pediarix and Diphtheria, Tetanus and Pertussis vaccine at longer time than recommended which led to lengthening of vaccination schedule. The reporter consented to follow up. More
2855930 IA 08/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
they had been given Menveo (1 vial) to 2-month-old infants; This non-serious case was reported by a ... they had been given Menveo (1 vial) to 2-month-old infants; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: they had been given Menveo (1 vial) to 2-month-old infants). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 They just realize that Menveo product had 2 presentations, one that said that was for ages 10 through 55, and one that said for ages 2 months though 55, so they had been, reporter thought, given the adolescent product, the 10 through 55 years of age (Menveo 1 vial), probably to 2 month old infants which led to inappropriate age at vaccine administration. During the call, the healthcare professional informed that they had been given Menveo (1 vial) to 2 month old infants, however, they did not provide any patient details. More
2855931 22 F NC 08/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
a Menveo 1 vial vaccination was given instead of Bexsero; This non-serious case was reported by a nu... a Menveo 1 vial vaccination was given instead of Bexsero; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. On 21-JUL-2025, the patient received Menveo. The patient did not receive Bexsero. On 21-JUL-2025, an unknown time after receiving Menveo, the patient had wrong vaccine administered (Verbatim: a Menveo 1 vial vaccination was given instead of Bexsero). The outcome of the wrong vaccine administered 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-AUG-2025 Nurse practitioner called to report that a Menveo 1 vial vaccination was given instead of Bexsero, which led to wrong vaccine administered. The reporter needed further guidance on this situation. The vaccine administration facility was the same as primary reporter. More
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