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
2850354 26 M NM 07/18/2025 VARCEL
 MERCK & CO. INC.
 z003767
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event More
client on Methotrexate given a varicella vaccine, no adverse effects at time or post injection. client on Methotrexate given a varicella vaccine, no adverse effects at time or post injection.
2850355 5 F NC 07/18/2025 DTAPIPV
DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4L454
4L454
Fatigue, Headache, Injection site erythema, Injection site pain, Injection site ... Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus; Injection site warmth More
started with fatigue and Headache the night she got the vaccine. started c/o of left arm pain, near ... started with fatigue and Headache the night she got the vaccine. started c/o of left arm pain, near her deltoid last night (7/17/25) and itchiness last night. swelling and redness/warm to touch started last night and is worse today. Provider started child on zyrtec 5 mg daily and triamcinalone 0.1% topically twice daily. may use ibuprofen, as needed More
2850356 11 M IN 07/18/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y007193
Y007193
U8194AA
U8194AA
9YB4G
9YB4G
Hyperhidrosis, Musculoskeletal stiffness, Nausea, Pallor, Sensory disturbance; U... Hyperhidrosis, Musculoskeletal stiffness, Nausea, Pallor, Sensory disturbance; Unresponsive to stimuli; Hyperhidrosis, Musculoskeletal stiffness, Nausea, Pallor, Sensory disturbance; Unresponsive to stimuli; Hyperhidrosis, Musculoskeletal stiffness, Nausea, Pallor, Sensory disturbance; Unresponsive to stimuli More
Immediately after HPV given child became tense and pushed backward into chair and was unresponsive t... Immediately after HPV given child became tense and pushed backward into chair and was unresponsive to verbal stimuli for about 15 seconds. Skin diaphoretic. Lips pale. Gradually became more responsive. Color improved. Said he felt like he was in a "movie trailer". Felt nauseated, but no emesis. Had breakfast before appointment and given juice drink at time of vaccination. Observed additional 15 minutes after said was feeling better. Walked to car unassisted. Gait steady. More
2850357 53 M TX 07/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Blood test normal, Infection, Injection site pain Blood test normal, Infection, Injection site pain
pt states after a couple of days of getting the first dose of the vaccine he started having pain in ... pt states after a couple of days of getting the first dose of the vaccine he started having pain in his right arm at the injection site. As time went on the pain continued to move down his arm but the major pain is at the injection site. He contacted his doctor to let them know he was in pain and he was told to come in to have a steroid shot. He did not go in to have the shot. He had to go to the ER on 7/17/2025. He was told by Dr that he had an infection. He was given an IV with antibiotics and pain medication. He was discharged to home and prescribed Amoxicillin, amox-clav 125 mg, naproxen 500 mg, and cyclobenzaprine 10mg. He continues to be in pain and will need to follow up with his primary doctor. More
2850358 79 F FL 07/18/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Chills, Fatigue, Headache, Injection site pain, Pyrexia Chills, Fatigue, Headache, Injection site pain, Pyrexia
Chills, fever, pain at injection site, fatigue, headaches, Chills, fever, pain at injection site, fatigue, headaches,
2850359 0.33 F IL 07/18/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 9C295
Y016315
LN4928
2117047
Body temperature increased; Body temperature increased; Body temperature increas... Body temperature increased; Body temperature increased; Body temperature increased; Body temperature increased More
Rectal temperature of 103.3 degrees Farenheit within 24 hours of vaccine administration. Rectal temperature of 103.3 degrees Farenheit within 24 hours of vaccine administration.
2850360 46 M UT 07/18/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 020621A
023C21A
007J212A
Libido decreased; Libido decreased; Libido decreased Libido decreased; Libido decreased; Libido decreased
I had, up until the injections, a very strong libido and experienced strong penal erections at any t... I had, up until the injections, a very strong libido and experienced strong penal erections at any time of the day with only a certain mental exertion, but since the injections I have not only experienced the opposite (low libido and only experiencing few soft erections, only able to have semi-flacid erections during intercourse, and when using deer-antler-velvet sprays would only ejaculate without any erection). Calling it a disorder would be an understatement! More
2850362 52 M PA 07/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Infectious mononucleosis, Malaise, SARS-CoV-2 test positive COVID-19, Infectious mononucleosis, Malaise, SARS-CoV-2 test positive
He has been sick every month since getting the shots. He said he received 4 vaccinations in the span... He has been sick every month since getting the shots. He said he received 4 vaccinations in the span of 6 months. He also said that he tested positive for Covid at least 5 times. When I asked if he has a PCP he said he'd talk to her about it but she would just yell at him. Said he's always been in good health prior and is a non-smoker, body builder. He said he keeps getting mono since the vaccine which is surprising at 52. More
2850363 60 M CA 07/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 U6455CB
Wrong product administered Wrong product administered
Patient order for Trumenba vaccine but was dispensed/administered Bexsero product. Patient order for Trumenba vaccine but was dispensed/administered Bexsero product.
2850364 71 F TX 07/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2HJ99
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Patient reports swelling and heat on area of arm surrounding injection site. Also some redness at in... Patient reports swelling and heat on area of arm surrounding injection site. Also some redness at injection site. I instructed patient to take Benadryl if she had it and contact her doctor for further follow up. More
2850365 18 F AL 07/18/2025 TDAP
 SANOFI PASTEUR
 U8274AA
Erythema, Pain in extremity, Peripheral swelling Erythema, Pain in extremity, Peripheral swelling
4 days after administration redness, pain and fluid filled bump noted to left arm 4 days after administration redness, pain and fluid filled bump noted to left arm
2850366 11 M GA 07/18/2025 MNQ
 SANOFI PASTEUR
 U6596AA
Injection site rash Injection site rash
Rash at site of injection Rash at site of injection
2850367 7 F ID 07/18/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9PT2F
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Infanrix was administered to a seven-year-old patient above max age requirements. As of today, 07/18... Infanrix was administered to a seven-year-old patient above max age requirements. As of today, 07/18/25, no known reactions or complications post-administration. More
2850368 16 F TN 07/18/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 cd44a
gb73y
Oropharyngeal discomfort, Peripheral swelling, Rash, Swelling face; Oropharyngea... Oropharyngeal discomfort, Peripheral swelling, Rash, Swelling face; Oropharyngeal discomfort, Peripheral swelling, Rash, Swelling face More
left arm localized swelling,rash on face with facial swelling, and throat tingling left arm localized swelling,rash on face with facial swelling, and throat tingling
2850369 1.25 F MI 07/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 537LH
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
15 month old given Menveo (1vial) immunization. Provider informed and no signs or symptoms occurred ... 15 month old given Menveo (1vial) immunization. Provider informed and no signs or symptoms occurred while in the office. More
2850370 33 F MN 07/18/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Injection site mass, Rash pruritic Injection site mass, Rash pruritic
Diffuse itchy rash, hard lump at injection site. Diffuse itchy rash, hard lump at injection site.
2850371 55 F RI 07/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Biopsy lymph gland, Biopsy skin, Blood test normal, Computerised tom... Arthralgia, Biopsy lymph gland, Biopsy skin, Blood test normal, Computerised tomogram abdomen; Injection site pruritus, Injection site rash, Lymphadenopathy, Multicentric reticulohistiocytosis, Rash More
itchiness at vaccine site, rash at vaccine site within 1 week, rash spread to back, shoulders, hands... itchiness at vaccine site, rash at vaccine site within 1 week, rash spread to back, shoulders, hands,face, scalp, nose, ears within 1 month, joint pain in hands and wrists within 1 month, enlarged lymph node in groin within 2 months. June 5: Went to PCP for advice on rash, abdomen CT on June 6, 2025 resulted in ER visit on June 6. General surgeon advised lymph node biopsy on June 10 (negative for lymphoma), PCP recommended visits to infectious disease and dermatologist. 2 punch biopsies performed on June 25 and pathology ultimately reports a finding of multicentric reticulohistiocytosis on July 1. Infectious disease tests for a variety of potential illnesses, bloodwork has been good from a variety of sources. PCP recommends visit to oncologist who orders more bloodwork which returns good. After MRH diagnosis, patient contacts rheumatology at hospital and consults with Dr who recommends testing to rule out any malignancies and a consult with a dermatologist in order to coordinate a treatment plan for MRH. Visit to Dr on July 18 for diagnosis confirmation and treatment plan More
2850373 51 F ND 07/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 FT95N
FT95N
Chills, Injection site pain, Injection site rash, Injection site swelling, Pain;... Chills, Injection site pain, Injection site rash, Injection site swelling, Pain; Pyrexia More
Rash, swelling, pain at sight of injection about 5" in diameter. Fever, chills, body aches. Rash, swelling, pain at sight of injection about 5" in diameter. Fever, chills, body aches.
2850374 55 F AL 07/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 35A77
35A77
Arthralgia, Blister, Blister rupture, Erythema, Pruritus; Rash Arthralgia, Blister, Blister rupture, Erythema, Pruritus; Rash
Patient presented with a rash to upper arm around 4 inches vertically and wrapping around half her a... Patient presented with a rash to upper arm around 4 inches vertically and wrapping around half her arm. She said it was sore the day after, then it got red, a few days later it turned into a rash with what she described as some blisters that popped open. It appeared to be sensitive raise bumps at the upper right quadrant of the arm. She said it still itched some, recommended hydrocortisone otc since there were no open wounds. No other issues were reported to me. She is still recovering from the rash. More
2850375 18 M AZ 07/18/2025 UNK
 UNKNOWN MANUFACTURER
 LX5014
Product preparation issue Product preparation issue
The vaccine has two a Lyophilized MenACWYC component and the other is the Men B component The MenB c... The vaccine has two a Lyophilized MenACWYC component and the other is the Men B component The MenB component was given and not the Lyophilized MenACWY Component was not given. thus, was given a partial dose. More
2850376 12 F MD 07/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 X357E
Rash erythematous Rash erythematous
Adverse effect: mild redness, no swelling, no pain, no itching, child able to move arms well and nor... Adverse effect: mild redness, no swelling, no pain, no itching, child able to move arms well and normally. Treatment: discussed concerns and findings and that rash needs to be observed. Keep area clean and practice hygiene, using running water and soap. May apply moisturizer frequently. Discussed apply cold compress and indications to meds (Cephalexin, Mupirocin, Triamcinolone Acetonide) If rash does not improve or resolve in a few days, or if rash changes in appearance, gets worse, symptoms seem uncontrollable, or other symptoms develop, to seek medical attention immediately. More
2850377 1 F CO 07/18/2025 HIBV
 SANOFI PASTEUR
 UK093AB
Extra dose administered, No adverse event Extra dose administered, No adverse event
administration of an extra dose of Hib vaccine on a patient, with no reported adverse event; Initial... administration of an extra dose of Hib vaccine on a patient, with no reported adverse event; Initial information received on 17-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administration an extra dose of HIB (PRP/T) Vaccine [ACT-HIB] 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 Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation. On 15-Jul-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK093AB, expiry date 30-Sep-2025; strength not reported) via intramuscular route in the left thigh for Immunization and extra dose was administered with no reported adverse event (extra dose administered) (latency same day). Reportedly, ACTHIB and Pentacel were administered on the same day. She wanted to know any safety information in relation to this incident Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850378 1 F CO 07/18/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK233AC
Extra dose administered, No adverse event Extra dose administered, No adverse event
inappropriate use due to extra dose of Hib administered with no reported adverse event; Initial info... inappropriate use due to extra dose of Hib administered with no reported adverse event; Initial information received on 17-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered to extra dose of Haemophilus Type B (Hib) Vaccine (ACT-HIB) 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 Haemophilus Type B (Hib) Vaccine (ACT-HIB) for Immunisation. On 15-Jul-2025, the patient received 0.5mL (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK233AC, expiry date 31-Aug-2026, strength standard, frequency once) via intramuscular route in the right thigh for Immunisation and inappropriate use due to extra dose of hib administered with no reported adverse event (extra dose administered) (latency same day). Reportedly, ACTHIB and Pentacel were administered on the same day. She wanted to knowany safety information in relation to this incident. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2850379 17 F 07/18/2025 FLUX
FLUX
FLUX
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 No batch number
No batch number
No batch number
No batch number
Abnormal behaviour, Behaviour disorder, CSF cell count normal, CSF protein norma... Abnormal behaviour, Behaviour disorder, CSF cell count normal, CSF protein normal, Condition aggravated; Drug screen positive, Encephalopathy, Human metapneumovirus test positive, Hyperphagia, Hypersomnia; Hypersomnia-bulimia syndrome, Intensive care, Magnetic resonance imaging head normal, Mental status changes, Metapneumovirus infection; Microbiology test normal, Pyrexia, Sleep study, Sleep study normal, Substance use More
Kleine-Levin Syndrome; Hyperphagia; Changes in behavior including self-gratifying behavior; Hypersom... Kleine-Levin Syndrome; Hyperphagia; Changes in behavior including self-gratifying behavior; Hypersomnolence; This literature report (initial receipt 8-Jul-2025) concerns an adolescent female patient with Kleine-Levin Syndrome (KLS). KLS is a rare disease characterized by relapsing-remitting episodes of severe hypersomnolence in association with cognitive, psychiatric, and behavioral disturbances. Described below is a case of KLS associated with viral infection, menstrual cycles, and vaccination. Patient presented to the pediatric sleep clinic for evaluation of recurrent episodic behavioral changes associated with prolonged sleep time. An initial episode of manipulative behavior associated with family stressors was concerning for underlying depression and she was prescribed escitalopram but continued to report ๏ฟฝdissociative' episodes. Approximately six months later, the patient developed a fever associated with acute changes in mentation and increased sleep duration of 18 hours per 24-hour period. The patient underwent evaluation in a pediatric ICU. Workup included MRI brain (negative), respiratory viral panel (positive for human metapneumovirus), urine drug screen (positive for cannabis), and a lumbar puncture with viral testing (normal protein, cell count, and microbiologic testing [note that CSF human metapneumovirus testing was not performed]). She was diagnosed with encephalopathy due to human metapneumovirus and was discharged home with persistent prolongation of sleep duration for the subsequent 8 days. Over the next 7 months, the patient experienced 3 more episodes of hyperphagia, hypersomnolence, and changes in behavior including self-gratifying behavior lasting for 7-12 days. Two of these episodes were associated with the onset of menstruation. The third episode occurred after influenza vaccination (trade name, manufacturer and lot number not reported - to be requested upon follow up). Note that between episodes, the patient was noted by her mother to return to baseline mentation and have a normalization of sleep duration within a given 24-hour period. Upon evaluation in the pediatric sleep clinic, the patient underwent polysomnography with mean sleep latency testing demonstrating absence of sleep disordered breathing and a mean sleep latency of 8 minutes 24 seconds with no observed sleep onset REM (Rapid Eye Movement) periods. Therapy with modafinil was trialed but she had recurrent episodes. The patient is currently on carbamazepine with an overall reduction in the frequency and duration of episodes. Authors' comments: Presented above is a rare case of KLS associated with various triggers including viral infection, menstrual cycle, and vaccination.; Reporter's Comments: Causality : Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related for event Kleine-Levin Syndrome with associated symptoms in line with reporter causality and plausible temporal association (third episode occurred after influenza vaccination). Of note, viral infection with human metapneumovirus, menstruation were triggers for other similar episodes. Adolescent age, family stressors, cannabis intake act as contributing factors which increase the likelihood of developing Kleine-Levin Syndrome. More
2850381 55 M MN 07/18/2025 PNC20
 PFIZER\WYETH
Injection site rash, Injection site swelling, Rash erythematous Injection site rash, Injection site swelling, Rash erythematous
Noted a red rash and swelling around the injection site that spread down about half way down the upp... Noted a red rash and swelling around the injection site that spread down about half way down the upper arm (patient had mark the furthest spreading of the rash with pen on the arm). Patient had told this to their neighbor who had a similar reaction that turned out to be an infection and advised patient see a doctor. Patient completed a tele-health visit who sent in a prescription for Doxycycline Hyclate 100 mg caps, taking 1 capsule twice daily for 5 days. Associated ICD10 code: L089. Rash and swelling reduced significantly at the time that I saw him on 07/18 (3 days of therapy completed). More
2850382 11 F FL 07/18/2025 TDAP
 SANOFI PASTEUR
 4CA04C1
Injection site erythema, Injection site induration, Injection site pain, Injecti... Injection site erythema, Injection site induration, Injection site pain, Injection site swelling More
Localized swelling , firmness, and redness to left arm measuring ~6 cm in diameter. Site tender. Ex... Localized swelling , firmness, and redness to left arm measuring ~6 cm in diameter. Site tender. Exam otherwise normal More
2850383 29 F PR 07/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4279
Exposure during pregnancy, Injection site erythema, Injection site inflammation,... Exposure during pregnancy, Injection site erythema, Injection site inflammation, Injection site warmth More
PATIENT AT 35 WEEKS OF PREGNANCY HAD INFLAMMATION, REDNESS AND HEAT SENSATION LOCALLY AT THE LEFT A... PATIENT AT 35 WEEKS OF PREGNANCY HAD INFLAMMATION, REDNESS AND HEAT SENSATION LOCALLY AT THE LEFT ARM WERE TDAP VACCINE WAS GIVEN ON 07/15/2025 . PATIENT ADVISED TO CONSULT PRESCRIBER TO SEE IF ANY FURTHER TREATMENT IN ADDITION TO COLD COMPRESS WAS NEEDED SINCE WE NOTICED HER ARM WHILE ADMINISTERING RSV VACCINE ON 07/18/2025 AT THE ALTERNATE RIGHT ARM More
2850384 4 F CA 07/18/2025 DTAPIPV
DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Anticonvulsant drug level, Blood electrolytes, Full blood count, Injection site ... Anticonvulsant drug level, Blood electrolytes, Full blood count, Injection site swelling, Seizure; Syncope More
She got her 4 year vaccines and 4 hours later she had a seizure. Since Monday she?s had 11-12 seizur... She got her 4 year vaccines and 4 hours later she had a seizure. Since Monday she?s had 11-12 seizures, injection site swelled beyond 5 inches reaching 8 across and 4 up and down wrapping towards her inner thigh. Contacted pediatrician 24 hours after vaccination for guidance as well as Wednesday 7/16. My daughter Thursday 7/17 was taken by ambulance for prolonged seizures not being controlled even with rescue doses and experienced syncope the entire week. More
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2850397 60 F MD 07/18/2025 PNC21
 MERCK & CO. INC.
 Y019158
Pain, Pyrexia, Swelling Pain, Pyrexia, Swelling
COMPLAINED OF PAIN, SWELLING, AND FEVER COMPLAINED OF PAIN, SWELLING, AND FEVER
2850398 25 M AZ 07/18/2025 HPV9
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z007940
9JT4S
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Administered Tdap to adult patient with previous Tdap given on 2/11/2025. No treatment necessary. P... Administered Tdap to adult patient with previous Tdap given on 2/11/2025. No treatment necessary. Pt is doing well. More
2850399 16 M AZ 07/18/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 LW8910
U8194AA
Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope; Dyskinesi... Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope; Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope More
Patient was given 2 vaccines and experienced a fainting episode. Immediately after fainting episode,... Patient was given 2 vaccines and experienced a fainting episode. Immediately after fainting episode, pt experienced brief involuntary muscle jerks/spasms. Patient regained consciousness and was evaluated by medical staff in office. Vitals signs normal post syncope episode. More
2850400 37 M 07/18/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4482
H4279
Injection site erythema, Injection site pain, Injection site pruritus; Injection... Injection site erythema, Injection site pain, Injection site pruritus; Injection site erythema, Injection site pain, Injection site pruritus More
Delayed local site reaction, itching, tender, erythema. Treated with antihistamine and oral abx for ... Delayed local site reaction, itching, tender, erythema. Treated with antihistamine and oral abx for possible cellulitis. More
2850401 18 F NV 07/18/2025 VARCEL
 MERCK & CO. INC.
Exposure during pregnancy Exposure during pregnancy
Patient received vaccine on 6/9/25 in liver transplant clinic as she is multiple years out from her... Patient received vaccine on 6/9/25 in liver transplant clinic as she is multiple years out from her transplant with negative varicella titer results and denied contraindications including pregnancy. Patient's OBGyn notified the liver transplant team of patient's pregnancy on 7/2/25 and estimated that patient was 12 weeks pregnant at time of vaccine administration. OB advised no additional live vaccines. Patient to be counseled about risk of congenital varicella syndrome and to be set up for early anatomy scan. More
2850402 4 M FL 07/18/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Rash; Rash Rash; Rash
Pink dots next day on Thursday 7/17. Today he has a rash that covers arms, face neck and legs. There... Pink dots next day on Thursday 7/17. Today he has a rash that covers arms, face neck and legs. There was no advice from the doctor that this might happened. After consulting with a doctor today, recommended to report due to this reaction being abnormal. More
2850403 80 F CA 07/18/2025 PNC20
 PFIZER\WYETH
 LN4929
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
Patient received pneumonia vaccine but had severe arm pain and could not lift objects. Did not resol... Patient received pneumonia vaccine but had severe arm pain and could not lift objects. Did not resolve in 2 days so patient went to urgent care and received a steroid prescription. Patient improving but when presented to pharmacy, pharmacist noted the vaccine was administered higher than recommended. More
2850404 55 M MO 07/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9L944
9L944
Axillary pain, Computerised tomogram, Limb mass, Pain in extremity, Shoulder inj... Axillary pain, Computerised tomogram, Limb mass, Pain in extremity, Shoulder injury related to vaccine administration; X-ray normal More
Pt reported having pain in arm approximately 3 days after injection. He had gone to PCP, who did an... Pt reported having pain in arm approximately 3 days after injection. He had gone to PCP, who did an X-ray and didn't find anything wrong, and so pt went home. A few days later pt had more severe pain under the armpit down to elbow, and noticed a knot under the arm. He ended up going to the ER to rule out a heart attack since it was his left arm, which concerned him. They did a CT scan and after some discussion with pt, in regards to type of pain, onset of pain, and fact that pt had recently had a vaccine, that it was likely a case of Sirva. Pt has extremely double jointed shoulders that he has been able to pull in and out of socket easily over the years. He has had surgery on the right should to help correct this, but not the left one. The ER doctor thinks that when pt relaxed his shoulder prior to injection, it may have shifted his joint down lower than what would be normal and expected, which could have resulted in IMZ going into the joint or bursa. Even though dose was given correctly in what appeared to be pt's deltoid area, due to his unusual anatomy, (which the doctor indicated he had a longer than normal structure in his shoulder, but the pt couldn't recall exactly what part), the injection did not end up just in his deltoid muscle. Pt left the ER after confirming his heart was ok. The pain subsided over the next 6 weeks or so, and is currently minimal. Pt did not seek any other treatment other than putting ice on it from home. Pt did not feel like this was due to negligence on the administration of the IMZ, but just a fluke incident due to his non-traditional shoulder anatomy. More
2850405 66 F CA 07/18/2025 MNQ
 SANOFI PASTEUR
 u8493aa
Headache, Metamorphopsia, Nausea, Vision blurred Headache, Metamorphopsia, Nausea, Vision blurred
distorted vision, blured vision, headache and nausea distorted vision, blured vision, headache and nausea
2850468 0.75 M MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was recei... No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance More
2850469 0.67 MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was recei... No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance More
2850470 1.25 M MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was recei... No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance as to whether or not the patient needs to be revaccinated. More
2850471 1 M MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was recei... No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance More
2850472 5 F MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LT7425
Expired product administered Expired product administered
Vaccine was given 2 days after the "10-week once received" expiration date. The local heal... Vaccine was given 2 days after the "10-week once received" expiration date. The local health department does not allow us to enter that date into computer, but rather the date on the box, which is much farther out. As a result, we have to manually check a little label handwritten on the vaccine box. If the actual date of expiration (10 week) was allowed to be put in the computer, errors like this could be avoided. More
2850473 2.75 F MI 07/18/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was recei... No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance More
2849994 F PA 07/17/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Autonomic nervous system imbalance, Decreased appetite, Dizziness, Fatigue, Hear... Autonomic nervous system imbalance, Decreased appetite, Dizziness, Fatigue, Heart rate increased; Hypersomnia, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive; Autonomic nervous system imbalance, Decreased appetite, Dizziness, Fatigue, Heart rate increased; Hypersomnia, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive; Autonomic nervous system imbalance, Decreased appetite, Dizziness, Fatigue, Heart rate increased; Hypersomnia, Loss of personal independence in daily activities, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive More
Postural Orthostatic Tachycardia Syndrome (POTS), increased heart rate, intense fatigue, dizziness, ... Postural Orthostatic Tachycardia Syndrome (POTS), increased heart rate, intense fatigue, dizziness, and lightheadedness, abnormally long hours of sleep, vasovagal syncope, decrease in appetite; debilitating autoimmune, autonomic, and neurological, injuries; debilitating autoimmune, autonomic, and neurological, injuries; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 16-year-old female patient (pt). The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date, the pt was vaccinated with the first, second and third doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cervical cancer. It was reported that on an unknown date (reported as within a few weeks of receiving the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience increased heart rate, intense fatigue, dizziness, and lightheadedness. On an unknown day (reported as following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt's fatigue increased and she experienced abnormally long hours of sleep. Furthermore, pt often felt like she was going to faint, she sought an expert opinion and evaluation after experiencing these abnormalities, such as a cardiologist and electrophysiologist. She was diagnosed with a vasovagal syncope. After undergoing a tilt table test, the pt was diagnosed with dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). Since those diagnoses, the pt had been prescribed propranolol to help control her heart rate. However, she continued to experience daily fatigue, dizziness, an increased heart rate, and a decrease in appetite. As the months progressed, so did pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: lightheadedness, chronic fatigue, dizziness, increased heart rate, and a decrease in appetite. As a result of his post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she had been unable to engage in activities that a normal young person would enjoy. She was obligated to make lifestyle accommodation for the rest of her life that were opposite to the active lifestyle she had before receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccines. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been diagnosed with various medical conditions, including but not limited to, dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS). Pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to dysautonomia and Postural Orthostatic Tachycardia Syndrome (POTS), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the company's alleged wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) manufacturing defects, pt suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. Also, she 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 his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, she 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 those losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events POTS, autoimmune disorder and neurological disorder, were considered disabling by the reporter. More
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2849995 58 F PA 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55TH4
Injection site swelling, Peripheral swelling, Pruritus, Wound Injection site swelling, Peripheral swelling, Pruritus, Wound
5 bumps appear on her left arm at injection site; one bump on her right foot; bumps itch and open wh... 5 bumps appear on her left arm at injection site; one bump on her right foot; bumps itch and open when scratched; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. On 30-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUL-2025, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: 5 bumps appear on her left arm at injection site), local swelling (Verbatim: one bump on her right foot) and pruritus (Verbatim: bumps itch and open when scratched). The outcome of the injection site swelling, local swelling and pruritus were not resolved. It was unknown if the reporter considered the injection site swelling, local swelling and pruritus to be related to Shingrix. It was unknown if the company considered the injection site swelling, local swelling and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 The patient mentioned she had normal reactions following the vaccination (not disclosed) for the first two days following vaccination. However, she then had 5 bumps appear on her left arm at injection site and one bump on her right foot. The patient mentioned that the bumps look like mosquito bites which itched, when scratched then they open up and the open bumps that hurt a little bit. The patient stated she did not take any medication and had no health concerns. More
2849996 07/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
I was sick with my first round too; This non-serious case was reported by a consumer via interactive... I was sick with my first round too; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I was sick with my first round too). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-JUL-2025 This case was reported by a consumer via interactive digital media. The patient was sick with his/her first round too. More
2850000 0.33 F CA 07/17/2025 DTAPIPVHIB
PNC15
RV5
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UK233AC
Y017360
2096663
Diarrhoea, Infant irritability, Vomiting projectile; Diarrhoea, Infant irritabil... Diarrhoea, Infant irritability, Vomiting projectile; Diarrhoea, Infant irritability, Vomiting projectile; Diarrhoea, Infant irritability, Vomiting projectile More
prolonged fussiness, projectile vomiting and diarrhea x 1 week after 4 mo vaccines prolonged fussiness, projectile vomiting and diarrhea x 1 week after 4 mo vaccines
2850007 37 F CA 07/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XP4
Underdose Underdose
Engerix-B pediatric dose was administered to an adult; Engerix-B pediatric dose was administered to ... Engerix-B pediatric dose was administered to an adult; Engerix-B pediatric dose was administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 37-year-old female patient who received HBV (Engerix B) (batch number 47XP4, expiry date 17-JUL-2027) for prophylaxis. On 10-JUL-2025, the patient received the 3rd dose of Engerix B. On 10-JUL-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose was administered to an adult) and underdose (Verbatim: Engerix-B pediatric dose was administered to an adult). The outcome of the adult use of a child product and underdose 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: 11-JUL-2025 The nurse reported that the administration of a pediatric dose of Engerix-B to an adult patient, which led to adult use of a child product and underdose It was third dose in the Engerix-B series and nurse called to get guidance on how to proceed. The reporter asked if an Engerix-B pediatric dose was administered to an adult, was that less effective and could it be combined with an adult dose The Vaccine Administration Facility is the same as Primary Reporter. More
2850010 07/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Burning sensation, Herpes zoster, Hypoaesthesia, Neck pain, Vaccination failure Burning sensation, Herpes zoster, Hypoaesthesia, Neck pain, Vaccination failure
suspected vaccination failure; seemed to think it was related to shingles; burning sensation; got th... suspected vaccination failure; seemed to think it was related to shingles; burning sensation; got this pain on the back of neck; neck felt numb to the touch; 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), shingles (Verbatim: seemed to think it was related to shingles), burning sensation (Verbatim: burning sensation), neck pain (Verbatim: got this pain on the back of neck) and neck numbness (Verbatim: neck felt numb to the touch). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure, shingles and neck numbness were not reported and the outcome of the burning sensation was resolved and the outcome of the neck pain was resolving. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, neck pain and neck numbness to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, burning sensation, neck pain and neck numbness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 This case was reported by a patient via interactive digital media. The patient decided to get the Shingles shot a year ago and a couple of weeks ago a got this pain on the back of neck as if he/she had slept the wrong way. Well, it got worse and then the back of neck felt numb to the touch and then periodically the patient got this burning sensation as if someone was using a hot poker on the back of neck and that would come and go just about every hour or so. The patient made an appointment to see doctor and he/she was told that it was not muscle related but had more to do with skin. The patient had no redness whatsoever, but the doctor seemed to think it was related to shingles. The patient was prescribed Valacyclovir to fight the virus and so far after taking this after a few days the pain has subsided and that burning sensation has gone away. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2850011 40 F IL 07/17/2025 DTAPIPV
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U7908AB
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no rep... inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; Initial information received on 14-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 40 years old female patient who was inadvertently administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] that and was intended to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jul-2025, the patient received 0.5 ml of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Suspension for injection with standard strength (expiry date- 03-OCT-2025 and lot U7908AB) once via intramuscular route in the right deltoid for Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot not reported) for prophylactic vaccination (Immunization) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency- same day). Reportedly, the caller was not aware of any treatment post administration. List concomitant: no other immunizations. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
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