🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2852037 11 M KY 07/31/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8375AA
LX494
Headache, Injection site swelling, Pain in extremity, Rash; Headache, Injection ... Headache, Injection site swelling, Pain in extremity, Rash; Headache, Injection site swelling, Pain in extremity, Rash More
GM called HD on 7/31/25 to report reaction. Stated child c/o headache morning of 7/29/25 and was gi... GM called HD on 7/31/25 to report reaction. Stated child c/o headache morning of 7/29/25 and was given Tylenol. Stated on 7/30/25 child c/o sore left arm- had large red, swollen area at injection site on left arm and c/o rash on both arms, legs, trunk, and face. Stated she called PMD and was instructed to give child Benadryl and Hydro-cortisone cream. Stated rash areas are better today and left arm is less swollen. Advised GM to notify PMD if child gets worse and to notify HD if child gets worse. States she thinks child is doing better now. More
2852038 5 F MI 07/31/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult dose administered instead of pediatric dose. Adult dose administered instead of pediatric dose.
2852039 5 F 07/31/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult dose administered instead of pediatric dose. Adult dose administered instead of pediatric dose.
2852040 17 F LA 07/31/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 B4J4B
Erythema, Induration, Swelling Erythema, Induration, Swelling
initial reaction redness and swelling followed by 1 cm knot. initial reaction redness and swelling followed by 1 cm knot.
2852041 41 F VA 07/31/2025 COVID19
 MODERNA
 013F21A
Feeling abnormal, Migraine, Pain, Vomiting Feeling abnormal, Migraine, Pain, Vomiting
I received my Covid-19 booster shot and that day got a migraine. I've had constant migraines ev... I received my Covid-19 booster shot and that day got a migraine. I've had constant migraines ever since. It's awful and no way to live. I see a neurologist and have tried many interventions but nothing truly works. I have to take migraine medicine constantly and even that doesn't always work. I'm in pain all the time and generally feel awful. More
✓
2852042 41 F FL 07/31/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 eb499
eb499
Chills, Impaired work ability, Injection site pain, Muscle spasms, Pain in extre... Chills, Impaired work ability, Injection site pain, Muscle spasms, Pain in extremity; Product administered at inappropriate site, Sleep disorder More
On 7/17/2025 I went to employee health clinic for my N95 Mask fitting and TDAP vaccine. I felt that ... On 7/17/2025 I went to employee health clinic for my N95 Mask fitting and TDAP vaccine. I felt that the nurse gave the injection too high in my left deltoid. Initially, I felt left deltoid pain. On 7/18/25 my left deltoid & arm pain continued with chills. The pain continued on 7/19/25 and 7/20/2025. On 7/21/25 I woke up in excruciating pain in left arm left upper back and I couldn't move my left arm. I had to call off of work due to the left arm and upper back pain and inability to move left arm on 7/21/25. As a result, on 7/21/25 I completed a televisit with a provider that recommended rest, warm/cool compress and over the counter ibuprofen. The pain got worse overnight so on 7/22/25 I went to an urgent care and saw a provider there. I was diagnosed with left arm left upper back spasm and I was prescribed, rest, warm/cool compress, extra strength Ibuprofen and baclofen. The pain continued so I went to a message therapist and chiropractic specialist. The pain and decrease in mobility continued, I went to my primary care on 7/30/2025 and was diagnosed with frozen shoulder, was prescribed mobic for pain, an left upper shoulder US and physical therapy order was placed. Since the TDAP vaccine administration, I have been in continuous left deltoid pain, left arm pain with numbness and tingling, left upper back pain. I have decreased mobility of left arm due to pain. I can't sleep at night due to pain. More
2852043 16 M CT 07/31/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Headache, Injection site erythema, Injection site pruritus, Injection site swell... Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
Itchy, red, swelling, warm to touch at site of injection measuring 11.5cm x 13cm. Started yesterday ... Itchy, red, swelling, warm to touch at site of injection measuring 11.5cm x 13cm. Started yesterday (7/30/25). Mom gave Ibuprofen & "Paracetamol" as pt also had a headache yesterday. More
2852044 11 F NC 07/31/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8256AB
U8122AA
Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm Erythema, Pain, Pruritus, Skin warm; Erythema, Pain, Pruritus, Skin warm
5 INCHBY 2.5 INCH RED AREA, HOT TO TOUCH, SORE AND ITCHING 5 INCHBY 2.5 INCH RED AREA, HOT TO TOUCH, SORE AND ITCHING
2852045 70 F NY 07/31/2025 PNC20
 PFIZER\WYETH
 MA2519
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received prevnar 20 in 3/25/2025. We accidently given her extra dose of prevnar 20 today. N... patient received prevnar 20 in 3/25/2025. We accidently given her extra dose of prevnar 20 today. No adverse reaction at this time. More
2852046 4 F CA 07/31/2025 DTAP
IPV
MMR
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 3CA55C1
Y1A201M
Y008592
Z004245
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
On 7/16/25. The patient presented for a routine 4-year-old well-child examination accompanied by his... On 7/16/25. The patient presented for a routine 4-year-old well-child examination accompanied by his father seen by me. Per the father s report, the child is currently healthy, and there are no parental concerns at this time. Following the physical examination, I informed the father that the patient is due for the recommended 4-year-old immunizations, which include: DTaP (Diphtheria, Tetanus, and Pertussis), Varicella, MMR (Measles, Mumps, and Rubella), and IPV (Inactivated Poliovirus Vaccine). The father did not bring the patient's immunization records to the visit. I clarified with the father regarding the child s vaccination history, and the father stated that the patient has not received any vaccines since turning four years old. A thorough review of the patient's electronic health record (EHR) confirmed that no DTaP, Varicella, MMR, or IPV vaccines had been administered after the patient s fourth birthday. I provided education regarding the benefits and potential side effects of these vaccines using the appropriate Vaccine Information Statements (VIS). I told the father to take photographs of each VIS for his records in the room before gave vaccines. I also instructed the medical assistant (MA) to verify the vaccination status through the Immunization Registry, which similarly showed no record of the aforementioned vaccines being administered post age four. Based on this information, the I placed orders for the age-appropriate vaccines. The father consented to immunization and assisted the MA in holding the patient during vaccine administration. The patient received DTaP, Varicella, MMR, and IPV vaccines. No immediate side effects or adverse reactions were observed following immunization. On 07/30/2025, the patient's father came to the office and reported that the patient received DTaP, Varicella, MMR, and IPV vaccines on 05/06/2025 from another healthcare provider. He stated that he forgot to inform us during the previous visit on 07/16/2025. No side effects or adverse reactions have been observed to date. More
2852047 9 F MI 07/31/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T5727
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient presented in clinic for Vaccines. Gave TDaP, Polio, Hep B, VAR & Hep A. It was found in ... Patient presented in clinic for Vaccines. Gave TDaP, Polio, Hep B, VAR & Hep A. It was found in records from visit 12/04/2024 that patient had already had a dose of Hep A, making today's dose incorrect time interval from dose 1 to dose 2 less than 6 months. There were no adverse effects related to this vaccine, no tests or labs needed. Parent & patient ad to return on or after 07/28/2025 to get dose 2 at correct interval to correct error. More
2852048 69 M FL 07/31/2025 FLU3
 SANOFI PASTEUR
 U8764BB
Asthenia, Chills, Lacrimation increased, Lethargy, Ocular discomfort Asthenia, Chills, Lacrimation increased, Lethargy, Ocular discomfort
Patient reported having chills, body aches and watery eyes around 1:30 AM on 7/31/2025. Patient desc... Patient reported having chills, body aches and watery eyes around 1:30 AM on 7/31/2025. Patient described the watery eyes felt more like sand in his eyes which required him to wipe often. Patient took ibuprofen and melatonin. His symptoms subsided around 4:30 AM. However, he reported feeling weak and lethargic. More
2852049 36 M IL 07/31/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946889
Extra dose administered, No adverse event Extra dose administered, No adverse event
Per RN on 7/29/2025 - Patient presents for 3rd dose of Hep B vaccine. Prepared and administered with... Per RN on 7/29/2025 - Patient presents for 3rd dose of Hep B vaccine. Prepared and administered without adverse reaction. Upon review of chart and medication instruction insert, patients are supposed to only receive 2 doses of Heplisav-B vaccine. Incident report filed, patient and provider informed. More
2852050 15 M LA 07/31/2025 HEPA
MMR
TDAP
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.



Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
The patient enrolled in school and was sent to establish care and receive vaccines. The school nurs... The patient enrolled in school and was sent to establish care and receive vaccines. The school nurse entered the vaccine record provided by the parents into system and sent the patient with a letter indicating what vaccines were needed. When we looked into the system the vaccines forecasting matched what the school nurse indicated were needed. We received a call from the parents stating that the child had received multiple vaccines that were not needed. Upon closer review of the immunization record provided from the state, (we were not familiar with the format of what was given to us), we saw that the 4 vaccines above had already been received. The patient is not having any complications at this time. More
2852051 41 F MI 07/31/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 z27pb
Rash Rash
Rash on arm (biceps) that radiated to the back. Rash on arm (biceps) that radiated to the back.
2852053 81 F FL 07/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Erythema, Joint swelling, Skin warm Erythema, Joint swelling, Skin warm
Patient describes swollen red arm, hot to the touch and reported this on 7/31 about 2-3 weeks after ... Patient describes swollen red arm, hot to the touch and reported this on 7/31 about 2-3 weeks after the vaccination. Informed patient to contact their provider for treatment. More
2852054 65 F IL 07/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Erythema, Skin reaction Erythema, Skin reaction
Pt got redness and a localized dermal reaction that started the day after the vaccine was giving. N... Pt got redness and a localized dermal reaction that started the day after the vaccine was giving. No discomfort just a red area. More
2852055 68 M IL 07/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2hj99
Headache, Influenza like illness, Pyrexia Headache, Influenza like illness, Pyrexia
fever one hour after administration - headache and flu-like symptoms for 3 days after administration fever one hour after administration - headache and flu-like symptoms for 3 days after administration
2852056 12 F NY 07/31/2025 MENB
 PFIZER\WYETH
 HD2729
Chills, Erythema, Injection site rash, Peripheral swelling, Pyrexia Chills, Erythema, Injection site rash, Peripheral swelling, Pyrexia
Arm is red, swollen, fever, chills. Rash developed below injection site following day. Arm is red, swollen, fever, chills. Rash developed below injection site following day.
2852057 6 M VA 07/31/2025 COVID19
 PFIZER\BIONTECH
 MD3414
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient did NOT have an adverse reaction. Patient was given the adult dose of Covid-19 (Comirnaty) ... Patient did NOT have an adverse reaction. Patient was given the adult dose of Covid-19 (Comirnaty) by mistake instead of the Pediatric dose of pfizer (5y-11y) that was ordered. More
2852058 12 F WA 07/31/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Z002903
U8558BA
3RE73
Dizziness, Unresponsive to stimuli; Dizziness, Unresponsive to stimuli; Dizzines... Dizziness, Unresponsive to stimuli; Dizziness, Unresponsive to stimuli; Dizziness, Unresponsive to stimuli More
Roughly 30-45 seconds after receiving HPV into Right deltoid @ 0811 patient stated "I feel like... Roughly 30-45 seconds after receiving HPV into Right deltoid @ 0811 patient stated "I feel like I'm going to pass out". MA informed patient to lean back on bench towards parent, shortly after patient became unresponsive, patient body became tense and ridged. Patient remained on bench and was being held by parent during this time. MA got up and stepped out of room and called DO to assist. As provider entered the room patient became alert and responsive. Provider requested medical assistant get apple juice and crackers. Provider evaluated patient and requested patient wait 10-15 minutes before leaving and to continue to eat and drink apple juice and crackers. MA informed parent that RN was to speak with patient prior to leaving facility. per RN clinical note: "Patient states that she is feeling fine after drinking juice and eating crackers. BP rechecked:110/50." More
2852059 4 F CO 07/31/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U7838AA
Y018161
Expired product administered; Expired product administered Expired product administered; Expired product administered
expired vaccine given expired vaccine given
2852060 1 M MO 07/31/2025 MMR
 MERCK & CO. INC.
 Y020518
Pallor, Rash, Rash erythematous Pallor, Rash, Rash erythematous
Red to pink, flat, blanching rash to scalp, upper back/shoulders, and few small spots to extremities... Red to pink, flat, blanching rash to scalp, upper back/shoulders, and few small spots to extremities occurring 7 days after vaccination, rash fading to scalp on day 8. Family attempted use of Zyrtec, oral benadryl, and hydrocortisone cream with no improvement to rash. More
2852061 12 M NM 07/31/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8361AA
37R35
Dizziness, Hyperhidrosis, Pallor; Dizziness, Hyperhidrosis, Pallor Dizziness, Hyperhidrosis, Pallor; Dizziness, Hyperhidrosis, Pallor
Pt received the Tdap and Meningococcal conjugate vaccines. Approximately 4 minutes alter the patient... Pt received the Tdap and Meningococcal conjugate vaccines. Approximately 4 minutes alter the patient states that he was feeling lightheaded patient needed to sit down. Once the pt was sitting a set of vitals was taken and his BP was 59/28, HR 60, O2 was 100% on room air. Pt was alert the entire time and there was no syncope but he was pale and diaphoretic. Once the provider showed up a dose of adult epi was given and the pt's vitals improved. Pt was transported to ER for monitoring. More
2852062 13 M TN 07/31/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 X022737
X022737
U7950AA
U7950AA
KR75K
KR75K
Disorientation, Erythema, Fall, Head injury, Pallor; Syncope; Disorientation, Er... Disorientation, Erythema, Fall, Head injury, Pallor; Syncope; Disorientation, Erythema, Fall, Head injury, Pallor; Syncope; Disorientation, Erythema, Fall, Head injury, Pallor; Syncope More
10:50 code blue called to lobby, myself and RN responded, crash cart and AED on site, 911 called by ... 10:50 code blue called to lobby, myself and RN responded, crash cart and AED on site, 911 called by PHOA. Mom and PHOA reported that patient was walking to check out area and fell to chair then floor. Initial VS and exam: 108/78, HR 96, pulse ox 98%, pale, disoriented, HR RRR, lungs CTA, PERRLA, slight erythema to left side of neck and back of head Mom reports NKDA, only medication is singulair, no known medical hx, family hx juvenile myoclonic epilepsy. Patient reports had not eaten today. Today's event happened about 2 minutes after vaccinations were given. Has had one prior syncopal episode after tooth was pulled with much blood. Suspect vasovagal syncope; however pt hit head and will await EMS for further evaluation. VS recheck: 100/72, HR 77, pulso ox 97%, patient alert and oriented. Patient provided with crackers and water/mountain dew. EMS arrived at 11:26 and performed EKG and further examination and agreed with probable vasovagal syncope. Mom declined EMS transport to ED at this time. Counseled to immediately call 911 if reoccurence or any other symptoms today. Take it easy, rest. Eat a meal. During vaccinations/blood draws in future recommend lying flat during procedure and for 15 min after. More
2852063 12 M CO 07/31/2025 PNC15
 MERCK & CO. INC.
 Z008265
No adverse event, Wrong product administered No adverse event, Wrong product administered
VACCINE ADMINISTRATION ERROR. VAXNEUVANCE GIVEN INSTEAD OF HPV ORDERED BY PHYSICIAN. NO ADVERSE RE... VACCINE ADMINISTRATION ERROR. VAXNEUVANCE GIVEN INSTEAD OF HPV ORDERED BY PHYSICIAN. NO ADVERSE REACTION REPORTED BY PATIENT/PARENT. More
2852064 75 F CA 07/31/2025 FLU3
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 ut8419da
425cr
Dizziness, Pyrexia, Urinary tract infection; Dizziness, Pyrexia, Urinary tract i... Dizziness, Pyrexia, Urinary tract infection; Dizziness, Pyrexia, Urinary tract infection More
Pt experienced high fever, dizziness, UTI. Was hospitalized. Recovered. Pt experienced high fever, dizziness, UTI. Was hospitalized. Recovered.
✓
2852065 64 M CA 07/31/2025 PNC20
 PFIZER\WYETH
Tinnitus Tinnitus
Strong tinnitus - multiple tones. My brother received the vaccine at the same time and also has stro... Strong tinnitus - multiple tones. My brother received the vaccine at the same time and also has strong tinnitus. More
2852066 63 M CA 07/31/2025 PNC20
 PFIZER\WYETH
Tinnitus Tinnitus
Strong tinnitus - multiple tones. Brother received vaccine at same time and also developed tinnitus. Strong tinnitus - multiple tones. Brother received vaccine at same time and also developed tinnitus.
2852067 0.33 M VA 07/31/2025 VARCEL
 MERCK & CO. INC.
 z005456
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
As of now no adverse events m As of now no adverse events m
2852068 60 M KS 07/31/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 ZJ9FF
Expired product administered Expired product administered
Patient was given RSV vaccine while documenting realized that one of the vials was expired 7/01/25. ... Patient was given RSV vaccine while documenting realized that one of the vials was expired 7/01/25. Only exp date on vial was inspected. Upon administration discovered other vial expired. 16 month difference between two vial expiration dates. More
2852069 57 F WA 07/31/2025 HEP
PNC20
TDAP
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 946063
lx4484
u8503aa
23ah3
Injection site reaction, Rash erythematous, Rash pruritic; Injection site reacti... Injection site reaction, Rash erythematous, Rash pruritic; Injection site reaction, Rash erythematous, Rash pruritic; Injection site reaction, Rash erythematous, Rash pruritic; Injection site reaction, Rash erythematous, Rash pruritic More
pt states they have a slightly itchy red rash that has developed on their arm near the vaccination s... pt states they have a slightly itchy red rash that has developed on their arm near the vaccination site that extends in a line towards their armpit.. pt was advised to try benadryl and hydrocortisone cream and to follow up with provider if condition worsens. More
2852070 29 F KS 07/31/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4BX39
Wrong product administered Wrong product administered
HPV vaccine intended. Hep B vaccine administered HPV vaccine intended. Hep B vaccine administered
2852071 1 M KS 07/31/2025 VARCEL
 MERCK & CO. INC.
 X017490
Expired product administered Expired product administered
Expired medication administered. Expired medication administered.
2852072 29 F AK 07/31/2025 CHIK
 BAVARIAN NORDIC
 FDP00691
Lymphadenopathy Lymphadenopathy
Patient's Lymph nodes were swollen massively for days following administration. Clear to see on... Patient's Lymph nodes were swollen massively for days following administration. Clear to see on neck and right side of body without even having to palpate. (yes it was the right side and the injection was on the left). Nodes resumed normal size after many days More
2852073 21 F TX 07/31/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
Dizziness, Exposure during pregnancy, Seizure, Syncope Dizziness, Exposure during pregnancy, Seizure, Syncope
Patient is currently pregnant 28 weeks 3 days, EDD 10/20/2025. Patient had 2 previous pregnancies 20... Patient is currently pregnant 28 weeks 3 days, EDD 10/20/2025. Patient had 2 previous pregnancies 2019 and 2024. Patient received Tdap vaccine and 5 minutes later became dizzy/lightheaded and when walking down the hall with a staff member began to faint and seized. Patient was lowered to the floor and protected, physician called to come provide aid, patient came out of seizure and he administered a snack and apple juice. Physician ordered to call EMS, upon arrival patient was evaluated and declined EMS transport to labor and delivery at the hospital. Patients' significant other took patient to the hospital instead for further evaluation. More
✓
2852106 F IL 07/31/2025 RVX
 UNKNOWN MANUFACTURER
Immediate post-injection reaction, Underdose, Vomiting Immediate post-injection reaction, Underdose, Vomiting
Nurse calling to request information on redosing a patient who received ROTATEQ and vomited/regurgit... Nurse calling to request information on redosing a patient who received ROTATEQ and vomited/regurgitated the vaccine immediately after it was administered. She states the patient is a 6 month old female. Nurse did not provide additional information r; received ROTATEQ and vomited/regurgitated the vaccine immediately after it was administered; This spontaneous report was received from a nurse and refers to a 6-months-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Jul-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), dose number 1, administered by Oral route (lot # and expiration date were not reported) as prophylaxis. On the same date (09-Jul-2025), the patient vomited/regurgitated the vaccine immediately after it was administered (accidental under dose). The reporting nurse was calling to request information on redosing a patient who received Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and did not provide additional information. At the reporting time, the outcome of the patient vomited/regurgitated was unknown. The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided. Lot # is being requested and will be submitted if received. More
2852107 11 F MS 07/31/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 K010574
Inappropriate schedule of product administration, Interchange of vaccine product... Inappropriate schedule of product administration, Interchange of vaccine products, Smear cervix abnormal; Inappropriate schedule of product administration, Interchange of vaccine products, Smear cervix abnormal More
patient's Papsmear test done in July 2025 showed that she has HPV.; She received GARDASIL-9 as ... patient's Papsmear test done in July 2025 showed that she has HPV.; She received GARDASIL-9 as her second dose on 07-Sep-2016 about 13 months after the first dose.; She received GARDASIL-9 as her second dose on 07-Sep-2016 about 13 months after the first dose.; This spontaneous report was received from a nurse and refers to a 21-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Jul-2015, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) injection (lot# K010574, expiration date not reported, but upon internal validation established as 08-Apr-2017; strength, dose and anatomical site not provided) administered by intramuscular route for prophylaxis. On 07-Sep-2016, the patient was vaccinated with the second dose of HPV vaccine, as Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) injection administered by intramuscular route (strength, dose, anatomical site, lot # and expiration date were not reported) for prophylaxis (Interchange of vaccine products and Inappropriate schedule of product administration). On an unknown date in July 2025, the patient had Papsmear test done and it showed that she has HPV. The patient sought medical attention due to the event, and no treatment was given. The patient is going to get a repeat Papsmear test in 1 year. At the reporting time, the outcome of HPV infection was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not applicable. The causal relationship between the event of HPV infection and the suspect vaccines was not provided. Lot# for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) is being requested and will be submitted if received. More
2852108 F MS 07/31/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Interchange of vaccine products, Papilloma viral infection; Interchange of vacci... Interchange of vaccine products, Papilloma viral infection; Interchange of vaccine products, Papilloma viral infection More
the patient was diagnosed with HPV; HCP calling regarding an inquiry for GARDASIL-9 dosing schedule ... the patient was diagnosed with HPV; HCP calling regarding an inquiry for GARDASIL-9 dosing schedule and mentioned that she previously had a patient who received one dose of GARDASIL 4 valent vaccine and a dose of GARDASIL-9 as the second dose of the series; This spontaneous report was received from a Nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Injection, dose number 1. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered as the second dose of the series (Interchange of vaccine products); both vaccines were administered as prophylaxis (dose, formulation, route of administration, anatomical site of injection, lot number and expiration date were not provided for any of the vaccines). On an unknown date, the patient was diagnosed with Human papilloma virus (HPV) (Papilloma viral infection), but the reporter was not sure whether the patient had the HPV even before she had the vaccine. Caller stated this happened a long time ago and she does not recall any further details. No further information was available. At the time of the report, the outcome of the event of Papilloma viral infection was not reported. The causal relationship between the suspect vaccines and the event of Papilloma viral infection was not provided. More
2852109 F 07/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Scleritis Scleritis
Scleritis; This serious case was reported by a physician via sales rep and described the occurrence ... Scleritis; This serious case was reported by a physician via sales rep and described the occurrence of scleritis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included rosuvastatin. On 20-JUN-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, less than a day after receiving Shingrix, the patient experienced scleritis (Verbatim: Scleritis) (serious criteria GSK medically significant and other: Serious as per reporter). In JUL-2025, the outcome of the scleritis was resolved. The reporter considered the scleritis to be related to Shingrix. The company considered the scleritis to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 23-JUL-2025 The physician reported that the patient received Shingrix and experienced scleritis; Sender's Comments: A case of Scleritis, less than a day after receiving Shingrix, in a 66-year-old female 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
2852110 70 F VA 07/31/2025 RSV
RSV
RSV
RSV
RSV
RSV
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EA4RB
EA4RB
EA4RB
EA4RB
EA4RB
EA4RB
9Y92F
9Y92F
9Y92F
9Y92F
9Y92F
9Y92F
Alpha-1 anti-trypsin normal, Asthma, Bronchial secretion retention, Chest X-ray ... Alpha-1 anti-trypsin normal, Asthma, Bronchial secretion retention, Chest X-ray abnormal, Computerised tomogram thorax abnormal; Condition aggravated, Decreased activity, Fatigue, Full blood count, Influenza like illness; Insomnia, Knee operation, Lung infiltration, Lung opacity, Nausea; Night sweats, Paranasal sinus discomfort, Pneumonia, Productive cough, Pulmonary function challenge test abnormal; Pulmonary function test abnormal, Pulmonary mass, Pyrexia, Radioallergosorbent test negative, Rhinorrhoea; Sinusitis, Wheezing; Alpha-1 anti-trypsin normal, Asthma, Bronchial secretion retention, Chest X-ray abnormal, Computerised tomogram thorax abnormal; Condition aggravated, Decreased activity, Fatigue, Full blood count, Influenza like illness; Insomnia, Knee operation, Lung infiltration, Lung opacity, Nausea; Night sweats, Paranasal sinus discomfort, Pneumonia, Productive cough, Pulmonary function challenge test abnormal; Pulmonary function test abnormal, Pulmonary mass, Pyrexia, Radioallergosorbent test negative, Rhinorrhoea; Sinusitis, Wheezing More
Right knee surgery; Orthopedic Surgery; Nasal discharge; insomnia; nausea; sinus infection; bilatera... Right knee surgery; Orthopedic Surgery; Nasal discharge; insomnia; nausea; sinus infection; bilateral pneumonia; This serious case was reported by a consumer and described the occurrence of bilateral pneumonia in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 9Y92F) for prophylaxis, mepolizumab (Nucala) solution for injection in pre-filled syringe (batch number UX7C, expiry date 31-JAN-2027) for asthma and budesonide for product used for unknown indication. The patient's past medical history included cataract operation, cataract operation, appendectomy and knee injury (orthopedic surgery on 23-JUN-2023). Previously administered products included Pregabalin with an associated reaction of no adverse event, Pregabalin with an associated reaction of no adverse event (BID), ProAir with an associated reaction of no adverse event and Singulair with an associated reaction of no adverse event. Concurrent medical conditions included chronic cough (for several years.), alcohol use (occasional), asthma (ER visit for asthma), bronchitis, sinusitis, seasonal allergic rhinitis, drug allergy (Budosenide), grass allergy, pollen allergy, food allergy, multiple allergies and hay fever. Additional patient notes included Patient had animal exposure, patient was a nonsmoker and patient never used electronic cigarettes.. Concomitant products included fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy Ellipta), fexofenadine hydrochloride (Allegra Allergy), calcium, magnesium, colecalciferol (Vitamin D3), menaquinone (Vitamin K2), levocetirizine dihydrochloride (Xyzal), azithromycin, salbutamol sulfate (Albuterol Sulfate Hfa), amoxicillin, clavulanate potassium (Potassium Clavulanate), benzonatate, doxycycline hyclate, erythromycin, prednisone, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), INFLUENZA VACCINE, INFLUENZA VACCINE and tiotropium bromide (Spiriva). On 14-OCT-2023, the patient received Arexvy. On 18-APR-2024, the patient received Shingrix. On 05-MAY-2021, the patient started Nucala (subcutaneous) 100 mg every 4 weeks. On an unknown date, the patient started budesonide twice a day. On 16-JAN-2025, 460 days after receiving Arexvy, 273 days after receiving Shingrix, 1352 days after starting Nucala and an unknown time after starting budesonide, the patient experienced bilateral pneumonia (Verbatim: bilateral pneumonia) (serious criteria GSK medically significant). On 12-JUN-2025, the patient experienced sinus infection (Verbatim: sinus infection). On an unknown date, the patient experienced knee operation (Verbatim: Right knee surgery) (serious criteria clinically significant/intervention required), orthopedic procedure (Verbatim: Orthopedic Surgery) (serious criteria clinically significant/intervention required), nasal discharge (Verbatim: Nasal discharge), insomnia (Verbatim: insomnia) and nausea (Verbatim: nausea). The patient was treated with levofloxacin (Levaquin) and methylprednisolone (Medrol). Nucala was continued with no change. Budesonide was discontinued. The outcome of the bilateral pneumonia was resolving and the outcome of the knee operation, orthopedic procedure, nasal discharge, sinus infection, insomnia and nausea were not reported. It was unknown if the reporter considered the bilateral pneumonia, knee operation, orthopedic procedure, nasal discharge, sinus infection, insomnia and nausea to be related to Arexvy, Shingrix, Nucala and Nucala Pre-Filled Syringe Device. It was unknown if the reporter considered the bilateral pneumonia, knee operation, orthopedic procedure, nasal discharge, sinus infection and insomnia to be related to budesonide. The reporter considered the nausea to be related to budesonide. The company considered the bilateral pneumonia, knee operation and orthopedic procedure to be unrelated to Arexvy, Shingrix, Nucala and Nucala Pre-Filled Syringe Device. The company considered the nausea to be related to budesonide. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK Receipt date: 19-MAY-2025 This information was received from consumer.. Patient had pneumonia but feeling much better. Follow up received on 09-JUL-2025 The patient had cough. Severity was she was able to sleep during episode Onset/Timing was greater than equal to 2 days per week, Status was improving. She had a history of ER visit for asthma. On 16 Jan 2025, she was here after recent visit to ER on 08 Jan 2025. She had hx of fevers, chills, headache, body aches, productive cough, chest pain while coughing, decreased appetite, and generalized fatigue x 6 day. She was diagnosed with bilateral pneumonia in the ER and prescribed Levaquin. She was doing better. On 27 Jan 2025, she presented with night sweats, cough with clear sputum, low grade fever. On 20 Feb 2025, she presented for Nucala inj. She was feeling better after antibiotics. She still had residual cough. On 20 Mar 2025, she presented for Nucala inj. She was slowly getting better but still having coughing fits twice a day. On 17 Apr 2025, she presented for Nucala inj. She had residual cough otherwise doing okay. On 15 May 2025, she presented for Nucala. She had no complaints and doing well. On 12 Jun 2025, she presented for Nucala inj. She had sinus infection otherwise doing okay. She reported diminished activity and fatigue but reported no excess weight gain, no excess weight loss, no loss of appetite, no fever, and not fussy. She reports nasal discharge but reports no ear pain, no ear discharge, no hearing loss, no sinus pressure, no drooling, no swelling, no congestion, no sore throat, no hoarseness, no mouth lesions, no foul smelling breath, sneezing, no runny nose, and not constantly clearing the throat. She reported coughing up sputum and clear sputum but repots Wheezing, no chest tighthess, no pain with respiration, normal breathing sounds, normal respiration rate, and no difficulty breathing. She reports sinus pressure but reports no itching. She reports no eye pain, no blurry vision, no eye redness, no eye itchiness, no eye swelling, and no eye discharge. She reports no chest pain, no rapid heart rate, no cyanosis, and no pallor. She reports no difficulty swallowing, no abdominal pain, no nausea, no vomiting, no diarrhea, no constipation, no blood in stools, no mucus in stools, and no regurgitation, water brash. She reports no discharge, no blood in urine, no pain during urination, no increased frequency of urination, and no voiding urgency. She reports no soft tissue swelling, no joint swelling, no limited motion, no previous injuries, and no myalgia. She reports no pain, no itchiness, no dry skin, no skin flaking, no skin redness, no rash, no diaper rash, no hives, no skin lesions, no swelling, no bruising, no insect bites, and no acanthosis nigricans. She reported no numbness, no weakness, no tingling, no burning, no shooting pain, no headache, no diziness, and no loss of consciousness. She reported no increased thirst and no temperature intolerance. She reports no depression, no sleep disturbances, feeling safe in relationship, and no alcohol abuse. She reported no swollen glands. On 09 Jan 2025, she went to ER for flu like symptoms and she was found to have bilateral pneumonia. She was discharged with levaquin. She was having increasing cough and unable sleep. She continued with Levaquin. She made aware of side effects such as tendinitis, Gl issues. She started medrol pak, continued with trelegy, add budesonide BID and alb nebs prn. She was slowly improving on levaquin. Stopped medrol due to insomnia. Using nebs. She was doing better initially with Levaquin initialby but now much more symptomatic. She had chest Xray on 27Jan 2025, Improving pneumonia. She was feeling better. She had chest Xray on 26 feb 2025, Improving LUL pulm infiltrate. She had asthma. Nucala inj given. She was doing okay with current regimen and denies any symptoms. Stop Breo/Spiriva and try Breztri. It was explained to her that Breztri was FDA approved for COPD. She was okay with trying this. It was advised the patient to rinse mouth after each use of innaler. It was advised to her the risks of oral thrush if she fails so. Talked to her regarding the side effects of the inhaler. She was agreeable to using it. Continued with Nucala for now and reevaluate in one month with spiro. On 24 Aug 2023, she was called office and did not want Breztri. On 20 Sep 2023, Nucala inj given, Lot TX7V, Exp 01/2026. She tolerated well and no reaction. Cont with Trelegy. On 18 Oct 2023, PFT looks better. Cont with current regimen. Nucala inj given, Lot TX7V, Exp Jan 2026. She tolerated well and no reaction. On 15 Nov 2023, Nucala ini given L ot XA2M Fxp Jan 2026 No reaction noted. Cont with current regimen. On 13 Dec 2023, Nucala injection given L posterior arm No incident Lot 2T7M Exp Feb 26. On 10 Jan 2024, Nucala inj given, Lot 8R7X, Exp 05/2026. Cont with Trelegy. On 07 Feb 2024, Nucala inj given, Lot 5R6S, Exp May 2026. Cont with current regimen. On 06 Mar 2024, Nucala inj given, Lot 8R7X, Exp May 2026. Cont with Trelegy. On 04 Apr 2024, She was on Nucala and Trelegy. She had been on Nucala for almost 3 years. felt her asthma was doing well with it. PFT with FEV1 56 percent with sig reversibility, FVC 56 percent with reversibility, FEF 25 to75 is 60% with sig reversibility, TLC 69 percent , RV 95 percent, DLco 104 percent of pred. Decline in spiro but pt reports she is doing well with current regimen, Trelegy and Nucala. Nucala inj given, Lot E97E, Exp 7/2026. Pt tolerated well. Repeat PFT in 3 months. On 02 May 2024, Nucala inj given, Lot E97E, Exp 07/2026. No reaction noted. Cont with Trelegy. On 30 May 2024, Nucala inj given, Lot HC8J, Exp 10/2026. Cont with Trelegy. On 27 Jun 2024, Nucala inj given, Lot HC8J, Exp 10/2026. Cont with Trelegy. PFT on 25 Jul 2024, FEV1 79 percent , FVC 72 percent/, FEF 25 to75 is 118 percent, TLC 67 percent , RV 66 percent , DLco 84percent of pred. On 25 Jul 2024, Nucala inj given, Lot M42L, Exp 11/2026. Cont with Trelegy. She was having physical therapy. She was doing well Spiro on 21 Aug 2024, FEV1 74 percent, FVC 66 percent, FEF 25 to75 is 133 percent of pred. On 21 Aug 2024, Nucala inj given, Lot R337, Exp 1/2027. Cont with Trelegy. She reported being in physical thera??/rsibility, TLC 85 percent, RV 113 percent, DLco 85 percent of pred. On 17 Oct 2024, PFT was stable. Cont with Trelegy and Nucala. On 14 Nov 2024, Nucala inj given, Lot UX7C, Exp 01/2027. Pt tolerated well. Cont with Trelegy. /Spiro on 23 Jan 2025, FEV1 56 percent, FVC 51 percent of pred. Decline in spiro due pneumonia. Nucala inj given, Lot UX7C, Exp 01/2027. Cont with trelegy/nucala and stop budesonide. Se had nausea from it. On 20 Feb 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with trelegy/nucala. Pt had labs done with PCP. On 20 Mar 2025, Nucala inj given, Lot 558S, Exp May 2026 on L upper arm. Cont with treleay for now and start benzonatate for cough. On 17 Apr 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with current regimen. She would like prednisone and zpak for travel. On 15 May 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with trelegy. On 12 Jun 2025, Nucala inj given, Lot 5S6K, Exp Jul 2027. Schedule PFT for next visit. She had hx of chronic cough ongoing for several years. She had seen a Pulmonologist in to give us a copy of her records. She was currently on Pregablin. On 15 Sep 2020, she had a Methacholine challenge test on and its positive for asthma. Her cough was likely sec to asthma. On 26 Oct 2020, she was improving with breo. Still using Pregablin. She continued to have cough. She would like to refill the Pregablin. On 20 Dec 2020, she continued to be on Pregabalin BID. Asked her to cut back to qd as she was doing so much better. NO refills given. On 25 Feb 2021, she was still on the pregabalin. On 02 Mar 2021, she presented to the office for follow up. She reported persistent dry cough. She was currently on Breo 200/25 mcg, Spiriva, ProAir, and Singulair. Methacholine challenge test on 15 Sep 2020, and its positive for asthma. She denied any Fever, Chills, or CP. She was still on Pregabalin 25 mg. She was having coughing episodes 3x a day instead of all day. She was off of Pregabalin since Jan 2021. Cough was improving after Nucala injections, her coughing episodes was down to 2x a day now from 3x a day. She denied any SOB, Wheezing or CP. She started her nebs with some relief. She also scheduled to see a GI MD sometime in September. On 25 Aug 2021, she continued to be on Breo and Spiriva. On 12 Jan 2022, she stated her cough was better with current medications. On 14 Dec 2022, her cough resolved with current regimen. On 08 Mar 2023, she had a productive cough since December. On 28 Jun 2023, her cough had resolved. On 23 Aug 2023, she denied cough. On 25 Jul 2024, she had occ cough but doing okay. She had Multiple nodules of lung. She had CT chest in Jun 2017 showed 4 to 5mm nodules. She had not had a f/u CT done. Though she was a non smoker, the nodule was upper lobe location and hence needs a f/u. Onset date for right knee surgery was Jun 2023 and Orthopedic Surgery was 23 Jun 2023. Summary of changes: The event verbatim updated to Bilateral pneumonia. Events of Rhinorrhea, sinusitis, insomnia and nausea were added. Current conditions, allergies, Historical conditions and historical drugs added. Lab data added. Co-suspect, Concomitant and treatment drug added.; Sender's Comments: The company considers that there was no reasonable possibility that the events Pneumonia, knee operation and Orthopaedic procedure may have been caused by the Nucala drug, Nucala Pre filled Syringe Device, Arexvy vaccine and Shingrix vaccine.The Pneumonia is not listed in publicly available labelling for the study drug. There is an alternative etiology (medical procedure). More
2852111 07/31/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; was exposed to it multiple times; This serious case was reported by ... Suspected vaccination failure; was exposed to it multiple times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: was exposed to it multiple times). The patient was treated with paracetamol (Acetaminophen). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via interactive digital media. The reporter stated that the RSV drug does not guarantee that one would not contract the virus and asked others to read more about the vaccine before getting injected. The reporter mentioned that RSV vaccine was used to boost the immune system so that RSV infection would not put people in the hospital or the morgue. The reporter stated he/she got the RSV injection and was exposed to it (Respiratory syncytial virus infection) multiple times due to events and was fortunate enough to have only mild symptoms, nothing an Acetometaphine could not handle. Further, reporter stated that if someone was not deceased or in the hospital, then vaccine worked. The reporter advised others to seek medical advice and questioned about how they know the symptoms are RSV related and asked to have a professional check them out. The reported stated that he/she was having Chronic obstructive pulmonary disease (COPD) which has the same symptoms as pneumonia and would rather take a twice-a-day antibiotic pill for a week than have another CT scan and a stronger inhaler for the rest of whatever. The reporter stated he/she was glad that other were intelligent enough and societally conscientious enough to get the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2852112 18 CA 07/31/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult dose to 18 year-old patient; Adult dose to 18 year-old patient; This non-serious case was repo... Adult dose to 18 year-old patient; Adult dose to 18 year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old patient who received HBV (Engerix B adult) for prophylaxis. On 18-JUN-2025, the patient received Engerix B adult. On 18-JUN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Adult dose to 18 year-old patient) and overdose (Verbatim: Adult dose to 18 year-old patient). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The reporter reported that an 18-year-old received an adult dose and came to them 4 weeks later for a 2nd dose, and they did not knew if they have anything supporting do you just count that as a first dose or you just skip a dose. They were going to administer the pediatric dose but then read they may be prone to increase side effects because we look at the volume for than the antigen content but then they did not know how to professionally guide this patient since he was new to them and wondered if GSK had any studies regarding overdosing on the first dose vs underdosing. The pharmacist, he came to their location Saturday to get a 2nd dose and that's when the pharmacist noticed that he was given adult dose 4 weeks ago which should have given pediatrics, which led to adult product administered to child and overdose. They were going to give but deicide to call GSK for guidance because they did not want him to have any side effects. More
2852113 IA 07/31/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation issue Product preparation issue
Inadvertent Administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menv... Inadvertent Administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertent Administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The reporter reported that the provider only gave the liquid part of the Menveo 2-part vaccine (1st dose in series for 12 year old) which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The lyophilized vial was not given. The reporter asked were there any recommendations for this situation. The reporter asked could the powder be given separately, and if so what should it be diluted with. More
2852114 M CA 07/31/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Shingrix potential off-label early administration due to uncertainty in the immunocompromised status... Shingrix potential off-label early administration due to uncertainty in the immunocompromised status in a diabetic patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix potential off-label early administration due to uncertainty in the immunocompromised status in a diabetic patient). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The health care provider wanted to know if it was okey to give Shingrix to a 48-year-old patient with diabetes which led to inappropriate age at vaccine administration. The reporter mentioned that the patient had already received the first dose. The agent tried to collect adverse event details for the uncertainty of the immunodeficient state of the patient at the beginning of the call, but the health care provider only provided gender and date of birth and refused to give the rest. Transfer to second line was made for further assistance, after this, the health care provider mentioned to not consider the patient diabetes as a cause of an immunodeficient state. The healthcare professional refused to provide more details than patient gender and date of birth and MI agent understood this as a denial of consent for follow up, as she did not want to delve further into the matter and provide more details. More
2852115 F IA 07/31/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Inappropriate schedule of product administration Inappropriate schedule of product administration
administering an early second dose of Twinrix (21 days after the first dose); This non-serious case ... administering an early second dose of Twinrix (21 days after the first dose); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 23-JUL-2025, the patient received the 2nd dose of Twinrix. On 23-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: administering an early second dose of Twinrix (21 days after the first dose)). The outcome of the drug dose administration interval too short 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: 24-JUL-2025 The reporter wanted to know how to proceed after administering an early second dose of Twinrix (21 days after the first dose) to a patient that was getting vaccinated for immigration matters. The patient received 2nd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule. More
2852116 M 07/31/2025 COVID19
 MODERNA
Death Death
he is dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (... he is dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (he is dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. Patient took 5 shots, and he died. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case; Reported Cause(s) of Death: he is dead More
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2852117 07/31/2025 COVID19
COVID19
 MODERNA
MODERNA

Mental disorder, Myocarditis, Nervous system disorder, Pericarditis, Rash; Tinni... Mental disorder, Myocarditis, Nervous system disorder, Pericarditis, Rash; Tinnitus, Visual impairment More
Myocarditis/inflammation of the heart; inflammation of the lining of the outside of the heart; Neuro... Myocarditis/inflammation of the heart; inflammation of the lining of the outside of the heart; Neurological issues; psychological issues; vision issues; tinnitus; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/inflammation of the heart) and PERICARDITIS (inflammation of the lining of the outside of the heart) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/inflammation of the heart) (seriousness criterion medically significant), PERICARDITIS (inflammation of the lining of the outside of the heart) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes). At the time of the report, MYOCARDITIS (Myocarditis/inflammation of the heart), PERICARDITIS (inflammation of the lining of the outside of the heart), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient had myocarditis, which was the inflammation of the heart, inflammation of the lining of the outside of the heart. Also had chest pain, shortness of breath, fluttering, neurological issues, psychological issues, vision issues, rashes and tinnitus. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case More
2852118 M 07/31/2025 COVID19
 MODERNA
Tinnitus Tinnitus
causing tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of T... causing tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (causing tinnitus) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (causing tinnitus). At the time of the report, TINNITUS (causing tinnitus) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient probably took the same doses. These shots were causing tinnitus. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:For doctor More
2852119 07/31/2025 COVID19
 PFIZER\BIONTECH
Cardiac failure, Lymphatic disorder Cardiac failure, Lymphatic disorder
Heart Failure; lymphatic system failed; The initial case was missing the following minimum criteria:... Heart Failure; lymphatic system failed; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "Heart Failure"; LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic system failed". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
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