🏥 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 💀 🏥 🚑 ♿ ⚠️
2844054 M 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness Influenza like illness
felt more like he had case of flu; This non-serious case was reported by a consumer via other manufa... felt more like he had case of flu; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of influenza in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: felt more like he had case of flu). The outcome of the influenza was resolved (duration 36 hrs). It was unknown if the reporter considered the influenza to be related to Shingrix. It was unknown if the company considered the influenza to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAY-2025 Reporter stated that after receiving Shingrix they felt more like patient had a case of flu. This case is linked with case US2025AMR066426, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR066426:same reporter/female patient More
2844055 F 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
feel a bit under the weather; This non-serious case was reported by a consumer via other manufacture... feel a bit under the weather; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax with an associated reaction of pruritus (received in 2012 and had arm itch for a week). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: feel a bit under the weather). The outcome of the feeling unwell was resolved (duration 36 hrs). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR066426 Additional Information: GSK Receipt Date: 28-MAY-2025 Patient received first dose of Shingrix in 2018, which made her feel a bit under the weather on the day after. She was fine after 24-36 hours.; Sender's Comments: US-GSK-US2025AMR070488:same reporter/male patient US-GSK-US2025AMR066426:same patient/second dose More
2844056 19 F TN 06/05/2025 HPV9
 MERCK & CO. INC.
 Y013712
Extra dose administered Extra dose administered
I accidentally gave the patient an extra dose of this vaccine because i did not realize her first do... I accidentally gave the patient an extra dose of this vaccine because i did not realize her first dose was given when she was 12 years old. She would have only needed 2 doses. More
2844057 64 M CO 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Headache, Pain Fatigue, Headache, Pain
Fatigue, soreness, headaches lasting multiple days Fatigue, soreness, headaches lasting multiple days
2844058 15 F TN 06/05/2025 HPV9
 MERCK & CO. INC.
 Y007197
Extra dose administered Extra dose administered
Patient did not need third dose. Patient did not need third dose.
2844059 16 F NY 06/05/2025 HPV9
MENB
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Y009051
Injection site nodule, Injection site pain; Injection site nodule, Injection sit... Injection site nodule, Injection site pain; Injection site nodule, Injection site pain More
Tender nodule in left deltoid, that measure 0.25 inch without: erythema, induration, swelling, and d... Tender nodule in left deltoid, that measure 0.25 inch without: erythema, induration, swelling, and discoloration. Clinical Notes: May likely be lipohypertrophy or granulation due to HPV vaccine. Unlikely lipoma. No signs of infection or injury. Treatment: NSAIDs PRN and apply ice & heat. Recommended to RTC in 1 month for re-evaluation. More
2844060 4 F MA 06/05/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
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 More
Child inadvertently received an extra dose of vaccine. No signs or symptoms of adverse outcome at th... Child inadvertently received an extra dose of vaccine. No signs or symptoms of adverse outcome at this time. More
2844061 68 M 06/05/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 7MN4C
U8361AA
Vaccination error; Vaccination error Vaccination error; Vaccination error
Patient was administered a 3rd MenQuadfi dose in error Patient was administered a 3rd MenQuadfi dose in error
2844062 M 06/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
My baby was vaccinated at 6 months and 1 yr old; This non-serious case was reported by a consumer vi... My baby was vaccinated at 6 months and 1 yr old; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: My baby was vaccinated at 6 months and 1 yr old). The outcome of the inappropriate age at vaccine administration 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:02-JUN-2025 The patient was vaccinated with Bexsero at 6 months and 1 year old and asked if he need additional shots, which led to inappropriate age at vaccine administration. More
2844063 67 M PA 06/05/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Chills, Pain, Pyrexia Chills, Pain, Pyrexia
received covid vaccine on 6/3/2025 fever of 101.6 identified on 06/04/2025 with chills and body ache... received covid vaccine on 6/3/2025 fever of 101.6 identified on 06/04/2025 with chills and body aches resolved with prn Tylenol 500 mg More
2844064 22 M VA 06/05/2025 TDAP
 SANOFI PASTEUR
 U7626AA
Expired product administered Expired product administered
a TDAP vaccine was given to a patient that had expired in 12/2024. a TDAP vaccine was given to a patient that had expired in 12/2024.
2844065 0.5 M TX 06/05/2025 DTAPHEPBIP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 5YB7L
UK198AA
LJ5282
Abnormal behaviour, Sleep disorder; Abnormal behaviour, Sleep disorder; Abnormal... Abnormal behaviour, Sleep disorder; Abnormal behaviour, Sleep disorder; Abnormal behaviour, Sleep disorder More
The mother reports that on the same day (04/15/2025) that the patient received his vaccines his beha... The mother reports that on the same day (04/15/2025) that the patient received his vaccines his behavior changed: 1) his normal crying and babbling sounds were reduced to muffled moans; 2) his usual calm behavior, for example, during breast feeding, changed to hitting, biting and clawing actions 'as if desperate'; 3) he was clingy and didn't want to be put down; 4)he was no longer sleeping well. The mother brought the patient back into the office on 05/01/2025 because these behaviors had persisted for over 2 weeks and she was concerned that they were vaccine-related. The mother reports that she noted that the patient's behaviors had fully returned to normal when she heard the patient cry normally on 05/05/2025. More
2844066 11 M MI 06/05/2025 MENB
 PFIZER\WYETH
 HP9988
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was given incorrect vaccine. Patient given MenB-FHbp (Trumemba). Order was for MenACWY-TT ... Patient was given incorrect vaccine. Patient given MenB-FHbp (Trumemba). Order was for MenACWY-TT (MenQuadfi). No adverse affect to the patient. No harm to the patient. More
2844067 1 M CO 06/05/2025 HIBV
HIBV
MMR
MMR
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
 UK210AA
UK210AA
Y004114
Y004114
HR3650
HR3650
Blood glucose decreased, Ear infection, Hypophagia, Lethargy, Oliguria; Pyrexia;... Blood glucose decreased, Ear infection, Hypophagia, Lethargy, Oliguria; Pyrexia; Blood glucose decreased, Ear infection, Hypophagia, Lethargy, Oliguria; Pyrexia; Blood glucose decreased, Ear infection, Hypophagia, Lethargy, Oliguria; Pyrexia More
5/22-5/25: Child had low grade fever, lethargy, not eating/drinking much per MOC. 5/26 child spiked ... 5/22-5/25: Child had low grade fever, lethargy, not eating/drinking much per MOC. 5/26 child spiked 101 fever and was seen by PCP 5/27 child was brought to ER by MOC for fever 105 not dropping with medication, low urine output, lethargy, low BS. Child was dx with ear infection and stared on Amoxicillin. Administered IVF and fever reducing meds and child was discharged. 5/28 child's fever was better but still not eating/drinking. 5/29 child was sent via ambulance back to ER after broke out in facial rash, fever, lethargy, low UO. Per MOC ER administered benedryl and believed it to be a abx related rash. Kept child on amoxicillin. Rash described as red, raised, started on face and moved down body. Child was inpt x 3 days and sent home on 5/31. Fever, rash and lethargy have resolved. More
✓
2844068 51 F 06/05/2025 PNC21
 MERCK & CO. INC.
 Y019157
Haemorrhage, Immediate post-injection reaction, Swelling Haemorrhage, Immediate post-injection reaction, Swelling
Pt had a lot of swelling and bleeding immediately after the vaccination. She did not have any signs ... Pt had a lot of swelling and bleeding immediately after the vaccination. She did not have any signs of an allergic reaction. I called her one hour later and it was still swollen but no other symptoms. More
2844069 61 F CT 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 FJ9A7
Vomiting Vomiting
Patient reported she Vomited afterwards Patient reported she Vomited afterwards
2844070 52 M VA 06/05/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LK6650
7ZM55
Injection site rash, Injection site warmth, Pain in extremity; Injection site ra... Injection site rash, Injection site warmth, Pain in extremity; Injection site rash, Injection site warmth, Pain in extremity More
Patient came into pharmacy with complaint of pain in left arm with visible rash from shoulder to elb... Patient came into pharmacy with complaint of pain in left arm with visible rash from shoulder to elbow. Pt reported that it started the day after the vaccine and only had pain which he treated with tylenol. Rash came about lunchtime next day and has been spreading towards elbow and it hot to touch and has some pain. More
2844071 38 F LA 06/05/2025 TDAP
 SANOFI PASTEUR
 3CA17C1
Bell's palsy, Facial paralysis, Facial paresis Bell's palsy, Facial paralysis, Facial paresis
Pt is G3P2 at 36w3d at time of vaccination. Pt began having facial droop/weakness about 7 hours afte... Pt is G3P2 at 36w3d at time of vaccination. Pt began having facial droop/weakness about 7 hours after vaccination and was diagnosed with Bell's palsy. More
2844072 41 F NH 06/05/2025 UNK
 UNKNOWN MANUFACTURER
 Y019158
Hypoaesthesia, Peripheral coldness Hypoaesthesia, Peripheral coldness
5/30--pt received PCV21 in R deltoid. Pt notes both arms with intermittent numbness since Friday nig... 5/30--pt received PCV21 in R deltoid. Pt notes both arms with intermittent numbness since Friday night and coldness in hands--no discoloration. Denies tingling or weakness--pt notes numbness resolved yesterday and per her research PCV21 can cause some numbness a few days after immunization. Pt notes injection site tender to touch but no pain with movement. Redness noticed today, +warmth to touch. Oval shaped redness 3.5 x 2 inches. Denies red streaking, drainages, fevers, SOB, wheezing, swelling of face/lips/tongue More
2844073 73 F OK 06/05/2025 COVID19
 MODERNA
 O32H21A
Amnesia, Craniofacial fracture, Fall, Shoulder fracture, Wrist fracture Amnesia, Craniofacial fracture, Fall, Shoulder fracture, Wrist fracture
I was in town for the booster, we were exiting the expo for Christmas. I had been standing for a hou... I was in town for the booster, we were exiting the expo for Christmas. I had been standing for a hour and all i could remember was exiting on the east side holding the door open with my right hand, i don't remember my head turning around or anything i woke up in an ambulance with them asking who should we contact. And then i kinda don't remember too much of anything until i was in the exam room , my glasses were knocked off my shoe was knocked off and it was on concrete and i had tripped over that concrete bumper and there was a brick wall behind it 2.5 feet away and i was laying between the both i had fallen on my left side. I broke my shoulder and my wrist and the left side of my face. I went to see a facial surgeon and my doctor and i got an eye exam done. More
2844074 1.25 F MN 06/05/2025 PNC20
 PFIZER\WYETH
 MF0425
Injection site erythema, Irritability Injection site erythema, Irritability
Raised red mark surrounding the injection. Very irritable the morning after the injection and days a... Raised red mark surrounding the injection. Very irritable the morning after the injection and days after More
2844075 63 F TX 06/05/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 XX9N4
Arthralgia, Hypersomnia, Inflammation, Musculoskeletal stiffness, Pain in extrem... Arthralgia, Hypersomnia, Inflammation, Musculoskeletal stiffness, Pain in extremity More
Hands and feet/ankles began hurting (stiff and painful) approximately 2 weeks after vaccination. My ... Hands and feet/ankles began hurting (stiff and painful) approximately 2 weeks after vaccination. My feet/ankles are mostly okay, but will stiffen up after sleep, rest, and walking). Hands, and especially right hand, are inflamed. I have been sleeping more, but more likely because of my back and sciatica pain. More
2844077 67 M CO 06/05/2025 HEPAB
HEPAB
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 344J3
344J3
3J252
3J252
Arthralgia, Headache, Ligament sprain, Lip blister, Pain in extremity; Pruritus;... Arthralgia, Headache, Ligament sprain, Lip blister, Pain in extremity; Pruritus; Arthralgia, Headache, Ligament sprain, Lip blister, Pain in extremity; Pruritus More
After receiving the shingles vaccine I developed blisters on my upper lip that were present for 2 da... After receiving the shingles vaccine I developed blisters on my upper lip that were present for 2 days, My left wrist felt like it was sprained. Mild Arthritis pain in thumbs and fingers became extreme pain, Constant headaches, still to this day. My knees are both hurting ion the joints and I have NEVER had knee pain. Plus I have episodes of itching, all over my body. Especially at night and it wakes me up. More
2844078 0.5 M VA 06/05/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
PNC20
RV5
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U7623AA
U7623AA
U7623AA
LN4929
LN4929
LN4929
2052023
2052023
2052023
Dehydration, Diarrhoea, Erythema, Hypophagia, Lethargy; Nasal congestion, Pallor... Dehydration, Diarrhoea, Erythema, Hypophagia, Lethargy; Nasal congestion, Pallor, Pyrexia, Retching, Secretion discharge; Vomiting; Dehydration, Diarrhoea, Erythema, Hypophagia, Lethargy; Nasal congestion, Pallor, Pyrexia, Retching, Secretion discharge; Vomiting; Dehydration, Diarrhoea, Erythema, Hypophagia, Lethargy; Nasal congestion, Pallor, Pyrexia, Retching, Secretion discharge; Vomiting More
Chief Complaint Vomiting yellow-green bile for over 1.5 hours yesterday, lethargy, pallor, dehydrati... Chief Complaint Vomiting yellow-green bile for over 1.5 hours yesterday, lethargy, pallor, dehydration requiring ER visit and IV fluids History of Present Illness Patient, an infant male with a recent history of adenovirus and parainfluenza 3 in early May, presents for follow-up after an emergency room visit and hospitalization due to acute vomiting and lethargy. Yesterday, around 2:30 PM, while napping in his swing, patient began vomiting. The vomiting episodes occurred every 1-2 minutes, progressing from what appeared to be a mix of spit-up and vomit to yellow-green bile. The episodes continued until after 4 PM. Accompanying symptoms included pallor, lethargy, and refusal to nurse. Patient's mother reports he became pale, with his lips losing color, and he didn't smile. He was gagging, whimpering, and dry-heaving, with his face turning red during episodes. His grandmother noted he looked gray. Due to the severity of symptoms, patient was taken to the emergency room where he received IV fluids, labs, and imaging studies. The ER pediatrician initially suspected a possible partial intussusception based on x-ray findings. Patient was transferred by ambulance to another hospital for further evaluation, where repeat scans were normal. He regained his color by 9 PM and stopped vomiting after 7 PM. He received IV fluids and was able to nurse before being discharged with instructions to follow up with the pediatrician. Since discharge, patient has been tired but nursing normally. He hasn't had any solid foods. This morning at 11 AM, he had light brown diarrhea. The mother notes that patient had a slight fever from shots on Friday, but has no fever now. She also mentions that his stool on Saturday night was mucousy, which she attributes to the rotavirus vaccine. Today, patient appears pale with some nasal contractions. The mother reports that patient had adenovirus and parainfluenza 3 in early May, which caused yellow diarrhea. She states he hasn't had any bloody or mucousy stools indicative of intussusception. The mother mentions that patient had avocado yesterday morning, which she suspects might be linked to his symptoms. Medical History - Emergency room visit and hospitalization for severe vomiting and dehydration - Adenovirus and parainfluenza 3 infections in early May - Vaccinations received, including rotavirus vaccine Medications and Supplements - Rotavirus vaccine - Administered Friday - Side effect: Mucousy poop on Saturday night Social History - Living Situation: Lives with parents - Diet: Exclusively breastfed, no solid foods introduced yet except for recent avocado trial - Caretaker Arrangement: Primary care provided by mother, grandmother involved in care Review of Systems General: Positive for fatigue, lethargy, pallor. Negative for fever. HEENT: Positive for nasal contractions. Respiratory: Positive for whimpering. Gastrointestinal: Positive for vomiting, diarrhea. Negative for bloody stools. More
2844079 11 M NC 06/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 DL4YY
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Redness & swelling & some itching at injection site; itching that worsened over past 2 days Redness & swelling & some itching at injection site; itching that worsened over past 2 days
2844080 42 F WA 06/05/2025 COVID19
COVID19
 MODERNA
MODERNA
 023C21A
050C21A
Menstruation irregular; Menstruation irregular Menstruation irregular; Menstruation irregular
Before I was given any Covid vaccine, I had regularly monthly menstruation. So regular it started ev... Before I was given any Covid vaccine, I had regularly monthly menstruation. So regular it started every 28 days and lasted 4 days. Every month. However, after receiving the vaccines my monthly menstruation completely stopped being regular, meaning I wasn?t menstruating monthly any longer. I went from monthly and regular to sporadic and maybe 3-4 times per year for the first year after the vaccine. The second year I menstruated no more than 3 times, the third and year post vaccine I had maybe 1 period. This year I menstruated one time for two days. This is concerning, not so much for me, but for younger people who are trying to have babies. More
✓
2844081 77 M FL 06/05/2025 COVID19
TDAP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 MD3414
39lb7
Back pain, Pain in extremity, Pyrexia; Back pain, Pain in extremity, Pyrexia Back pain, Pain in extremity, Pyrexia; Back pain, Pain in extremity, Pyrexia
patient stated he was running a fever and his left arm and back were aching, he stated he took some ... patient stated he was running a fever and his left arm and back were aching, he stated he took some tylenol and it temporarily relieves the symptoms. I advised patient to seek medication attention if his symptoms became severe, if he developed a rash, or developed shortness of breath More
2844082 11 F GA 06/05/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 AMBV064A
KR75K
Pruritus; Pruritus Pruritus; Pruritus
BODY WIDE PRUITITS 15 MINUTES POST VACCINES. ITCHING RESOLVED WITHIN 24 HOURS AFTER VACCINE ADMINIS... BODY WIDE PRUITITS 15 MINUTES POST VACCINES. ITCHING RESOLVED WITHIN 24 HOURS AFTER VACCINE ADMINISTRATION. More
2844083 15 F FL 06/05/2025 HPV9
IPV
TDAP
VARCEL
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y013407
Y1A212M
L5229
Y015559
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Other language speaking pt here with dad and sibling. Language line interpreter #463318 and #425625 ... Other language speaking pt here with dad and sibling. Language line interpreter #463318 and #425625 used in succession during appt. During assessment of vaccines it was determined that Tdap, IPV, HPV and VAR were needed. LMP- 05/20/25. NKA. No sig med hx per pts dad. All vaccines administered IM. Upon entering vaccines into database, it was realized that pt was already complete with VAR and therefore received an extra dose. Dad made aware and instructed on s/s to watch out for-temp over 104.0, seizures, sob, lethargy. Also instructed if any concerns or issues develop to RTC or seek ER care. Dad stated via interpreter "That is fine". Pt BP taken on L arm-118/78, pulse-83. Medical Executive Director contacted due to nature of incident and received instructions to make pt aware of s/s to watch for as stated above. Pt remained in clinic 30 min after vaccines were administered and stated via interpreter "I feel fine". More
2844084 24 M TX 06/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 T5D73
Diarrhoea, Nausea, Vomiting Diarrhoea, Nausea, Vomiting
Patient returned(06/05/2025) one month later to receive the Hep A vaccine, however, his lab shows po... Patient returned(06/05/2025) one month later to receive the Hep A vaccine, however, his lab shows positive titers for Hep A. Pt reported that after he received the Hep B vaccine on 05/05/2025, that "a few hours" later he began experiencing nausea vomiting and diarrhea. Patient was seen in the ED the next day for these symptoms. Patient reports today that his symptoms improved. More
2844085 1.42 M CO 06/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 DN273
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient was given Havrix 13 days early and off schedule. Patient was given Havrix 13 days early and off schedule.
2844086 45 F PR 06/05/2025 HPV9
 MERCK & CO. INC.
 Z005469
Induration, Peripheral swelling, Tenderness Induration, Peripheral swelling, Tenderness
Patient came to the pharmacy to report that she had a severe localized reaction to Gardasil. She sai... Patient came to the pharmacy to report that she had a severe localized reaction to Gardasil. She said that her arm is very swollen, tender, and hard to the touch. We advise her to apply cold compresses and referred to her doctor for evaluation. More
2844087 39 M OH 06/05/2025 COVID19
TDAP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 LN0590
9N4E7
Arthralgia, Loss of personal independence in daily activities, Mobility decrease... Arthralgia, Loss of personal independence in daily activities, Mobility decreased; Arthralgia, Loss of personal independence in daily activities, Mobility decreased More
shoulder pain and declined ROM within 2 hours of shots and lasting over 4 weeks. limiting activities shoulder pain and declined ROM within 2 hours of shots and lasting over 4 weeks. limiting activities
2844088 68 F OR 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Diarrhoea, Joint swelling, Pain Arthralgia, Diarrhoea, Joint swelling, Pain
Multiple arthralgias and multiple swollen joints. acute diarrhea, body pain. Started approx 24 hours... Multiple arthralgias and multiple swollen joints. acute diarrhea, body pain. Started approx 24 hours after vaccination, causing intense pain. More
2844089 56 F CO 06/05/2025 PNC20
 PFIZER\WYETH
 ln4927
Erythema, Swelling Erythema, Swelling
pt presented with swelling and erythema. No fever noted pt presented with swelling and erythema. No fever noted
2844090 4 F FL 06/05/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5G23D
y016872
Injection site cellulitis, Injection site rash, Injection site warmth; Injection... Injection site cellulitis, Injection site rash, Injection site warmth; Injection site cellulitis, Injection site rash, Injection site warmth More
1 day after the vaccine, a rash showed up on Left thigh near injection site It started to spread and... 1 day after the vaccine, a rash showed up on Left thigh near injection site It started to spread and has spread across her thigh, it's hot to touch. No fevers. Patient seen in office 3 days after vaccines given and diagnosed with cellulitis at injection site. patient started on cephalexin to treat infection More
2844091 75 F IL 06/05/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Paraesthesia, Paraesthesia oral Paraesthesia, Paraesthesia oral
Starting experiencing tingling in extremities (hands, and feet) yesterday. Today (6-5-2025) startin... Starting experiencing tingling in extremities (hands, and feet) yesterday. Today (6-5-2025) starting experiencing tingling on tongue More
2844092 55 F 06/05/2025 HPV9
PNC20
VARZOS
 MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Injection site erythema, Injection site pruritus, Injection site swelling; Injec... Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling More
patient stated that the same day she received the 3 vaccines she began experiencing itching, redness... patient stated that the same day she received the 3 vaccines she began experiencing itching, redness, and swelling in the area of her arm that the vaccines were given,...the area became larger after a 6 day time frame More
2844093 21 F IA 06/05/2025 HEP
HEP
HEP
HEP
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 PE9G5



UNK
Antibody test negative, Expired product administered, Incomplete course of vacci... Antibody test negative, Expired product administered, Incomplete course of vaccination; Antibody test negative, Expired product administered, Incomplete course of vaccination; Antibody test negative, Expired product administered, Incomplete course of vaccination; Antibody test negative, Expired product administered, Incomplete course of vaccination; Antibody test negative, Expired product administered, Incomplete course of vaccination More
they got an antibody test and it came negative; incomplete course of vaccination; patients received ... they got an antibody test and it came negative; incomplete course of vaccination; patients received an expire dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 21-year-old female patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 28-MAY-2025, the patient received the 4th dose of Engerix B. The patient did not receive the 2nd dose of Twinrix, on an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 28-MAY-2025, an unknown time after receiving Engerix B and not applicable after receiving Twinrix, Engerix B, Engerix B and Engerix B, the patient experienced expired vaccine used (Verbatim: patients received an expire dose of Engerix-B). On an unknown date, the patient experienced therapy non-responder (Verbatim: they got an antibody test and it came negative) and incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the therapy non-responder, expired vaccine used and incomplete course of vaccination 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: 28-MAY-2025 Nurse called and reported that one of their patients received an expire dose of Engerix-B, the vaccination date was 28-May-2025 and the vaccine was expired since 19-May-2025, which led to expired vaccine used. The patient had 3 doses a long time ago, so this was the 5th dose, they had 3 doses when they were a child, and then they were going to school, colleague, and they got an antibody test and it came negative, which led to Therapy non-responder. So they want attempt start over, so she had a Twinrix on 20-Apr-2025. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination. More
2844094 AL 06/05/2025 DTAP
DTAPHEPBIP
DTAPIPV
HEP
HEPA
HIBV
MENB
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS








Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Product Storage error with vaccine administration outside stability conditions / some patients got v... Product Storage error with vaccine administration outside stability conditions / some patients got vaccinated with those products; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Hib (Hiberix) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patients received Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Product Storage error with vaccine administration outside stability conditions / some patients got vaccinated with those products). The outcome of the incorrect storage of drug 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: 02-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter. The Medical Assistant called to report about a below freezing temperature excursion and reactively mentioned that he/she not aware of this information and some patients got vaccinated with those products. According to Medical Assistant precision, multiple patients were vaccinated Bexsero, Boostrix, Engerix B, Hiberix, Havrix, Infanrix, Kinrix, Menveo and Pediarix which led to incorrect storage of drug. No specific information about vaccination date, vaccine detail and patient demographics were obtained in this call No further information was obtained in this call. More
2844095 F NY 06/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 D23D3
Expired product administered Expired product administered
Expired Product Used; This non-serious case was reported by a pharmacist via call center representat... Expired Product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis. On 02-JUN-2025, the patient received Engerix B. On 02-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used 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:03-JUN-2025 The reporter reported that administration of an expired dose of Engerix-B the day before reporting to a patient, which led to expired vaccine used. The reporter asked if there was any data on when to repeat the dose of Engerix-B. The reporter consented to follow up. More
2844096 41 F GA 06/05/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 32YB4
Product preparation issue Product preparation issue
Incorrect Preparation/nurses administered just the diluent portion; Incorrect Preparation/nurses adm... Incorrect Preparation/nurses administered just the diluent portion; Incorrect Preparation/nurses administered just the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 41-year-old female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis. On 02-JUN-2025, the patient received Priorix. On 02-JUN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incorrect Preparation/nurses administered just the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Incorrect Preparation/nurses administered just the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 03-JUN-2025 The reporter had one of our nurses administered just the diluent portion, missed to combine the vial, the powder and just wanted to know when they should try to re-administer the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. More
2844097 67 M UT 06/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a pharmacist via call center repres... Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 31-MAR-2025) for prophylaxis. On 02-JUN-2025, the patient received Arexvy. On 02-JUN-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date:03-JUN-2025 Pharmacist reported that a patient received Arexvy the day before reporting, which led to expired vaccine used. The reporter consented to follow up More
2844098 F FL 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix + Late 2nd dose; This non-serious case was reported by a pharmacist via call center represe... Shingrix + Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (On 18-FEB-2021, the patient got the first dose). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix + Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-JUN-2025 The pharmacist called to confirm if what a physician said was true. The physician said Shingrix should be restarted if more than 6 months had passed after the first dose. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. More
2844099 16 F VA 06/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB030A
Expired product administered Expired product administered
Expired dose administered.; This non-serious case was reported by a other health professional via ca... Expired dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis. On 03-JUN-2025, the patient received Menveo. On 03-JUN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 03-JUN-2025 The reporter had a patient received Menveo at the time of reporting, but it was expired, which led to expired vaccine used. They were wondering when we should revaccinate. The reporter consented to follow up by email. More
2844100 F CO 06/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
A female patient around 50 years old received Havrix on 2018 and did not complete the series.; This ... A female patient around 50 years old received Havrix on 2018 and did not complete the series.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received one dose in 2018). On an unknown date, the patient did not receive Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: A female patient around 50 years old received Havrix on 2018 and did not complete the series.). The outcome of the incomplete course of vaccination 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: 03-JUN-2025 The reporter called to report that a patient around 50 years old who received a dose of Havrix on 2018 and had not completed the dosing schedule for Havrix. The reporter asked if she could get Twinrix. The reporter consented to follow up. Till the time of reporting, the patient did not receive the further dose of Havrix, which led to incomplete course of vaccination. More
2844101 IA 06/05/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Kinrix plus use as 4th Dtap; This non-serious case was reported by a other health professional via s... Kinrix plus use as 4th Dtap; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate schedule of vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix plus use as 4th Dtap). The outcome of the inappropriate schedule of vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JUN-2025 Patient got Kinrix last year when she was behind on vaccine, still 5 years old and still behind on Dtap and polio which led to inappropriate schedule of vaccine administered. The reporter enquired could she do a 2nd Kinrix this year. More
2844102 50 M MD 06/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
now want to receive 2nd dose; This non-serious case was reported by a pharmacist via call center rep... now want to receive 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2023 with batch number YC51Y7). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: now want to receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-JUN-2025 The registered pharmacist wanted to know how to proceed with a patient that received the first dose of Shingrix back in 2023 and now wanted to receive the second dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2844103 F TX 06/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 XS27B
Expired product administered Expired product administered
expiration date was on 17 March 2025, and it was administered to a 22 year old; This non-serious cas... expiration date was on 17 March 2025, and it was administered to a 22 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number XS27B, expiry date 17-MAR-2025) for prophylaxis. On 04-JUN-2025, the patient received the 1st dose of Engerix B. On 04-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expiration date was on 17 March 2025, and it was administered to a 22 year old). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 04-JUN-2025 On 4 June 2025 a pharmacist of called to asked how to proceed after the administration of an expired dose of Engerix-B. The expiration date was on 17th March 2025, and it was administered to a 22 year-old female patient on 4 June 2025, which led to Expired vaccine used. It was for the first dose. The reporter was consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. More
2844104 F 06/05/2025 COVID19
 MODERNA
Neuropathy peripheral Neuropathy peripheral
One lady had neuropathy; This female subject of an unknown age was involved in an other study and re... One lady had neuropathy; This female subject of an unknown age was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of NEUROPATHY PERIPHERAL (One lady had neuropathy). No Medical History information was reported. On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On an unknown date, the subject experienced NEUROPATHY PERIPHERAL (One lady had neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (One lady had neuropathy) outcome was unknown. The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown. For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter did not provide any causality assessments. ID was reported as DCP-0420-25. Regulatory Authority name was reported as mRNA-1083 Life Cycle Management Concept Evaluation. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-786903 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-May-2025: Live follow up received that contains no new information. On 26-May-2025: Live follow up received that contains no new information. On 27-May-2025: Live follow up received that contains significant information includes added Regulatory Authority number and narrative was updated.; Reporter's Comments: The reporter causality for the event was not provided. The company causality was assessed conservatively as related to the vaccine in the context of limited information available. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786903:Female patient More
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