🏥 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 💀 🏥 🚑 ♿ ⚠️
2831193 0.42 F PA 03/13/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J235K
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
first Influenza dose was given at age 5.5 months. It was ultimately counted as an invalid dose, an... first Influenza dose was given at age 5.5 months. It was ultimately counted as an invalid dose, and the correct first dose was given 3/13/25. No adverse events occurred, but dose was given at invalid date of age More
2831194 49 M OH 03/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 003B21A
041B21A
Coronary arterial stent insertion, Coronary artery occlusion, Myocardial infarct... Coronary arterial stent insertion, Coronary artery occlusion, Myocardial infarction; Coronary arterial stent insertion, Coronary artery occlusion, Myocardial infarction More
Heart Attack. 100% Blockage of RCA. Total of 3 stents placed in the RCA. Taking Anti-coagulants. lif... Heart Attack. 100% Blockage of RCA. Total of 3 stents placed in the RCA. Taking Anti-coagulants. lifetime pharma recipient as a result. More
✓ ✓ ✓
2831195 3 M VA 03/13/2025 HEP
 MERCK & CO. INC.
 X006977
Wrong product administered Wrong product administered
Incorrect vaccine was given. Hep B was ordered, but Hep A was given. Incorrect vaccine was given. Hep B was ordered, but Hep A was given.
2831196 2 M CO 03/13/2025 FLU3
 SANOFI PASTEUR
 TFAA2418
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
patient has private Insurance so I know it has to be from non-vfc stock, but unfortunately, I grabbe... patient has private Insurance so I know it has to be from non-vfc stock, but unfortunately, I grabbed FluB instead of Flupf. So 2 year ol patient received the FluB, Parents were notified, also Dr. I called parent's of child a few day after and they stated that no allergic reaction. More
2831197 5 F NC 03/13/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.


Urticaria, Vulvovaginal pain, Vulvovaginal swelling; Urticaria, Vulvovaginal pai... Urticaria, Vulvovaginal pain, Vulvovaginal swelling; Urticaria, Vulvovaginal pain, Vulvovaginal swelling; Urticaria, Vulvovaginal pain, Vulvovaginal swelling More
3/11/2025(Vaccination date at 9:40a) with two nurses that didn't not inform me of MMR and Varic... 3/11/2025(Vaccination date at 9:40a) with two nurses that didn't not inform me of MMR and Varicella containing traces of egg, 3/12/24 (Called on-call nurse), My daughter had a quarter size hive in-between her vaginal and naval; cluster of hives from the top of her butt to her ankle on both legs; pain and swelling in vaginal area, 2.5ml Benadryl administer at 6:30pm, 12:30am, 6:30am, & 12:30pm 3/13/25 (Follow up appointment at 9;40am) I requested that the incident be recording on her file along with a restriction for any medications or vaccines with any of her know allergies along with a note to excuse her from any other busters regarding MMR, Varicella, the active Flu vaccine, and any vaccination containing yeast, egg, or nut. I was told that everything was recorded, and that the incident was a mild reaction since there was no trouble breathing or swelling in the face. The Benadryl administrated at home has contained the issue at hand that could have been very severe since my daughter has a 45.80% allergy to egg white and 30.90% allergy to egg yolk which was presented to the clinic last year from the testing done at the allergist recommended by a previous pediatrician. More
2831198 68 F NE 03/13/2025 FLU3
 SANOFI PASTEUR
 UT8463AA
Wrong product administered Wrong product administered
Wrong vaccine was administered. Provider entered orders than canceled and reentered. Provider ordere... Wrong vaccine was administered. Provider entered orders than canceled and reentered. Provider ordered covid-19 for patient. And Flu was administered. Provider was notified More
2831199 69 M FL 03/13/2025 RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH


Arteriosclerosis, Carotid artery stenosis, Cerebral artery occlusion, Cerebral a... Arteriosclerosis, Carotid artery stenosis, Cerebral artery occlusion, Cerebral atrophy, Cerebral infarction; Cerebral small vessel ischaemic disease, Cognitive disorder, Computerised tomogram head abnormal, Fatigue, Feeling abnormal; Impaired work ability, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Vertebral artery stenosis, White matter lesion More
Woke on morning of 2/27/25 feeling tired, "something is wrong", napped four hours. Woke an... Woke on morning of 2/27/25 feeling tired, "something is wrong", napped four hours. Woke and worked in office, trying to read and couldn't make sense of written language. Went to ED for workup. More
✓ ✓ ✓
2831200 19 F PA 03/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Chills, Gastrointestinal viral infection, Neck pain, Pain in extremity, Paraesth... Chills, Gastrointestinal viral infection, Neck pain, Pain in extremity, Paraesthesia More
pt reported chills, pain in R arm and neck, tingling in fingers of same arm. Treated with APAP and ... pt reported chills, pain in R arm and neck, tingling in fingers of same arm. Treated with APAP and advil, cool compresses. arm achey the following day. However she concurrently developed a viral GI illness More
2831201 0.67 M NC 03/13/2025 DTAP
RV1
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 3ca11c1
ex434
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Vaccination was given at 8m8d. Maximum age was exceeded. No adverse reaction at the time of this rep... Vaccination was given at 8m8d. Maximum age was exceeded. No adverse reaction at the time of this report. Mother to call with any concerning symptoms. More
2831202 17 M TX 03/13/2025 HPV9
 MERCK & CO. INC.
 X025115
Contusion, Musculoskeletal stiffness, Pallor, Posture abnormal Contusion, Musculoskeletal stiffness, Pallor, Posture abnormal
He received Bexero first to the right arm. Patient requested HPV in the same arm. He got the HPV va... He received Bexero first to the right arm. Patient requested HPV in the same arm. He got the HPV vaccine to right arm. He sat down in the chair next to his dad. MA walked to his computer and sat down. Dad began yelling for help. Patient was rigid/stiff, arms bent and fists inward, head back, mouth open, and was pale. Both dad and MA got patient to the table. I (the provider) walked in as his legs were going up on the exam table. He continued rigidity for another 15-30 seconds. After the episode, he was awake, alert and said he was fine. He tried to brush it off that he tends to faint with pain. He was not drowzy or confused. He told me he was fine. VS were taken. Gave him some water and a lollipop. Watched him for 10 more minutes before he left. Referred him to neurology and has an appointment in April. More
2831204 66 M AR 03/13/2025 COVID19
 PFIZER\BIONTECH
 GJ6739
COVID-19 COVID-19
covid infection with hospitalization after vaccination covid infection with hospitalization after vaccination
2831205 53 F SC 03/13/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site erythema, Injection site mass, Injection site warmth Injection site erythema, Injection site mass, Injection site warmth
A red, warm, hard lump started forming at the injection site the night of the vaccination. It progr... A red, warm, hard lump started forming at the injection site the night of the vaccination. It progressively got larger and a not formed in under arm lymph node area also. Patient was seen today by physician who diagnosed it as an allergic reaction to the vaccine and prescribed an oral steroid. More
2831206 11 M WI 03/13/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8361AA
U7928AA
Abdominal pain, Diarrhoea haemorrhagic, Occult blood positive; Abdominal pain, D... Abdominal pain, Diarrhoea haemorrhagic, Occult blood positive; Abdominal pain, Diarrhoea haemorrhagic, Occult blood positive More
Patient received vaccines in clinic on 8/12/2025. On 8/13/2025 around 7am patient developed numerous... Patient received vaccines in clinic on 8/12/2025. On 8/13/2025 around 7am patient developed numerous (>10) episodes of bloody diarrhea with some abdominal cramping. No fevers or vomiting. Still able to eat and drink. Presented to the local ED around noon on 3/13/2025. Hemoccult was positive. More
2831207 11 F AZ 03/13/2025 PNC20
 PFIZER\WYETH
 LG5574
Extra dose administered, No adverse event Extra dose administered, No adverse event
Inadvertent and extraneous dose administered. No other adverse events noted. Inadvertent and extraneous dose administered. No other adverse events noted.
2831208 3 F IA 03/13/2025 COVID19
 PFIZER\BIONTECH
 LN8272
Expired product administered, No adverse event Expired product administered, No adverse event
There was no adverse reaction noted- vaccination given after BUD 2/28/25. There was no adverse reaction noted- vaccination given after BUD 2/28/25.
2831209 17 M NJ 03/13/2025 MNQ
 SANOFI PASTEUR
 U8271AB
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a second dose of Menquadfi at age 16 which was not necessary, due to first dose bei... Patient received a second dose of Menquadfi at age 16 which was not necessary, due to first dose being given at age 16. Pt is doing well. More
2831210 4 F CA 03/13/2025 MMRV
 MERCK & CO. INC.
 Y009344
Angioedema Angioedema
angioedema angioedema
2831211 13 F CA 03/13/2025 HPV9
 MERCK & CO. INC.
 Y000206
Blood pressure decreased, Pallor, Syncope, Tachycardia, Unresponsive to stimuli Blood pressure decreased, Pallor, Syncope, Tachycardia, Unresponsive to stimuli
Right after the vaccine administration, she fainted, she was pale and unresponsive. She had to be st... Right after the vaccine administration, she fainted, she was pale and unresponsive. She had to be stimulated, placed in supine position with legs elevated, her Blood pressure dropped to 77/47. Hr was tachycardic. It took her at least 15-20 minutes to be alert and her skin profusion improved and her blood pressure reading was 109/69,HR 69. We were contemplating calling 911 and transferring to ER but mom preferred her to be monitored here. We offered her water and a popsicle. She was also fasting for religion and was reluctant to break her fast. We monitored her for a total duration of about an hour in office. More
2831212 1.08 M TX 03/13/2025 MMR
 MERCK & CO. INC.
 Y011709
Cough, Rash Cough, Rash
RASH/COUGH RASH/COUGH
2831213 78 F OH 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3x97j
Hypoaesthesia oral, Mouth swelling Hypoaesthesia oral, Mouth swelling
Patient experienced numbness without swelling in corner of mouth approximately 10 minutes after vacc... Patient experienced numbness without swelling in corner of mouth approximately 10 minutes after vaccine administration with no other symptoms. Patient reported that numbness progressed to lower lip and nose over the next 5-10 minutes, but denies additional symptoms beyond numbness. Patient was advised to visit the emergency room. Patient accepted this and was transported by woman who brought her to receive her vaccine. More
2831214 11 M PR 03/13/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y014510
FX3EB
9429J
Asthenia, Dizziness; Asthenia, Dizziness; Asthenia, Dizziness Asthenia, Dizziness; Asthenia, Dizziness; Asthenia, Dizziness
PATIENT PRESENTS DIZZINESS AND WEAKNESS PATIENT PRESENTS DIZZINESS AND WEAKNESS
2831215 55 F WV 03/13/2025 PNC21
 MERCK & CO. INC.
 A5T73
Erythema, Pain in extremity, Pruritus, Skin warm Erythema, Pain in extremity, Pruritus, Skin warm
her whole upper arm became red and hot to the touch. Somewhat painful and intermittently itchy. Of... her whole upper arm became red and hot to the touch. Somewhat painful and intermittently itchy. Offered patient topical steroid creams or oral medications to help with the pruritus, patient declines at this time and states she can use OTC medications - discussed use of supportive care, such as cold compresses, OTC analgesics like tylenol/ibuprofen, antihistamines or topical creams for itchiness - discussed red flag symptoms to look for concerning for severe anaphylaxis that would require immediate attention, patient understanding -Follow up as needed. More
2831216 18 F GA 03/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ZK9P4
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
swelling and redness at injection site swelling and redness at injection site
2831217 54 M NY 03/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
54-year-old male patient coming into the hospital after a traumatic fall off a ladder at work. Patie... 54-year-old male patient coming into the hospital after a traumatic fall off a ladder at work. Patient was seen in the hospital emergency department and received fentanyl 50 mcg for pain management and iohexol for contrast for CT imaging. After imaging, Tdap vaccine (Boostrix) was given by RN for tetanus prophylaxis as patient had unknown Tdap vaccine history. RN reports giving Tdap via intravenous route instead of intramuscular route after administration. Poison Control Center was contacted. Discussed concerns for possible anaphylaxis reaction when administering Tdap via intravenous route based on prior literature with patient. Patient was monitored for 3 hours after Tdap administration without any reports of adverse reactions. Pharmacist, RN, and MD were at bedside to discuss anaphylaxis symptoms and return precautions. More
2831218 32 F PA 03/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LP1776
U8465BA
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Patient states she got the vaccine and about 2 hours later her arm began to hurt. It got better afte... Patient states she got the vaccine and about 2 hours later her arm began to hurt. It got better after a day or so and then she started having trouble with her arm again. She said she got PT for the pain. More
2831219 56 F NC 03/13/2025 PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y013009
Y013009
Y013009
Y013009
Y013009
Y013009
Y013009
Y013009
Chills, Fatigue, Injection site cellulitis, Injection site discolouration, Injec... Chills, Fatigue, Injection site cellulitis, Injection site discolouration, Injection site pain; Injection site swelling; Bone pain, Discomfort, Injection site discharge, Injection site erythema, Injection site pain; Injection site pruritus, Injection site warmth, Pyrexia; Chills, Fatigue, Injection site cellulitis, Injection site discolouration, Injection site pain; Injection site swelling; Bone pain, Discomfort, Injection site discharge, Injection site erythema, Injection site pain; Injection site pruritus, Injection site warmth, Pyrexia More
Right upper arm tenderness, swelling, and discoloration with chills and fatigue. Diagnosed with C... Right upper arm tenderness, swelling, and discoloration with chills and fatigue. Diagnosed with Cellulitis, was treated with oral Bactrim and mupirocin cream More
2831221 1 M MI 03/13/2025 HEPA
HIBV
MMRV
PNC20
 MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH



Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test p... Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test positive, Parotitis; Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test positive, Parotitis; Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test positive, Parotitis; Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test positive, Parotitis More
Developed right side parotitis and acute cerebellar ataxia that last 2-3 days Developed right side parotitis and acute cerebellar ataxia that last 2-3 days
2831222 34 F OR 03/13/2025 HPV9
 MERCK & CO. INC.
 Y008843
Arthralgia, Asthenia, Myalgia, Myositis Arthralgia, Asthenia, Myalgia, Myositis
Patient reported Myositis. She stated full body weakness, muscle and joint pain starting on 1/18. Th... Patient reported Myositis. She stated full body weakness, muscle and joint pain starting on 1/18. This did not resolve after 8 days so she started a round of steroids. The steroids helped diminish symptoms, but she had a reaction to the steroids and had to stop. Joint pain returned when she stopped the steroids. Per patient symptoms have diminished for the last 3-4 weeks. More
2831223 41 F ID 03/13/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y010372-P
Y010372-P
Fatigue, Lymph node pain, Lymphadenopathy, Malaise, Measles; Oedema, Oropharynge... Fatigue, Lymph node pain, Lymphadenopathy, Malaise, Measles; Oedema, Oropharyngeal pain, Rash papular, Rash pruritic More
12 days after vaccination developed swelling in lymph nodes bilaterally next to ear with tenderness,... 12 days after vaccination developed swelling in lymph nodes bilaterally next to ear with tenderness, then progressed swelling of lymph nodes in neck, and back of head. Continued swelling, having fatigue, malaise.. Fine papular rash developed all over neck, torso, back arms, face and ears . Rash is itchy. Edema in tonsils with Koplik spots, sore throat. Progressed into swelling in glands behind right knee. More
2831224 81 F ID 03/13/2025 COVID19
 MODERNA
 3043823
Back pain, Dizziness, Flushing Back pain, Dizziness, Flushing
severe flushing, light-headedness within five minutes after injection, followed by lower back pain; ... severe flushing, light-headedness within five minutes after injection, followed by lower back pain; reaction abated within fifteen minutes and patient exited store under own volition. More
2831225 56 M OR 03/13/2025 PNC20
 PFIZER\WYETH
 HR3650
Electric shock sensation, Gait disturbance, Pain, Pain in extremity Electric shock sensation, Gait disturbance, Pain, Pain in extremity
Patient reported that morning after he received the vaccine that he had pain shooting down like elec... Patient reported that morning after he received the vaccine that he had pain shooting down like electricity through both his legs and that he had difficulties walking. Patient stated that it did go away by Wednesday, patient declines calling anyone or getting treatment. More
2831226 63 M MI 03/13/2025 UNK
 UNKNOWN MANUFACTURER
Bell's palsy, Blood test, Computerised tomogram head normal, Electrocardiog... Bell's palsy, Blood test, Computerised tomogram head normal, Electrocardiogram More
i was requested to get a shingals shot from insurance, my doctors office and in emails . i called a... i was requested to get a shingals shot from insurance, my doctors office and in emails . i called and was granted day of monday Febuary 24@ 2:pm. recived shot continued shopping returned home dinner and bed. Tuesday morning i was having a bell palsy event, call doc, went to ER and was admitted to hospital . ct scan clear , no stroke, went home to rest. More
✓ ✓
2831227 70 F IL 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3334Y
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Red circle around the injection site, slightly warm to the touch Red circle around the injection site, slightly warm to the touch
2831228 55 F CO 03/13/2025 TDAP
TDAP
TDAP
TDAP
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 324B2
324B2
324B2
324B2
4NG3F
4NG3F
4NG3F
4NG3F
Biopsy, Blood test, Computerised tomogram, Dyspnoea, Dysstasia; Fatigue, Feeding... Biopsy, Blood test, Computerised tomogram, Dyspnoea, Dysstasia; Fatigue, Feeding disorder, Gait disturbance, Gait inability, Influenza like illness; Lethargy, Magnetic resonance imaging, Nephropathy, Oedema, Pain; Peripheral swelling, Swelling, Ultrasound Doppler normal, X-ray; Biopsy, Blood test, Computerised tomogram, Dyspnoea, Dysstasia; Fatigue, Feeding disorder, Gait disturbance, Gait inability, Influenza like illness; Lethargy, Magnetic resonance imaging, Nephropathy, Oedema, Pain; Peripheral swelling, Swelling, Ultrasound Doppler normal, X-ray More
11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu ... 11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu like symptoms, lethargic for 2 to 3 days. 12/02/2023 noticed legs swelling and getting worse. 12/05/2023 went to er for ultrasound no blood clots. 12/08/2023 admitted to hospital for edima and cardicac arrest but ended up being minimal kidney disease. Did blood tests, xrays, catscan, mri and biopsy. released 12/13/2023. Next 2 weeks sever edima. could not walk without assistance. couldn't eat or drink, swelled up. weighed 199 lbs. when admitted to hospital 12/30/2023. couldn't walk, eat, drink, difficult breathing, Blood test, xrays, mri, catscans, and every other test they could do. Released on 01/09/2024. After release had to see a heart doctor and a cancer doctor both turned out to be normal. Still have minimal kidney disease today. Chronic pain throughout body, hard to get up, fatigue, and edima. More
✓
2831229 36 F MD 03/13/2025 PNC20
 PFIZER\WYETH
 LJ5284
Erythema, Peripheral swelling, Skin warm Erythema, Peripheral swelling, Skin warm
Left arm reaction, soreness and redness since vaccination on 3/7/25, but upon awakening on 3/12/25 t... Left arm reaction, soreness and redness since vaccination on 3/7/25, but upon awakening on 3/12/25 the area had marked increased redness/swelling/warmth as compared to previous night. Pharmacy recommended pt contact PCP, PCP prescribed Keflex More
2831230 71 M TX 03/13/2025 RSV
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5f5xk
93kk4
Dizziness; Dizziness Dizziness; Dizziness
Pt call Thursday complaining of dizziness. Pt explained that the dizziness started the day after th... Pt call Thursday complaining of dizziness. Pt explained that the dizziness started the day after the vaccinations and was wanting to know how long he symptoms would last. Pt further explained that the dizziness only occurred when his eyes were open. Pt was directed to immediate medical care for evaluation/treatment. More
2831270 F NC 03/13/2025 PNC21
 MERCK & CO. INC.
Chills, Pain, Pain in extremity, Urticaria Chills, Pain, Pain in extremity, Urticaria
having body aches/ she couldn't do anything due to the pain of the body aches; Patient woke the... having body aches/ she couldn't do anything due to the pain of the body aches; Patient woke the next day with her arm very sore; Patient experiencing chills to the point that her lips were chattering; Patient indicated that the liquid "hurt when going in; Size of the welt on her arm is 4 "long and 3.5"/ the injection spot is still raised, red and grew since yesterday; This spontaneous report has been received from a patient of 59-years-old referring to herself. Patient's concomitant medications included "a statin" and multi vitamins. There was no information about medical history or previous drug allergies. On 10-FEB-2025 at 3:00pm, patient was vaccinated as recommended by her HCP with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) formulation as default as solution for injection (strength, exact dose, anatomical route of administration, lot # and expiration date was not reported). Patient indicated that the liquid "hurt when going in" (injection site pain). Patient woke the next day (on 11-FEB-2025) with her arm very sore (pain in extremity). She went to work but started experiencing chills to the point that her lips were chattering (chills) and was having body aches (pain), so she decided to go home. By 12-FEB-2025 she "could not do anything" due to the pain of the body aches and chills so she didn't go to work. Patient stated that as of today the chills are gone, but the size of the welt on her arm is 4" long and 3.5" (vaccination site urticaria) wide and she is still experiencing body aches. The injection spot is still raised, still red, and grew since yesterday (12-FEB-2025). Patient had not contacted her HCP because when reading the PI she saw that 1% of people have side effects. She felt she fell in that 1%. Patient felt it was irrelevant to supply HCP contact information but did authorize contact with her. The outcome of the event vaccination site pain and urticaria was considered as not recovered, while for the event pain and injection site pain was unknown. On an unspecified date in February 2025, the patient was recovered from the event chills. The causal relationship between aforementioned adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot number is being requested and will be submitted if received. More
2831271 69 F FL 03/13/2025 PNC21
 MERCK & CO. INC.
Erythema, Peripheral swelling, Skin tightness, Skin warm Erythema, Peripheral swelling, Skin tightness, Skin warm
Patient thought she was having a reaction as she is allergic to preservatives, but did see there wer... Patient thought she was having a reaction as she is allergic to preservatives, but did see there were no preservatives listed in the vaccine.; possible infection; This spontaneous report was received from a consumer and refers to a 69-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Rheumatoid arthritis. Historical drugs included adalimumab (Humira), rituximab (Rituxan), and Contrast media. Concomitant medications included atorvastatin calcium, amlodipine and atorvastatin (Amlodipine besilate (+) atorvastatin calcium), clonidine, levothyroxine sodium (synthroid), fexofenadine hydrochloride (Allegra), estriol, famotidine, calcium carbonate (Caltrate), ergocalciferol (Vitamin D), lactobacillus acidophilus (Acidophilus), folic acid, and prednisolone. On 09-Feb-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) (strength, formulation, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. On 09-Feb-2025, the patient initially had a minor irritation at the injection spot and couldn't sleep. On 10-Feb-2025 (Monday), the arm swelled up, her skin was very tight due to the swelling, the arm was hot & red (like a giant red hive) and was continuing to spread. The patient indicated she could not lift her arm. Therefore, patient went to her cardiologist on 11-Feb-2025 (Tuesday), as the swelling was almost under the arm. The cardiologist prescribed methylprednisolone (SOLUMEDROL) which worked until it wore off. The arm again became hot, red and swollen. The patient thought she was having a reaction as she was allergic to preservatives but did see there were no preservatives listed in the vaccine (Hypersensitivity). The patient was placed on cefalexin (KEFLEX) (500 m/4 times a day) in a case of an infection (infection unspecified (NOS) and prednisone (higher dose than currently taking). The patient sought medical attention and was to the emergency department. At the reporting time, the patient still had swelling (not recovered from hypersensitivity event). The outcome of the event of infection NOS was not provided. The causal relationship between the events with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. More
2831273 F 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Facial paralysis Facial paralysis
her face was paralyzed for almost a year; This serious case was reported by a consumer via interacti... her face was paralyzed for almost a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a adult female 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 facial paralysis (Verbatim: her face was paralyzed for almost a year) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the facial paralysis was resolved. The reporter considered the facial paralysis to be related to Shingrix. The company considered the facial paralysis to be unrelated to Shingrix. Additional Information: GSK receipt date: 09-MAR-2025 This case was reported by a patient's sister via interactive digital media. The patient got it (Shingrix) and her face was paralyzed for almost a year.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2831274 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected Vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that they received the Shingrix vaccine and still got shingles, it was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2831275 F GA 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Dyspnoea, Post procedural infection, Pruritus, Urticaria Dyspnoea, Post procedural infection, Pruritus, Urticaria
infection from the oral surgery; Hives all over her body; Itching; Trouble breathing; This non-serio... infection from the oral surgery; Hives all over her body; Itching; Trouble breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included oral surgery. Concomitant products included ibuprofen (Motrin). On 25-FEB-2025, the patient received the 1st dose of Shingrix. On 03-MAR-2025, 6 days after receiving Shingrix and 1 days after starting clindamycin, the patient experienced generalized urticaria (Verbatim: Hives all over her body). In MAR-2025, the patient experienced pruritus (Verbatim: Itching) and difficulty breathing (Verbatim: Trouble breathing). On an unknown date, the patient experienced postoperative infection (Verbatim: infection from the oral surgery). The patient was treated with clindamycin and diphenhydramine hydrochloride (Benadryl). The outcome of the generalized urticaria, pruritus, difficulty breathing and postoperative infection were not resolved. It was unknown if the reporter considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix. It was unknown if the company considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The patient self-reported this case. The patient wanted to get back to the emergency room. The patient's sister was the main reporter, but the patient also took part in the conversation, so the reporter details were that of the patient. The patient had the first dose of Shingrix last Tuesday on 25 February 2025. The patient also had oral surgery the same day. The patient was started on Clindamycin on Sunday on 02 March 2025 due an infection from the oral surgery. It was unclear if the patient was taking another antibiotic prior to the Clindamycin. The patient also had been taking Motrin and an unnamed nausea medication due to the oral surgery. On Monday 03 March 2025 the patient stated to experience hives. At 5:30 am this morning 04 March 2025 the patient went to the emergency room with complaints of severe hives which were all over her body, trouble breathing, and itching. The patient was given steroids and IV Benadryl while in the emergency room. Since being home from the emergency room, the patient was using anti-itch spray and took an epsom salt bath. Since the patient was not getting better, the patient was going back to the emergency room for further evaluation. Reporter consent to contact was not given. More
2831276 F NJ 03/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Family stress, Irritability, Pain, Skin discolouration, Vaccination failure; Fam... Family stress, Irritability, Pain, Skin discolouration, Vaccination failure; Family stress, Irritability, Pain, Skin discolouration, Vaccination failure More
suspected vaccination failure; reoccurrence now and may need the vaccination again; irritating; inte... suspected vaccination failure; reoccurrence now and may need the vaccination again; irritating; intensity of the pain; spot on her skin; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (painful episode of shingles over ten years ago (prior to Shingrix dose 1) in 2011 or 2012) and pain. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: reoccurrence now and may need the vaccination again), feeling irritated (Verbatim: irritating), pain (Verbatim: intensity of the pain) and rash (Verbatim: spot on her skin). The outcome of the vaccination failure and shingles were not resolved and the outcome of the feeling irritated, pain and rash were not reported. It was unknown if the reporter considered the vaccination failure, shingles, feeling irritated, pain and rash to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, feeling irritated, pain and rash to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 The patient had a reoccurrence of shingles at the time of reporting and might need the vaccination again. She did not know the exact dates of the Shingrix shots, but she said that she got both shots about 5 years ago from reporting. The pharmacy where she got the shots did not have the injection dates on file. Limited information collected due to the lack of information (and the length of time since the shots were given) as well as a bad or noisy phone connection. She indicated she would call GlaxoSmithKline back if she was able to acquire the dates or lot numbers of the Shingrix shots she received. The patient indicated that her physician did not think she has a current shingles outbreak, but the patient think shingles because something was irritating. The intensity of the pain was similar to what she experienced in the past when she had shingles over ten years ago. The patient mentioned a little spot on her skin (that her physician could not saw). The pharmacy where the Shingrix vaccine was given did not maintain the information for more than 2 years. The physician office did not keep that type of record beyond 5 years. The patient asking how long have to wait in between vaccinations. The patient attributes this outbreak of shingles to have been triggered by family stress. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose) More
2831277 0.58 F 03/13/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
UNK
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
received first dose of Bexsero at 7 months and the second dose after a year; This non-serious case w... received first dose of Bexsero at 7 months and the second dose after a year; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero and the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: received first dose of Bexsero at 7 months and the second dose after a year). 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: 05-MAR-2025 The patient was 3 years and 10 months of age. The reporter had a child who received first dose of Bexsero at 7 months and the second dose after a year, which led to inappropriate age at vaccine administration. The reporter asked that was this safe or she should get another dose. More
2831278 M 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Ulcer, Vaccination failure Herpes zoster, Ulcer, Vaccination failure
Suspected vaccination failure; keeps getting shingles on his face; This serious case was reported by... Suspected vaccination failure; keeps getting shingles on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: keeps getting shingles on his face). The outcome of the vaccination failure and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix. The company considered the vaccination failure and facial herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-MAR-2025 This case was reported by a patient via interactive digital media. The reporter's brother received Shingrix vaccines and now he keeps getting shingles on his face. He ends up with sores. It sounds like you can't win. The reporter haven't had the vaccine himself and was still debating. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix vaccine. More
2831279 62 M MD 03/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 A2J35
Product preparation error Product preparation error
administered only the sterile water for injection component of the Priorix vaccine; administered onl... administered only the sterile water for injection component of the Priorix vaccine; administered only the sterile water for injection component of the Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old male patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis. On 02-MAR-2025, the patient received Priorix. On 02-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the sterile water for injection component of the Priorix vaccine) and inappropriate dose of vaccine administered (Verbatim: administered only the sterile water for injection component of the Priorix vaccine). 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-MAR-2025 The patient was administered only the sterile water for injection component of the Priorix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2025026202, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025026202:Same reporter/Diffrent patient More
2831280 F PA 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5JX9Z
Fatigue, Malaise, Myalgia, Pain, Pyrexia Fatigue, Malaise, Myalgia, Pain, Pyrexia
fever; pain; Fatigue; myalgia; malaise; this as Late 2nd dose; This non-serious case was reported by... fever; pain; Fatigue; myalgia; malaise; this as Late 2nd dose; This non-serious case was reported by a nurse and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 12-OCT-2018) and Covid 19 vaccine (received on an unknown date). On 29-JUL-2019, the patient received the 2nd dose of Shingrix. On 29-JUL-2019, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: this as Late 2nd dose). On an unknown date, the patient experienced fever (Verbatim: fever), pain (Verbatim: pain), fatigue (Verbatim: Fatigue), myalgia (Verbatim: myalgia) and malaise (Verbatim: malaise). The outcome of the fever was unknown and the outcome of the pain, fatigue, myalgia and malaise were not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the fever, pain, fatigue, myalgia and malaise to be related to Shingrix. It was unknown if the company considered the fever, pain, fatigue, myalgia and malaise to be related to Shingrix. Additional Information: GSK Receipt Date: 03-MAR-2025 and 04-MAR-2025 The nurse Anesthetist called and reported that she have an incomplete record for 2nd Shingrix dose, she have a lot number and a date, but nobody would admit to have given that shot, and shot need a complete record for the employment and they want to see that. So if nobody admit that they gave the shot and amend records the patient gonna have to get a 3rd shot, was that gonna be harmful. She mentioned that when she got the vaccines, she had fever. After the second vaccine, they suffered from pain, fatigue, myalgia, malaise and that every time they suffered ever, as well as every time they received the COVID vaccine. More
2831281 16 M OH 03/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB043A
Product preparation error Product preparation error
Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patien... Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient; Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis. On 03-MAR-2025, the patient received Menveo. On 03-MAR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient) and inappropriate dose of vaccine administered (Verbatim: Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 05-MAR-2025 The reporter stated that on Monday, 3rd March 2025 Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. More
2831282 45 F KY 03/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
a female patient received a 1st Twinrix dose on 04-Nov-2024; This non-serious case was reported by a... a female patient received a 1st Twinrix dose on 04-Nov-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (a female patient received a 1st Twinrix dose on 04-Nov-2024, batch number 2KR55, expiry date 03 January 2025). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a female patient received a 1st Twinrix dose on 04-Nov-2024). 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 : 06-MAR-2025 On 06th March 2025 pharmacist mentioned that a female patient received a 1st Twinrix dose on 04th November 2024, and now, the patient was late for the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2831283 71 M KS 03/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 M4B34
Inappropriate schedule of product administration Inappropriate schedule of product administration
HCP gave 2nd dose on 22-Feb-2025; This non-serious case was reported by a pharmacist via call center... HCP gave 2nd dose on 22-Feb-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix adult) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix adult (got his first shot on 14-JUNE-2024). On 22-FEB-2025, the patient received the 2nd dose of Twinrix adult. On 22-FEB-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: HCP gave 2nd dose on 22-Feb-2025). The outcome of the drug dose administration interval too long 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 : 07-MAR-2025 The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule. More
2831284 60 M NY 03/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
recived expired dose of Arexvy; This non-serious case was reported by a other health professional vi... recived expired dose of Arexvy; 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 60-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 24-FEB-2025) for prophylaxis. On 07-MAR-2025, the patient received the 1st dose of Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: recived expired dose of Arexvy). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 10-MAR-2025 The director of a site explained that they administered an expired dose of Arexvy vaccine which led to, expired vaccine used. It was the first dose of a Respiratory Syncytial Virus vaccine for this patient. The reporter did not had lot number for the vaccine. The Vaccine Administration Facility is the same as Primary Reporter. More
📋 Privacy Policy & Data Disclaimer