🏥 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 💀 🏥 🚑 ♿ ⚠️
2865112 41 F FL 10/11/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Pain, Pain in extremity Pain, Pain in extremity
Painful arm on side of shot, very painful body for about 18 hours. Now better Painful arm on side of shot, very painful body for about 18 hours. Now better
2865113 5 M TN 10/11/2025 FLU3
 SANOFI PASTEUR
 U8864CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient recieved flublok 9+, he is 5 years 8m old. He has had no adverse effects or side effects. Th... Patient recieved flublok 9+, he is 5 years 8m old. He has had no adverse effects or side effects. The correct vaccine was scanned in and ready to give. Patient and 10 year old sister were getting flu shots at the same time. Both were hiding and trying to avoid the shot. Brother decided that he would go first in front of sister and I had sisters shot in my hand. SO the 9+ dose was given instead of the fluzone 6m+ More
2865114 55 F OR 10/11/2025 PNC21
 MERCK & CO. INC.
 00006-4347-02
Injection site pruritus, Injection site rash, Injection site swelling Injection site pruritus, Injection site rash, Injection site swelling
Rash developed on injection site after about 24 hours, itching, red, raised, about 6 to 7? in diamet... Rash developed on injection site after about 24 hours, itching, red, raised, about 6 to 7? in diameter. Still growing on Saturday morning 10/11/2025. More
2865115 81 F AL 10/11/2025 COVID19
 PFIZER\BIONTECH
 na0589
Rash erythematous, Swelling face Rash erythematous, Swelling face
Redness in face that looks like a rash to patient. Mild swelling - no swelling in mouth/throat/nose.... Redness in face that looks like a rash to patient. Mild swelling - no swelling in mouth/throat/nose. Recommended antihistamines and to contact physician if symptoms do not resolve for further treatment. More
2865116 18 F IL 10/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0587
409415
Feeling hot, Hyperhidrosis, Pallor, Syncope; Feeling hot, Hyperhidrosis, Pallor,... Feeling hot, Hyperhidrosis, Pallor, Syncope; Feeling hot, Hyperhidrosis, Pallor, Syncope More
patient sitting in vaccine room and began to feel hot and stated she felt as if she was sweating. Th... patient sitting in vaccine room and began to feel hot and stated she felt as if she was sweating. This feeling began a couple minutes after receiving both vaccines (COVID and FLU). She stopped speaking and became very pale and essentially had a minor fainting episode. She laid down and regained color, full speaking, and full awareness after a few minutes. Offered 9-1-1 services and patient declined. Patient and father waited 15 minutes and decided to leave. More
2865117 52 F MD 10/11/2025 CHIK
JEV1
 BAVARIAN NORDIC
INTERCELL AG
 FDP00694
JEV23J01E
Urticaria; Urticaria Urticaria; Urticaria
Client reports that she received Chikungunya (Vimkunya) and JE 09/25/2025 around 11am. She later wen... Client reports that she received Chikungunya (Vimkunya) and JE 09/25/2025 around 11am. She later went to her local pharmacy to receive Hep B (Heplisav #2) around 1pm on that same day. Patient stated that around 9pm that same evening that she started to develop hives in the bottom of her feet which progressively got worse and continues to this day. Client denied shortness of breath, throat swelling or signs of severe distress. Client reports that she has been using Benadryl and topical creams to control the itching. Denied any changes to food or detergent. RN advised to follow up with PCP. More
2865118 69 F PA 10/11/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 70461-0025-03
70461-0025-03
Chills, Feeling hot, Headache, Influenza, Muscle spasms; Pain Chills, Feeling hot, Headache, Influenza, Muscle spasms; Pain
Pharmacist gave me injection in right arm muscle felt warm sensation between my breast, heart, lungs... Pharmacist gave me injection in right arm muscle felt warm sensation between my breast, heart, lungs? It was strange. Then I got muscle spasms in top right back, middle right back near kidneys at the same time I was getting spasms in left top back, middle above kidneys. Then was in hips then moved to my thighs down my legs. Was not dizzy. Just painful nonstop muscle spasms. I sat for a couple minutes then went to my car. After a few minutes all of the spasms were gone. That evening, I did get flu symptoms, chills, achy, headache. Lasted for two to three days. Have gotten the flu shots for quite some time. Never the 65+.. More
2865119 78 F TN 10/11/2025 PNC20
 PFIZER\WYETH
 ma2488
Extra dose administered Extra dose administered
It was a duplicate. Patient got 1 dose of Prevnar on 10/5/2023. I called pt and could not leave a me... It was a duplicate. Patient got 1 dose of Prevnar on 10/5/2023. I called pt and could not leave a message (call rejected) More
2865121 71 F FL 10/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7523J
7523J
Chills, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Sleep disorde... Chills, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia; Sleep disorder More
Patient reported painful swollen arm that itches. Lasting 4 days at time of notification. Fever, chi... Patient reported painful swollen arm that itches. Lasting 4 days at time of notification. Fever, chills, and disrupted sleep. More
2865122 81 F 10/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
Patient received Arexvy 10/25/2024 and on 10/10/2025 received an additional dosage Patient received Arexvy 10/25/2024 and on 10/10/2025 received an additional dosage
2865123 51 M NY 10/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3t74x
Injection site warmth, Malaise Injection site warmth, Malaise
Patient complains of pain by injection site.. feels hot.. (no fever) general malaise Patient complains of pain by injection site.. feels hot.. (no fever) general malaise
2865124 52 F MO 10/11/2025 COVID19
 MODERNA
 8080803
Expired product administered, No adverse event Expired product administered, No adverse event
Product was expired (expired 06/11/2025) by 4 months. Took it out of the freezer the day before and... Product was expired (expired 06/11/2025) by 4 months. Took it out of the freezer the day before and didn't notice that it was last years stock (2024-2025). Both packages were identical besides year on box. Patient has not had any adverse events but is concerned about efficacy since it was past it's expiration . I have contacted both CDC and Moderna but have not been given a firm confirmation if the patient should revaccinate. More
2865125 52 F MI 10/11/2025 FLU3
 SEQIRUS, INC.
Wrong product administered Wrong product administered
Patient received fluad instead of fluarix Patient received fluad instead of fluarix
2865126 80 F VA 10/11/2025 PNC21
 MERCK & CO. INC.
 z004302
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
arm turned red from site of injection down to the elbow and then after 5 days it has begun to itch arm turned red from site of injection down to the elbow and then after 5 days it has begun to itch
2865127 21 M UT 10/11/2025 FLU3
 SEQIRUS, INC.
 409413
Syncope Syncope
Pt received flu shot, a few minutes later he fainted. Pt's mom says he faints fairly often beca... Pt received flu shot, a few minutes later he fainted. Pt's mom says he faints fairly often because of a hereditary condition. Pt fully recovered after a few minutes, he was given water and carbohydrates. More
2865128 82 M FL 10/11/2025 COVID19
FLU3
RSV
 PFIZER\BIONTECH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 na0589
ut8781da
bg5j4
Brain scan normal, Cardiac function test normal, Dizziness, Gait disturbance, Ve... Brain scan normal, Cardiac function test normal, Dizziness, Gait disturbance, Vertigo; Brain scan normal, Cardiac function test normal, Dizziness, Gait disturbance, Vertigo; Brain scan normal, Cardiac function test normal, Dizziness, Gait disturbance, Vertigo More
The patient stated that within a few days of getting the RSV, COVID, and FLU vaccines he experienced... The patient stated that within a few days of getting the RSV, COVID, and FLU vaccines he experienced terrible vertigo symptoms. He ended up at the hospital because he was so dizzy he couldn't walk. The hospital completed brain imaging and heart tests and the results were clear. The doctors at the hospital concluded that the three vaccines he got are the cause of his extreme vertigo. He has tried and failed multiple treatment options following being discharged from the hospital. More
2865129 54 F CA 10/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 NA0590
2CA5M
Injection site haemorrhage, Injection site reaction, Urticaria; Injection site h... Injection site haemorrhage, Injection site reaction, Urticaria; Injection site haemorrhage, Injection site reaction, Urticaria More
Upon intramuscular injection of the COVID19 vaccine into the left deltoid, there was a rush of blood... Upon intramuscular injection of the COVID19 vaccine into the left deltoid, there was a rush of blood at the site of injection. The blood stopped after the vaccine administrator applied pressure with cotton, and blood was wiped with alcohol wipes. There was a welt that developed soon after the bleeding, underneath the skin. The welt at first increased in size. The patient's daughter who was with her at the time was translating for her. When asked if the patient experienced any symptoms, such as lightheadedness or nausea, the patient said no. The vaccine administrator and health professionals at the clinic monitored the patient and the size of the welt. Over time, as ice was put on the site of injection, the welt started to decrease in size very gradually. About 10 minutes later, the welt was minimal but still visible, and the patient proceeded to receive a flu vaccine on the right arm by a different vaccine administrator. More
2865130 84 M AZ 10/11/2025 FLU3
FLU3
HEPAB
HEPAB
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 UT8794CA
UT8794CA
AZ2A3
AZ2A3
Z007870
Z007870
Asthenia, Blood pressure decreased, Dizziness, Echocardiogram, Fatigue; Laborato... Asthenia, Blood pressure decreased, Dizziness, Echocardiogram, Fatigue; Laboratory test; Asthenia, Blood pressure decreased, Dizziness, Echocardiogram, Fatigue; Laboratory test; Asthenia, Blood pressure decreased, Dizziness, Echocardiogram, Fatigue; Laboratory test More
Patient received the 3 shots, left to shop in the store with his wife. Approximately 45 minutes la... Patient received the 3 shots, left to shop in the store with his wife. Approximately 45 minutes later he apparently began experiencing lightheadedness, and dizziness. He was concerned enough that he asked his wife to get help. She go the store management involved who intern called EMS. The got him seated in a chair, and he became very tired, weak, and closed his eyes. When I heard about his situation, as soon as I could I met up with the paramedics who already were monitoring patient. They were giving him IV fluids. They said his blood pressure was very low. The one male paramedic stated that he wondered if the patient had experienced a vagal response to the shots. The wife wondered if it was related at all to a seizure he had had a week or so ago. When the ambulance arrived, with support, he was able to stand and climb onto the gurney and was taken in the ambulance. More
✓
2865131 75 F CT 10/11/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.



Dizziness, Fatigue, Heart rate increased, Injected limb mobility decreased, Pain... Dizziness, Fatigue, Heart rate increased, Injected limb mobility decreased, Pain; Pain in extremity, Peripheral swelling, Sensory disturbance; Dizziness, Fatigue, Heart rate increased, Injected limb mobility decreased, Pain; Pain in extremity, Peripheral swelling, Sensory disturbance More
During shot, it was really painful going in. (never had this happen before with multiple shots over ... During shot, it was really painful going in. (never had this happen before with multiple shots over years). Arm was in severe pain for three days, unable to life above waist level. BP shot up into ranges I don't normally see. Had been in the 120/68 area for a couple months, including at GP's office 3 days before this shot. My feet and legs started swelling and caused a lot of pain on top outsides of feet. I was getting BP readings as high has 187/89 and at times heart rate was high. I still feel fluttering in my neck like my heart is beating fast when I am just sitting. I was given lasix that caused bad cramping so was told to go back to HCTZ. I suffered for days like this, calling GP, kidney doctor and cardiologist. Only one who wanted to see me was kidney doctor. By the time I saw him on 9/30/25, the swelling had gone down a couple days before. The pain started subsiding 2 days after swelling went down. It took a few more days before most of the pain had disappeared. I reported the painful arm to the pharmacy but did not report the other issues to them as of yet. I have also been very tied and light headed and this has not stopped. More
2865132 92 M SC 10/11/2025 FLU3
 SANOFI PASTEUR
 U8859BA
Chills, Dysstasia, Pyrexia, Tremor Chills, Dysstasia, Pyrexia, Tremor
The patient's wife came in the pharmacy and said that about two days after he got his flu vacci... The patient's wife came in the pharmacy and said that about two days after he got his flu vaccine he spiked a fever. She said he had the chills and was very shaky and had trouble standing. I called him and spoke with him and he said he was taking tylenol four times daily to help with the fever. I spoke with him today on 10/11 and he still said he's having some fever and chills and taking the tylenol. More
2865133 0.5 F TN 10/11/2025 UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER





Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal... Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase normal, Blood albumin decreased, Blood alkaline phosphatase normal; Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Carbon dioxide normal; Endotracheal intubation, Haematocrit normal, Haemoglobin normal, Neutrophil count normal, Platelet count normal; Procalcitonin increased, Protein total decreased, Respiratory failure, Seizure, Status epilepticus; White blood cell count normal More
Pt received routine 6-mth vaccines at PCP on the day prior to admission to my service. Please reach ... Pt received routine 6-mth vaccines at PCP on the day prior to admission to my service. Please reach out to PCP regarding individual vaccines and lot numbers. At approximately 0300 this morning, the patient developed status epilepticus and subsequent respiratory failure requiring intubation and significant antiepileptic doses to control seizures. Pt was subsequently found to have rhinovirus and adenovirus on nasal swab. Given the positive RPP, this would typically not reach my threshold for adverse event reporting; however, patient also developed complex febrile seizures at age 4-months the day following her vaccines. More
✓ ✓
2865134 67 M NC 10/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3e27g
Extra dose administered Extra dose administered
Patient received a 3rd lifetime dose of Shingrix Patient received a 3rd lifetime dose of Shingrix
2865135 32 F CA 10/11/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2CA5M
Paraesthesia, Pharyngeal swelling, Sinus congestion Paraesthesia, Pharyngeal swelling, Sinus congestion
Patient received Fluarix flu shot at an offsite event at Center on 10/11/2025 at around 12:45pm. At ... Patient received Fluarix flu shot at an offsite event at Center on 10/11/2025 at around 12:45pm. At 1:00pm patient came back to state she was experiencing the following side effects: tingling on hands and legs and swelling in the back of her throat, in her "back sinuses" per patient. Patient was speaking in clear/full sentences, she was not in any signs of distress. at 1:00pm, vitals were taken 135/90, O2 99%, RR 22, and then at 1:13pm a second assessment was completed BP 142/90, O2 sat 99%, RR 20, Temp: 98.8F. 911 was called at 1:16pm, Epi-pen given on right thigh at 1:19pm. Patient wanted to hold off on the Epi-Pen during first assessment, I explained to the patient that this must be given if she is continuing having symptoms and throat feels swollen, patient requested for EMS to be called and then okay to give Epi-pen. Patient has received an Epi-pen in the past for a food allergy (unknown, patient did not state exact allergy), however states no reactions to Flu vaccines in the past. Paramedics arrived to the scene at 1:26pm, paramedics stated patient was stable, but patient taken to ER for further evaluation. More
2865137 63 F MI 10/11/2025 HEPAB
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 P2443
Y019157
Injection site reaction, Muscle atrophy; Injection site reaction, Muscle atrophy Injection site reaction, Muscle atrophy; Injection site reaction, Muscle atrophy
Patient came in 10/10/2025 for second Dose of Twinrix and stated she has muscle loss at site of inje... Patient came in 10/10/2025 for second Dose of Twinrix and stated she has muscle loss at site of injection More
2865138 54 F FL 10/11/2025 FLU3
 SANOFI PASTEUR
 ut8852na
Peripheral swelling, Swelling face Peripheral swelling, Swelling face
patient had swollen arms and face within 20 min of administration patient had swollen arms and face within 20 min of administration
2865139 62 F MA 10/11/2025 PNC20
 PFIZER\WYETH
 LX4484
Dyspnoea, Palpitations, Rash erythematous Dyspnoea, Palpitations, Rash erythematous
Patient reported that she has had a round, red rash on and off for the past week, starting on the da... Patient reported that she has had a round, red rash on and off for the past week, starting on the day after she received the Prevnar20 vaccine. The rash is visible, slightly raised, and about 1.5 inches in diameter on the day of reporting. She also noted that she had heart palpitations and shortness of breath on 10/4/25 when she first noticed the rash. I advised her to take OTC benadryl for the rash and follow up with her doctor if it doesn't get better. Of note, she had also received a flu shot in the same (right) arm just 4 days prior to the Prevnar20 vaccine on 9/29/25. More
2865140 43 F MI 10/11/2025 FLU3
 SANOFI PASTEUR
 u8832aa
Dizziness Dizziness
Patient felt dizzy. upon asking if she has had this before in the past, she said no. Patient said sh... Patient felt dizzy. upon asking if she has had this before in the past, she said no. Patient said she did not eat much today and that could potentially cause the dizziness More
2865141 67 F OR 10/11/2025 FLU3
 SANOFI PASTEUR
 ut8804ca
Chills, Nausea, Pain Chills, Nausea, Pain
body aches chills nausea about around 5 hours after administration body aches chills nausea about around 5 hours after administration
2865142 65 M OR 10/11/2025 FLU3
 SANOFI PASTEUR
 U8830AA
Peripheral swelling, Rash Peripheral swelling, Rash
Patient reported having arm swelling and rash that started 4 to 5 days after getting flu shot. Has h... Patient reported having arm swelling and rash that started 4 to 5 days after getting flu shot. Has had flu shots previously prior to this year with no adverse effects, this is the first year he received the high dose version for adults over 65. He also started a new beet supplement at the same time. He self treated with diphenhydramine which had nearly eliminated symptoms at time of report a week after shot. More
2865143 89 F MI 10/11/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8855AA
Z009681
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
Patient came to the pharmacy and said she had developed a reaction to the two vaccines she had recei... Patient came to the pharmacy and said she had developed a reaction to the two vaccines she had received on 10/8/25. She had opted to receive both vaccines in her left arm. She showed me her left arm and it was red in a circular pattern around where both of the vaccines had been given and where the two Inject safe barrier bandages had sat. The redness was limited to her upper arm in the deltoid region. She denied any swelling or itching but said that it did feel slightly warm to the touch. She said that she had showed her doctor at her regularly scheduled office visit on 10/10/25 and they wrote her an antibiotic prescription "just in case" of infection because of the warmness to the touch in addition to the redness. More
2865144 84 F CA 10/11/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8164BB
U8164BB
Dysstasia, Fall, Injected limb mobility decreased, Muscular weakness, Pain in ex... Dysstasia, Fall, Injected limb mobility decreased, Muscular weakness, Pain in extremity; Spinal column injury More
received flu shot around 4-5 pm on 10/9, started experiencing symptoms around 9:30 pm of strong pain... received flu shot around 4-5 pm on 10/9, started experiencing symptoms around 9:30 pm of strong pain in the arm of injections Left arm, pain was so bad could not use her arm, currently can raise arm not too high but uncomfortable. Also experiencing around 6 am very weak legs, had hard time getting out of bed that she fell and hit the tail bone on the floor. can walk and stand, but have hard time getting into the bed. currently feel weak but able to function. (also stated husband had same shot w/o issue), feels like not necessary to go to emergency room, suggested her to go to ER just for peace of mind due to possibility of guillain Barre Syndrome, she said her daughter may be coming over and can probably assist her to ER More
2865145 66 F TN 10/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0738
407253
Lip erythema, Lip swelling; Lip erythema, Lip swelling Lip erythema, Lip swelling; Lip erythema, Lip swelling
PATIENT PRESENTED TO THE PHARMACY ON 10/11/2025 AT ABOUT 7PM WITH COMPLAINS OF SWOLLEN LIPS. WHEN A... PATIENT PRESENTED TO THE PHARMACY ON 10/11/2025 AT ABOUT 7PM WITH COMPLAINS OF SWOLLEN LIPS. WHEN ASKED BY THE PHARMACIST, PTATIENT STATED THAT SHE COULD BREATH WELL, THERE WERE NO RASHES OR OTHER HEALTH CONCERNS. VISUALL INSPECTION OF THE LIPS SHOWS RED AND SWOLLEN UPPER LIP, FROM THE LEFT SIDE OF THE MOTH UPTO THE CENTER OF THE LIPS More
2865146 86 F CO 10/11/2025 RSV
 PFIZER\WYETH
 LN5489
Extra dose administered Extra dose administered
received a second abrysvo in error- pt stated that she did not have a previous rsv shot, no shot on ... received a second abrysvo in error- pt stated that she did not have a previous rsv shot, no shot on database- only found after processing after shot was given More
2865147 77 F 10/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 72R4G
Pain, Pain in extremity Pain, Pain in extremity
Body aches and sore arm Body aches and sore arm
2865149 74 F PA 10/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Unknown
Unknown
Unknown
Unknown
3052733
3052733
3052733
3052733
Encephalitis, Magnetic resonance imaging head abnormal, Unresponsive to stimuli;... Encephalitis, Magnetic resonance imaging head abnormal, Unresponsive to stimuli; Asthenia, Confusional state, Diarrhoea, Dizziness, Headache; Loss of consciousness, Pyrexia, Syncope, Tremor, Unresponsive to stimuli; Vomiting; Encephalitis, Magnetic resonance imaging head abnormal, Unresponsive to stimuli; Asthenia, Confusional state, Diarrhoea, Dizziness, Headache; Loss of consciousness, Pyrexia, Syncope, Tremor, Unresponsive to stimuli; Vomiting More
Found unresponsive MRI vaccine induced encephalitis MRI brain Imaging Imaging findings suggestive of... Found unresponsive MRI vaccine induced encephalitis MRI brain Imaging Imaging findings suggestive of meningitis/encephalitis with pachymeningeal thickening/enhancement, leptomeningeal enhancement, and parenchymal enhancement. findings suggestive of meningitis/encephalitis with pachymeningeal thickening/enhancement, leptomeningeal enhancement, and parenchymal More
✓ ✓
2865150 9 M LA 10/11/2025 FLU3
 SANOFI PASTEUR
 ut8858na
Swelling face Swelling face
approximately 30 minutes after receiving the vaccine, the patient experienced swelling of the face, ... approximately 30 minutes after receiving the vaccine, the patient experienced swelling of the face, particularly the eyes and lips. No trouble breathing More
2865151 23 F AK 10/11/2025 HPV9
 MERCK & CO. INC.
Fatigue, Narcolepsy Fatigue, Narcolepsy
As the patient after the second dose I began to notice chronic fatigue. I completed the 3 shot serie... As the patient after the second dose I began to notice chronic fatigue. I completed the 3 shot series, every 3 months. Symptoms worsened and eventually visited: Dr (withheld name, address, city, state, phone number) at the time I was not informed of possible side effects of the Gardasil vaccine nor did any primary care I addressed my issues make a connection to it being a vaccine injury. Eventually was sent sent to a neurologist for further testing and Diagnosed with Narcolepsy in Summer of 2010 after multiple visits to OBGYN and Primary care office with a referral to see Neurologist. More
✓
2865152 10 M CO 10/11/2025 FLU3
 SANOFI PASTEUR
 U8881AA
Dizziness, Fall Dizziness, Fall
Vaccine was administered to child patient around 5:00 pm on 10/11/2025. Patient's father consen... Vaccine was administered to child patient around 5:00 pm on 10/11/2025. Patient's father consented to have Fluzone administered to his son. After vaccine was administered, patient left the vaccination area, got lightheaded and fell to the floor. More
2865153 49 F WA 10/11/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 u8863aa
z003579
Injection site erythema, Injection site mass, Injection site pain, Injection sit... Injection site erythema, Injection site mass, Injection site pain, Injection site swelling; Injection site erythema, Injection site mass, Injection site pain, Injection site swelling More
Red raised lump on and around injection site. The area is swollen and painful. Developed the evening... Red raised lump on and around injection site. The area is swollen and painful. Developed the evening of immunization. More
2865154 62 F 10/11/2025 COVID19
 MODERNA
Dysgeusia, Influenza like illness, Paraesthesia oral Dysgeusia, Influenza like illness, Paraesthesia oral
Also Influenza vaccine, unsure of manufacturer. Flu-like symptoms for 2 days. On day 5 until present... Also Influenza vaccine, unsure of manufacturer. Flu-like symptoms for 2 days. On day 5 until present, oral paresthesia and dysgeusia. More
2865155 28 M 10/11/2025 COVID19
 PFIZER\BIONTECH
Abdominal discomfort, Abdominal pain, Diarrhoea Abdominal discomfort, Abdominal pain, Diarrhoea
severe abdominal pain and cramping two days after, continued intermitent discomfort and diarrhea for... severe abdominal pain and cramping two days after, continued intermitent discomfort and diarrhea for 10 days after More
2866249 11 F NY 10/11/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Z002903
Z002903
U8508AA
U8508AA
YCA04C1
YCA04C1
Computerised tomogram head, Headache, Intracranial pressure increased, Magnetic ... Computerised tomogram head, Headache, Intracranial pressure increased, Magnetic resonance imaging head abnormal, Pain; Papilloedema, Ventriculo-peritoneal shunt; Computerised tomogram head, Headache, Intracranial pressure increased, Magnetic resonance imaging head abnormal, Pain; Papilloedema, Ventriculo-peritoneal shunt; Computerised tomogram head, Headache, Intracranial pressure increased, Magnetic resonance imaging head abnormal, Pain; Papilloedema, Ventriculo-peritoneal shunt More
child starting headache and bodyache with no fever 3rd day or 2nd day after vaccine. child sent to h... child starting headache and bodyache with no fever 3rd day or 2nd day after vaccine. child sent to hospital twice for severe headache CT done WNL. Send again to same ER 10-2-25 for severe headache MRI done showed sign of Inc. ICPS papilledema with stasis of Trauma Central Vein. Shunt done. Attached documented for hospital visits and D/C and report of Neurosurgeon More
✓
2864755 AZ 10/10/2025 HPV9
 MERCK & CO. INC.
 Y007197
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Incorrect product storage; This spontaneous report was received from a medical ass... No additional AE; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Aug-2025, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007197 has been verified to be a valid lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date: 18-Aug-2026) syringe, 0.5 mL, for prophylaxis (Product storage error) (frequency and route of administration were not reported). The temperature excursion was 71.11 F for 5 minutes. Time frame for 0 hours 5 minutes. There was a previous temperature excursion of 52.16 F for 1 hour 0 minutes 0 seconds. No adverse event was reported. This is one of two cases from the same reporter. More
2864756 TX 10/10/2025 HEPA
 MERCK & CO. INC.
 Z005472
No adverse event, Product administered to patient of inappropriate age, Wrong pa... No adverse event, Product administered to patient of inappropriate age, Wrong patient received product More
No effects reported; VAQTA was inadvertently administered to a 6 day old patient; This spontaneous r... No effects reported; VAQTA was inadvertently administered to a 6 day old patient; This spontaneous report was received from a Physician and refers to a 6-day-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 19-Sep-2025, in the morning, the patient was inadvertently vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 mL (lot #Z005472, expiration date: 08-Jul-2026) (route of administration, anatomical location not provided) as prophylaxis, at the age of 6 days-old. It was reported that it was due to the medical assistant had accidentally gone into the wrong patient room. No effects reported. More
2864757 F 10/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Renal disorder, Vaccination failure; Herpes zoster, Renal disorde... Herpes zoster, Renal disorder, Vaccination failure; Herpes zoster, Renal disorder, Vaccination failure More
Suspected Vaccination failure; shingles; very hard on the kidneys; This serious case was reported by... Suspected Vaccination failure; shingles; very hard on the kidneys; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and renal disorder (Verbatim: very hard on the kidneys). The outcome of the vaccination failure, shingles and renal disorder were not reported. It was unknown if the reporter considered the vaccination failure, shingles and renal disorder to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and renal disorder to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-SEP-2025 and 01-OCT-2025 This case was reported by a patient via interactive digital media. Patient received two vaccine doses, but she still got shingles. The shingles shots did not prevent the shingles and were very hard on her kidneys. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (1st and 2nd dose), in a female patient. Based on the available information a? possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864758 F VA 10/10/2025 COVID19
 PFIZER\BIONTECH
Vaccination site mass Vaccination site mass
lump; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 62-ye... lump; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "arthritic" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: within first year or year and a half, think was in 2021, or may have been as late as 2022-had twice; "heart issues" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing), notes: penicillin and sulfa medications. The patient's family history included: "autoimmune disease" (unspecified if ongoing), notes: Son. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; CETIRIZINE HCL taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for gastrooesophageal reflux prophylaxis. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1; left arm-Lot Number: EP7534), administration date: 13Mar2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 2; right arm-Lot Number: EW0151), administration date: 03Apr2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 3; Lot Number: FH8020), administration date: 14Oct2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 4; Lot Number: FJ4991), administration date: 09Apr2022, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 5; Lot Number: FP7138), administration date: 12Aug2022, for COVID-19 immunization, reaction(s): "lump". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "lump". Therapeutic measures were taken as a result of vaccination site mass. Additional information: the very first shot was very painful, thereafter, it really bothered her. It was stated, "there was a hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot." Each time she would get a COVID vaccination, it was stated that the "lump would go back and forth between her two arms." The patient clarified, she experienced lumps in both arms, as she had shots in both arms. The first vaccination was in the left arm. This event happened in the right arm as well and was described as "just terrible." The patient stated when rubbing her arm, she felt lumps and were "still sore but not horrible." The patient felt that this was not anything that would keep her from doing what she needed to do, just made it maybe a little less comfortable. The lumps started in the arm where she initially had the vaccination (in left arm). Then over time the lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. The patient now had multiple lumps, in both arms. The patient did not know the specific date the lumps started. When she received the first vaccination, within a few days, the lump was still there. The patient was told by the pharmacist that it was a significant lump, and the pharmacist would call the lump an injection injury. When the patient mentioned the event to her doctor, the doctor said they did not know what she was talking about. The patient then clarified, she now had multiple lumps. The patient said, "almost every time she has gotten a shot, she would get a lump and has multiple lumps in both arms." Regarding treatment, when she asked if she should use a hot or cold compress she was told no and that it would work itself out over time and told her to just take acetaminophen (TYLENOL), or acetylsalicylic acid (ASPIRIN). The patient was afraid to massage too much, and she did not really rub it but would check to see if it was still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2864759 75 F ME 10/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.

Abdominal pain, Decreased appetite, Dyspepsia, Flatulence, Nausea; Abdominal pai... Abdominal pain, Decreased appetite, Dyspepsia, Flatulence, Nausea; Abdominal pain, Decreased appetite, Dyspepsia, Flatulence, Nausea More
indigestion; Gas/Flatulence; abdominal pain; nausea; anorexia; This is a spontaneous report received... indigestion; Gas/Flatulence; abdominal pain; nausea; anorexia; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 03Oct2025 as dose 11, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 03Oct2025 as 0.5 ml, single, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 3: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 4: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 5: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 6: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 7: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 8: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 9: in left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 omicron (lp.8.1) (Dose 10: in left arm), administration date: 2025, for Covid-19 immunization, reaction(s): "Abdominal pain", "Chills", "anorexia", "Indigestion", "constant burping", "Gas/Flatulence", "felt really crummy", "nausea", "fever". The following information was reported: DYSPEPSIA (non-serious), outcome "recovering", described as "indigestion"; FLATULENCE (non-serious), outcome "recovering", described as "Gas/Flatulence"; ABDOMINAL PAIN (non-serious), outcome "recovering"; NAUSEA (non-serious), outcome "recovering"; DECREASED APPETITE (non-serious), outcome "recovering", described as "anorexia". Therapeutic measures were not taken as a result of dyspepsia, flatulence, abdominal pain, nausea, decreased appetite. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Second side effects with the Pfizer COVID-19 vaccine: patient confirmed second side effects with the Pfizer COVID-19 vaccine were the same side effects, same things, abdominal issues, clarified as indigestion, gas/flatulence, abdominal pain, nausea, and anorexia. That is when put two and two together, thought oh that's why felt like that after COVID shot last Spring. Had the most recent COVID shot Friday morning, 03Oct2025. Was in bed all day Saturday. All side effects the second time, abdominal issues, clarified as indigestion, gas/flatulence, abdominal pain, nausea, and anorexia, are resolving, not completely resolved at this point, but all are resolving. No treatment or medical interventions, patient then stated she just took over the counter remedies herself. Patient doesn't have dates handy at time of call for previous 1 to 9 doses and patient took 10th dose in spring 20205 also patient believes all doses were in left arm since she is right handed. Patient also had the shingles vaccine, but waited at least 6 weeks ago from the most recent dose of the COVID vaccine, didn't want close together. More
2864760 80 M NC 10/10/2025 COVID19
 PFIZER\BIONTECH
 NDC 00069-2528=
Heart rate, Heart rate increased Heart rate, Heart rate increased
HEART RATE INCREASE. RESTING HR FROM 62 TO 78, SLEEPING HR FROM 58 TO 76, HAD TO CALL EMS AT 2AM O... HEART RATE INCREASE. RESTING HR FROM 62 TO 78, SLEEPING HR FROM 58 TO 76, HAD TO CALL EMS AT 2AM ON 10/7/25 AND THEY DOCUMENTED HR at 159-168 FOR 32 MINUTES.; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 at 09:30 as dose 1, single (Lot number: NDC 00069-2528=10) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HAD PHYSICAL" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Oct2025 at 02:00, outcome "not recovered", described as "HEART RATE INCREASE. RESTING HR FROM 62 TO 78, SLEEPING HR FROM 58 TO 76, HAD TO CALL EMS AT 2AM ON 10/7/25 AND THEY DOCUMENTED HR at 159-168 FOR 32 MINUTES.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased. Additional information: Patient didn't receive any other vaccines on the same date as the vaccine(s) for which reporting. Patient didn't receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which reporting.Patient wasn't taking any other medications within 2 weeks of the event starting. More
2864788 F 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
I am in pain now from the 1st shot; This non-serious case was reported by a consumer via interactive... I am in pain now from the 1st shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Ethnicity- other. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I am in pain now from the 1st shot). The outcome of the pain was not resolved. The reporter considered the pain to be related to Shingrix. The company considered the pain to be related to Shingrix. Additional Information: GSK receipt date:28-SEP-2025 The patient reported case for herself. The batch number was not provided, and we are unable to contact the reporter. The patient mentioned that she was in pain now from the 1st shot. The next one is due after 1st December, and she need a tranquilizer first. More
2864789 M CT 10/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 3J9G4
Expired product administered, Product administered to patient of inappropriate a... Expired product administered, Product administered to patient of inappropriate age More
Expired dose administered; Inappropriate age at vaccine administration; This non-serious case was re... Expired dose administered; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a infant male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis. On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the expired vaccine used and inappropriate age at vaccine administration 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: 23-SEP-2025 Nurse practitioner reported that in terms of the maximum efficacy post expiration date and asked that if the vaccine still effective after the expiration date. More
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