🏥 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 💀 🏥 🚑 ♿ ⚠️
2865774 17 M ID 10/14/2025 FLU3
FLU3
MENB
MENB
TDAP
TDAP
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 F4A7R
F4A7R
LL0641
LL0641
9JT4S
9JT4S
Z008082
Z008082
Dyspnoea, Eye movement disorder, Loss of consciousness, Pallor, Tremor; Unrespon... Dyspnoea, Eye movement disorder, Loss of consciousness, Pallor, Tremor; Unresponsive to stimuli; Dyspnoea, Eye movement disorder, Loss of consciousness, Pallor, Tremor; Unresponsive to stimuli; Dyspnoea, Eye movement disorder, Loss of consciousness, Pallor, Tremor; Unresponsive to stimuli; Dyspnoea, Eye movement disorder, Loss of consciousness, Pallor, Tremor; Unresponsive to stimuli More
Patient was administered all 4 vaccines on Left arm / deltoid. As vaccines were being administered, ... Patient was administered all 4 vaccines on Left arm / deltoid. As vaccines were being administered, patient mentioned that he was feeling well and was talking. Upon injecting the last vaccine (Influenza), patient was inquiring regarding if not eating before vaccination could cause fainting. Patient then became pale and his eyes started rolling back. Patient was making sounds as if gasping for air and shaking. Patient was laid down and ice pack was placed on the back of patient's neck. Patient's name was called out a few times but no response was received by patient. Provider FNP was pulled into the room for advise. After around 1-2 minutes of unresponsiveness, patient started laughing and asking what had happened. Patient mentioned that he had lost consciousness and did not recall any of the events after receiving the last vaccine. Provider FNP advised that patient not receive other vaccines that he was due for at this time. Patient was instructed to sit back for a few minutes to make sure that he was feeling better. While patient was sitting for a few minutes, he was also brought in a cup of water and was instructed to take small sips of water. After 10 minutes, patient got up and stated that he was feeling better and was ready to go home. More
2865775 67 F TX 10/14/2025 COVID19
 MODERNA
 3052835
Decreased appetite, Fatigue, Wrong product administered Decreased appetite, Fatigue, Wrong product administered
Patient was given Spikevax vaccine instead of mNexspike as intended by patient; Patient did not rep... Patient was given Spikevax vaccine instead of mNexspike as intended by patient; Patient did not report any unusual side effects aside from loss of appetite, possibly some nausea/ vomiting ( patient attributed to Zepbound which she is currently taking) and fatigue More
2865776 12 F OR 10/14/2025 HPV9
 MERCK & CO. INC.
 Z005469
Loss of consciousness, Nausea, Pallor, Syncope, Vomiting Loss of consciousness, Nausea, Pallor, Syncope, Vomiting
Pallor, syncope about 3 min after vaccine administered. Immediate return of consciousness. Felt naus... Pallor, syncope about 3 min after vaccine administered. Immediate return of consciousness. Felt nauseous. Vomited once 60 min after administration then was back to baseline. More
2865777 69 F FL 10/14/2025 RSV
 PFIZER\WYETH
 MF2162
Extra dose administered, No adverse event Extra dose administered, No adverse event
No Adverse event, submitting a vaers incident because patient had received the Arexvy RSV vaccine ba... No Adverse event, submitting a vaers incident because patient had received the Arexvy RSV vaccine back in January 2024, she came in asking for RSV shot again on 10/13/2025 and we gave her the Abrysvo. More
2865779 41 F MD 10/14/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9fg5m
9fg5m
Arthralgia, Contusion, Impaired work ability, Injection site pain, Product admin... Arthralgia, Contusion, Impaired work ability, Injection site pain, Product administered at inappropriate site; X-ray limb normal More
Pain upon injection. I thought it was more than usual. Look at the site and it was very high on my... Pain upon injection. I thought it was more than usual. Look at the site and it was very high on my shoulder. bruised on the top "corner" of the should. 11 days after the injection still had pain in the shoulder, more in the joint, not muscular. Went to Urgent Care 9/29, they took X-rays, their X-ray did not show anything abnormal in the should, but was instructed to call an orthopedic doctor the next day as it was after hours. Orthopedic doctor 10/2 prescribed anti inflammatory medication, and gave a referral for physical therapy, if I wanted to. I continue to have symptoms and some days feels worse. This situation is ongoing, I'm attempting to get into physical therapy and contemplating getting a second opinion from a different orthopedic doctor. I have also been unable to work my secondary job as a server in a restaurant and have had to modify some things through my day job. More
2865780 28 F 10/14/2025 COVID19
 PFIZER\BIONTECH
 NA4452
Dizziness, Tremor, Vertigo Dizziness, Tremor, Vertigo
Patient reports vertigo, dizziness, "head is shaking" Patient reports vertigo, dizziness, "head is shaking"
2865781 50 F TN 10/14/2025 FLU3
 SEQIRUS, INC.
 406986
Chills, Headache, Pyrexia, Syncope Chills, Headache, Pyrexia, Syncope
Patient described fever, chills, headaches, and fainted several days after receiving immunization. Patient described fever, chills, headaches, and fainted several days after receiving immunization.
2865782 24 M CA 10/14/2025 FLU3
 SANOFI PASTEUR
 UT8836KA
Injection site discomfort, Injection site erythema, Injection site induration, I... Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth, Sleep disorder More
Patient experienced red, hot, induration beginning less than 24 hours after receiving immunization 1... Patient experienced red, hot, induration beginning less than 24 hours after receiving immunization 1.5-2 inches above right elbow. Patient presented to clinic 3 days after receiving immunization with red patch on right arm. Patient is now presenting to clinic 7 days later, reports experiencing discomfort when flexing tricep and when laying on his arm. Redness has decreased, but patient describes discomfort as "feeling it beyond the muscle, all the way inside." More
2865783 62 F GA 10/14/2025 COVID19
COVID19
FLU3
FLU3
PNC21
PNC21
RSV
RSV
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
 na4452
na4452
tfaa2533
tfaa2533
z005765
z005765
mf2147
mf2147
Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia; Skin warm; Arthralgia, E... Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia; Skin warm; Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia; Skin warm; Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia; Skin warm; Arthralgia, Erythema, Pain, Pain in extremity, Pyrexia; Skin warm More
Patient reports fever of 101-102 degrees farenheit, redness, warmth, throbbing pain and a 6 inch are... Patient reports fever of 101-102 degrees farenheit, redness, warmth, throbbing pain and a 6 inch area of redness on left deltoid and elbow. Warm, swelling and throbbing pain in arm and shoulder. On 7th day symptoms are getting worse. More
2865784 65 F 10/14/2025 PNC21
 MERCK & CO. INC.
Cellulitis, Rash erythematous Cellulitis, Rash erythematous
pt had a red rash she had a dr appointment already for something else so asked dr about it since she... pt had a red rash she had a dr appointment already for something else so asked dr about it since she was there and was given cephalexin bc dr said it was cellulitis More
2865785 31 F CA 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age, Underdose Product administered to patient of inappropriate age, Underdose
received "half a dose" of SHINGRIX instead of the full dose; Patient was 31 years; This no... received "half a dose" of SHINGRIX instead of the full dose; Patient was 31 years; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 31-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: received "half a dose" of SHINGRIX instead of the full dose) and inappropriate age at vaccine administration (Verbatim: Patient was 31 years). The outcome of the incomplete dose administered and inappropriate age at vaccine administration were not applicable. Additional Information: GSK receipt date: 24-SEP-2025 Physician stated that patient received half a dose of Shingrix instead of the full dose, she did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine. Also stated that dates of administration were between 23 JUN 2025 to 27 JUN 2025. The batch number was not provided and a request for this information has been made. This case is one of the linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025122808:Same reporter/Different patient US-GSK-US2025122818:Same reporter/Different patient US-GSK-US2025122813:Same reporter/Different patient US-GSK-US2025122805:Same reporter/Different patient US-GSK-US2025122804:Same reporter/Different patient More
2865786 77 F OK 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Injection site pain, Limb discomfort, Pain in extremity, Sleep... Feeling abnormal, Injection site pain, Limb discomfort, Pain in extremity, Sleep disorder More
Keeps awake/Cannot sleep on right side; miserable; arm feels heavy; right arm was hurting all the ti... Keeps awake/Cannot sleep on right side; miserable; arm feels heavy; right arm was hurting all the time; pain she was feeling was at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (got shingles (not a severe case)) and shoulder operation (had shoulder surgery was already going to therapy). Previously administered products included Shingles vaccine (she had another shingles vaccine 10-15 years ago). On 16-JUL-2025, the patient received the 1st dose of Shingrix (right arm). On 16-JUL-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: right arm was hurting all the time) and injection site pain (Verbatim: pain she was feeling was at the injection site). On an unknown date, the patient experienced difficulty sleeping (Verbatim: Keeps awake/Cannot sleep on right side), feeling miserable (Verbatim: miserable) and heaviness in arm (Verbatim: arm feels heavy). The patient was treated with ibuprofen sodium (Ibuprofen) and cola spp., manganese glycerophosphate, phosphoric acid (Biotone). The outcome of the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm were not resolved. It was unknown if the reporter considered the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm to be related to Shingrix. It was unknown if the company considered the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The patient reported that right after receiving the vaccine, she noticed persistent pain in her right arm. She had been undergoing therapy for a left shoulder surgery done on 20-MAY-2025, using both arms during therapy. After completing therapy, her left shoulder pain resolved, but she continued to feel pain at the injection site of the Shingrix vaccine. The patient stated the pain kept her awake 24 by 7 and has been going on for several months. She took Ibuprofen, one or two tablets in the morning, and occasionally another if she used her arm a lot. She applied a cold pack in the morning, took hot showers, rubbed Biotone on her arm if needed, and rested to relieve the pain. She used a pillow at night to lie her arm and could not sleep on her right side due to the pain. ' She described her arm was feeling heavy, felt miserable and she had to keep her arm at her side to not exert it too much. Her physician suggested the pharmacist might have injected the vaccine into a vein and recommended using a massager. The patient mentioned that her physician advised that she receive Shingrix due to hearing it would help with dementia, but the patient does not have dementia. The batch number was not provided and a request for this information has been made. More
2865787 F 10/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Inappropriate schedule of product administration, Pain, Product use in unapprove... Inappropriate schedule of product administration, Pain, Product use in unapproved indication; Inappropriate schedule of product administration, Pain, Product use in unapproved indication More
Shingrix administered to patient when patient had ongoing episode of Shingles; 2nd dose after 1 year... Shingrix administered to patient when patient had ongoing episode of Shingles; 2nd dose after 1 year; I have Shingles after vaccination; This non-serious case was reported by a consumer and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concomitant products included diltiazem (Cardizem). On 01-NOV-2023, the patient received the 1st dose of Shingrix. On 03-OCT-2025, the patient received the 2nd dose of Shingrix. On 20-SEP-2025, 689 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: I have Shingles after vaccination). On 03-OCT-2025, the patient experienced drug use for unapproved indication (Verbatim: Shingrix administered to patient when patient had ongoing episode of Shingles) and drug dose administration interval too long (Verbatim: 2nd dose after 1 year). The outcome of the shingles was not resolved and the outcome of the drug use for unapproved indication and drug dose administration interval too long were not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 03-OCT-2025 Patient had forgotten how painful Shingles were. The second time the pain wasn't as bad as the first time. Don't misunderstand this time has gotten to a 8 or 9 out of 10. Also, patient was on a lot of medicines. More
2865788 30 F CA 10/14/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 DJ22N
Expired product administered Expired product administered
maladministration expired vaccine/staff member administered an expire vaccine, expired 13-Jun-2025, ... maladministration expired vaccine/staff member administered an expire vaccine, expired 13-Jun-2025, to one of our staff members"; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number DJ22N, expiry date 13-JUN-2025) for prophylaxis. On 07-OCT-2025, the patient received FluLaval Quadrivalent 2023-2024 season (unknown arm). On 07-OCT-2025, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced expired vaccine used (Verbatim: maladministration expired vaccine/staff member administered an expire vaccine, expired 13-Jun-2025, to one of our staff members"). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:08-OCT-2025 The reporter reported expired FluLaval administered to patient. Patient had not reported any adverse events to healthcare professional. More
2865792 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Nerve block, Pain, Resuscitation Herpes zoster, Nerve block, Pain, Resuscitation
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (in JAN-2023). On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 06-OCT-2025 This case was reported by a patient via interactive digital media. The patient got shingles in January 2023 and had three nerve blocks and the third one had to be resuscitated and didn't have a fourth and the patient still have severe pain. The patient went to a new doctor and got the Shingrix vaccine and two weeks later a new case of shingles and said get it as soon as you can. Unless you have had it, you cannot even try to fathom how painful it is. More
2865794 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
Felt sick for a week; This non-serious case was reported by a consumer via interactive digital media... Felt sick for a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. 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 sickness (Verbatim: Felt sick for a week). The outcome of the sickness was resolved (duration 1 week). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 06-OCT-2025 The patient reported that today (on the reporting day) he/she received 2nd dose of Shingrix shot and the 1st dose made the patient pretty sick for a full week. The patient crossed fingers as no side effects this time More
2865795 F 10/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
I had it 5 years ago for 4 months. I've had the vaccine but I am experiencing a flare up now./s... I had it 5 years ago for 4 months. I've had the vaccine but I am experiencing a flare up now./suspected vaccination failure; Shingles/ experiencing flare up; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (the patient had shingles 5 years ago for 4 months). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had it 5 years ago for 4 months. I've had the vaccine but I am experiencing a flare up now./suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ experiencing flare up). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 09-SEP-2025 This case was reported by a consumer via interactive digital media. The patient had shingles 5 years ago and received vaccine. But the patient now experiencing flare up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was unknown. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a adult 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
2865796 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
Hurt; This non-serious case was reported by a consumer via interactive digital media and described t... Hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Hurt). The outcome of the pain was resolved (duration 2 days). It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 06-OCT-2025 This case was reported by a patient via interactive digital media. The Shingrix vaccine hurt them for a couple of days. More
2865797 F 10/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; suffering with Shingles; This serious case was reported by a consumer... Suspected vaccination failure; suffering with Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: suffering with Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 08-OCT-2025 This case was reported by a patient's parent via interactive digital media. The reporter reported that the patient in age 50 plus was suffering with Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine, in a adult 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
2865798 F 10/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; My daughter is suffering with shingles right now; This serious case w... Suspected vaccination failure; My daughter is suffering with shingles right now; 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 (Herpes Zoster vaccine) for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My daughter is suffering with shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 08-OCT-2025 This case was reported by a patient via interactive digital media. Reporter's daughter was suffering with shingles right now. She was over 50 and she had lupus. 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: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine, 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
2865799 0.5 M AR 10/14/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 39KS9
Expired product administered Expired product administered
patient was maladministered with an expired dose of PEDIARIX on an eight month old patient.; This no... patient was maladministered with an expired dose of PEDIARIX on an eight month old patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis. On 15-SEP-2025, the patient received Pediarix. On 15-SEP-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was maladministered with an expired dose of PEDIARIX on an eight month old patient.). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-SEP-2025 The patient was maladministered with an expired dose of Pediarix. Nurse needed advice on this matter. No further information was obtained. More
2865800 F CA 10/14/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Unevaluable event Unevaluable event
Administration of a Second dose; This non-serious case was reported by a pharmacist via call center ... Administration of a Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included common variable immunodeficiency (Patient had a condition called CVID which is an immunological disease which does not allow her body to produce full immunity when she receives vaccines). Previously administered products included Arexvy (first dose was received in 2023). The patient did not receive the 2nd dose of Arexvy. The patient experienced off label use (Verbatim: Administration of a Second dose). The outcome of the off label use was not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 The pharmacist reported that he had a patient who came in on the day of reporting for RSV vaccine (Arexvy). The reporter was wondering if still it was ok or the protocol was in regards of giving her a second RSV vaccine because per the centers for disease control and prevention, she did not need another additional one. It was recommended by the patient's immunologist. The patient was immunocompromised, and her immunologist recommended to have a second dose of RSV vaccine however, she had not received the dose. The batch number was not provided and a request for this information had been made. More
2865801 M NY 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Exposure via skin contact, Underdose, Wrong technique in product usage process Exposure via skin contact, Underdose, Wrong technique in product usage process
Underdose/decent amount of the dose went down the patient's arm; decent amount of the dose went... Underdose/decent amount of the dose went down the patient's arm; decent amount of the dose went down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 18-SEP-2025, the patient received the 2nd dose of Shingrix. On 18-SEP-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Underdose/decent amount of the dose went down the patient's arm) and accidental exposure while administering drug (Verbatim: decent amount of the dose went down the patient's arm). The outcome of the incomplete dose administered and accidental exposure while administering drug were not applicable. Additional Information: GSK Receipt Date: 18-SEP-2025 Reporter reported that the second dose of Shingrix was administered to a patient today and the needle and syringe seem to have not been connected properly and a decent amount of the dose went down the patient's arm. Not sure if any of the dose really made it into patient's arm. So, looking to see if it is appropriate to re-dose or if this would count as a partial dose, not sure how to continue that. The patient was checking with the doctor to see what they would recommend. Reporter looking to see the manufacturer's recommendation of what to do about an improperly administered second Shingrix dose. The batch number was not provided and a request for this information has been made. More
2865802 6 F IN 10/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Wrong product administered Wrong product administered
gave Bexsero vaccine to a child 6 years old, Intention was to administered (Engerix-B) hepatits B; T... gave Bexsero vaccine to a child 6 years old, Intention was to administered (Engerix-B) hepatits B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received Men B NVS (Bexsero) (batch number 49M9N, expiry date 29-FEB-2028) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 18-SEP-2025, the patient received the 1st dose of Bexsero. The patient did not receive Engerix B. On 18-SEP-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: gave Bexsero vaccine to a child 6 years old, Intention was to administered (Engerix-B) hepatits B). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-SEP-2025 A medical assistant had given an incorrect vaccine to a child who was 6 years old. Instead of Engerix-B (Hepatitis B), which was intended as the first dose, the child had received Bexsero. They had wanted to know what to monitor following the administration. The child was due to turn 6 in October. More
2865803 80 F NC 10/14/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4K3S
Wrong product administered Wrong product administered
Boostrix instead of Fluad; This non-serious case was reported by a pharmacist via call center repres... Boostrix instead of Fluad; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 80-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4K3S, expiry date 30-OCT-2027) for prophylaxis. Co-suspect products included Influenza vaccine inact sAg 3v (Fluad) for prophylaxis. Concomitant products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20). On 02-SEP-2025, the patient received Boostrix. The patient did not receive Fluad. On 02-SEP-2025, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Fluad). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-SEP-2025 A pharmacist had explained that on 2nd September 2025, patient had come in to receive pneumonia and flu vaccines, but had apparently been accidentally given Boostrix instead of Fluad. Patient had also received Prevnar 20 on the same day. Patient had not appeared to have received any prior doses of Tetanus, Diphtheria, or Pertussis vaccines. More
2865804 66 M NJ 10/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55TH4
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repres... Shingrix late second dose; 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 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 47AE2, expiry date 26-SEP-2025) and (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine on 09-OCT-2023). On 02-JUL-2025, the patient received the 2nd dose of Shingrix. On 02-JUL-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 29-SEP-2025 The batch number was not provided, and we are unable to contact the reporter. More
2865805 5 F OR 10/14/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 F4A7R
Inappropriate schedule of product administration Inappropriate schedule of product administration
early 2nd dose; This non-serious case was reported by a other health professional via call center r... early 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) (batch number F4A7R, expiry date 06-JUN-2026) for prophylaxis. Concomitant products included Influenza vaccine inact split 3v (Flulaval). On 29-SEP-2025, the patient received the 2nd dose of FluLaval 2025-2026 season. On 29-SEP-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced drug dose administration interval too short (Verbatim: early 2nd dose). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-SEP-2025 A medical assistant had reported that someone else had given a child an early second dose of FluLaval. The child had never been vaccinated before and was scheduled to receive two doses. The first dose had been administered on 23rd September 2025, and the second dose had been given on 29 September 2025.; Sender's Comments: GSK-US2025125443:Same reporter/Diffrent patient More
2865806 73 F TX 10/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Multiple doses; Multiple doses; This non-serious case was reported by a pharmacist via call center r... Multiple doses; Multiple doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 06-SEP-2019) and Shingrix (received 2nd dose on 21-DEC-2019). On 01-JUN-2022, the patient received the 3rd dose of Shingrix. On 02-SEP-2022, the patient received the 4th dose of Shingrix. On 01-JUN-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Multiple doses). On 02-SEP-2022, the patient experienced extra dose administered (Verbatim: Multiple doses). The outcome of the extra dose administered and extra dose administered were not applicable. Additional Information: GSK receipt Date: 06-OCT-2025 The pharmacist reported that looked at the patient profile recently and noticed she got 2 rounds of the Shingrix vaccine one in 2019 2 shots again in 2022, wondering what harm the patients would have in getting 4 shots in the system. The reporter did not know if there was some lag and guess between the patient did not know she received it and the system did not show she already received it so we administered to her again. The reporter was ask any side effects or what do we tell to the patient. The batch number was not provided upon follow up with the reporter. More
2865807 63 F TX 10/14/2025 COVID19
 MODERNA
COVID-19, Immunodeficiency, Viral test COVID-19, Immunodeficiency, Viral test
Immunosuppressed due to the reason of taking Methotrexate and Humira; COVID/did not do very well; Th... Immunosuppressed due to the reason of taking Methotrexate and Humira; COVID/did not do very well; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Methotrexate sodium (Methotrexate) for an unknown indication and Adalimumab (Humira) for an unknown indication. Concurrent medical conditions included Autoimmune disorder NOS (rare autoimmune disease related to uveitis (also known as bird shot)) and Uveitis (rare autoimmune disease related to uveitis (also known as bird shot)). In December 2020, the patient started Methotrexate sodium (Methotrexate) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and Adalimumab (Humira) (unknown route) at an unspecified dose. In June 2023, the patient experienced COVID-19 (COVID/did not do very well). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunosuppressed due to the reason of taking Methotrexate and Humira) had not resolved and COVID-19 (COVID/did not do very well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: titer was not very high the first time she got the vaccine. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient was immunosuppressed due to the reason of taking Methotrexate and Humira. She had always taken the Moderna vaccine and had not missed any COVID vaccines. She took time off her medications to get the vaccine; she stopped the meds 2 weeks prior and 2 weeks after taking the medication again. She started Methotrexate at the end of December 2020 and could not remember if she had done Humira yet. Her doctor at the time recommended that she get her first dose of COVID and "see what happens". Her titer was not very high the first time she got the vaccine, but that they decided on the next one. She had COVID in June 2023 and did not do very well, so she did not want it again. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up received included reference numbers were added.; Reporter's Comments: Patients immunosuppresion is secondary to Methotrexate and Humira. Hence, this event is assessed as not related to Moderna COVID-19 vaccine. The benefit-risk relationship of product is not affected by this report. More
2865808 M NY 10/14/2025 COVID19
 MODERNA
Lung disorder Lung disorder
Lung conditions; This spontaneous case was reported by a consumer and describes the occurrence of LU... Lung conditions; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung conditions) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (Lung conditions). At the time of the report, LUNG DISORDER (Lung conditions) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that the patient received Moderna vaccine since 2021 but now they cannot find it in their area. It was reported that the patient has a serious lung condition, and he must avoid all the respiratory infections. It was also reported that if patient did not find Moderna vaccine, then he can use Pfizer vaccination. No treatment medications provided by the reporter. This case was linked to MOD-2025-789971 (Patient Link). More
2865809 M 10/14/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
the vaccine where his hand hurt him; This spontaneous case was reported by a consumer and describes ... the vaccine where his hand hurt him; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the vaccine where his hand hurt him) in a male patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (the vaccine where his hand hurt him). At the time of the report, PAIN IN EXTREMITY (the vaccine where his hand hurt him) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Patient had this weird side effect from the vaccine where his hand hurt him. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No causality provided This case was linked to US-MODERNATX, INC.-MOD-2025-790041 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790041:Son's case More
2865810 M MI 10/14/2025 COVID19
 MODERNA
COVID-19 COVID-19
Both my husband and I got covid for the first time; This spontaneous case was reported by a consumer... Both my husband and I got covid for the first time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Both my husband and I got covid for the first time) in a male patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (every 6 months and have never had covid before). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Both my husband and I got covid for the first time). At the time of the report, COVID-19 (Both my husband and I got covid for the first time) outcome was unknown. Patient had Moderna vaccines faithfully every 6 months and never had covid before. The patient was very careful. No concomitant medication was reported. The patient was disappointed with mNexspike. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790130 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790130:Wife Case More
2865811 IL 10/14/2025 COVID19
 MODERNA
 3052549
No adverse event, Syringe issue No adverse event, Syringe issue
No adverse effect; more than half of the dose came out as I tried to remove the cap to attach the ne... No adverse effect; more than half of the dose came out as I tried to remove the cap to attach the needle.; This spontaneous case was reported by a nurse and describes the occurrence of SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection (batch no. 3052549) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 01-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (more than half of the dose came out as I tried to remove the cap to attach the needle.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported an issue with a Moderna Spikevax vaccine syringe, where more than half of the dose was expelled upon attempting to remove the cap to attach the needle. The syringe showed no visible cracks, and the cap remained in place. They were seeking guidance on how to address this issue. The Device Problem Information included FDA code: 1250, IMDRF Code: A050401, Device problem: Fluid Leak. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2025: Live non-significant follow-up information received: Reference ids added. More
2865812 66 F OK 10/14/2025 COVID19
 MODERNA
Syphilis, Syphilis test Syphilis, Syphilis test
syphilis; This spontaneous case was reported by a consumer and describes the occurrence of SYPHILIS ... syphilis; This spontaneous case was reported by a consumer and describes the occurrence of SYPHILIS (syphilis) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Hysterectomy. Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Batch Number: 053D22A, dose and expiry date was unknown.) on 17-Nov-2022, Moderna COVID-19 Vaccine (Batch Number: 038K20A), SPIKEVAX NOS (2 shots, unknown details) and Moderna COVID-19 Vaccine (Batch Number: 016M20A). Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and SPIKEVAX NOS. On 14-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 28-Nov-2024, after starting, the patient experienced SYPHILIS (syphilis) (seriousness criterion medically significant). At the time of the report, SYPHILIS (syphilis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2024, Syphilis test: Positive. Concomitant medications were not reported. The patient had total 7 Moderna COVID-19 vaccine since they came out. The patient was sexually inactive. The patient went to neurologist 2 weeks after the administration, drew her blood and told her that she had syphilis. The patient had not had sex since 2009. The patient said she knew she didn't have syphilis, unless her ex-husband had given it to her at some point. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.; Reporter's Comments: Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit-risk relationship of product is not affected by this report. More
2865813 F 10/14/2025 COVID19
 MODERNA
Asthenia, Pain in extremity, Vaccination site swelling Asthenia, Pain in extremity, Vaccination site swelling
weakness; pain on the arm; injection site swelling; This spontaneous case was reported by a consumer... weakness; pain on the arm; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concomitant products included Ibuprofen and Paracetamol (Tylenol) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (pain on the arm) and VACCINATION SITE SWELLING (injection site swelling) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was taking ibuprofen and Tylenol for several years before ever having a Moderna vaccine. The patient had all Moderna COVID -19 vaccines since Moderna started them. She always had some side effects post vaccination like weakness, unable to go to work for few days, injection site swelling and pain on the arm, etc. She got very nervous while getting the COVID shots. She became nervous cause she got so sick from that. On 03-Oct-2025, the patient received 8th Moderna vaccine. Prior to that, she had received all 7 doses from Moderna. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789984, MOD-2025-789988 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. On 06-Oct-2025: Live significant follow-up received included patient's DOB was added, concomitant medications added, narrative updated and reference numbers were added. On 06-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. On 07-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. More
2865814 75 F PA 10/14/2025 COVID19
 MODERNA
Antiphospholipid syndrome, Bone marrow disorder Antiphospholipid syndrome, Bone marrow disorder
Has affected her bone marrow from her fingers to her toes; antiphospholipid syndrome; This spontaneo... Has affected her bone marrow from her fingers to her toes; antiphospholipid syndrome; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Protein S deficiency (Protein-S deficiency at least 25 years). Concomitant products included Warfarin for Protein S deficiency. In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In April 2025, the patient experienced ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) (seriousness criterion medically significant). On an unknown date, the patient experienced BONE MARROW DISORDER (Has affected her bone marrow from her fingers to her toes). At the time of the report, ANTIPHOSPHOLIPID SYNDROME (antiphospholipid syndrome) and BONE MARROW DISORDER (Has affected her bone marrow from her fingers to her toes) outcome was unknown. It was reported that patient received COVID Moderna ever since they came out and it was worked well for the patient. It was reported that the patient most recent dose was in Mar-2025 or Apr-2025. The patient antiphospholipid syndrome was diagnosed in Apr-2025 which was related to autoimmune disease. The antiphospholipid syndrome has affected to the patient bone marrow from her fingers and to her toes. It was in the lining of vessels and arteries. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: Medical history of Protein S deficiency could be a risk factor. The benefit-risk relationship of the product is not affected by this report More
2865815 26 M 10/14/2025 COVID19
 MODERNA
 3052668
Abdominal pain, Chills, Diarrhoea, Pyrexia Abdominal pain, Chills, Diarrhoea, Pyrexia
Abdominal and digestive issues; cramping; diarrhea; fever; chills; This spontaneous case was reporte... Abdominal and digestive issues; cramping; diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal and digestive issues; cramping), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) in a 26-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052668) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 07-Oct-2025, the patient experienced ABDOMINAL PAIN (Abdominal and digestive issues; cramping), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN (Abdominal and digestive issues; cramping), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) had not resolved. Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2865816 PA 10/14/2025 COVID19
 MODERNA
Myalgia, Pain, Pain in extremity Myalgia, Pain, Pain in extremity
my arm felt as though I had pulled a muscle. It was a very mild but noticeable pain; body aches and ... my arm felt as though I had pulled a muscle. It was a very mild but noticeable pain; body aches and pains that were similar to having the flu; body aches and pains that were similar to having the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm felt as though I had pulled a muscle. It was a very mild but noticeable pain), PAIN (body aches and pains that were similar to having the flu) and MYALGIA (body aches and pains that were similar to having the flu) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 09-Oct-2025, the patient experienced PAIN IN EXTREMITY (my arm felt as though I had pulled a muscle. It was a very mild but noticeable pain), PAIN (body aches and pains that were similar to having the flu) and MYALGIA (body aches and pains that were similar to having the flu). At the time of the report, PAIN IN EXTREMITY (my arm felt as though I had pulled a muscle. It was a very mild but noticeable pain), PAIN (body aches and pains that were similar to having the flu) and MYALGIA (body aches and pains that were similar to having the flu) outcome was unknown. Concomitant medication was not provided. It was reported that the patient had received the Moderna Spikevax booster on 09-Oct-2025. According to the patient, within 2 to 3 hours of receiving the shot, the patient experienced mild arm pain that felt similar to a pulled muscle. Approximately 8 hours after the vaccination, the patient began to feel body aches and pains resembling flu symptoms, which were more pronounced. It was emphasized that the patient did not regret getting the booster and mentioned having received every Moderna COVID vaccine available and also noted prior participation in a CDC program for reporting symptoms, although that program was no longer active. It was unknown if the patient experienced any additional symptoms or events. It was reported that the patient took OTC pain reliever as a treatment medication. This case was linked to MOD-2025-790127 (Patient Link). More
2865817 F 10/14/2025 COVID19
 MODERNA
Fatigue Fatigue
little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FA... little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little fatigued) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In April 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced FATIGUE (little fatigued). At the time of the report, FATIGUE (little fatigued) outcome was unknown. The patient's age was reported as more than 65. The concomitant medication was not reported by the reporter. It was reported that the patient had their last dose of Spikevax in April and had no side effects to speak of and was just a little fatigued. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. Reporter did not allow further contact More
2865818 72 F MI 10/14/2025 COVID19
 MODERNA
COVID-19 COVID-19
Both my husband and I got covid for the first time; This spontaneous case was reported by a consumer... Both my husband and I got covid for the first time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Both my husband and I got covid for the first time) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (every 6 months and have never had covid before.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 11-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 07-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced COVID-19 (Both my husband and I got covid for the first time). At the time of the report, COVID-19 (Both my husband and I got covid for the first time) was resolving. Patient had Moderna vaccines faithfully every 6 months and never had covid before. Patient was very careful. No concomitant medication was reported. The patient was disappointed with mNexspike. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790134 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790134:Wife Case More
2865819 79 F CA 10/14/2025 COVID19
COVID19
FLUX
FLUX
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Blood pressure increased, Blood pressure measurement, Body temperature, Chills, ... Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Heart rate; Pain, Pyrexia, Rash, Vaccination site swelling; Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Heart rate; Pain, Pyrexia, Rash, Vaccination site swelling More
Rash; Had the swelling at injection site; pain/soreness; Chills; Fever; High blood pressure/One day ... Rash; Had the swelling at injection site; pain/soreness; Chills; Fever; High blood pressure/One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81/It got to 166/78/Got as high as 175/89; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 26Sep2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol being up a little" (unspecified if ongoing); "white coat syndrome" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for hypertension; COZAAR taken for hypertension (ongoing); LIPITOR taken for blood cholesterol increased, start date: Apr2025. Past drug history included: Amoxicillin, reaction(s): "Allergy:rash". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 2025, outcome "not recovered", described as "High blood pressure/One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81/It got to 166/78/Got as high as 175/89"; CHILLS (non-serious) with onset 27Sep2025, outcome "recovered" (27Sep2025); PYREXIA (non-serious) with onset 27Sep2025, outcome "recovered" (27Sep2025), described as "Fever"; VACCINATION SITE SWELLING (non-serious) with onset 27Sep2025, outcome "unknown", described as "Had the swelling at injection site"; PAIN (non-serious) with onset 27Sep2025, outcome "unknown", described as "pain/soreness"; RASH (non-serious) with onset 28Sep2025, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, rash. Additional information: Is over 65, knows they had her reading consent forms for the shot. Had flu shot at same time, was not going to get them together but, had to stand in line, about an hour. They gave her both shots in left arm. Had normal swelling a little bit, normal problems with it. Then, had fever of 100.3. Had chills the following day. Then, had rash on left arm, which went aways after a while. Also, her blood pressure, her systolic blood pressure has been way higher than normal. Does not know if that was part of the combination of the 2. Clarified, caller had both Covid shot and flu shot at same time. Always got flu shot separately, now with the 2, does not know what each has done. Not sure if anyone has reported increased blood pressure with this. Has appointment with doctor Wednesday, on telephone, and physical coaming at end of month. No matter what she is taking, is taking Losartan, also takes Metoprolol, that do not seem to be helping. It got her a little bit nervous, wondered if something because, they did mention, conditions can put her at risk for heart failure and coronary artery disease and high blood pressure. Would think the symptoms would have stopped or lessened. Chills, Fever: The chills started, maybe around 3PM then, after that, the fever came, then, the rash. Chills lasted, maybe about an hour, fever probably lasted maybe 45 minutes. Rash: Rash came the day after that, Sunday, 28Sep2025. Rash is mostly gone now. Put some cream on it, seemed to dissipate, seems to be ok now, as far as she can see. Treatment: For fever and chills, took aspirin and, thinks she did take dose Nyquil. Concomitant Products/Medical Conditions: Does have high blood pressure, taking Losartan and another drug called Metoprolol. Clarified, the blood pressure medications, the Losartan and Metoprolol, did not help. Did not really seem to help because, one day, one evening out of whole week and a half, this happened. It got to 166/78. High blood pressure: One time, blood pressure went down to 124/72, when on her blood pressure medication. Has been pretty much in that that range, maybe 124 one day, has been pretty manageable, to have normal blood pressure. Has no idea why this is happening. Is a little concerned how long this will continue. Knows blood pressure can be dangerous. Worries about blood pressure being higher. The day before the shot, the blood pressure was up a little but. Has white coat syndrome to start with, always nervous before the shot. Takes blood pressure every day. The day before the shot, which was 26Sep2025, blood pressure was 104/70, pulse 72. The day of the shot, blood pressure was 154/70, pulse 82, then went down to 142/73 then down, to 129/76. Got as high as 175/89, pulse 94, this morning, 8AM. This afternoon, around noon, was 163/79, pulse down to 72. The diastolic numbers seems to be ok but, systolic seems to be pushing the envelope. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as no. AE does not required to visit Emergency Room or Physician's Office. just called advice nurse, set up appointment for phone conversation Wednesday. Patient Medical History. Did the patient previously receive the Pfizer suspect vaccine? not provided. Are you allergic to any previous vaccination, medications, food or other products? Does have allergy to amoxicillin and another one. When clarifying specific reaction to amoxicillin, caller states, she had rash from neck down, after taking it for about 4 days. Would say it was maybe 15 years ago, maybe longer May just be basic, like she has allergy problem or, whatever. Never had this happen before, with shots. Had the swelling at injection site or, had a little fever and chills but, not where blood pressure has gone up so high, it kind of scares her. Does not help that, she tries to go to sleep at night, tries to calm herself down that it will go down but, it is not going down, that is why she is calling. Hopefully this information will help someone, and help her too. Caller was thinking that taking the combination of the two vaccines together can probably have an interaction and could possibly cause issues too. Caller said that she did check with the other vaccine, the flu vaccine, and they did mention that there are some people who had blood pressure problems, so she thinks that the possibility of having the two vaccines together probably caused an interaction. Caller said that she does have an appointment with her HCP tomorrow and a physical coming up on the 28th, so she'll let them know what's going on. Caller said that the vaccines were given in her same arm, the left arm, and on Saturday she had a rash, and she also had (carcinoma) pain and swelling. She even had a fever of 100.3 and chills. The side effects kind of went away, but the rash came back a little bit that day. It wasn't terrible, but it was there. Today, caller said that she's still experiencing a little bit of soreness. She was thinking that after 2 weeks it would be okay. Caller also said that she is over 65 years old, and her blood pressure is higher than normal. The diastolic is okay, but the systolic is elevated, and she is on medication (losartan). Caller is wondering if anyone else is reporting increased blood pressure. Caller is aware that it is not listed in the side effects since she received a pamphlet about it after receiving the vaccine. Caller said that the blood pressure increase started the day after the shot, and her normal BP is around 119/73. She kept a record of her blood pressure monitoring and it is as follows: in the morning it was 154/70, then the next morning it was 142/73, then it went down to 136/78 and it's been fluctuating. One day she had 160/78, then 134/74, then it jumped to 158/81, and then 161/75, then down to 151/81. She said it's been bouncing around, and she just wants to know if other people have similar issues with it. Caller is mainly concerned about her blood pressure and she wants to know if other people experienced it too. More
2865820 F FL 10/14/2025 COVID19
 PFIZER\BIONTECH
Anonychia, Erythema Anonychia, Erythema
redness in the finger nail bed/she still has redness over each cuticle bed; lost all 10 finger nails... redness in the finger nail bed/she still has redness over each cuticle bed; lost all 10 finger nails; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received BNT162b2 (COMIRNATY), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunisation; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunisation; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: ERYTHEMA (non-serious), outcome "not recovered", described as "redness in the finger nail bed/she still has redness over each cuticle bed"; ANONYCHIA (non-serious), outcome "recovered", described as "lost all 10 finger nails". Additional information: Caller stated that she has received 4 of the Pfizer Covid-19 vaccines in which her last one received was in 2022. Caller stated that she "lost all 10 finger nails, however they have came back over a period of 2 years, but she still has redness over each cuticle bed". Caller stated "it doesn't hurt and she doesn't have a medical problem, but it's very obvious to see". Caller stated that there isn't any infection or anything there. Caller stated that she has been to her general practitioner, dermatologist and allergist in which no infection was found, but they do not know how to treat it. Caller stated she saw an online study that spoke about the covid vaccine causing nail psoriasis. Caller asked if Pfizer has figured out how to treat redness in the finger nail bed. Questioned upon referring to HCP for treatment recommendations, caller stated "they can't fix something that they don't know how to fix. That's not helpful". Responded that referred to HCP for treatment recommendations. Batch/lot number is not provided, and it cannot be obtained. More
2865821 10/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Should I get another Covid vaccine if I didn't wait ninety days after having Covid?; Should I g... Should I get another Covid vaccine if I didn't wait ninety days after having Covid?; Should I get another Covid vaccine if I didn't wait ninety days after having Covid?; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE(medically significant), outcome "unknown" and all described as "Should I get another Covid vaccine if I didn't wait ninety days after having Covid?". More
2865822 73 M TX 10/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
took Pfizer Covid-19 vaccine, very next day, tested positive for Covid-19.; This is a spontaneous re... took Pfizer Covid-19 vaccine, very next day, tested positive for Covid-19.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, MANUFACTURE UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "took Pfizer Covid-19 vaccine, very next day, tested positive for Covid-19.". The event "took pfizer covid-19 vaccine, very next day, tested positive for covid-19." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for BNT162b2 omicron (kp.2) was unknown. Therapeutic measures were not taken as a result of covid-19. Additional information: The patient reported that last year he received the Pfizer COVID-19 vaccine, previously also received Moderna. He was cancer and heart patient, and after getting last year's Pfizer shot, the very next day he began feeling very unwell. When he went to his doctor, he confirmed that he actually had COVID-19.His concern was whether there was anything in Pfizer's COVID-19 vaccine that could actually cause someone to develop the virus. Patient was reporting adverse event that last year he took Pfizer Covid-19 vaccine, very next day, tested positive for Covid-19. He Tested positive for Covid-19: Doctor decided to treat symptoms with over the counter stuff. When clarifying, if it was just this one dose Pfizer Covid-19 vaccine patient had Just never had problem with Moderna vaccines for Covid. Batch/lot number is not provided, and it cannot be obtained. More
2865823 10/14/2025 COVID19
 PFIZER\BIONTECH
Hallucination Hallucination
severe hallucinations; This is a spontaneous report received from a Consumer or other non HCP. Other... severe hallucinations; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789858. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2023 (unspecified if ongoing); "Respiratory disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HALLUCINATION (medically significant) with onset 2023, outcome "recovered", described as "severe hallucinations". No follow-up attempts are possible. Clinical course: Patient received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) 1 dosage form. On an unknown date, received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 ( got Covid about 2 years ago). On an unknown date, the patient experienced HALLUCINATION (severe hallucinations) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2023 at an unspecified dose and frequency. In 2023, COVID-19 ( got Covid about 2 years ago) had resolved. It was reported that patient had always Moderna vaccine but 2 times took Pfizer dose vaccination. However, both times had a reaction. It was reported that the Patient had severe hallucinations. When the patient slept, used to see images in brain. This was very disturbing for . It was reported that patient got COVID about 2 years ago after having multiple vaccines. Patient had COVID for 3 weeks though had treatment medication of Paxlovid. It was interpreted that got COVID because always had Moderna vaccines and had gotten Pfizer which was premature. The Patient unable to take penicillin but it was not explained the reason. It was unknown if the patient experienced any additional symptoms or events. Company comment: The benefit-risk relationship of the product is not affected by this report. Batch/lot number is not provided, and it cannot be obtained. More
2865824 10/14/2025 COVID19
 PFIZER\BIONTECH
Vasculitis Vasculitis
vasculitis; This is a spontaneous report received from a Consumer or other non HCP from medical info... vasculitis; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VASCULITIS (non-serious), outcome "unknown". Additional information:Submitted by Call Centre 1 Ref: System Reference: Selected Report Type: Initial Is the patient also the reporter?: No Reporter consent to contact given: Yes Reporter type: Consumer or other non health professional HCP postal address: Is COVID-19 Vaccine a Pfizer product? Yes COVID-19 Vaccine manufacturer:unspecified NDC number of COVID-19 Vaccine:Unknown UPC number of COVID-19 Vaccine:Unknown Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report Expiry Date of COVID-19 Vaccine: Unknown Additional Context: Reporter stated, "I was given this extension from a different part of Pfizer. I was calling today to try to see, I read a few article saying that Vasculitis was severe but rare side-effect of the COVID Vaccine (clarified as Pfizer COVID-19 Vaccine) and I was just trying to see if there was documentation anywhere of that being a side effect but you guys are able to provide me for a workers comp claim that I have." When paraphrased the concern, reporter stated, "That is correct." Reporter was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information. Reporter stated, "I think that's who I just got off the phone with that provided to you but if you want to transfer me over, I will try again." In response to further probing, reporter stated, "No, I am just trying to get this done firs please." Further probing could not be done as the reporter was unwilling to complete the report. Thus,product details (LOT#, NDC#, UPC# and expiration date) and purchase details were unknown. Hence, limited information was available over the call. Call was transferred to Pfizer Medical Information. However, reporter hung up the call before conferencing. QR Comment:AE Filed Conservatively. -This might be a split case however number of patients could not be clarified over the call hence split not made. -Permission to contact reporter is unknown as question could not be probed. However, Consent to Contact field in report populated as YES due to being a mandatory field. -Reporter type could not be probed hence captured as Consumer or other non-health professional in tab by default. Country of incidence could not be clarified hence b default captured. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865825 45 F MD 10/14/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.

Facial asymmetry, Oral discomfort, Pain of skin, Paraesthesia; Facial asymmetry,... Facial asymmetry, Oral discomfort, Pain of skin, Paraesthesia; Facial asymmetry, Oral discomfort, Pain of skin, Paraesthesia More
my skin hurts when I move my face; Area is at angle from ear to side of mouth; The following morning... my skin hurts when I move my face; Area is at angle from ear to side of mouth; The following morning I also felt a difference inside the left side of my mouth; tingling sensation when touching the left side of my face/the area closer to my ear actually felt like prickling when touched; This is a spontaneous report received from a Consumer or other non HCP. A 45-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 08:30 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 07Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Almonds allergy" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 08Oct2025 at 16:00, outcome "not recovered", described as "tingling sensation when touching the left side of my face/the area closer to my ear actually felt like prickling when touched"; ORAL DISCOMFORT (non-serious) with onset 09Oct2025, outcome "not recovered", described as "The following morning I also felt a difference inside the left side of my mouth"; FACIAL ASYMMETRY (non-serious) with onset 10Oct2025, outcome "not recovered", described as "Area is at angle from ear to side of mouth"; PAIN OF SKIN (non-serious) with onset 10Oct2025, outcome "not recovered", described as "my skin hurts when I move my face". Therapeutic measures were taken as a result of paraesthesia, oral discomfort, pain of skin, facial asymmetry. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine for which reporting. Patient was taking other medications within 2 weeks of the event starting. On 08Oct2025 in the afternoon she began noticing a tingling sensation when touching the left side of her face. It bothered her overnight and the following morning she also felt a difference inside the left side of her mouth. Also, the area closer to her ear actually felt like prickling when touched. She went to the doctor 09Oct2025 and was given Valtrex in case she was starting shingles. By 10Oct2025 and up to today, now her skin hurts when she move her face. No rash. No paralysis. Area was at angle from ear to side of mouth. Treatment received for the adverse event reported as Valtrex. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2865826 F CT 10/14/2025 COVID19
 PFIZER\BIONTECH
Balance disorder, Chills, Dizziness, Nausea, Pyrexia Balance disorder, Chills, Dizziness, Nausea, Pyrexia
Off balance; Fever; Chills; feel like I am going to vomit; Dizziness; This is a spontaneous report r... Off balance; Fever; Chills; feel like I am going to vomit; Dizziness; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Oct2025 at 12:30 as dose number unknown,single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN POTASSIUM taken for hypertension. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown", described as "feel like I am going to vomit"; DIZZINESS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Patient stated, "It said on the website to report when you had a reaction to the Pfizer COVID Shot (Clarified as Comirnaty), Patient was reporting it." She stated, "Fever, chills, feel like I am going to vomit and dizziness, off balance." Age at the time of event of the patient was "80 years, 8 months." Product details (LOT#, expiration date, NDC# and UPC#): She stated, "So, Stop and shop Pharmacy and it said Comirnaty 12 plus." Indication was stated by patient as "Because it was recommended that everyone over 80 years get it to prevent various sickness." She stated Thyroid was Indication of Levothyroxine. She stated the Date and time of vaccination was On Monday the 6Oct2025 probably about 12:30 in the afternoon. Patient stated For the Treatment Just a Ibuprofen as recommended. Additional Information for Other medicines Losartan Potassium: Indication: Patient stated, "Mild high blood pressure." More
2865827 54 M OH 10/14/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Chest discomfort, Dizziness, Dyspnoea, Throat irritation; Chest discomfort, Dizz... Chest discomfort, Dizziness, Dyspnoea, Throat irritation; Chest discomfort, Dizziness, Dyspnoea, Throat irritation More
chest tightening; SOB; Itchy throat; Lightheadedness; This is a spontaneous report received from a C... chest tightening; SOB; Itchy throat; Lightheadedness; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 08Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: THROAT IRRITATION (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "Itchy throat"; DIZZINESS (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "Lightheadedness"; DYSPNOEA (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "SOB"; CHEST DISCOMFORT (non-serious) with onset 10Oct2025 at 23:30, outcome "recovering", described as "chest tightening". Therapeutic measures were taken as a result of chest discomfort, dyspnoea, throat irritation, dizziness. Additional information: The patient was taking any other medications within 2 weeks of the event starting. Patient has not taken Breo in over a week, may be due to that, however has experienced chest tightening since getting Comirnaty/Flu vaccines. Tonight, SOB, itchy throat, and lightheadedness landed him at urgent care. The treatment received with Steroids, inhaler for the adverse events. Upon follow up his wife mentioned that he hasn't taken his Breo in 10 days, most likely the issue. However, he had just received both Covid and flu vaccines. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2865828 30 F 10/14/2025 COVID19
 PFIZER\BIONTECH
Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity
diarrhea; nausea; headache; severe fatigue; arm pain; This is a spontaneous report received from a C... diarrhea; nausea; headache; severe fatigue; arm pain; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Peanuts allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vancomycin, reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "arm pain"; DIARRHOEA (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "diarrhea"; HEADACHE (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025); NAUSEA (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025); FATIGUE (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "severe fatigue". Therapeutic measures were not taken as a result of diarrhoea, nausea, headache, fatigue, pain in extremity. Additional information: The patient did not receive any other vaccines on the same date as the vaccine for which reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine for which reporting. The patient was taking other medications within 2 weeks of the event starting. In the ~36 hours following the vaccine patient had diarrhea, nausea, headache, severe fatigue and arm pain. Patient got the vaccine at 6 pm on a Wednesday and felt 100% better by Friday morning. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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