๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2869571 45 F NC 10/30/2025 FLU3
SEQIRUS, INC.
Ax5588A
Flushing, Paraesthesia, Urticaria Flushing, Paraesthesia, Urticaria
Hives, skin felt blistered but wasn't, face flushed, torso felt like pen pricks, hives on neck.... Hives, skin felt blistered but wasn't, face flushed, torso felt like pen pricks, hives on neck. Took 12.5mg of benadryl and 2 Pepcid More
2869573 9 M UT 10/30/2025 COVID19
FLU3
MODERNA
SEQIRUS, INC.
3052581
407003
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
0.5 mL dose for those 12+ given to 9 year old in error 0.5 mL dose for those 12+ given to 9 year old in error
2869575 10 F OR 10/30/2025 COVID19
FLU3
HPV9
MODERNA
SANOFI PASTEUR
MERCK & CO. INC.
3053667
UT8861KA
Y019751
Fall, Head injury, Presyncope, Skin laceration; Fall, Head injury, Presyncope, S... Fall, Head injury, Presyncope, Skin laceration; Fall, Head injury, Presyncope, Skin laceration; Fall, Head injury, Presyncope, Skin laceration More
Patient had a vasovagal reaction, falling backwards and hitting head on computer and wall in exam ro... Patient had a vasovagal reaction, falling backwards and hitting head on computer and wall in exam room. Patient required one staple to the laceration in back of scalp due to hitting the computer. More
2869576 84 M 10/30/2025 FLU3
SEQIRUS, INC.
407245
Headache Headache
Patient complained of headache starting the day after receiving the vaccine which has continued for ... Patient complained of headache starting the day after receiving the vaccine which has continued for several days. More
2869579 10 M UT 10/30/2025 COVID19
FLU3
MODERNA
SEQIRUS, INC.
3052581
407003
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
MODERNA SPIKEVAX .5 ML FOR 12+ GIVEN TO AGE 10 IN ERROR MODERNA SPIKEVAX .5 ML FOR 12+ GIVEN TO AGE 10 IN ERROR
2869581 67 F NJ 10/30/2025 FLU3
SEQIRUS, INC.
407264
Hallucination, auditory Hallucination, auditory
auditory hallucinations, during sleep auditory hallucinations, during sleep
2869582 65 F LA 10/30/2025 FLU3
VARZOS
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS

23E4B
Injection site erythema, Injection site swelling, Pruritus, Rash macular, Urtica... Injection site erythema, Injection site swelling, Pruritus, Rash macular, Urticaria; Injection site erythema, Injection site swelling, Pruritus, Rash macular, Urticaria More
On Wednesday 10/29/25 patient woke up and injection site was red and swollen and said that skin look... On Wednesday 10/29/25 patient woke up and injection site was red and swollen and said that skin look splotchy. patient says later that night that the the area looked there were "whelps" developing and it looked like it was spreading. Patient reports that affected area is itchy. More
2869584 75 F TX 10/30/2025 COVID19
MODERNA
3046714
Injection site erythema, Injection site haemorrhage, Injection site pain Injection site erythema, Injection site haemorrhage, Injection site pain
Patient experienced significant bleeding at the injection site along with slight redness and pain 4-... Patient experienced significant bleeding at the injection site along with slight redness and pain 4-6 inches from the injection site. More
2869585 77 M CO 10/30/2025 FLU3
FLU3
GLAXOSMITHKLINE BIOLOGICALS
SEQIRUS, INC.


Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient was given both the high and regular dose of the Flu vaccine. No signs or symptoms are presen... Patient was given both the high and regular dose of the Flu vaccine. No signs or symptoms are presented at this time. More
2869586 40 M IL 10/30/2025 COVID19
PFIZER\BIONTECH
En2613
Blood test, Deep vein thrombosis, Pulmonary embolism Blood test, Deep vein thrombosis, Pulmonary embolism
DVTs/PE DVTs/PE
โœ“ โœ“
2869587 63 F MS 10/30/2025 COVID19
PFIZER\BIONTECH
na0589
Eye haemorrhage, Retinal vein occlusion, Vision blurred Eye haemorrhage, Retinal vein occlusion, Vision blurred
Pt vision became blurry with no being able to see letters in words almost immediately after vaccine.... Pt vision became blurry with no being able to see letters in words almost immediately after vaccine. Pt was diagnosed with Central vein occlusion with hemorrhaging. Pt will get monthly shots in eye for 6 months and continue to be monitored for 1 year More
2869588 89 F NJ 10/30/2025 COVID19
PFIZER\BIONTECH
NA0587
Arthralgia, Injection site pain, Orthosis user, Pain in extremity Arthralgia, Injection site pain, Orthosis user, Pain in extremity
customer described pain at site initially then down arm , then wrist, and shoulder , wrist still hu... customer described pain at site initially then down arm , then wrist, and shoulder , wrist still hurts at night , wears a brace and used lidocaine and diclofenac gel externally. More
2869589 35 F 10/30/2025 MMR
GLAXOSMITHKLINE BIOLOGICALS
4SB5S
Exposure via skin contact, Syringe issue Exposure via skin contact, Syringe issue
improper preparation of vaccine; Inappropriate preparation of medication; Accidental exposure to pro... improper preparation of vaccine; Inappropriate preparation of medication; Accidental exposure to product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a 35-year-old female patient who received MMR (Priorix) (batch number 4SB5S) for prophylaxis. On 30-SEP-2025, the patient received Priorix. On 30-SEP-2025, an unknown time after receiving Priorix, the patient experienced exposure via skin contact (Verbatim: improper preparation of vaccine), inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication ) and accidental exposure to product (Verbatim: Accidental exposure to product). The outcome of the exposure via skin contact, inappropriate preparation of medication and accidental exposure to product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 30-SEP-2025 Reporter stated about a leaky Priorix syringe after reconstitution. She did not used a Luer-Lok need to mix the medication. PQC ruled out. Reporter stated that the Medication leaked on her hand. More
2869591 6 M UT 10/30/2025 FLU3
FLU3
SEQIRUS, INC.
SEQIRUS, INC.
407003
407003
Febrile convulsion, Hyperhidrosis, Hypotension, Pallor, Somnolence; Syncope Febrile convulsion, Hyperhidrosis, Hypotension, Pallor, Somnolence; Syncope
patient fainted 10-15 minutes after flu shot, diaphoretic, hypotensive and pale, drowsy. Mom states ... patient fainted 10-15 minutes after flu shot, diaphoretic, hypotensive and pale, drowsy. Mom states he had a febrile seizure when he had influenza in December. Nurse monitored blood pressure & pulse. Given granola bar, juice and water. Patient because more alert. No medication given. More
2869592 64 M CA 10/30/2025 FLU3
FLU3
FLU3
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
7JZ2R
7JZ2R
7JZ2R
Areflexia, Bulbar palsy, Burning sensation, Coagulopathy, Guillain-Barre syndrom... Areflexia, Bulbar palsy, Burning sensation, Coagulopathy, Guillain-Barre syndrome; Immunoglobulin therapy, Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia, Scan with contrast; Thrombocytopenia More
64 y/o right handed man who says, he had paresthesias in his feet 2 days ago (10/28/25), slowly asce... 64 y/o right handed man who says, he had paresthesias in his feet 2 days ago (10/28/25), slowly ascending up, then with burning sensation to his hips yesterday (10/29/25), and found with weakness ascending from feet up as of yesterday afternoon/evening (10/29/25). Today (10/30/25), arms/hands are weak, and concern for aspiration. Flu vaccine 10/26/25. Clinically, high suspicion for GBS Ascending paralysis Bulbar symptoms Areflexia in legs He definitely can have cord disease/compression, however, would not explain bulbar symptoms. Hx aligns more with GBS, will start IVIG pending MRI spine studies, C spine being most crucial wwo contrast. Flu vaccine likely culprit if GBS -pending MRI studies -cannot get an LP due to thrombocytopenia, coagulopathy -IVIG x5 days -nif/vc q2h More
โœ“
2869593 1.08 F TX 10/30/2025 FLU3
HIBV
PNC20
UNK
VARCEL
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
UNKNOWN MANUFACTURER
MERCK & CO. INC.
UT8623KA
UK010AA
HN5980

Y010045
Paralysis; Paralysis; Paralysis; Paralysis; Paralysis Paralysis; Paralysis; Paralysis; Paralysis; Paralysis
Paralysis at least 12 hours at home no treatment Paralysis at least 12 hours at home no treatment
2869594 48 F CA 10/30/2025 FLU3
HEP
IPV
MMR
TDAP
VARCEL
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
37KF3
9K34M
Y1D03P1
Z004811
37F34
Z008873
Injection site erythema, Injection site induration, Injection site oedema, Injec... Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site erythema, Injection site induration, Injection site oedema, Injection site pain; Injection site erythema, Injection site induration, Injection site oedema, Injection site pain More
Patient came into the Public Health Center Immunization Clinic on 10/30/2025 around 12:20 PM request... Patient came into the Public Health Center Immunization Clinic on 10/30/2025 around 12:20 PM requesting information and further assessment of a potential localized vaccine site reaction on the RA following vaccines administered at the clinic on 10/28/2025. Client reported she received MMR, TDAP, Varicella, and Polio vaccines on 10/28/2025 and S/S started that evening. Client reported erythema, edema, pain, and hardness at the injection site. Client denied fever, chills, malaise, drainage, streaking, or other S/S of infection. Client denied worsening of S/S from onset of localized reaction. PHN notified PHN Manager, of client concerns. PHN Manager assessed client concerns and reinforced PCP follow up. PHN validated client concerns and referred Client to PCP for further assessment of localized vaccine site reaction concerns. Client reported she is uninsured and does not have a PCP provider. PHN provided client with Area Community Health Centers By Region list and Whole Person Care Clinic resource information for follow up with a provider. PHN explained resources to the client and reinforced follow up. Client verbalized understanding of seeking further assessment of localized vaccine site reaction concerns. More
2869595 67 M MS 10/30/2025 FLU3
TDAP
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
U8862EA
94KG2
No adverse event, Wrong technique in product usage process; No adverse event, Wr... No adverse event, Wrong technique in product usage process; No adverse event, Wrong technique in product usage process More
Patient was given the intramuscular injection Fluzone High dose in the left deltoid using a 5/8 inch... Patient was given the intramuscular injection Fluzone High dose in the left deltoid using a 5/8 inch needle rather than the appropriate 1 inch needle length. Called the patient the day after vaccine to alert him of the error, and he did not report any adverse effects. Offering to repeat vaccine per ACIP recommendations; however, patient has not returned for this. More
2869597 69 F KY 10/30/2025 HEPAB
GLAXOSMITHKLINE BIOLOGICALS
AV2A3
Tinnitus Tinnitus
Ringing in ears; This non-serious case was reported by a other health professional via call center ... Ringing in ears; This non-serious case was reported by a other health professional via call center representative and described the occurrence of ringing in ears in a 69-year-old female patient who received HAB (Twinrix) (batch number AV2A3) for prophylaxis. On 08-OCT-2025, the patient received Twinrix. On 09-OCT-2025, 1 days after receiving Twinrix, the patient experienced ringing in ears (Verbatim: Ringing in ears). The outcome of the ringing in ears was not resolved. It was unknown if the reporter considered the ringing in ears to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the ringing in ears to be related to Twinrix and Twinrix Pre-Filled Syringe Device. 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: 13-OCT-2025 Pharmacy student reported that a patient had received a Twinrix injection on 8th October 2025. On the following day, she experienced ringing in the ears, which continued thereafter. More
2869599 2 F VA 10/30/2025 DTAPHEPBIP
GLAXOSMITHKLINE BIOLOGICALS
9c295
Extra dose administered Extra dose administered
a pediatric patient received an extra dose of Pediarix; This non-serious case was reported by a nurs... a pediatric patient received an extra dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9c295, expiry date 02-FEB-2027) for prophylaxis. Previously administered products included Pentacel (1st dose received on an unknown date), Pentacel (2nd dose received on an unknown date), Pentacel (3rd dose received on an unknown date) and Infanrix (one dose received on an unknown date). On 15-OCT-2025, the patient received Pediarix (intramuscular, left thigh). On 15-OCT-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: a pediatric patient received an extra dose of Pediarix). The outcome of the extra dose 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: 15-OCT-2025 The reporter stated that a pediatric patient received an extra dose of Pediarix today (on the day of reporting) due to recordkeeping issues. She stated that she thought she was giving a catch-up dose today, dose 2. But then after administration the records came through showing that this patient had already had three doses of Pentacel and one dose of Infanrix. More
2869602 NY 10/30/2025 MMR
GLAXOSMITHKLINE BIOLOGICALS
UNK
Expired product administered Expired product administered
Priorix was administered post expiration; This non-serious case was reported by a nurse via other ma... Priorix was administered post expiration; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) (expiry date 01-SEP-2025) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Priorix was administered post expiration). 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-OCT-2025 Nurse calling to report an adverse event for Priorix and realized she meant to call company. The reporter stated that Priorix was administered post expiration. Confirmed no Merck product was involved. No other information was provided. No additional adverse event or no product quality complaint reported was unspecified. The batch number was not provided and a request for this information has been made. More
2869606 24 F GA 10/30/2025 TDAP
TDAP
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
94KG2
4YA34
Exposure during pregnancy, Extra dose administered, Wrong product administered; ... Exposure during pregnancy, Extra dose administered, Wrong product administered; Exposure during pregnancy, Extra dose administered, Wrong product administered More
Drug Exposure During Pregnancy; Extra dose administered.; she was supposed to get Flu vaccine and in... Drug Exposure During Pregnancy; Extra dose administered.; she was supposed to get Flu vaccine and instead was accidentally given TDAP; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 25-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 94KG2, expiry date 28-NOV-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 4YA34, expiry date 05-NOV-2027) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis. On 06-OCT-2025, the patient received the 2nd dose of Boostrix. On 04-SEP-2025, the patient received the 1st dose of Boostrix. The patient did not receive Flu vaccine. On 06-OCT-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose administered.) and wrong vaccine administered (Verbatim: she was supposed to get Flu vaccine and instead was accidentally given TDAP). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the extra dose administered, wrong vaccine administered and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Flu vaccine): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:06-OCT-2025 The reporter had a question one was related to the TDAP vaccine and the other was related to, actually, only one question was related to TDAP. A pregnant patient who on, September Fourth, received Boostrix, she got TDAP administered by our staff. At the time of reporting, she returned, she was supposed to get Flu vaccine and instead was accidentally given TDAP. So, she had TDAP twice in a month. So, his/her question was: She was pregnant, she was 32 weeks and 6 days pregnant. The reporter asked if they had any information, any clinical information, on patients who received Two TDAP vaccines in pregnancy. More
2869609 F 10/30/2025 COVID19
MODERNA

Malaise, Pyrexia Malaise, Pyrexia
General malaise; Maybe a fever; This spontaneous case was reported by a consumer and describes the o... General malaise; Maybe a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise) and PYREXIA (Maybe a fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus erythematosus (diagnosed in 1989) since 1989, NASH (diagnosed 29 years ago), Liver nodule (ongoing liver problem) and Cough (always had cough). In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (General malaise) and PYREXIA (Maybe a fever). At the time of the report, MALAISE (General malaise) and PYREXIA (Maybe a fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that the patient used to get sick for 2- or 3-days post vaccination. The reported symptoms included a fever or a general malaise. And it was reported that the reported symptom used to go away. No treatment medications provided by the reporter. This case was linked to MOD-2025-790549 (Patient Link). More
2869610 82 M 10/30/2025 COVID19
MODERNA

COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
Covid test resulted positive; This spontaneous case was reported by a consumer and describes the occ... Covid test resulted positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid test resulted positive) in an 82-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (It was reported that since the vaccinations were offered in 2020 and the patient had received all the vaccinations) in 2020. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid test resulted positive). At the time of the report, COVID-19 (Covid test resulted positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medications were provided. It was reported that since the vaccinations were offered in 2020, the patient had received all the vaccinations until last year. It was reported that, in the fall of 2024, the doctor said, at this point it was probably October, get the flu shot now and get the RSV shot now, and then hold off on getting your COVID. The patient had held off and got the COVID, the disease. The patient had no signs nor symptoms, but Covid test resulted positive. The patient was not sick. The patient just tested positive. The patient also had a pre-existing oncology condition which required a bone marrow test in December 2024. It was reported that the bone marrow test was denied being for anything that developed after having received a Covid vaccine. It was something he had been worked up for about 5 different things for the oncologist, but it had nothing connected anything to do with Covid. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790549 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790549:Wife case More
2869611 F 10/30/2025 COVID19
MODERNA

Chills, Pyrexia Chills, Pyrexia
high fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of... high fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever) and CHILLS (chills). At the time of the report, PYREXIA (high fever) and CHILLS (chills) had resolved. No concomitant medications provided by the reporter. It was reported the patient used to have a bad reaction to the vaccine, usually it went off for 2 or 3 days with a symptom of high fever and chills. No treatment medications provided by the reporter. This case was linked to MOD-2025-790556 (Patient Link). More
2869612 82 F MD 10/30/2025 COVID19
COVID19
FLUX
FLUX
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
3052741
3052741


Blood pressure measurement, Blood test, Body temperature, Gynaecological examina... Blood pressure measurement, Blood test, Body temperature, Gynaecological examination, Hot flush; Laboratory test, Renal function test, Thyroid function test, Urine analysis; Blood pressure measurement, Blood test, Body temperature, Gynaecological examination, Hot flush; Laboratory test, Renal function test, Thyroid function test, Urine analysis More
hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a n... hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) in an 82-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052741) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052741) for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. On 19-Sep-2025, the patient received sixth dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night). At the time of the report, HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2025, Blood pressure measurement: normal. On 14-Oct-2025, Blood test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Body temperature: normal. On 14-Oct-2025, Laboratory test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Renal function test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Thyroid function test: everything was perfectly normal; test date September 2025. On 14-Oct-2025, Urine analysis: everything was perfectly normal; test date September 2025. On an unknown date, Gynaecological examination: everything was fine. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter considered HOT FLUSH (hot flashes, that last 10 minutes to 2 hours and come intermittently through out the day but not a night) to be related. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that the patient believed that the side effects she had been experiencing were caused by the mNEXSPIKE vaccine, as she had undergone extensive medical testing over the past month and all results had been normal. Also reported that the symptoms began on 22 September 2025 and consisted of hot flashes lasting between 10 minutes and 2 hours, occurring intermittently throughout the day but not at night. She mentioned that she had received both the mNEXSPIKE vaccine and a flu shot on 19 September 2025, although she did not know the brand name of the flu shot. She described the flu shot as the "super flu shot" typically administered to older individuals. It was explained that she had been evaluated for heat waves but not specifically for hot flashes. She stated that the first heat wave occurred on 22 September 2025. She had undergone several tests. According to her, all results were normal, and her doctor had confirmed this after reviewing the laboratory findings. She also noted that her body temperature and blood pressure had been checked during episodes of hot flashes and were found to be within normal ranges. Despite this, she described feeling extremely hot during these episodes. She indicated that the tests had been conducted on the Tuesday prior to the call, which she believed might have been 14 October 2025, although she was not certain of the exact date. She emphasized that she had continued to experience these symptoms daily since 22 September 2025. During the call, she mentioned that she was experiencing a heat wave at that very moment. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2025: Live follow-up received and significant information includes reporter causality updated. More
2869613 68 F 10/30/2025 COVID19
MODERNA

Brain fog, Illness, Immunisation reaction Brain fog, Illness, Immunisation reaction
I was sick for a while; brain fog/ brain fogging; I just haven't been the same/felt different a... I was sick for a while; brain fog/ brain fogging; I just haven't been the same/felt different after receiving the vaccine/something's been different with me in the last few years; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick for a while), BRAIN FOG (brain fog/ brain fogging) and IMMUNISATION REACTION (I just haven't been the same/felt different after receiving the vaccine/something's been different with me in the last few years) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Patient had the vaccines from several different places at the time.). Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick for a while), BRAIN FOG (brain fog/ brain fogging) and IMMUNISATION REACTION (I just haven't been the same/felt different after receiving the vaccine/something's been different with me in the last few years). At the time of the report, ILLNESS (I was sick for a while), BRAIN FOG (brain fog/ brain fogging) and IMMUNISATION REACTION (I just haven't been the same/felt different after receiving the vaccine/something's been different with me in the last few years) outcome was unknown. Concomitant medication was not provided. It was reported that the patient was a poor narrator and asked whether brain fog was one of the side effects of the SPIKEVAX. She explained that she had felt different after receiving the vaccine. She mentioned that she was unsure whether she had contracted COVID-19 but had been sick for a while. She stated that after taking the vaccine, she hadn't felt the same and wanted to know if brain fog could be a side effect, as she had heard such claims. She believed the vaccine she received was administered in 2021 but wasn't certain and said she would need to confirm with her daughter. She expressed concern that something had changed in her over the past few years and noted that others had observed this as well. She further added that the connection was poor and she couldn't hear well on her end. She recalled receiving vaccines from several different locations where she had gone with her daughter. She admitted that her daughter would have better knowledge of the details, as she herself didn't remember them clearly. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2025: Live follow-up received and significant information includes added reporter phone number, added medical history, new event brain fog added, updated suspect drug and updated narrative On 23-Oct-2025: Upon internal review on 24-Oct-2025, it was identified that the case MOD-2025-790537 (US-MODERNATX-MOC20251024000012) was created inadvertently as an initial case instead of adding follow up to the already existing case MOD-2025-790427 (US-MODERNATX-MOC20251021000013). Hence, all the information from the case MOD-2025-790537 (US-MODERNATX-MOC20251024000012) has been added and merged into the retained case MOD-2025-790427 (US-MODERNATX-MOC20251021000013) as a follow-up. The case MOD-2025-790537 (US-MODERNATX-MOC20251024000012) will be deleted from the safety database. Live Follow-up received contains no new information. On 23-Oct-2025: Live follow-up received and non-significant information includes reference ids added. More
2869614 67 F WA 10/30/2025 COVID19
FLUX
MODERNA
UNKNOWN MANUFACTURER


Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
her arm started beginning to feel sore/her arm was so sore, it was so painful; This spontaneous case... her arm started beginning to feel sore/her arm was so sore, it was so painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 7, last vaccine before that was a year ago) in 2024, PFIZER BIONTECH COVID-19 VACCINE (Dose 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 6), PFIZER BIONTECH COVID-19 VACCINE (Dose 4), PFIZER BIONTECH COVID-19 VACCINE (Dose 5), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 3). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. On 17-Oct-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Oct-2025, the patient experienced PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful). On 19-Oct-2022, PAIN IN EXTREMITY (her arm started beginning to feel sore/her arm was so sore, it was so painful) had resolved. No concomitant medication was reported. It was mentioned she has an oncologist that she would see on Monday. Patient had only had Pfizer covid vaccines before mNEXSPIKE. It was stated so far, she did not fall sick, so it was fine, it was only a very sore arm, but it was fine. Patient received mNEXSPIKE in the morning of 17-Oct-2025 and late in the afternoon that day, her arm started beginning to feel sore. It was pretty sore for 2 days, and then it was fine. She did not get fever. She was worried she might get fever since it was a change from a different manufacturer. Patient has had 7 previous covid vaccinations. It was noted she got the influenza vaccine on the same day at the same time in the same arm as mNEXSPIKE and said maybe that was why her arm was so sore, why it was so painful. It was unknown if the patient experienced any additional symptoms/events. No treatment information as reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790469 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790469:Caller's friend More
2869615 75 F 10/30/2025 COVID19
MODERNA

Pruritus Pruritus
Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to t... Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Influenza vaccine on 11-Nov-2024; for COVID-19 prophylaxis: Spikevax NOS (Had 7 doses). Past adverse reactions to the above products included No adverse effect with Influenza vaccine and Spikevax NOS. Concurrent medical conditions included Blood pressure high. On 10-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In December 2024, the patient experienced PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled). At the time of the report, PRURITUS (Incredible itch all over her body/It was worse from her thighs, her legs and her feet/From head to toe/She scratched until she bled) was resolving. The patient was taking cholesterol and high blood pressure medications. The patient received her COVID shot on 10-Dec-2024. Within a few days, she developed an intense, widespread itch all over her body. Although there was no visible rash or redness, the itch was so severe that she scratched herself until she bled, but the scratching brought no relief, she consulted a dermatologist, an allergist, an internist, and an endocrinologist. All of them conducted various tests, but no one could determine the cause of her symptoms. She believed the only possible trigger might have been the Moderna vaccine, although she hoped she was wrong especially since she was due for another shot and was terrified of experiencing the same reaction again. She mentioned that this was the first adverse reaction she had ever experienced from a COVID vaccine, despite having received seven doses previously. The itchiness affected her entire body but was particularly severe on her thighs, legs, and feet. The condition disrupted her sleep, as the constant itching kept her awake at night. She tried allergy pills, creams, and ointments, but nothing provided lasting relief. The patient had such a terrible reaction, felt so itchy that she was scratching till bled and the itching did not stop, no rash, nothing you could see visibly, but whole body was just one big itch. She used salves and lotions from the doctors that helped, whenever she stopped using the topical treatments, the itch would return. She said it had almost been a year and she currently had slight itchiness. It had gotten progressively better but it had taken all of these months. Itching was slight, not as horrible or as horrendous as it was last winter and last spring and summer. It was unknown if the patient experienced any additional symptoms or events. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2025: Live non-significant follow-up information accepted: Event verbatim and narrative was updated. More
2869616 64 F 10/30/2025 COVID19
MODERNA

Diverticulitis Diverticulitis
acute diverticulitis; This spontaneous case was reported by a consumer and describes the occurrence ... acute diverticulitis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (acute diverticulitis) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 11-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced DIVERTICULITIS (acute diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (acute diverticulitis) outcome was unknown. No concomitant medication was reported. Approximately three weeks later, she was diagnosed with acute diverticulitis, a condition she had never experienced before. The reporter inquired whether this could be a reported side effect of the Moderna COVID-19 vaccine. The reporter sought advice on this matter. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2869617 29 F MA 10/30/2025 COVID19
COVID19
TTOX
TTOX
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
3053669
3053669


Back pain, Fatigue, Feeling cold, Feeling hot, Headache; Night sweats, Pain, Som... Back pain, Fatigue, Feeling cold, Feeling hot, Headache; Night sweats, Pain, Somnolence; Back pain, Fatigue, Feeling cold, Feeling hot, Headache; Night sweats, Pain, Somnolence More
experienced being extremely cold; slight lower back pain; hot and in a sweat; hot and in a sweat; my... experienced being extremely cold; slight lower back pain; hot and in a sweat; hot and in a sweat; my body has felt fatigued and slightly achy; fell asleep around 6 pm after feeling fatigued; fatigued; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat) and PAIN (my body has felt fatigued and slightly achy) in a 29-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3053669) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3053669) for COVID-19 prophylaxis and non-company product included Tetanus vaccine toxoid (Tetanus vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: flu shot on 06-Oct-2025. Past adverse reactions to the above products included No adverse effect with flu shot. Concurrent medical conditions included Narcolepsy (Type 2 Narcolepsy) and Asthma. On 20-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter and dose of Tetanus vaccine toxoid (Tetanus vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 20-Oct-2025, the patient experienced FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat), PAIN (my body has felt fatigued and slightly achy), SOMNOLENCE (fell asleep around 6 pm after feeling fatigued), FATIGUE (fatigued) and HEADACHE (a slight headache). At the time of the report, FEELING COLD (experienced being extremely cold), BACK PAIN (slight lower back pain), FEELING HOT (hot and in a sweat), NIGHT SWEATS (hot and in a sweat), FATIGUE (fatigued) and HEADACHE (a slight headache) was resolving and PAIN (my body has felt fatigued and slightly achy) and SOMNOLENCE (fell asleep around 6 pm after feeling fatigued) outcome was unknown. The patient did not have any additional medical history, concomitant disease or risk factor. No concomitant medications were reported. The patient received the vaccination at work on 20-Oct-2025 at approximately 1:45 P.M. Later on, that same evening, she experienced being extremely cold, fell asleep around 6 P.M after feeling fatigued, and then woke up at 10:45 P.M feeling hot and in a sweat. Since then, her body had felt fatigued and slightly achy. She experienced slight lower back pain and a slight headache as well. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment information was provided. More
2869618 17 F CA 10/30/2025 COVID19
COVID19
FLUX
FLUX
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER




Arthralgia, Back pain, Dizziness, Ear discomfort, Headache; Myalgia, Nausea, Vis... Arthralgia, Back pain, Dizziness, Ear discomfort, Headache; Myalgia, Nausea, Visual impairment; Arthralgia, Back pain, Dizziness, Ear discomfort, Headache; Myalgia, Nausea, Visual impairment More
sore back; ear muffled; vision faintness; headache; nausea; various joint pain/Knee; muscle aches; l... sore back; ear muffled; vision faintness; headache; nausea; various joint pain/Knee; muscle aches; light headedness; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache) and NAUSEA (nausea) in a 17-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. On 21-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (various joint pain/Knee), MYALGIA (muscle aches) and DIZZINESS (light headedness). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, BACK PAIN (sore back), EAR DISCOMFORT (ear muffled), VISUAL IMPAIRMENT (vision faintness), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (various joint pain/Knee), MYALGIA (muscle aches) and DIZZINESS (light headedness) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 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. Concomitant medications were not reported. It was reported that patient experienced nausea, headache, sore back, knees, ear muffled, various joint pain, muscle aches, vision faintness (light headedness). It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. More
2869619 F TX 10/30/2025 COVID19
MODERNA

COVID-19 COVID-19
mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence... mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Cancer. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild case of COVID-19). At the time of the report, COVID-19 (mild case of COVID-19) was resolving. Concomitant medications were not reported. It was reported that in 2021, patient received two doses of the Moderna vaccine. It was reported that patient wanted to express the interest in volunteering for any ongoing or future studies related to the long-term effectiveness of the mRNA COVID-19 vaccine, particularly in individuals with a history of cancer. In 2021, patient had received two doses of the Moderna vaccine as part of a study coordinated by the Leukemia and Lymphoma Society. At that time, patient was one-year post-treatment for cancer. Patient was grateful to share that patient had remained in excellent health since then, with only one mild case of COVID-19 and no additional boosters. Patient had given the unique medical background and positive response to the vaccine, she will be honored to contribute to research that may help others with similar health histories. Patient wanted to know If there were any studies or data collection efforts where her participation could be of value, patient would welcome the opportunity to be involved. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2869620 73 F 10/30/2025 COVID19
MODERNA

Contusion, Feeling hot, Pruritus, Skin discolouration, Swelling Contusion, Feeling hot, Pruritus, Skin discolouration, Swelling
it is purple and bruised; it is purple and bruised; it was also hot to touch and very itchy; it got ... it is purple and bruised; it is purple and bruised; it was also hot to touch and very itchy; it got bumpy and was itching; she woke up and the reaction was bigger and swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it got bumpy and was itching), FEELING HOT (it was also hot to touch and very itchy), SKIN DISCOLOURATION (it is purple and bruised), CONTUSION (it is purple and bruised) and SWELLING (she woke up and the reaction was bigger and swollen) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Penicillin; for COVID-19 prophylaxis: Spikevax NOS (This was the first time this had happened and and she had Moderna COVID vaccines every year since the beginning and had no problems.). Past adverse reactions to the above products included Drug allergy with Penicillin; and No adverse effect with Spikevax NOS. Concurrent medical conditions included Allergy to molds, Allergy to animals (pets), Smoke sensitivity and Penicillin allergy. On 17-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 17-Oct-2025, the patient experienced PRURITUS (it got bumpy and was itching) and SWELLING (she woke up and the reaction was bigger and swollen). On 18-Oct-2025, the patient experienced FEELING HOT (it was also hot to touch and very itchy). On 21-Oct-2025, the patient experienced SKIN DISCOLOURATION (it is purple and bruised) and CONTUSION (it is purple and bruised). The patient was treated with Hydrocortisone on 17-Oct-2025 at an unspecified dose and frequency and Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency. On 21-Oct-2025, SWELLING (she woke up and the reaction was bigger and swollen) had resolved. At the time of the report, PRURITUS (it got bumpy and was itching) had not resolved and FEELING HOT (it was also hot to touch and very itchy), SKIN DISCOLOURATION (it is purple and bruised) and CONTUSION (it is purple and bruised) outcome was unknown. Concomitant product use was not provided by the reporter. Patient had received a dose of Moderna Spikevax (2025-2026) at a mall on Friday 17-Oct-2025 and it got bumpy and was itching while she was shopping in the mall. When she got home, the itchiness and bumps increased. She woke up and the reaction was bigger and swollen. On the second day the patient wondered if it would go away. It was also hot to touch and very itchy. On 20-Oct-2025, the patient went back to the mall to show the Pharmacist, and the Pharmacist provided her with information to contact Moderna to report it. The patient did not a fever. On 21-Oct-2025, it was purple and bruised, and the swelling went down, but it was still itchy around it. This was the first time this had happened, and she had Moderna COVID vaccines every year since the beginning and had no problems. No other details provided. The patient took Aspirin, but agent unsure when she took it. When she went home, she used hydrocortisone cream, but it continued to itch. It was unknown if the patient experienced any additional symptoms/events. Event causality not reported. Reporter did not allow further contact More
2869621 F 10/30/2025 COVID19
MODERNA

Erythema, Fatigue, Feeling hot, Vaccination site pain Erythema, Fatigue, Feeling hot, Vaccination site pain
sore arm where the shot was given, and it is red and warm to the touch; sore arm where the shot was ... sore arm where the shot was given, and it is red and warm to the touch; sore arm where the shot was given, and it is red and warm to the touch; feels tired; sore arm where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu shot, Flu shot, Flu shot, Pfizer, Pfizer, Pfizer, Pfizer and Flu shot. Past adverse reactions to the above products included Localised erythema with Flu shot and Pfizer; Localised feeling of warmth with Flu shot and Pfizer; Tiredness with Flu shot and Pfizer; and Vaccination site pain with Flu shot and Pfizer. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given). At the time of the report, ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FEELING HOT (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) had resolved. No concomitant medication was reported. She had received COVID shots twice a year since they had been offered. She received Pfizer at the beginning but then switched to Moderna since she thinks she had a better response from the Moderna product. The patient definitely felt the effects of the vaccine and if this was what the vaccination was like, she really did not want COVID. The patient had noticeable effects every single time she received a COVID vaccination, and it didn't 'slam her' but it woke up her immune system and, like it said, 'pay attention', which means it was really working. The patient experienced a sore arm where the shot was given, and it was red and warm to the touch. She did not experience a fever, but felt tired, but was still fully functionable. She experienced these effects for the first 48 hours and considered these to be "normal side effects." Her experience wasn't any different to her than every other COVID shot she's had, nor was it different from every other flu shot she's ever had. It's nothing extreme; she was not passing out or having extreme reactions. The reporter declined to provide any additional details. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-790756 (Patient Link). Reporter did not allow further contact More
2869622 77 F 10/30/2025 COVID19
MODERNA
3052133
Arthralgia, Discomfort, Taste disorder Arthralgia, Discomfort, Taste disorder
altered taste; discomfort under both armpits; pain in all joints; This spontaneous case was reported... altered taste; discomfort under both armpits; pain in all joints; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (altered taste), DISCOMFORT (discomfort under both armpits) and ARTHRALGIA (pain in all joints) in a 77-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052133) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052133) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced TASTE DISORDER (altered taste), DISCOMFORT (discomfort under both armpits) and ARTHRALGIA (pain in all joints). At the time of the report, TASTE DISORDER (altered taste), DISCOMFORT (discomfort under both armpits) and ARTHRALGIA (pain in all joints) was resolving. No concomitant medications were reported. The reporter was asking about the correct storage conditions for the COVID vaccine and reported experiencing unusual side effects. She noted that the vaccine was at room temperature when administered and asked for clarification on whether those side effects were recognized, expressing concern about the pharmacy's storage practices. She also contacted her doctor the day before, who was unfamiliar with those side effects and suggested that the vaccine's storage might have influenced them. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. More
2869623 M 10/30/2025 COVID19
MODERNA

Cardiac disorder, Confusional state, Nausea Cardiac disorder, Confusional state, Nausea
I have been experiencing really strong and random heart problems; confusion; Nausea; This spontaneou... I have been experiencing really strong and random heart problems; confusion; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (I have been experiencing really strong and random heart problems), CONFUSIONAL STATE (confusion) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Long COVID. In October 2025, the patient received first dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced CARDIAC DISORDER (I have been experiencing really strong and random heart problems), CONFUSIONAL STATE (confusion) and NAUSEA (Nausea). At the time of the report, CARDIAC DISORDER (I have been experiencing really strong and random heart problems), CONFUSIONAL STATE (confusion) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient got the very first COVID vaccine ever about 2 weeks ago, and it was the (SPIKEVAX 2025-26), which was the name that appears on the vaccine statement the day the patient got the vaccine. The patient had been experiencing really strong and random heart problems and nausea and confusion. The patient wanted to want to know when patient would start to feel better. It's been a few days, the patient felt like this. The patient wanted to get the first vaccine to build immunity. The main reason for this was that the patient had been experiencing LONG-COVID symptoms for a while now and decided it might be because the patient was never unvaccinated. The patient wanted to feel better and recover from a long COVID and never experience long COVID or any COVID ever again. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. The reporter causality was not reported. More
2869624 22 F MA 10/30/2025 COVID19
MODERNA

Body temperature, Pyrexia, Vaccination site pain Body temperature, Pyrexia, Vaccination site pain
fever; pain at site of administration on arm; This spontaneous case was reported by a consumer and d... fever; pain at site of administration on arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm) in a 22-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 25-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Oct-2025, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (pain at site of administration on arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2025, Body temperature: 102 degree fever. The concomitant medication was not reported by the reporter. The patient had 102-degree fever 4 to 5 hours after administration and had pain at site of administration on arm. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2869625 30 M MA 10/30/2025 COVID19
MODERNA

Asthenia, Myalgia, Pain in extremity Asthenia, Myalgia, Pain in extremity
arm pain; mild body aches; weakness; This spontaneous case was reported by a consumer and describes ... arm pain; mild body aches; weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MYALGIA (mild body aches) and ASTHENIA (weakness) in a 30-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concomitant products included Influenza vaccine (Flu) for an unknown indication. On 25-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Oct-2025, the patient experienced PAIN IN EXTREMITY (arm pain), MYALGIA (mild body aches) and ASTHENIA (weakness). On 26-Oct-2025, PAIN IN EXTREMITY (arm pain), MYALGIA (mild body aches) and ASTHENIA (weakness) had resolved. The patient had no medical history, concomitant disease or risk factors. The patient had arm pain for 24 hours, mild body aches and weakness the day after shot. The patient did not experience any additional symptoms or events. There was no lab data or results available. The treatment medication was not reported by the reporter. More
2869626 GA 10/30/2025 RSV
PFIZER\WYETH
LL8391
Device breakage Device breakage
Exploded, it just broke and everything went everywhere; The initial case was missing the following m... Exploded, it just broke and everything went everywhere; The initial case was missing the following minimum criteria: not reportable adverse event. Upon receipt of follow-up information on 17Oct2025 this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "Exploded, it just broke and everything went everywhere". Additional information: "the patient has been using Abrysvo (Act-O-Vial) for quite a while. The one you put together and when I went to do it this morning, just a little while ago the thing that just exploded it just broke and everything went everywhere. I have never had that happened." NDC Number: 0069-0344-01. UPC Number: 300690344010. Causality for "exploded, it just broke and everything went everywhere" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). More
2869627 10/30/2025 COVID19
PFIZER\BIONTECH

Pain in extremity Pain in extremity
sore arm three times; This is a spontaneous report received from a Consumer or other non HCP, Progra... sore arm three times; 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 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, Single), for Covid-19 Immunization, reaction(s): "sore arm three times"; Covid-19 vaccine (Dose 2, Single), for Covid-19 Immunization, reaction(s): "sore arm three times". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm three times". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869628 F 10/30/2025 COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
EH9899
EH9899
EH9899
Arthralgia, Chills, Fatigue, Headache, Joint stiffness; Joint swelling, Pain, Py... Arthralgia, Chills, Fatigue, Headache, Joint stiffness; Joint swelling, Pain, Pyrexia, Vaccination site pain, Vaccination site swelling; Vaccination site warmth More
Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection si... Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Fever; Headache; body aches; chills; fatigue; stiffness multiple bilateral joints; swelling, pain, stiffness multiple bilateral joints; swelling, pain, stiffness multiple bilateral joints; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EH9899), in right arm for covid-19 immunisation. Vaccination date of dose 1 was 21Dec2021 (as reported). The patient's relevant medical history included: "Intolerant to non-specific beta blockers" (unspecified if ongoing); "Intolerant to non-specific beta blockers" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nitroglycerin, reaction(s): "allergies:nitroglycerin". The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "Pain, swelling, increased warmth at injection site"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered"; JOINT STIFFNESS (non-serious), outcome "recovered", described as "stiffness multiple bilateral joints"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "swelling, pain, stiffness multiple bilateral joints". Additional information: The reaction to the first dose were less severe with shorter duration of acute symptoms. The second dose was given on 11Jan2021. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500211948 same patient/suspect vaccine; different dose/AE.; More
2869629 F 10/30/2025 COVID19
PFIZER\BIONTECH

COVID-19, Drug ineffective COVID-19, Drug ineffective
She got COVID; She got COVID; This is a spontaneous report received from a Consumer or other non HCP... She got COVID; She got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 92-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: got covid 87 years old. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She got COVID". Clinical course: It was reported that Caller's neighbor was 92 years old and was on her third or fourth covid shot or booster. The neighbor she got covid 87 years old but they go out and go out to eat, it was her third time getting covid, she is sick and gets the shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869630 M 10/30/2025 RSV
PFIZER\WYETH

Malaise Malaise
patient was so sick; This is a spontaneous report received from a Consumer or other non HCP, Program... patient was so sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 53-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "patient was so sick". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. Additional information: patient stated "I was so sick" (respondent reports being a past user of Abrysvo). More
2869631 F KY 10/30/2025 COVID19
PFIZER\BIONTECH

COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
tested positive for COVID yesterday; This is a spontaneous report received from a Consumer or other ... tested positive for COVID yesterday; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: COVID-19 (non-serious) with onset 26Oct2025, outcome "unknown", described as "tested positive for COVID yesterday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: During an inbound call for financial assistance, the Patient, (name withheld) stated, "I am so confused. I tested positive for Covid yesterday. They gave me a prescription for Paxlovid." Later, (name withheld) stated, "I've always gotten the vaccine from day one, and it's always been a Pfizer vaccine. And this year I was getting ready to get my booster, and I've never had COVID. And I almost fell over yesterday when I tested positive." More
2869633 66 F NC 10/30/2025 COVID19
PFIZER\BIONTECH

Chills, Pyrexia, Urticaria Chills, Pyrexia, Urticaria
Fever, . chills , hives to upper torso. Fever, . chills , hives to upper torso.
2869635 86 F SC 10/30/2025 FLU3
RSV
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
UT8829BA
B5NJ9
Injection site bruising, Injection site erythema, Injection site pruritus, Injec... Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth; Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth More
The patient received a RSV (Arexvy) immunization on 10/24/25 and called the pharmacy on 10/30/25 to ... The patient received a RSV (Arexvy) immunization on 10/24/25 and called the pharmacy on 10/30/25 to report injection area was red, feverish, itchy ,and bruised (yellow/black about 5 inches in diameter). The patient was told by pharmacist to use ice, Hydrocortisone cream and Zyrtec or Benadryl until MD called on 10/31/25 More
2869636 53 F WA 10/30/2025 FLU3
PNC21
SANOFI PASTEUR
MERCK & CO. INC.
U8832CA
Z007870
Injection site erythema, Injection site pain, Injection site swelling; Injection... Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling More
The customer came 4 days after the administration date and reported that the site of injection has ... The customer came 4 days after the administration date and reported that the site of injection has been red, swollen and is still painful. The customer mentioned she visited a clinic today and that her doctor told to go and show it to the pharmacy. She also mentioned the doctor stated that there might be case of cellulitis, requiring antibiotic(s) treatment. More
2869637 74 F FL 10/30/2025 FLU3
SANOFI PASTEUR
UT8829BA
Erythema, Pruritus, Skin warm Erythema, Pruritus, Skin warm
patient said after vaccination she started getting a red arm which she thought was normal, the redne... patient said after vaccination she started getting a red arm which she thought was normal, the redness continued and started itching also. 5 days after vaccine the redness had continued to spread, itching continued and was warm to touch. The patient sought medical treatment from her primary care provider. Provider indicated reaction to vaccine. More
2869639 79 F MI 10/30/2025 COVID19
COVID19
COVID19
TTOX
TTOX
TTOX
MODERNA
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER






Animal bite, Balance disorder, Breast cancer female, Cancer surgery, Injected li... Animal bite, Balance disorder, Breast cancer female, Cancer surgery, Injected limb mobility decreased; Limb mass, Limb ultrasound, Pain, Pain in extremity, Ultrasound scan normal; Walking aid user; Animal bite, Balance disorder, Breast cancer female, Cancer surgery, Injected limb mobility decreased; Limb mass, Limb ultrasound, Pain, Pain in extremity, Ultrasound scan normal; Walking aid user More
Pain, off balance, aches One June 22 three years and four months ago, our mayor had a nurse come to ... Pain, off balance, aches One June 22 three years and four months ago, our mayor had a nurse come to homes from the Health Department to give Covid vaccines. My arm is still sore for three years and four months. I have had four shots in the same arm. The first three were sore only for two or three weeks, but this fourth one which is the booster is different. I am still having trouble raising my arm to put my clothes on and reaching back to pull up my pants. This is my left arm. I have stabbing pains which lets me know that the rain is coming. I have had physical therapy and an ultrasound, which they said that it was normal. I had to pay $20 per visit for physical therapy, which was unfair to me. How can something be normal when it has been hurting for over three years? My therapist said that she felt a knot in my arm, but the lab folk said it was normal. How can it be normal hurting for three years and four months? On the same day, June 22, I got bit by a squirrel that came in my house. I went to emergency and got a tetnus vaccine in the right arm. That arm is still sore, also. The sad thing about all of this is that I have been diagnosed with breast cancer in the left breast, on the same side the vaccines were given. My arm feels like it has arthritis and my breast has cancer. All on the left side where the shots were given. Did the Covid vaccines give me arthritis and breast cancer? Please research this. I really want to know for my sake and for others. Oh, by the way I also am off balance. I use a cane to walk. Had breast cancer surgery on Oct 15, 2025. More