🏥 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 💀 🏥 🚑 ♿ ⚠️
2869065 51 F IL 10/28/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LT9HP
LT9HP
Dizziness, Vision blurred; Dizziness, Vision blurred Dizziness, Vision blurred; Dizziness, Vision blurred
I got my flu vaccine and less than 24 hrs. I was having severe light headedness then vision issues. ... I got my flu vaccine and less than 24 hrs. I was having severe light headedness then vision issues. lightheaded, and blurry vision. As of 10/28/25 they have not resolved. Referred to Occupational Health Clinic and PMD. More
2869066 7 M MN 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052671
948406
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
7-year-old patient received moderna 12+ instead of 6m-11y. 7-year-old patient received moderna 12+ instead of 6m-11y.
2869067 65 M WI 10/28/2025 FLU3
FLU3
PNC20
PNC20
 SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH



Cough, Headache, Influenza like illness, Oropharyngeal pain, Pain; Pyrexia; Coug... Cough, Headache, Influenza like illness, Oropharyngeal pain, Pain; Pyrexia; Cough, Headache, Influenza like illness, Oropharyngeal pain, Pain; Pyrexia More
Came down with flu like symptoms for 4 days. Cough, fever, headache, body ache, sore throat. Came down with flu like symptoms for 4 days. Cough, fever, headache, body ache, sore throat.
2869068 14 M UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
PEDS COVID-19 DOSE 0.25 mL GIVEN IN ERROR TO 14 YEAR OLD PEDS COVID-19 DOSE 0.25 mL GIVEN IN ERROR TO 14 YEAR OLD
2869069 14 M UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
PEDS COVID-19 DOSE 0.25 ML GIVEN IN ERROR TO AGE 14 YEAR OLD PEDS COVID-19 DOSE 0.25 ML GIVEN IN ERROR TO AGE 14 YEAR OLD
2869071 59 F CA 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052669
948404
Pruritus, Swelling face; Pruritus, Swelling face Pruritus, Swelling face; Pruritus, Swelling face
Patient reports itch on face the evening after vaccinations on 10/25/2025. On 10/26/2025, patient n... Patient reports itch on face the evening after vaccinations on 10/25/2025. On 10/26/2025, patient noticed swelling on the right side of face. The patient took Benadryl in the afternoon which calmed the reaction down a bit. On 10/27/2025, patient reports itch has resolved but face and under chin remains swollen. Patient saw her primary care physician that recommended continuing Benadryl. On 10/282025, patient reports to pharmacy and continues to be swollen on both sides of her face. More
2869072 55 F NC 10/28/2025 FLU3
 SEQIRUS, INC.
 AX6339A
Death Death
N/A patient was found down at her job EMS was called and declared Deceased on the scene. Medical exa... N/A patient was found down at her job EMS was called and declared Deceased on the scene. Medical examiner declined to do autopsy More
✓
2869074 82 F OH 10/28/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Blood creatine phosphokinase increased, Malaise, Muscular weakness Blood creatine phosphokinase increased, Malaise, Muscular weakness
Patient states that she did not feel well the night of vaccination, ended up on the floor that night... Patient states that she did not feel well the night of vaccination, ended up on the floor that night with limited use of muscles. States was like that all night since she could not reach her phone. Ended up hospitalized, states that her CPK was high at the hospital as well. Was discharged on Monday and staying with family until she has her strength build back up. Called us on Tuesday morning 10/28/25 to let us know. More
✓
2869076 61 F KS 10/28/2025 FLU3
 SEQIRUS, INC.
 408924
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was given the high dose Fluad shot even though she is only 61 and should have been given the... Patient was given the high dose Fluad shot even though she is only 61 and should have been given the regular flu shot at the time she received it. More
2869077 78 F MN 10/28/2025 COVID19
 MODERNA
 3052581
Refusal of vaccination, Wrong product administered Refusal of vaccination, Wrong product administered
Gave client moderna instead of flu. Client asked which vaccine, told her moderna. She wanted pfizer.... Gave client moderna instead of flu. Client asked which vaccine, told her moderna. She wanted pfizer. Said that "I don't want flu shot now because if I react I don't know which vaccine caused it". Told her it was okay to mix flu and covid. She passed on flu. More
2869078 0.5 F DC 10/28/2025 COVID19
 MODERNA
 3052741
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
6-month old in clinic for well child visit, Beyfortus 100mg ordered but nurse administered 0.5mg COV... 6-month old in clinic for well child visit, Beyfortus 100mg ordered but nurse administered 0.5mg COVID-19 vaccine intended for 12+age group. Parent notified of error in vaccine administration advised to monitor baby for routine vaccine reactions. None reported More
2869079 48 M GA 10/28/2025 COVID19
 PFIZER\BIONTECH
Ear pain Ear pain
Receive vaccine in my right arm. I am having an earache in my right ear (same side) Receive vaccine in my right arm. I am having an earache in my right ear (same side)
2869080 67 F NE 10/28/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8820AA
UT8820AA
Erythema, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia; Skin warm, Swelling,... Erythema, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia; Skin warm, Swelling, Tenderness More
Per Provider APRN ... Per Provider APRN Right arm pain: - Patient reports pain following influenza vaccination on 10/07/2025 - Symptoms began 48 hours post-vaccination: redness, swelling, warmth, deep pain - Pain worsens with movement - Tenderness over lateral aspect of elbow and humeral head - Pain present when making a fist with right hand - X-ray of right shoulder to be conducted today to rule out other causes - Rest, apply ice and heat to sore areas - Ibuprofen 800 mg every 8 hours with food - Tylenol 1000 mg every 4-6 hours for baseline pain management - Flexeril 10 mg every 8 hours as needed for muscle spasms - Avoid driving, alcohol consumption, and operating heavy machinery while on Flexeril - Consider physical therapy or cortisone injection if no improvement 2. Numbness and tingling of the right hand: - Numbness and tingling in right hand, especially index and middle fingers and thumb - Symptoms worsen with use - Monitor for changes and report new symptoms - Further evaluation and potential referral to specialist if symptoms persist 3. History of influenza vaccination: - Received influenza vaccination on 10/07/2025 in right arm - Symptoms of pain, redness, swelling, warmth began 48 hours post-vaccination - Suspecting possible SIRVA or shoulder injury related to vaccine administration Follow-up: - Patient advised to follow up in the next couple of weeks to report progress More
2869083 11 M MN 10/28/2025 COVID19
 MODERNA
 3052581
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
11-year-old received Moderna 12+ vaccine. 11-year-old received Moderna 12+ vaccine.
2869084 70 M MN 10/28/2025 FLU3
 SEQIRUS, INC.
 409493
Immediate post-injection reaction, Injection site induration Immediate post-injection reaction, Injection site induration
Gave fluad in clients left deltoid and small, hard bump immediately formed. Informed patient a that ... Gave fluad in clients left deltoid and small, hard bump immediately formed. Informed patient a that this is a reaction that can happen and it should go away on its own. "Pt was visually ok" - bump was not red or hot. Advised to see a doctor if it did not go away in a few days or it began to appear hot, red, or infected. More
2869085 18 F WA 10/28/2025 FLU3
 SANOFI PASTEUR
 u8864aa
Immediate post-injection reaction, Loss of consciousness, Syncope Immediate post-injection reaction, Loss of consciousness, Syncope
pt fainted immediately after vaccine was administered. pt was out for around 2-3 minutes before rega... pt fainted immediately after vaccine was administered. pt was out for around 2-3 minutes before regaining full consciousness More
2869087 87 M MO 10/28/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

C-reactive protein, Full blood count, Metabolic function test, Rash, Rash erythe... C-reactive protein, Full blood count, Metabolic function test, Rash, Rash erythematous; Skin exfoliation More
Patient presented to the emergency department with red, flaking, rash to back that he noticed appro... Patient presented to the emergency department with red, flaking, rash to back that he noticed approximately 2 days after getting COVID booster. More
2869088 71 M OR 10/28/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Abdominal discomfort, Headache, Lacrimation increased, Pruritus, Respiratory tra... Abdominal discomfort, Headache, Lacrimation increased, Pruritus, Respiratory tract congestion; Rhinorrhoea More
Patient experienced systemic symptoms beginning 1.5 days after receiving high-dose influenza vaccine... Patient experienced systemic symptoms beginning 1.5 days after receiving high-dose influenza vaccine on October 6th at pharmacy, including gastrointestinal upset, headache, pruritus, congestion, rhinorrhea, and lacrimation lasting approximately one week. More
2869090 21 M IN 10/28/2025 FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
TDAP
TDAP
TDAP
TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 UT8475JA
UT8475JA
UT8475JA
UT8475JA
UT8475JA
UT8475JA
Y010656
Y010656
Y010656
Y010656
Y010656
Y010656
U8264AA
U8264AA
U8264AA
U8264AA
U8264AA
U8264AA
Alanine aminotransferase, Alpha-1 anti-trypsin, Antinuclear antibody, Aspartate ... Alanine aminotransferase, Alpha-1 anti-trypsin, Antinuclear antibody, Aspartate aminotransferase, Asthenia; Bilirubin urine, Blood bilirubin, Blood creatine phosphokinase, Blood immunoglobulin A, Blood immunoglobulin G; Blood immunoglobulin M, C-reactive protein, Ceruloplasmin, Complement factor C3, Complement factor C4; Cytomegalovirus test, Double stranded DNA antibody, Epstein-Barr virus antibody, Fatigue, Full blood count; Hepatic enzyme increased, Hepatitis A virus test, Hepatitis B virus test, Histone antibody, Inflammatory marker increased; Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Smooth muscle antibody, Ultrasound liver; Alanine aminotransferase, Alpha-1 anti-trypsin, Antinuclear antibody, Aspartate aminotransferase, Asthenia; Bilirubin urine, Blood bilirubin, Blood creatine phosphokinase, Blood immunoglobulin A, Blood immunoglobulin G; Blood immunoglobulin M, C-reactive protein, Ceruloplasmin, Complement factor C3, Complement factor C4; Cytomegalovirus test, Double stranded DNA antibody, Epstein-Barr virus antibody, Fatigue, Full blood count; Hepatic enzyme increased, Hepatitis A virus test, Hepatitis B virus test, Histone antibody, Inflammatory marker increased; Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Smooth muscle antibody, Ultrasound liver; Alanine aminotransferase, Alpha-1 anti-trypsin, Antinuclear antibody, Aspartate aminotransferase, Asthenia; Bilirubin urine, Blood bilirubin, Blood creatine phosphokinase, Blood immunoglobulin A, Blood immunoglobulin G; Blood immunoglobulin M, C-reactive protein, Ceruloplasmin, Complement factor C3, Complement factor C4; Cytomegalovirus test, Double stranded DNA antibody, Epstein-Barr virus antibody, Fatigue, Full blood count; Hepatic enzyme increased, Hepatitis A virus test, Hepatitis B virus test, Histone antibody, Inflammatory marker increased; Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Smooth muscle antibody, Ultrasound liver More
Two weeks following injection, patient developed muscle aches, weakness, and fatigue. Went to PCP 2/... Two weeks following injection, patient developed muscle aches, weakness, and fatigue. Went to PCP 2/18/25 with initial labs showing elevated inflammatory markers. Additional labs order and showed severely elevated liver enzymes. Sent for Stat Liver ultrasound and Stat referral to Hepatolgy 3/7/25. Given and initial round of oral steroids and had extensive lab work confirming an autoimmune reaction to the vaccines. Then referred to rheumatology 4/14/25 and had additional lab work drawn to rule out rheumatoid arthritis or other causes of the elevated lab values. Rheumatology confirmed that this was likely an autoimmune reaction to the vaccines. Continued to require labwork to monitor liver enzymes and inflammatory markers until 8/2025. More
2869092 34 F UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
PEDIATRIC COVID-19 0.25ML GIVEN TO 34 YEAR OLD IN ERROR PEDIATRIC COVID-19 0.25ML GIVEN TO 34 YEAR OLD IN ERROR
2869137 F 10/28/2025 FLUX
MMR
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.


Gait disturbance, Product preparation issue; Gait disturbance, Product preparati... Gait disturbance, Product preparation issue; Gait disturbance, Product preparation issue; Gait disturbance, Product preparation issue More
a change in the patient's walk; The vaccines were mixed with flu vaccine instead of the dilutio... a change in the patient's walk; The vaccines were mixed with flu vaccine instead of the dilution solvent; This spontaneous report was received from an employee and refers to a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2025, at patient's pediatric appointment for 12-month shots, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, vaccination site, lot and expiration date were not reported); and with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, route of administration, vaccination site, lot and expiration date were not reported), both administered for prophylaxis. The vaccines were mixed with flu vaccine instead of the dilution solvent (typical solution) (product preparation error). Provider spoke to "vaccine rep" who advised it should not be harmful although they did not have data on this possible interaction. The mother was to monitor the baby for 2 weeks and to call with any concerns. Per discussion the following was recommended: a booster for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) in 1 month in case the mixture caused the vaccine to not be as effective. Therefore, in total, the patient received 3 injections at the appointment. On 08-Sep-2025 (also reported as after this vaccination), the patient's mother noticed a change in the patient's walk (gait disturbance). The patient's walking has been affected and she was walking funny after. This has improved since the event (in the month since), but the mother was taking the patient to a neurologist for follow up today. She has since changed pediatrician providers and contacted the department of health and vaccine specialists. No additional adverse event (AE) or product quality complaint (PQC) was noted. At the time of reporting, the patient was recovering from the event of gait disturbance. The causal relationship between the event of gait disturbance and the suspect vaccines was not reported. Lot # is being requested and will be submitted if received.; Reporter's Comments: Keywords : OCL; Sender's Comments: Priority : 5 , Is case serious : No , Index user , Index date : 2025-10-03 , MNSC number : 02882925 , CLIC number : , ESTAR number : , IRMS number : 02882926 , Central date : 2025-10-03 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2869142 F 10/28/2025 COVID19
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Injected limb mobility decreased; Injected limb mobility decreased Injected limb mobility decreased; Injected limb mobility decreased
now cannot use hand; This non-serious case was reported by a consumer and described the occurrence o... now cannot use hand; This non-serious case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Concurrent medical conditions included migraine (has migraine). Concomitant products included sumatriptan succinate (Imitrex). On 09-OCT-2025, the patient received Flu vaccine (unknown arm) and COVID-19 vaccine. On 11-OCT-2025, 2 days after receiving Flu vaccine and COVID-19 vaccine, the patient experienced injected limb mobility decreased (Verbatim: now cannot use hand). The outcome of the injected limb mobility decreased was not resolved. It was unknown if the reporter considered the injected limb mobility decreased to be related to Flu vaccine and COVID-19 vaccine. It was unknown if the company considered the injected limb mobility decreased to be related to Flu vaccine and COVID-19 vaccine. Additional Information: GSK Receipt Date: 11-OCT-2025 The patient reported that the arm where she received the flu shot was dead upon waking in the morning. She stated she could not use the arm at first, but movement gradually returned. However, she was then unable to use her hand, her ring and little fingers. The batch number was not provided and a request for this information has been made. More
2869144 M FL 10/28/2025 FLUX
PPV
TTOX
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Skin sensitisation; Skin sensitisation; Skin sensitisation; Skin sensitisation Skin sensitisation; Skin sensitisation; Skin sensitisation; Skin sensitisation
Skin sensitization; This non-serious case was reported by a consumer via call center representative ... Skin sensitization; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin sensitization in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis and Tetanus vaccine toxoid (Tetanus vaccine) for prophylaxis. Concurrent medical conditions included hypertension, diabetes and blood cholesterol increased. Concomitant products included hydrochlorothiazide, valsartan (Valsartan), metformin hydrochloride (Metformin) and atorvastatin calcium (Atorvastatin). On an unknown date, the patient received the 1st dose of Shingrix, Influenza vaccine, Pneumococcal vaccine and Tetanus vaccine. On an unknown date, an unknown time after receiving Shingrix, Influenza vaccine, Pneumococcal vaccine and Tetanus vaccine, the patient experienced skin sensitization (Verbatim: Skin sensitization). The outcome of the skin sensitization was unknown. It was unknown if the reporter considered the skin sensitization to be related to Shingrix, Influenza vaccine and Pneumococcal vaccine. The reporter considered the skin sensitization to be not reported if related to Tetanus vaccine. It was unknown if the company considered the skin sensitization to be related to Shingrix, Influenza vaccine and Pneumococcal vaccine. The company considered the skin sensitization to be not reported if related to Tetanus vaccine. Linked case(s) involving the same patient: US2025AMR132424 Additional Information: GSK Receipt Date: 14-OCT-2025 The reporter was patient itself. The reporter mentioned that the patient had some skin sensitivity in two small areas on the body approximately 2 weeks after receiving these vaccinations. The reporter also mentioned that the sensitivity resolved prior to second dose of Shingrix. The batch number was not provided and a request for this information has been made. This case is linked with case US2025AMR132424. More
2869146 M 10/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered Incorrect dose administered
The adult dose was given to a 19 year-old; Overdose; This non-serious case was reported by a other h... The adult dose was given to a 19 year-old; Overdose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a 19-year-old male patient who received HBV (Engerix B adult) for prophylaxis. On 14-OCT-2025, the patient received Engerix B adult (unknown deltoid). On 14-OCT-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: The adult dose was given to a 19 year-old) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 14-OCT-2025 The reporter reported that the adult dose was given to a 19 year-old patient. The batch number was not provided and a request for this information has been made. More
2869148 10/28/2025 RSV
TDAP
 PFIZER\WYETH
UNKNOWN MANUFACTURER
 UNK
UNK
Injection site pruritus; Injection site pruritus Injection site pruritus; Injection site pruritus
Itchy at injection site to the point of going to the ER; possible infection at injection site; This ... Itchy at injection site to the point of going to the ER; possible infection at injection site; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of injection site itching in a 20-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. Concurrent medical conditions included anxiety (has anxiety), attention deficit hyperactivity disorder, depression and drug allergy (allergic to sulfa antibiotics). Concomitant products included Prenatal. On 17-SEP-2025, the patient received Tdap Vaccine (right arm). On 17-SEP-2025 09:45, the patient received Abrysvo (left arm). On 19-SEP-2025, 2 days after receiving Tdap Vaccine and Abrysvo, the patient experienced injection site itching (Verbatim: Itchy at injection site to the point of going to the ER) and injection site infection (Verbatim: possible infection at injection site). The patient was treated with cefalexin monohydrate (Keflex). On 22-SEP-2025, the outcome of the injection site itching and injection site infection were resolved (duration 3 days). It was unknown if the reporter considered the injection site itching and injection site infection to be related to Tdap Vaccine, Dtpa Vaccine Pre-Filled Syringe Device and Abrysvo. It was unknown if the company considered the injection site itching and injection site infection to be related to Tdap Vaccine, Dtpa Vaccine Pre-Filled Syringe Device and Abrysvo. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-OCT-2025 The patient received the Tdap Vaccine and Abrysvo and experienced itchy at the injection site to the point of going to the emergency room. The doctor gave antibiotic due to possible infection at injection site ad was treated with Keflex The patient did not receive any other vaccine within 4 weeks prior to the vaccinations. The batch number was not provided, and we are unable to contact the reporter. More
2869151 F CA 10/28/2025 UNK
 UNKNOWN MANUFACTURER
 JST7414
Immediate post-injection reaction, Injection site pain, Injection site swelling,... Immediate post-injection reaction, Injection site pain, Injection site swelling, Pruritus, Wrong technique in product usage process More
Pain in injection site; Swelling; Itchy arm; the vaccine did not push out the air from the PFS; This... Pain in injection site; Swelling; Itchy arm; the vaccine did not push out the air from the PFS; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number JST7414) for prophylaxis. On 02-OCT-2025, the patient received Fluarix 2025-2026 season. On 02-OCT-2025, less than a day after receiving Fluarix 2025-2026 season, the patient experienced injection site pain (Verbatim: Pain in injection site), injection site swelling (Verbatim: Swelling), itchy upper limbs (Verbatim: Itchy arm) and wrong technique in product usage process (Verbatim: the vaccine did not push out the air from the PFS). The outcome of the injection site pain, injection site swelling and itchy upper limbs were not resolved and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the injection site pain, injection site swelling and itchy upper limbs to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site swelling and itchy upper limbs to be related to Fluarix 2025-2026 season and Fluarix 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: 02-OCT-2025 The Licensed Vocational Nurse stated that the person (nurse) who administered the vaccine did not expel the air from the pre-filled syringe (PFS) and administered the vaccine as it was. The nurse who administered the vaccine informed them that she did not prime the vaccine or push out the air, and that the vaccine was much more painful that way. She said that was the correct method. The patient experienced swelling and pain at injection site and noted that it had never been painful before. However, her arm immediately started to become very itchy. The patient mentioned that it was more painful to receive the vaccine without expelling the air bubble, compared to when it was pushed out. The batch number was not provided upon follow- up with the reporter. More
2869153 MI 10/28/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
inadvertently received Kinrix (instead of Pentasil); This non-serious case was reported by a other h... inadvertently received Kinrix (instead of Pentasil); 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 2-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included Pentacel for prophylaxis. On an unknown date, the patient received Kinrix and did not receive Pentacel. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently received Kinrix (instead of Pentasil)). 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: 03-OCT-2025 Health care provider wanted to know how to proceed with the patient that inadvertently received Kinrix instead of Pentacel it was first dose in the DTaP series. The batch number was not provided upon follow- up with the reporter. This case is linked with case US2025127287, reported by the same reporter.; Sender's Comments: US-GSK-US2025127287: More
2869154 MI 10/28/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 93H32
Wrong product administered Wrong product administered
Kinrix inadvertent administration; This non-serious case was reported by a other health professional... Kinrix inadvertent administration; 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 7-month-old patient who received DTPa-IPV (Kinrix) (batch number 93H32, expiry date 19-OCT-2026) for prophylaxis. Co-suspect products included Pentacel for prophylaxis. On 30-SEP-2025, the patient received Kinrix. The patient did not receive Pentacel. On 30-SEP-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix inadvertent administration). 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: 03-OCT-2025 Health care provider wanted to know how to proceed with the patient that inadvertently received Kinrix instead of Pentacel it was third dose in the DTaP series. This case is linked with case US2025127285, reported by the same reporter.; Sender's Comments: US-GSK-US2025127285: More
2869156 22 F SC 10/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 72742
Exposure during pregnancy, Product use issue, Wrong product administered Exposure during pregnancy, Product use issue, Wrong product administered
Drug Exposure During Pregnancy; wrong vaccine; arexvy administered during pregnancy; This non-serio... Drug Exposure During Pregnancy; wrong vaccine; arexvy administered during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 22-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 02-OCT-2025, the patient received Arexvy. On an unknown date, the patient did not receive Abrysvo. On 02-OCT-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine) and drug use in unapproved population (Verbatim: arexvy administered during pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the wrong vaccine administered, drug use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Estimated Delivery/Due date: 17-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 The reporter reported that the pregnant patient received AREXVY instead of Abrysvo. This was 1 of 6 reports reported by same reporter.; Sender's Comments: US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER More
2869157 28 F SC 10/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 72742
Exposure during pregnancy, Product use issue, Wrong product administered Exposure during pregnancy, Product use issue, Wrong product administered
Drug Exposure During Pregnancy; wrong vaccine; arexvy administered during pregnancy; This non-seriou... Drug Exposure During Pregnancy; wrong vaccine; arexvy administered during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 72742, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On 02-OCT-2025, the patient received Arexvy. On an unknown date, the patient did not receive Abrysvo. On 02-OCT-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine) and product use in unapproved population (Verbatim: arexvy administered during pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the wrong vaccine administered, product use in unapproved population and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Estimated Delivery/Due date: 25-NOV-2025 Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-OCT-2025 The reporter reported that the pregnant patient received Arexvy instead of Abrysvo. This is 1 of 6 report reported by same reporter.; Sender's Comments: US-GSK-US2025137791:SAME REPORTER US-GSK-US2025137785:SAME REPORTER US-GSK-US2025137784:SAME REPORTER More
2869158 M 10/28/2025 COVID19
 MODERNA
Dizziness, Illness, Nausea, Pulmonary embolism Dizziness, Illness, Nausea, Pulmonary embolism
he had blood clots in his lungs/he couldn't breathe; get numerous vaccines a year and they get ... he had blood clots in his lungs/he couldn't breathe; get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"; nausea; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe) (seriousness criterion medically significant), ILLNESS (get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, PULMONARY EMBOLISM (he had blood clots in his lungs/he couldn't breathe), ILLNESS (get numerous vaccines a year and they get sick after it every time/" it feels like they're getting sick"), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient had not taken any vaccines in the past 4 weeks. It was stated that patient who was over 65 years old get a COVID vaccine every 3 months, it was asked for it and got it every time patient travel. It was stated that patient got numerous vaccines a year and got sick after it every time. It was stated that patient got it because wanted to get it, patient was not being recommended by anyone and was just continuing to take it. Patient got the symptoms what listed on there as the nausea, dizziness, general queasiness, " it felt like patient was getting sick. Patient had a terrible incident where he had blood clots in his lungs, it was several years ago, so were not going to connect it, nothing was ever connected to a COVID vaccine, it was very serious. He was still on blood thinners because would never take him off them because he was 77 years old. This happened 2 or 3 days after he got his 17th COVID vaccine. It was stated that before the blood clots, there has never been any issues that was aware of, he might have had something, but it was never diagnosed by a doctor, when he went to the doctor it was surprising. It was said the blood clots only happened once and it was a whole incident because he had to go to the ER, it was painful and he couldn't breathe, it was a very severe reaction. Patient was going to the doctor again because he was sick. it was not unusual; it was the listed side effects. It was stated not to the severity patient has ever had. It was unknown if the patient experienced any additional symptoms/events. No specific treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790351 (E2B Linked Report). This case was linked to MOD-2025-790352 (Patient Link).; Reporter's Comments: The serious adverse event of pulmonary embolism was assessed s possibly related to suspected vaccine, however missing information regarding medical history and type of vaccine as ell as advance age were all assessed as confounding factors. All other non-serious events were assessed s related as all of them are in safety profile of suspected vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790351:mother case More
2869159 52 F 10/28/2025 COVID19
 MODERNA
Dizziness Dizziness
In past, the patient had dizziness after moderna vaccines - 2021; This spontaneous case was reported... In past, the patient had dizziness after moderna vaccines - 2021; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (In past, the patient had dizziness after moderna vaccines - 2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Latex allergy, Drug allergy (Allergy to certain medicines), Dust allergy, Pollen allergy and Adhesive tape allergy (allergy to some adhesives). In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (In past, the patient had dizziness after moderna vaccines - 2021). At the time of the report, DIZZINESS (In past, the patient had dizziness after moderna vaccines - 2021) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient was receiving unspecified concomitant medications; however, details were not provided by the reporter. At the time of reporting, the patient was 56 years old. The patient's height was reported as 5 feet 3-4 inches. It was reported that the patient had Moderna every year since COVID was known. Treatment medication was not reported by the reporter. This case was linked to MOD-2025-789607 (Patient Link). More
2869160 F WA 10/28/2025 COVID19
 MODERNA
Illness Illness
changed from Pfizer to Moderna for her 3rd or 4th vaccine and she was sick, she felt sick; This spon... changed from Pfizer to Moderna for her 3rd or 4th vaccine and she was sick, she felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (changed from Pfizer to Moderna for her 3rd or 4th vaccine and she was sick, she felt sick) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (changed from Pfizer to Moderna for her 3rd or 4th vaccine and she was sick, she felt sick). At the time of the report, ILLNESS (changed from Pfizer to Moderna for her 3rd or 4th vaccine and she was sick, she felt sick) outcome was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790468 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790468:Caller's case More
2869161 F MI 10/28/2025 COVID19
 MODERNA
Arthralgia, Vaccination site pain, Vaccination site urticaria Arthralgia, Vaccination site pain, Vaccination site urticaria
buttock pain/sore; had a large welt there for a month; hip pain; This spontaneous case was reported ... buttock pain/sore; had a large welt there for a month; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip pain), VACCINATION SITE PAIN (buttock pain/sore) and VACCINATION SITE URTICARIA (had a large welt there for a month) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. In March 2025, 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 March 2025, the patient experienced VACCINATION SITE PAIN (buttock pain/sore) and VACCINATION SITE URTICARIA (had a large welt there for a month). In 2025, the patient experienced ARTHRALGIA (hip pain). In 2025, VACCINATION SITE URTICARIA (had a large welt there for a month) had resolved. At the time of the report, ARTHRALGIA (hip pain) and VACCINATION SITE PAIN (buttock pain/sore) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that in March, the patient had received a Moderna Covid shot, which had been administered in her upper left buttock. She reported that a large welt had developed there and had lasted for about a month, causing significant soreness. She noted that this soreness had led to hip pain, which she had not experienced before. Seven months later, she stated that the pain was still present and occasionally woke her up at night, including on the night she wrote the message. She expressed a need to find out whether any research or data existed regarding this issue and inquired if others who had received the shot in the upper buttock had also developed hip pain. She requested any relevant information about similar cases or possible treatment options. She mentioned that she was consulting with her primary care physician and planned to follow up with an orthopedic doctor but hoped to obtain information directly from Moderna in the meantime. She acknowledged that the hip and buttock pain might have been caused by the vaccine she had received in that area, especially since the pain had started immediately after the vaccination. However, she admitted that she was not certain and did not pursue the matter further. She added that she did not want to place the burden of researching the issue on her healthcare provider, which was why she had decided to contact the company directly. 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 16-Oct-2025: Live follow-up received and significant information includes patient gender added, reporter details updated, new event of vaccination site pain added, onset date updated for the events, updated vaccine administration date and updated narrative. More
2869162 F 10/28/2025 COVID19
 MODERNA
Ageusia, Anosmia, COVID-19 Ageusia, Anosmia, COVID-19
a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including... a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more; a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more; all the symptoms of COVID after receiving mNEXSPIKE; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more), ANOSMIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more) and COVID-19 (all the symptoms of COVID after receiving mNEXSPIKE) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 09-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 AGEUSIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more), ANOSMIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more) and COVID-19 (all the symptoms of COVID after receiving mNEXSPIKE). In October 2025, AGEUSIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more), ANOSMIA (a severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. SM lost that for three days and maybe a little more) and COVID-19 (all the symptoms of COVID after receiving mNEXSPIKE) had resolved. Concomitant medications were not reported. It was reported that patient had severe reaction including all the symptoms of COVID after receiving mNEXSPIKE last week, including the taste and smell. Patient lost that for three days and maybe a little more and wanted to know if it was something that had been reported at all. Patient did report her side effects to the pharmacist, though she hadn't had the food and smell yet at that time. The pharmacist wasn't saying that it was COVID itself and wanted to know if the side effects patient had experienced made it real COVID or some kind of reaction to vaccine. Reporter wanted to know if patient could be contagious if she was coughing and sneezing around other people, if she could give them COVID-19. Treatment information was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2869163 80 F 10/28/2025 COVID19
 MODERNA
Malaise Malaise
doesn't feel well for a while after; This spontaneous case was reported by a consumer and descr... doesn't feel well for a while after; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (doesn't feel well for a while after) in an 80-year-old female patient 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 MALAISE (doesn't feel well for a while after). At the time of the report, MALAISE (doesn't feel well for a while after) had resolved. No concomitant medication was reported. It was reported that the patient did not experience many side effects from Moderna vaccines and that she had always taken Moderna vaccines. The patient only did not feel well for a while after. The patient did not have any serious side effects from any of the vaccines she had received. No treatment information was provided. Reporter did not allow further contact More
2869164 73 F FL 10/28/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
My L arm became so painful; This spontaneous case was reported by a consumer and describes the occur... My L arm became so painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My L arm became so painful) in a 73-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 15-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. On 15-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced PAIN IN EXTREMITY (My L arm became so painful). At the time of the report, PAIN IN EXTREMITY (My L arm became so painful) had resolved with sequelae. The concomitant medication was not reported by the reporter. It was reported that the patient's left arm became so painful that she could not lift it or apply touch to it. It started to feel better within 24 hours. She was able to lift it with assistance from her other hand. She thought it was resolved by Sunday, but her arm later had a feeling of pain when she lifted it. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2869165 67 F 10/28/2025 COVID19
 MODERNA
Chills, Pain Chills, Pain
she felt achy; chills; This spontaneous case was reported by a consumer and describes the occurrence... she felt achy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she felt achy) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (previous vaccines). Past adverse reactions to the above products included No adverse effect with Pfizer. On 21-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 21-Oct-2025, the patient experienced PAIN (she felt achy) and CHILLS (chills). On 22-Oct-2025, PAIN (she felt achy) and CHILLS (chills) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Patient never had a reaction to any vaccination. The patient had received every vaccination recommended since the beginning of the COVID pandemic. Since the first one given was by Pfizer, she continued with that specific vaccine until this booster. The patient received a Moderna booster on Tuesday morning, 21-Oct-2025. The patient never gave it another thought. Around 9pm, the patient started feeling achy, then began having chills. The patient was perplexed (could not remember the last time she was sick) and began getting ready for bed. By 10:00 or so, the patient was bundled up, climbed into bed & slept through the night. The patient was a little slow starting the next morning, but otherwise everything seemed fine. Sometimes that morning she had a moment, realizing that patient must had a reaction to the vaccine. The patient had no complaints. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact More
2869166 F 10/28/2025 COVID19
 MODERNA
White blood cell count, White blood cell count decreased White blood cell count, White blood cell count decreased
white blood cell count had decreased; This spontaneous case was reported by a consumer and describes... white blood cell count had decreased; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (white blood cell count had decreased) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. On 20-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 22-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced WHITE BLOOD CELL COUNT DECREASED (white blood cell count had decreased). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (white blood cell count had decreased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2025, White blood cell count: decreased. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. Patient had received a Moderna COVID-19 vaccination on a Monday. Following this, she underwent routine bloodwork on Wednesday. Coincidentally, her doctor informed her that her white blood cell count had decreased. As a precaution, her doctor had requested another round of bloodwork to be conducted in one month. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. More
2869167 M TX 10/28/2025 RSV
 PFIZER\WYETH
Occupational exposure to product, Product container issue, Skin laceration Occupational exposure to product, Product container issue, Skin laceration
Pharmacist pushed down on Abrysvo act o vial to reconstitute vaccine, and the vial shattered cutting... Pharmacist pushed down on Abrysvo act o vial to reconstitute vaccine, and the vial shattered cutting his hand; Pharmacist pushed down on Abrysvo act o vial to reconstitute vaccine, and the vial shattered cutting his hand; This is a spontaneous report received from a Pharmacist from a Pfizer sales representative. A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). The patient was not taking any other medications within 2 weeks of the event starting. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "Pharmacist pushed down on Abrysvo act o vial to reconstitute vaccine, and the vial shattered cutting his hand". It was unknown if therapeutic measures were taken as a result of occupational exposure to product, limb injury. Additional information: The Pharmacist pushed down on Abrysvo act o vial to reconstitute vaccine, and the vial shattered cutting his hand. It happened at the pharmacy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869168 F 10/28/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthritis, Autoimmune thyroiditis, COVID-19, Drug ineffective, Incomplete course... Arthritis, Autoimmune thyroiditis, COVID-19, Drug ineffective, Incomplete course of vaccination; Mycobacterium avium complex infection, Pain More
She had COVID; She had COVID; Autoimmune Hashimoto; Bacterial infection called (MAC) Mycobacterium a... She had COVID; She had COVID; Autoimmune Hashimoto; Bacterial infection called (MAC) Mycobacterium avium complex non-tuberculosis; make her arthritis worst; I cannot take anymore pain; Caller just got 1 of the 2 shots required in the beginning; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart procedures" (unspecified if ongoing); "WPW or supra ventricle tachycardia" (unspecified if ongoing), notes: was born with WPW or supra ventricle tachycardia; "WPW" (unspecified if ongoing); "cardiac ablations" (not ongoing), notes: had 3 cardiac ablations since she was 29 years old; "immunocompromise" (unspecified if ongoing); "pericarditis" (unspecified if ongoing), notes: once in her life; "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "recovering" and all described as "She had COVID"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Autoimmune Hashimoto"; MYCOBACTERIUM AVIUM COMPLEX INFECTION (medically significant), outcome "recovering", described as "Bacterial infection called (MAC) Mycobacterium avium complex non-tuberculosis"; ARTHRITIS (non-serious), outcome "unknown", described as "make her arthritis worst"; PAIN (non-serious), outcome "unknown", described as "I cannot take anymore pain"; INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "Caller just got 1 of the 2 shots required in the beginning". Clinical course: Caller is immunocompromise and had heart procedures. Caller was born with WPW or supra ventricle tachycardia. Caller would like to know if she can take the medication with WPW arrhythmia, that is the top question as a lot of people had tachycardia. Caller had 3 cardiac ablations since she was 29 years old, Caller is now 73 years old and she is fine. Caller do swimming and exercising until she had covid in 21Jan. Caller also have autoimmune Hashimoto and had a bacterial infection called (MAC) Mycobacterium avium complex non-tuberculosis. Caller's system could not fight covid and MAC. Caller ended up on antibiotics for 15 months and messed her up. Caller has been in and out the hospital 19 times since 2021 and now she is getting better. Caller just got 1 of the 2 shots required in the beginning. Caller would like to know if it is okay to get the shot if the caller gets immune shot with culture for almost a year. Caller would like to know if there are research that make her arthritis worst? Caller does not know what did it the covid or the shot. It was terrible caller thought it was the covid did it. Caller just want to be cautious, she does not know what to do. Its like a death sentence as per caller. Caller stated "How does it adopting. I get immune shot for my immune system and now I have issues because I had covid. That bacteria that was in my body and they said a lot of people have it. I cannot take anymore pain. I was on one medication for my thyroid but due to all these it interfered with my arrhythmia that I started getting cut-off my oxygen and had to have a portable oxygen but then now I don't do that anymore. I did swim but notice it got worst." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
✓
2869169 F NY 10/28/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Aphonia, Asthma, Cough, Disease recurrence, Dysphonia; Hypersensitivity, Lung di... Aphonia, Asthma, Cough, Disease recurrence, Dysphonia; Hypersensitivity, Lung disorder, Nasal congestion, Oropharyngeal discomfort, Rhinorrhoea; Vaccination site pain More
like an allergy/allergic reaction; compromised lungs; asthma; asthma; coughing a lot/coughing so bad... like an allergy/allergic reaction; compromised lungs; asthma; asthma; coughing a lot/coughing so bad; a little congested/ congestion like; my throat is killing me; hoarse; My nose was running; soreness in my arm /the arm is a little sore this is from the injection site; I have no voice/I am losing my voice; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 74-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma; ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Pfizer covid vaccine (Dose number unknown), for COVID-19 immunization. The following information was reported: APHONIA (non-serious) with onset Oct2025, outcome "unknown", described as "I have no voice/I am losing my voice"; RHINORRHOEA (non-serious) with onset Oct2025, outcome "recovering", described as "My nose was running"; DYSPHONIA (non-serious) with onset Oct2025, outcome "recovering", described as "hoarse"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset Oct2025, outcome "recovering", described as "my throat is killing me"; VACCINATION SITE PAIN (non-serious) with onset Oct2025, outcome "unknown", described as "soreness in my arm /the arm is a little sore this is from the injection site"; NASAL CONGESTION (non-serious) with onset 23Oct2025, outcome "recovering", described as "a little congested/ congestion like"; ASTHMA (non-serious), DISEASE RECURRENCE (non-serious) all with onset 23Oct2025, outcome "recovering" and all described as "asthma"; LUNG DISORDER (non-serious) with onset 23Oct2025, outcome "recovering", described as "compromised lungs"; COUGH (non-serious) with onset 23Oct2025, outcome "recovering", described as "coughing a lot/coughing so bad"; HYPERSENSITIVITY (non-serious) with onset 23Oct2025, outcome "recovering", described as "like an allergy/allergic reaction". Therapeutic measures were taken as a result of hypersensitivity, asthma, disease recurrence, cough, rhinorrhoea. Additional information: the patient took Comirnaty vaccine yesterday (23Oct2025) from Privacy, last night the patient do have compromised lungs, have asthma. Caller states, I was coughing a lot and uncontrollable like an allergy, I think this is an allergic reaction. I have been taking Pfizer COVID since it came out, when COVID first happened. Caller states, I was coughing so bad I feel like today my throat is killing me and I am hoarse. My nose was running it was almost like an allergy. I am a little congested, and I was coughing a lot last night and now my voice, I am losing my voice. I never had a reaction to this I have been using the Pfizer vaccine since the beginning. I had it yesterday and when I went to sleep the coughing started. I had soreness in my arm but that's normal, your arm is supposed to be a little sore so you know it's working. Caller clarified the arm is a little sore this is from the injection site. Caller adds, and congestion like. I take sprays for my breathing. I take Symbicort is what I use and albuterol. Now last night because of the running nose and coughing I took Allegra that is an OTC allergy pill, time release. I have asthma and I took my Symbicort before I went to bed and then I used Albuterol after that, it is the other thing that was taken. Then I took Allegra for allergies, because I needed it and it did not really help. Caller states, that was last night and thank god it calmed down. I have no voice, it's all in my throat. I have a lot of trouble this time of year, I live in Privacy and the weather changes, but I never had anything like this. I have an appt after next week anyway and will go after this. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869170 F GA 10/28/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity, Peripheral swelling, Physical examination, X-ray Pain in extremity, Peripheral swelling, Physical examination, X-ray
pain and swelling in dorsum of left foot; pain and swelling in dorsum of left foot; This is a sponta... pain and swelling in dorsum of left foot; pain and swelling in dorsum of left foot; This is a spontaneous report received from a Nurse. A 71-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Oct2025 at 07:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 09Oct2025 at 07:00, outcome "not recovered" and all described as "pain and swelling in dorsum of left foot". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Pain and swelling in dorsum of left foot that began about 12 hours following the vaccine. Vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines on the same date as the covid vaccine. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event was Podiatrist exam and xrays (x4). The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869171 10/28/2025 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 (BNT162B2 NOS), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm three times". Additional information: Patient stated it seems their COVID jab had little effect other than to give a sore arm three times. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500126606 same patient, different dose/event; More
2869172 10/28/2025 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 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunisation, 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
2869173 CO 10/28/2025 COVID19
 PFIZER\BIONTECH
 MY955Ds
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
the arm hurts and has been hurting since that day from the shoulder to the elbow in various places; ... the arm hurts and has been hurting since that day from the shoulder to the elbow in various places; the arm hurts and has been hurting since that day from the shoulder to the elbow in various places; 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)), on 10Sep2025 as dose 1, single (Lot number: MY955Ds), in right arm for covid-19 immunisation, Device Lot Number: MY955Ds. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Sep2025, outcome "not recovered" and all described as "the arm hurts and has been hurting since that day from the shoulder to the elbow in various places". Additional information: The patient received the injection on 10Sep2025 at a pharmacy and as of today 23Oct2025 it was reported that "my arm still hurts. I am unable to use my right hand to touch my left shoulder. It was my right arm that I received the injection in and the arm hurts and has been hurting since that day from the shoulder to the elbow in various places". More
2869174 F VA 10/28/2025 COVID19
 PFIZER\BIONTECH
Beta haemolytic streptococcal infection, Body temperature, COVID-19, Drug ineffe... Beta haemolytic streptococcal infection, Body temperature, COVID-19, Drug ineffective More
COVID shot didn't work and I had Pfizer; COVID shot didn't work and I had Pfizer; I'v... COVID shot didn't work and I had Pfizer; COVID shot didn't work and I had Pfizer; I've got strep A; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old female patient 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 "COVID shot didn't work and I had Pfizer"; BETA HAEMOLYTIC STREPTOCOCCAL INFECTION (non-serious), outcome "unknown", described as "I've got strep A". Therapeutic measures were taken as a result of beta haemolytic streptococcal infection. Clinical information: During an inbound call for financial assistance, the patient, (Name withheld), stated, she just tried to get Paxlovid through her insurance. When provided with enrollment options, (Name withheld) stated, Asking if they could just do it? Asking if they could help her because she was sick. She have COVID, and got strep A, and she have a fever of 101. After being provided with the income requirements, (Name withheld) stated, she was retired. Reported that the COVID shot didn't work and she had Pfizer. When provided information on the voucher, (Name withheld) stated, "Oh my gosh. Well, this was worth the phone call even though I feel like crap..." When asked if she would like assistance in finding a pharmacy, (Name withheld) stated "...She gave me penicillin just now for my strep... It's (Name withheld)..." At the conclusion of the call, (Name withheld) stated, "... It's hard to pay attention when you're not feeling well." The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869175 10/28/2025 PNC20
 PFIZER\WYETH
Drug ineffective, Pneumonia Drug ineffective, Pneumonia
I was vaccinated last month and still got pneumonia; I was vaccinated last month and still got pneum... I was vaccinated last month and still got pneumonia; I was vaccinated last month and still got pneumonia; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA PNEUMOCOCCAL (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2025, outcome "unknown" and all described as "I was vaccinated last month and still got pneumonia". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2869176 10/28/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I got COVID twice after three of their jabs.; I got COVID twice after three of their jabs.; This is ... I got COVID twice after three of their jabs.; I got COVID twice after three of their jabs.; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID twice after three of their jabs.". Clinical course: On 24Oct2025 Their COVID jab certainly did not have much effect on me. I got COVID twice after three of their jabs. As evidenced by the statement above, it seems their COVID jab had little effect other than to give me a sore arm three times. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869177 CA 10/28/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity, Peripheral swelling, Pruritus Pain in extremity, Peripheral swelling, Pruritus
The patient arm was swollen; very itchy; Arm was very sore; This is a spontaneous report received fr... The patient arm was swollen; very itchy; Arm was very sore; 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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "The patient arm was swollen"; PRURITUS (non-serious), outcome "unknown", described as "very itchy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was very sore". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
📋 Privacy Policy & Data Disclaimer