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
2858908 3 M ID 09/15/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 406989
406989
Circumstance or information capable of leading to medication error, Scratch, Vac... Circumstance or information capable of leading to medication error, Scratch, Vaccination site erythema, Vaccination site pain, Vaccination site rash; Vaccination site swelling, Vaccination site warmth More
Parent called and reported redness, heat ,swelling and pain at vaccination site. There was also a ra... Parent called and reported redness, heat ,swelling and pain at vaccination site. There was also a rash reported surrounding the area. This was noticed the morning following vaccine administration. Patient was seen in urgent care and given amoxicillin 400 mg/5 ml 2.8ml Q8 hours x 7 days. Mom reports patient is recovering although not fully recovered att his time. MOm stated she feels comfortable monitoring and will report if not fully recovered soon. More
2858909 83 F TX 09/15/2025 FLU3
 SANOFI PASTEUR
 u8837ca
Back pain, Dizziness, Dyspnoea Back pain, Dizziness, Dyspnoea
right after patient received the flu vaccine in her left deltoid she became very faint and light he... right after patient received the flu vaccine in her left deltoid she became very faint and light headed. Then she had difficulty breathing and stated that her back was hurting. We had patient sit down and had a little fan on her. She said she was feeling better but we called an ambulance anyway. they came to pick her up and took her to the hospital. around 2:30pm person called to say she was fine and doing well. More
2858910 32 F TX 09/15/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 MY9550
406986
Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling
Patient received 2 immunizations on 9/13/25. On the morning of 9/15/25, patient called the pharmacy ... Patient received 2 immunizations on 9/13/25. On the morning of 9/15/25, patient called the pharmacy saying that the arm she received the Covid vaccine in is in pain and swollen. Patient said the affected area was on the inside of the arm in the underarm/armpit area. Patient said there were no adverse reactions at the injection site. Patient was referred to call primary care physician to see if an office visit was needed to assess the reaction. More
2858911 1.25 F NJ 09/15/2025 PNC20
PNC20
VARCEL
VARCEL
 PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.



Dysstasia, Facial asymmetry, Gait disturbance, Granulomatous lymphadenitis, Labo... Dysstasia, Facial asymmetry, Gait disturbance, Granulomatous lymphadenitis, Laboratory test normal; Lymphocytosis, Scar, Thrombocytosis; Dysstasia, Facial asymmetry, Gait disturbance, Granulomatous lymphadenitis, Laboratory test normal; Lymphocytosis, Scar, Thrombocytosis More
Right cervical lymphadenopathy with necrotizing granulomatous histology. Biopsy on 6/5/25 - 06/05/20... Right cervical lymphadenopathy with necrotizing granulomatous histology. Biopsy on 6/5/25 - 06/05/2025 ? Necrotizing/suppurative granulomatous lymphadenitis; no lymphoma; special stains negative. All infectious and autoimmune tests negative; mild thrombocytosis and lymphocytosis. Large scar; mild facial asymmetry; not walking or standing independently at 18 months; no definitive infectious etiology identified. More
โœ“ โœ“
2858912 60 M IL 09/15/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 406986
LN4930
Myalgia, Pain, Rash; Myalgia, Pain, Rash Myalgia, Pain, Rash; Myalgia, Pain, Rash
Wednesday morning 9/10/25 woke up with raw sore (he described as rash) on LEFT shoulder above acromi... Wednesday morning 9/10/25 woke up with raw sore (he described as rash) on LEFT shoulder above acromion process, size of a quarter. Looks like an abrasion, clean borders, looks non-infected. Describes "muscle deep" pain at all times, not worse with movement. Treating with bandage and ointment. Afebrile. This pharmacist sees an abrasion unrelated to vaccination. More
2858913 65 F GA 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ft95n
Erythema Erythema
Patient called stating that their arm was bright red from the injection received. Patient called stating that their arm was bright red from the injection received.
2858914 4 F NM 09/15/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Z007578
Injection site erythema, Injection site nodule, Injection site swelling; Injecti... Injection site erythema, Injection site nodule, Injection site swelling; Injection site erythema, Injection site nodule, Injection site swelling More
Mother complains of redness and swelling to left and right upper leg. Left leg has softball size sw... Mother complains of redness and swelling to left and right upper leg. Left leg has softball size swelling and redness and right leg has quarter size knot with redness and swelling. no complaints of fever. Mother administered Ibuprofen at home. Patient returned on 08/14/2025 Mother states patient is doing better but still has slight swelling. More
2858915 36 M VA 09/15/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 U8618AA
No adverse event No adverse event
No treatment need no adverse effects No treatment need no adverse effects
2858916 1.25 M 09/15/2025 DTPPVHBHPB
DTPPVHBHPB
FLU3
FLU3
PNC20
PNC20
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH





Body temperature increased, Electroencephalogram abnormal, Febrile convulsion, G... Body temperature increased, Electroencephalogram abnormal, Febrile convulsion, Generalised tonic-clonic seizure, Respiratory viral panel; Viral test negative; Body temperature increased, Electroencephalogram abnormal, Febrile convulsion, Generalised tonic-clonic seizure, Respiratory viral panel; Viral test negative; Body temperature increased, Electroencephalogram abnormal, Febrile convulsion, Generalised tonic-clonic seizure, Respiratory viral panel; Viral test negative More
To clarify: I do not know the brand name of the Flu shot the child received. He received his shots a... To clarify: I do not know the brand name of the Flu shot the child received. He received his shots at the (withheld) and I am a hospitalist. The child has had temps to 101 after prior vaccines (he is up-to-date on vaccines). The only shot he had never received is Flu. Grandma usually pre-treats with Tylenol but she did not this time. He spiked a temp of 105 at home; 41 on arrival to the ED. He had GTC seizure at home for 1-2 minutes, then stopped for 5-6 minutes, then again for another 1-2 minutes. EMS did not give antipyretics before ED arrival. Had another seizure in the ED while on LTM monitor & temp was 39.1. Received Ativan at 11:14am. Diagnosis: complex febrile seizure. Received Keppra Load. Admitted to the hospital for LTM (EEG monitoring). Did well. No more seizures. EEG normal other than during the seizure. No viral symptoms. Resp viral panel negative. No identified source of infection so we do think the fever was from the vaccines. He went home the next day on Keppra & Diastat prn, to f/u with neuro. He was in good condition. No long-term effects expected. More
โœ“
2858917 60 M WA 09/15/2025 FLU3
 SANOFI PASTEUR
 U8830AA
Incorrect dose administered Incorrect dose administered
Given high dose to patient on DMARD. 60 yo male. Given high dose to patient on DMARD. 60 yo male.
2858918 22 M CA 09/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 K7JY3
Cellulitis, Extra dose administered, Mobility decreased, Pain in extremity, Swel... Cellulitis, Extra dose administered, Mobility decreased, Pain in extremity, Swelling More
Swelling / pain in the arm / cellulitis, still with pain and reduced mobility Swelling / pain in the arm / cellulitis, still with pain and reduced mobility
2858919 4 F OR 09/15/2025 COVID19
 MODERNA
 3052553
Refusal of vaccination Refusal of vaccination
My 4 year old daughter was brought into office today 09/15/25 for a 4 year old well child check up. ... My 4 year old daughter was brought into office today 09/15/25 for a 4 year old well child check up. The medical Assistant told my wife and mother of our child upon entering patient care room that patient was due for some vaccinations today. My wife asked which vaccines were being offered and medical assistant stated, DTaP-POL (KINRIX), COVID-19, HIB PRP-T, (Fluzone trivalent) (influenza) and PCV13 (PREVNAR13) (Pneumococcal conjugate, 13 valent). My wife at that time verbally declined the COVID-19 vaccine. After the MD saw our daughter for her physical exam the medical assistant came back in the room for vaccine administration. My wife had to help hold my daughter still due to her being scared of getting shots. After the vaccines were administered, the medical assistant stated that she gave four vaccines and admitted to giving COVID-19 vaccine. My wife verbally declined this vaccine and did NOT sign a consent form for this vaccine to be given. The doctor did come in afterward and apologized to my wife that it was "her fault" because she ordered it by mistake. The medical assistant also did not do a final verification with. my wife prior to injecting patient. More
2858920 51 F OH 09/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 A5DP7
Device connection issue, Needle issue, Underdose Device connection issue, Needle issue, Underdose
Needle on syringe came lose when injection was given. (BD Integra Syringe was used). The needle hub... Needle on syringe came lose when injection was given. (BD Integra Syringe was used). The needle hub was even tightened prior to administration. Minimal vaccine contents were given to patient as most of it came out of the syringe and not even through the needle. Patient will come back to pharmacy to be revaccinated. More
2858921 12 F NC 09/15/2025 FLU3
 SANOFI PASTEUR
 UT8770NA
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Pt came in for vaccines after offsite physical clinic. Pt with family of four including a sibling al... Pt came in for vaccines after offsite physical clinic. Pt with family of four including a sibling also needing vaccines. Both pts required a flu vaccine and A HPV vaccine each. All four vaccines were taken from the pharmacy to prepare and entered into the immunization registry. The first set of vaccines prepared and given to nurse to administer to pt. Vaccines administered. Nurse prepared to administer second set of vaccines to second pt and realized there were 2 HPV Vaccines left. Nurse communicated with other nurse and immediately contacted nurse manager and supervisor. Nurse clinic supervisor contacted available FNP and made aware. Provider inquired if child had any adverse reactions and nursing supervisor made her aware child had not. Provider verbalized understanding and did not give any further recommendations. Nurse discussed appropriate precautions and plan for pt that received two flu vaccines. Mother aware of vaccine error and counseled on potential symptoms of anaphylaxis. Pt monitored for > 30 minutes. No other vaccines given to pt today. Referred for a later date. More
2858922 5 F WA 09/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 GC3N4
Extra dose administered Extra dose administered
Parent asked for immunization record of vaccine from today. After charting vaccine in patients chart... Parent asked for immunization record of vaccine from today. After charting vaccine in patients chart, a previous dose showed in patients chart that was given on 3/18/2025, which did not show prior to reviewing vaccine record. Database still shown patient had not had the 6 month dose. After charting todays dose and pulling the Query, database shows todays dose that was given but not the dose from 3/18/2025. So patient received a 5th dose of HEP B on 9/12/2025. Spoke to mom, informed her that the state records and our charts was showing she was due, but after giving the vaccine it stated she had been given this vaccine in March. Advice that per ARNP advised patient will be okay, its an extra dose/ booster. Asked mom if she wanted to talk to a provider about it, and she stated no. Mom verbalized understanding and agreement. More
2858923 39 F TN 09/15/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Injection site inflammation, Injection site pain, Injection site reaction Injection site inflammation, Injection site pain, Injection site reaction
Redness at injection site, inflammation, pain at local site Redness at injection site, inflammation, pain at local site
2858924 71 F MI 09/15/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8146545
u8764cb
Rash; Rash Rash; Rash
Patient claims a widespread rash from the Moderna vaccine that didn't happen from the Pfizer va... Patient claims a widespread rash from the Moderna vaccine that didn't happen from the Pfizer vaccines. She claims that immunocompromised people, which she claims to be despite not checking the yes box on the VAR, has known side effects from Moderna vaccines despite FDA approval. More
2858925 76 F FL 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ft95n
Injection site erythema, Pain in extremity Injection site erythema, Pain in extremity
Injection side reactions: patient said her arm is sore and the injection area looks red. She is appl... Injection side reactions: patient said her arm is sore and the injection area looks red. She is applying ice and icy hot to the area (alternating) More
2858926 62 M OH 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 y5yh2
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient received 3 Shingrix vaccines accidentally. The dates are as follows: 11/05/2019, 05/23/2... The patient received 3 Shingrix vaccines accidentally. The dates are as follows: 11/05/2019, 05/23/2020, and 02/15/2024. The patient did not remember getting his first 2 vaccines and thought the vaccination on 02/15/2024 was his first. Patient came to get what he thought would be his second vaccination of Shingrix on 09/09/2025 and that is when this error was discovered. Patient did not experience any adverse effects from getting 3 Shingrix vaccines. More
2858927 1 M IL 09/15/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
Y008289
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE case reported.; HCP stated MMR II was inadvertently administered during a T/E on 7/... No additional AE case reported.; HCP stated MMR II was inadvertently administered during a T/E on 7/09/2025.; HCP stated MMR II was inadvertently administered during a T/E on 7/09/2025.; This spontaneous report was received from a Physician Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 09-Jul-2025, the patient was inadvertently vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL (route of administration and anatomical location were not reported) lot # Y008289 has been verified to be valid and expiration date: 24-Apr-2026, reconstituted with sterile diluent solution for injection (lot# and expiry date were not reported) as Prophylaxis. Temperature excursion(TE) was 9.69 degree Celsius (C) for 15 minutes. No previous TE nor additional adverse events were reported. This is one of four reports from the same reporter. Follow-up information has been received from medical assistant on 10-Sep-2025 via telephone memo. Patient's demographics were added. The 1-year-old male patient had the vaccine administration on 07-Jul-2025 (Conflicting information as temperature excursion occurred on 09-Jul-2025) in left thigh. On the same date, the patient also received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (+) sterile diluent (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided); and other company suspect vaccine: Hepatitis a vaccine inact (HAVRIX) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided). No vaccines were administered in previous 4 weeks and no illness at time of vaccination. Additional information is not expected. More
2858928 3 NV 09/15/2025 VARCEL
 MERCK & CO. INC.
 X021282
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE/No PQC; expired VARIVAX (exp: 08/20/25) administered today; This spontaneous report... No additional AE/No PQC; expired VARIVAX (exp: 08/20/25) administered today; This spontaneous report was received from medical assistant and refers to a 3-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-Aug-2025, the patient was vaccinated with expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection, lot #X021282, expiration date: 20-Aug-2025 (dosage, route of administration and anatomical location were not provided) as prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot#, expiration date, dosage, route of administration and anatomical location were all not provided). There was no additional adverse event (AE) or product quality issue (PQC) . Confirmed patient not symptomatic. Confirmed no temperature excursions (TEs). Supported by memo. No other information available at this time. More
2858929 M TX 09/15/2025 VARCEL
 MERCK & CO. INC.
 Z005233
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP called to report TE occurring on 8/21/2025 for VARIVAX and PROQUAD. VARIVAX (L... No additional AE; HCP called to report TE occurring on 8/21/2025 for VARIVAX and PROQUAD. VARIVAX (Lot Z005233 exp 2/27/2027) was administered after the TE on 8/22/2025. No additional AE/PQC. VARIVAX Lot Z005233 exp 2/27/2027 Prior excursion: (-12.6C) for 2 hours,; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Aug-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z005233, expiration date: 27-Feb-2027) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (expiration date, and lot # were not reported), which underwent temperature excursion (TE) on 21-Aug-2025, of 15.6 C in time of 1 hour, 3 minutes, 0 seconds (reported as current excursion); prior excursion was with temperature od -12.6 C for 2 hours, 31 minutes, 0 seconds (product storage error). No additional AE (adverse event) was reported. More
2858930 29 NY 09/15/2025 VARCEL
 MERCK & CO. INC.
 Z008196
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; TE for VARIVAX; This spontaneous report was received from a Registered Nurse Pract... No additional AE; TE for VARIVAX; This spontaneous report was received from a Registered Nurse Practiotner on 04-Sep-2025 and refers to a 29-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-Aug-2025, the patient was vaccinated with an improperly stored of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Z008196, expiration date: 30-Apr-2027, dose:0.5 mL , total,(route, dose number unspecified) for prophylaxis (Product storage error) The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) , dose: 0.5 mL, total (lot # and expiration date were not reported) (route, dose, lot#, expiration date were unspecified ) for prophylaxis, adminsitered on the same date. The administered dose of the vaccine experienced a temperature excursion -11.8 degrees Celsius for 45 minutes. No previous temperture excursion reported. There was no adverse effect reported. This is one of several reports from the same source. Lot # is being requested and will be submitted if received. More
2858931 ID 09/15/2025 VARCEL
 MERCK & CO. INC.
 Y010184
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP reported that one dose of improperly stored VARIVAX was administered to a pati... No additional AE; HCP reported that one dose of improperly stored VARIVAX was administered to a patient. HCP reported that the product had two current temperature excursions.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y010184 with expiration date reported as and upon internal validation established 31-May-2026) 0.5 mL (route of administration and vaccination site were not reported) with sterile diluent (BAXTER STERILE DILUENT) (lot #1950652 with expiration date reported as and upon internal validation established as 27-Jan-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. One dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered to the patient (product storage error). The product had two current temperature excursions (temperature 14๏ฟฝF up to 46๏ฟฝF (19.4F) for 0 hours 32 minutes 0 seconds; 6๏ฟฝF up to 14๏ฟฝF (9.3F) for 0 hours 16 minutes 0 seconds). There was no previous temperature excursion. No symptoms were reported. No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2858932 67 F 09/15/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 623732
623732
623732
623732
126616
126616
126616
126616
Atrial fibrillation, Blood chloride increased, Blood creatinine normal, Blood ma... Atrial fibrillation, Blood chloride increased, Blood creatinine normal, Blood magnesium normal, Blood pressure fluctuation; Blood thyroid stimulating hormone normal, Cardiac pacemaker insertion, Chest X-ray normal, Echocardiogram abnormal, Ejection fraction normal; Electrocardiogram ST-T segment abnormal, Haemoglobin normal, Mitral valve incompetence, Scan myocardial perfusion, Tachycardia; Tricuspid valve incompetence, Troponin, Ventricular hypertrophy; Atrial fibrillation, Blood chloride increased, Blood creatinine normal, Blood magnesium normal, Blood pressure fluctuation; Blood thyroid stimulating hormone normal, Cardiac pacemaker insertion, Chest X-ray normal, Echocardiogram abnormal, Ejection fraction normal; Electrocardiogram ST-T segment abnormal, Haemoglobin normal, Mitral valve incompetence, Scan myocardial perfusion, Tachycardia; Tricuspid valve incompetence, Troponin, Ventricular hypertrophy More
Atrial fibrillation with fast ventricular response; This 67-year-old female subject was enrolled in ... Atrial fibrillation with fast ventricular response; This 67-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 13-OCT-2022, for prophylaxis. Concurrent medical conditions included hypertension, atrial fibrillation, obesity and hypercholesterolemia. Concomitant products included ezetimibe, apixaban (Eliquis), amlodipine, lisinopril, sotalol and rosuvastatin. On 12-JAN-2023, 91 days after receiving RSVPreF3 vs Placebo the subject developed moderate - grade 2 atrial fibrillation with rapid ventricular response (Verbatim: Atrial fibrillation with fast ventricular response). Serious criteria included hospitalization. The subject was treated with sotalol, sucralfate (Carafate), metoprolol and sodium chloride (Normal Saline). The outcome of atrial fibrillation with rapid ventricular response was resolved on 19-JAN-2023. Relevant Tests: On 19JAN2023 showed EKG showed Atrial fibrillation with rapid ventricular response, 117, nonspecific ST/T wave abnormalities. On 19JAN2023 LABS TSH was 1.41uIU/mL (0.35-4.94) On 19JAN2023 CXR showed Negative. Cardiac device in Left pectoral with leads through the Right atrium and ventricle. No airspace consolidation. Prior tests mentioned: On Unknown Date In MAY22 echocardiogram showed normal L ventricular size and EF:55-59 percent, mildly increased LV wall thickness, mild MR/TR. On Unknown date In APR22 Lexi scan stress test showed normal myocardial SPECT perfusion with no scintigraphic evidence of ischemia. Negative pharmacological stress test by EKG criteria. On an UNK-JAN-2023 BP showed 126/88 and 115/80. On an UNK-JAN-2023 HR showed 74 and 111. On an UNK-JAN-2023 O2sat showed 96 percent. On JAN2023, EKG and found with heart rate in 120s so referred to ER. On Unk-Jan-2023, She went to her PCP(primary care physician) who did an EKG and found with heart rate in 120s so referred to ER(emergency room). In ER(emergency room), she had an EKG that showed Atrial fibrillation with Fast ventricular response 117, but as per cardiology consult notes it spontaneously converted to sinus and paced rhythm at 60bpm (per Discharge). On Unk-May-2022 she had ECHO(echocardiogram) that showed normal L ventricular size and EF(ejection fraction). On Unk-Apr-2022 had a L Exiscan stress test, result was normal myocardial SPECT perfusion. Troponin as above were negative x 2.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood chloride- 19-JAN-2023 110 mmol/L, (98.00-107.00). Blood creatinine- 19-JAN-2023 0.78 mg/dL, (0.60-1.10). Blood magnesium- 19-JAN-2023 2.0 mg/dL, (1.60-2.60). Blood pressure measurement- 19-JAN-2023 fluctuating. Haemoglobin- 19-JAN-2023 12.5 g/dL, (11.40-14.70). Heart rate- 19-JAN-2023 elevated. Troponin- 19-JAN-2023 less than 4 ng/L, (0.00-14.00). The investigator considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date: 30-JAN-2023 Virtual surveillance call informed "Went to hospital for tachycardia, stayed overnight for observation. No meds prescribed, she needs to follow up with cardiologist'. Update, 02FEB2023- she said saw PCP(primary care physician) who found her with some tachycardia, contacted cardiology and sent her to the hospital for further evaluation of heart rate. Normotensive. Further info to be added when get Medical Records. Update, 04APR2023- obtained Medical records today. She was admitted from 19JAN2023 and discharged 20JAN2023. She presented with a chief complaint of palpitations with hx (history) of intermittent elevated heart rate and fluctuating Blood pressure readings in the week before admission (not reported on call 16JAN2023). Cardiology evaluated subject and indicated hx of atrial fibrillation ablation approx 17yrs ago and on med management but had pacemaker placed on 19JUN2022. They cleared subject for discharge on Metoprolol if needed. Follow-up information received on 02-Feb-2023. Summary of changes: SAE onset date, end date, TTO and investigator text updated. Follow-up information received on 03-APR-2023, 04-APR-2023. Summary of changes: Event term updated from tachycardia to Atrial fibrillation with fast ventricular response, start date of event, Lab data, Current condition, Treatment drugs, End date of event and Narrative updated. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 17-Apr-2023. Summary of changes: Treatment medication added. Follow-up information received on 24-Apr-2023. Summary of changes: Aspirin deleted, Carafate updated from treatment to concomitant and action taken updated. Follow-up information received on 17-Aug-2023. Summary of changes: No new information. Follow-up information received on 25-SEP-2023. Summary of changes: Dose details for Metoprolol updated. Follow-up information received on 28-SEP-2023 and 02-OCT-2023. Summary of changes: SAE start date, TTO updated and concomitant medication Carafate changed to treatment. Follow-up information received on 04-OCT-2023. Summary of changes: Event outcome date updated. Follow-up information received on 25-OCT-2023. Summary of changes: concomitant, treatment drugs added, general narrative updated. Follow-up information received on 02-Nov-2023. Summary of changes: Medical history and concomitant product updated. Follow-up information received on 13-NOV-2023. Summary of changes: End date removed for concomitant medication Ezetimibe, Eliquis. Follow-up information received on 01Dec2023. Summary of changes: For concomitant medication Ezetimibe continue at the end of study updated as yes Follow-up information received on 18Dec2023. Summary of changes: action taken updated from no change to not applicable Follow-up information received on: 14-May-2024 Summary of changes: Medications Amlodipine; Rosuvastatin and metoprolol end date updated as Continuing at the end of the study. Follow up information received on 06-Jun-2024. Summary of changes: Unit of treatment medication Sotalol updated from tablet to mg Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 502 days after receiving 1st dose of RSVPreF3 in a 67-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternate risk factor (previous known atrial fibrillation) based on clinical history. More
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2858933 64 F OH 09/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Injection site erythema, Injection site pain, Injection site scab, Injection sit... Injection site erythema, Injection site pain, Injection site scab, Injection site warmth, Malaise; Pain, Pruritus, Pyrexia More
Itching; General malaise, fever, general pain; General malaise, fever, general pain; General malaise... Itching; General malaise, fever, general pain; General malaise, fever, general pain; General malaise, fever, general pain; Pain at injection site; redness at injection site; injection site warm to touch; Scab Injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included fibromyalgia (Fibromyalgia), blood pressure (Blood pressure) and diabetes (Diabetes). On 06-AUG-2025, the patient received Shingrix. On 06-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site warmth (Verbatim: injection site warm to touch), injection site scab (Verbatim: Scab Injection site), malaise (Verbatim: General malaise, fever, general pain), fever (Verbatim: General malaise, fever, general pain) and general body pain (Verbatim: General malaise, fever, general pain). On 16-AUG-2025, the patient experienced pruritus (Verbatim: Itching). In AUG-2025, the outcome of the injection site pain, injection site erythema, injection site warmth, malaise, fever and general body pain were resolved. The outcome of the injection site scab and pruritus were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site scab, pruritus, malaise, fever and general body pain to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema, injection site warmth, injection site scab, pruritus, malaise, fever and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 21-AUG-2025 The customer reported that after she received the Shingrix vaccine, she experienced pain at injection site for many days, redness, warm to touch, a scab developed at the injection site. Experienced itching, general malaise, fever, general pain. More
2858934 F 09/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema, Injection site swelling, Injection site warmth, Mass Injection site erythema, Injection site swelling, Injection site warmth, Mass
3"x5" red patch about 3" below injection site. Swollen, hot,; 3"x5" red pat... 3"x5" red patch about 3" below injection site. Swollen, hot,; 3"x5" red patch about 3" below injection site. Swollen, hot,; 3"x5" red patch about 3" below injection site. Swollen, hot,; A lump under my skin, like a tennis ball; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 85-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-AUG-2025, the patient received the 2nd dose of Shingles vaccine. In AUG-2025, less than a week after receiving Shingles vaccine, the patient experienced mass (Verbatim: A lump under my skin, like a tennis ball). On 21-AUG-2025, the patient experienced injection site swelling (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,), injection site erythema (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,) and injection site warmth (Verbatim: 3"x5" red patch about 3" below injection site. Swollen, hot,). The patient was treated with apixaban (Eliquis), furosemide (Lasix), gabapentin, allopurinol and escitalopram oxalate (Lexapro). The outcome of the injection site swelling, injection site erythema and injection site warmth were not resolved and the outcome of the mass was not reported. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and mass to be related to Shingles vaccine. It was unknown if the company considered the injection site swelling, injection site erythema, injection site warmth and mass to be related to Shingles vaccine. Additional Information: GSK receipt date: 23 Aug 2025 The case was reported by patient itself. The patient had a lump under her skin, like a tennis ball and she enquired whether it was a normal reaction? Should she need to seek medical attention? The patient received treatment with malbeq. More
2858935 F 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination, Malaise, Nasopharyngitis, Urticaria Incomplete course of vaccination, Malaise, Nasopharyngitis, Urticaria
Hives; she was sick; Suspected cold; This non-serious case was reported by a consumer via call cente... Hives; she was sick; Suspected cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives), sickness (Verbatim: she was sick) and cold (Verbatim: Suspected cold). The outcome of the hives was resolved and the outcome of the sickness and cold were not reported. It was unknown if the reporter considered the hives, sickness and cold to be related to Shingrix. It was unknown if the company considered the hives, sickness and cold to be related to Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 Patient received shot 1 of Shingrix on 03-Jan-2025 and her "docket" said that she could get shot number 2 between 28-FEB-2025 and 30-AUG-2025. Reporter explained that shot number 2 should be given 2 to 6 months later (between 03-MAR-2025 and 03-JUL-2025) and she had missed 6-month window. She was going to try to get the pharmacy to administer shot on the day of reporting. She mentioned that she had intended to come in for shot on earlier occasions but was prevented from doing so because she was sick. She did not specify the type of sickness perhaps a cold etc. She mentioned that after getting Shingrix shot 1 she got a little reaction of hives and was told that she should take Zyrtec (antihistamine) for a week before getting Shingrix shot 2. More
2858936 0.58 M 09/15/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 A32BB
Expired product administered Expired product administered
Adminstered expired vaccine; This non-serious case was reported by a other health professional via s... Adminstered expired vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB) for prophylaxis. On 02-SEP-2025, the patient received Pediarix (right thigh). On 02-SEP-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Adminstered expired vaccine). 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: 03-SEP-2025 The reporter reported that patient had administered expired vaccine which led to expired vaccine used. More
2858937 F UT 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not come back for her second dose; This non-serious case was reported by a other health professi... did not come back for her second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who did not received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 12-OCT-2020 on left deltoid, batch number AG7M9 and expiry date 06-MAY-2022). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: did not come back for her second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 05-SEP-2025 The medical assistant reported that the patient was currently scheduling the second dose of Shingrix. More
2858938 50 F TX 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3334y
Pain in extremity Pain in extremity
Pain in arm; This non-serious case was reported by a consumer via call center representative and des... Pain in arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 3334y, expiry date MAR-2027) for prophylaxis. On 26-JUN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The reporter was the patient who had received her first dose of Shinrix on 26th June 2025. She stated that she had experienced arm pain. More
2858939 F 09/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; hero's(shingles) appear again; This serious case was reported by... Suspected vaccination failure; hero's(shingles) appear again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: hero's(shingles) appear again). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 26-AUG-2025 This case was reported by a consumer via interactive digital media. The patient husband reported that his wife had received vaccine few months ago and after 3 months hero's(shingles) appeared again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 3 months after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2858940 F NH 09/15/2025 HEP
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination, Wrong product administered Incomplete course of vaccination, Wrong product administered
did not receive the second dose of Hepatitis B vaccine; This non-serious case was reported by a nurs... did not receive the second dose of Hepatitis B vaccine; This non-serious case was reported by a nurse and described the occurrence of incomplete course of vaccination in a female patient who did not receive Hepatitis B vaccine for prophylaxis. Concomitant products included Hepatitis b vaccine. On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. The patient experienced incomplete course of vaccination (Verbatim: did not receive the second dose of Hepatitis B vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 26-AUG-2025 The patient in today on 26th August 2025, for a vaccination for Hepatitis B. However, the patient received Hepatitis A vaccine (Havrix) instead and asked what the timeline would be for the patient to get the Hepatitis B vaccine if the patient decides to continue with the Hepatitis A vaccine or if the patient decides to not continue with the Hepatitis A vaccine. Could they switch to the combination vaccine if she decided to continue with both vaccines? The patient's initial Hepatitis B vaccine was back in June 2025 which led to incomplete course of vaccination and the Hepatitis A vaccine series technically was started today on 26th August 2025. More
2858941 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
Mine has caused it hung and pain for years; This non-serious case was reported by a consumer via int... Mine has caused it hung and pain for years; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Mine has caused it hung and pain for years). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. More
2858942 09/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blister, Burning sensation, Herpes zoster, Vaccination failure Blister, Burning sensation, Herpes zoster, Vaccination failure
I have had shingles it's the worst damn thing to get; Shingles; This serious case was reported ... I have had shingles it's the worst damn thing to get; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I have had shingles it's the worst damn thing to get) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 The case was received from the patient via interactive digital media The reporter reported that he/she had shingles, it was the worst thing to get. The reporter reported that it felt like a sunburn with blisters. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix , in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858943 09/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Headache, Underdose Headache, Underdose
right side headache for several weeks; Could only do half; This non-serious case was reported by a ... right side headache for several weeks; Could only do half; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache unilateral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache unilateral (Verbatim: right side headache for several weeks) and underdose (Verbatim: Could only do half). The outcome of the headache unilateral was resolved and the outcome of the underdose was not applicable. It was unknown if the reporter considered the headache unilateral to be related to Shingles vaccine. It was unknown if the company considered the headache unilateral to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via interactive digital media The patient mentioned that he/she tried to get vaccinated. He/she could only do half. After vaccination, the patient got a right-side headache for several weeks. More
2858944 09/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
General physical health deterioration, Herpes zoster, Vaccination failure General physical health deterioration, Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; ruined my health in three short months; This serious case w... suspected vaccination failure; shingles; ruined my health in three short months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and general physical health deterioration (Verbatim: ruined my health in three short months). The outcome of the vaccination failure, shingles and general physical health deterioration were not reported. It was unknown if the reporter considered the vaccination failure, shingles and general physical health deterioration to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and general physical health deterioration to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via interactive digital media. The patient stated that the vaccine ruined their health in three short months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858945 09/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pyrexia Pyrexia
Had a high fever from the second shot; This non-serious case was reported by a consumer via interact... Had a high fever from the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Had a high fever from the second shot). The outcome of the fever was resolved (duration 1 day). It was unknown if the reporter considered the fever to be related to Shingles vaccine. It was unknown if the company considered the fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. The high fever was gone in a day. More
2858946 M AZ 09/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 5XA2J
Product storage error Product storage error
patient received a dose of Bexsero after the cap was removed and needle attached and stored for less... patient received a dose of Bexsero after the cap was removed and needle attached and stored for less than 24 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5XA2J, expiry date 31-MAY-2028) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: patient received a dose of Bexsero after the cap was removed and needle attached and stored for less than 24 hours). The outcome of the incorrect storage of drug 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: 22-AUG-2025 The reporter reported that patient was administered with a dose of Bexsero that was opened and stored for less than 24 hours. The cap was removed a sterile needle was attached. Then it was administered under 24 hours to a 16-year-old male patient. The reporter asked that was this ok for the patient and do patient had to revaccinate. More
2858947 TX 09/15/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 25-AUG-2025 The pharmacist reported a temperature excursion for Menveo 1-vial at 47.4 Degree Fahrenheit for 1 hour (above the normal storage conditions of temperature) which led to incorrect storage of drug. There was potential administration of vaccine to patient. More
2858948 36 M DC 09/15/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
Product storage error Product storage error
vaccine administration after a temperature excursion; This non-serious case was reported by a other ... vaccine administration after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old male patient who received HAV (Havrix) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 03-JUL-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: vaccine administration after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-AUG-2025 A Health Care Provider asked for information on vaccine administration after a temperature excursion given that three vaccines involved in the excursion which led to incorrect storage of drug. This case was linked with US2025111571, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025111571:same reporter, different patient More
2858949 F MD 09/15/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3rt93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration in 5 month patient; This non-serious case was reported by a other health professional... Administration in 5 month patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3rt93) for prophylaxis. On 03-SEP-2025, the patient received the 1st dose of Kinrix. On 03-SEP-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in 5 month patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 A healthcare professional called in to report that a 5 month old patient was accidentally given a dose of Kinrix on 03 Sep 2025 and wanted to know what could be done. This was being their first dose in the series. More
2858950 25 F GA 09/15/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
 t75mp
Expired product administered Expired product administered
Expire dose; This non-serious case was reported by a nurse via call center representative and descri... Expire dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra) (batch number t75mp, expiry date 30-JUN-2025) for prophylaxis. On 10-SEP-2025, the patient received FluLaval Tetra. On 10-SEP-2025, an unknown time after receiving FluLaval Tetra, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-SEP-2025 The nurse accidentally gave the 2024/2025 flu vaccine (Flulaval) as opposed to the new 2025/2026 formula and wants to know if it was safe to administer the current formula or if we have to wait a period of time before giving the correct. The vaccine administration facility was the same as primary reporter. The health care professional informed that the vaccine exp date was 30-JUN-2025 and they administered on the day of reporting, which led to expired vaccine used. More
2858951 M 09/15/2025 COVID19
 MODERNA
Influenza like illness, Vaccination site pain Influenza like illness, Vaccination site pain
he did not want to move and that he felt "achy flu-y"/tenderness at the side and the '... he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting; he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Chest infection (frequent/annual chest infections). Concurrent medical conditions included Allergic asthma (allergy caused asthma). 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 INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting). At the time of the report, INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. He was a male. He had been getting the COVID vaccine twice a year. He had a strong reaction with all of his COVID vaccines and took it as a signal that his immune system was responding. It was reported that, he felt like crud and would always take the vaccine on a Friday, and spent Saturday laying down, Sunday getting better and back to work on Monday. He did not want to move and that he felt "achy flu-y". He experienced tenderness at the side and the 'achy chill stuff' but no vomiting. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789161 (Patient Link). More
2858952 F 09/15/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm; This s... had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm) in an elderly 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 PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm). At the time of the report, PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that, the patient had a COVID-19 shot every year and noted that her worst symptom was a sore arm. The last booster she had was a month before her trip in March. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2025-789235, MOD-2025-789239 (Patient Link). More
2858953 32 M 09/15/2025 COVID19
 MODERNA
Decreased appetite, Lethargy Decreased appetite, Lethargy
Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appe... Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite; Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite) and DECREASED APPETITE (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite) in a 32-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite) and DECREASED APPETITE (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite). At the time of the report, LETHARGY (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite) and DECREASED APPETITE (Ha a worst symptom was in bed for a week, "lethargic", experienced "lack/loss of appetite) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the patient had the worst symptom and was in bed for a week, lethargic, and experienced lack/loss of appetite. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789235 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789235:Patient case, Spikevax LP.8.1 PFS More
2858954 67 M 09/15/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Influenza like illness, Vaccination site pain; COVID-19, Influenza lik... COVID-19, Influenza like illness, Vaccination site pain; COVID-19, Influenza like illness, Vaccination site pain More
he did not want to move and that he felt "achy flu-y"/tenderness at the side and the '... he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines; he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines; COVID for the first time at the start of the year 2025; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID for the first time at the start of the year 2025), INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines) in a 67-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. The patient's past medical history included Chest infection. Concurrent medical conditions included Allergic asthma. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In April 2025, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In January 2025, the patient experienced COVID-19 (COVID for the first time at the start of the year 2025). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines). At the time of the report, COVID-19 (COVID for the first time at the start of the year 2025), INFLUENZA LIKE ILLNESS (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines) and VACCINATION SITE PAIN (he did not want to move and that he felt "achy flu-y"/tenderness at the side and the 'achy chill stuff' but no vomiting/The reporter states that he had a strong reaction with all of his COVID vaccines) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient was a male. The patient received the COVID vaccine twice a year. He had a strong reaction with all of his COVID vaccines and took it as a signal that his immune system was responding. It was reported that, the patient had taken all Moderna COVID vaccines but one Pfizer since the first emergency authorization. The reporter stated that he had felt like crud and had consistently taken the vaccine on a Friday, spent Saturday lying down, Sunday recovering, and had returned to work on Monday. He reported that he had not wanted to move and had felt "achy flu-y." He noted that he had responded more strongly to the Moderna vaccine than to the Pfizer vaccine. He also stated that he had experienced tenderness at his side and the "achy chill stuff," but had not experienced any vomiting. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789163 (Patient Link). More
2858955 M 09/15/2025 COVID19
 MODERNA
Pyrexia Pyrexia
Patient believed that he had some fever; This spontaneous case was reported by a consumer and descri... Patient believed that he had some fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient believed that he had some fever) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient believed that he had some fever). At the time of the report, PYREXIA (Patient believed that he had some fever) had resolved. No concomitant medications were provided. Patient had 7 doses but not necessarily had an allergic reaction, just some minor reaction, believed it to be fever and but did not remember more than that. Patient would like to know which vaccine he should take and for what variant the mNEXSPIKE 25-26 and Spikevax 25-26. He would probably take Spikevax 25-26. He also stated that it would take some days for his HCP to get back to him, it might be at the end of the week and his pharmacy stated they may run out of the vaccine by that time. No treatment medication was provided. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-789254 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789254:Case for multiple patient More
2858956 F 09/15/2025 COVID19
 MODERNA
Nasopharyngitis Nasopharyngitis
she has a cold; This spontaneous case was reported by a consumer and describes the occurrence of NAS... she has a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she has a cold) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (she has a cold). At the time of the report, NASOPHARYNGITIS (she has a cold) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had scheduled a Covid 19 vaccine on that day. However, she had a cold and wanted to know if she should postpone it. It was also reported that the patient had received other Covid 19 vaccines in the past. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. More
2858957 F 09/15/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR



Body temperature, Erythema, Fatigue, Influenza, Injection site pain; Myalgia, Py... Body temperature, Erythema, Fatigue, Influenza, Injection site pain; Myalgia, Pyrexia, Swelling; Body temperature, Erythema, Fatigue, Influenza, Injection site pain; Myalgia, Pyrexia, Swelling More
swelling; redness; she had a little bit of flu; pain at the injection site at the right arm; muscle ... swelling; redness; she had a little bit of flu; pain at the injection site at the right arm; muscle aches; developed fever on one occasion which had reached to 100'F which lasted for 24 hours; then felt tired and fatigued for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm) and MYALGIA (muscle aches) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Concurrent medical conditions included Multiple sclerosis, Hypothyroidism (hypothyroidism(underactive)) and Chronic insomnia. Concomitant products included Clonazepam, Zolpidem tartrate (Ambien) and Suvorexant (Belsomra) for Chronic insomnia, Levothyroxine for Hypothyroidism, Aciclovir (Acyclovir) for an unknown indication. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In September 2024, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In March 2025, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm), MYALGIA (muscle aches), PYREXIA (developed fever on one occasion which had reached to 100'F which lasted for 24 hours) and FATIGUE (then felt tired and fatigued for 2 days). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), INFLUENZA (she had a little bit of flu), INJECTION SITE PAIN (pain at the injection site at the right arm), MYALGIA (muscle aches), PYREXIA (developed fever on one occasion which had reached to 100'F which lasted for 24 hours) and FATIGUE (then felt tired and fatigued for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100degree F and 97degree F. Patient was taking supplements. Patient had swelling and redness, pain at the injection site at the right arm. Also had muscle aches which started first then developed fever on one occasion which had reached to 100degree F which lasted for 24 hours, which was quite high for the patient as she usually had 97degree F. It took a day before the fever started. There was no vomiting, no diarrhea, but she felt a little bit of flu and then felt tired and fatigued for 2 days. No treatment medication was reported. More
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