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
2866809 76 F FL 10/18/2025 FLU3
 SANOFI PASTEUR
 UT8781DA
Condition aggravated, Confusional state, Migraine with aura, Visual impairment Condition aggravated, Confusional state, Migraine with aura, Visual impairment
AFTER RECEIVING HER FLUSHOT, THE PATIENT STATES WHEN SHE WAS LEAVING THE STORE SHE BEGAN EXPERIENCIN... AFTER RECEIVING HER FLUSHOT, THE PATIENT STATES WHEN SHE WAS LEAVING THE STORE SHE BEGAN EXPERIENCING A COMPLEX MIGRAINE WITH AURA AND APHASIA. WHEN SHE GOT HOME, SHE STATES HAD CONFUSION, VISUAL ISSUES. PATIENT THEN TOOK HER MIGRAINE MEDICATION TO TREAT THE HEADACHE. THE MEDICATION WAS INEFFECTIVE AND THE APHASIA AND MIGRAINE SYMPTOMS CONTINUED FROM TUESDAY TO WEDNESDAY EVENING. EVENTUALLY THE PATIENT RECOVERED AND WISHED TO REPORT THE ABOVE TO VAERS. More
2866811 64 F AZ 10/18/2025 FLU3
 SANOFI PASTEUR
 TFAA2504
Injection site pain Injection site pain
Patient called the pharmacy on 10/18/2025 stating that her shoulder/arms still hurts from a influenz... Patient called the pharmacy on 10/18/2025 stating that her shoulder/arms still hurts from a influenza vaccine that she received on 10/06/25 from our pharmacy. She said that the pain was localized to the injection area, not tingly down the arm or radiating. I advised patient that if the pain persists to contact her primary care provider for care and assessment. More
2866812 52 F MA 10/18/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


NA4457
NA4457
NA4457
Chest pain, Electrocardiogram, Hemiparesis, Lip swelling, Musculoskeletal chest ... Chest pain, Electrocardiogram, Hemiparesis, Lip swelling, Musculoskeletal chest pain; Pharyngeal swelling, Swollen tongue; Dyspnoea, Pruritus, Throat irritation; Chest pain, Electrocardiogram, Hemiparesis, Lip swelling, Musculoskeletal chest pain; Pharyngeal swelling, Swollen tongue; Dyspnoea, Pruritus, Throat irritation More
Left sided weakness, in arm and leg. Pain in left rib cage/chest. lips swelling and Toung and throat... Left sided weakness, in arm and leg. Pain in left rib cage/chest. lips swelling and Toung and throat swelling. Needed to use EpiPen and get treated at the hospital. More
2866813 44 M CA 10/18/2025 COVID19
 PFIZER\BIONTECH
Autonomic nervous system imbalance, Influenza like illness, Nasopharyngitis Autonomic nervous system imbalance, Influenza like illness, Nasopharyngitis
I?m in the middle of it now, but it?s following the same pattern as when I got vaccinated in Oct 20... I?m in the middle of it now, but it?s following the same pattern as when I got vaccinated in Oct 2023: expected flu-like symptoms the next day, following by cold-like symptoms for days later. In Oct 2023 I ended up having autonomic crash a week after recovery (after being sick for 1.5 weeks)? it was assumed at the time to be a virus I got at the same time. I?m still seeing treatment for the dysautonomia to this day. But given the same exact scenario seems to be playing right now, I?m suspecting it was the Covid booster versus a coincidental virus. More
2866814 50 F FL 10/18/2025 COVID19
FLU3
VARZOS
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 NA4457
2L353
7yd42
Injection site pain, Injection site swelling, Injection site warmth; Injection s... Injection site pain, Injection site swelling, Injection site warmth; Injection site pain, Injection site swelling, Injection site warmth; Injection site pain, Injection site swelling, Injection site warmth More
Injection site pain began within 30 minutes of receiving the injection. Pain, heat & swelling c... Injection site pain began within 30 minutes of receiving the injection. Pain, heat & swelling continues to increase. I had a similar reaction when I had the first dose in July. More
2866815 26 F MD 10/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 N9CS2
Injection site mass, Injection site warmth Injection site mass, Injection site warmth
Hard lump at injection site and warm to the touch Hard lump at injection site and warm to the touch
2866816 33 M CA 10/18/2025 COVID19
FLU3
TDAP
 PFIZER\BIONTECH
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 my9547
407004
H4k3s
Arthralgia, Pain, Pain in extremity; Arthralgia, Pain, Pain in extremity; Arthra... Arthralgia, Pain, Pain in extremity; Arthralgia, Pain, Pain in extremity; Arthralgia, Pain, Pain in extremity More
Patient called 10/7 25 at 6:50pm regarding getting help to cover injury related to immunization on 9... Patient called 10/7 25 at 6:50pm regarding getting help to cover injury related to immunization on 9/24/25. Initial symptoms were soreness in arm for 24 hours, pain in shoulder area after the 48 hours, sharp pain in arm with movement. He said we went to md regarding the incidence and md recommended he takes NSAIDs and gets a muscular ultrasound done to check of everything is in order and no injuries regarded to rotator cuff (SIRVA). More
2866817 73 M GA 10/18/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 407264
407264
407264
Blood cholesterol normal, Blood electrolytes normal, Computerised tomogram head ... Blood cholesterol normal, Blood electrolytes normal, Computerised tomogram head normal, Computerised tomogram neck, Electrocardiogram normal; Full blood count normal, Gait disturbance, Glycosylated haemoglobin normal, Myocardial necrosis marker normal, Nausea; Pain in extremity, Retching, Scan with contrast normal, Vertigo, Vestibular neuronitis More
Vaccination given at store (just arrived by air to the area for 2 week vacation). "Senior dose... Vaccination given at store (just arrived by air to the area for 2 week vacation). "Senior dose". Mild soreness left arm first day, then 30 hours after vaccination, started with Severe Vertigo. Slept 36 hours, with continued vertigo with movement and nausea, dry heaves. Symptoms somewhat controlled with meclizine 25 mg Q 12 hrs. Day 3 + 4 post vaccine, continued severe vertigo with sudden head movements and very unsteady gait. Day 4 post vaccine, with continued intermittent vertigo, went to local ER. More
2866818 32 F WA 10/18/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0739
U8864BA
Dizziness, Syncope, Vomiting; Dizziness, Syncope, Vomiting Dizziness, Syncope, Vomiting; Dizziness, Syncope, Vomiting
After providing both vaccines, patient stated that she wanted to sit down for a minute. After ~10 mi... After providing both vaccines, patient stated that she wanted to sit down for a minute. After ~10 minutes she came back to the pharmacy and stated that she had fainted and woke up from the ground. My tech and I immediately came out to care for the patient; stated that she felt dizzy and needed to vomit (vomited for <5 minutes). I went to provide her water and a protein bar to soothe her stomach. She said that this was her first time ever fainting from the vaccines, but did say that she always felt dizzy after getting her blood drawn. Did not eat all morning and only drank coffee before coming in. After drinking plenty of water and eating, she stated that she felt a lot better, but told her to stick around for an additional 10-15 minutes before leaving.so I could continuously monitor her. After that period, she stated that she felt normal and was okay to leave since she lived very close. Around 1:30, I called her back to check up with her status and she stated that she felt okay and was back to normal. Suggested her to get both vaccinations at different times for next year. More
2795171 77 F CA 10/17/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 HG4629
Hg4629
Balance disorder, Fatigue, Tremor; Asthenia, Fatigue Balance disorder, Fatigue, Tremor; Asthenia, Fatigue
Extreme fatigue; developed gradually balance problem; tremor; This is a spontaneous report received ... Extreme fatigue; developed gradually balance problem; tremor; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1 (toppac), single (Lot number: HG4629) at the age of 77 years intramuscular, in arm for covid-19 immunization. The patient had no relevant medical history. There were no other diagnosed illnesses/medical history/chronic health conditions to report. The patient is not allergic to any previous vaccination, medications, food or other products. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Location of injection/shot: arm, lot number: EW0150), administration date: 12Apr2021, when the patient was 75-year-old, for Covid-19 Immunization, reaction(s): "extreme fatigue", "developed gradually balance problems", "tremor"; BNT162b2 (Dose 2, Location of injection/shot: arm, lot number: ER8735), administration date: 04May2021, when the patient was 75-year-old, for Covid-19 Immunization, reaction(s): "extreme fatigue", "developed gradually balance problem/can't stand for more than a couple of seconds", "tremor", "Surgery to remove cancerous kidney", "couldn't walk at all"; BNT162b2 (Dose 3, Location of injection/shot: arm, lot number: FJ1620), administration date: 29Nov2021, when the patient was 75-year-old, for Covid-19 Immunization, reaction(s): "extreme fatigue/extreme debilitating fatigue, long term", "developed gradually balance problems", "tremor"; BNT162b2 (Dose 4 (booster), Location of injection/shot: arm, lot number: FJ4991), administration date: 13May2022, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "gradually decreased walking to 15 mins, then 10 mins, then 5 ending at her door gasping for breath", "developed gradually balance problems", "tremor", "extreme fatigue"; BNT162b2 (Dose 5 (booster), Location of injection/shot: arm, lot number: GJ6738), administration date: 10Nov2022, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "extreme fatigue", "developed gradually balance problems", "tremor". The following information was reported: FATIGUE (disability), outcome "unknown", described as "Extreme fatigue"; BALANCE DISORDER (non-serious), outcome "unknown", described as "developed gradually balance problem"; TREMOR (non-serious), outcome "unknown".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500107080 same patient, different dose and event; More
โœ“
2866033 11 AZ 10/17/2025 PPV
 MERCK & CO. INC.
 X022827
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; The patient received the vaccine for "cochlear implant"; patient receive... No additional AE; The patient received the vaccine for "cochlear implant"; patient received an expired PNEUMOVAX 23 vaccine on 10/13/2025; This spontaneous report was received from a nurse and refers to an 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 13-Oct-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) Solution for injection (valid lot #X022827, expiration date reported and confirmed as 14-Aug-2025), 1 dosage form, total (route of administration and anatomical location were not provided) administered for cochlear implant (expired vaccine used / product use in unapproved indication). No additional adverse events reported (no adverse event). More
2866491 CA 10/17/2025 HEPA
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z010429
Z003402
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; Medical assistant reported that VAQTA and MMR II which underwent a temperature exc... No additional AE; Medical assistant reported that VAQTA and MMR II which underwent a temperature excursion were both administered to a patient; This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 08-OCT-2025, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL administered as prophylaxis (lot number reported as Z003402, which has been verified as valid, expiration date reported and validated as 23-JAN-2027) (vaccination scheme, route of administration, and anatomical site of injection were not reported), reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot number and expiration date were not reported); and with Hepatitis A Vaccine, Inactivated (VAQTA) (lot number reported as Z010429, which has been verified as valid, expiration date reported and validated as 09-OCT-2026) 0.5 mL administered as prophylaxis (vaccination scheme, route of administration, and anatomical site of injection were not reported). The administered doses were exposed to a temperature excursion of 47.7 Fahrenheit degree (F) for 30 minutes (Product storage error). No symptoms were reported. More
2866492 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Peripheral swelling, Pyrexia Feeling abnormal, Peripheral swelling, Pyrexia
Arm swollen; feel like a bus hit me; fever; This non-serious case was reported by a consumer and des... Arm swollen; feel like a bus hit me; fever; This non-serious case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. In OCT-2025, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever). On an unknown date, the patient experienced swelling arm (Verbatim: Arm swollen) and feeling abnormal (Verbatim: feel like a bus hit me). On 10-OCT-2025, the outcome of the fever was resolved. The outcome of the swelling arm was resolved and the outcome of the feeling abnormal was not reported. It was unknown if the reporter considered the fever, swelling arm and feeling abnormal to be related to Shingrix. It was unknown if the company considered the fever, swelling arm and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date:10-OCT-2025 The reporter stated that for anyone considering the second dose of Shingrix vaccine and would plan on it ruining a few days. The patient woke at 3 am with a fever. The reporter had that fever all day at the time of reporting. The patient's arm was swollen, and he/she felt like a bus hit him/her. This was on home from work now, hot shower and going to bed. More
2866493 M NY 10/17/2025 PNC20
 PFIZER\WYETH
 LN4928
Injection site cellulitis, Injection site erythema, Pruritus, Rash, Tenderness Injection site cellulitis, Injection site erythema, Pruritus, Rash, Tenderness
Erythema to the injection site; like a little bit tenderness; Itching; Rash; Cellulitis at the injec... Erythema to the injection site; like a little bit tenderness; Itching; Rash; Cellulitis at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4928, Expiration Date: Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Erythema to the injection site"; TENDERNESS (non-serious), outcome "unknown", described as "like a little bit tenderness"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; RASH (non-serious), outcome "unknown"; VACCINATION SITE CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis at the injection site". Additional information: The reporter stated they had one of the lot numbers of Prevnar 20 and they had reactions for 3 of the 4 patients that they gave the injections to. 3 patients give the same lot number had a reaction. The patient had erythema to the injection site and they also had like a little bit tenderness, itching, cellulitis at the injection site and rash. It happened like couple of days after the vaccine so, within 3 to 4 days, the patient had a reaction. NDC number of Prevnar 20: 0005-2000-10. Causality for "erythema to the injection site", "like a little bit tenderness", "itching", "rash" and "cellulitis at the injection site" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500202597 same reporter/drug/event, different patient;US-PFIZER INC-202500202833 same reporter/drug/event, different patient; More
2866513 38 F OR 10/17/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052586
3052586
Erythema, Flushing, Headache, Lip swelling, Swelling face; Urticaria Erythema, Flushing, Headache, Lip swelling, Swelling face; Urticaria
Received Moderna Covid-19 vaccine on 10/13/2025 around 4:45pm. Hives started on my stomach on 10/14... Received Moderna Covid-19 vaccine on 10/13/2025 around 4:45pm. Hives started on my stomach on 10/14/2025. Severe headache, took Benadryl for hives and tried to forgo pain meds for headache until it got so bad I had to take Tylenol, went to bed. Woke up 10/15/2025 with severe facial swelling of lips, swelling under my eyes, puffiness redness, was not recognizable in the mirror and immediately took Zyrtec, famotidine 40 mg and a Benadryl at 6 AM and went straight to urgent care around 8 AM. Urgent care physician prescribed oral prednisone 40 mg daily for five days for allergic reaction related to Covid-19 vaccine. More
2866526 10/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Malaise Herpes zoster, Malaise
almost died from the vaccine; Right away I got horrible shingles two months; This serious case was r... almost died from the vaccine; Right away I got horrible shingles two months; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience 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 near death experience (Verbatim: almost died from the vaccine) (serious criteria GSK medically significant) and shingles (Verbatim: Right away I got horrible shingles two months). The outcome of the near death experience was not reported and the outcome of the shingles was resolved (duration 2 months). It was unknown if the reporter considered the near death experience and shingles to be related to Shingles vaccine. The company considered the near death experience 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: 13-OCT-2025 This case was reported by a patient via interactive digital media. The patient reported that wake up people, vaccines were not helping to prevent shingles. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Near death experience, on an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received. More
2866529 63 M TX 10/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 429P7
Product preparation issue Product preparation issue
patient was possible given diluent only instead of reconstituted vaccine; patient was possible given... patient was possible given diluent only instead of reconstituted vaccine; patient was possible given diluent only instead of reconstituted vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 429P7) for prophylaxis. On 31-JUL-2025, the patient received Arexvy. On 31-JUL-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was possible given diluent only instead of reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: patient was possible given diluent only instead of reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 Pharmacist explained that a patient was possible given diluent only instead of reconstituted vaccine of Arexvy. More
2866535 69 F 10/17/2025 COVID19
 MODERNA
Extra dose administered, Spinal pain, Vaccination site pain, Wrong product admin... Extra dose administered, Spinal pain, Vaccination site pain, Wrong product administered More
She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous s... She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose; She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu; extra pain for the fractured vertebrae; painful injection site; This spontaneous case was reported by a nurse and describes the occurrence of SPINAL PAIN (extra pain for the fractured vertebrae), VACCINATION SITE PAIN (painful injection site), EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052034) for COVID-19 prophylaxis. Concurrent medical conditions included Vertebral hyperplasia (hypoplasty of three vertebrae) and Vertebral fracture (fractured vertebrae right now). On 07-Oct-2025, the patient received first dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 10-Oct-2025, received second dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) dosage was changed to .2 milliliter. On 08-Oct-2025, the patient experienced SPINAL PAIN (extra pain for the fractured vertebrae). On 10-Oct-2025, the patient experienced EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose). 10-Oct-2025, the patient experienced WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu). In October 2025, the patient experienced VACCINATION SITE PAIN (painful injection site). In October 2025, SPINAL PAIN (extra pain for the fractured vertebrae) and VACCINATION SITE PAIN (painful injection site) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter considered SPINAL PAIN (extra pain for the fractured vertebrae) to be related. No further causality assessments were provided for VACCINATION SITE PAIN (painful injection site), EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu). No concomitant medication was reported. The patient had received two doses of mNEXSPIKE 2025-2026 formula both on 07-Oct-2025 (assumed as 0.2 ml) and on 10-Oct-2025 respectively. The patient was supposed to receive the flu shot on 10-Oct-2025 but the pharmacist that gave her the shot had administered the mNEXSPIKE instead of the flu shot. The patient termed the second dose administered to her as "erroneous second dose." The patient also confirmed she had no reactions on the day of reporting but confirmed she had a very painful injection site but had no redness or any problem as such and then added she had a hypoplasty of three vertebrae adding she had a fractured vertebra right now. And so that ached quite a bit the following day pertaining to the shot she had received on 07-Oct-2025. She was assuming that extra pain for the fractured vertebrae was caused by the first COVID vaccine which she referred to was the dose she got on 07-Oct-2025 at 3 o'clockish in the afternoon. The patient did not experience any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2025: Significant live follow-up received. Reporter's mail ID was added, additional reporter was added, medical history was added, suspect details updated, additional events were added, and narrative was updated. On 13-Oct-2025: Live follow-up received that contains non-significant information (reference ids were added). More
2866559 10/17/2025 PNC21
 MERCK & CO. INC.
Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling
Since the day I got the vaccine, my arm is still swollen and painful.; Since the day I got the vacci... Since the day I got the vaccine, my arm is still swollen and painful.; Since the day I got the vaccine, my arm is still swollen and painful.; This spontaneous report was received from a patient of unknown age and gender (Patient ID: 1002ad61-5cea-4972-b058-d15d7f639699), referring to themselves, via a vendor. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). Since the day the patient was vaccinated, the patient's arm was swollen and painful. At the reporting time, the patient had not recovered from the events. Causality assessment was not provided. Lot# is being requested and will be submitted if received. More
2866560 CA 10/17/2025 HEPA
 MERCK & CO. INC.
 Z010429
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Medical assistant reported that VAQTA which underwent a temperature excursion was ... No additional AE; Medical assistant reported that VAQTA which underwent a temperature excursion was administered to a patient. No symptoms reported. Also see AE cases 02889575 and 02889576. No additional AE/no PQC reported. ? Names of vaccines involved (i; This spontaneous report was received from another health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improper storage dose of Hepatitis A Vaccine, Inactivated (VAQTA)(lot #Z010429, expiration date: 09-Oct-2026) (0.5 mL) (anatomical location and administration route were not reported) for prophylaxis. The reporting medical assistant stated that the vaccine Hepatitis A Vaccine, Inactivated (VAQTA) underwent a temperature excursion and was administered to the patient. However, no symptoms or adverse events were reported. It was confirmed that the temperature excursion occurred at 47.7 Fahrenheit degrees (F) for 30 minutes and did not experience previous temperature excursions. More
2866561 F PA 10/17/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
Rash Rash
RASH; A spontaneous report has been received from a consumer. The report concerns a female patient (... RASH; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist, via unknown on an unknown date. The patient received 1 dose(s). On an unknown date, the patient experienced rash (preferred term: Rash). The outcome of the event(s) of rash was unknown. The event was considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): rash. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): rash. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem;Insufficient Information Manufacturer Name:ASTRAZENECA Labeled for single use:No Non-significant correction on 16-Oct-2025: correction product start date. Narrative updated. Non-significant correction on 17-Oct-2025: Nullflavor removed for telephone and fax, Narrative amended. More
2866562 M MD 10/17/2025 SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
 BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
 Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Antinuclear antibody negative, Arthralgia, Aspiration joint abnormal, Blood HIV ... Antinuclear antibody negative, Arthralgia, Aspiration joint abnormal, Blood HIV RNA below assay limit, Blood test normal; Borrelia test negative, C-reactive protein increased, CD4 lymphocytes normal, Cardiac monitoring abnormal, Chest X-ray normal; Chills, Chlamydia test negative, Ciliary hyperaemia, Culture negative, Cytomegalovirus test negative; Diarrhoea, Dysuria, Echocardiogram normal, Electrocardiogram abnormal, Erythema; Fundoscopy normal, HLA-B*27 assay, Inflammation, Iridocyclitis, Joint effusion; Joint swelling, Ligament rupture, Magnetic resonance imaging abnormal, Mobility decreased, Neisseria test negative; Nucleic acid test, Ocular hyperaemia, Oedema, Polyarthritis, Pyrexia; Red blood cell sedimentation rate increased, Respiratory viral panel, Rheumatoid factor negative, Sexually transmitted disease test, Sinus tachycardia; Skin warm, Stool analysis normal, Troponin normal, Ultrasound Doppler normal, Urine analysis normal; Visual acuity reduced, Visual impairment, Vitreous floaters More
diarrhea, asym๏ฟฝmetric arthritis, dysuria, and uveitis due to reactive arthritis; Literature citati... diarrhea, asym๏ฟฝmetric arthritis, dysuria, and uveitis due to reactive arthritis; Literature citation. Case reference number US-BN-2025-001627 is a spontaneous literature case report, title as stated above, identified on 02-Oct-2025, and concerns a 51-years-old male patient. The patient's medical history includes asthma. The patient's family history was remarkable for premature coronary artery disease in patient's father. The patient's past procedure included right rotator cuff tear status post right arthroscopic rotator cuff repair. The patient's current condition included Human Immunodeficiency Virus (HIV) . The patient's concomitant included HIV medications, gabapentin, emtricitabine/tenofovir, dolu-tegravir (brand names: unknown) and albuterol inhaler (salbutamol) On an unspecified date, the patient received the Jynneos (batch number: unknown), at an unknown dose, route or site of administration, for the indication prevention from mpox. On an unspecified date, two hours after vaccination with Jynneos, fever for two weeks with associated rigors, despite taking treatment of acetaminophen every four h. On an unspecified date, reported as two days later, the patient experienced severe watery diarrhea which lasted for about a week. On an unspecified date, the patient had treatment with bismuth subsalicylate for diarrhea and ibuprofen for fever. Patient denied nausea, vomiting, mucocutaneous rash, increased urinary frequency/urgency, recent travel, or sick contact. On an unspecified date the patient have a fever of 100.9๏ฟฝ Fahrenheit and sinus tachycardia (110-120 beats per minute) with normal respiratory rate and oxygen saturation. Physical examination was unremarkable except for slight tenderness in the right shoulder joint at the site of the previous arthroscopy. On unspecified date, the patient's laboratory examination included no leukocytosis, elevated acute phase reactants C-reactive protein was67.82 mg/L (reference range: 0-10 mg/L); erythrocyte sedimentation rate was 38 mm/h (reference range: 0-30 mm/h). Patient's HIV viral load was undetectable with normal absolute CD4 count was673 cells/U (reference range: 404-1612 cells/UL). Blood, urine, and stool studies for infectious pathogens were negative. Cytomegalovirus PCR, respiratory viral panel, and tests for sexually transmitted infections, including nucleic acid amplification testing for chlamydia/gonorrhea, were negative. Chest X-ray was unremarkable. Patient's electrocardiogram showed sinus tachycardia with ventricular rate of 110 beats per minute, and echocardiogram showed left ventricular function of 60%-65% with no obvious valvular vegetation or pericardial effusion. Troponin T 5th-generation test was negative. A seven-day cardiac monitor showed sinus rhythm with average rate of 104 beats per minute. On an unspecified date, the patient's Left knee synovial fluid analysis showed Clarity was transparent (normal range: transparent); color was clear (normal range: clear), viscosity was low ( normal range: high), , white blood cells (WBC) was 1751 / mm3 (normal range: less 200), polymorphonuclear (PMN) leucocyte cells was 30% (normal range: less 25), glucose 119 mg/dL (normal range: 70-110), Protein was 5.3 gm/dL (normal range: 15-2.5) and crystal was negative (normal range: negative) On an unspecified date, the patient was under evaluation for tachycardia and fever, but patient started having progressively worsening pain and swelling of the left knee and ankle joint, restricting mobility. On examination, patient's left knee was red, swollen, and warm with positive tenderness in the left medial knee and 1+ pitting edema extending from the left foot to the knee. A complete duplex ultrasound of the left lower extremity was negative for deep vein thrombosis. MRI left knee without contrast showed grade 2 tear to the origin of the medial collateral ligament with some underlying medial femoral condyle edema and knee effusion. Patient underwent aspiration of the left knee effusion, yielding 50 cc of clear fluid with slightly elevated white blood cell count and protein level suggestive of inflammatory arthritis. Antinuclear antibody, rheumatoid factors, and HLAB27 were negative. Joint fluid crystals, cultures, and Lyme PCR testing were negative (normal range: negative). . The patient subsequently developed migratory arthritis (left elbow, right knee, bilateral temporomandibular joints) and redness in the left eye with floater spots and decreased vision. On an unspecified date, eye examination showed normal fundus with reduced visual acuity, circum-corneal congestion, keratin precipitate, irregular pupil, and anterior chamber cells suggestive of anterior uveitis. Visual acuity (Snellen-linear): right eye was 20/20 and left eye was 20/50 (normal range: 20/20), tonometry: right eye was 15 mmHg and left eye was 10 mmHg (normal range: 10๏ฟฝ21 mmHg),pupil reaction: right eye was brisk and left eye was sluggish (normal: brisk), pupil shape: right eye was round and left eye was irregular (normal: round), lids/lashes: both eyes were normal, conjunctiva/sclera: right eye was white and quiet; left eye showed 1+ injection 360๏ฟฝ (normal: white and quiet), cornea: right eye was clear; left eye showed mild Descemet's folds without NaFl staining (normal: clear), anterior chamber: right eye was deep and quiet with no cells; left eye showed 2+ cells without hypopyon (normal: deep and quiet, no cells), iris: right eye was normal; left eye showed scattered posterior synechiae (normal: normal), lens: right eye was clear; left eye showed scattered pigment on the anterior capsule (normal: clear), vitreous: right eye was normal; left eye showed 1+ vitreous cells (normal: clear). On an unspecified date, the patient was started with treatment of prednisone eye drops every one hour and cyclopentolate twice a day. It was considered unlikely that extensive left knee swelling with effusion and pitting edema distally was associated with the small meniscal tear. The patient's diarrhea, asymmetric arthritis, dysuria, and uveitis were believed to be due to reactive arthritis. After septic arthritis was ruled out, the patient was started on methylprednisolone for two weeks. Patient's arthralgia improved when the patient was taking methylprednisolone, but it returned after finishing the course. On an unspecified date, patient started treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) three times daily with minimal benefit. Given the diminished visual field and migratory arthritis unresponsive to NSAIDs, patient was re-started on prednisone 20 mg daily for one week followed by 10 mg daily with meloxicam 15 mg daily. One month after treatment with steroids and NSAIDs, patient's arthralgia was well controlled and acute phase reactants returned to baseline. The patients visual field defect persisted. At the time of initial report, it was unknown if the patient recovered from event of 'reactive arthritis'. The reporter did not provide a seriousness and causality assessment for the event of 'reactive arthritis', however, the event of reactive arthritis was assessed as serious due to the seriousness criteria of medical significance. No further information was provided.; Reporter's Comments: This case concerns a 51-years-old male patient, who experienced serious (medically significant) event of reactive arthritis, on unspecified date after the patient receiving the first dose of Jynneos vaccine for the indication prevention from Mpox. Reactive arthritis is unlisted as per CCDS v7 and unexpected per USPI. Patient's medical history includes asthma and concomitant medication details were not provided. Outcome is unknown. For regulatory reporting purposes, causality is assessed as possibly related to the suspect. This case is considered as serious due to medical significance criteria.; Sender's Comments: This case concerns a 51-years-old male patient, who experienced serious (medically significant) event of reactive arthritis, on unspecified date after the patient receiving the first dose of Jynneos vaccine for the indication prevention from Mpox. Reactive arthritis is unlisted as per CCDS v7 and unexpected per USPI. Patient's medical history includes asthma and concomitant medication details were not provided. Outcome is unknown. For regulatory reporting purposes, causality is assessed as possibly related to the suspect. This case is considered as serious due to medical significance criteria. More
2866564 M 10/17/2025 PNC21
PNC21
RVX
RVX
PNC21
PNC21
RVX
RVX
 MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
B5NJ9
B5NJ9
Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain... Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin; Laryngeal pain, Pain of skin More
left side scalp sore; area behind left ear intermittent pain.; larynx sore; This non-serious case w... left side scalp sore; area behind left ear intermittent pain.; larynx sore; This non-serious case was reported by a consumer and described the occurrence of scalp pain in a 82-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number B5NJ9) for prophylaxis. Co-suspect products included Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for prophylaxis. On 09-SEP-2025, the patient received RSV vaccine .5 ml and Capvaxive. On 10-SEP-2025, 1 days after receiving RSV vaccine and Capvaxive, the patient experienced scalp pain (Verbatim: left side scalp sore), ear pain (Verbatim: area behind left ear intermittent pain.) and laryngeal pain (Verbatim: larynx sore). The outcome of the scalp pain was not resolved and the outcome of the ear pain and laryngeal pain were resolved. It was unknown if the reporter considered the scalp pain, ear pain and laryngeal pain to be related to RSV vaccine and Capvaxive. It was unknown if the company considered the scalp pain, ear pain and laryngeal pain to be related to RSV vaccine and Capvaxive. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient received RSV vaccine and Merck Capvaxive at the same time and experienced left side scalp sore, intermittent pain in area behind left ear and left side of larynx sore. All symptoms except scalp soreness have stopped. More
2866566 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose was on September 1, 2025,; This non-serious case was reported by a consumer via interact... second dose was on September 1, 2025,; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 12-FEB-2025). On 01-SEP-2025, the patient received the 2nd dose of Shingrix. On 01-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was on September 1, 2025,). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date:3 October 2025 The patient got the 1st dose of herpes zoster vaccine on 12-FEB-2025, and the second dose was on 01-SEP-2025 was it still effective or would need to get another vaccine. The reporter was ask even if there was a 7 month gap between doses it still works. The batch number was not provided and we and unable to contact the reporter. More
2866567 10/17/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Just getting over RSV; This serious case was reported by a consumer v... Suspected vaccination failure; Just getting over RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included transplant (had a transplant 3 years ago). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Just getting over RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolving. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 12-OCT-2025 This case was reported by the patient via interactive digital media. The patient said that he/she was just getting over RSV (respiratory syncytial virus infection). The patient had the vaccine 2 years ago (from the date of reporting) but did not end up in the hospital. This case was considered as suspected vaccination failure as details of time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV vaccine, in a 75-year-old 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
2866568 F 10/17/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; ill with RSV; This serious case was reported by a consumer via intera... Suspected vaccination failure; ill with RSV; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: ill with RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 10-OCT-2025 This case was reported by a reporter who knew the patient via interactive digital media. Reporter stated that patient was ill with respiratory syncytial virus infection (RSV) despite vaccination was scary. This case was considered as suspected vaccination failure as details of time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter. This case was linked with US2025AMR134560, reported by same reporter for different patient.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV 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. US-GSK-US2025AMR134560:Case for Another girl More
2866569 10/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected Vaccination failure/shot did not work; shingles/shot did not work/pain comes and goes but ... Suspected Vaccination failure/shot did not work; shingles/shot did not work/pain comes and goes but never leaves for good; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure/shot did not work) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/shot did not work/pain comes and goes but never leaves for good). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-OCT-2025 This case was reported by a patient via interactive digital media. The patient had both shots for shingles and just getting over them obviously the shot did not work and the pain comes and goes but never leaves for good. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine (dose 1 and dose 2), 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
2866570 WI 10/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Extra diluent found possible mixed with diluent; Inappropriate dose of vaccine administered; This no... Extra diluent found possible mixed with diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Extra diluent found possible mixed with diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 18-SEP-2025 The reporter reported that our hospital ended up having an extra diluent for Priorix, which means one of the Priorix vaccines may have been given and mixed with the wrong diluent. The reporter asked that we have not yet confirmed which diluent or if this was true, but if this did occur, was the vaccine null. The reporter said we are unsure which diluent was used and are trying to find out and wanted to know what next steps would be to report this and if you think the vaccine would be nullified. The reporter reported that Anay patient involved not that we know of as of yet, we were still investigating it and the only thing we know if the extra diluent. More
2866571 73 F IN 10/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AV4TN
Underdose Underdose
Administration of Less than the Recommended Dose of Engerix B in Adults; Underdose; This non-seriou... Administration of Less than the Recommended Dose of Engerix B in Adults; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 73-year-old female patient who received HBV (Engerix B pediatric) (batch number AV4TN, expiry date 25-JAN-2027) for prophylaxis. On 11-SEP-2025, the patient received the 2nd dose of Engerix B pediatric. On 11-SEP-2025, less than a day after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Administration of Less than the Recommended Dose of Engerix B in Adults) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose 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: 18-SEP-2025 and 03-OCT-2025 The reporter reported that an adult patient received Engerix-B second pediatric dose on 11th September 2025 with lot AV4TN and expiration date on 25th January 2027. More
2866572 1 M NY 10/17/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 793PT
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Wrong vaccine administered; Boostrix to a fifteen month old patient/unapproved age; This non-serious... Wrong vaccine administered; Boostrix to a fifteen month old patient/unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 793PT, expiry date 29-AUG-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 16-JUN-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 16-JUN-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered) and inappropriate age at vaccine administration (Verbatim: Boostrix to a fifteen month old patient/unapproved age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-SEP-2025 The nurse declared that the patient was going to receive his fourth dose of Infanrix. More
2866573 F PA 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
Reconstitution of Shingrix with an Unapproved Diluent; Reconstitution of Shingrix with an Unapproved... Reconstitution of Shingrix with an Unapproved Diluent; Reconstitution of Shingrix with an Unapproved Diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-SEP-2025, the patient received the 1st dose of Shingrix. On 24-SEP-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution of Shingrix with an Unapproved Diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstitution of Shingrix with an Unapproved Diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt date: 01-OCT-2025 A nurse called to report that a Shingrix vaccine had been reconstituted using an unapproved diluent, rather than the adjuvant provided with the vaccine. The reconstituted vaccine was administered to a female patient on 24th September 2025. The nurse contacted the appropriate authority to confirm whether revaccination was required and, if so, when it should be administered. The batch number was not provided upon follow- up with the reporter. More
2866574 OH 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received the 1st dose of Shingrix but put off getting the 2nd dose; This non-serious case was report... received the 1st dose of Shingrix but put off getting the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patients did not receive the 2nd dose of Shingrix. The patients experienced incomplete course of vaccination (Verbatim: received the 1st dose of Shingrix but put off getting the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date 02-OCT-2025 These unspecified number of patients who did not receive Shingrix. Patients received the first dose of Shingrix but delayed getting the second dose, with some individuals waiting a year or two since receiving the initial dose. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The batch number was not provided and a request for this information has been made. More
2866575 57 M LA 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ZM749
Expired product administered Expired product administered
today a patient received an expired dose of Shingrix. The vaccine expired on 8/22/2025.; This non-s... today a patient received an expired dose of Shingrix. The vaccine expired on 8/22/2025.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis. On 08-OCT-2025, the patient received Shingrix. On 08-OCT-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: today a patient received an expired dose of Shingrix. The vaccine expired on 8/22/2025.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 08-OCT-2025 The nurse reported that the patient received an expired dose of Shingrix vaccine. The reporter was asked for recommendations on this situation. More
2866576 62 F IL 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273H
Product preparation error Product preparation error
administration of Shingrix reconstituted with an unapproved diluent; administration of Shingrix reco... administration of Shingrix reconstituted with an unapproved diluent; administration of Shingrix reconstituted with an unapproved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 31-MAR-2027) for prophylaxis. On 03-OCT-2025, the patient received Shingrix. On 03-OCT-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administration of Shingrix reconstituted with an unapproved diluent) and wrong solution used in drug reconstitution (Verbatim: administration of Shingrix reconstituted with an unapproved diluent). The outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were not applicable. Additional Information: GSK Receipt Date: 08-OCT-2025 A medical assistant wanted to get recommendations on the administration of Shingrix vaccine reconstituted with an unapproved diluent but she was not sure which of two patients received it. Thus the details of each patient were taken to file the adverse event report and the advice to communicate again, if she had a confirmation of which of the two got it was given. The vaccine administration facility was the same as primary reporter. More
2866577 IA 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
only received the liquid portion of the vaccine; only received the liquid portion of the vaccine; Th... only received the liquid portion of the vaccine; only received the liquid portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: only received the liquid portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: only received the liquid portion of the vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 10-OCT-2025 The pharmacist reported that a patient at a nursing facility only received the liquid portion of the vaccine. The facility forgot to mix it. They wanted to know if it would harm the patient if they get the full shot now. The batch number was not provided upon follow up with the reporter. More
2866578 F 10/17/2025 COVID19
 MODERNA
Vaccination site erythema, Vaccination site warmth Vaccination site erythema, Vaccination site warmth
Had bright red and hot to the touch responses to vaccines for as long as remembered; Had bright red ... Had bright red and hot to the touch responses to vaccines for as long as remembered; Had bright red and hot to the touch responses to vaccines for as long as remembered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had bright red and hot to the touch responses to vaccines for as long as remembered) and VACCINATION SITE ERYTHEMA (Had bright red and hot to the touch responses to vaccines for as long as remembered) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Had bright red and hot to the touch responses to vaccines for as long as remembered) and VACCINATION SITE ERYTHEMA (Had bright red and hot to the touch responses to vaccines for as long as remembered). At the time of the report, VACCINATION SITE WARMTH (Had bright red and hot to the touch responses to vaccines for as long as remembered) and VACCINATION SITE ERYTHEMA (Had bright red and hot to the touch responses to vaccines for as long as remembered) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. The patient received all Covid vaccine shots, which were Moderna. The patient always had visible reactions to vaccine injections around the injection site. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790215, MOD-2025-790157 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2025: Live follow up received that contains non-significant information includes reference numbers were added. On 13-Oct-2025: Live follow up received that contains non-significant information includes reference numbers were added. More
2866579 83 M 10/17/2025 COVID19
 MODERNA
COVID-19 COVID-19
Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Co... Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in an 83-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 COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was unknown if the patient received vaccines within the past 4 weeks. It was reported that the patient had received Moderna vaccine, and it was proven at that time to those last several years of this, it was a much better alternative for them that were older. He got COVID and had those vaccines and that's what saved his life. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790239 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2025: Live follow-up received contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790239:Different patient More
2866580 F 10/17/2025 COVID19
 MODERNA
Malaise, Pain, Pyrexia Malaise, Pain, Pyrexia
sore; sick; feverish; This spontaneous case was reported by a consumer and describes the occurrence ... sore; sick; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), MALAISE (sick) and PYREXIA (feverish) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore), MALAISE (sick) and PYREXIA (feverish). At the time of the report, PAIN (sore), MALAISE (sick) and PYREXIA (feverish) outcome was unknown. Concomitant medication was not provided. It was reported that the reporter and his wife had received Moderna's annual Spikevax shot every year. But this time the reporter had noticed that it was no longer called Spikevax. He mentioned it was something like Nexspike or Moderna Spike, which the reporter found was not exactly easy to say. However, reporter clarified that this wasn't the main reason he was writing. Reporter explained that he and his wife had gotten their shots the previous Tuesday and everything had gone fine at first, although his wife had felt a bit sick afterward. She had been feverish and sore for three days. According to reporter, she had received the Spikevax version, while he had noticed that he had received a different one, though he wasn't sure why. He said her reaction had been similar to past years after vaccination. He also expressed curiosity about his service dog, who had started acting sick around the same time. He said she had seemed to have flu-like symptoms and had been lethargic for two to three days. He wanted to know if it was possible that she had caught something from his wife, as this hadn't happened before and had only occurred after their vaccination schedule. He suspected they might have caught something at the clinic and passed it on to Beenie, possibly through his wife since her response to the vaccine had seemed worse. It was unknown if the patient experienced any additional symptoms or events . Treatment medication was not reported. This case was linked to MOD-2025-790248 (Patient Link). More
2866581 50 M 10/17/2025 COVID19
 MODERNA
Fatigue, Pain in extremity Fatigue, Pain in extremity
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ... sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 50-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included Pituitary tumor NOS (The Patient had pituitary tumor at age 13). On 10-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In October 2025, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown. No concomitant medications provided by the reporter. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790267 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790267:Mother's case More
2866582 10/17/2025 COVID19
 MODERNA
 3052087
Device issue, Intercepted product administration error, No adverse event Device issue, Intercepted product administration error, No adverse event
No adverse effect; they discovered that the syringe had no plunger/a syringe without a plunger in a ... No adverse effect; they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment; The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment), INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052087) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 08-Oct-2025, the patient experienced DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment) and INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (they discovered that the syringe had no plunger/a syringe without a plunger in a drop shipment), INTERCEPTED PRODUCT ADMINISTRATION ERROR (The HCP called and reported that they tried to administer an mNEXSPIKE 2025-2026 vaccine yesterday; however, they discovered that the syringe had no plunger, which prevented them from administering the vaccine) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. The HCP reported that they had attempted to administer the mNEXSPIKE 2025๏ฟฝ2026 COVID-19 vaccine to a patient the previous day but were unable to do so. They explained that the syringe, which had been received was missing a plunger despite having a needle attached. As a result, the vaccine could not be administered. The HCP confirmed that no patient administration had occurred and requested a replacement for the defective syringe. It was unknown if the patient experienced any additional symptoms or events. The Device problem code for pre-filled syringe include FDA code 2306, code A020602 which included Component Missing. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2025: Live follow-up received and non-significant information includes reference numbers added. On 10-Oct-2025: Live follow-up received and non-significant information includes verbatim updated and reference numbers added. More
2866583 F 10/17/2025 COVID19
 MODERNA
Limb discomfort, Vaccination site erythema, Vaccination site warmth Limb discomfort, Vaccination site erythema, Vaccination site warmth
Very hot to the touch; Real discomfort raising the injected arm for about 3 days; Arm around the inj... Very hot to the touch; Real discomfort raising the injected arm for about 3 days; Arm around the injection site was bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to the touch), LIMB DISCOMFORT (Real discomfort raising the injected arm for about 3 days) and VACCINATION SITE ERYTHEMA (Arm around the injection site was bright red) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced VACCINATION SITE WARMTH (Very hot to the touch), LIMB DISCOMFORT (Real discomfort raising the injected arm for about 3 days) and VACCINATION SITE ERYTHEMA (Arm around the injection site was bright red). In 2024, LIMB DISCOMFORT (Real discomfort raising the injected arm for about 3 days) had resolved. At the time of the report, VACCINATION SITE WARMTH (Very hot to the touch) and VACCINATION SITE ERYTHEMA (Arm around the injection site was bright red) outcome was unknown. Concomitant medication use information was not provided by reporter. The patient received all Covid vaccine shots, which were Moderna. The patient always had visible reactions to vaccine injections around the injection site. The last Covid vaccine shot, prior to the one last Friday, was administered exactly one year earlier, on Thursday, 10-Oct-2024. Following the 2024 vaccination, the arm around the injection site was bright red, very hot to the touch, and there was real discomfort raising the injected arm for about 3 days. (That immune response was not unusual. The patient had bright red and hot to the touch responses to vaccines for as long as remembered.). It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790215, MOD-2025-790158 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2025: Live follow up received that contains non-significant information includes reference numbers were added. On 13-Oct-2025: Live follow up received that contains non-significant information includes reference numbers were added. More
2866584 10/17/2025 COVID19
 MODERNA
 3052553
Device breakage, Device colour issue, No adverse event Device breakage, Device colour issue, No adverse event
HCP had a damaged/broken vaccine; tip of the syringe was yellowish or is having some kind of discolo... HCP had a damaged/broken vaccine; tip of the syringe was yellowish or is having some kind of discoloration; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052553) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052553) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .25 milliliter and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE BREAKAGE (HCP had a damaged/broken vaccine), DEVICE COLOUR ISSUE (tip of the syringe was yellowish or is having some kind of discoloration) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were provided. It was reported that the HCP had a damaged/broken vaccine and the tip of the syringe was yellowish or was having some kind of discoloration. HCP was asking if they can get a replacement or credit for that. It was unknown if the patient experienced any additional symptoms/events. The Device Problem Information included FDA code: 2284, Code: A0204, Device problem: Device Damaged Prior to Use and FDA code: 1170, Code: A0407, Device problem: Material Discolored. No treatment medication was provided. More
2866585 10/17/2025 COVID19
 MODERNA
Fatigue, Pyrexia, Vomiting Fatigue, Pyrexia, Vomiting
fatigue/tiredness; vomiting; fever; This spontaneous case was reported by a consumer and describes t... fatigue/tiredness; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue/tiredness), VOMITING (vomiting) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included General physical health deterioration (other health issues). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue/tiredness), VOMITING (vomiting) and PYREXIA (fever). At the time of the report, FATIGUE (fatigue/tiredness), VOMITING (vomiting) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications were reported. Patient first took the Moderna vaccine in 2020, it hit hard and had vomiting, fever, tiredness, fatigue that lasted a week. Patient recently took another Moderna COVID-19 Vaccine in 2025 and described the reactions were virtually none but only had a very sore arm. The patient waited this time for the reaction to hit. Patient was not young person, so the patient needed to get an update for Covid Vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790238 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790238:Same patient with different suspect Spikevax LP.8.1 PFS More
2866586 F 10/17/2025 COVID19
 MODERNA
Malaise, Pain, Pyrexia Malaise, Pain, Pyrexia
She was feverish and sore for 3 days; felt a bit sick afterward; She was feverish and sore for 3 day... She was feverish and sore for 3 days; felt a bit sick afterward; She was feverish and sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She was feverish and sore for 3 days), MALAISE (felt a bit sick afterward) and PYREXIA (She was feverish and sore for 3 days) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In October 2025, the patient experienced PAIN (She was feverish and sore for 3 days), MALAISE (felt a bit sick afterward) and PYREXIA (She was feverish and sore for 3 days). In October 2025, PAIN (She was feverish and sore for 3 days) and PYREXIA (She was feverish and sore for 3 days) had resolved. At the time of the report, MALAISE (felt a bit sick afterward) outcome was unknown. Concomitant medication was not provided. It was reported that the reporter and his wife had received Moderna's annual Spikevax shot every year. But this time the reporter had noticed that it was no longer called Spikevax. He mentioned it was something like Nexspike or Moderna Spike, which the reporter found wasn't exactly easy to say. However, reporter clarified that this wasn't the main reason he was writing. Reporter explained that he and his wife had gotten their shots the previous Tuesday and everything had gone fine at first, although his wife had felt a bit sick afterward. She had been feverish and sore for three days. According to reporter, she had received the Spikevax version, while he had noticed that he had received a different one, though he wasn't sure why. He said her reaction had been similar to past years after vaccination. He also expressed curiosity about his service dog, who had started acting sick around the same time. He said she had seemed to have flu-like symptoms and had been lethargic for two to three days. He wanted to know if it was possible that she had caught something from his wife, as this hadn't happened before and had only occurred after their vaccination schedule. He suspected they might have caught something at the clinic and passed it on to dog, possibly through his wife since her response to the vaccine had seemed worse. 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-2025-790254 (E2B Linked Report). This case was linked to MOD-2025-790249 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790254:Husband case More
2866587 1.92 M MA 10/17/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Body temperature, Lethargy, Pyrexia, Vomiting; Body temperature, Lethargy, Pyrex... Body temperature, Lethargy, Pyrexia, Vomiting; Body temperature, Lethargy, Pyrexia, Vomiting More
lethargic; vomiting (once)/patient threw up; low grade fever (temporal 99C); This spontaneous case w... lethargic; vomiting (once)/patient threw up; low grade fever (temporal 99C); This spontaneous case was reported by a non-health professional and describes the occurrence of LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)) in a 24-month-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. On 13-Oct-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 13-Oct-2025 at 5:20 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 14-Oct-2025 at 10:00 AM, the patient experienced LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)). On 15-Oct-2025, LETHARGY (lethargic), VOMITING (vomiting (once)/patient threw up) and PYREXIA (low grade fever (temporal 99C)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2025, Body temperature: low grade fever (temporal 99C). The patient had no medical history, concomitant disease or risk factor. No concomitant medications were provided. At 5:20 on 13-Oct-2025, a shot was administered in the leg. At 10A.M, the next day, patient threw up and had low grade fever (temporal 99C). There were no lab data/results available. Patient was administered an unspecified drug 100mg twice. By 15-Oct-2025, all symptoms alleviated. The patient did not experience any additional symptoms/events. Reporter causality was not provided. More
2866588 9 F PA 10/17/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 8052860
N9C52
Dyspnoea, Flushing, Hyperventilation; Dyspnoea, Flushing, Hyperventilation Dyspnoea, Flushing, Hyperventilation; Dyspnoea, Flushing, Hyperventilation
After Patient received vaccine a few minutes later reported shortness of breath and was having some ... After Patient received vaccine a few minutes later reported shortness of breath and was having some episodes of hyperventilation. Face was flushed. Breath sounds were auscultated and normal. a few minutes after sitting down, patient returned to normal tempo breathing. No interventions needed, patient calmed down, drank water and stayed with nurse for about 20-30 minutes. More
2866589 33 F WV 10/17/2025 FLU3
 SEQIRUS, INC.
 406995
Injection site erythema, Injection site pruritus, Injection site rash, Rash Injection site erythema, Injection site pruritus, Injection site rash, Rash
5 minutes after receiving the vaccine employee noticed the site became red and itching. Later that e... 5 minutes after receiving the vaccine employee noticed the site became red and itching. Later that evening employee noticed rash at the site and neck. Employee woke up the next morning and had a rash on left arm at site, left side of neck, chest, and abdomen. More
2866591 61 F CT 10/17/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 AX5811A
AX5811A
Feeling abnormal, Feeling of body temperature change, Immediate post-injection r... Feeling abnormal, Feeling of body temperature change, Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased; Pain, Pain in extremity More
When vaccine was administered it was given very aggressively and very deep. It caused immediate pain... When vaccine was administered it was given very aggressively and very deep. It caused immediate pain. It was hard lifting my arm even a few inches. The pain continued all day and when I got home from work, I was hot and cold, hurting all over and my left arm was very painful. I had to call out of work since I would not be able to function feeling that bad. It is two weeks later, and I still hurt and have a hard time lifting me arm. Yesterday 10/16/25 I spoke with Employee Health, and they advised me to come in to be seen so I went to Employee Health at work and was advised to see an orthopedic dr. More
2866592 67 F IA 10/17/2025 COVID19
HEPA
TDAP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 LM2219
HR4RB
U8339BA
Injection site pain, Pain, Sleep disorder; Injection site pain, Pain, Sleep diso... Injection site pain, Pain, Sleep disorder; Injection site pain, Pain, Sleep disorder; Injection site pain, Pain, Sleep disorder More
Adverse effect is in the left arm, deltoid area and deeper, ranging into the shoulder. Pain initiall... Adverse effect is in the left arm, deltoid area and deeper, ranging into the shoulder. Pain initially began with in a day. It wasn't muscular pain common with vaccinations. It was deep and excruciating with any type of shoulder rotation or movement. The pain was at the injection site and spread to the entire lateral and posterior portions of the upper left arm. The pain as lessened somewhat in intensity but is still limiting mobility. I wake up at night with the pain. More
2866594 76 M OH 10/17/2025 PNC21
 MERCK & CO. INC.
 z009681
Oropharyngeal pain, Speech disorder Oropharyngeal pain, Speech disorder
Patient said she almost immediately started having a sore throat on the way home after leaving the p... Patient said she almost immediately started having a sore throat on the way home after leaving the pharmacy. She also said she has difficulty talking now. More
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