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
2859435 3 F CA 09/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 7F7DM
Injection site pain, Local reaction Injection site pain, Local reaction
Large Local Reaction to DTaP Vaccine Approximately 48 hours after receiving her fourth dose of the ... Large Local Reaction to DTaP Vaccine Approximately 48 hours after receiving her fourth dose of the DTaP vaccine (Infanrix brand) in the leg, the patient developed a large local reaction measuring about 110 millimeters at its largest dimension. The reaction was initially painful yesterday but is not currently causing discomfort or interfering with her activities. The mother notes the reaction may be mildly itchy. The mother has documented the reaction in the immunization record. Severe local reaction to DTaP vaccine (measured at 110mm), not associated with significant functional impairment or ongoing pain; child can continue normal activities. - Symptomatic management: pain medication as needed for discomfort, topical diphenhydramine for pruritus if present. - Reaction may still get a little bigger but is not expected to spread much more after today. - Instructed to document the reaction in the Immunization Registry. More
2859436 75 F NC 09/17/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LK6655
55KB9
Arthralgia, Muscular weakness, Rales, Respiratory tract congestion; Arthralgia, ... Arthralgia, Muscular weakness, Rales, Respiratory tract congestion; Arthralgia, Muscular weakness, Rales, Respiratory tract congestion More
Patient states she had intense pain in her right shoulder the next morning. She stated it was hard f... Patient states she had intense pain in her right shoulder the next morning. She stated it was hard for her to make a fist. Today she states that it is much better, but she's still experiencing congestion and/or ''gurgling''. She states she is going to see if she's feeling any better before going to the Emergency Room. More
2859437 36 F NJ 09/17/2025 FLU3
 SEQIRUS, INC.
 unknown
Differential white blood cell count, Electrocardiogram, Full blood count, Metabo... Differential white blood cell count, Electrocardiogram, Full blood count, Metabolic function test, Vertigo positional More
Patient developed positional vertigo 1 hour post inoculation with the flu vaccine. Patient developed positional vertigo 1 hour post inoculation with the flu vaccine.
2859438 18 F DE 09/17/2025 MENB
 PFIZER\WYETH
 MA2515
Induration, Local reaction, Pain Induration, Local reaction, Pain
20 x 21 cm large local reaction w/ 6cm induration, painful to raise arm 20 x 21 cm large local reaction w/ 6cm induration, painful to raise arm
2859439 17 F TX 09/17/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 cd44a
cd44a
Chills, Dizziness, Erythema, Localised oedema, Swelling; Tenderness, Vision blur... Chills, Dizziness, Erythema, Localised oedema, Swelling; Tenderness, Vision blurred More
localized edema, tenderness, erythema, and swelling (CURRENT). Patient also experienced chills, dizz... localized edema, tenderness, erythema, and swelling (CURRENT). Patient also experienced chills, dizziness, and blurry vision (ALL RESOLVED). Will start treatment with cephalexin antibiotic, and cetirizine for 7 days, and follow up in 2 days. More
2859440 58 F KY 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Pain, Pain in extremity Pain, Pain in extremity
Right arm pain when lifting or moving a certain way Right arm pain when lifting or moving a certain way
2859441 77 M CA 09/17/2025 COVID19
 MODERNA
 3052036
Fatigue, Hypersomnia, Lethargy Fatigue, Hypersomnia, Lethargy
mild symptoms including fatigue, lethargy, and excessive sleeping lasting for 10 days mild symptoms including fatigue, lethargy, and excessive sleeping lasting for 10 days
2859442 1 F OH 09/17/2025 VARCEL
 MERCK & CO. INC.
 Z003882
Circumstance or information capable of leading to medication error, Injury assoc... Circumstance or information capable of leading to medication error, Injury associated with device More
While administering vaccine to patient was arms were being held by the patient's father. As I ... While administering vaccine to patient was arms were being held by the patient's father. As I was going to give the vaccine (Varicella) in the thigh the patient was trying to move around and her leg broke free. She kicked toward my hand with the vaccine as I was going to give the vaccine. The needled came in contact with the patients toe on the opposite leg of the vaccine. At the time, I believed I had withdrawn the syringe quick enough and did not see any blood while repositioning the patient's leg and dad repositioned his hands to help hold the patient on the bed so I continued to give the vaccine. After administering Varicella I gave the other vaccines in the other leg I noticed a saw small drop of blood on the table paper. It appeared the infants toe had been puncture when kicking earlier. I informed father of the patient what had had happened. I got gauze to clean the area and apply pressure. The provider was notified and went back to the room to evaluate the area. Father was instructed to keep the area clean. Incident report has been completed internally. More
2859443 15 F PA 09/17/2025 HPV9
 MERCK & CO. INC.
 Z002093
Lymphadenopathy Lymphadenopathy
lymphadenopathy - cervical and inguinal lymphadenopathy - cervical and inguinal
2859444 66 F WI 09/17/2025 FLU3
PNC21
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 TFAA2503
Z006889
4YA34
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More
Patient stated that after receiving her vaccinations on 9/13/25, her right arm started to become red... Patient stated that after receiving her vaccinations on 9/13/25, her right arm started to become red, swollen and slightly warm. She came in to the pharmacy today, 9/17/25 stating that the condition had not improved and the redness had spread around the entire upper arm. She has tried ice packs, ibuprofen and an allergy medication but did not see any improvement. I advised the patient that without improvement, she should follow up with her provider or go to walk-in/urgent care/ER. More
2859455 F GA 09/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No patient symptoms were reported/No additional AE; Nurse called and reported that a 20 year old pa... No patient symptoms were reported/No additional AE; Nurse called and reported that a 20 year old patient received their 1st dose of GARDASIL 9 in 2017 and their 2nd dose in March of 2025. Caller stated the patient has not yet received a 3rd dose. Caller stated no patient symptoms were reported. No add; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown exact date in 2017, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #, expiration date, exact dose route of administration and anatomical location were not provided) for prophylaxis. On an unknown exact day in March 2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #, expiration date, exact dose route of administration and anatomical location were not provided) for prophylaxis ( inappropriate schedule of product administration). No additional adverse event reported (no adverse event). More
2859456 13 M TX 09/17/2025 HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Aphasia, Arthralgia, Body temperature decreased, Dizziness, Dizziness postural; ... Aphasia, Arthralgia, Body temperature decreased, Dizziness, Dizziness postural; Educational problem, Fatigue, Head injury, Immediate post-injection reaction, Insomnia; Loss of personal independence in daily activities, Migraine, Nausea, Pain in extremity, Sensory disturbance; Syncope, Vomiting More
autoimmune disease; resulting in head injuries; fainting episodes; abnormal sensations in his arms a... autoimmune disease; resulting in head injuries; fainting episodes; abnormal sensations in his arms and legs; insomnia; Vomiting; severe migraines that hindered his ability to read and caused difficulty with word recall and communication/ neurological injuries; joint and limb pain; a persistently cold body temperature; joint and limb pain; lightheadedness/ lightheadedness when rising from a seated or lying position; Nausea; Information has been received from a lawyer regarding a case in litigation concerning to a 13-year-old male patient (pt). The pt's concurrent conditions, his medical history and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with his first and only dose of quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route and anatomical location of administration, lot number and expiration date were not provided) administered for prevent cervical cancer. The pt's mother, agreed to her son receiving the vaccine after being exposed to Company's marketing that the vaccine was very safe, prevents cancer, and that teenagers must get the vaccine. Pt's health care provider recommended that pt receive the quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL), which was touted as a safe and effective vaccine for preventing cervical cancer. Prior receiving the vaccination, the pt was happy, bright, athletic, and healthy. Immediately after receiving the vaccination, pt experienced lightheadedness, and nausea, he waited 20 minutes before he was able to leave. On an unspecified date, the pt sustained serious autoimmune (autoimmune disorder), autonomic, and neurological injuries as a result of his vaccine. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his ongoing symptoms, which included increased nausea and vomiting, fainting episodes (syncope) resulting in head injuries, lightheadedness when rising from a seated or lying position (dizziness postural), joint and limb pain particularly in his legs (arthralgia/ pain in extremity), abnormal sensations in his arms and legs (sensory disturbance), a persistently cold body temperature (body temperature decreased), insomnia, and severe migraines that hindered his ability to read and caused difficulty with word recall and communication (migraine with aura). As a result of his post-vaccine symptoms, pt was unable to engage in activities that a normal young person would enjoy. Pt was highly athletic and full of energy, playing soccer, basketball, t-ball, and flag football. He also enjoyed karate, bike riding, skateboarding, and even playing on a pogo stick. Academically, pt excelled, attending a school for gifted and talented students. However, his ongoing exhaustion significantly impacted his ability to focus on schoolwork and complete assignments, while also preventing him from maintaining an active, competitive sports lifestyle due to the physical toll. He suffered and continues to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by the vaccine. As a direct and proximate result of his vaccine-induced injuries, pt had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he would continue to incur these losses and expenses in the future. At the reporting time, the pt had not recovered from all the events. The reporter considered all the events to be related to quadrivalent human papillomavirus (Types 6, 11, 16, 18) recombinant vaccine (GARDASIL) vaccine. All the events were considered to be disabling by the reporter. More
โœ“
2859457 UT 09/17/2025 HPV9
 MERCK & CO. INC.
 Y017907
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Customer called to report TE. GARDASIL9 was administered to one patient. No additi... No additional AE; Customer called to report TE. GARDASIL9 was administered to one patient. No additional AE/No PQC ? Names of vaccines involved (including lot/exp) GARDASIL9 Y017907 12/15/2026 ? Temperature 8.42 C ? Time frame for; This spontaneous report was received from a Nurse Practitioner and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-Sep-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #Y017907, expiration date: 15-Dec-2026) 0.5 mL total for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 8.42 C (the time frame was 0 hours 10 minutes 0 seconds) (product storage error). There were previous temperature excursions (not specified). No additional adverse event (AE) was reported (no adverse event). More
2859459 68 F FL 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
injection site pain; This non-serious case was reported by a consumer via call center representative... injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included seborrheic dermatitis (Seborrheic dermatitis mostly located on her scalp, resolved over a year ago), eosinophilic esophagitis (Eosinophilic esophagitis) and hives (Hives due to allergies to cats and codeine). Concurrent medical conditions included allergic to cats and allergic reaction to analgesics. Concomitant products included levothyroxine sodium (Levothyroxine). On 21-APR-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR119374 Additional Information: GSK receipt date: 20-AUG-2025 Patient experienced short term injection site pain from that injection. Patient was taking Levothyroxine from the year 2000.; Sender's Comments: US-GSK-US2025AMR119374:SAME PATIENT More
2859460 09/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered, Product use in unapproved indication Incorrect dose administered, Product use in unapproved indication
reported administering twinrix at double the recommended dose as therapeutic vaccination in a CHB pa... reported administering twinrix at double the recommended dose as therapeutic vaccination in a CHB patient; reported administering twinrix at double the recommended dose as therapeutic vaccination in a CHB patient; This non-serious case was reported by a physician via sales rep and described the occurrence of overdose in a patient who received HAB (Twinrix) for prophylaxis. Concurrent medical conditions included chronic hepatitis b. On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced overdose (Verbatim: reported administering twinrix at double the recommended dose as therapeutic vaccination in a CHB patient) and drug use for unapproved indication (Verbatim: reported administering twinrix at double the recommended dose as therapeutic vaccination in a CHB patient). The outcome of the overdose and drug use for unapproved indication 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. More
2859461 77 F NC 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Axillary pain, Bone pain, Pain in extremity Axillary pain, Bone pain, Pain in extremity
arm hurt fall the way down to thumb; stabbing, stinging pain on iliac crest; stabbing, stinging pain... arm hurt fall the way down to thumb; stabbing, stinging pain on iliac crest; stabbing, stinging pain under armpit and about 4 inches above her iliac crest; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism (Hypothyroidism) and glaucoma (Glaucoma). On 14-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm hurt fall the way down to thumb), bone pain (Verbatim: stabbing, stinging pain on iliac crest) and axillary pain (Verbatim: stabbing, stinging pain under armpit and about 4 inches above her iliac crest). The outcome of the pain in arm, bone pain and axillary pain were not resolved. It was unknown if the reporter considered the pain in arm, bone pain and axillary pain to be related to Shingrix. It was unknown if the company considered the pain in arm, bone pain and axillary pain to be related to Shingrix. Additional Information: GSK receipt date: 21-AUG-2025 The consumer is the reporter. The patient stated she was vaccinated with her first dose of Shingrix on 14th April 2025 in the right arm. After the vaccination the consumer stated her arm hurt fall the way down to her thumb. The consumer stated exactly three months later she experienced a stabbing, stinging pain on her left side on her iliac crest and about 4 inches above her iliac crest and 2 or 3 inches under her armpit. More
2859462 M 09/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
75-year-old asplenic patient was administered Menveo; This non-serious case was reported by a pharma... 75-year-old asplenic patient was administered Menveo; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a elderly male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo (unknown deltoid). On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 75-year-old asplenic patient was administered Menveo). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 22-AUG-2025 The pharmacist reported that asplenic patient was administered Menveo off-label. The patient received dose of Menveo vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. More
2859463 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
sick; This non-serious case was reported by a consumer via interactive digital media and described t... sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by the patient via interactive digital media. The reporter wanted to know would the second shot make him/her sick too. More
2859464 F 09/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; shingles was causing all this pain; This serious case was reported by... Suspected vaccination failure; shingles was causing all this pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles was causing all this pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported via interactive digital media. The reporter reported that the patient was telling absolutely she was still going through it. This case is linked with US2025AMR113708, reported by same reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR113708:same reporter /different patient More
2859465 NY 09/17/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
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UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Oral he... Herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain, Pyrexia; Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain, Pyrexia; Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain, Pyrexia; Vaccination failure More
Suspected vaccination failure; now shingles returned on the other side of my head; This serious case... Suspected vaccination failure; now shingles returned on the other side of my head; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now shingles returned on the other side of my head). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 The patient self-reported this case for himself/herself. The patient had shingles many times and got the vaccine in 2021 and now (at the time of reporting days) shingles returned on the other side of his/her head. The reporter wanted to know should he/she obtain a booster once the symptoms were gone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingrix, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2859466 09/17/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; still got it; This serious case was reported by a consumer via inter... Suspected vaccination failure; still got it; 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. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-SEP-2025 This case was reported by a patient via interactive digital media. The patient got shingles, on the left thigh and still got it even with the shot, which was really painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2859467 FL 09/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received SHINGRIX vaccine in 2019 and is past due for the second dose; This non-serious case was rep... received SHINGRIX vaccine in 2019 and is past due for the second dose; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: received SHINGRIX vaccine in 2019 and is past due for the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-SEP-2025 The pharmacist reported that the patient received Shingrix vaccine in 2019 and is past due for the second dose. The caller wanted to know if they should restart the series. The caller confirmed that the dose administered in 2019 was Shingrix vaccine and not the Zostavax. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This case is linked with US2025118623, reported by same reporter.; Sender's Comments: US-GSK-US2025118623:same reporter / different patient More
2859468 AL 09/17/2025 DTAPHEPBIP
DTAPIPV
HEP
HEPA
MENB
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS

7NA57
L4EA4

GB73Y
Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Across vaccines- Administration to patients after a temperature excursion; This non-serious case was... Across vaccines- Administration to patients after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number GB73Y) and (batch number DL4YY) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis, HBV (Engerix B) (batch number 7NA57) for prophylaxis, HAV (Havrix pediatric) (batch number L4EA4) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, the patient received Bexsero, Engerix B, Havrix pediatric, Pediarix, Boostrix and Kinrix. On an unknown date, an unknown time after receiving Menveo, Bexsero, Engerix B, Havrix pediatric, Pediarix, Boostrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Across vaccines- Administration to patients after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-AUG-2025 The medical assistant has found a temperature excursion for Menveo, Bexsero, Engerix-B, Havrix, Pediarix, Boostrix and Kinrix vaccines back. Highest temperature reached was 52.3 degree Fahrenheit, lowest was 38.1 degree Fahrenheit Vaccines were out of temperature range for 2 hours and 50 minutes. These vaccines have not been in any other temperature excursion. Since the vaccines have been administer to patients until today 21st August 2025 which led to incorrect storage of drug. The vaccine administration facility was the same as primary. More
2859469 PA 09/17/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered at inappropriate site Product administered at inappropriate site
Administered in same limb as Hep B immune globulin; This non-serious case was reported by a pharmac... Administered in same limb as Hep B immune globulin; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced vaccine administered at inappropriate site (Verbatim: Administered in same limb as Hep B immune globulin). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 29-AUG-2025 There was an inquiry regarding the need to readminister Energix-B vaccine to a newborn who was given the vaccine in the same limb as Hep B immune globulin asking if they should readminister the vaccine. The reporter wanted to know if company has any guidance or recommendations for this. More
2859470 TN 09/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
a patient was administered with a Flulaval expired dose; This non-serious case was reported by a ph... a patient was administered with a Flulaval expired dose; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (expiry date 30-JUN-2025) for prophylaxis. On 02-SEP-2025, the patient received FluLaval 2024-2025 season. On 02-SEP-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: a patient was administered with a Flulaval expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-SEP-2025 For vaccine detail only expiration date was provided from doctor of medicine's end. No patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2859471 M WA 09/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
age inappropriate- 9 year old; This non-serious case was reported by a other health professional via... age inappropriate- 9 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 05-SEP-2025, the patient received Kinrix. On 05-SEP-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: age inappropriate- 9 year old). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 The reporter reported that the nurse administered the Kinrix to given to 9 years old, which led to inappropriate age at vaccine administration The reporter asked was it ok and would it be effective. More
2859472 FL 09/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix given IM; This non-serious case was reported by a pharmacist via call center representative ... Priorix given IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On 08-SEP-2025, the patient received Priorix (intramuscular). On 08-SEP-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix given IM). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-SEP-2025 The reporter (pharmacist) mentioned that a dose of Priorix vaccine was accidentally administered via the IM (intramuscular) route. More
2859473 VA 09/17/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This no... 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-SEP-2025 Reporter called to report a temperature excursion involving Boostrix and Shingrix vaccines. The Reporter stated that the vaccines were exposed to a temperature of 32.8?๏ฟฝC for 93 hours, with no prior excursions reported. During the call, the HCP inquired about the stability of Boostrix and Shingrix following the excursion. They also mentioned that 6 doses of Boostrix and 4 doses of Shingrix had already been administered to 10 different patients after the temperature deviation. They asked whether revaccination would be necessary for the affected individuals.; Sender's Comments: GSK-US2025117361:same reporter US-GSK-US2025117362:same reporter US-GSK-US2025117369:same reporter US-GSK-US2025117367:same reporter US-GSK-US2025117352:same reporter GSK-US2025117365:same reporter US-GSK-US2025117353:same reporter US-GSK-US2025117358:same reporter US-GSK-US2025117349:same reporter More
2859474 SC 09/17/2025 COVID19
 MODERNA
Chills, Fatigue, Pyrexia Chills, Fatigue, Pyrexia
Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrenc... Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case contains information for the 1st of 2 patients described by the reporter. No concomitant medication was reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2021-622055 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-622055:Patient 1 of 2 More
2859475 F 09/17/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm; This s... had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm). At the time of the report, PAIN IN EXTREMITY (had a sore arm/had a COVID-19 shot every year and noted that her worst symptom is a sore arm) had resolved. No concomitant medication was reported. It was reported that, the patient had a COVID-19 shot every year and noted that her worst symptom was a sore arm. The last booster she had was a month before her trip in March. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case was linked to MOD-2025-789235, MOD-2025-789240 (Patient Link). More
2859476 F 09/17/2025 COVID19
 MODERNA
COVID-19, Limb discomfort, Muscular weakness COVID-19, Limb discomfort, Muscular weakness
muscle strength was not really strong; COVID at the same time even with the vaccine (after 3rd vacci... muscle strength was not really strong; COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu; physical discomfort for 4 days in the arm after the (2nd or 3rd generation); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle strength was not really strong), LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)) and COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax Nos (Unspecified). Past adverse reactions to the above products included No adverse effect with Spikevax Nos. Concurrent medical conditions included Disability, Bedridden, Chronic disease (Terminal Diseases) and Immunocompromised. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle strength was not really strong) and LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)). At the time of the report, MUSCULAR WEAKNESS (muscle strength was not really strong) and COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu) was resolving and LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)) had resolved. No concomitant medications were reported. The reporter confirmed that, the disability and bedridden had nothing to do with the vaccines. However, the patient experienced physical discomfort for 4 days in the arm after the (2nd or 3rd generation) and her disease was sort of terminal that there was really not a lot of treatment for, and she was very susceptible. Her immune system was compromised and that's why it was very important for her to get that new generation vaccine. The reporter also mentioned that the patient got COVID at the same time even with the vaccine (after 3rd vaccine), two summers ago and it was like really a bad case of the flu. Her muscle strength was not really strong and was more advanced in chronic disease. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789290 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789290:Master case (Husband case) More
2859477 M 09/17/2025 COVID19
 MODERNA
Fatigue, Illness Fatigue, Illness
he has gotten really really sick/ feeling sick/ He gets real sick for the next day; fatigue; This sp... he has gotten really really sick/ feeling sick/ He gets real sick for the next day; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he has gotten really really sick/ feeling sick/ He gets real sick for the next day) and FATIGUE (fatigue) in an adult 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 ILLNESS (he has gotten really really sick/ feeling sick/ He gets real sick for the next day) and FATIGUE (fatigue). At the time of the report, ILLNESS (he has gotten really really sick/ feeling sick/ He gets real sick for the next day) and FATIGUE (fatigue) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had similar reactions to the reporter. The patient was a young guy, and he had gotten really sick - the fatigue, the feeling sick, not being able to function. He said it would start around 12 hours after the vaccine. He got real sick for the next day. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2024-773529 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2024-773529:Same reporter More
2859478 09/17/2025 UNK
 UNKNOWN MANUFACTURER
Pain in extremity Pain in extremity
my side effects were minimal (sore arm)/ I only had a sore arm/it definitely gave me only one side e... my side effects were minimal (sore arm)/ I only had a sore arm/it definitely gave me only one side effect of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my side effects were minimal (sore arm)/ I only had a sore arm/it definitely gave me only one side effect of a sore arm) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (my side effects were minimal (sore arm)/ I only had a sore arm/it definitely gave me only one side effect of a sore arm). At the time of the report, PAIN IN EXTREMITY (my side effects were minimal (sore arm)/ I only had a sore arm/it definitely gave me only one side effect of a sore arm) had resolved. Concomitant medication was not provided. It was reported that the patient had been happy to receive the vaccine as minimal side effects had been experienced. 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-2025-789277 (E2B Linked Report). This case was linked to MOD-2025-789285 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789277:Patient 2 More
2859479 69 F CA 09/17/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
came down with covid; This spontaneous case was reported by a nurse and describes the occurrence of ... came down with covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (came down with covid) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Received since March or April 2021) in 2021, Spikevax NOS (Fall of 2024, always gotten Moderna COVID-19 vaccine and received vaccines every 6 months) in 2024. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine and Spikevax NOS. In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced COVID-19 (came down with covid). On 10-Sep-2025, COVID-19 (came down with covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2025, SARS-CoV-2 test: Negative. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. The patient always received Moderna COVID-19 vaccines since they first became available and had gotten boosters approximately every 6 months. The patient recently contracted COVID-19. The reporter heard that there was a need to wait before scheduling the vaccine for the fall. The patient had an appointment with a pharmacy to receive a Moderna COVID-19 vaccine on 10-Oct-2025. The patient did not want to wait 3 months after the COVID-19 infection. At the time of the report, the patient tested negative after being positive all last week. The patient was unsure about waiting 3 months as recommended by the CDC. The patient last received a COVID vaccine in the spring and had no complaints. Moderna's vaccine was effective and kept many people of the patient's age out of the hospital. The patient was ready to receive Moderna's vaccine very soon but then contracted COVID last week. The patient received the last COVID-19 vaccine months ago in the spring. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter. More
2859480 M 09/17/2025 COVID19
 MODERNA
COVID-19, Limb discomfort, Muscular weakness COVID-19, Limb discomfort, Muscular weakness
muscle strengths are not really strong; COVID at the same time even with the vaccine (after 3rd vacc... muscle strengths are not really strong; COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu; physical discomfort for 4 days in the arm after the (2nd or 3rd generation); This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle strengths are not really strong), LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)) and COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax Nos (unspecified). Past adverse reactions to the above products included No adverse effect with Spikevax Nos. Concurrent medical conditions included Disability, Bedridden, Chronic disease (Chronic diseases) and Immunocompromised. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu). On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle strengths are not really strong) and LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)). At the time of the report, MUSCULAR WEAKNESS (muscle strengths are not really strong) and COVID-19 (COVID at the same time even with the vaccine (after 3rd vaccine)/a really bad case of the flu) was resolving and LIMB DISCOMFORT (physical discomfort for 4 days in the arm after the (2nd or 3rd generation)) had resolved. No concomitant medications were reported. The reporter confirmed that, the disability and bedridden had nothing to do with the vaccines. However, the patient experienced physical discomfort for 4 days in the arm after the 2nd or 3rd generation vaccines and her disease was sort of terminal so much that there was really not a lot of treatment for, and she was very susceptible. Her immune system was compromised and that's why it was very important for her to get that new generation vaccine. The reporter also mentioned that the patient got COVID at the same time even with the vaccine (after 3rd dose of vaccine), two summers ago and it was like really a bad case of the flu. Her muscle strength was not really strong and was more advanced in chronic disease. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789301 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789301:Wife case More
2859481 78 F 09/17/2025 UNK
 UNKNOWN MANUFACTURER
 3052583
Decreased appetite, Injection site rash, Rash pruritic, Urticaria Decreased appetite, Injection site rash, Rash pruritic, Urticaria
got hives that come and go on various parts of her body; she got a rash at the injection site/ itchy... got hives that come and go on various parts of her body; she got a rash at the injection site/ itchy rash at the injection site; headache; fatigue; loss of appetite; itchy rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), VACCINATION SITE PRURITUS (itchy rash at the injection site), URTICARIA (got hives that come and go on various parts of her body), VACCINATION SITE RASH (she got a rash at the injection site/ itchy rash at the injection site) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052583) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) in January 2021 and Pfizer (Dose 2) in February 2021. Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. On 08-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 09-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced URTICARIA (got hives that come and go on various parts of her body). In September 2025, the patient experienced DECREASED APPETITE (loss of appetite), VACCINATION SITE PRURITUS (itchy rash at the injection site), VACCINATION SITE RASH (she got a rash at the injection site/ itchy rash at the injection site), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (loss of appetite), VACCINATION SITE PRURITUS (itchy rash at the injection site), URTICARIA (got hives that come and go on various parts of her body), VACCINATION SITE RASH (she got a rash at the injection site/ itchy rash at the injection site), HEADACHE (headache) and FATIGUE (fatigue) had not resolved. No concomitant medication was reported. The patient got a rash at the injection site and 24 hours after the vaccine she got hives that come and go on various parts of her body. She thought she was getting mosquito bites, but they did not look like that, and they were coming and going. The patient was concerned about whether these were going to go away. The patient always had side effects that start around 3 in the afternoon because she always gets the vaccines early in the morning. They subsided by nighttime in the next day. This time, her usual side effects - headache, fatigue, loss of appetite - were actually milder in comparison to the vaccine she had in March. She was desperately sick from the March vaccine but did not have this itchy rash at the injection site plus the hives that come and go on different parts of her body. She always planned it when she did not have important things to do the day after the COVID vaccine because she knows she was going to be real sick. Currently she had the rash at the injection site on the right arm and a few hives. The hives she had right now were on her right leg. The ones she had before, she thinks, had all been on the right. The patient did not remember but her feeling was that it was on her right hand and right arm. The patient cannot say for sure but that was her thinking, because she thought it was mosquito bites at first but then they went away too fast and did not look like mosquito bites. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2024-773529 (Patient Link). More
2859482 F 09/17/2025 UNK
 UNKNOWN MANUFACTURER
Chills, Headache, Nausea Chills, Headache, Nausea
nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurre... nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) 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 11-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) had not resolved. No concomitant medication was reported. The patient had nausea, headache, and chills. The patient did not experience any additional symptoms/events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact More
2859483 F 09/17/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
tested positive on Sept 14; This spontaneous case was reported by a consumer and describes the occur... tested positive on Sept 14; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive on Sept 14) 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 07-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 14-Sep-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (tested positive on Sept 14). At the time of the report, COVID-19 (tested positive on Sept 14) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. The patient had vaccine on 7-Jun-2025 and tested positive on 14-Sep-2025. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789367 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789367:Husband case More
2859484 66 F PA 09/17/2025 UNK
 UNKNOWN MANUFACTURER
Abdominal discomfort, Injection site pain, Myalgia, Vomiting Abdominal discomfort, Injection site pain, Myalgia, Vomiting
stomach discomfort; Injection sight soreness; muscle soreness throughout my body; vomiting; This spo... stomach discomfort; Injection sight soreness; muscle soreness throughout my body; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach discomfort), VACCINATION SITE PAIN (Injection sight soreness), MYALGIA (muscle soreness throughout my body) and VOMITING (vomiting) in a 66-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 14-Sep-2025, the patient experienced ABDOMINAL DISCOMFORT (stomach discomfort), VACCINATION SITE PAIN (Injection sight soreness), MYALGIA (muscle soreness throughout my body) and VOMITING (vomiting). At the time of the report, ABDOMINAL DISCOMFORT (stomach discomfort), VACCINATION SITE PAIN (Injection sight soreness), MYALGIA (muscle soreness throughout my body) and VOMITING (vomiting) was resolving. No concomitant medication was reported. The patient had injection site soreness, muscle soreness throughout her body, stomach discomfort, and vomiting. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not provided. No treatment medication was reported. More
2859485 64 M 09/17/2025 UNK
 UNKNOWN MANUFACTURER
Headache, Injection site pain, Myalgia, Nausea, Vomiting Headache, Injection site pain, Myalgia, Nausea, Vomiting
injection site pain; muscle pain; headache; nausea and vomiting; nausea and vomiting; This spontaneo... injection site pain; muscle pain; headache; nausea and vomiting; nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle pain), HEADACHE (headache), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting) in a 64-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 14-Sep-2025, the patient experienced VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle pain), HEADACHE (headache), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting). At the time of the report, VACCINATION SITE PAIN (injection site pain), MYALGIA (muscle pain), HEADACHE (headache) and VOMITING (nausea and vomiting) had not resolved and NAUSEA (nausea and vomiting) outcome was unknown. The concomitant medication was not reported by the reporter. The patient had injection site pain, muscle pain, headache, nausea and vomiting. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2859486 TN 09/17/2025 RSV
 PFIZER\WYETH
 LL8391
Device connection issue, Exposure via skin contact, No adverse event Device connection issue, Exposure via skin contact, No adverse event
the liquid/diluent spilled on her; the liquid/diluent spilled on her; the luer lock broke off; The i... the liquid/diluent spilled on her; the liquid/diluent spilled on her; the luer lock broke off; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 15Sep2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) and all described as "the liquid/diluent spilled on her"; DEVICE BREAKAGE (non-serious), described as "the luer lock broke off". Additional information: The reporter was contacted for clarification on how the product broke. She stated that, when she connected the syringe and turned the Luer Lok, it broke off and the liquid/diluent spilled onto her. Causality for "the liquid/diluent spilled on her" and "the luer lock broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). More
2859487 M 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
The patient has been getting the Pfizer COVID boosters yearly and the last one was in Nov2024, but t... The patient has been getting the Pfizer COVID boosters yearly and the last one was in Nov2024, but this is the second time he got covid19; The patient has been getting the Pfizer COVID boosters yearly and the last one was in Nov2024, but this is the second time he got covid19; This is a spontaneous report received from a Nurse from medical information team. A 21-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Covid 19" (unspecified if ongoing), notes: but this is the second time he got covid19. The patient's concomitant medications were not reported. Past drug history included: Lantus for type 1 diabetes, notes: two types of insulin everyday (Humalog as needed, Lantus once daily); Humalog for type 1 diabetes, notes: two types of insulin everyday (Humalog as needed, Lantus once daily). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Sep2025, outcome "unknown" and all described as "The patient has been getting the Pfizer COVID boosters yearly and the last one was in Nov2024, but this is the second time he got covid19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2025) Positive, notes: He tested positive for Covid 19 yesterday. Clinical course: The patient was considered high risk due to his diabetes. He tested positive for Covid 19 yesterday (09Sep2025). He just got the coupon for Paxlovid and had not started Paxlovid yet. Yesterday the patient took one Mucinex in the morning and one in the evening and one "cough pearl". This morning the patient took one Mucinex and one "cough pearl". The patient had been getting the Pfizer COVID boosters yearly and the last one was in Nov2024, but this was the second time he got covid19. This was the first time he was going to take Paxlovid but this was the second time he had COVID. He got Pfizer and then basically he had all the Pfizer's. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA) can not be fully excluded. More
2859488 F ME 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
she is up to date all of the shots, all of the boosters and she had the Corona four times; she is up... she is up to date all of the shots, all of the boosters and she had the Corona four times; she is up to date all of the shots, all of the boosters and she had the Corona four times; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from medical information team and product quality group. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, manufacturer unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she is up to date all of the shots, all of the boosters and she had the Corona four times". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300072369 same patient and drug, different event, separated in time; More
2859489 09/17/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



COVID-19, Drug ineffective; Blood pressure measurement, Hypertension; COVID-19, ... COVID-19, Drug ineffective; Blood pressure measurement, Hypertension; COVID-19, Drug ineffective; Blood pressure measurement, Hypertension More
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or... diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series complete), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182241 same reporter/patient, different dose/AE; More
2859490 F GA 09/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I never got COVID except for the one time that I said back a couple of years ago; I never got COVID ... I never got COVID except for the one time that I said back a couple of years ago; I never got COVID except for the one time that I said back a couple of years ago; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I never got COVID except for the one time that I said back a couple of years ago". The event "i never got covid except for the one time that i said back a couple of years ago" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient went to a senior medical center. Patient had COVID and was prescribed Paxlovid. Patient had Pfizer for all her booster shots. Patient had COVID but didn't have it during the epidemic time in 2021 and all that but had it later. She went somewhere and got it; she only had a mild case and took Paxlovid. She doesn't remember when she last took Paxlovid, but she has a shot book that tells all her medication-boosters and everything that she got from Pfizer. Clarified she had six boosters. She never got COVID except for the one time that she said back a couple of years ago. Not during the big time or anything, but she has had COVID the one time. More
2859491 59 M MA 09/17/2025 COVID19
 PFIZER\BIONTECH
Fatigue, Vaccination site pain Fatigue, Vaccination site pain
Injection Site Pain; fatigue; This is a spontaneous report received from a Consumer or other non HCP... Injection Site Pain; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 07:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2025 at 02:00, outcome "recovering", described as "Injection Site Pain"; FATIGUE (non-serious) with onset 13Sep2025 at 02:00, outcome "recovering". Therapeutic measures were taken as a result of vaccination site pain, fatigue. Additional information: treatment received was Advil. The patient did receive any other vaccines on the same date nor within 4 weeks PRIOR COMIRNATY (2025-2026 FORMULA). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859492 67 M NY 09/17/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



COVID-19, Drug ineffective; Palpitations, Scan brain; COVID-19, Drug ineffective... COVID-19, Drug ineffective; Palpitations, Scan brain; COVID-19, Drug ineffective; Palpitations, Scan brain More
ended up coming down with Covid; ended up coming down with Covid; This is a spontaneous report recei... ended up coming down with Covid; ended up coming down with Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: benign. The patient's concomitant medications were not reported. Vaccination history included: Moderna (first dose), for covid-19 Immunization; Moderna (second dose), for covid-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2024, outcome "unknown" and all described as "ended up coming down with Covid". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500181961 same patient/drug, different event with time gap; More
2859493 59 M 09/17/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LN4932
LN4932
Chills, Injection site erythema, Injection site pain, Injection site pruritus, I... Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Pyrexia More
Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle;... Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle; Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle; Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle; Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle; Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle; Low fever and chills on Day 1-3; Low fever and chills on Day 1-3; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Sep2025 at 09:00 as dose number unknown, single (Lot number: LN4932) at the age of 59 years, in left arm for immunisation. The patient informed that the facility where vaccine was administered was in doctor's office/urgent care. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The following information was reported: VACCINATION SITE SWELLING (medically significant), VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE WARMTH (medically significant), VACCINATION SITE PRURITUS (medically significant), VACCINATION SITE PAIN (medically significant) all with onset 12Sep2025 at 14:30, outcome "not recovered" and all described as "Injection site swelling, redness, hot, itchiness, and pain. Area enlarged to -12 cm diameter circle"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 12Sep2025 at 14:30, outcome "not recovered" and all described as "Low fever and chills on Day 1-3". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site warmth, vaccination site pruritus, vaccination site pain, pyrexia, chills. More
2859494 09/17/2025 COVID19
 PFIZER\BIONTECH
Post-acute COVID-19 syndrome, Thyroid disorder Post-acute COVID-19 syndrome, Thyroid disorder
negatively impacted their thyroid gland; Long Covid; This is a spontaneous report received from a Co... negatively impacted their thyroid gland; Long Covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN). The following information was reported: THYROID DISORDER (non-serious), outcome "unknown", described as "negatively impacted their thyroid gland"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid". Additional information: Caller stated that they had been "inoculated" twice with the COVID vaccine and on the 2nd time they began to experience "Long Covid" which negatively impacted their thyroid gland. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859495 CA 09/17/2025 FLU3
 SANOFI PASTEUR
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
inappropriate use due to the administration of FLUZONE HD to a patient intended to receive FLUZONE N... inappropriate use due to the administration of FLUZONE HD to a patient intended to receive FLUZONE NP with no adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this case US-SA-2025SA276446. This case involves an unknown age and unknown gender patient who was inappropriately administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] who was intended to receive Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient inappropriately received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) who was intended to receive fluzone np with no adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly,In addition, the specialist reported that a medication error occurred due to the mix-up discovered on 09-Sep-2025. They appeared upset when explaining that a patient received the FLUZONE HD instead of the FLUZONE NP. The specialist also reported that they discovered another similar mix-up in another clinic, wherein 2 doses of FLUZONE HD were located in a box of FLUZONE NP. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA276446: More
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