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
2821304 43 F PA 01/16/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 B0001
B0001
U84442aa
U84442aa
Abdominal pain lower, Abortion spontaneous, Exposure during pregnancy, Malaise, ... Abdominal pain lower, Abortion spontaneous, Exposure during pregnancy, Malaise, Muscle spasms; Pain, Pregnancy test urine positive, Ultrasound antenatal screen abnormal, Vaginal discharge; Abdominal pain lower, Abortion spontaneous, Exposure during pregnancy, Malaise, Muscle spasms; Pain, Pregnancy test urine positive, Ultrasound antenatal screen abnormal, Vaginal discharge More
Pt began having lower abdominal pain about 8 hours after vaccines. Took tylenol, did not help. Start... Pt began having lower abdominal pain about 8 hours after vaccines. Took tylenol, did not help. Started having some vaginal discharge the next morning, Felt vaguely unwell until 1/15/2025 when increasing pain and cramping and pt had miscarriage. Pt was approximately 11 weeks pregnant and Due Aug 15, 2025. Pt denies having prior episodes of spotting, cramping during this pregnancy. More
2821305 64 M TN 01/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Headache, Myalgia, Nausea Headache, Myalgia, Nausea
Muscle ache, nausea, headache Muscle ache, nausea, headache
2821306 77 F CA 01/16/2025 COVID19
 PFIZER\BIONTECH
 LM2224
Atrial fibrillation Atrial fibrillation
Pt called 6 days later stating that she experienced about 14 hours of Afib after the vaccine but did... Pt called 6 days later stating that she experienced about 14 hours of Afib after the vaccine but did not go to her MD's office nor seek medical attention. stated that she was familiar with the feeling and assumed it would go away. Pt had no record of prior reporting to pharmacy that she had history of AFib. rph added to pt's profile today 01/16/2025. More
2821307 74 F CA 01/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9429J
Arthralgia, Joint stiffness, Joint swelling, Pain in extremity, Peripheral swell... Arthralgia, Joint stiffness, Joint swelling, Pain in extremity, Peripheral swelling More
Pt called pharmacy to report that he had both of his hands and wrist swell about 2 days after the va... Pt called pharmacy to report that he had both of his hands and wrist swell about 2 days after the vaccine admin day. he stated that they feel very stiff and there is some pain. counseled pt to take Ibuprofen but he stated he had renal issues so he may not take those NSAIDs. advised pt to see his PCP if it doesn't get better. Per facts and comparisons it is already listed that s/e may include myalgia, joint swelling, and arthralgia. More
2821308 2 F IA 01/16/2025 FLU3
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 KM5GK
HR4RB
Incorrect dose administered, No adverse event; Incorrect dose administered, No a... Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event More
I accidentally administered adult dose of Havrix rather than pediatric dose. I called mom this after... I accidentally administered adult dose of Havrix rather than pediatric dose. I called mom this afternoon (1/16) to see how patient was doing and let her know what occurred. Mom states she is doing well and hasn't had any side effects. I let her know that patient may be at an increased risk for decreased appetite, nausea, vomiting, and fevers (as per GSK documentation), and requested she let us know if patient has any of these reactions. More
2821309 9 M WI 01/16/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
The pt was given the Comirnaty vaccine (12 years and older), and the pt is 6 years old. No side effe... The pt was given the Comirnaty vaccine (12 years and older), and the pt is 6 years old. No side effects seen. More
2821310 10 M UT 01/16/2025 COVID19
 PFIZER\BIONTECH
 lm2045
Unevaluable event Unevaluable event
n/a n/a
2821337 F CA 01/16/2025 MMRV
 MERCK & CO. INC.
 X018732
Expired product administered, No adverse event Expired product administered, No adverse event
no adverese event; Vaccine was administered to a patient one day after expiration date; This spontan... no adverese event; Vaccine was administered to a patient one day after expiration date; This spontaneous report was received from a nurse, referring to a 4-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported. On 07-JAN-2025, the patient was vaccinated with expired vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X018732, expiration date: 06-JAN-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). Expired dose never experienced a temperature excursion. No side effects or symptoms reported (no adverse event). More
2821338 32 M NC 01/16/2025 HPV9
 MERCK & CO. INC.
 1965046
Device connection issue, Exposure via skin contact, No adverse event, Syringe is... Device connection issue, Exposure via skin contact, No adverse event, Syringe issue, Underdose More
No additional adverse event was reported; medicine leaked down patients arm from syringe while injec... No additional adverse event was reported; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; This spontaneous report was received from Other Health Professional and refers to a 32-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-OCT-2024, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1965046, expiration date: 22-JAN-2026, administered intramuscularly for prophylaxis (strength was not provided). While administerin the vaccine, the medicine leaked aownd patients arm from the connection between syringe hub or luer lock and syringe needle (Accidental exposure to product, exposure via skin contact, accidental underdose, device leakage and poor quality device used). No additional adverse events were reported. ; Sender's Comments: US-009507513-2412USA005429: More
2821339 35 M NC 01/16/2025 HPV9
 MERCK & CO. INC.
 1965046
Device connection issue, Exposure via skin contact, No adverse event, Syringe is... Device connection issue, Exposure via skin contact, No adverse event, Syringe issue, Underdose More
No additional adverse event was reported; medicine leaked down patients arm from syringe while injec... No additional adverse event was reported; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; medicine leaked down patients arm from syringe while injected; This spontaneous report was received from Other Health Professional and refers to a 35-year-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-OCT-2024, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1965046, expiration date: 22-JAN-2026, administered intramuscularly for prophylaxis (strength was not provided). While administerin the vaccine, the medicine leaked aownd patients arm from the connection between syringe hub or luer lock and syringe needle (Accidental exposure to product, exposure via skin contact, accidental underdose, device leakage and poor quality device used). No additional adverse events were reported. ; Sender's Comments: US-009507513-2412USA005429: More
2821340 12 F AZ 01/16/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Abdominal pain upper, Arthralgia, Brain fog, Complex regional pain syndrome, Dep... Abdominal pain upper, Arthralgia, Brain fog, Complex regional pain syndrome, Depressed level of consciousness; Diarrhoea, Fatigue, Food intolerance, Gait inability, Gastrointestinal disorder; Headache, Heart rate irregular, Hyperacusis, Hypoaesthesia, Insomnia; Loss of personal independence in daily activities, Mast cell activation syndrome, Migraine, Nausea, Neck pain; Orthostatic intolerance, Pain, Photophobia, Postural orthostatic tachycardia syndrome, Skin discolouration; Syncope More
POTS; Complex Regional Pain Syndrome (CRPS); Sustained Serious Autoimmune injuries; Gastrointestinal... POTS; Complex Regional Pain Syndrome (CRPS); Sustained Serious Autoimmune injuries; Gastrointestinal issues/ food intolerance; Mast Cell Activation Syndrome ("MCAS"); Information was received from a lawyer, regarding a case in litigation and refers to a 12-years-old female patient (pt). The pt's concurrent conditions, concomitant medications and medical history were not provided. On an unknown date (at the age of 12-years-old), the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (also reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's physician recommendation and the pt's mother consented. On unspecified dates, the pt experienced serious autoimmune and neurological injuries as a result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). On other unknown dates, within a few weeks after receiving the vaccine, the patient developed stomach pains, diarrhea, and body pains. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints which included: extreme body pain to the point where she could no longer walk, insomnia, nausea, fatigue, brain fog, erratic heartbeats, food intolerances, gastrointestinal issues, headaches, numbness in her arms and legs, neck pain, legs turning purple after prolonged standing, light and sound sensitivity, and syncope. As a result of her symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Prior to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), she was an active teenager who enjoyed playing sports and participating in extracurricular activities at school. Since receiving the vaccine, the patient has had difficulty attending school and had to enroll in community college instead of a full-time university. She has also had to apply for disability. Based upon her chronic and severe post-quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been diagnosed with various medical conditions, including but not limited to, Postural orthostatic tachycardia syndrome (POTS), Complex Regional Pain Syndrome (CRPS), joint pain, chronic migraine, neck pain, orthostatic intolerance, decreased level of consciousness, and Mast Cell Activation Syndrome ("MCAS"). It was also confirmed that the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). Upon internal review, the events of mast cell activation syndrome and autoimmune disorder were determined to be medically significant. The reporter considered all events to be disabling. More
โœ“
2821341 F 01/16/2025 HEP
 MERCK & CO. INC.
Urticaria Urticaria
chronic hives after a Hep.B booster; This spontaneous report was received from Consumer and refers t... chronic hives after a Hep.B booster; This spontaneous report was received from Consumer and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, booster dose administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient experienced chronic hives. At the time of reporting, the outcome of the event was not known. The causal relationship between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown. Lot # is being requested and will be submitted if received. More
2821342 U TX 01/16/2025 RV5
 MERCK & CO. INC.
Extra dose administered Extra dose administered
No symptoms reported; Medical assistant calling to report an AE on "overvaccination" with ... No symptoms reported; Medical assistant calling to report an AE on "overvaccination" with ROTATEQ. Per the HCP, a patient has already completed the ROTATEQ vaccine series as of Nov 2024 and was administered an additional dose on 01/14/2025; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the 1st and 2nd doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose, lot # and expiry date were not provided) administered orally (po). On an unspecified date in November 2024, the patient completed the vaccine series with the 3rd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose, lot # and expiry date were not provided) po. Then, on 14-JAN-2025, the patient received an additional dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml po once after completing 3 doses, lot # 2081735, expiration date 03-MAR-2026 (extra dose administered). All vaccine doses were administered as prophylaxis. There were no symptoms reported (no adverse event). No further information was available. Lot # is being requested and will be submitted if received. More
2821343 U PA 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00019
Unevaluable event Unevaluable event
Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7... Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines; Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines; Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines; Patient female, 40 years old received only one dose of Jynneos vaccine and did not come back for second dose; Patient female, 25 years old received second dose of Jynneos 37 days after the first dose; Case reference number US-BN-2024-002887 is a spontaneous case report initially received from other health professional via agency (reference number: USBAV24-3275) on 11-Dec-2024 and concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. The patient's relevant medical history and concomitant medications were not provided. As reported, Jynneos vaccines have been stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally (explicitly coded as 'product storage error', ๏ฟฝproduct administration error' and ๏ฟฝintradermal injection'). On 02-Jun-2024, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration for unknown indication (explicitly coded as ๏ฟฝintradermal injection'). As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose (explicitly coded as ๏ฟฝincomplete course of vaccination'). On 02-Jul-2024, 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration (explicitly coded as ๏ฟฝintradermal injection'). On 09-Jul-2024, 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration (explicitly coded as ๏ฟฝintradermal injection' and ๏ฟฝinappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. Additional information received from a HCP via agencyon 11-Dec-2024 included confirmation of additional reference numbers (USBAV24-3283 and USBAV24-3280).; Reporter's Comments: This case report concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. Reportedly, Jynneos vaccines have been stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally, considered as product storage error, product administration error and intradermal injection. Reportedly, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration for unknown indication, considered as intradermal injection. As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose which is considered as incomplete course of vaccination. 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine, at dose of 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection. 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection and inappropriate schedule of vaccine administered. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. Reportedly, Jynneos vaccines have been stored in a freezer between -18.7๏ฟฝF to -16๏ฟฝF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally, considered as product storage error, product administration error and intradermal injection. Reportedly, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration for unknown indication, considered as intradermal injection. As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose which is considered as incomplete course of vaccination. 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine, at dose of 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection. 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection and inappropriate schedule of vaccine administered. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all assessed as not related to suspect product but to human factor. The case is non-serious. More
2821344 M CA 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Inappropriate schedule of product administration, Incorrect route of product adm... Inappropriate schedule of product administration, Incorrect route of product administration More
The patient received the Jynneos vaccine intramuscularly two months ago and then received a subcutan... The patient received the Jynneos vaccine intramuscularly two months ago and then received a subcutaneous injection last month; The patient received the Jynneos vaccine intramuscularly two months ago and then received a subcutaneous injection last month; Case reference number US-BN-2025-000004 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0006) on 02-Jan-2025 and concerns a male patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as two months ago, the patient received first dose of Jynneos vaccine (batch number: unknown) intramuscularly, at unknown dose, site of administration for unknown indication (explicitly coded as 'Inappropriate route of vaccination'). On unspecified date, reported as last month, for unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine (batch number: unknown) subcutaneously, at unknown dose, site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos vaccine. No further information was provided.; Reporter's Comments: A male patient with unspecified age received the first dose of Jynneos vaccine, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On unspecified date, reported as last month, an unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due Jynneos vaccine. Incorrect route of product administration and inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient with unspecified age received the first dose of Jynneos vaccine, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. On unspecified date, reported as last month, an unknown amount of time from the first dose, the patient received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due Jynneos vaccine. Incorrect route of product administration and inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2821345 F 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Incomplete course of vaccination Incomplete course of vaccination
The patient received first dose of Jynneos vaccine in October 2024 and then was beyond the recommend... The patient received first dose of Jynneos vaccine in October 2024 and then was beyond the recommended four weeks interval; Case reference number US-BN-2025-000006 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0021) on 03-Jan-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 01-Oct-2024, the patient received first dose of Jynneos vaccine (batch number: FDP00017, expired date: Oct-2024) at unknown dose, route or site of administration for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos. No further information was provided.; Reporter's Comments: A female patient of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Jynneos. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human actor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, the patient was due for the second dose and was beyond the recommended four weeks interval, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Jynneos. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human actor. This case is considered as non-serious. More
2821346 U IL 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 #96867
Product storage error Product storage error
The Jynneos vaccine was left in freezer, freezer malfunctioned and the final temperature reached 30 ... The Jynneos vaccine was left in freezer, freezer malfunctioned and the final temperature reached 30 degrees Fahrenheit for six hours, vials were half melted and was moved to different freezer; The Jynneos vaccine was left in freezer, freezer malfunctioned and the final temperature reached 30 degrees Fahrenheit for six hours, vials were half melted and was moved to different freezer; The patient received the Jynneos vaccine which temperature reached 30 degrees Fahrenheit for six hours; Case reference number US-BN-2025-000014 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0025) on 06-Jan-2025 and concerns a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, eight vials of Jynneos vaccine had temperature excursion, as reported freezer malfunctioned and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point (explicitly coded as 'product storage error too high' and 'product temperature excursion issue') On unspecified date, as reported five days later, the patient received defected dose of Jynneos vaccine (batch number: #96867; expiration date: 04/2024), at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos. No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received defected dose of Jynneos vaccine for unknown indication. Reportedly, Jynneos vaccine had temperature excursion, freezer malfunctioned, and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point, which is considered as product storage error too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due Jynneos. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient with unspecified age and gender received defected dose of Jynneos vaccine for unknown indication. Reportedly, Jynneos vaccine had temperature excursion, freezer malfunctioned, and the final temperature reached 30 degrees F for six hours, vials were half melted, and vaccine was moved to different freezer at that point, which is considered as product storage error too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any adverse events due Jynneos. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2821347 M KY 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patients had not come in for their second dose yet; Case reference number US-BN-2025-000016 is a... The patients had not come in for their second dose yet; Case reference number US-BN-2025-000016 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-0028) on 06-Jan-2025 and concerns two male patients of unspecified age (MULTI 2). The patient's relevant medical history and concomitant medications were not provided. On 25-Oct-2024, the second patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication. On 28-Oct-2024, the first patient was vaccinated with the first dose of Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration for unknown indication. As reported, the patients had not come in for their second dose of Jynneos yet (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. Additional information received from pharmacist via Communications (reference number: USBAV25-0029) on 08-Jan-2025: Information included reference number and confirmation there was two male patients.; Reporter's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two male patients of unspecified age did not receive the second dose of Jynneos yet in Jan-2025, after they were vaccinated with the first dose in Oct-2024, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2821348 M 01/16/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Pain in extremity, Product administered at inappropriate site Pain in extremity, Product administered at inappropriate site
The patient received second dose of Jynneos vaccine into the back fatty part of upper arm, which got... The patient received second dose of Jynneos vaccine into the back fatty part of upper arm, which got a bit sore for a week; The patient received first dose of Jynneos vaccine into the muscle (intramuscularly); Case reference number US-BN-2025-000003 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-0007) on 02-Jan-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) at an unknown dose, intramuscularly, administered into the muscle, for unknown indication (explicitly coded as 'inappropriate route of vaccination'). On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown) at an unknown dose, and route, administered into back fatty part of upper arm which got a bit sore for a week. At the time of the initial report, it was unknown if the patient recovered from the event 'pain in arm'. The reporter did not provide a seriousness and causality assessment for the event 'pain in arm'. No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, intramuscularly, administered into the muscle, for unknown indication, which is considered as inappropriate route of vaccination. On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered into back fatty part of upper arm which got a bit sore for a week. Pain in extremity is listed per CCDS v7 and unexpected per agency for Jynneos, whilst incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Jynneos. Incorrect route of product administration is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos, intramuscularly, administered into the muscle, for unknown indication, which is considered as inappropriate route of vaccination. On an unspecified date, unknown amount of time after first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos, administered into back fatty part of upper arm which got a bit sore for a week. Pain in extremity is listed per CCDS v7 and unexpected per agency for Jynneos, whilst incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Jynneos. Incorrect route of product administration is considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2821349 M FL 01/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Endotracheal intubation, Pulmonary alveolar haemorrhage Endotracheal intubation, Pulmonary alveolar haemorrhage
critically ill with DAH; This serious case was reported by a consumer and described the occurrence o... critically ill with DAH; This serious case was reported by a consumer and described the occurrence of diffuse alveolar hemorrhage in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included insulin degludec (Tresiba). On 28-DEC-2024, the patient received the 1st dose of Shingles vaccine. On 01-JAN-2025, 4 days after receiving Shingles vaccine, the patient experienced diffuse alveolar hemorrhage (Verbatim: critically ill with DAH) (serious criteria hospitalization and GSK medically significant). The outcome of the diffuse alveolar hemorrhage was not resolved. It was unknown if the reporter considered the diffuse alveolar hemorrhage to be related to Shingles vaccine. The company considered the diffuse alveolar hemorrhage to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 05-JAN-2025 Consumer stated that 3 days after the vaccine patient became critically ill with DAH, also stated that patient was intubated at the time of reporting. Hospitalization dates were unknown..; Sender's Comments: Pulmonary alveolar haemorrhage is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
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2821350 M 01/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
ill since receiving the vaccine; This serious case was reported by a consumer via sales rep and desc... ill since receiving the vaccine; This serious case was reported by a consumer via sales rep and described the occurrence of illness in a male 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 illness (Verbatim: ill since receiving the vaccine) (serious criteria hospitalization). The outcome of the illness was not resolved. It was unknown if the reporter considered the illness to be related to Shingrix. The company considered the illness to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 06-JAN-2025 While in market research, the patient mentioned that her brother had received the Shingrix vaccine and had an adverse event. She stated that he had been ill since receiving the vaccine and had been hospitalized (unclear whether it was the result of the vaccination or for other reasons).; Sender's Comments: Illness is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
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2821351 30 F 01/16/2025 COVID19
FLU4
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 6024MFO14A
2724I
Asthenia, Dizziness, Flushing, Hyperhidrosis; Asthenia, Dizziness, Flushing, Hyp... Asthenia, Dizziness, Flushing, Hyperhidrosis; Asthenia, Dizziness, Flushing, Hyperhidrosis More
Dizziness/ Lightheadness; Weakness/asthenia; Flushed; Sweating/ diaphoretic/hyperhidrosis; This non-... Dizziness/ Lightheadness; Weakness/asthenia; Flushed; Sweating/ diaphoretic/hyperhidrosis; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of light headedness in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 2724I) for prophylaxis. Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MFO14A) for covid-19 immunization. On 11-OCT-2024, the patient received FluLaval Quadrivalent 2024-2025 season (intramuscular, left deltoid) and the 1st dose of NOVAVAX COVID-19 VACCINE (intramuscular). On 11-OCT-2024, less than an hour after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced light headedness (Verbatim: Dizziness/ Lightheadness), weakness (Verbatim: Weakness/asthenia), flushing (Verbatim: Flushed) and diaphoresis (Verbatim: Sweating/ diaphoretic/hyperhidrosis). On 11-OCT-2024, the outcome of the light headedness, weakness, flushing and diaphoresis were resolved. The reporter considered the light headedness, weakness, flushing and diaphoresis to be possibly related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. The company considered the light headedness, weakness, flushing and diaphoresis to be possibly related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-DEC-2024 The patient received Covid and flu injections and experienced mild dizziness/light headedness, flushed/sweating, weakness. Roughly 15 seconds after the flu shot was administered, the patient became diaphoretic and weak. The patient closed eyes for approximately 15 seconds and then her eyes reopened. She complained of weakness at that time also and Gatorade was given to the patient and stayed post vaccination for about 20 minutes. Patient's gait was checked and she was steady. She was and oriented to person, place, and time. She was escorted and left store with her boyfriend. No concomitants were used/reported. The reporter considered the light headedness, weakness, flushing and diaphoresis to be possibly related to Novavax Covid-19 Vaccine. This report was one of several cases received as part of a line-listing, each containing minimal information. No further information was expected. More
2821352 U 01/16/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pyrexia Pyrexia
Fever; This non-serious case was reported by a consumer via interactive digital media and described ... Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Arexvy. It was unknown if the company considered the fever to be related to Arexvy. Additional Information: GSK Receipt Date: 17-DEC-2024 The reporter reported what about a fever More
2821353 U 01/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; have shingles have been supposedly Vaccinated against them; This seri... Suspected vaccination failure; have shingles have been supposedly Vaccinated against them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have shingles have been supposedly Vaccinated against them). 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: 03-JAN-2025 This case was reported by a patient via interactive digital media. The only people the report knew that had shingles have been supposedly vaccinated against them, every case the report knew. The reporter reported that do not take the supposed shingles Vaccine. There was no such thing as a viable Vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2821354 M NY 01/16/2025 MEN
MNQ
MNQ
 UNKNOWN MANUFACTURER
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 U81138A
EK7DG
3443E
Extra dose administered, Interchange of vaccine products; Extra dose administere... Extra dose administered, Interchange of vaccine products; Extra dose administered, Interchange of vaccine products; Extra dose administered, Interchange of vaccine products More
Patient received 1st dose on 17th Oct and then again 21st nov, they received a dose of Menveo; patie... Patient received 1st dose on 17th Oct and then again 21st nov, they received a dose of Menveo; patient received a dose of Menveo after having received a dose of MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 3443E, expiry date 30-SEP-2025) for prophylaxis and meningococcal vaccine a/c/y/w conj (tet tox) (Menquadfi) (batch number U81138A, expiry date 31-JUL-2026) for prophylaxis. On 21-NOV-2024, the patient received the 2nd dose of Menveo. On 17-OCT-2024, the patient received the 1st dose of Menveo. On 21-AUG-2024, the patient started Menquadfi. On 17-OCT-2024, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: patient received a dose of Menveo after having received a dose of MenQuadfi). On 21-NOV-2024, the patient experienced extra dose administered (Verbatim: Patient received 1st dose on 17th Oct and then again 21st nov, they received a dose of Menveo). The outcome of the extra dose administered and interchange of vaccine products were unknown. Additional Information: GSK Receipt Date: 22-NOV-2024 A registered nurse reported that they had a patient who on 21st august 2024 received a dose of MenQuadfi, and then on 17th October 2024 and then again on 21st November 2024, they received a dose of Menveo. Patient received 1st dose on 17th October and then again on 21st November, they received a dose of Menveo, which led to Extra dose administered. Patient received a dose of Menveo after having received a dose of MenQuadfi, which led to Interchange of vaccine products. Reporter provided consent to follow up. The Vaccine Administration Facility was the same as Primary Reporter. More
2821355 F ME 01/16/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Product dose omission issue, Product preparation issue; Product dose omission is... Product dose omission issue, Product preparation issue; Product dose omission issue, Product preparation issue More
administered the adjuvant only; missed dose; This non-serious case was reported by a pharmacist via ... administered the adjuvant only; missed dose; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In MAY-2023, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered the adjuvant only) and incomplete course of vaccination (Verbatim: missed dose). The outcome of the inappropriate preparation of medication and incomplete course of vaccination were unknown. Additional Information: GSK Receipt Date: 19-DEC-2024 Reporter stated that a 64-year-old female was administered the adjuvant only for Shingrix (inappropriate reconstitution technique.). Reports that this event happened in May 2023. When the doctor's office realized the mistake, they vaccinated the patient with her first dose of Shingrix 2 months later. The patient was transferred to a pharmacy to receive her second dose of Shingrix, the pharmacy attempted to bill insurance for the second dose in 2024 (late dose,) however, received a rejection from insurance because the doctor's office submitted the first attempt at vaccinating with Shingrix to the insurance carrier, although the patient was only vaccinated with the adjuvant component. Now the insurance was under the assumption the consumer received both doses of Shingrix. Therefore, the patient was unable to have the second dose of Shingrix paid for by insurance resulting in a missed dose. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with case US2023133828 by the same reporter.; Sender's Comments: US-GSK-US2023133828:same reporter More
2821356 F OR 01/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 235D2
Occupational exposure to product, Product complaint, Syringe issue Occupational exposure to product, Product complaint, Syringe issue
plunger had fallen out and the vaccine fluid had gotten her hand wet; plunger fell out of the back e... plunger had fallen out and the vaccine fluid had gotten her hand wet; plunger fell out of the back end and the medication leaked out; Pharmaceutical product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 235D2, expiry date 10-JAN-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced occupational exposure via skin contact with product (Verbatim: plunger had fallen out and the vaccine fluid had gotten her hand wet), syringe leak (Verbatim: plunger fell out of the back end and the medication leaked out) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, syringe leak and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-DEC-2024 The pharmacist stated when she was preparing the vaccine, the plunger fell out of the back end and the medication leaked out. The suspect product was not administered. During preparation step the defect was discovered that the plunger falls out completely and she said that she put the needle on and turned the syringe in her hand so that the needle was up and then she suddenly noticed that her hand was all wet, related to accidental exposure because the plunger had fallen out and the vaccine fluid had gotten her hand wet which led to occupational exposure via skin contact with product and syringe leak. She was not wearing gloves. She would return the suspect syringe. She had since removed the needle and the detachment happens during preparation. More
2821357 U MA 01/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Urticaria Urticaria
Urticaria after 1st dose; This non-serious case was reported by a nurse via call center representati... Urticaria after 1st dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of urticaria 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 urticaria (Verbatim: Urticaria after 1st dose). The outcome of the urticaria was unknown. It was unknown if the reporter considered the urticaria to be related to Shingrix. It was unknown if the company considered the urticaria to be related to Shingrix. Additional Information: GSK Receipt Date: 19-DEC-2024 A nurse called in to request data about the incidence of urticaria after the first dose of Shingrix. They mentioned case involved one of their sister's friend but had no more information available. They stated the did not consent to receive follow up and would instruct said individual to reach out to GlaxoSmithKline.; Sender's Comments: US-GSK-US2024125616:same reporter More
2821358 0.92 M TX 01/16/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 34MF9
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
were supposed to administer Pentacel, she administered the Kinrix; she inadvertently administered an... were supposed to administer Pentacel, she administered the Kinrix; she inadvertently administered an 11-month-old Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. On 24-DEC-2024, the patient received Kinrix. On 24-DEC-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: were supposed to administer Pentacel, she administered the Kinrix) and inappropriate age at vaccine administration (Verbatim: she inadvertently administered an 11-month-old Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. 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: 24-DEC-2024 The nurse reported that a patient inadvertently administered an 11-month-old Kinrix, they were supposed to administer Pentacel, but did not have that vaccine, so she administered the Kinrix along with the Hib vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. More
2821359 U TX 01/16/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Syringe issue, Underdose Syringe issue, Underdose
losing too much of the vaccine trying to escape that air bubble HCP administered these vaccines; Thi... losing too much of the vaccine trying to escape that air bubble HCP administered these vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: losing too much of the vaccine trying to escape that air bubble HCP administered these vaccines). The outcome of the accidental underdose was unknown. 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: 26-DEC-2024 The reporter reported that they were concerned if they were losing too much of the Bexsero vaccine trying to escape that air bubble, which led to accidental underdose. They had multiple syringes with that issue. Also, healthcare professional declared that she administered these vaccines and she had multiple syringes with the air bubble syringe issue. More
2821360 20 F ID 01/16/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ZK9P4
Expired product administered Expired product administered
Bexsero expired dose; This non-serious case was reported by a nurse via call center representative a... Bexsero expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ZK9P4, expiry date 03-NOV-2024) for prophylaxis. On 27-DEC-2024, the patient received Bexsero. On 27-DEC-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Bexsero expired dose). The outcome of the expired vaccine used was unknown. 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-JAN-2025 Nurse reported an expired dose of Bexsero was administered to a patient, which led expired vaccine used. The reporter consented to follow up. More
2821361 84 M 01/16/2025 COVID19
 MODERNA
COVID-19 COVID-19
Patient and her husband got covid last October; This spontaneous case was reported by a patient fami... Patient and her husband got covid last October; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient and her husband got covid last October) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax bivalent Original / Omicron (Dose 4) on 05-Jan-2023. Past adverse reactions to the above products included No adverse effect with Spikevax bivalent Original / Omicron. On 20-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced COVID-19 (Patient and her husband got covid last October). At the time of the report, COVID-19 (Patient and her husband got covid last October) had resolved. The concomitant medication was not reported by reporter. Patient got covid last October and lasted for 3 months. The treatment medication was not reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-781169 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781169:Wife case More
2821362 U 01/16/2025 COVID19
 MODERNA
Myocardial infarction, Myocarditis Myocardial infarction, Myocarditis
myocarditis; Heart attack; This spontaneous case was reported by a patient and describes the occurre... myocarditis; Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (myocarditis) and MYOCARDIAL INFARCTION (Heart attack) in a patient of an unknown age and gender 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, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. No concomitant medication was reported. It was reported that, patient had been vaccinated with 2 doses of Moderna and got heart attack after taking 2 shots and was being diagnosed with Myocarditis. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2821363 M 01/16/2025 COVID19
 MODERNA
Cerebral disorder, Immunisation reaction Cerebral disorder, Immunisation reaction
Severe side effects to his body and brain to the extent of having to file for Disability; Severe sid... Severe side effects to his body and brain to the extent of having to file for Disability; Severe side effects to his body and brain to the extent of having to file for Disability; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Stroke (At the age of 52.). Concurrent medical conditions included Congestive heart failure and Parkinsonism (Dealing with parkinsonism.). In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) (seriousness criterion disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) (seriousness criterion disability). At the time of the report, CEREBRAL DISORDER (Severe side effects to his body and brain to the extent of having to file for Disability) and IMMUNISATION REACTION (Severe side effects to his body and brain to the extent of having to file for Disability) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient stated that according to his doctors, the COVID-19 vaccine he received in 2020 had caused severe side effects to his body and brain to the extent of having to file for Disability. He stated that at the age of 52, he had a stroke, CHF, and was dealing with Parkinsonism. He stated that he no longer works, therefore he was researching a way to hold our company accountable in a courtroom for damages. He also stated that his lifestyle, finances, and mobility had taken a horrible turn for the worse. As soon as his research was completed, he will be filing with the court system, with a tremendous amount of evidence. Treatment information was not reported.; Reporter's Comments: Concurrent medical conditions of Congestive heart failure and Parkinsonism could be confounders for the event. However, very limited information was provided at this time. The benefit-risk relationship of product is not affected by this report. More
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2821364 63 F MD 01/16/2025 COVID19
 MODERNA
Dysgeusia, Dyspepsia, Nausea, Oesophageal pain, Oropharyngeal discomfort Dysgeusia, Dyspepsia, Nausea, Oesophageal pain, Oropharyngeal discomfort
heartburn; burning of esophagus; throat discomfort; bitter taste; nausea; This spontaneous case was ... heartburn; burning of esophagus; throat discomfort; bitter taste; nausea; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. null Patient was diagnosed with Covid 19. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) in October 2023. On 05-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 07-Jan-2025, the patient experienced DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea). At the time of the report, DYSPEPSIA (heartburn), OESOPHAGEAL PAIN (burning of esophagus), OROPHARYNGEAL DISCOMFORT (throat discomfort), DYSGEUSIA (bitter taste) and NAUSEA (nausea) was resolving. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient received Gavascon. More
2821365 79 F 01/16/2025 COVID19
 MODERNA
COVID-19 COVID-19
Patient got covid last October; This spontaneous case was reported by a patient and describes the oc... Patient got covid last October; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got covid last October) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax bivalent original/omicron ba.4-5 (4th shot (but no information if it was booster or not)) on 05-Jan-2023. Past adverse reactions to the above products included No adverse effect with Spikevax bivalent original/omicron ba.4-5. Concurrent medical conditions included Asthma. On 20-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced COVID-19 (Patient got covid last October). At the time of the report, COVID-19 (Patient got covid last October) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. No concomitant medications were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-781172 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781172:Husband case More
2821367 F 01/16/2025 PNC20
 PFIZER\WYETH
Rash Rash
rash; This is a spontaneous report received from a Pharmacist from medical information team. A fema... rash; This is a spontaneous report received from a Pharmacist from medical information team. A female patient (unknown if pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "allergic to gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown". The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received. More
2821368 M NJ 01/16/2025 COVID19
 PFIZER\BIONTECH
Death Death
passed away; This is a spontaneous report received from a Consumer or other non HCP. A male patient... passed away; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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 completed.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that he had both his parents vaccinated ongoing until they passed away. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007783 Same event/vaccine, different patient;; Reported Cause(s) of Death: Unknown cause of death More
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2821369 M NJ 01/16/2025 COVID19
 PFIZER\BIONTECH
Fatigue Fatigue
a little tired; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-o... a little tired; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little tired". Additional information: The patient thinks the 2nd one he had he was a little tired with but that's it and that one was definitely Pfizer. The first two he had were Pfizer. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007822 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007906 Same patient/suspect vaccine; different dose/events; More
2821370 M NJ 01/16/2025 COVID19
FLUX
PPV
RVX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Lymphadenopathy, Peripheral swelling; Lymphadenopathy, Peripheral swelling; Lymp... Lymphadenopathy, Peripheral swelling; Lymphadenopathy, Peripheral swelling; Lymphadenopathy, Peripheral swelling; Lymphadenopathy, Peripheral swelling More
swelling of the lymph nodes; swelling under his arms; This is a spontaneous report received from a C... swelling of the lymph nodes; swelling under his arms; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine (RSV VACCINE), as dose number unknown, single) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (unspecified if ongoing); "slight food reactions" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling under his arms". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Additional information: Last Apr2024, the patient received a booster he believed was Pfizer last spring. With the Pfizer covid vaccine he had in Apr2024, he had swelling of the lymph nodes and swelling under his arms about two weeks which was not very much but received it with the RSV vaccine, influenza vaccine and a pneumonia vaccine; he has no manufacturer names or lot numbers to provide for the RSV vaccine, influenza vaccine and a pneumonia vaccine and there is no way to tell which he reacted to; he did not have any noticeable reaction to any other covid vaccines he had.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007822 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007905 Same patient/suspect vaccine; different dose/events; More
2821371 48 M MA 01/16/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 LN0588
946638
Deafness neurosensory; Deafness neurosensory Deafness neurosensory; Deafness neurosensory
Sudden sensorineural hearing loss; This is a spontaneous report received from an Other HCP. A 48-ye... Sudden sensorineural hearing loss; This is a spontaneous report received from an Other HCP. A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 at 10:00 as dose 1, single (Lot number: LN0588) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 06Dec2024 as dose number unknown, single (Lot number: 946638), in left arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 10 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DEAFNESS NEUROSENSORY (medically significant) with onset 18Dec2024 at 20:00, outcome "not recovered", described as "Sudden sensorineural hearing loss". Therapeutic measures were taken as a result of deafness neurosensory. Clinical course: No other vaccine in four weeks. No other medications in two weeks. Patient received high dose of steroid as treatment for the event. No known allergies.; Sender's Comments: The event deafness neurosensory is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2821372 77 F KS 01/16/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ... COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 breast cancer" (unspecified if ongoing), notes: Small nodules in her lungs, lymphs glands, and in her bones. The patient was taking Ibrance. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2025, outcome "recovering" and all described as "COVID-19". More
2821373 M 01/16/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
Dad tested positive for COVID / dad picked up COVID; Dad tested positive for COVID / dad picked up C... Dad tested positive for COVID / dad picked up COVID; Dad tested positive for COVID / dad picked up COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single 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) all with onset 07Jan2025, outcome "recovering" and all described as "Dad tested positive for COVID / dad picked up COVID". The clinical course was reported as follows: Patient's daughter stated that her dad tested positive for COVID on 07Jan2025 morning and hadn't had it in all five years, right first time, went to the doctor and got nirmatrelvir/ritonavir. Reporter's mom wasn't feeling good, didn't look good on 09Jan2025 night, so she tested her. Sure enough, she was positive, got the prescription for nirmatrelvir/ritonavir on 10Jan2025 teleconference with the doctor. Reporter's dad picked up COVID and he got kicked in the butt, but he was on the renal dose. Patient stated that he didn't think he would have survived this if he hadn't had the vaccine and if he hadn't had the nirmatrelvir/ritonavir. Reporter stated that patient was doing better; he spent 2 days in bed he was doing better, and of course, then he gave it to her mom. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2025) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. More
2821374 16 M GA 01/16/2025 MEN
MENB
 UNKNOWN MANUFACTURER
PFIZER\WYETH
 U8256AB
LF5308
Pain in extremity, Rash; Pain in extremity, Rash Pain in extremity, Rash; Pain in extremity, Rash
right arm soreness; Patient states right arm soreness and rash; This is a spontaneous report receive... right arm soreness; Patient states right arm soreness and rash; This is a spontaneous report received from an Other HCP. A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 09Jan2025 at 15:00 as dose 1, single (Lot number: LF5308) at the age of 16 years, in right arm for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 09Jan2025 as dose 2, single (Lot number: U8256AB), in left arm. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 09Jan2025, outcome "recovering", described as "Patient states right arm soreness and rash"; VACCINATION SITE PAIN (non-serious) with onset 09Jan2025, outcome "recovering", described as "right arm soreness". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site rash. Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the Trumenba vaccine. Patient taking any other medications within 2 weeks of the event starting was unknown. Patient states right arm soreness and rash. More
2821375 1 M 01/16/2025 COVID19
 PFIZER\BIONTECH
Overdose, Product administered to patient of inappropriate age, Pyrexia Overdose, Product administered to patient of inappropriate age, Pyrexia
fever/has a fever of 101 degrees.; 1 year old received the pfizer vaccine 12 and plus/was administer... fever/has a fever of 101 degrees.; 1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older; 1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 1-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 1 year for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever/has a fever of 101 degrees."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "1 year old received the pfizer vaccine 12 and plus/was administered Pfizer vaccine for age 12 and older". Additional information: Two children (3 year old and 1 year old) received the Pfizer vaccine 12 and plus and they are having a fever. The reporter is the children's parent. They went to the doctor to get the vaccine, and they received a call that the vaccine that was administered to both patients is the Pfizer vaccine for age 12 and older. The patients have fevers at the time of the report. The reporter was asking if the children should be taken to the ER/hospital. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500008598 same drug/event; different patient; More
2821376 F 01/16/2025 COVID19
 PFIZER\BIONTECH
Postmenopausal haemorrhage Postmenopausal haemorrhage
A 62-year-old female patient had a period for 2 months; This is a spontaneous report received from a... A 62-year-old female patient had a period for 2 months; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "A 62-year-old female patient had a period for 2 months". The clinical course was reported as follows: The patient stated that she had the shot when Pfizer first introduced it out. When they were supposed to take it, but the side effect that she had with this shot was, she is 62, and had a period for 2 months. The patient asked if that was normal. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2821377 M 01/16/2025 COVID19
 PFIZER\BIONTECH
Brain fog, Chills, Fatigue, Pyrexia Brain fog, Chills, Fatigue, Pyrexia
head fog; chills; fever; tired and not feeling like doing anything; This is a spontaneous report rec... head fog; chills; fever; tired and not feeling like doing anything; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN FOG (non-serious), outcome "not recovered", described as "head fog"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovering", described as "tired and not feeling like doing anything". Additional information: the patient got the latest COVID-19 vaccine and he was looking for help with head fog he had after a month of having the vaccine. At first he had chills and fever that subsided and then a head fog, a really bad one; he was tired and not feeling like doing anything and it was slowly going away but not really going away. The patient had been taking water and keeping hydrated, but he was looking for recommendations on things to do to make him feel better. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2821382 67 M NJ 01/16/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Dysphonia, Dyspnoea, Fatigue, Influenza, Myalgia; Urticaria, Vaccination site pa... Dysphonia, Dyspnoea, Fatigue, Influenza, Myalgia; Urticaria, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling More
tired; he felt like he had the flu for about 60 hours; muscle aching/tenderness and soreness like mu... tired; he felt like he had the flu for about 60 hours; muscle aching/tenderness and soreness like muscle aching in the entire upper arm and shoulder area; shortness of breath; left arm was increasingly itchy; the soreness at the shoulder that was injected in; the site was a little swollen; itching and hives were in the upper arm; his voice being hoarse; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma, approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (unspecified if ongoing), notes: Chronic lymphocytic leukemia; "pollen allergy" (unspecified if ongoing); "hives" (unspecified if ongoing); "itching" (unspecified if ongoing); "having a reaction to some deodorant" (unspecified if ongoing); "slight food reactions" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol for back problems. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "a little tired"; Moderna (Dose number unknown), for COVID-19 immunisation; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), administration date: Apr2024, for COVID-19 immunisation, reaction(s): "swelling of the lymph nodes", "swelling under his arms". The following information was reported: INFLUENZA (non-serious) with onset Dec2024, outcome "unknown", described as "he felt like he had the flu for about 60 hours"; DYSPHONIA (non-serious) with onset Dec2024, outcome "unknown", described as "his voice being hoarse"; URTICARIA (non-serious) with onset Dec2024, outcome "unknown", described as "itching and hives were in the upper arm"; VACCINATION SITE PRURITUS (non-serious) with onset Dec2024, outcome "unknown", described as "left arm was increasingly itchy"; MYALGIA (non-serious) with onset Dec2024, outcome "unknown", described as "muscle aching/tenderness and soreness like muscle aching in the entire upper arm and shoulder area"; DYSPNOEA (non-serious) with onset Dec2024, outcome "unknown", described as "shortness of breath"; VACCINATION SITE SWELLING (non-serious) with onset Dec2024, outcome "unknown", described as "the site was a little swollen"; VACCINATION SITE PAIN (non-serious) with onset Dec2024, outcome "unknown", described as "the soreness at the shoulder that was injected in"; FATIGUE (non-serious) with onset Dec2024, outcome "unknown", described as "tired". Additional information: patient received all the vaccines and boosters when they were released except for the fourth one which he probably waited 6 months to get and to his memory all were Pfizer except for maybe his fourth or fifth dose of the covid vaccines that he had which were Moderna. Patient stated with the Pfizer covid vaccine he had in Apr2024, he had swelling of the lymph nodes and swelling under his arms about two weeks which was not very much but received it with the RSV vaccine, influenza vaccine and a pneumonia vaccine; he has no manufacturer names or lot numbers to provide for the RSV vaccine, influenza vaccine and a pneumonia vaccine and there is no way to tell which he reacted to; he did not have any noticeable reaction to any other covid vaccines he had. He thinks the 2nd one he had he was a little tired with but that's it and that one was definitely Pfizer and the first two he had were Pfizer. The negative reaction one he had in Apr2024 was the one he had with a group of four other vaccines and he can't say whether or not it had to do with the covid vaccine and could not really single that out and does not have an opinion on whether it was the covid or not and he suspected it was not as he was reading up on other vaccines when he had them. Patient confirmed the other vaccines he had were the RSV vaccine, influenza vaccine and a pneumonia vaccine despite having said previously it was four. This one vaccine he had just about 5 weeks ago, he just stopped reacting to. Patient clarified he had no swelling with the most recent vaccine and no did not get any and did not experience any swelling and this dose was definitely Pfizer. With that vaccine, he got tired, had no fever that he could measure and he felt like he had the flu for about 60 hours and like he was getting flu about 60 hours and was tired and had some fatigue, muscle aching and a little bit of shortness of breath and generally overall feeling like oncoming influenza and he did not experience anything more than normal pain. States pain is the wrong word, but it was soreness at the injection site for that period of time of like 60 hours and was sore where the injection site was and the site was a little swollen for like 60 hours. States these symptoms of being tired, muscle aching, and shortness of breath began and he had received the vaccine on 05Dec2024 in the afternoon and had the negative reaction on 06Dec2024, 07Dec2024 and through 08Dec2024. It seemed very unusual and he is certain it was different for him than other vaccines he had had. He did not have any reactions before not that he noticed anyways.Clarified that his Moderna vaccine was three vaccines back and was not the 4th or 5th one but probably was the 4th one but he is not sure. The most recent vaccine was on 05Dec2024 and he does not know the dosage but it was administered to his left shoulder. After the initial reaction subsided underneath his armpit of the left arm where the injection was, states he has slight food reactions and allergies and pollen allergy and has asthma and that is ongoing. He took Tylenol and states it was Acetaminophen and he takes that steadily as he has some back problems and has some substantial pollen allergies and asthma and has only had what he calls hives and itching two to three times in his entire life and his left arm was increasingly itchy until about three days ago for the entire period of time and he thought he might be having a reaction to some deodorant he used and used the deodorant one to two times during that time period.Towards the end he realized he had tenderness and soreness like muscle aching in the entire upper arm and shoulder area until about 3 days ago. The itching and hives were in the upper arm the entire time and the soreness at the shoulder that was injected in, he did not get any lymph node swelling as he did previously with other injections and never had reactions like this after 3.5 to 4.5 weeks. There was no other cause other than this dosage of the vaccine.Other medical conditions included he does not think this affects this but he has chronic lymphocytic leukemia and it is inactive because it is monitored. He did not realize what this was and it not occur to him it was cause by the vaccine and he experienced itchy underarm the whole month and after he realized it was the vaccine. States he is having trouble with his voice being hoarse. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007905 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007906 Same patient/suspect vaccine; different dose/events; More
2821384 F NC 01/16/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 946624
946624
Chills, Cough, Ear pain, Fatigue, Influenza; Influenza A virus test positive, Pa... Chills, Cough, Ear pain, Fatigue, Influenza; Influenza A virus test positive, Pain, Respiratory tract congestion, Vaccination failure More
Tested positive for Flu Strain A; Vaccination failure; Aches; Chills; Congestion; Severe cough; Tire... Tested positive for Flu Strain A; Vaccination failure; Aches; Chills; Congestion; Severe cough; Tiredness; Pain in ears; This spontaneous case, initially received on 07-Jan-2025, was reported by a health professional and concerns a female patient. Administration of company suspect drug: On 22-Oct-2024, the patient received Flucelvax (TIV) for Influenza Immunization, Dose regimen: 0.5 ml. Route of administration: Not reported. Anatomical location: Left Deltoid. Lot number: 946624. Expiration 30-Jun-2025, CSL Seqirus batch number 946624. No additional suspect drugs. Adverse reactions/events and outcomes: On 03-Jan-2025, the patient experienced Vaccination failure (Medically Significant, outcome: Unknown). On 03-Jan-2025, the patient experienced Tested positive for Flu Strain A (Medically Significant, outcome: Unknown). Associated symptoms included: Aches, Chills, Congestion, Severe cough, Tiredness, Pain in ears. On 03-Jan-2025, after visiting for the week, patient had returned home with aches and chills. Over the weekend, congestion, and a severe cough continued. Other symptoms consisted of tiredness, and pain in ears. Finally, after going to a local urgent care on 06-Jan-2025 she tested positive for Flu Strain A. She has been to the doctor to confirm the diagnosis, but it was not known if she has received any treatment. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the events as non-serious and causality assessment was not reported. The event Tested positive for Flu Strain A and Vaccination failure upgraded to serious considering event's clinical significance.; Reporter's Comments: Casuality: Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible. More
2821385 6 M UT 01/16/2025 COVID19
 PFIZER\BIONTECH
 lm2045
Unevaluable event Unevaluable event
N/A N/A
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