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
2865515 10/13/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Blister, Herpes zoster, Pain, Pruritus, Scab; Vaccination failure; Blister, Herp... Blister, Herpes zoster, Pain, Pruritus, Scab; Vaccination failure; Blister, Herpes zoster, Pain, Pruritus, Scab; Vaccination failure More
Shingles; Shingles; This serious case was reported by a consumer via interactive digital media and d... Shingles; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (The patient had one shot deal). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In SEP-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-OCT-2025 This case was reported by a patient via interactive digital media. The patient got shingles about 3 weeks ago at 72 years of age. The patient had both shots, one and then the second one 3 months later. The patient couldn't imagine the pain for someone without the vaccine. It was horrible and excruciating. The doctor prescribed gabapentin for the patient, which was amazing. The pain was tolerable, and the itching minimal. Most of the blisters were scabbed over, but not all. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine and Shingles vaccine, in a 72-year-old patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2865516 26 F TX 10/13/2025 FLU3
 SANOFI PASTEUR
Hypotonia, Lethargy, Swelling face, Urticaria Hypotonia, Lethargy, Swelling face, Urticaria
This patient received a influenza vaccine called Flublok Tri 0.5ml NDC 49281072510 , manufacture Sa... This patient received a influenza vaccine called Flublok Tri 0.5ml NDC 49281072510 , manufacture Sanofi., The patient called stating that, afterward when she was home, she experienced a swollen face, hives and feeling lethargic/limp-limbed. She took benadryl and all symptoms when away except for the hives. She did not seek medical attention but was advised to do so if symptoms worsened or new symptoms arise. More
2865517 89 F MI 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 72R4G
Extra dose administered, No adverse event Extra dose administered, No adverse event
Extra dose of shingrix, no reaction Extra dose of shingrix, no reaction
2865519 8 F NC 10/13/2025 COVID19
 PFIZER\BIONTECH
 NA4452
Erythema, Pain in extremity, Product administered to patient of inappropriate ag... Erythema, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia More
This is an 8 year old patient who was administered the Comirnaty (Pfizer) Covid vaccine intented for... This is an 8 year old patient who was administered the Comirnaty (Pfizer) Covid vaccine intented for patients 12 years of age and older at around 3:50pm. I (the pharmacist) realized the error at 5:25pm. I called the parents and informed them of the error. I counseled them that the patient could experience worse vaccine side effects than normal, including arm pain, redness, and fever. At the time of my call the mother reported the patient was feeling fine. I attempted to contact the parents the next day (Sunday) at 9am. I notified the provider of the error at 7:30am on Monday 10/13/25. I faxed them documentation of the immunization at 8:40am More
2865520 6 F ID 10/13/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 YF3413
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient was given a live vaccine 20 days prior to flumist Patient was given a live vaccine 20 days prior to flumist
2865522 61 F TN 10/13/2025 FLU3
 SANOFI PASTEUR
 U8832CA
Injection site urticaria Injection site urticaria
The day after the patient's flu shot, she developed hives on her left arm. The hives spread fro... The day after the patient's flu shot, she developed hives on her left arm. The hives spread from her shoulder to her elbow (about 10-12 hives on her arm). More
2865523 72 F IA 10/13/2025 COVID19
 PFIZER\BIONTECH
Blood test, Electrocardiogram, Generalised tonic-clonic seizure, Scan brain Blood test, Electrocardiogram, Generalised tonic-clonic seizure, Scan brain
Grand mail seizure Grand mail seizure
2865524 40 M TX 10/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FD8448
FD8448
FD8448
FJ5603
FJ5603
FJ5603
Anxiety, Blood test abnormal, Brain fog, Cardiac stress test normal, Echocardiog... Anxiety, Blood test abnormal, Brain fog, Cardiac stress test normal, Echocardiogram normal; Electrocardiogram normal, Fatigue, Impaired driving ability, Magnetic resonance imaging normal, Neuralgia; Palpitations, Postural orthostatic tachycardia syndrome, Tinnitus; Anxiety, Blood test abnormal, Brain fog, Cardiac stress test normal, Echocardiogram normal; Electrocardiogram normal, Fatigue, Impaired driving ability, Magnetic resonance imaging normal, Neuralgia; Palpitations, Postural orthostatic tachycardia syndrome, Tinnitus More
After my last jab, I developed noticeble brain fog and fatigue and after a year around March 2023 I ... After my last jab, I developed noticeble brain fog and fatigue and after a year around March 2023 I had this 1st episode of heavy and fast palpitaions which unable me to drive back home that day. Since then my health spiralled down, aside from palpitaions, I developed POTS like symtops, neuropathic pain, tinatus and anxiety. More
2865525 76 F FL 10/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052733
3052733
Arthralgia, Chills, Fatigue, Headache, Myalgia; Nausea, Pyrexia, Vomiting Arthralgia, Chills, Fatigue, Headache, Myalgia; Nausea, Pyrexia, Vomiting
Fever, chills, headache, muscle and joint aches, fatigue and nausea starting at 12.30 am on 10/10/20... Fever, chills, headache, muscle and joint aches, fatigue and nausea starting at 12.30 am on 10/10/2025 and lasting through 10/11/2025. Severe vomiting (5 times in less than 90 minutes) starting at 5.15 pm on 10/11/2025 and lasting until 7pm on 10/11/2025. Nausea persisting until 4pm on 10/12/2025 More
2865526 52 F WI 10/13/2025 UNK
 UNKNOWN MANUFACTURER
 7345R
Injection site bruising, Pain in extremity, Sleep disorder Injection site bruising, Pain in extremity, Sleep disorder
Patient called to report she had a flu vaccine on 10/1/25 at (withheld) Cancer Center and it was adm... Patient called to report she had a flu vaccine on 10/1/25 at (withheld) Cancer Center and it was administered by a (withheld) to her left arm. Patient stated it was difficult for the (withheld) to administer the shot and took a long time to administer it, Patient stated (withheld) pushed really hard to get needle into her arm. Patient stated now has bruise and left arm is sore and has constant pain to left arm and can't sleep. Taking Ibuprofen for pain but wants to see a provider. Patient advised she can go to Occ Health. Patient stated she will go to Occupational Health. Occupational Health site information given to Patient. More
2865527 83 M CA 10/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Unevaluable event Unevaluable event
None None
2865528 42 F WI 10/13/2025 COVID19
 PFIZER\BIONTECH
 NA0587
Burning sensation, Hypoaesthesia, Injection site pain, Paraesthesia Burning sensation, Hypoaesthesia, Injection site pain, Paraesthesia
Intermittent burning pins/needles near injection site, shoulder, neck on left side of body. Mild num... Intermittent burning pins/needles near injection site, shoulder, neck on left side of body. Mild numbness in left arm More
2865529 51 F TX 10/13/2025 FLU3
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 ut879ka
g77f3
Eye movement disorder, Tremor; Eye movement disorder, Tremor Eye movement disorder, Tremor; Eye movement disorder, Tremor
I had just finished giving the second shot for the pt, which was the flu shot. I had put needle away... I had just finished giving the second shot for the pt, which was the flu shot. I had put needle away in hazardous bucket and turned to pt. she started to talk, then all of a sudden, she sat back into the chair, her eyes rolled back, and she started to shake. I was able to hold her on to the chair, so she did not fall to the ground. I called for the nurses and dr to provide help. More
2865530 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
Sore arm; This non-serious case was reported by a consumer via interactive digital media and descri... Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine gave it a sore arm. The Novavax Covid with Flu barely registers. The patient was hale and hearty and still wearing an N95. The batch number was not provided and we and unable to contact the reporter. More
2865532 64 F NJ 10/13/2025 UNK
 UNKNOWN MANUFACTURER
 MY9550
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Patient accidentally received 2 doses of Comirnaty vaccine. She was supposed to get 1 Flu and 1 Covi... Patient accidentally received 2 doses of Comirnaty vaccine. She was supposed to get 1 Flu and 1 Covid vaccine. More
2865533 10/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Have had it on forehead and eyebrow going on; This serious case was ... Suspected vaccination failure; Have had it on forehead and eyebrow going on; 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 had it on forehead and eyebrow going on). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 08-OCT-2025 This case was reported by a patient via interactive digital media. Patient had it on forehead and eyebrow going on 2 yrs. Also, indicated that did have the shot early on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2865534 F TX 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55TH4
Inappropriate schedule of product administration Inappropriate schedule of product administration
first being administered in 11-AUG-2023 and second was given March 2nd, 2025; This non-serious case ... first being administered in 11-AUG-2023 and second was given March 2nd, 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (1st dose received on 11-AUG-2023 Batch no.: 3777F Expiry date: 30-MAY-2024). On 02-MAR-2025, the patient received the 2nd dose of Shingrix. On 02-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first being administered in 11-AUG-2023 and second was given March 2nd, 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 A pharmacist called in to request data about the stability of Shingrix. More
2865535 58 F TX 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9DM72
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repres... Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28-JAN-2023) for prophylaxis. Previously administered products included Shingrix (received first dose on 21-SEP-2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 The reporter reported that patient got Shingrix first dose on 21st September 2021 with batch lot 9DM72 and expiry on 28th January 2023. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. This case US2025125451 was reported by same reporter.; Sender's Comments: US-GSK-US2025125451:first patient case More
2865536 71 M NC 10/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 B5NJ9
Extra dose administered Extra dose administered
Extra dose; This non-serious case was reported by a pharmacist via call center representative and d... Extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B5NJ9, expiry date 05-DEC-2026) for prophylaxis. Previously administered products included Arexvy (Received 1st dose of Arexvy vaccine on 25-OCT-2023). On 02-OCT-2025, the patient received the 2nd dose of Arexvy. On 02-OCT-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra dose). The outcome of the extra dose administered was not applicable. More
2865537 F NJ 10/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 94kg2
Inappropriate schedule of product administration Inappropriate schedule of product administration
Administration in short intervals; This non-serious case was reported by a pharmacist via call cente... Administration in short intervals; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 94kg2, expiry date 28-NOV-2027) for prophylaxis. Previously administered products included Boostrix (received first dose on 21-MAR-2025). On 30-SEP-2025, the patient received the 2nd dose of Boostrix. On 30-SEP-2025, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: Administration in short intervals). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-OCT-2025 The reporter reported that patient was administrated with Boostrix in intervals that are less than 10 years. The patient received the first dose on 21st March 2025 and the second dose on 30th September 2025. The patient's initials were MA, female and 50 years of age. The vaccine dose administered in September had a lot number of 94kg2 and expiration date 28th November 2027. More
2865538 60 M NJ 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Inappropriate schedule of product administration Inappropriate schedule of product administration
got by accident an early second dose of Shingrix; This non-serious case was reported by a other heal... got by accident an early second dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number PJ353, expiry date 31-MAR-2027) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 02-SEP-2025, the patient received the 2nd dose of Shingrix. On 02-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: got by accident an early second dose of Shingrix). The outcome of the drug dose administration interval too short was not applicable. More
2865539 M CA 10/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
2nd dose of vaccine not received; This non-serious case was reported by a pharmacist via call center... 2nd dose of vaccine not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 23-SEP-2023). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: 2nd dose of vaccine not received). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-OCT-2025 A pharmacist reported that the patient did not receive the 2nd dose of Shingrix yet. The reporter enquired if they should give the 2nd dose or restart the series. The batch number was not provided upon follow- up with the reporter. More
2865540 58 M 10/13/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, CSF test, Creutzfeldt-Jakob disease, Electroencephalogram, Magnetic re... COVID-19, CSF test, Creutzfeldt-Jakob disease, Electroencephalogram, Magnetic resonance imaging head; Physical examination, SARS-CoV-2 test, Venogram, Viral test More
Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD); positive SARS-CoV-2 antigen... Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD); positive SARS-CoV-2 antigen test/ COVID-19 illness; This literature-non-study case was reported in a literature article and describes the occurrence of CREUTZFELDT-JAKOB DISEASE (Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD)) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (positive SARS-CoV-2 antigen test/ COVID-19 illness). In September 2022, the patient experienced CREUTZFELDT-JAKOB DISEASE (Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD)) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on sometime in September 2022 due to CREUTZFELDT-JAKOB DISEASE. The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) in 2022 at an unspecified dose and frequency; Methylprednisolone (intravenous use) in 2022 at an unspecified dose and frequency and Levetiracetam in 2022 at an unspecified dose and frequency. The patient died in 2023. The reported cause of death was post-covid neurodegeneration/ sporadic creutzfeldt-jakob disease (scjd). It is unknown if an autopsy was performed. At the time of death, COVID-19 (positive SARS-CoV-2 antigen test/ COVID-19 illness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, CSF test: Initial cerebrospinal fluid (CSF) analysis was normal. In 2022, Electroencephalogram: initial EEG revealed diffuse intermixed theta and delta activity throughout the trace with diffuse slowing, suggestive of severe encephalopathy likely due to an infectious, post-ictal, vascular, or metabolic etiology and A repeat EEG demonstrated diffuse slowing with intermixed periodic lateralized epileptiform discharges (PLEDs), which are nonspecific and not considered characteristic of CJD. In 2022, Viral test: (Negative) negative results for many possible viral encephalitis etiologies. In August 2022, SARS-CoV-2 test: (Positive) SARS-Cov-2 antigen test. In September 2022, Magnetic resonance imaging head: More extensive cortical-based abnormalities involving the bilateral frontal, parietal, and posterior temporal lobes which was done 7 days after initial MRI Scan. In September 2022, Physical examination: gait abnormalities and abnormal finger to nose testing bilaterally. In September 2022, Venogram: a magnetic resonance venography (MRV) scan showed normal patent dural venous vessels. On 22-Sep-2022, Magnetic resonance imaging head: subtle abnormal signal intensity throughout most of the parietal cortex bilaterally with nonspecific periventricular white matter T2 hyperintensities that favored sequelae of chronic small vessel disease but no masses, hemorrhage, or acute/subacute ischemia (first visit). On 11-Oct-2022, Magnetic resonance imaging head: A third brain MRI scan showed cortical-based high/intermediate T2/fluid attenuated inversion recovery (FLAIR) signal intensity with restricted diffusion involving the bilateral frontal, parietal, and temporal lobes, as well as the insula. Additionally, intermediate T2/FLAIR signal intensity involving both amygdalae and hippocampi and high T2/FLAIR bilateral hyperintensity involving lentiform nuclei, caudate nuclei, and thalami were noted. The entire cortex of both cerebral hemispheres showed intermediate to high T2/FLAIR signal intensity in the frontal, parietal, and temporal lobes, with similar changes now evident in the caudate, putamina, and thalami as noted on the axial FLAIR. Signal hyperintensity of the cortical gyri (cortical ribbon sign), typical of Creutzfeldt-Jakob disease, is now more evident on DWI. In October 2022, CSF test: CSF biomarker analysis obtained from the Pathology Surveillance Center in late Oct-2022 for prion disease, obtained from the Pathology Surveillance Center in late October, indicated that the patient had a > 98% likelihood of prion disease based on a positive real-time quaking-induced conversion (RT-QuIC), along with elevated T-tau protein (result valule-17293 pg/mL, Normal range- 0- 1149 pg/mL) and 14-3-3 gamma protein concentrations (60801 AU/mL, Normal range-<30 ๏ฟฝ 1,999 AU/mL). For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. A previously healthy patient had a positive SARS-CoV-2 antigen test in Aug-2022 after experiencing moderate flu-like symptoms, including chest tightness, dry cough, fever, malaise, and generalized weakness. Two weeks afterwards, he began to experience difficulty completing basic tasks, suffering from brain fog in addition to fatigue, frequent nightmares, and episodes of vertigo. Over the next 2 weeks, his symptoms worsened, resulting in recurrent episodes of vertigo, visual disturbances, tremors, cerebellar ataxia, and difficulty concentrating. Consequently, he presented to the emergency room (ER) in Sep-2022. Initial evaluation in the ER revealed an alert, oriented, and communicative with a chief complaint of worsening neuropsychiatric symptoms. Past medical history was unremarkable, besides a recent COVID-19 illness 4 weeks prior. He had previously received two doses of the Moderna COVID-19 vaccine without complications. The wife, who accompanied the patient, also claimed to notice some mood and behavior alterations over the past few weeks. It was determined to hospitalized patient to perform additional diagnostic evaluations. Lumbar puncture was performed to rule out infectious etiologies. Initial cerebrospinal fluid (CSF) analysis was normal, and while waiting for additional CSF results, empiric therapy for infectious and/or autoimmune encephalitis with intravenous immunoglobulin and IV methylprednisolone was started. A sample of his CSF was sent to the (withheld) Pathology Surveillance Center for the possibility of CJD. Over the subsequent weeks, the patient deteriorated rapidly, developing occasional episodes of myoclonic jerks, seizures, weakness, speech apraxia, and dysarthria. A repeat brain MRI several days after admission. In response to the onset of seizures, an electroencephalography (EEG) was conducted. By mid-to-late October, he was suffering from severe confusion and disorientation, generalized myoclonus, akinetic mutism, and global neurocognitive decline. The prior MRI, however, demonstrated cortical ribboning, a finding more typical of CJD. Given the patient's clinical and laboratory findings, the patient met all of the required criteria for a probable diagnosis of sporadic CJD (sCJD) according to the Centers for Disease Control and Prevention's (CDC) diagnostic guidelines. He was ultimately transferred to hospice and died in early 2023, approximately 5 months after symptom onset. Author concluded that this case highlights the unusually rapid progression of CJD symptoms following COVID-19 infection. While the link between SARS-CoV-2 and CJD remains unclear, clinicians should remain vigilant. New or rapidly worsening cognitive decline after COVID-19 may signal the onset of a rapidly progressive neurodegenerative disorder like CJD, warranting prompt evaluation and monitoring. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received with FTA contains significant information: Reporter information, literature citation, patient details, laboratory test, suspect product information, treatment medications, events added, cause of death and narrative updated. Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2025: Live follow-up received with FTA contains significant information: Reporter information, literature citation, patient details, laboratory test, suspect product information, treatment medications, events added, cause of death and narrative updated.; Reporter's Comments: Company comment: Concurrent COVID 19 infection is a confounder. It is possible that virus induced immune dysregulation have accelerated underlying neurodegenerative process, which manifested following vaccination and COVID 19 infection. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Post-COVID Neurodegeneration/ sporadic Creutzfeldt-Jakob Disease (sCJD) More
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2865541 44 M 10/13/2025 COVID19
 MODERNA
Pain Pain
feeling achy for a day; This spontaneous case was reported by a consumer and describes the occurrenc... feeling achy for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling achy for a day) in a 44-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (feeling achy for a day). At the time of the report, PAIN (feeling achy for a day) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. After receiving COVID vaccines, the patient felt achy for a day, nothing out of the ordinary. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790046 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790046:Master case (Patient 2 of 3) More
2865542 M 10/13/2025 COVID19
 MODERNA
Pain, Pyrexia Pain, Pyrexia
Achy type of reaction; A fever; This spontaneous case was reported by a consumer and describes the o... Achy type of reaction; A fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy type of reaction) and PYREXIA (A fever) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with Flu vaccine. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy type of reaction) and PYREXIA (A fever). At the time of the report, PAIN (Achy type of reaction) and PYREXIA (A fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Patient had received the first shot back in 2021 or whenever it first came out. It was reported that patient does a lot, it was just the usual things, patient would get maybe a little bit of a fever something like that. After the first one patient had a reaction, a fever, achy type of reaction, and now it was much less. For the first shot patient had most reacted. It was just that patient reacted to the flu shot the same way. It was reported that years ago, for the shingles shot patient had a shot reaction to it. It was nothing alarming, so it was not any big deal. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to MOD-2025-790050 (Patient Link). More
2865543 70 F 10/13/2025 COVID19-2
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CO... COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Nucala (Used to be on Nucala). Past adverse reactions to the above products included No adverse effect with Nucala. Concurrent medical conditions included Asthma and Allergy NOS (Highly allergic to different things). On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) Home test as well as pharmacy. Concomitant medication use information was not provided by reporter. The current age of the patient was reported as 73-year-old. Treatment medication use information was not provided by reporter. This case was linked to MOD-2021-026563 (Patient Link). More
2865544 71 F 10/13/2025 COVID19
 MODERNA
Asthma, Pneumonia, Respiratory syncytial virus infection Asthma, Pneumonia, Respiratory syncytial virus infection
RSV triggered her asthma; pneumonia; RSV triggered her asthma; This spontaneous case was reported by... RSV triggered her asthma; pneumonia; RSV triggered her asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (RSV triggered her asthma), PNEUMONIA (pneumonia) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Nucala (used to be on Nucala). Past adverse reactions to the above products included No adverse effect with Nucala. Concurrent medical conditions included Allergic asthma (asthma was allergy-induced) and Allergy NOS (highly allergic to different things). On 01-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced ASTHMA (RSV triggered her asthma) (seriousness criterion hospitalization), PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) (seriousness criterion hospitalization). At the time of the report, ASTHMA (RSV triggered her asthma), PNEUMONIA (pneumonia) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV triggered her asthma) outcome was unknown. No concomitant medication was reported. The patient was currently 73 years old. She did not want to get COVID, as she had asthma and her immune system, the older she gets the more problems she had. She gets allergy shots twice a week because her asthma was allergy-induced. She used to be on Nucala but at the time of reporting, she was trying on Xolair. She wore a mask everywhere she goes because she cannot chance COVID and she cannot chance getting the RSV virus again. It was two years ago this winter, and it almost killed her. The RSV triggered her asthma, went into pneumonia and she ended up in the hospital. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2021-026563 (Patient Link).; Reporter's Comments: Company comment: Respiratory syncytial virus infection, asthma (aggravated) and pneumonia are assessed as not related considering infectious nature of events and lack of biological plausibility for causality, and underlying asthma as contributing factor. The benefit-risk relationship of product is not affected by this report. More
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2865545 73 F 10/13/2025 COVID19
 MODERNA
SARS-CoV-2 test, Vaccination site reaction SARS-CoV-2 test, Vaccination site reaction
covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINAT... covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 in November 2022. Previously administered products included for Allergic asthma: Nucala. Past adverse reactions to the above products included No adverse effect with Nucala. Concurrent medical conditions included Allergic asthma (asthma was allergy-induced). Concomitant products included Omalizumab (Xolair) for Allergic asthma. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) on a home test. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. It was reported that, they gave her the shot, and she waited a half only because she had problems in the past with vaccines, not Moderna, but she was highly allergic to different things, so she chose to wait 30 minutes after vaccination. She did not want to get COVID, as she had asthma, her immune system, the older she got the more problems she had, and she got allergy shots twice a week because her asthma was allergy-induced. She used to be on Nucala, but they were now trying on Xolair. She also timed out her COVID vaccine between her Xolair shots. The patient had not missed one COVID vaccine. She had a COVID arm once and had previously reported it, could not recall when she had it. She wore a mask everywhere she went because she could not chance COVID and she could not chance getting the RSV virus again. She stated that it would be two years ago that winter and it almost killed her. She stated that the RSV triggered her asthma, went into pneumonia and she ended up in the hospital. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2021-026563 (Patient Link). More
2865546 72 F 10/13/2025 COVID19
 MODERNA
Pericarditis Pericarditis
Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERIC... Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Cardiac disorder and Mitral valve repair on 18-Jul-2025. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had pericarditis short-term after the surgery. Patient had never reacted to a Moderna vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Past medical history of Cardiac disorder and Mitral valve repair are contributors for the event. Due to nonsuggestive temporal association and recent cardiac surgery as alternative explanation, the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2865547 88 F FL 10/13/2025 COVID19
 MODERNA
 3052671
Fatigue, Pain, Skin mass Fatigue, Pain, Skin mass
soreness; extended fatigue/extreme fatigue; a couple of bumps; This spontaneous case was reported by... soreness; extended fatigue/extreme fatigue; a couple of bumps; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness), SKIN MASS (a couple of bumps) and FATIGUE (extended fatigue/extreme fatigue) in an 88-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052671) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE; for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and SPIKEVAX NOS. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In 2025, the patient experienced SKIN MASS (a couple of bumps). On 26-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced FATIGUE (extended fatigue/extreme fatigue). On 27-Sep-2025, the patient experienced PAIN (soreness). In 2025, SKIN MASS (a couple of bumps) had resolved. At the time of the report, PAIN (soreness) and FATIGUE (extended fatigue/extreme fatigue) had not resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had received vaccine on 26-Sep-2025, since then, she had an extended period of extreme fatigue, no rash, no fever, no cardiac manifestations, no nothing except extraordinary fatigue. Sometimes she can stand for 10 minutes and then has to lie down. No rash that they can see, a couple of bumps that have been there for a while but nothing else. No fever, no dizziness. She also had soreness. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789931 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live significant follow-up information received included: event couple of bumps was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789931:Husband case More
2865548 M NY 10/13/2025 COVID19
 MODERNA
Lung disorder Lung disorder
lung conditions; This spontaneous case was reported by a consumer and describes the occurrence of LU... lung conditions; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (lung conditions) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (lung conditions) (seriousness criterion medically significant). At the time of the report, LUNG DISORDER (lung conditions) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that the patient received Moderna vaccine since 2021 but now they cannot find it in their area. It was reported that the patient has a serious lung condition, and he must avoid all the respiratory infections. It was also reported that if patient did not find Moderna vaccine, then he can use Pfizer vaccination. No treatment medications provided by the reporter. This case was linked to MOD-2025-790011 (Patient Link).; Reporter's Comments: Unspecified lung disorder was assessed as not related to suspected vaccine. Based on available, very limited information this condition seems to be part of medical history, not an adverse reaction. Additionally, patient is taking Moderna COVID-19 Vaccine since 2021 to prevent infections as he has lung disorder, which suggest presence of lung disorder before the first vaccination. The benefit-risk relationship of the product is not affected by this report. More
2865549 70 M 10/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 039K20A
039K20A
Arthralgia, Chills, Headache, Immunisation reaction, Malaise; Myalgia, Pain, Pyr... Arthralgia, Chills, Headache, Immunisation reaction, Malaise; Myalgia, Pain, Pyrexia More
muscle pains; if he got up in the morning and felt pretty lousy, he was better by the afternoon; he ... muscle pains; if he got up in the morning and felt pretty lousy, he was better by the afternoon; he did pretty good until 9 o'clock that night - that's when the symptoms started coming/he felt like he had been hit by a truck; terrible joint pains/body aches that started in his ankles and his knees; chills; fever; headache; aching pain/it was bodily aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching pain/it was bodily aches), MALAISE (if he got up in the morning and felt pretty lousy, he was better by the afternoon), IMMUNISATION REACTION (he did pretty good until 9 o'clock that night - that's when the symptoms started coming/he felt like he had been hit by a truck), ARTHRALGIA (terrible joint pains/body aches that started in his ankles and his knees) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemical exposure (medications he takes are probably due to conditions from the chemicals he ate over there). Previously administered products included for Product used for unknown indication: Flu (he always takes his flu shots on his birthday) and SHINGRIX (he would not have taken it at the same time of the COVID one). Past adverse reactions to the above products included No adverse effect with Flu and SHINGRIX. Concurrent medical conditions included Blood pressure abnormal (he is on a mild blood pressure medication) and Blood cholesterol abnormal (he is on a cholesterol medication). Concomitant products included Adalimumab bwwd (Hadlima) and Rosuvastatin calcium (Crestor) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (if he got up in the morning and felt pretty lousy, he was better by the afternoon) and IMMUNISATION REACTION (he did pretty good until 9 o'clock that night - that's when the symptoms started coming/he felt like he had been hit by a truck). On 12-Feb-2021, the patient experienced MYALGIA (muscle pains). In 2021, the patient experienced PAIN (aching pain/it was bodily aches), CHILLS (chills) and HEADACHE (headache). 2021, the patient experienced ARTHRALGIA (terrible joint pains/body aches that started in his ankles and his knees) and PYREXIA (fever). On 12-Feb-2021, MALAISE (if he got up in the morning and felt pretty lousy, he was better by the afternoon) and IMMUNISATION REACTION (he did pretty good until 9 o'clock that night - that's when the symptoms started coming/he felt like he had been hit by a truck) had resolved. On 13-Feb-2021, MYALGIA (muscle pains) had resolved. In 2021, PAIN (aching pain/it was bodily aches), ARTHRALGIA (terrible joint pains/body aches that started in his ankles and his knees), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, HEADACHE (headache) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. It was stated that patient was on a mild blood pressure medication, a cholesterol medication, and a biosimilar to Humira (because he gets it for free), called Hadlima. Patient did not receive any vaccines within 4 weeks of receiving his doses of Spikevax NOS. It was stated that patient had 8 Moderna vaccines but provided the information for the first two as the symptoms only happened after the second one. He hasn't had symptoms since that second one. The patient was in pretty good health because of the medications he was on everything was in normal range. He didn't have any issues with those medications and that's why he could took the Moderna vaccine, because he had already had 8 of them. He worked at the hospital which gave him access to getting the COVID vaccines since he crossed paths frequently with COVID patients. The only vaccine he had a problem with was the second one out of all 8 of them. The second one was like a bus ran over him. It took him 24 hours to get over that one. He wasn't going to take Pfizer since he had 8 Moderna's and he has not had COVID. After his vaccine he had mild reactions to it headache, chills, fever, and body aches that started in his ankles and his knees. It was bodily aches. After his second dose, he felt like he had been hit by a truck. It was like all symptoms he gave (from his first vaccine) and multiply them by 100. It was pretty much like a bus ran over him. He could go to work if he didn't have a fever and didn't want to stay in bed. His symptoms from the second vaccine lasted 24 hours. He takes the vaccine in the morning so he would have taken it on the 11th in the morning and that he did pretty good until 9 o'clock that night that's when the symptoms started coming. All of them were pretty much the same, his symptoms didn't start coming on until 8 hours later. He would wake up with an aching pain, terrible joint pains, muscle pains, chills, fever. That was the only bad one (the second vaccine), the first one (vaccine) he endured pretty good. He just took it off and got up and went to work. The second one (vaccine), he could not go to work the next day and that was rare for him. The symptoms after his first vaccine lasted around a day. if he got up in the morning and felt pretty lousy, he would have been better by the afternoon. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789985 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789985:Case created for "People" More
2865550 74 F 10/13/2025 COVID19
 MODERNA
Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site rash... Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site reaction More
COVID arm; Sore arm; Red rash around the injection site (unspecified which arm); Red rash around the... COVID arm; Sore arm; Red rash around the injection site (unspecified which arm); Red rash around the injection site (unspecified which arm); Being tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy NOS (Different allergies). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Red rash around the injection site (unspecified which arm)), VACCINATION SITE RASH (Red rash around the injection site (unspecified which arm)) and FATIGUE (Being tired the next day) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Previously, the patient received the Moderna COVID-19 shots. The products were okay in your vaccine, so the patient was right with that. The patient had quite a few of the Moderna COVID-19 shots in the past, saying she had it since the beginning but added she had done that only once and had the other one. The patient did not experience any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789965 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789965:Husband case More
2865551 F MN 10/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052087
3052087
Dizziness, Fatigue, Headache, Nausea, Paranasal sinus discomfort; Vaccination si... Dizziness, Fatigue, Headache, Nausea, Paranasal sinus discomfort; Vaccination site rash More
lightheaded; rash at the injection site; Not like super blowing my nose, but pressure in my face; he... lightheaded; rash at the injection site; Not like super blowing my nose, but pressure in my face; headache; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Not like super blowing my nose, but pressure in my face), VACCINATION SITE RASH (rash at the injection site), DIZZINESS (lightheaded), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 2), PFIZER BIONTECH COVID-19 VACCINE (dose 1) and PFIZER BIONTECH COVID-19 VACCINE (dose 2). Past adverse reactions to the above products included Headache with PFIZER BIONTECH COVID-19 VACCINE; No adverse effect with PFIZER BIONTECH COVID-19 VACCINE; and Vaccination site reaction with PFIZER BIONTECH COVID-19 VACCINE. On 01-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2025, the patient experienced PARANASAL SINUS DISCOMFORT (Not like super blowing my nose, but pressure in my face), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On 04-Oct-2025, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 05-Oct-2025, the patient experienced DIZZINESS (lightheaded). The patient was treated with Echinacea purpurea (Echinacea) in 2025 at an unspecified dose and frequency and Zinc in 2025 at an unspecified dose and frequency. At the time of the report, PARANASAL SINUS DISCOMFORT (Not like super blowing my nose, but pressure in my face), VACCINATION SITE RASH (rash at the injection site), DIZZINESS (lightheaded), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) was resolving. The patient always had the Pfizer Covid vaccine, since the beginning and gotten it every time and had various reactions. With the first Pfizer Covid vaccine, patient felt like they had nothing. Had no reaction, had no spot. The second Pfizer Covid vaccine, the patient was in bed for a couple of days. The patient had a headache and developed a big red thing at the injection site with some of them. When the vaccine first came out, the patient got it that January. No concomitant medication was reported. On Thursday, 02-Oct-2025, the patient had pressure in her face, not like a super blowing nose. It's a pretty extreme headache, nausea, and fatigue. On Friday 03-Oct-2025, the symptoms all continued and worsened with activity. When the patient tried to do stuff, it got worse, so the patient had to slow down and wait for that nausea. It took several hours for that to go down. So, activity caused an issue with it. On Saturday 04-Oct-2025, the patient was fine in the morning, a little fatigued, and then everything else got worse. A rash at the injection site was noted, ended up finding just a slight little, almost looked like a rash in that area, like not really anything big. So, nothing big there. On Sunday, 05-Oct-2025, the patient had the same things with the headache, nausea, and lightheaded. On Monday, 06-Oct-2025, the patient was pretty good, just had a little bit of some of those things, but pretty mild. On Tuesday 07-Oct-2025, the patient might have a little bit. On 05-Oct-2025-night, the patient finally took something that had echinacea and zinc in it and patient used the neti pot and that helped kind of clear some of that out. The patient used the neti pot on 08-Oct-2025. The patient had taken that stuff with the echinacea. Zinc kind of does help. The patient was on her way to becoming normal. It was unknown if the patient experienced any additional symptoms/events. The reported causality was not reported. More
2865552 69 F 10/13/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First vaccine series (Dose 1)) and PFIZER BIONTECH COVID-19 VACCINE (First vaccine series (Dose 2)). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Spikevax NOS. On 25-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In August 2025, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. It was reported that the patient was never really reacted to the Moderna. The patient had first vaccine series with Pfizer, then switched to Moderna. The patient was diagnosed with COVID-19 in late August 2025. Diagnosis was based on positive testing result, symptoms and doctor visit. No hospitalization required. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790047, US-MODERNATX, INC.-MOD-2025-790050 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790047:Patient 02 US-MODERNATX, INC.-MOD-2025-790050:Patient 01 More
2865553 76 M 10/13/2025 COVID19
 MODERNA
Asthenia, Balance disorder, Tremor Asthenia, Balance disorder, Tremor
shaking uncontrollably; lost all strength when he tried to get up to use the restroom; lost his bala... shaking uncontrollably; lost all strength when he tried to get up to use the restroom; lost his balance; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking uncontrollably), ASTHENIA (lost all strength when he tried to get up to use the restroom) and BALANCE DISORDER (lost his balance) in a 76-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, the patient experienced TREMOR (shaking uncontrollably), ASTHENIA (lost all strength when he tried to get up to use the restroom) and BALANCE DISORDER (lost his balance). In 2023, TREMOR (shaking uncontrollably), ASTHENIA (lost all strength when he tried to get up to use the restroom) and BALANCE DISORDER (lost his balance) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was stated that patient had a severe reaction to the Moderna Covid vaccine 12 hours after administration. He started shaking uncontrollably, lost all strength when he tried to get up to use the restroom, as well as lost his balance. It was also stated that this happened to him two years ago with his health regaining back to normal after several weeks. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2865554 67 F 10/13/2025 COVID19
COVID19
 MODERNA
MODERNA

Decreased appetite, Fatigue, Headache, Nausea, Vaccination site erythema; Vaccin... Decreased appetite, Fatigue, Headache, Nausea, Vaccination site erythema; Vaccination site pain, Vaccination site swelling, Vaccination site warmth More
no appetite; Patient had huge swelling, the size of a goose egg, it was very hot, very red; Patient ... no appetite; Patient had huge swelling, the size of a goose egg, it was very hot, very red; Patient had huge swelling, the size of a goose egg, it was very hot, very red; Patient had huge swelling, the size of a goose egg, it was very hot, very red; very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm; incredible fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red) and VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm) in a 67-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer. Concurrent medical conditions included Celiac disease (Patient had it for 35 years). On 21-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 22-Sep-2025, the patient experienced DECREASED APPETITE (no appetite), VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm), FATIGUE (incredible fatigue), HEADACHE (headache) and NAUSEA (nausea). In 2025, DECREASED APPETITE (no appetite), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE ERYTHEMA (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE SWELLING (Patient had huge swelling, the size of a goose egg, it was very hot, very red), VACCINATION SITE PAIN (very sore to touch on her arm, where the injection went in (left arm)/tenderness in her arm) and FATIGUE (incredible fatigue) had not resolved. No concomitant medications were provided. It was reported that she usually got Pfizer vaccine. It was reported that she got sicker than she ever had with any vaccine in all of her 67 years. Her symptoms started the day after the vaccine. Most of her side effects were abated but she was going into week 3 now and she still had incredible fatigue. It also reported that she had huge swellings, the size of a goose egg, it was very hot, very red and very sore to touch on her arm, where the injection went in (left arm). She had extreme fatigue and could not even get out of bed, only to use the bathroom. She had a headache, nausea, absolutely no appetite and no fever. She still had some of them, but the worst of the symptoms lasted a week and a half. She still had tenderness in her arm and a pink outline of where that goose egg was. She still had fatigue, but it was better to the point where she can get out of bed, but it was a good thing she was not working or else she would have been in real trouble. She was surprised that she so violently reacted to the vaccine. Patient thought to herself, what in the heck did they put in that vaccine to be that sick. The patient never had COVID. It was unusual for her to get that from a vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. More
2865555 57 F IL 10/13/2025 COVID19
 PFIZER\BIONTECH
 FA7485
Illness, Loss of personal independence in daily activities Illness, Loss of personal independence in daily activities
Sick; I have not been able to work since; This is a spontaneous report received from a Consumer or o... Sick; I have not been able to work since; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received BNT162b2 (BNT162B2), on 14Sep2021 as dose 1, single (Lot number: FA7485) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "depressed" (ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LEXAPRO; LORAZEPAM. The following information was reported: ILLNESS (hospitalization) with onset 2021, outcome "unknown", described as "Sick"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I have not been able to work since".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500198212 same patient, different vaccine dose number/event;US-PFIZER INC-PV202300015030 same patient, different vaccine dose number/event; More
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2865556 F ME 10/13/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other n... would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 6, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 2, SINGLE; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 3, SINGLE; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 4, SINGLE; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (DOSE 5, SINGLE; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "With previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "would feel crummy for a day or two". Additional information: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. Sixth dose date does not have dates handy at time of call, could get if needed. Dose, route, anatomical location: Thinks all doses were in left arm since caller was right handed. With early doses had no problems, just with the last two doses. With previous doses would feel crummy for a day or two, as people do after any immunization. Patient also had the shingles vaccine, but waited at least 6 weeks ago from the most recent dose of the COVID vaccine, didn't want close together. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865557 F ME 10/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Malaise; Abdominal pain, Chills, Decreased appetite, Dyspepsia, Eructation; Flat... Malaise; Abdominal pain, Chills, Decreased appetite, Dyspepsia, Eructation; Flatulence, Malaise, Nausea, Pyrexia; Malaise; Abdominal pain, Chills, Decreased appetite, Dyspepsia, Eructation; Flatulence, Malaise, Nausea, Pyrexia More
With previous doses would feel crummy for a day or two; This is a spontaneous report received from a... With previous doses would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "With previous doses would feel crummy for a day or two". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865558 F ME 10/13/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other n... would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 7, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two"; Bnt162b2 (Dose: 2, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two"; Bnt162b2 (Dose: 3, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two"; Bnt162b2 (Dose: 4, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two"; Bnt162b2 (Dose: 5, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two"; Bnt162b2 (Dose: 6, Anatomical location: left arm), for COVID-19 Immunization, reaction(s): "would feel crummy for a day or two". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "would feel crummy for a day or two". Additional information: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. Seventh dose doesn't have dates handy at time of call, could get if needed. NDC, lot, expiry: Unknown at time of call. Dose, route, anatomical location: Thinks all doses were in left arm since caller is right handed. With early doses had no problems, just with the last two doses. With previous doses would feel crummy for a day or two, as people do after any immunization. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865559 75 F ME 10/13/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other n... would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "would feel crummy for a day or two". Batch/lot number is not provided, and it cannot be obtained. Additional information: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. Third dose date does not have dates handy at time of call, could get if needed. Dose, route, anatomical location: Thinks all doses were in left arm since caller was right handed. With early doses had no problems, just with the last two doses. With previous doses would feel crummy for a day or two, as people do after any immunization. More
2865560 F ME 10/13/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other n... would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 8, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 3: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 4: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 5: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 6: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 7: In left arm), for COVID-19 IMMUNIZATION, reaction(s): "With previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "would feel crummy for a day or two". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Additional information: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. Eight dose date does not have dates handy at time of call, could get if needed. Dose, route, anatomical location: Thinks all doses were in left arm since caller was right handed. With early doses had no problems, just with the last two doses. With previous doses would feel crummy for a day or two, as people do after any immunization. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865561 F 10/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Body temperature, Feeling hot, Hot flush, Pain, Pain in extremity; Pyrexia, Vacc... Body temperature, Feeling hot, Hot flush, Pain, Pain in extremity; Pyrexia, Vaccination site erythema More
my head feels hot after/ fever/ 102 on my head; hot flash; head feels hot; site redness; soreness in... my head feels hot after/ fever/ 102 on my head; hot flash; head feels hot; site redness; soreness in the arm; slight soreness; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immune system is damaged" (unspecified if ongoing); "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chemo for cancer.The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "my head feels hot after/ fever/ 102 on my head"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flash"; FEELING HOT (non-serious), outcome "unknown", described as "head feels hot"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "site redness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; PAIN (non-serious), outcome "unknown", described as "slight soreness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is a consumer calling about the Covid-19 mRNA vaccine. The reason she is calling is because she is one of the most vaccinated people with the covid vaccine in her community. She tries to get a booster ever 4 months. She does this because she studied coronaviruses and said that she knows how they affect farms and run through them. She has never worked in a laboratory, but was paying attention in class to know how coronaviruses go through farms and how to manage them. She is also a cancer patient and has had Chemo and because of that her immune system is damaged. She tries to stay vaccinated, and said that she is at high risk and if she were to get covid she could die from it. The most recent vaccine she had was the Pfizer mRNA Covid vaccine and she had it 10 days ago. Usually when she gets a vaccine she can tell that she had it because her head feels warmer and she checks for fever, but does not have a fever, but her head feels warmer. Stated that she has had the Moderna and Pfizer vaccines and has not had any reactions to the vaccines. Every time I have been vaccinated for Covid, my head feels hot after; like I think I'm running a fever but then again maybe it is a hot flash. I am not sure so I use a thermometer that checks your forehead and I have the ear thermometer and so I check around and yes the inside of my head gets warmer but it's never like dangerously warm. I get up to like 102 on my head but my throat stays normal temperature, the surface of my head is normal temperature, my arm pits are normal temperature. It's just like my brain says oh, we gotta warm up here, and so I don't worry about it. It's just the normal way that my body lets me know that I've been vaccinated for covid. I have none of that this time. I didn't even have a site reaction. I am not having any symptoms like I have in the past - no fever, no slight reaction, no site redness, no soreness in the arm afterwards. I felt the needle go in my arm but no signs or indication that I got the vaccine this time. I would not put it past this current administration that I may have gotten just placebo - either to replace product with something that is water or tell somebody they were vaccinated when they weren't or tampered with the product." "In the past, I have run a fever with the Covid 19 vaccines. I had slight soreness previously as well. I have received the Pfizer mRNA Covid vaccine and I have received Moderna, whatever is available at the pharmacy. I probably have been vaccinated more than 10 times, possibly 15-16 times, since the vaccine became available, since my immune system is damaged. I understand how coronavirus immunity is only short term so I need to stay vaccinated up, because I am high risk to die if I catch Covid. I attempt to get a Covid booster every 4 months, but I don't always succeed, since sometimes the pharmacy does not have product. I also have asthma and allergies and can't get it if my immune system is having issues going on so have to wait until the asthma or allergy problem clears up. I had to wait 8 months before I got this one and maybe my body forgot how to react to antigens. No signs of vaccination this time (COMIRNATY (2025-2026 Formula)). My immune system is damaged but it is not gone. After I got the first COVID vaccine, I think it was in 2021, my primary care physician arranged for me to have the covid test to see if I have had covid, It showed I did not have covid but I did have immunity from the vaccine. I may speak with him again about this and get tested again." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865562 F 10/13/2025 RSV
 UNKNOWN MANUFACTURER
Pain in extremity Pain in extremity
makes my arm very sore, like someone punched me in my arm, and it hurt so bad one day after I got it... makes my arm very sore, like someone punched me in my arm, and it hurt so bad one day after I got it; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 63-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "makes my arm very sore, like someone punched me in my arm, and it hurt so bad one day after I got it". The action taken for rsv vaccine prot.subunit pref 2v was unknown. Additional information: The patient reported that the RSV vaccine makes her arm very sore, like someone punched her in her arm, and it hurt so bad one day after she got it she was unable to provide RSV brand name at the time of report but indicated it would be in her records at the pharmacy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865563 10/13/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Hallucination; Hallucination Hallucination; Hallucination
severe hallucinations; This is a spontaneous report received from a Consumer or other non HCP. Other... severe hallucinations; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789858 (Moderna Clinical Safety and Pharmacovigilance). A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Respiratory disorder" (unspecified if ongoing); "unable to take penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunization, reaction(s): "severe hallucinations". The following information was reported: HALLUCINATION (medically significant), outcome "recovered", described as "severe hallucinations". Clinical course: It was reported that patient had always Moderna vaccine, but 2 times took Pfizer dose vaccination. However, both times had a reaction. It was reported that the patient had severe hallucinations. When the patient slept, used to see images in brain. This was very disturbing for the patient. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865564 80 F FL 10/13/2025 COVID19
 PFIZER\BIONTECH
 GH9702
COVID-19, Drug ineffective COVID-19, Drug ineffective
she got Omicron 3 weeks after receiving that dose; she got Omicron 3 weeks after receiving that dose... she got Omicron 3 weeks after receiving that dose; she got Omicron 3 weeks after receiving that dose; This is a spontaneous report received from a Consumer or other non HCP. An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2021 as dose 4, (booster) single (Lot number: GH9702) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), on 27Mar2021 as dose 2, single (Lot number: EP7534) and on 28Oct2021 as dose 3, (booster) single (Lot number: FF2593) 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 Jan2022, outcome "unknown" and all described as "she got Omicron 3 weeks after receiving that dose". More
2865565 F 10/13/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Rash pruritic, Rash vesicular Rash pruritic, Rash vesicular
small rashes spread out throughout body (looks like little small blisters, itchy); small rashes spre... small rashes spread out throughout body (looks like little small blisters, itchy); small rashes spread out throughout body (looks like little small blisters, itchy); This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 10Oct2025 as dose 1, single (Lot number: NA0589) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH PRURITIC (non-serious), RASH VESICULAR (non-serious), outcome "unknown" and all described as "small rashes spread out throughout body (looks like little small blisters, itchy)". Additional information: Patient did not receive any other vaccines on the same date as the vaccine(s) and did not receive any other vaccines within 4 weeks prior to the vaccine(s). Not on any other medications within 2 weeks of the event starting. No follow-up attempts are possible. More
2865566 F IL 10/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
thankful for the release of Pfizer's vaccine. I know that it saved me/my recent Paxlovid; thank... thankful for the release of Pfizer's vaccine. I know that it saved me/my recent Paxlovid; thankful for the release of Pfizer's vaccine. I know that it saved me/my recent Paxlovid; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "thankful for the release of Pfizer's vaccine. I know that it saved me/my recent Paxlovid". Clinical course: Patient inquired as to whether they could find any recourse to the fee, they had to pay for patient's recent Paxlovid prescription. Patient tried to apply with program beforehand, to find out that as patient have, patient would not be eligible. For that patient somewhat grateful but patient was 75, retired and on a fixed income it took some consideration. Not taking it was not an option for patient. As patient was immunocompromised with Chronic Lymphocytic Leukemia. Patient's husband was 78 year old now has Covid and has underlying lung disease. Another redacted keeping him from wanting to fill the prescription. Still patient encouraging him to do that. Patient understood that assistance was available for those without insurance, it remains a hardship for those of them in "the middle". It needn't be said, as it was the product and apart from the Covid vaccine, Paxlovid is almost singularly crucial in the management and reduction of symptoms, and often critical to the elderly and those with underlying medical conditions to prevent complications and hospitalization or worse. Patient was incredibly thankful for the release of Pfizer's vaccine. Patient know that it saved her. Patient then came out of retirement to administer Covid vaccines for a year and a half and have sponsored vaccine clinics as a nurse.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (COVID-19) with the suspect product BNT162B2 OMICRON (LP.8.1) cannot be fully excluded. More
2865567 10/13/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Fatigue, Pain, Pain in extremity; Fatigue, Pain, Pain in extremity Fatigue, Pain, Pain in extremity; Fatigue, Pain, Pain in extremity
soreness of the arm; achy feeling in the body; tiredness; This is a spontaneous report received from... soreness of the arm; achy feeling in the body; tiredness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789886 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single intramuscular for covid-19 prophylaxis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose number unknown (at least 2 or 3 shots with Moderna COVID-19 vaccine, but had more Pfizer COVID-19 shots)), for COVID-19 immunization; Pfizer covid-19 shots (dose number unknown (at least 2 or 3 shots with Moderna COVID-19 vaccine, but had more Pfizer COVID-19 shots)), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "soreness of the arm"; PAIN (non-serious), outcome "recovered", described as "achy feeling in the body"; FATIGUE (non-serious), outcome "recovered", described as "tiredness". Additional information: No concomitant medication was reported. No medical conditions, no vaccines within the past 4 weeks prior to receiving last COVID-19 vaccine. The patient probably had at least 2 or 3 shots with Moderna COVID-19 vaccine, but had more Pfizer COVID-19 shots and received several Moderna COVID-19 shots. But the patient was unsure if it was the Pfizer or the Moderna COVID-19 vaccine had a year ago. The patient wanted to know if the Spikevax vaccine would alter anything of their laboratory work on Monday as the patient would be receiving the said product on the day of reporting in the afternoon. The patient also asked if the mNEXSPIKE covered the same variant with Spikevax. The patient then followed up by asking if would have a reaction to the said product if did not have any major reaction with previous Moderna COVID-19 vaccine. The patient had soreness of the arm as everybody does, a little achy feeling in the body, tiredness which usually went away after 2 days. The patient did not remember which Moderna COVID-19 vaccine or Pfizer COVID-19 vaccine had to the said reactions. The patient described these reactions as slight, light and not bad. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact. Batch/lot number is not provided, and it cannot be obtained. More
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