🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

  • ✅ Early warning system for potential safety signals
  • ✅ Open and transparent - publicly accessible
  • ✅ Accepts all reports regardless of likelihood of causation
  • ✅ Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2859192 4 F TX 09/16/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Expired product administered Expired product administered
Expired vaccine used/ an expire Kinrix vaccine was administered to a 4-year-old; This non-serious ca... Expired vaccine used/ an expire Kinrix vaccine was administered to a 4-year-old; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. On 02-SEP-2025, the patient received Kinrix (intramuscular, right thigh) .5 ml. On 02-SEP-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine used/ an expire Kinrix vaccine was administered to a 4-year-old). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-SEP-2025 The reporter was the office coordinator of a family health center. No additional event was provided for this report. More
2859193 13 F MA 09/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 EB9ZX
Incorrect dose administered Incorrect dose administered
adult version of Engerix was given to a pediatric patient; adult version of Engerix was given to a p... adult version of Engerix was given to a pediatric patient; adult version of Engerix was given to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 13-year-old female patient who received HBV (Engerix B adult) (batch number EB9ZX) for prophylaxis. On 08-SEP-2025, the patient received Engerix B adult. On 08-SEP-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: adult version of Engerix was given to a pediatric patient) and overdose (Verbatim: adult version of Engerix was given to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:08-SEP-2025 Nurse reported that the adult version of Engerix was given to a pediatric patient, which led to adult product administered to child and Overdose. More
2859194 M NC 09/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
For unknown reasons he did not yet receive the second dose; This non-serious case was reported by a ... For unknown reasons he did not yet receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: For unknown reasons he did not yet receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 10-SEP-2025 The patient self-reported this case for himself. Nothing else was reported. More
2859195 09/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Arthralgia, Back pain Arthralgia, Back pain
back and joint pains; back and joint pains; This non-serious case was reported by a consumer via int... back and joint pains; back and joint pains; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In MAY-2025, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced back pain (Verbatim: back and joint pains) and joint pain (Verbatim: back and joint pains). The outcome of the back pain and joint pain were resolved (duration 2 weeks). It was unknown if the reporter considered the back pain and joint pain to be related to RSV vaccine. It was unknown if the company considered the back pain and joint pain to be related to RSV vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. The patient had this respiratory syncytial virus vaccine shot and had back and joint pains for almost 2 weeks afterwards. More
2859196 09/16/2025 MEN
 UNKNOWN MANUFACTURER
 UNK
Musculoskeletal stiffness Musculoskeletal stiffness
stiff neck; This non-serious case was reported by a consumer via interactive digital media and descr... stiff neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of stiff neck in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced stiff neck (Verbatim: stiff neck). The outcome of the stiff neck was not reported. It was unknown if the reporter considered the stiff neck to be related to Meningococcal B vaccine. It was unknown if the company considered the stiff neck to be related to Meningococcal B vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter had teenager grandchildren and only know that stiff neck was a symptom. The reporter heard about it occasionally on a college campus. More
2859197 F 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
Hypoaesthesia, Peripheral swelling, Swelling, Swelling face Hypoaesthesia, Peripheral swelling, Swelling, Swelling face
my arm got swelled up the whole way down to my wrist; numb right arm/neck numbness/numb right side o... my arm got swelled up the whole way down to my wrist; numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face; Swelling went up my neck and the back of my skull on the right side, right where my ears are; Swelling in the side of my face on the right side; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extensive swelling of vaccinated limb (Verbatim: my arm got swelled up the whole way down to my wrist), hypoesthesia (Verbatim: numb right arm/neck numbness/numb right side of the face/numb skull/numb front of the face), local swelling (Verbatim: Swelling went up my neck and the back of my skull on the right side, right where my ears are) and facial swelling (Verbatim: Swelling in the side of my face on the right side). The outcome of the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling were not reported. It was unknown if the reporter considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. It was unknown if the company considered the extensive swelling of vaccinated limb, hypoesthesia, local swelling and facial swelling to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025106918 Additional Information: GSK Receipt Date: 19-AUG-2025 The patient self-reported this case for herself. Patient explained she got a first dose of Shingles vaccine (unknown brand name or lot number) a few years ago (unknown specific date) and she got a bad reaction. And now her physician recommended to restart the series, and she got recombinant zoster vaccine (unknown brand name or lot number), but she was having a bad reaction again, exactly the same reaction than the first time, numbing of the one side of her face, and the back of her skull and down her right arm were she got the shot. The patient did tell her physician the first Shingles shot she had, she had bad reactions from and she really did not want to take the shot again, but she just said that she thought it was a very good idea if she would, she said this one was different, it might have been different but it was still the same reaction, first dose and second dose was exactly the same, she got it and her arm got swelled up the whole way down to her wrist and then it went up her neck and the back of her skull on the right side, right where her ears were and the side of her face on the right side, it was like a numbing, both her skull and the front of her face were like numb and she did not like those reactions.; Sender's Comments: US-GSK-US2025106918:same patient More
2859198 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersensitivity Hypersensitivity
Patient had allergic reaction to this shot; This non-serious case was reported by a non-health profe... Patient had allergic reaction to this shot; This non-serious case was reported by a non-health professional via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction (Verbatim: Patient had allergic reaction to this shot). The outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. It was unknown if the company considered the allergic reaction to be related to Shingles vaccine.; Sender's Comments: US-GSK-US2025AMR113017:Original Case Number : US2025AMR113017 US-GSK-US2025AMR113023:Original Case Number : US2025AMR113017 More
2859199 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was 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: 02-SEP-2025 This case was reported by a patient via interactive digital media. The patient had the shots around 5 years ago and just got over a mild case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2859200 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I forgot to get the second one; This non-serious case was reported by a consumer via interactive dig... I forgot to get the second one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 16-JUL-2024). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. The patient had incomplete course of vaccination (Verbatim: I forgot to get the second one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 31-AUG-2025 The reporter reported that he/she had the first shingles vaccine on 16th July 2024. The reporter forgot to get the second one. The reporter asked could he/she get the 2nd one now. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine which led to incomplete course of vaccination. More
2859201 M 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-SEP-2025 This case was reported by a patient's relative via interactive digital media. The patient (reporter's uncle) got shot about 6 months from he got shingles, but his case was mild. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 6 months after receiving Shingles vaccine, in a male 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
2859202 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
I just got the second shot, and my arm is killing me but better than shingles; This non-serious case... I just got the second shot, and my arm is killing me but better than shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: I just got the second shot, and my arm is killing me but better than shingles). The outcome of the arm discomfort was not reported. It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine. It was unknown if the company considered the arm discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by the patient via interactive digital media. More
2859203 09/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never followed up on my second dose; This non-serious case was reported by a consumer via call cente... never followed up on my second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose of vaccine in 2017). The patient did not receive the 2nd dose of Shingles vaccine. The patient had incomplete course of vaccination (Verbatim: never followed up on my second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 10-SEP-2025 This case was reported by a patient via interactive digital media. Patient had received a shingles vaccine in 2017 but never followed up with the second dose. He/she wondered if he/she could still get another vaccination and be okay. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2859204 0.5 M MO 09/16/2025 DTAPHEPBIP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9C295
7NX57
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Extra dose administered; the patient was given pediarix that also has hep B in it and they gave also... Extra dose administered; the patient was given pediarix that also has hep B in it and they gave also separately Hep B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 9C295, expiry date 02-FEB-2027) for prophylaxis. Previously administered products included Pentacel (received 1st dose on an unknown date) and Pentacel (received 2nd dose on an unknown date). On 18-AUG-2025, the patient received the 4th dose of Engerix B pediatric and Pediarix. On 18-AUG-2025, an unknown time after receiving Engerix B pediatric and not applicable after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra dose administered) and overdose (Verbatim: the patient was given pediarix that also has hep B in it and they gave also separately Hep B vaccine). The outcome of the extra dose administered and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-AUG-2025 The reporter was calling to see if you have any information on if a patient were to get a Pediarix along with the Hepatitis B at the same time, if they have any information on any kind of adverse side effects that the reporter look at the patient. The reporter asked if the patient received both, the Pediarix and the Hepatitis B separately in the same visit was there any side effects that they needed to be watching for any in danger to the patient. The reporter asked it was the First dose of Pediarix, they had two pentacel. They did not Pentacel anymore, so they have switched for pediarix so then, the patient was given pediarix that also has hepatitis B in it and they gave also separately Hep B vaccine on the day of reporting as well. This would be the Third, actually, the Fourth Hepatitis B, because they had 2 doses on the day of reporting which led to extra dose administered and overdose. More
2859205 F TN 09/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Inappropriate schedule of product administration, Incorrect dose administered Inappropriate schedule of product administration, Incorrect dose administered
A 19 years old female patient received a 20 mcg dose of Engerix-B.; Overdose; drug dose administrati... A 19 years old female patient received a 20 mcg dose of Engerix-B.; Overdose; drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 28-AUG-2025, the patient received the 2nd dose of Engerix B adult. On 28-AUG-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: A 19 years old female patient received a 20 mcg dose of Engerix-B.), overdose (Verbatim: Overdose) and drug dose administration interval too long (Verbatim: drug dose administration interval too long). The outcome of the adult product administered to child, overdose and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-AUG-2025 The reporter reported on 28th August 2025 an assistant director of quality and nursing called to report that they administered on the day of reporting an adult dose of Engerix-B (20 mcg) to a patient who was 19 years old. The patient would be 20 years old in December. This was the 2nd dose of Engerix-B that the patient has received which led to overdose, Adult product administered to child and lengthening of vaccination schedule. First dose of Engerix-B was administered on 18th July 2025. The reporter asked how did they have to proceed with the third dose. More
2859206 6 M MN 09/16/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Expired product administered Expired product administered
expired dose was administered; This non-serious case was reported by a nurse via call center repres... expired dose was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. On 28-AUG-2025, the patient received the 1st dose of Kinrix. On 28-AUG-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose was administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-AUG-2025 According to the nurse, one expired vaccine was left at the fridge by accident and that was the reason it was administered inadvertently. The reporter contacted to seek guidance after this incident and if re vaccination was required. The vaccine administration facility was the same as primary reporter. More
2859207 FL 09/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minut... the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, and confirmed that they had already been administered, but did not specify to whom or which lots; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, and confirmed that they had already been administered, but did not specify to whom or which lots). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:02-SEP-2025 Other Health Professional called in to request data about the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, after review of temperature logs. They stated that the vaccines were gone to which probing questions were made and the healthcare professional confirmed that they had already been administered but did not specify to whom or which lots, which led to incorrect storage of drug. The HCP was consented to receive follow-up for this scenario. The Vaccine Administration Facility was the same as Primary Reporter. More
2859208 37 F OH 09/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 D4774
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early Third Dose; This non-serious case was reported by a pharmacist via call center representative ... Early Third Dose; 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 37-year-old female patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix) and Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 10-MAY-2025, the patient received the 3rd dose of Twinrix. On 10-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Early Third Dose). 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: 11-SEP-2025 The reporter reported that patient wanted to come in for her third shot and noted that the schedule was zero, one, six months but she has gotten one in March and then another in April and one month later again in May as had early third dose which led to shortening of vaccine schedule. The vaccines were given as follows 1st dose was given on 9th March 2025, 2nd dose on 9th April 2025 and 3rd dose on 10th May 2025. More
2859209 F 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Vertigo Vertigo
Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (... Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: COVID vaccine (had vertigo once before 3 days after receiving a Covid Vaccine). Past adverse reactions to the above products included Vertigo with COVID vaccine. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Patient woke up during the night with vertigo after receiving the vaccine. Patient have had this issue once before and when looked back through the patient's records, it turned out that during that time, it occurred 3 days after receiving a Covid vaccine. It was reported that probably it might be a coincidence, but it gave the patient a pause. When patient looked it up, the patient could not find anything conclusive. Treatment information was not reported. This case was linked to MOD-2025-789132 (Patient Link). More
2859210 09/16/2025 COVID19
 MODERNA
Influenza like illness Influenza like illness
Patient had body aches, headache, chills and fever (flu-like, bed-confining) symptoms; This spontane... Patient had body aches, headache, chills and fever (flu-like, bed-confining) symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient had body aches, headache, chills and fever (flu-like, bed-confining) symptoms) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Patient had body aches, headache, chills and fever (flu-like, bed-confining) symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Patient had body aches, headache, chills and fever (flu-like, bed-confining) symptoms) had resolved. No concomitant medications were provided. Patient had the body aches, headache, chills and fever (flu-like, bed-confining) symptoms for a day or so that patient had gotten with all previous Moderna COVID vaccines & 6-month boosters. No treatment medication was provided. This case was linked to MOD-2025-789274 (Patient Link). More
2859211 64 F NJ 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Asthenia, Fatigue, Lip swelling, Pain Asthenia, Fatigue, Lip swelling, Pain
swollen lips; asthenia; local pain aches; fatigue; This spontaneous case was reported by a consumer ... swollen lips; asthenia; local pain aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 06-Sep-2025, the patient experienced LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue). At the time of the report, LIP SWELLING (swollen lips), ASTHENIA (asthenia), PAIN (local pain aches) and FATIGUE (fatigue) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2859212 F 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Erythema, Swelling Erythema, Swelling
had a localized reaction in her arm (red swollen area); had a localized reaction in her arm (red swo... had a localized reaction in her arm (red swollen area); had a localized reaction in her arm (red swollen area); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)). At the time of the report, VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)) was resolving. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. More
2859213 69 M 09/16/2025 COVID19
 MODERNA
Follicular lymphoma recurrent Follicular lymphoma recurrent
Diagnosed with Lymphoma in 2019 before the vaccines and was cured in 2022 then had a relapse sometim... Diagnosed with Lymphoma in 2019 before the vaccines and was cured in 2022 then had a relapse sometime after; This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULAR LYMPHOMA RECURRENT (Diagnosed with Lymphoma in 2019 before the vaccines and was cured in 2022 then had a relapse sometime after) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Follicular lymphoma from 2019 to 2022 and CAR T-cell therapy. 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 FOLLICULAR LYMPHOMA RECURRENT (Diagnosed with Lymphoma in 2019 before the vaccines and was cured in 2022 then had a relapse sometime after) (seriousness criterion medically significant). At the time of the report, FOLLICULAR LYMPHOMA RECURRENT (Diagnosed with Lymphoma in 2019 before the vaccines and was cured in 2022 then had a relapse sometime after) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication information was not provided. It was reported that the patient had first been diagnosed with lymphoma in 2019, before the vaccines, and was cured in 2022. He later experienced a relapse with his condition becoming particularly severe in December 2024.The patient then received treatment again and was reported to be cured. It was unknown if the patient experienced any additional symptoms or events.; Reporter's Comments: Company comment: Underlying history of follicular lymphoma is a risk factor for disease recurrence. The benefit-risk relationship of product is not affected by this report. More
2859214 78 F 09/16/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 3052549
3052549
Cold sweat, Feeling abnormal, Feeling cold, Malaise, Pain in extremity; Sleep di... Cold sweat, Feeling abnormal, Feeling cold, Malaise, Pain in extremity; Sleep disorder More
her arm hurt; It was just really a malaise, and the worst reaction ever to a vaccine; she was clammy... her arm hurt; It was just really a malaise, and the worst reaction ever to a vaccine; she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.; she didn't sleep all night.; was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees; felt really awful after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.) and FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine). At the time of the report, PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had received her most recent vaccine in the previous week and had experienced the worst reaction to any vaccine she had ever had. The patient had initially thought that she had received Spikevax 2024-2025 formula or last year's formulation, but on further investigation it had been confirmed that she had received Spikevax 2025-2026 formula. The patient had been very upset that no one at Pharmacy had offered her mNEXSPIKE as an option. On Saturday, she had felt so cold that, although the temperature had been 90 degrees, she had needed two quilts. She never had COVID and also not had fever. She had not slept all night on Friday. She felt crappy and had cold and not sweaty. It was also reported that after that horrible reaction and then seeing a commercial for mNEXSPIKE, which she had not been offered, had caused her to question whether she had received the most up-to-date vaccine formulation Treatment medication was not reported.. This case was linked to US-MODERNATX, INC.-MOD-2021-034872 (E2B Linked Report). This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.) and FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine). At the time of the report, PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had received her most recent vaccine in the previous week and had experienced the worst reaction to any vaccine she had ever had. The patient had initially thought that she had received Spikevax 2024-2025 formula or last year's formulation, but on further investigation it had been confirmed that she had received Spikevax 2025-2026 formula. The patient had been very upset that no one at Pharmacy had offered her mNEXSPIKE as an option. On Saturday, she had felt so cold that, although the temperature had been 90 degrees, she had needed two quilts. She never had COVID and also not had fever. She had not slept all night on Friday. She felt crappy and had cold and not sweaty. It was also reported that after that horrible reaction and then seeing a commercial for mNEXSPIKE, which she had not been offered, had caused her to question whether she had received the most up-to-date vaccine formulation Treatment medication was not reported.. This case was linked to US-MODERNATX, INC.-MOD-2021-034872 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-034872:Same patient, Moderna COVID-19 Vaccine More
2859215 M 09/16/2025 COVID19
 MODERNA
Fatigue, Pyrexia Fatigue, Pyrexia
he had fatigue/he was tired; maybe a little bit of temperature which lasted 12 hours; This spontaneo... he had fatigue/he was tired; maybe a little bit of temperature which lasted 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (he had fatigue/he was tired) and PYREXIA (maybe a little bit of temperature which lasted 12 hours) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. In 2021, the patient experienced FATIGUE (he had fatigue/he was tired) and PYREXIA (maybe a little bit of temperature which lasted 12 hours). In 2021, PYREXIA (maybe a little bit of temperature which lasted 12 hours) had resolved. At the time of the report, FATIGUE (he had fatigue/he was tired) outcome was unknown. No concomitant medication was reported. The patient had first and second dose roughly 4 to 6 weeks apart. The patient had at least 7 to 8 Moderna COVID vaccines and had no side effects from the last 4 or 5 vaccines. He had a reaction to his first and second Moderna COVID vaccines, as predicted and as most people did. After the first Moderna COVID vaccine, the patient had a severe reaction, and he had fatigue and maybe a little bit of temperature which lasted 12 hours, about half a day. The second Moderna COVID vaccine wasn't too bad. He was tired and had no temperature, for just a short period of time, 3 to 6 hours. No other details were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789287, US-MODERNATX, INC.-MOD-2025-789294, US-MODERNATX, INC.-MOD-2025-789298, US-MODERNATX, INC.-MOD-2025-789300 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789287:Case for multiple patients (Invalid) US-MODERNATX, INC.-MOD-2025-789294:Patient 1 (Brother 1) US-MODERNATX, INC.-MOD-2025-789298:Patient 3 (Brother 3) US-MODERNATX, INC.-MOD-2025-789300:Patient brother 2 More
2859216 70 M MS 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Chills, Fatigue, Feeling abnormal, Headache Chills, Fatigue, Feeling abnormal, Headache
I felt very bad; headache; fatigue; chills; This spontaneous case was reported by a consumer and des... I felt very bad; headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt very bad), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 08-Sep-2025, the patient experienced FEELING ABNORMAL (I felt very bad), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (I felt very bad), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events Treatment medication was not reported. Reporter causality was not reported. More
2859217 77 F 09/16/2025 COVID19
 MODERNA
Headache, Pain in extremity, Pyrexia Headache, Pain in extremity, Pyrexia
Sore arm for several days; fever; headache 12 hours later; This spontaneous case was reported by a c... Sore arm for several days; fever; headache 12 hours later; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for several days), PYREXIA (fever) and HEADACHE (headache 12 hours later) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In April 2025, the patient experienced PYREXIA (fever) and HEADACHE (headache 12 hours later). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for several days). The patient was treated with Paracetamol (Tylenol) for Fever and Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm for several days), PYREXIA (fever) and HEADACHE (headache 12 hours later) had resolved. No concomitant medications were provided. No other vaccinations were reported within the 4 weeks. Patient had experienced a fever and headache 12 hours later. However, these symptoms were resolved after taking Tylenol. Patient also mentioned that her arm was sore for several days. It was unknown if the patient experienced any additional symptoms/events. Reporter did not allow further contact More
2859218 F 09/16/2025 UNK
 UNKNOWN MANUFACTURER
Headache Headache
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE ... headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in an adult female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with Paracetamol (Acetaminophen) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. No concomitant medication was reported. The patient had the vaccine and took acetaminophen for her headache afterwards. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. Reporter did not allow further contact More
2859220 F 09/16/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
 MY9550
Ear pain, Pain in extremity, Tympanic membrane disorder, Vaccination site pain, ... Ear pain, Pain in extremity, Tympanic membrane disorder, Vaccination site pain, Vaccination site warmth; Ear pain, Pain in extremity, Tympanic membrane disorder, Vaccination site pain, Vaccination site warmth More
swollen eardrum; I still had ear pain; it felt hot at the shot point; my arm is really hurting and s... swollen eardrum; I still had ear pain; it felt hot at the shot point; my arm is really hurting and sore/slight pain in my arm; arm pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 at 14:30 as dose 1, single (Lot number: MY9550, Expiration Date: 12Jun2026) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Sep2025 at 14:30 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR PAIN (non-serious) with onset Sep2025, outcome "recovering", described as "I still had ear pain"; VACCINATION SITE PAIN (non-serious) with onset Sep2025, outcome "recovering", described as "arm pain at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Sep2025, outcome "unknown", described as "it felt hot at the shot point"; PAIN IN EXTREMITY (non-serious) with onset Sep2025, outcome "recovering", described as "my arm is really hurting and sore/slight pain in my arm"; TYMPANIC MEMBRANE DISORDER (non-serious) with onset Sep2025, outcome "recovering", described as "swollen eardrum". Therapeutic measures were taken as a result of tympanic membrane disorder, ear pain, pain in extremity, vaccination site pain. Additional information: As of 10Sep2025, Consumer stated, I got my COVID-19 Pfizer shot this past Sunday (07Sep2025) at 2:30. I am very happy with it, but since you are a pharmacist, right? I have a question. So, when I went to see my doctor a week ago, she told me my ear was bothering me, she said it's some allergies. She knew that I got my COVID and my Flu shot (Unspecified Flu shot) this past Sunday, but I had texted her that I still had ear pain, so she recommended, she prescribed Methylprednisolone (manufacturer was unknown) and she did 4 mg here so, for the first day, it's six doses, so that's 24 mg tapering each day 5,4,3,2,1 and so, when I went to the pharmacist to get those pills yesterday. The pharmacist said, did you just have a COVID shot on Sunday? He said I must wait with the Methylprednisolone. Wait a couple of days before you take it, because it could interfere with your COVID shot, but I thought well, I will contact my doctor to make sure because she knew I had my COVID shot. So, I called her, my doctor's team, and they didn't get back to her, I thought I was making a nuisance of myself. My doctor knows that I had the shot, it must be okay. I looked online, it said that on low dose it should be perfect. So, when I figured, I did not hear back from my doctor, probably I should just take it like I was being a nuisance and so at dinner last night, I took it. That was 48 hours after my COVID shot. Now, today, like yesterday my arm is really hurting and sore, and it felt hot at the shot point but today it's a lot less. What I am wondering and now I am worried about is because my doctor said she called me this morning. She said alright, I messaged you. I forgot you had the COVID shot and said, did you get my message? I did not get any message. She said she was going to tell me to stay, to wait. Now I am worried because I only had slight pain in my arm and I am worried that it is going to ruin my immune response to the COVID shot, which is more important. Caller received the Pfizer covid vaccine on Sunday, 07Sep2025 at 2:30 PM and has arm pain at the injection site. She has an allergy in her ear and was given prednisolone but her doctor told her she should not take it because she got the covid shot. She wanted more info. It was reported that the patient got the shot the past Sunday at 2:30 and then I was talking to my doctor about how I have that, I have a swollen eardrum and she recommended and she prescribed methylprednisolone and so the first day I take 6 of those 4 mg pills so it's like 24mg, when I went to pick up the medicine the pharmacist said that can interfere with your covid shot you just had Sunday, I tried calling my doctor but I'm unable to reach her so I took the first dose of the methylprednisolone after dinner last night, it seems to be helping my ear but yesterday my arm is like in decent amount of pain which is good because the covid shot is working but then now, today it was not in a lot of pain. my doctor calls me first thing this morning and she said did you get my message, but I did not get a message, she said I was going to tell you to hold off on it. Do you think it would interfere because I do not know if it was normal for the pain to start going away today or it was just starting to get activated, I do not know because I wonder if I need another shot. No follow-up attempts are possible. More
2859221 F 09/16/2025 COVID19
 PFIZER\BIONTECH
Herpes zoster Herpes zoster
experienced shingles after taking COVID Vaccine, consumer stated, "Yes, I did. Yes, day two to ... experienced shingles after taking COVID Vaccine, consumer stated, "Yes, I did. Yes, day two to day five/had reaction to all four; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 2023, outcome "unknown", described as "experienced shingles after taking COVID Vaccine, consumer stated, "Yes, I did. Yes, day two to day five/had reaction to all four". Additional information: The patient was just asking that where she can give some feedback on her vaccination which was not last year, 2023. She had four vaccines that year and thought two of them were Pfizer and she do not think Pfizer do the shingles one, but patient was not positive. The patient had two shingles shot (Unspecified shingles shot) that year, had a flu, the annual flu shot, and I had the COVID booster or whatever in the fall as well and that was Pfizer." The patient could not clarify the vaccination but stated it was COVID, it was flu shot and it was the two-shot series were the shingles, but she do not know if Pfizer does that one. she just have not looked it up, she did not, She know she got the Pfizer COVID booster that year." When clarified the manufacturer name as Pfizer for COVID Booster, the patient stated, "No, no she was saying she know for sure that COVID, that COVID shot was Pfizer because she had only ever gotten Pfizer." When asked if consumer experienced shingles after taking COVID Vaccine, consumer stated, "Yes, she did. Yes, day two to day five." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859222 F TX 09/16/2025 MNP
 PFIZER\WYETH
Pain in extremity Pain in extremity
Patient received Penbraya and got a sore arm for an extended period of time.; This is a spontaneous ... Patient received Penbraya and got a sore arm for an extended period of time.; This is a spontaneous report received from an Other HCP from a sales representative. An adolescent female patient received meningococcal group abcwy vaccine (PENBRAYA), 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 "Patient received Penbraya and got a sore arm for an extended period of time.". It was unknown if therapeutic measures were taken as a result of pain in extremity. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received. More
2859223 79 F 09/16/2025 COVID19
 PFIZER\BIONTECH
 NA0587
Arthralgia, Vaccination site bruising, Vaccination site erythema, Vaccination si... Arthralgia, Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site swelling More
Significant swelling, hardness and redness of upper right arm, deltoid region.; Bruising at injectio... Significant swelling, hardness and redness of upper right arm, deltoid region.; Bruising at injection site appeared later.; Significant swelling, hardness and redness of upper right arm, deltoid region.; Significant swelling, hardness and redness of upper right arm, deltoid region.; Right shoulder pain; This is a spontaneous report received from a Nurse. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Lot number: NA0587) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS; CALCIUM. Past drug history included: Contrast dye, reaction(s): "Allergy". The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 05Sep2025, outcome "recovering", described as "Bruising at injection site appeared later."; ARTHRALGIA (non-serious) with onset 05Sep2025, outcome "recovering", described as "Right shoulder pain"; VACCINATION SITE INDURATION (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 05Sep2025, outcome "recovering" and all described as "Significant swelling, hardness and redness of upper right arm, deltoid region.". Therapeutic measures were not taken as a result of vaccination site induration, vaccination site bruising, vaccination site erythema, arthralgia. No follow-up attempts are possible. More
2859224 54 M 09/16/2025 COVID19
 PFIZER\BIONTECH
Chills, Headache, Polyuria Chills, Headache, Polyuria
excessive urination; Chills; headache; This is a spontaneous report received from a Consumer or othe... excessive urination; Chills; headache; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering"; POLYURIA (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering", described as "excessive urination"; HEADACHE (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of polyuria, chills, headache. Additional information: Patient didn't received any other vaccines on the same date as the vaccine. Patient didn't received any other vaccines within 4 weeks prior to the vaccine. Patient didn't took any other medications within 2 weeks of the event started. No known drug allergy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859225 37 NJ 09/16/2025 COVID19
 PFIZER\BIONTECH
Agitation, Cognitive disorder, Disorientation, Pyrexia, Vomiting Agitation, Cognitive disorder, Disorientation, Pyrexia, Vomiting
not cognitively aware- not using right words when trying to talk; high fever; disoriented; agitated;... not cognitively aware- not using right words when trying to talk; high fever; disoriented; agitated; Threw up; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Pleomorphic xanthroastrocytoma" (unspecified if ongoing) and no known allergies. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 04Sep2025 as dose number unknown, single; ATORVASTATIN; KEPPRA [LEVETIRACETAM]; METOPROLOL; AVASTIN [BEVACIZUMAB]; KEYTRUDA. The following information was reported: VOMITING (hospitalization) with onset 13Sep2025 at 07:00, outcome "recovering", described as "Threw up"; AGITATION (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "agitated"; DISORIENTATION (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "disoriented"; PYREXIA (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "high fever"; COGNITIVE DISORDER (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "not cognitively aware- not using right words when trying to talk". The patient was hospitalized for vomiting, cognitive disorder, pyrexia, disorientation, agitation (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of vomiting, cognitive disorder, pyrexia, disorientation, agitation. Additional information: Patient received covid shot COMIRNATY (2025-2026 FORMULA) at 4P on 12Sep2025 - cognitively aware. Patient threw up at 7A the next morning 13Sep2025 and still cognitively aware. Patient then threwup at 9A but not cognitively aware, not using right words when trying to talk, had high fever, disoriented and agitated. As the result of these events, patient was hospitalized for 2 days. Treatment received for events included: Tylenol, antibiotics, anti-virals, morphine. The outcomes of events were reported as "recovering". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
✓
2859226 53 F NY 09/16/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pain Vaccination site pain
Injection site pain; This is a spontaneous report received from a Consumer or other non HCP. A 53-y... Injection site pain; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Sep2025 at 16:00, outcome "recovering", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Patient didn't received any other vaccines on the same date as the vaccine. Patient didn't received any other vaccines within 4 weeks prior to the vaccine. Patient took other medications within 2 weeks of the event started. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859228 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day.; stayed in bed with generalized muscle aches and fever for at least one full day.; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergies" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day.". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2859229 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day.; stayed in bed with generalized muscle aches and fever for at least one full day.; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunization, reaction(s): "Generalized muscle aches", "fever", "vaccination site erythema", "vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Sep2025 at 04:30, outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious) all with onset 14Sep2025 at 04:30, outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day.". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, myalgia, pyrexia. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, different vaccine/event; More
2859230 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day; stayed in bed with generalized muscle aches and fever for at least one full day; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unknown), for covid-19 immunisation, reaction(s): "generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; BNT162B2 (Dose 2, single, lot number unknown), for COVID-19 immunisation, reaction(s): "Generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, events after different doses of the vaccine; More
2859231 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day.; stayed in bed with generalized muscle aches and fever for at least one full day.; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "GI cramps" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for covid-19 immunization, reaction(s): "generalized muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; Bnt162b2 (2nd dose), for covid-19 immunization, reaction(s): "generalized muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; Bnt162b2 (3rd dose), for covid-19 immunization, reaction(s): "generalized muscle aches", "fever", "vaccination site erythema", "vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day.". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, different drug and event; More
2859232 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day; stayed in bed with generalized muscle aches and fever for at least one full day; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 5, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unknown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; BNT162B2 (Dose 2, single, lot number unknown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; BNT162B2 (Dose 3 (booster), single, lot number unknown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain"; BNT162B2 (Dose 4, single, lot number unknown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "vaccination site erythema", "vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, events after different doses of the vaccine; More
2859233 F PA 09/16/2025 COVID19
 PFIZER\BIONTECH
Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle ac... redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day; stayed in bed with generalized muscle aches and fever for at least one full day; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 6, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unkown), for COVID-19 immunisation, reaction(s): "Generalised muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; BNT162B2 (Dose 2, single, lot number unkown), for COVID-19 immunisation, reaction(s): "Generalised muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; BNT162B2 (Dose 3 (booster), single, lot number unkown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; BNT162B2 (Dose 4, single, lot number unkown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain"; BNT162B2 (Dose 5, single, lot number unkown), for COVID-19 immunisation, reaction(s): "generalised muscle aches", "fever", "Vaccination site erythema", "Vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500182329 same patient, events after different doses of the vaccine.; More
2859234 F 09/16/2025 COVID19
 PFIZER\BIONTECH
Chills, Fatigue Chills, Fatigue
rigors; fatigue; This is a spontaneous report received from a Physician. An elderly female patient ... rigors; fatigue; This is a spontaneous report received from a Physician. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), on 13Sep2025 for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 13Sep2025, outcome "recovered" (14Sep2025); CHILLS (non-serious) with onset 13Sep2025, outcome "recovered" (14Sep2025), described as "rigors". Therapeutic measures were not taken as a result of chills, fatigue. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2859235 09/16/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
felt more sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (... felt more sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt more sick". Additional Information: I don't know I never heard about Pfizer up until COVID and I just didn't not hear anything good about them. I was forced to get the vaccine where I was living with the people I was living with made this huge deal about it and wouldn't stop until I got it and I only got one and then I moved out because I didn't feel good about it I actually felt more sick and it's not something that I would ever do again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859242 M 09/16/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Having COVID after receiving vaccination (Pfizer COVID-19 Vaccine); Having COVID after receiving vac... Having COVID after receiving vaccination (Pfizer COVID-19 Vaccine); Having COVID after receiving vaccination (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a Consumer or other non HCP. A male 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Having COVID after receiving vaccination (Pfizer COVID-19 Vaccine)". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859243 56 F NV 09/16/2025 COVID19
 MODERNA
Appendix cancer Appendix cancer
Appendicial cancer - agressive Appendicial cancer - agressive
✓ ✓
2859244 84 F CA 09/16/2025 FLU3
 SANOFI PASTEUR
Extra dose administered Extra dose administered
PATIENT PREVIOUSLY RECEIVED FLUZONE HD ON 8-16-25. SHE CAME BACK ON 9-6-25 AND RECEIVED ANOTHER DOS... PATIENT PREVIOUSLY RECEIVED FLUZONE HD ON 8-16-25. SHE CAME BACK ON 9-6-25 AND RECEIVED ANOTHER DOSE OF FLUZONE HD. IT WENT THROUGH THE SAME INSURANCE AGAIN. More
2859245 86 M MI 09/16/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052583
407246
Dizziness, Fall; Dizziness, Fall Dizziness, Fall; Dizziness, Fall
Patient had a fall at approximately 3:30 p.m. upon questioning patient stated that he was walking an... Patient had a fall at approximately 3:30 p.m. upon questioning patient stated that he was walking and went to turn, got dizzy, and fell. EMS was contacted and patient left in ambulance. More
2859246 44 M GA 09/16/2025 HPV9
 MERCK & CO. INC.
Arthralgia Arthralgia
patient states they are still having joint pain and soreness that has not resolved since receiving t... patient states they are still having joint pain and soreness that has not resolved since receiving the vaccine. patient is going to follow up with doctor and let us know More
2859247 4 M WI 09/16/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 x7r4z
Wrong product administered Wrong product administered
Picked up the wrong vaccine Picked up the wrong vaccine
2859248 23 F NC 09/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9k34m
Syncope Syncope
fainting fainting
2859249 3 M CO 09/16/2025 FLU3
 SANOFI PASTEUR
 TFAA2504
Unevaluable event Unevaluable event
n/A n/A
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