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
2388264 56 F MN 07/25/2022 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH

FH8028
FH8028
FH8028
FH8028
FH8028
FH8028
FH8028
FH8028
FM7553
FM7553
FM7553
FM7553
FH8028
FH8028
FH8028
FH8028
Alopecia, Blood testosterone decreased, Ephelides, Folliculitis, Influenza like ... Alopecia, Blood testosterone decreased, Ephelides, Folliculitis, Influenza like illness; Scar; Fungal infection, Infection parasitic; Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss; Bacterial infection, Bacterial test positive, Cryptococcus test positive, Fungal infection, Fungal test positive; Gene mutation identification test positive, Laboratory test abnormal; Fungal infection, Infection parasitic; Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss; Bacterial infection, Bacterial test positive, Cryptococcus test positive, Fungal infection, Fungal test positive; Gene mutation identification test positive, Laboratory test abnormal; Fungal infection, Infection parasitic; Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss; Bacterial infection, Bacterial test positive, Cryptococcus test positive, Fungal infection, Fungal test positive; Gene mutation identification test positive, Laboratory test abnormal; Fungal infection, Infection parasitic; Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss; Bacterial infection, Bacterial test positive, Cryptococcus test positive, Fungal infection, Fungal test positive; Gene mutation identification test positive, Laboratory test abnormal More
She got her vaccine, she started noticing a sore spot on the back of her head. It ended up spreadin... She got her vaccine, she started noticing a sore spot on the back of her head. It ended up spreading into a huge bald spot in the back of her head. It then moved from there to the side of her head, front of her head and at no time she was completely bald. During that time she had large clumps of hair rolling of her shoulders, she had long hair. She has very low testosterone at age 40, and she is thinking that with the COVID vaccine and her low hormone levels that this may have tripped up her hair loss. She is in the process of seeking medical advice. She has an appointment to see an endocrinologist and OB physician in a couple of weeks. She did see a dermatologist as she ended up getting folliculitis and she is on long-term antibiotics to keep her scalp calm. She thinks there was some scaring alopecia from the result of it. She is starting to grow her hair back, but there are some white dots all over her scalp, like freckles in the frontal area of her scalp. She did not have any reactions to the COVID vaccines other than feeling flu-like symptoms for a few days. More
2821143 25 F CA 01/15/2025 HPV9
 MERCK & CO. INC.
 1965046
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given 3 doses of HPV quadrivalent, competing the series at age 14. On recent visit with ... Patient was given 3 doses of HPV quadrivalent, competing the series at age 14. On recent visit with PCP on 10/22/2024 patient was given a 4th dose but with HPV9. More
2821144 73 F OH 01/15/2025 FLU3
 SANOFI PASTEUR
 u8519ea
Chest discomfort, Dyspnoea, Incontinence, Intensive care Chest discomfort, Dyspnoea, Incontinence, Intensive care
Patient stated stated feeling symptoms of very tight chest, extreme difficulty breathing at home abo... Patient stated stated feeling symptoms of very tight chest, extreme difficulty breathing at home about an hour after after vaccination. She called the ambulance and was taking to hospital and was incontinent at the hospital loosing a sizeable amount of fluid. Patient stated was in the ICU until 12/10/24. More
โœ“
2821145 82 F CA 01/15/2025 UNK
 UNKNOWN MANUFACTURER
 tfaa2422
Extra dose administered Extra dose administered
Patient said she had not received a flu vaccine for current season. Batched after vaccine given. Ins... Patient said she had not received a flu vaccine for current season. Batched after vaccine given. Insurance rejected saying already received from another facility in August. More
2821146 29 F ID 01/15/2025 FLU3
FLU3
FLU3
HEP
HEP
HEP
IPV
IPV
IPV
MMR
MMR
MMR
TDAP
TDAP
TDAP
VARCEL
VARCEL
VARCEL
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 388519
388519
388519
944918
944918
944918
X1C891M
X1C891M
X1C891M
X019107
X019107
X019107
TD2FD
TD2FD
TD2FD
Y007955
Y007955
Y007955
Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Inj... Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness; Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness; Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness; Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness; Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness; Axillary pain, Breast enlargement, Breast pain, Hypoaesthesia, Inflammation; Injected limb mobility decreased, Injection site pain, Lymphadenopathy, Neck pain, Pain; Pain in extremity, Paraesthesia, Tenderness More
pain in left arm Patient reports pain in left arm near deltoid and left axilla post vaccinations on ... pain in left arm Patient reports pain in left arm near deltoid and left axilla post vaccinations on 12/19/24. She states pain started in left deltoid area 2 days after getting immunizations, now radiating from neck down into all 5 fingers with associated numbness and tingling. Also describes pain radiating into left breast and axilla. Patient was seen at emergency room where they provided handout on lymphadenopathy, also recently seen with her PCP. On exam, sensation and strength of upper extremity are intact and symmetrical, there are no signs of infection at any injection sites. Her left upper extremity ROM is slightly decreased due to pain, however she is able to extend, flex, adduct, abduct, internally and externally rotate her left arm. Discussed in depth with patient that soreness, lymph node swelling, and inflammation can happen after immunizations. Patient is likely experiencing some inflammation post immunizations. Also discussed with patient potential for possible brachial neuritis, however she is not experiencing any weakness to left upper extremity. Advised to use ice, rest, continue taking diclofenac prescribed by her PCP. Discussed that pain radiating from neck down into fingers could possibly have to do with her neck and could be separate issue, and if symptoms do not resolve, speak to her PCP about work up. Seek care if unilateral weakness, lower extremity weakness, numbness, severe headaches, fevers, blurred vision or trouble speaking or any worsening symptoms. Patient agrees with this plan. All questions answered, no further concerns today. Patient left in stable condition. pain in axilla (Left) Patient reports left axillary pain and left breast pain after receiving immunizations on 12/19/24. She reports that her left breast has also been enlarged since getting vaccinations. Patient saw her PCP recently for this who ordered breast ultrasound and mammogram. No erythema, edema, signs of infection present on inspection of left breast or axilla. Tenderness to palpation of left axillary area, no tenderness to palpation of lateral aspect of left breast. Patient had mild cervical and left axillary lymphadenopathy. Vital signs stable. Patient was given ice pack for left axillary pain in office. Discussed with patient that lymph nodes can sometimes become enlarged and tender after immunizations and that her axillary pain is likely due to this. Also discussed with patient at length that breast pain can be due to multiple different etiologies and that it is very unlikely this pain is due to her recent immunizations. Encouraged patient to keep appointments for imaging and use diclofenac prescribed by her PCP for pain. All questions answered, no further concerns. Notes from clinic visit 1/9/2025 More
2821147 65 F WA 01/15/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 713ST
N547S
Injection site pain, Joint stiffness, Pain, Pain in extremity; Injection site pa... Injection site pain, Joint stiffness, Pain, Pain in extremity; Injection site pain, Joint stiffness, Pain, Pain in extremity More
On 11/23/2024 Patient reported, by phone, pain with motion in the right arm, joint stiffness, and pa... On 11/23/2024 Patient reported, by phone, pain with motion in the right arm, joint stiffness, and pain to the touch of the injection area. We advised she see a medical provider to assess the issue. More
2821148 0.42 F CA 01/15/2025 PNC20
 PFIZER\WYETH
 HR3650
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Redness around vaccine spot, warm to touch Redness around vaccine spot, warm to touch
2821162 79 F PA 01/15/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 Z7NG7
Dizziness, Laboratory test normal, Syncope Dizziness, Laboratory test normal, Syncope
Patient told me that she got dizzy and fainted two days after her Arexy vaccine. She was taken to th... Patient told me that she got dizzy and fainted two days after her Arexy vaccine. She was taken to the hospital and tests were run but nothing was found to be wrong with her. The doctors felt it was from the vaccination. More
2821163 4 M TX 01/15/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42Y93
Y012077
Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More
erythema and tenderness to left deltoid erythema and tenderness to left deltoid
2821164 93 F WA 01/15/2025 FLU3
 SEQIRUS, INC.
 388479
Injection site bruising Injection site bruising
Quote from the facility staff "had to have her arm looked at because it is bruised from her sho... Quote from the facility staff "had to have her arm looked at because it is bruised from her shoulder down to her elbow on the side she got her shot done. We recommend that she go to her doctor to get it checked out and they said that the shot must have nicked a vein which would of caused that to happen." More
2821165 11 F CA 01/15/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 x019196
x7r4z
Injection site rash, Pruritus; Injection site rash, Pruritus Injection site rash, Pruritus; Injection site rash, Pruritus
patient experienced large rash around injection site. The prescriber suggested to do cold compress a... patient experienced large rash around injection site. The prescriber suggested to do cold compress and gave her a cream for rash for itching. More
2821166 67 F NM 01/15/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3043838
u842pba
Fall, Head injury, Loss of consciousness; Fall, Head injury, Loss of consciousne... Fall, Head injury, Loss of consciousness; Fall, Head injury, Loss of consciousness More
Patient received both vaccines in left arm because she told the administrating technician that she d... Patient received both vaccines in left arm because she told the administrating technician that she does not have lymph nodes in her right arm. The administration went smooth and I asked patient to stay around afterwards for 30 minutes because she has a history of an allergic reaction to Boostrix in 2016. when she received anaphylaxis. She felt good after 30 minutes and left. She went shopping and while shopping she passed out and fell and hit a shelf with her head. She does not remember anything but waking up with glass around her from the shelf. She did not go the ER or to the DR office. She did leave a message with her neurologist and is waiting for a return call. More
2821167 19 M TX 01/15/2025 MNQ
 SANOFI PASTEUR
 U8256AB
Loss of consciousness Loss of consciousness
Patient passed out after receiving meningitis shot Patient passed out after receiving meningitis shot
2821168 74 M FL 01/15/2025 PNC20
 PFIZER\WYETH
 lj5281
Extra dose administered, No adverse event Extra dose administered, No adverse event
no adverse reaction pt got a second pneumonia shot within 2 years of last one. no adverse reaction pt got a second pneumonia shot within 2 years of last one.
2821169 54 F TX 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 354M3
Extra dose administered Extra dose administered
Patient has received 2 doses of Shingrix in one day due to duplicate eRx being sent to our pharmacy.... Patient has received 2 doses of Shingrix in one day due to duplicate eRx being sent to our pharmacy. Patient received the dose in the clinic but provider also sent over an eRx to the pharmacy. More
2821170 41 F MS 01/15/2025 COVID19
 MODERNA
Dizziness, Fatigue, Lymphadenopathy, Tinnitus Dizziness, Fatigue, Lymphadenopathy, Tinnitus
Tinnitus (whooshing in ears) Went to Urgent Care Clinic on December 16, 2024, and prescribed pre... Tinnitus (whooshing in ears) Went to Urgent Care Clinic on December 16, 2024, and prescribed prednisone 20 mg tablets for 5 days and taken off work for 2 days Tinnitus is still in ears Fatigue dizziness swollen lymph nodes More
2821171 68 M FL 01/15/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 255T2
JC7Z5
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient presented to pharmacy requesting RSV vaccination, patient received second dose of RSV vaccin... Patient presented to pharmacy requesting RSV vaccination, patient received second dose of RSV vaccination despite previously receiving an initial dose, contradictory to manufacturer and CDC guidelines. Patient did not present any complaints at time of vaccination regarding side effects that would result in need for treatment or any symptoms or signs in need of addressing. More
2821172 87 M VA 01/15/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52z52
Extra dose administered Extra dose administered
pt inappropriately received a second RSV vaccine, first dose was administered 1/4/24. has not report... pt inappropriately received a second RSV vaccine, first dose was administered 1/4/24. has not reported any rxn thus far. More
2821173 66 M NY 01/15/2025 FLU3
 SANOFI PASTEUR
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
He claims that RPH may hit the needle to near neve. He took ibuprofen and aspirin and got no relief.... He claims that RPH may hit the needle to near neve. He took ibuprofen and aspirin and got no relief. He did stretching, ice pack and heat pack as per MD advise and no relief too. HIs main CX is difficulty raising his arm to not more than 30-40% and feels like stabbing pain. Symptoms started after couple days and subsided and came back. HIs pain went from his fingers to shoulder. More
2821174 68 F VA 01/15/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
pt inappropriately received an additional RSV dose. initial dose received 12/4/23. no reaction repor... pt inappropriately received an additional RSV dose. initial dose received 12/4/23. no reaction reported from pt thus far. More
2821175 41 F MI 01/15/2025 COVID19
 PFIZER\BIONTECH
Lip swelling, Swelling face, Urticaria Lip swelling, Swelling face, Urticaria
Woke up with swollen lips a couple days after vaccine which continued over the course of several mon... Woke up with swollen lips a couple days after vaccine which continued over the course of several months (now 4 months later, I will have swelling of the lips and face periodically). Hives presented a few days later and became progressively worse. I take one Zyrtec 10 mg every other day as the drug wears off. As soon as it wears off, my body will quickly develop hives. They are usually on my trunk, thighs, bikini line, low back, arms and neck. I?ve never had a reaction to any vaccine before. More
2821176 65 F UT 01/15/2025 FLU3
 SEQIRUS, INC.
 388483
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Patient had already received a seasonal influenza vaccine on 9/30/24. She intended to get a Covid va... Patient had already received a seasonal influenza vaccine on 9/30/24. She intended to get a Covid vaccine at our facility, but was administered a dose of adjuvanted seasonal flu vaccine. So, she received two influenza vaccines in the same season. More
2821177 0.25 M CA 01/15/2025 PNC20
UNK
UNK
 PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Electroencephalogram, Magnetic resonance imaging, Seizure; Electroencephalogram,... Electroencephalogram, Magnetic resonance imaging, Seizure; Electroencephalogram, Magnetic resonance imaging, Seizure; Electroencephalogram, Magnetic resonance imaging, Seizure More
More than one seizures , neurologist prescribes keppra , still continuing seizures More than one seizures , neurologist prescribes keppra , still continuing seizures
โœ“
2821178 25 F OH 01/15/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Fatigue, Rash, Rash erythematous, Rash papular, Rash pruritic; Skin warm Fatigue, Rash, Rash erythematous, Rash papular, Rash pruritic; Skin warm
Raised rash that is red, warm to the touch, itchy, and aching . Fatigue, Raised rash that is red, warm to the touch, itchy, and aching . Fatigue,
2821185 18 M CO 01/15/2025 MENB
 PFIZER\WYETH
 GP8617
Chills, Pyrexia, Respiratory disorder Chills, Pyrexia, Respiratory disorder
Patient experienced breathing issues & chills 30-60 min after shot. In about 90-120 minutes afte... Patient experienced breathing issues & chills 30-60 min after shot. In about 90-120 minutes after shot, breathing fine, no chills, but got fever with 101.9 Took ibuprofen and tylenol to decrease fever. Waiting for fever to break after Tylenol. More
2821186 31 F CA 01/15/2025 FLU3
 SANOFI PASTEUR
 TFAA2442
Immediate post-injection reaction, Mobility decreased, Pain Immediate post-injection reaction, Mobility decreased, Pain
Had soreness and pain immediately after vaccine administration described as atypical from past vacci... Had soreness and pain immediately after vaccine administration described as atypical from past vaccination. Pain was persistent and progressive and eventually associated with decreasing range of motion and reduced function due to pain. More
2820746 U LA 01/14/2025 PPV
 MERCK & CO. INC.
Antibody test negative, Immunisation Antibody test negative, Immunisation
HCP called to report that she received a order from a doctor to revaccinate a patient with PNEUMOVAX... HCP called to report that she received a order from a doctor to revaccinate a patient with PNEUMOVAX 23 because they were not satisfied with their titer results stating the test is not showing immunity. The HCP could not confirm when the patient was; This spontaneous report was received from a pharmacist and refers to a currently 17 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) 0.5 mL (dose number, lot #, expiration date, route of administration, anatomical location not provided) as immunization for the prevention of pneumococcal disease. On an unspecified date, the patient was ordered to be revaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), because the physician was not satisfied with the titer results stating that the test did not show immunity (antibody test negative). At the reporting time, the patient had not recovered from the event. It was reported that it was sought medical attention but no treatment was given; and that the last time the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) could not be confirmed. More
2820747 M NC 01/14/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Influenza, Palpitations, Ulcer haemorrhage Influenza, Palpitations, Ulcer haemorrhage
I had a very adverse reaction to Type A influenza with heart palpitation; I had a very adverse react... I had a very adverse reaction to Type A influenza with heart palpitation; I had a very adverse reaction to Type A influenza with bleeding ulcer; Subtype A influenza; This spontaneous case, initially received on 30-Dec-2024 was (with additional information received on same date), reported by a non-health professional and concerns an Elderly male patient. Concomitant medication: Refer to the appropriate section. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: not reported and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 03-Jan-2024, the patient experienced Subtype A influenza (Hospitalized, outcome: Not Reported). On an unknown date in Jan-2024, the patient experienced I had a very adverse reaction to Type A influenza with heart palpitation (Hospitalized, outcome: Not Reported), I had a very adverse reaction to Type A influenza with bleeding ulcer (Hospitalized, outcome: Not Reported). I had a very adverse reaction to Type A influenza with heart palpitation and bleeding ulcer in January this year. I was hospitalized for 2 weeks and in rehab another 2 weeks. I do not want to have Type A influenza again this year. The patient had trouble with it quite a bit, it gave him a real. The patient had to stay in the hospital. So, he wanted to know if there was a type A flu in the current flu vaccines, he thinks that, if he gets the type A included, it will help resist catching type A flu again. Yes, that time type A flu caused the symptoms, so he was hoping the vaccine will help. Last year it was not included in the vaccine so that's why he was in the hospital, from 3 January for two weeks. The patient did not have a reaction to the vaccine, patient had a subtype A influenza infection which caused the mentioned symptoms and hospitalization. Patient did not know the vaccine he took before hospitalization. Fluad (TIV) action taken: Not Applicable Reporter Assessment: The reporter assesses the events as serious, and causality was not reported.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, heart palpitations and ulcer bleeding are attributed to subtype A influenza infection (probable consequences of infection). Furthermore, causality for subtype A influenza infection assessed as not related (as reported), as the reaction/infection not attributed to vaccination. More
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2820748 M IA 01/14/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Eye pain Eye pain
Pain In and Around the Right Eye; Initial report received on 18-Dec-2024. A consumer reported tha... Pain In and Around the Right Eye; Initial report received on 18-Dec-2024. A consumer reported that he, a 30-year-old male, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced pain in and around his right eye. Medical history was reported as an allergy to penicillin (PCN) that manifested as hyperventilation. No concomitant medications were reported. On approximately 26-Nov-2024 or 27-Nov-2024, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, and NDC number not available)] intramuscularly in the left arm. The patient stated that he has been having some pain in and around his right eye. The pain started in his temple area and in his right eye. The event was treated with unspecified oral steroids. Reporter stated that his symptoms were ongoing. No further adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2820749 U CA 01/14/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Malaise, Neuropathy peripheral, Pain, Sleep disorder Malaise, Neuropathy peripheral, Pain, Sleep disorder
Neuropathy; Painful / #9 levels of pain; Became ill; This spontaneous case initially received on 06-... Neuropathy; Painful / #9 levels of pain; Became ill; This spontaneous case initially received on 06-Jan-2025, was reported by a non health professional and patient of unknown age/gender. Administration of company suspect drug: On 31-Oct-2014, the patient received Fluad (TIV) for Indication not reported., dose Not reported route of administration in anatomical location Not reported, Lot number: No batch number available and would be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 01-Nov-2024, the patient experienced Became ill (outcome: Not Reported). On Dec-2024, the patient experienced Neuropathy (Medically Significant, outcome: Not Reported). Associated symptoms included: Painful / #9 levels of pain. On 31-Oct-2014, she had the Fluad shot for 65 and over at pharmacy, and became ill the next day, each day became worse so that the entire month of November I had never in the long life been so ill. Have had flu shots at my doctor's office or for years and no reaction. Contacted pharmacist at pharmacy and was told the company had increased the antigens several times over. This was the entire month of November, come December and I was now left with Neuropathy, so painful since the first part of December and I had this keeping me awake at night with very painful #9 levels of pain. If would like doctors name and I am happy to provide these shots should be accompanied with information about the increase. Fluad (TIV) action taken: Not Applicable Reporter๏ฟฝs assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Plausible temporal relationship for illness (next day of vaccination). Causal association cannot be completely ruled out for neuropathy in view of insufficient information (onset date, temporality, relevant medical history). More
2820759 59 M MN 01/14/2025 HEPA
PNC20
 MERCK & CO. INC.
PFIZER\WYETH
 X006702
HN2630
Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness, Tracheostomy... Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness, Tracheostomy; Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness, Tracheostomy More
Patient developed acute onset of severe muscle weakness 10 days after vaccination. Determined to be ... Patient developed acute onset of severe muscle weakness 10 days after vaccination. Determined to be severe Guillain-Barre Syndrome requiring mechanical ventilation, tracheostomy, etc. More
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2820760 57 F TN 01/14/2025 COVID19
 MODERNA
Tachycardia Tachycardia
Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant
2820761 81 M RI 01/14/2025 COVID19-2
TDAP
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 GJ6738
DR2GR
Herpes zoster, Rash; Herpes zoster, Rash Herpes zoster, Rash; Herpes zoster, Rash
Reported Symptoms: 10037844:RASH; 10040555:SHINGLES; Narrative: Other Relevant HX: 80 y/o male patie... Reported Symptoms: 10037844:RASH; 10040555:SHINGLES; Narrative: Other Relevant HX: 80 y/o male patient presented to urgent care with rash to left buttock noted this morning 11/9/2022. Other: treated for shingles More
2820762 56 M CA 01/14/2025 FLU3
 SANOFI PASTEUR
 UT8148KA
Diarrhoea Diarrhoea
Reported Symptoms: 10012727:DIARRHEA; Narrative: Patient received influenza vaccine 1/5/24 and repor... Reported Symptoms: 10012727:DIARRHEA; Narrative: Patient received influenza vaccine 1/5/24 and reported diarrhea on 1/111/24. Other Relevant HX: other: DIARRHEA More
2820763 82 M RI 01/14/2025 COVID19
COVID19
FLU4
FLU4
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 3032709
3032709
U8138CA
U8138CA
Cough, Dyspnoea, Hypertension, Oropharyngeal pain, Respiratory tract congestion;... Cough, Dyspnoea, Hypertension, Oropharyngeal pain, Respiratory tract congestion; Tachycardia, Troponin abnormal; Cough, Dyspnoea, Hypertension, Oropharyngeal pain, Respiratory tract congestion; Tachycardia, Troponin abnormal More
Reported Symptoms: 10011232:COUGHING; 10020772:HYPERTENSION; Narrative: Patient received COVID and F... Reported Symptoms: 10011232:COUGHING; 10020772:HYPERTENSION; Narrative: Patient received COVID and Flu Shot on 2/9/24. Presented to ED on 2/10 "reporting a few days of cough, chest congestion, and sore throat. (+) mild sob starting today. denies fevers/chills. States he received covid and flu shots yesterday." On arrival in the ER pt had a BP of 199/90 with a pulse of 105. He was admitted after he was to have tachycardia & abn troponin of 0.04. Discharged diagnosis "Uncontrolled HTN/Abnormal Troponins". Patient was restarted on Metorpolol which he had self-d/c'ed a year earlier. Other Relevant HX: Other: More
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2820764 53 M ID 01/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4723S
4723S
Arthralgia, Injected limb mobility decreased, Musculoskeletal discomfort, Myalgi... Arthralgia, Injected limb mobility decreased, Musculoskeletal discomfort, Myalgia, Pain; Paraesthesia, Product administered at inappropriate site More
Reported Symptoms: 10028411:MYALGIA; 10040617:SHOULDER PAIN; Narrative: On July 10th, I received my ... Reported Symptoms: 10028411:MYALGIA; 10040617:SHOULDER PAIN; Narrative: On July 10th, I received my second dose of Shingle vaccine in my left shoulder. Since that time, my shoulder is continually in pain, generally a level 8 pain, but often, and increasing in occurrences I will move my shoulder and it sends shooting pain through my arm. For instance, just yesterday I went to pick up a grocery sack with 2 loafs of bread, the pain was beyond measurable and I was unable to lift it. I am rotate my shoulder in a 360 degree motion. I believe that the nurse may have hit a nerve or the Bursa sack as the injection was very high on the joint Left shoulder pain - Shingrix shot 7/10/24 -8/10 left shoulder pain in the subacromial area with exacerbations lifting away from the body and with external rotation -He also reports some tingling in the left hand first through third fingers. Mild neck discomfort. Wonders if he could have some weakness but pain is also shutting him down. Other Relevant HX: Other: shoulder pain More
2820765 74 M RI 01/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 Y77XY
Arthritis, Erythema, Injection site rash, Pruritus, Urticaria Arthritis, Erythema, Injection site rash, Pruritus, Urticaria
Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: arrives with complaint of getti... Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: arrives with complaint of getting random areas on body that are red and itchy, hive like in appearance since receiving the Zoster Recom # 2 on 6/10/24. He has taken po benadryl with good effect. He denies difficulty breathing or swallowing, throat tightness. Last night his significant other also noted a "bull's eye rash" to back of left upper arm. States they had been in a field recently but he did not see any ticks on his body. He denies new joint pain, he normally has left hand pain from arthritis. States he has been treated for lyme in the past. Other Relevant HX: Other: URTICARIA More
2820766 80 M NV 01/14/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 HF9301
HF9301
Balance disorder, Blood glucose normal, Blood pressure increased, Dizziness, Dys... Balance disorder, Blood glucose normal, Blood pressure increased, Dizziness, Dysstasia; Gait disturbance, Headache, NIH stroke scale, Vertigo More
Reported Symptoms: 10047340:VERTIGO; Narrative: Resulted in admission to the medical center for vert... Reported Symptoms: 10047340:VERTIGO; Narrative: Resulted in admission to the medical center for vertigo. Other Relevant HX: 80 year old MALE with hx of hypertension, diabetes, COPD and hypothyroidism who presents to the ER with severe headache, dizziness and difficulty with balance. Patient's wife provided most the hx, she reports patient has been tired/fatigued since returning from vacation a few days ago. Today, he had an appointment with his PCP where her received his COVID booster. He then went to a few stores with is wife and returned home. He was resting and around 1630 he developed severe headache and room spinning. He had trouble standing and his wife called her son to bring him to the hospital. He needed assitance to walk into the hospital. Blood pressure was elevated to 162/80 and blood glucose was 152. NIHSS was 0. Patient was able to stand and take a few steps. Wife stated his balance was close to baseline. He was excluded from tPA due to non disabling symptoms. Pfizer Monovalent (Comirnaty) Administered: COVID-19 (PFIZER), MRNA, LNP-5, PF, TRIS-SUCROSE, 30 MCG/0.3 ML (Ages 12+ YEARS) Date Administered: Jul 05, 2024 11:00 Series: Booster Manufacturer: PFIZER, INC Lot : HF9301 Exp Date: Jan 30, 205 Admin Route/Site: INTRAMUSCULAR/RIGHT DELTOID Dosage: 0.3mL Vaccine Information Statement: COVID-19 MRNA VACCINE (12+ YRS) More
2820767 41 M TN 01/14/2025 COVID19
 MODERNA
Anaphylactic reaction Anaphylactic reaction
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Anaphylaxis which did not require intervention O... Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Anaphylaxis which did not require intervention Other Relevant HX: Other: ANAPHYLAXIS More
2820768 79 M RI 01/14/2025 COVID19
 MODERNA
 3032086
Hypotension, Monoplegia, Vomiting Hypotension, Monoplegia, Vomiting
Reported Symptoms: 10021097:HYPOTENSION; 10033814:PARALYSYS LEG; 10047700:VOMITING; Narrative: Pt. h... Reported Symptoms: 10021097:HYPOTENSION; 10033814:PARALYSYS LEG; 10047700:VOMITING; Narrative: Pt. had to be admitted to the hospital and later discharged to rehab facility Other Relevant HX: Other: paralysis of right leg More
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2820769 M RI 01/14/2025 COVID19
 MODERNA
 3032233
Asthenia, Myalgia Asthenia, Myalgia
Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Ot... Reported Symptoms: 10028411:MYALGIA; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS More
2820815 F NJ 01/14/2025 VARCEL
 MERCK & CO. INC.
Antibody test negative Antibody test negative
Nurse called and reported that she received a dose of VARIVAX in 1999 and a dose in 2017 and that he... Nurse called and reported that she received a dose of VARIVAX in 1999 and a dose in 2017 and that her titers for varicella are still negative. Dates the titers were drawn were not provided. Nurse did not provide additional information and stated that; This spontaneous report was received from nurse and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in 1999, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection and second dose on 2017, both administered for prophylaxis (strength, doses, lot #, expiry dates, and routes of administration were not provided). The patient stated that her titers for varicella were still negative (antibody test negative). Dates the titers were drawn were not provided. The causal relationship between antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided. Nurse did not provide additional information. Additional information is not expected. More
2820816 66 F 01/14/2025 FLUX
FLUX
FLUX
FLUX
TDAP
TDAP
TDAP
TDAP
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Back pain, Dizziness, Endophthalmitis, Eye operation, Glomerular filtration rate... Back pain, Dizziness, Endophthalmitis, Eye operation, Glomerular filtration rate decreased; Haemarthrosis, Haematoma evacuation, Hyperparathyroidism secondary, Hypoglycaemia, Lipoma excision; Magnetic resonance imaging abnormal, Muscle rupture, Nausea, SARS-CoV-2 test negative, Spinal fusion surgery; Vomiting, Walking aid user; Back pain, Dizziness, Endophthalmitis, Eye operation, Glomerular filtration rate decreased; Haemarthrosis, Haematoma evacuation, Hyperparathyroidism secondary, Hypoglycaemia, Lipoma excision; Magnetic resonance imaging abnormal, Muscle rupture, Nausea, SARS-CoV-2 test negative, Spinal fusion surgery; Vomiting, Walking aid user More
Tear in gluteal muscle; endophthalmitis left eye/left eye surgery; Uses roller walker; bilateral bac... Tear in gluteal muscle; endophthalmitis left eye/left eye surgery; Uses roller walker; bilateral back pain/Chronic bilateral low back pain without sciatica; spinal fusion done L3-L5; Secondary hyperparathyroidism; right hip right outer thigh lipoma removed; right hip hematoma/right hip hematoma I&D; Dizziness; Hypoglycemia; Nausea; Vomiting; This serious case was reported by a nurse via other manufacturer and described the occurrence of lipoma excision in a 67-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. The patient's past medical history included colorectal adenoma, nasal septum deviation (Bilateral Deviated septum), cyst removal, cryotherapy, shoulder arthroplasty (Since the Shoulder arthroplasty on 26Fe2015, her arm is not feeling or healing right), gout, shoulder operation, bronchospasm, cataract operation, cataract operation (also in 05Feb2017 and 02May2017, OD), chronic kidney disease (GFR 15-29 ml/min (HCC)), thrombosis, cataract operation, tobacco abuse, eye operation (2017 and 2018), cataract (unsuccessful), neurectomy, knee arthroplasty, nerve block, joint aspiration, product use issue, retinal bleeding, acute macular neuroretinopathy, rubber sensitivity (Rash/Urticaria), facet joint block (Facet injection R lower back), asthma (Mild intermittent asthma without complication), high frequency ablation, epidural injection and epidural injection. Previously administered products included MIDAZOLAM HCL with an associated reaction of drug hypersensitivity, PENTAZOCINE LACTATE with an associated reaction of swollen tongue, INFLUENZA VACCINE, PROPANTHELINE with an associated reaction of respiratory distress, HYDROCODONE/ACETAMINOPHEN with an associated reaction of mental status changes, HYDROCODONE/ACETAMINOPHEN with an associated reaction of dizziness, INFLUENZA VACCINE (one more dose on 29-Sep-2012), NITROGLYCERIN with an associated reaction of dizziness, MORPHINE with an associated reaction of drug intolerance, INFLUENZA VACCINE, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), THYME with an associated reaction of laryngeal oedema, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), ASPARTAME with an associated reaction of diarrhoea, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), CYCLOBENZAPRINE with an associated reaction of drug hypersensitivity, PNEUMOCOCCAL VACCINE (DOSE NUMBER UNKNOWN, SINGLE), BENZENE, NAPROXEN SODIUM, HYDROCODONE, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (INACT SPLIT 4V) and PNEUMOCOCCAL VACCINE POLYVALENT (DOSE NUMBER UNKNOWN, SINGLE). Concurrent medical conditions included hypoxia, obesity (BMI of 40 - 44.9, adult (HCC)), food allergy (respiratory distress, diarrhea), allergy to fermented products, food allergy (Respiratory distress, Fennel, Licorice, Fennel, Licorice) and allergy to chemicals. Concomitant products included acetylsalicylic acid (Aspirin Ec). On 10-SEP-2019, the patient received Tdap Vaccine. On 23-SEP-2019, the patient received Influenza vaccine. On 23-SEP-2019, 13 days after receiving Tdap Vaccine, the patient experienced lipoma excision (Verbatim: right hip right outer thigh lipoma removed) (serious criteria clinically significant/intervention required), hematoma (Verbatim: right hip hematoma/right hip hematoma I&D) (serious criteria clinically significant/intervention required), dizziness (Verbatim: Dizziness), hypoglycemia (Verbatim: Hypoglycemia), nausea (Verbatim: Nausea) and vomiting (Verbatim: Vomiting). On 06-FEB-2020, the patient experienced hyperparathyroidism secondary (Verbatim: Secondary hyperparathyroidism). On 02-MAR-2020, the patient experienced fusion lumbar spine (Verbatim: spinal fusion done L3-L5) (serious criteria clinically significant/intervention required). On 08-APR-2020, the patient experienced low back pain (without radiation) (Verbatim: bilateral back pain/Chronic bilateral low back pain without sciatica) (serious criteria clinically significant/intervention required). On 04-AUG-2020, the patient experienced endophthalmitis (Verbatim: endophthalmitis left eye/left eye surgery) (serious criteria GSK medically significant and clinically significant/intervention required) and walker user (Verbatim: Uses roller walker). On an unknown date, the patient experienced gluteal muscle tear (Verbatim: Tear in gluteal muscle) (serious criteria GSK medically significant). On 23-SEP-2019, the outcome of the lipoma excision was resolved. On 02-MAR-2020, the outcome of the fusion lumbar spine was resolved. The outcome of the hematoma, endophthalmitis, gluteal muscle tear, dizziness, hypoglycemia, nausea, vomiting and walker user were not reported and the outcome of the low back pain (without radiation) and hyperparathyroidism secondary were not resolved. It was unknown if the reporter considered the lipoma excision, hematoma, fusion lumbar spine, endophthalmitis, gluteal muscle tear, low back pain (without radiation), dizziness, hypoglycemia, nausea, vomiting, hyperparathyroidism secondary and walker user to be related to Tdap Vaccine. The company considered the lipoma excision, hematoma, fusion lumbar spine, endophthalmitis, gluteal muscle tear and low back pain (without radiation) to be unrelated to Tdap Vaccine. It was unknown if the company considered the dizziness, hypoglycemia, nausea, vomiting, hyperparathyroidism secondary and walker user to be related to Tdap Vaccine. Linked case(s) involving the same patient: US2024AMR135366, US2024AMR165842, US2024AMR165843 Additional Information: GSK Receipt Date: 30-OCT-2024 The nurse reported that a patient received Tdap vaccine on 10-Sep-2019. The patient had right hip right outer thigh lipoma removed, right hip hematoma/right hip hematoma inscision and drainage, spinal fusion done L3-L5, endophthalmitis left eye/left eye surgery, tear in gluteal muscle, bilateral back pain/Chronic bilateral low back pain without sciatica, dizziness, hypoglycemia, nausea, vomiting, and secondary hyperparathyroidism. This case linked with cases US2024AMR135366, US2024AMR165842 and US2024AMR165843 for the same patient from the same reporter. (Please refer to the linked cases for the medical history prior to the prior to 20-May-2010); Sender's Comments: Lipoma excision, Haematoma, Spinal fusion surgery, Endophthalmitis, Muscle rupture, Back pain are unlisted events which are considered unrelated to GSK Tdap Vaccine. US-GSK-US2024AMR135366:same patient US-GSK-US2024AMR165842: US-GSK-US2024AMR165842: US-GSK-US2024AMR165843: More
2820817 U HI 01/14/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Incorrect route of administration; This non-serious case was reported by a other health professional... Incorrect route of administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix (subcutaneous). On an unknown date, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Incorrect route of administration). The outcome of the intramuscular formulation administered by other route was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-DEC-2024 Boostrix inadvertently administered via the subcutaneous route (patient does not have a bleeding disorder), which led intramuscular formulation administered by other route. Evaluating whether an additional dose was needed. Looking for any data on vaccine absorption via the subcutaneous route verses the intramuscular route, or any literature on redosing the vaccine. More
2820818 2 F SC 01/14/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3BH5K
Wrong product administered Wrong product administered
patient received a dose of Boostrix instead of Flulaval this morning.; This non-serious case was rep... patient received a dose of Boostrix instead of Flulaval this morning.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3BH5K, expiry date 22-JAN-2027) for prophylaxis. Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis. On 20-DEC-2024, the patient received Boostrix. On an unknown date, the patient received FluLaval Quadrivalent. On 20-DEC-2024, immediately after receiving Boostrix and not applicable after receiving FluLaval Quadrivalent, the patient experienced wrong vaccine administered (Verbatim: patient received a dose of Boostrix instead of Flulaval this morning.). The outcome of the wrong vaccine administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:20-DEC-2024 The HCP called to report that a 2-year-old, female patient received a dose of Boostrix instead of Flulaval which led to wrong vaccine administered. There were no side effects reported. They were inquiring how to proceed. More
2820819 50 F WA 01/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TJ534
Product preparation issue Product preparation issue
diluent only given; diluent only given; This non-serious case was reported by a pharmacist via call ... diluent only given; diluent only given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ534, expiry date 23-OCT-2026) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On 20-DEC-2024, the patient received the 2nd dose of Shingrix. On 20-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: diluent only given) and inappropriate dose of vaccine administered (Verbatim: diluent only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 20-DEC-2024 The pharmacist reported that they just gave shingles vaccine to a patient, except they used two diluents on accident. The technician that did it, pulled out a diluent, put it into another diluent and then withdrew 0.5 mL and gave it. The specialist confirmed there was no powder used, and the patient received only the adjuvant portion of the vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was the patient's second dose in the series. More
2820820 M NC 01/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 EK7DG
Extra dose administered Extra dose administered
accidentally administered an extra dose of Menveo (1-vial) on December 20th 2024. Patient got a prio... accidentally administered an extra dose of Menveo (1-vial) on December 20th 2024. Patient got a prior dose of Menveo back in October 24th 2024; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 31-DEC-2025) and (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis. Previously administered products included Menactra (received a dose on 16-OCT-2018). Concomitant products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO). On 20-DEC-2024, the patient received the 2nd dose of Menveo. On 20-DEC-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: accidentally administered an extra dose of Menveo (1-vial) on December 20th 2024. Patient got a prior dose of Menveo back in October 24th 2024). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 20-DEC-2024 The physician stated they accidentally administered an extra dose of Menveo on 20th December 2024 which led to extra dose administered. The patient got a prior dose of Menveo back in 24th October 2024 and before that they got Menactra back in 16th October 2018. More
2820821 U 01/14/2025 COVID19
 JANSSEN
 Unknown
Weight increased Weight increased
I've gained 80lbs; This spontaneous report received from a patient by a company representative ... I've gained 80lbs; This spontaneous report received from a patient by a company representative concerned a patient of unspecified age and sex. The report was received from J&J managed social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced i've gained 80lbs. The patient reported that they were not fat but ever since receiving the covid-19 vaccine had gained 80lbs and did not think they were alone. The action taken with janssen covid-19 vaccine was not applicable. The outcome of i've gained 80lbs was not reported. This report was non-serious. More
2820822 U HI 01/14/2025 COVID19
 JANSSEN
 Unknown
Adverse event Adverse event
severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspe... severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint, EZ report and central compliant vigilance. Initial document was processed along with additional document received on 10-DEC-2024. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced severe medical issues. after taking COVID-19 shot. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of severe medical issues was not reported. This report was associated with a product quality complaint: Product Complaint 90000347803. Investigation Results: Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. This report was serious (other medically important condition).; Sender's Comments: V0: Medical assessment comment is not required per standard procedure as the case is a legal case. More
2820823 U HI 01/14/2025 COVID19
 JANSSEN
Adverse event Adverse event
Severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspe... Severe Medical issues; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe medical issues. after taking COVID-19 shot. (dose series is 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of severe medical issues was not reported. This report was serious (other medically important condition).; Sender's Comments: V0; Medical Assessment comment not required per standard procedure as it is legal case More
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