🏥 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 💀 🏥 🚑 ♿ ⚠️
2821058 62 F NY 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 97E7G
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse event reported- patient received 3 doses of shingrix which is 1 more than the recoemmende... No adverse event reported- patient received 3 doses of shingrix which is 1 more than the recoemmended More
2821059 66 F MO 01/15/2025 COVID19
 PFIZER\BIONTECH
 LM2219
Pain in extremity Pain in extremity
Patient came in for Covid-19 shot. The time would be 11/26/2024. Patient stated that the left arm ... Patient came in for Covid-19 shot. The time would be 11/26/2024. Patient stated that the left arm started aching around December 3, 2024. Patient was encouraged to see the doctor. Doctor prescribed an antibiotic and Prednisone. Patient still having pain in left arm and said that she was having an x ray on 01/20/2025. Patient did receive a Flu shot at Clinic on or around12/12/2024 after receiving the covid shot but it was in the right arm. According to patient More
2821060 58 F AZ 01/15/2025 FLU3
 SANOFI PASTEUR
 TFAA2425
Injection site bruising, Injection site pain Injection site bruising, Injection site pain
Patient came by pharmacy on 01/15/25 to report adverse event related to the vaccination. The patient... Patient came by pharmacy on 01/15/25 to report adverse event related to the vaccination. The patient described a painful site after injection of the arm with bruising and next day after receiving the shot had to go to Urgent Care for further treatment. Patient was then referred to hospital from urgent care and had an unknown length of stay (patient did not report). Currently patient is still experiencing a large amount of pain for the last three months and is still receiving further treatment More
✓
2821061 16 M GA 01/15/2025 MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8351CA
U8351CA
Dizziness, Hyperhidrosis, Nausea, Pallor, Pruritus; Rash macular Dizziness, Hyperhidrosis, Nausea, Pallor, Pruritus; Rash macular
Minor's grandmother reported reaction to health dept almost 24 hrs after vaccine administratio... Minor's grandmother reported reaction to health dept almost 24 hrs after vaccine administration by phone. Minor's grandmother reports 15 minutes after minor received vaccine reaction occurred while traveling in car. Pt. became pale , sweaty, dizzy, and nauseated. He was splotchy red from head to toe and itching. No breathing problems noted. Pt. did not lose consciousness. Benedryl 25mg was administered by guardian about 30 minutes after vaccine given. Symptoms began to resolve at that time but pt still felt faint and itchy after 2 hours so another benedryl 25mg tab was administered. Symptoms resolved shortly after. At this time, 22 hrs later, pt has not had another episode. More
2821062 44 M OR 01/15/2025 COVID19
FLU3
TDAP
 MODERNA
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 3043835
UT8434KA
235D2
Dizziness, Hypotension; Dizziness, Hypotension; Dizziness, Hypotension Dizziness, Hypotension; Dizziness, Hypotension; Dizziness, Hypotension
Patient presented to Employee Health office for pre-employment health screening. After administratio... Patient presented to Employee Health office for pre-employment health screening. After administration of Flu, Covid, and Tdap vaccine caregiver began experiencing lightheadedness and hypotension. No syncopal episode occurred. Caregiver reports hx of lightheadedness following blood draw, but states he normally recovers quickly. Caregiver was monitored for 20 minutes but hypotension and lightheadedness failed to resolve. Rapid response was called over facility intercom and rapid response nurse evaluated patient and transported patient to emergency department for evaluation. Caregiver denies any previous reaction to vaccines. Vitals as follows: 1135 am BP 83/43, 1140 am BP 69/39 HR 37, 1145 am BP 68/43 HR 45, 1150 am BP 74/44 HR 47. More
2821063 14 M PA 01/15/2025 COVID19
 MODERNA
 3042999
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administered the incorrect vaccine for the patient's age. Administered Covid 19 Moderna vaccine... Administered the incorrect vaccine for the patient's age. Administered Covid 19 Moderna vaccine for ages 6 -11 years (0.25ml, IM). More
2821064 4 F OH 01/15/2025 DTAPIPV
 SANOFI PASTEUR
 U7838AA
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
4 YEAR OLD presented to office with redness and swelling around in injection site of Quadracel. Give... 4 YEAR OLD presented to office with redness and swelling around in injection site of Quadracel. Given in right thigh. 7X5 cm. No wheezing, GI symptoms joint swelling or rash elsewhere. Suspected mild/ moderate local reaction to vaccine related to immune response. No concern for serum sickness. More
2821065 16 F PA 01/15/2025 COVID19
 MODERNA
 3042999
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administered the wrong Covid vaccine for the patient's age. Administered Moderna Covid 19 for a... Administered the wrong Covid vaccine for the patient's age. Administered Moderna Covid 19 for ages 6-11 years. More
2821067 4 M IN 01/15/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42y93
y013576
Abnormal behaviour, Loss of personal independence in daily activities, Pain, Pai... Abnormal behaviour, Loss of personal independence in daily activities, Pain, Pain in extremity, Rash; Abnormal behaviour, Loss of personal independence in daily activities, Pain, Pain in extremity, Rash More
4 year old received MMRV and Dtap-IPV on 12/2/24. In the days after had pain. It seemed to be better... 4 year old received MMRV and Dtap-IPV on 12/2/24. In the days after had pain. It seemed to be better for a week or so. Family reports that around Christmas he was noted to have a rash the mother thought was hive-like. Around that time he started to report leg pain and not wanting to do things. Pain seems to be less now but still will unprompted report pain. He has not played at school for the last three days due to leg pain. More
2821068 25 F MI 01/15/2025 HPV9
 MERCK & CO. INC.
 y007322
Unevaluable event Unevaluable event
n/a n/a
2821069 24 M 01/15/2025 DTAP
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
nothing nothing
2821070 1.33 F IL 01/15/2025 HIBV
 MERCK & CO. INC.
 Y005454
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Injection site Red, Swollen, Raised, Warm to touch. Injection site Red, Swollen, Raised, Warm to touch.
2821072 75 F GA 01/15/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP ... Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP guidelines. More
2821073 75 M GA 01/15/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered Extra dose administered
Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP ... Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP guidelines. More
2821074 42 F FL 01/15/2025 HEP
PNC21
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
 941589
011819
Abscess, Erythema, Peripheral swelling; Abscess, Erythema, Peripheral swelling Abscess, Erythema, Peripheral swelling; Abscess, Erythema, Peripheral swelling
pateint called on 01/15/2025 morning and reported that her right arm is swallon and red. later in da... pateint called on 01/15/2025 morning and reported that her right arm is swallon and red. later in day she had dr appoitment and dr said its looks like abses. pateint prescribed antibiotics. More
2821075 0.75 F ME 01/15/2025 DTAPIPVHIB
 SANOFI PASTEUR
 uk020aa
Product preparation error Product preparation error
On 1/6/2025 pt was to receive Pentacel vaccine (DTAP/IPV/HIB). The Medical Assistant administering d... On 1/6/2025 pt was to receive Pentacel vaccine (DTAP/IPV/HIB). The Medical Assistant administering did not administer the HIB vial as part of the vaccine. Before administering the DTAP/IPV part of the vaccine they mixed it with Sterile Water Diluent and administered the vaccine. Contacted manufacturer the vaccine is subpotent due to being administered with Sterile Water Diluent. More
2821106 F 01/15/2025 HPV9
 MERCK & CO. INC.
 Y014510
Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event
Vaccine exposure during pregnancy; No symptoms reported; This spontaneous report was received from O... Vaccine exposure during pregnancy; No symptoms reported; This spontaneous report was received from Other Health Professional 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 07-JAN-2025, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #Y014510, expiration date: 01-NOV-2026, administered for prophylaxis (strength, and route of administration were not provided). The patient was pregnant when vaccination (Vaccine exposure during pregnancy), no symptoms reported (no adverse event). More
2821107 U KY 01/15/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No additional AE; patient received GARDASIL 9 dose outside of the Prescribing Information schedule r... No additional AE; patient received GARDASIL 9 dose outside of the Prescribing Information schedule regimen/received first dose on July 2012, second dose September 2013 and has not yet received third dose; This spontaneous report was received from a nurse practitioner concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date in July 2012, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (lot #, expiry date, anatomical location and route of administration were not provided). Then, on an unknown date in September 2013, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (lot #, expiry date, anatomical location and route of administration were not provided) (inappropriate schedule of product administration). Both vaccine doses were administered as prophylaxis. The patient had not received vaccine 3rd dose yet. No additional adverse event (AE) was reported (no adverse event.) Lot # is being requested and will be submitted if received. More
2821108 F MI 01/15/2025 VARCEL
 MERCK & CO. INC.
 Y014868
Skin laceration, Syringe issue Skin laceration, Syringe issue
Injury to hand NOS; noticed that 2 of the vials were broken and multiple shreds of glass were in the... Injury to hand NOS; noticed that 2 of the vials were broken and multiple shreds of glass were in the tray; This spontaneous report as received from Medical Assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. On 09-JAN-2025, around 4:00pm, a shipment of varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y014868, expiration date: 03-SEP-2026 (strength, dose, dose number, route, and anatomical location were not provided) for prophylaxis arrived and when opening the carton, the customer noticed that 2 of the vials were broken and multiple shreds of glass were in the tray (Syringe issue); the body of the vial was broken; the neck and where the cap is was not affected There was lyophilized powder in the tray and some remained in the bottom of the vials. It was reported that there was a call to vaccine shop and they told her to discard the product so the product had been discarded and could not be returned and pictures cannot be provided; when cleaning up the shards of glass, the customer hand was cut a little bit. She reports that it was "no big deal" (Limb injury); The patient stated that it was cut on the hand by the shreds of glass when removing them from the tray The outcome of limb injury was unknown. The action taken with varicella virus vaccine live (oka/merck)(VARIVAX) wa snot reported. The causal relationship between limb injury and therapy with varicella virus vaccine live (oka/merck)(VARIVAX) was not provided. More
2821109 U 01/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Wrong product administered Wrong product administered
(Meningococcal B (Bexserol incorrectly administered to an adolescent intended to receive Meningococc... (Meningococcal B (Bexserol incorrectly administered to an adolescent intended to receive Meningococcal ACWY MenQuadfi; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of wrong vaccine administered in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On an unknown date, the patient received Bexsero and did not receive Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: (Meningococcal B (Bexserol incorrectly administered to an adolescent intended to receive Meningococcal ACWY MenQuadfi ). 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: 16-DEC-2024 The pharmacist reported that the patient received Meningococcal vaccine B (Bexsero) incorrectly who was intended to receive meningococcal ACYW 135 (T CONJ) vaccine (Menquadfi) with no reported adverse event, which led to wrong vaccine administered. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. More
2821110 U 01/15/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; shingles/got it again; This serious case was reported by a consumer v... suspected vaccination failure; shingles/got it again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (4 times on face) and pain. 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/got it again). 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: 31-DEC-2024 This case was reported by a patient via interactive digital media. The patient got vaccinated with Shingles vaccine because he/she got shingles 4 times on face, but a few months ago in 2024 (from the date of reporting) with everything plus Shingles vaccination he/she got it again, the only thing was that the pain was not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2821111 71 M TX 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Pain in extremity, Therapeutic response unexpected Pain in extremity, Therapeutic response unexpected
there were times that he could not sit; experienced extreme arm soreness of the injected arm ever si... there were times that he could not sit; experienced extreme arm soreness of the injected arm ever since receiving the vaccine; after receiving Shingrix vaccine this sensation in his buttocks went away; This non-serious case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included pain in arm. Previously administered products included Covid-19 vaccine (had received Covid-19 vaccine in the past). Concurrent medical conditions included feeling abnormal (before receiving Shingrix, he was having a sensation in his buttocks as if shingles was coming on) and mobility decreased (many times that he could not sit). In SEP-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: there were times that he could not sit), pain in arm (Verbatim: experienced extreme arm soreness of the injected arm ever since receiving the vaccine) and unexpected therapeutic effect (Verbatim: after receiving Shingrix vaccine this sensation in his buttocks went away). The outcome of the injected limb mobility decreased was not reported and the outcome of the pain in arm was not resolved and the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix. It was unknown if the company considered the injected limb mobility decreased and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 16-DEC-2024 The reporter self-reported this case for him. He received the first dose of Shingrix vaccine in first week of September 2024 in the upper left arm, close to the shoulder. The reporter was experiencing extreme soreness of the injected arm ever since receiving the vaccine and felt as if he was punched in the shoulder 3 to 4 times. The reporter stated that he did had mobility of the left arm, but when he uses it, it gets aggravated and becomes more sore. The patient stated that before receiving Shingrix, he was having a sensation in his buttocks as if shingles was coming on and there were times that he could not sit. The reporter reported that after receiving Shingrix, this sensation in his buttocks went away, which led to unexpected therapeutic effect. The patient stated he had received other vaccines in the past (such as COVID), but had not experienced long term soreness in the arm as he was with Shingrix. He reported that he had an appointment to see his doctor on the day of reporting. More
2821112 54 F GA 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Burning sensation, Injection site pain, Laboratory test, Pain in extremity, Urti... Burning sensation, Injection site pain, Laboratory test, Pain in extremity, Urticaria More
burning in her arm; arm hurt/ pain in her arm; hives all over body; This non-serious case was report... burning in her arm; arm hurt/ pain in her arm; hives all over body; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-SEP-2024, the patient received the 1st dose of Shingrix (left arm). On 07-SEP-2024, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm hurt/ pain in her arm). In SEP-2024, the patient experienced generalized urticaria (Verbatim: hives all over body). On an unknown date, the patient experienced burning sensation (Verbatim: burning in her arm). The patient was treated with loratadine (Claritin). The outcome of the generalized urticaria was not resolved and the outcome of the pain in arm and burning sensation were unknown. It was unknown if the reporter considered the generalized urticaria, pain in arm and burning sensation to be related to Shingrix. It was unknown if the company considered the generalized urticaria, pain in arm and burning sensation to be related to Shingrix. Additional Information: GSK Receipt Date 16-DEC-2024 The patient self-reported this case for herself. She stated that she was vaccinated with her first dose of Shingrix and a few days after vaccination with Shingrix she had hives all over her body. She was examined by her PCP (primary care physician) and given a prescription for short term steroid use and Claritin to be used for 30 days in 2024. The reporter instructed if hives did not resolve to make an appointment with an allergist. The patient stated she was exam and tested by an allergist who stated she did not show allergies to anything. The patient mentioned it had been 3 months since vaccination with Shingrix and she still currently has hives all over her body. She stated that her arm hurt immediately upon vaccination with Shingrix. She experienced burning and pain in her arm after the injection in 2024. The reporter did not provide lot number for Shingrix. More
2821113 F 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes simplex reactivation, Incomplete course of vaccination Herpes simplex reactivation, Incomplete course of vaccination
reactivation of Herpes Simplex/five days after the 1st vaccination she had an outbreak with herpes ... reactivation of Herpes Simplex/five days after the 1st vaccination she had an outbreak with herpes simplex; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes simplex (she was diagnosed with herpes simplex in the early 1970's and she stated that herpes outbreaks stopped in the mid 1970's). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced herpes simplex (Verbatim: reactivation of Herpes Simplex/five days after the 1st vaccination she had an outbreak with herpes simplex). The outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to Shingrix. It was unknown if the company considered the herpes simplex to be related to Shingrix. Additional Information: GSK receipt date: 16-DEC-2024 The patient was the reporter. The reporter reported that last forty years she had not had any outbreaks and was not on any medication used as a prevention for outbreaks. The patient stated that she was vaccinated with dose one of Shingrix in early 2023 and five days after the vaccination she had an outbreak with herpes simplex. The patient mentioned that she had one blister and that has resolved, and she had not had anymore outbreaks since her vaccination. The reporter reported that due to this reactivation of Herpes Simplex she had not had the second dose administered (missed dose). More
2821114 71 F CA 01/15/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Diplopia Diplopia
Vertical Double Vision; This non-serious case was reported by a consumer via call center representat... Vertical Double Vision; This non-serious case was reported by a consumer via call center representative and described the occurrence of double vision in a 71-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. On 06-DEC-2024, the patient received Fluarix 2024-2025 season. On 07-DEC-2024, 1 days after receiving Fluarix 2024-2025 season, the patient experienced double vision (Verbatim: Vertical Double Vision). The outcome of the double vision was resolving. It was unknown if the reporter considered the double vision to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the double vision to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-DEC-2024 The case was self reported by patient. The patient received Fluarix vaccine and the following day, the patient began experiencing vertical double vision which lasted all week. The vertical double vision was better yesterday and today. This case is linked with US2024159689, reported by same reporter.; Sender's Comments: US-GSK-US2024159689:Same reporter/Different patient More
2821115 0.33 M NE 01/15/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 FJ47R
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
a 4 month old patient was inadvertently administered with a first dose of FLULAVAL; This non-serious... a 4 month old patient was inadvertently administered with a first dose of FLULAVAL; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number FJ47R, expiry date 07-JUN-2025) for prophylaxis. On 22-NOV-2024, the patient received the 1st dose of FluLaval 2024-2025 season. On 22-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 month old patient was inadvertently administered with a first dose of FLULAVAL). The outcome of the inappropriate age at vaccine administration 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 The registered nurse reported that a patient of an inappropriate age was inadvertently administered with a first dose of Flu Laval vaccine, which led to inappropriate age at vaccine administration. The reporter wanted to knew if that can be considered a valid dose, or which advise or guidance can they provide them. The Vaccine Administration Facility was the same as Primary Reporter. More
2821116 18 F NJ 01/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 5JX2E
Incorrect dose administered Incorrect dose administered
overdose; 18 year old patient received an adult dose; This non-serious case was reported by a other ... overdose; 18 year old patient received an adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis. On 03-DEC-2024, the patient received the 1st dose of Engerix B adult. On 03-DEC-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: overdose) and adult product administered to child (Verbatim: 18 year old patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-DEC-2024 The 18 year old patient received an adult dose of Engerix B, which led to overdose and adult product administered to child. This is 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2024013448:SAME REPORTER US-GSK-US2024055489:SAME REPORTER US-GSK-US2024055491:SAME REPORTER US-GSK-US2024061882:SAME REPORTER More
2821117 F VA 01/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Antibody test abnormal, Therapeutic response decreased Antibody test abnormal, Therapeutic response decreased
Low Hepatitis B titers; This non-serious case was reported by a nurse via call center representative... Low Hepatitis B titers; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 18-year-old female patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapeutic response decreased (Verbatim: Low Hepatitis B titers). The outcome of the therapeutic response decreased 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: 23-DEC-2024 Reporter stated they had an 18-year-old patient who had low titers on her Hepatitis B and needed an Engerix-B booster. Therefore, there was no additional information available. The patient's previous Hepatitis B vaccination history was not known. More
2821118 0.33 M TX 01/15/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 5n2an
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration of Rotarix first dose over age; This non-serious case was reported by a nurse via cal... Administration of Rotarix first dose over age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5n2an, expiry date 10-MAY-2026) for prophylaxis. On 22-OCT-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 22-OCT-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Rotarix first dose over age). The outcome of the inappropriate age at vaccine administration 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: 23-DEC-2024 The patient's age was 17 weeks and 4 days old The nurse reported that the patient of inappropriate age received first dose of Rotarix vaccine, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. More
2821119 42 F OK 01/15/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XP4
Product administered to patient of inappropriate age, Underdose Product administered to patient of inappropriate age, Underdose
Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serio... Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 25-NOV-2024, the patient received Engerix B pediatric. On 25-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose to adult patient) and underdose (Verbatim: Engerix-B pediatric dose to adult patient). The outcome of the adult use of a child product and underdose were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-DEC-2024 The pharmacist reported that a pediatric dose of Engerix-B was given to an adult patient, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter. More
2821120 U MO 01/15/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 D2LP3
Expired product administered Expired product administered
3 patients have received a dose of Priorix expired on December 1st 2024; This non-serious case was r... 3 patients have received a dose of Priorix expired on December 1st 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a specified number of patients who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis. On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: 3 patients have received a dose of Priorix expired on December 1st 2024). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JAN-2025 The clinic administrator reported that at least 3 patients had received an expired dose of Priorix vaccine, which led to expired vaccine used. The reporter was not sure if the last dose was administered on 21st December and had no patient's data. The Vaccine Administration Facility was the same as Primary Reporter. More
2821121 U VA 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Second dose given after the maximum recommended interval; This non-serious case was reported by a ph... Second dose given after the maximum recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 01-JAN-2022). On 07-JAN-2025, the patient received the 2nd dose of Shingrix. On 07-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second dose given after the maximum recommended interval). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 07-JAN-2025 The pharmacist reported there was administration of 2nd dose of Shingrix after the recommended interval to the patient. The reporter asked Glaxo SmithKline to request data about the administration of Shingrix after the recommended interval. They mentioned this question was asked by someone at their site, so they could not offer data about the patient nor the vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2821122 U NJ 01/15/2025 COVID19
 JANSSEN
 Unknown
Osteolysis, Plasma cell myeloma Osteolysis, Plasma cell myeloma
multiple myeloma; lytic lesion; This spontaneous report received from a patient concerned a patient ... multiple myeloma; lytic lesion; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 and frequency not reported, administered on 13-Mar-2021, 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/lot numbers. No concomitant medications were reported. On 25-Jan-2023, the patient experienced lytic lesion. On Mar-2023, the patient experienced multiple myeloma and was hospitalized on an unspecified date. (dose series 1). The development of the disease has caused extreme physical, emotional, and financial suffering. Since the symptoms began, the patient's quality of life has diminished immensely. The vaccine was simultaneously impacting M-Spike protein levels, until the patient reached a point where chronic and worsening back pain forced to cease regular activities of dancing, roller skating, and playing tennis. The patient's exhaustion levels became increasingly concerning, becoming particularly notable over the holidays in December 2022 and finally coming to an unmistakable head when the patient was forced to take a leave of absence from work on February 28, 2023 when the patient no longer possessed the energy required to complete duties as a high school teacher. Once the diagnosis was finalized and a treatment plan was agreed upon, the patient was admitted to the hospital for what was supposed to be an overnight stay to observe physical reactions to the initial dose of chemotherapy. What resulted was a two-week hospital stay, during which the patient had to undergo multiple kyphoplasty's in an attempt to repair the irreversible damage caused by the lytic lesions from 2021 to present. Since this date, the physical effects have included a Curvature of backbone due to the compression on weakened spine due to the lytic lesions. Continuous pain in my right sternum and right upper shoulder, which has persisted and become more severe since March 2023, subsequently resulting in a shift in sternum's position within chest. Damage to heart resulting from multiple myeloma treatment, which cause severe mitral valve regurgitation and required the insertion of two mitral valve clips on April 18, 2024. The attempt to correct extreme shortness of breath was only partially successful, and to this day the patient continue to experience shortness of breath through even simple activities. Impacted lung function and an increased frequency of phlegm buildup. The action taken with janssen covid-19 vaccine was not applicable. The outcome of lytic lesion and multiple myeloma was not reported. This report was associated with a product quality complaint: Product Complaint 90000348998. Investigation Results: 90000348998-Voided- This record was reported as "There was a letter that came into the J&J Global Benefits Department via mail related to an adverse effect", which does not meet the definition of a product quality complaint or explicitly allege a potency issue. This record will be voided as no PQC. Forwarding this record to PQV Management review to void approval. This report describes medical adverse events for the patient. There is no allegation regarding a product quality issue or product efficacy in the information reported. Approval to void due to no PQC identified.. This report was serious (caused/prolonged hospitalization).; Sender's Comments: V0; Plasma cell myeloma; The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
✓
2821123 F 01/15/2025 COVID19
 MODERNA
COVID-19 COVID-19
The caller further describes the last infection in November as "the worst" as she experien... The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Head injury (5 closed head injuries), Lung scarring (scar tissue forming on lungs) and Gastrointestinal bleeding (bleed internally all the time in my stomach from scleroderma and have to keep on getting iron infusions). Concurrent medical conditions included Chronic kidney disease stage 3 (stage 3 kidney disease), Scleroderma (bleed internally all the time in stomach from scleroderma), Heart disorder (she was in really bad physical shape and the caller's heart was not good either) and Immunocompromised. On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.). At the time of the report, COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient shared that she contracted with COVID-19 despite receiving the said doses. It was reported that patient chest hurts, and heart rate was going up high. The caller was frightened of contracting with COVID-19 the 4th and more time. The caller shared that her provider previously recommended her to get 2 doses of Moderna vaccines by stating one time she was ok for her to have two of them. And they gave her a double dose. She went back a month later and she got another one of the latest vaccine. It was unknown if the patient experienced any additional symptoms and events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-781009, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781012 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781009:Same report for different Product (SPIKEVAX 2024-2025 PFS) US-MODERNATX, INC.-MOD-2025-781011:Same report for different Product US-MODERNATX, INC.-MOD-2025-781012:SPIKEVAX 2024-2025 PFS More
2821124 32 F MA 01/15/2025 COVID19
COVID19
COVID19
FLUX
FLUX
FLUX
 MODERNA
MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER





Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache; Pain, Pyrexia, ... Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache; Pain, Pyrexia, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling; Vaccination site warmth; Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache; Pain, Pyrexia, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling; Vaccination site warmth More
4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itc... 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; Felt odd, like sort of drunk and out of it; loss of appetite; low-grade fever; Felt extreme fatigue; splitting headache; chills; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite) and VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) in a 32-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. The patient's past medical history included Psoriasis. On 08-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Influenza vaccine (unknown route) 1 dosage form. On 08-Jan-2025, the patient experienced PAIN (body aches), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite), PYREXIA (low-grade fever), FATIGUE (Felt extreme fatigue), HEADACHE (splitting headache) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), VACCINATION SITE SWELLING (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) and VACCINATION SITE MASS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given). The patient was treated with Diphenhydramine hydrochloride (Benadryl) (oral use) on 10-Jan-2025 at a dose of 25 milligram every six hours. At the time of the report, PAIN (body aches), VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite), VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), PYREXIA (low-grade fever), FATIGUE (Felt extreme fatigue), HEADACHE (splitting headache), CHILLS (chills), VACCINATION SITE SWELLING (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) and VACCINATION SITE MASS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. Within 3 hours patient felt odd, like sort of drunk and out of it 3 hours-48 hours. Patient also felt extreme fatigue, splitting headache, body aches, chills, low-grade fever, loss of appetite 48 hours after vaccine. Symptoms previously mentioned mostly gone but then patient started developing a 4-inch hot, itchy, slightly swollen and tender lump in area where vaccine was given. The patient did not experience any additional symptoms/events. Patient started taking one benadryl tablet 10Jan25 and have taken 5 tablets so far once every 6-12 hours sporadically. The patient did not have any additional medical history, concomitant disease or risk factor. There were no lab data/results available. More
2821125 79 M FL 01/15/2025 COVID19
 PFIZER\BIONTECH
Lipoma, Positron emission tomogram, Vaccination site cyst, Weight, Weight decrea... Lipoma, Positron emission tomogram, Vaccination site cyst, Weight, Weight decreased More
large lump in abdomen/ it was a lipoma; lost 15 pounds; developed something hard, like a cyst, at in... large lump in abdomen/ it was a lipoma; lost 15 pounds; developed something hard, like a cyst, at injection site; This is a spontaneous report received from a Pharmacist from medical information team. A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation; apixaban (ELIQUIS). The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Anatomical Site of injection: Unknown, thinks left arm; , Lot number: EL9265), administration date: 03Feb2021, when the patient was 76-year-old, for covid-19 immunisation; comirnaty (DOSE 2, SINGLE, Anatomical Site of injection: Right or left arm, Lot number: EL9267), administration date: 24Feb2021, when the patient was 76-year-old, for covid-19 immunisation; comirnaty (DOSE 3, SINGLE, Lot number: FD8448), administration date: 31Aug2021, when the patient was 77-year-old, for covid-19 immunisation; comirnaty (DOSE 4, SINGLE, Lot number: FL3197), administration date: 05Apr2022, when the patient was 77-year-old, for covid-19 immunisation; comirnaty bivalente ba.4/ba.5 (DOSE 5, SINGLE, Lot number: Not quite sure, looks like GJ5342), administration date: 09Sep2022, when the patient was 78-year-old, for covid-19 immunisation. The following information was reported: VACCINATION SITE CYST (non-serious) with onset Apr2024, outcome "not recovered", described as "developed something hard, like a cyst, at injection site"; WEIGHT DECREASED (non-serious) with onset May2024, outcome "unknown", described as "lost 15 pounds"; LIPOMA (non-serious), outcome "recovering", described as "large lump in abdomen/ it was a lipoma". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for apixaban was unknown. Therapeutic measures were not taken as a result of vaccination site cyst. Additional information: Patient had injection Mar2024, everything was fine, did not notice this right away, did not notice until about Apr2024. At the injection site, did not know how to say but, developed something hard, like a cyst. Kept thinking it is going to go away, it does not, it just stays right there. It did not bother him, is just there. Was about the size of, smaller than a dime, was just hard on outside, could kind of feel it below the skin. Clarified, hardness in right arm, at injection site, size was about smaller than pea size, size of kernel of corn. Did not really stick up that much, sticks up about probably, just a centimeter or so, is round. Outcome of event: Still has this now, just getting around to reporting it. Kept thinking it will get better, had stayed about the same. Lost 15 pounds: Want to add 2 fact, that does not have anything to do with this. In May2024, for an unknown reason, lost 15 pounds. They always ask if he has lost weight. They followed up on him, he was 100 percent OK. Lump in abdomen: Even went to have PET scan because he had large lump in abdomen, about size of softball. They just think it is a lipoma. Because it was a lipoma, they are just leaving it there, just has it. Outcome of event: Can only go by feeling it, it feels a little better, thinks it went from hard ball to a softball. Indication: It was due. had gotten them all as they came out. PET scan for lump in abdomen: negative, was a good PET scan. No Prior Vaccinations (within 4 weeks). No family Medical History Relevant to Adverse Events (AEs). Would like to know is there some way they can get rid of this lump, dissolve it or whatever? Caller has also a question regarding Eliquis. While caller locating vaccination card, caller stated, he takes Eliquis, which is Pfizer. Caller mentioned he recently starting to take it and wonder if they make it in the PRIVACY territory. More
2821126 F IL 01/15/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Arthritis, Blood test Arthralgia, Arthritis, Blood test
Arthritis; Joint pain; This is a spontaneous report received from a Consumer or other non HCP. A 79... Arthritis; Joint pain; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Underactive thyroid" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "cancer" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ARTHRITIS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthritis, arthralgia. Additional information: Patient wanted to report the adverse reaction to her Covid vaccine (Clarified as Pfizer Covid-19 vaccine). Consumer stated, "Arthritis, Joint pain." Consumer stated, "Yes, however I did not have arthritis until after I took the vaccine. I have never had arthritis or joint pain and I have been taking all these other medications for years." Patient had blood work. It was also reported that the only treatment she have for the event is, she tried Tylenol and Tramadol. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2821127 F VA 01/15/2025 COVID19
 PFIZER\BIONTECH
 FJ8762
Cough, Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infectio... Cough, Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infection More
discomfort; URT; cough; throat pain; sick; This is a spontaneous report received from a Consumer or ... discomfort; URT; cough; throat pain; sick; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "Periodically eczema/Eczema, left wrist" (unspecified if ongoing), notes: sporadic mostly dormant; "Chigger bite allergy feet irritation" (unspecified if ongoing), notes: Spring plus summer; "Orthopaedic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, notes: (Tylenol occasionally but not at or near time plus date of vaccination (covid)); Relafen, reaction(s): "Drug allergy", notes: do not tolerate NSAIDs plus they generally cause or upper chest rash.; Relafen, reaction(s): "upper chest rash", notes: do not tolerate NSAIDs plus they generally cause or upper chest rash. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT"; COUGH (non-serious) with onset 2022, outcome "recovered"; ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "sick"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "throat pain"; DISCOMFORT (non-serious), outcome "recovered". Additional information: got sick before holiday with URT cough plus throat pain that took over a month to recover.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320520 Same patient, different vaccine and event.; More
2821129 12 M IN 01/15/2025 RV5
 MERCK & CO. INC.
 2032347
No adverse event, Wrong product administered No adverse event, Wrong product administered
No adverse effects were reported; ROTATEQ was administered instead of the RSV vaccine BEFORTUS to a ... No adverse effects were reported; ROTATEQ was administered instead of the RSV vaccine BEFORTUS to a 12 day old infant on 09-JAN-2025; This spontaneous report has been received from a Nurse referring a 12-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported. On 09-JAN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter (mL), administered orally (PO) (strength, and indication were not provided; lot # reported as 2032347, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on 22-OCT-2025), this vaccine was administered instead of the Respiratory Syncytial Virus (RSV) vaccine nirsevimab (BEYFORTUS) (also reported as BEFORTUS) to a 12 day old infant (wrong product administered). No adverse effects were reported (no adverse event). More
2821130 F UT 01/15/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Influenza like illness Fatigue, Influenza like illness
flu-like symptoms; felt exhausted; This non-serious case was reported by a consumer via call center ... flu-like symptoms; felt exhausted; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms) and exhaustion (Verbatim: felt exhausted). The outcome of the influenza-like symptoms and exhaustion were resolved (duration 2 days). It was unknown if the reporter considered the influenza-like symptoms and exhaustion to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms and exhaustion to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JAN-2025 The patient reported that after her first dose of Shingrix she felt exhausted and flu-like symptoms for 2 days. More
2821131 63 F VA 01/15/2025 COVID19
 PFIZER\BIONTECH
Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infection Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infection
discomfort; got sick; throat pain; URT cough; This is a spontaneous report received from a Consumer ... discomfort; got sick; throat pain; URT cough; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT cough"; ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "got sick"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "throat pain"; DISCOMFORT (non-serious), outcome "recovered". Additional information: Patient got sick before holiday (2022) with URT cough plus throat pain that took over a month to recover from that vaccine on 31Oct2022. Patient had discomfort that did not last long at all. 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-202400320520 Same patient, different vaccine and event;US-PFIZER INC-202500006963 same patient, different product/events; More
2821132 63 F VA 01/15/2025 COVID19
 PFIZER\BIONTECH
 GH9697
Cough, Discomfort, Oropharyngeal pain, Upper respiratory tract infection Cough, Discomfort, Oropharyngeal pain, Upper respiratory tract infection
discomfort; URT; Cough; Throat Pain; This is a spontaneous report received from a Consumer or other ... discomfort; URT; Cough; Throat Pain; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "periodically eczema, left wrist" (ongoing), notes: sporadic mostly dormant. Has Rx to use if needed plus rarely needed to; "allergic dermatitis from chigger bites" (ongoing), notes: in spring plus summer; "allergic dermatitis from chigger bites" (ongoing), notes: in spring plus summer; "orthopaedic problem from multiple body parts" (unspecified if ongoing), notes: knees, left finger middle finger, finger thumb base (both) exostoses bilateral, 1st cuneiform. The patient's concomitant medications were not reported. Past drug history included: Relafen, reaction(s): "did not tolerate NSAIDs plus they generally cause or upper chest rash", notes: NSAID; Relafen, reaction(s): "did not tolerate NSAIDs plus they generally cause or upper chest rash", notes: NSAID. Vaccination history included: Bnt162b2 (dose number unknown, batch lot number unknown), for Covid-19 immunization, reaction(s): "discomfort"; Bnt162b2 (dose number unknown, batch lot number FJ8762), for Covid-19 immunization, reaction(s): "discomfort". The following information was reported: COUGH (non-serious) with onset 2022, outcome "recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "Throat Pain"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT"; DISCOMFORT (non-serious), outcome "recovered". Additional information: The patient informed that the others were not painful when the injections were done and the discomfort did not last long at all. The patient informed that she got sick before holiday with URT, cough plus throat pain that took over a month to recover from that vaccine was 31Oct2022, done by pharmacy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320520 same patient, different product/events;US-PFIZER INC-202500006961 same patient, different product/events;US-PFIZER INC-202500006962 same patient, different product/events; More
2821133 71 F 01/15/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old... covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing), notes: unrelated. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, regular vaccinations/boosters, both Pfizer and Moderna), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2025) and all described as "covid". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 02Jan2025 to 06Jan2025. Paxlovid was wonderful, really knocked out the covid by the end of the 5 days of treatment. The patient had regular vaccinations/boosters, both Pfizer and Moderna, and last booster was 3-1/2 months before 12Jan2025. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received. More
2821134 M PA 01/15/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines; COVID af... COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines; COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID after Vaccine/Had COVID after five years of not getting it, after all these vaccines". The patient called and said he felt horrible, and he need this drug bad he was sick as a dog. The caller continues, he just wanted to feel better, this COVID, after five years of not getting it after all these vaccines, and now here he was getting it now. Every time he started to talk, he starts to cough. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient took Paxlovid. More
2821136 F MD 01/15/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vacci... COVID-19, SARS-CoV-2 test, Vaccination failure; COVID-19, SARS-CoV-2 test, Vaccination failure More
tested positive; did get the flu and Covid vaccine back at the beginning of Oct; tested positive; di... tested positive; did get the flu and Covid vaccine back at the beginning of Oct; tested positive; did get the flu and Covid vaccine back at the beginning of Oct; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: 2 years ago I think, we had tested positive. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive; did get the flu and Covid vaccine back at the beginning of Oct". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 2 years ago; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that the husband and wife (patient) had taken the Paxlovid already, and the caller stated "About 2 years ago I think, we had tested positive and we took it, and then just recently, and we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct. It was indicated that both husband and wife have previously had Covid, previously have taken Paxlovid, previously had a Covid vaccine, and are currently taking Paxlovid now. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received. More
2821137 U 01/15/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
got sick after taking the Pfizer vaccine; This is a spontaneous report received from a Consumer or o... got sick after taking the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-780965 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular 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 "got sick after taking the Pfizer vaccine". Additional information: Method of assessment was Global Introspection. It was unknown if the patient experienced any additional symptoms/events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2821138 F 01/15/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
SARS-CoV-2 reinfection; SARS-CoV-2 reinfection; This is a literature report for the following litera... SARS-CoV-2 reinfection; SARS-CoV-2 reinfection; This is a literature report for the following literature source(s). In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis). She received an additional dose of the Spikevax vaccine in September 2022. In October 2022, she completed a 5-day course of nirmatrelvir/ritonavir in the setting of a SARS-CoV-2 reinfection. She experienced three days with no fatigue and in which she described "feeling normal." However, these improvements did not persist, and she returned to her pre-reinfection baseline. Because of this temporary improvement, she completed a second, 15-day course of nirmatrelvir/ritonavir in late November 2022 outside of the context of an acute COVID-19 infection. This additional course of nirmatrelvir/ritonavir did not improve her fatigue or her other symptoms in any way.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500004601 Same patient/drug/event; different dose.; More
2821139 F MD 01/15/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other n... contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: medicine get every month. The patient took concomitant medications. Vaccination history included: Covid shot (dose number unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID". During an inbound call for financial assistance, the patient was calling in regards to Paxlovid. She said that she contracted COVID and her doctor prescribed the medication for her. The patient has never had COVID before, and thought when she travel, she must have picked it up, she got that, and she has it. She spoke with her doctor over the phone, and he wanted her to take it, and he wanted her to start it tonight. The patient also stated, "I actually got the shot, the new shot they had out, and I thought that was really going to protect me because I've gotten every shot they have out there for COVID." The patient stated, "I guess I'm trying to figure out what do I do; I was planning to have my son when he gets off, and he can come check on me, to pick up the medicine so I can start taking it." Follow-up activities are possible, information on the batch number has been requested. More
2821140 F TX 01/15/2025 FLUX
 UNKNOWN MANUFACTURER
Nausea, Vomiting Nausea, Vomiting
vomiting; nauseous; Initial information received on 08-Jan-2025 regarding an unsolicited valid non-... vomiting; nauseous; Initial information received on 08-Jan-2025 regarding an unsolicited valid non-serious case received from a Patient. This case was linked with US-SA-2025SA012010. This case involves Adult female patient (59.09 kg) who experienced vomiting and nauseous after receiving Influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Fluoxetine HCL and Aripiprazole. On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for immunisation. On an unknown date the patient developed vomiting and nauseous (nausea) (unknown latency). Reportedly, patient states she was vomiting and nauseous for 1 week after receiving the flu vaccine, but she is feeling better now. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.; Sender's Comments: US-SA-2025SA012010: More
2821141 0.33 M MO 01/15/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK112AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
HIB component of PENTACEL was given to a patient, but it was reconstituted using a sterile diluent a... HIB component of PENTACEL was given to a patient, but it was reconstituted using a sterile diluent and the DTaP-IPV component was not administered with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who received HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], but it was reconstituted using a sterile diluent and the DTAP-IPV component was not administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine; and pneumococcal vaccine CONJ 20V (CRM197) [Prevnar 20] both for Immunisation. On 07-Jan-2025, the patient received 0.5 ml of dose 2 of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection with standard strength (expiry date- 30-Sep-2025 and lot UK112AA) once via intramuscular route in the right thigh as Immunization and HIB component of pentacel was given to a patient, but it was reconstituted using a sterile diluent and the DTAP-IPV component was not administered with no reported adverse event (single component of a two-component product administered) (latency- same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
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