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
2836546 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Extra dose administered Extra dose administered
gave me 3 shingle shots; This non-serious case was reported by a consumer via interactive digital me... gave me 3 shingle shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: gave me 3 shingle shots). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 13-APR-2025 The patient received 3 Shingles shot, which led to extra dose administered. This case was reported by a patient via interactive digital media. More
2836547 F NY 04/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 PZ75H
Expired product administered Expired product administered
Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case w... Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number PZ75H, expiry date 28-FEB-2025) for prophylaxis. On 07-APR-2025, the patient received Menveo. On 07-APR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Maladministration of Menveo One-vial Presentation After the Expiration Date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 07-APR-2025 The reporter reported that 7th April 2025 a female patient received Menveo one vial presentation expired dose, with lot number PZ75H, expiration date 2/28/2025, which led to expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter. More
2836548 65 F NJ 04/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 CR5XF
CR5XF
Injection site erythema, Injection site paraesthesia, Paraesthesia, Rash; Inject... Injection site erythema, Injection site paraesthesia, Paraesthesia, Rash; Injection site erythema, Injection site paraesthesia, Paraesthesia, Rash More
she was still experiencing tingling at injection site of her Shingrix vaccine; tingling in left arm ... she was still experiencing tingling at injection site of her Shingrix vaccine; tingling in left arm and hand and also her left foot and middle of her back/intermittent tingling; erythemotous area about 2 inches below injection site; Rash faded but still present in initial area; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis. On 16-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 17-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In FEB-2024, an unknown time after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced rash (Verbatim: Rash faded but still present in initial area). On 19-FEB-2024, the patient experienced injection site erythema (Verbatim: erythemotous area about 2 inches below injection site). On 20-FEB-2024, the patient experienced tingling of extremity (Verbatim: tingling in left arm and hand and also her left foot and middle of her back/intermittent tingling). On 23-OCT-2024, the patient experienced injection site tingling (Verbatim: she was still experiencing tingling at injection site of her Shingrix vaccine). The outcome of the injection site erythema was unknown and the outcome of the injection site tingling, tingling of extremity and rash were not resolved. It was unknown if the reporter considered the injection site erythema, injection site tingling, tingling of extremity and rash to be related to Shingrix and Shingrix. It was unknown if the company considered the injection site erythema, injection site tingling, tingling of extremity and rash to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The physician reported that the patient received 2 doses of Shingrix and Fluzone and experienced paresthesia after both vaccines. The Fluzone was received on 31st October 2024 in right arm. The patient had erythemotous area about 2 inches below injection site and then on 20th February 2024 patient called complained of tingling in left arm and hand and also her left foot and middle of her back. On 28th February 2024 the patient complained of intermittent tingling throughout her whole body and the rash faded but still present in initial area. She felt site of erythematous area on left arm was more tingly than the rest of her body and that continued on. The physician sent patient to neurologist who didn't think much of anything and stated symptoms faded out on their own and then MD stated patient got the flu shot (Fluzone) and the symptoms started again. When asked for dates of the symptoms fading out, the MD stated she got call from patient on 23rd October 2024 stating she was still experiencing tingling at injection site of her Shingrix vaccine up her shoulders and down the arm and a little bit in her left leg and that it was very intermittent and very random. The reporter stated patient was still experiencing paresthesia as of today (till the time of reporting) More
2836549 11 F TX 04/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Accidentally administered Infanrix to 11 years patient; This non-serious case was reported by a othe... Accidentally administered Infanrix to 11 years patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) for prophylaxis. On 07-APR-2025, the patient received Infanrix. On 07-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Accidentally administered Infanrix to 11 years patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-APR-2025 On 08 Apr 2025, a medical assistant called to inform that there was a vaccine error. According to reporter, on 07 Apr 2025, an 11 year old patient received a dose of Infanrix which led to Inappropriate age at vaccine administration but originally the patient was intended to receive a Tdap dose. More
2836553 52 M NJ 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Fatigue, Muscular weakness Chills, Fatigue, Muscular weakness
Fatigue and chills and extreme leg weakness going on 11 days and counting from 2nd Shingrix shot. Fatigue and chills and extreme leg weakness going on 11 days and counting from 2nd Shingrix shot.
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2836554 M 04/17/2025 COVID19
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Blood glucose normal, Headache, Nausea, Retching, Vomiting; Blood glucose normal... Blood glucose normal, Headache, Nausea, Retching, Vomiting; Blood glucose normal, Headache, Nausea, Retching, Vomiting More
10021038--HYPONATREMIA^ 10047700--VOMITING 10/4/24 1240 patient received COVID and Influenza vaccine... 10021038--HYPONATREMIA^ 10047700--VOMITING 10/4/24 1240 patient received COVID and Influenza vaccine within the past two days and notes headache and nausea with some vomiting of bile this morning. Reports he work up nauseated, vomited and then consumed ice cream and yogurt around 0600 this morning. He denies any ongoing vomiting, fever, chills, abdominal pain, tremors. Blood sugar this morning was reported as 155. VS are WNL. 10/5/24 0331 (S) Situation patient reporting severe nausea without emesis (dry heaving) and requesting relief. PRN anti-emetic not effective. (B) Background patient reports side effects from recent covid vaccine received. (A) Assessment Nursing and medical intervention provided no relief. (R) Recommendations MOD ordered alternative anti-emetic. Nursing staff to monitor for interactions. Patient was hospitalized at Hospital ( 10/5/2024 - 10/8/2024) with hyponatremia (dx per patient Nephrologist on 10/5/2024 9:56 AM at hospital) related to his venlafexine. This was discontinued and patient was placed on Welbutrin. Oct 08, 2024@13:19:59 pharmacist entered allergy into system. Sodium levels were monitored closely upon return to CLC. More
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2836555 82 M CA 04/17/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH


Beta haemolytic streptococcal infection, Chills, Fatigue, Hyponatraemia, Influen... Beta haemolytic streptococcal infection, Chills, Fatigue, Hyponatraemia, Influenza; Laboratory test, Lactic acidosis, Pain, Pneumonia, Pyrexia; Sepsis More
I received pneumonia vaccination Prevnar 20 0.5 ML INJ PFIZ. Symptoms of fever, chill, exhaustion, b... I received pneumonia vaccination Prevnar 20 0.5 ML INJ PFIZ. Symptoms of fever, chill, exhaustion, body ache followed. On 04/03/2025 I was hospitalized (redacted hospital name) with pneumonia, sepsis, secondary bacterial injection, group B strep, and Influenza A. Discharge was 4/10/2025. I am recovering at home treating continuing hyponatremia and lactic acidosis. More
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2836556 70 M MN 04/17/2025 COVID19
 MODERNA
 011L20A
COVID-19, Deafness bilateral, Ear discomfort, Hypoacusis, SARS-CoV-2 test positi... COVID-19, Deafness bilateral, Ear discomfort, Hypoacusis, SARS-CoV-2 test positive More
I experienced loss of hearing after getting a two dose regimen of the Moderna shot in January and Fe... I experienced loss of hearing after getting a two dose regimen of the Moderna shot in January and February, 2021 and subsequently, On February 14, 2022, getting Covid 19, confirmed by an Abbott Labs Diagnostic test. My Audiologist doctor examined my ears after three and a half weeks of the loss of about 75% of my hearing in both of my ears and prescribed a regimen of Nasal rinse once per day and Flonase once per day. After four plus weeks my hearing slowly returned to pre-covid-19 acuity. Since then, my ears "plug up" with a decrease in hearing ability at the drop of a hat or for no obvious reason. It's a constant problem. I never had anything like this condition before the Covid shots and the subsequent Covid-19 infection. More
2836558 52 F 04/17/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Chills, Erythema, Injection site erythema, Injection site pruritus, Musculoskele... Chills, Erythema, Injection site erythema, Injection site pruritus, Musculoskeletal stiffness; Peripheral swelling, Skin warm More
Reaction / side effects from Pneumococcal Pneumonia vaccine last 5 days; arm was red and stiff / swo... Reaction / side effects from Pneumococcal Pneumonia vaccine last 5 days; arm was red and stiff / swollen about 5 inches in diameter and was hot to the touch. Also for these 5 days had itching around this red area on the arm where the vaccine administered. Had chills, but only within the first 48 hours. More
2836559 44 F 04/17/2025 FLUX
 UNKNOWN MANUFACTURER
Immunisation reaction Immunisation reaction
Betaseron working very well, no exacerbation for over 4 years. Her last exacerbation was around 2019... Betaseron working very well, no exacerbation for over 4 years. Her last exacerbation was around 2019 when she got a flu shot and she had allergic reaction to it. More
2836562 64 M TN 04/17/2025 RSV
 PFIZER\WYETH
 LH4511
Device connection issue Device connection issue
LPN attempted to administer an RSV (Abrysvo) vaccine to a patient and the reconstitution process of ... LPN attempted to administer an RSV (Abrysvo) vaccine to a patient and the reconstitution process of the vaccine kit, the luer locking section of the syringe fell off. LPN tried it a second time with another kit from the same box and lot number and it was defective as well. A third kit was obtained from a different box that had the same lot number and there was no issue with reconstituting the vial with that kit's syringe. The LPN had previous experience in reconstituting the kits. Situation- two RSV vaccine kits noted to be defective as the syringe and adapter had unsecure connection and detached while mixing medication causing the adapter and vial to vail onto dirty surface. LOT# LH4511 EXP: 2025/10. Background-potential risk for infection. Assessment--vaccines deemed defective and were not used. Response- vaccines wasted. More
2836565 MD 04/17/2025 COVID19
COVID19
 MODERNA
MODERNA

Condition aggravated, Mast cell activation syndrome, Mechanical urticaria, Rash,... Condition aggravated, Mast cell activation syndrome, Mechanical urticaria, Rash, Urticaria; Urticaria cholinergic More
I got the moderna COVID booster. And about a week after the booster I developed hives all over my bo... I got the moderna COVID booster. And about a week after the booster I developed hives all over my body and dermotagraphia. After several months of dealing with it and not being able to touch my own face without having hives and rashes in the areas touched I went to the allergist assuming I developed an allergy to soap or something to find out I have Mast Cell Activation Syndrome most likely caused as a reaction to the COVID booster. I now have an allergy to my own sweat which the allergist saw at the appointment and diagnosed me with MCAS. More
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2836570 1.08 F ME 04/17/2025 HIBV
 SANOFI PASTEUR
 UK201AC
Cyanosis Cyanosis
Circumoral cyanosis Blue skin - hands and feet developed 1 hour after administration of HiB vaccine.... Circumoral cyanosis Blue skin - hands and feet developed 1 hour after administration of HiB vaccine. Parent reports this reaction has occurred with administration of vaccines. Since receiving 4 month vaccines More
2836571 4 F CT 04/17/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Gait disturbance, Peripheral swelling Gait disturbance, Peripheral swelling
large red hot swollen thigh area came in to dr office to have it check out. Arnica PRN, MOTRIN prn,... large red hot swollen thigh area came in to dr office to have it check out. Arnica PRN, MOTRIN prn, Epson salt soaks. 4 cm x 2.5 cm all red around, hard to walk or climb More
2836572 3 CT 04/17/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Left thigh large area swollen, red and warm to touch. Mom did Epsom salt bath, area and warm compres... Left thigh large area swollen, red and warm to touch. Mom did Epsom salt bath, area and warm compresses More
2836620 MD 04/17/2025 VARCEL
 MERCK & CO. INC.
 Y011712
Product storage error Product storage error
No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional A... No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC.; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #0277601. HBP reported that vaccines were administered to patients. No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC; This spontaneous report was received from a consumer or other non-health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-MAR-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y011712 and expiration date: 02-JUL-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion lasted 13 hours 15 minutes 0 seconds in temperature of 14.65F. No previous temperature excursion noted (improper storage of product in use). More
2836621 ID 04/17/2025 VARCEL
 MERCK & CO. INC.
 y013350
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The nurse is reporting that a patient received improperly stored va... No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VARIVAX (y013350 8/2/2026) Temperature: 14.92F Time frame:; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Mar-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #y013350, expiration date: 02-Aug-2026) for prophylaxis (improper storage of product in use). No adverse event was reported. The vaccine underwent a temperature excursion of 14.92 degrees Fahrenheit for 1 hour and 40 minutes. More
2836622 TX 04/17/2025 HEPA
 MERCK & CO. INC.
 Y014585
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported at the time of the call; administration of improperly stored VAQTA to one patie... No symptoms reported at the time of the call; administration of improperly stored VAQTA to one patient on 2/3/2025; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On unspecified date, doses of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, underwent a temperature excursion at 34.6 degrees Fahrenheit (F) during 1 hour, 0 minutes and 0 seconds, without previous temperature excursions. On 03-Feb-2025, the patient was vaccinated by a healthcare professional, with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, lot #Y014585, expiration date reported as 12-Nov-2025 but upon internal verification established as 01-Feb-2026, 0.5 mL administered as prophylaxis (dosage regimen, anatomical location and route of administration were not provided) (product storage error.) There were no symptoms informed at the time of the report (no adverse event.) More
2836623 MI 04/17/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received th... A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20.; No additional AE nor PQC; Information has been received from Business Partner/CRO on 11-Apr-2025. This spontaneous report was received from a/an Pharmacist and refers to a(n) 20-year-old patient of unknown gender. 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, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). On an unknown date, the patient experienced A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20.. On an unknown date, the patient experienced No additional AE nor PQC. At the reporting time, the outcome of A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20. and No additional AE nor PQC was unknown. More
2836624 M OH 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
potential missed dose; This non-serious case was reported by a consumer via call center representati... potential missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (was vaccinated with his first dose on 7th March 2019 injected into his right deltoid, Batch Number:gz29l and expiry date :23rd May 2021). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: potential missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 However, current medical records did not show a vaccine was recorded as being administered potential missed dose. Consumer stated he believed it might not had been entered into the system as he was adamant about completing the series. Consumer also stated the provider was physician with. Reporter no longer had that insurance or that doctor as now live in, had been unsuccessful in contacting that doctor. Date and lot number was provided correspond to the first dose administered. Consumer was unable to provide the doctors phone number and address at the time of the call but would obtain the information and call back to update. No further information was obtained/provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2836625 F KY 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 J32PB
Product preparation issue Product preparation issue
administered the adjuvant without having it reconstituted with the vaccine; administered the adjuvan... administered the adjuvant without having it reconstituted with the vaccine; administered the adjuvant without having it reconstituted with the vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis. Concurrent medical conditions included hyperlipidemia. Concomitant products included atorvastatin. On 15-APR-2025, the patient received the 1st dose of Shingrix (left deltoid). On 15-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered the adjuvant without having it reconstituted with the vaccine) and inappropriate preparation of medication (Verbatim: administered the adjuvant without having it reconstituted with the vaccine). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 15-APR-2025 The health care professional reported that a patient administered the adjuvant without having it reconstituted with the vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. There was no anything would like to share about the primary disease. The patient was taking it as a preventive measure. There was no anything would like to share about a complicating disease. Patient was taking it as a preventive measure. More
2836626 FL 04/17/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
the patient became sick; This non-serious case was reported by a nurse via other manufacturer and de... the patient became sick; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of sickness in a patient who received MMR (Priorix) for prophylaxis. In MAR-2025, the patient received Priorix. On 08-APR-2025, less than 2 months after receiving Priorix, the patient experienced sickness (Verbatim: the patient became sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Priorix and Priorix Pre-Filled Syringe Device. It was unknown if the company considered the sickness to be related to Priorix and Priorix 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 : 08-APR-2025 Nurse reported that one month ago the patient received GlaxoSmithKline (GSK) version of vaccine (Priorix) and on the day of reporting the patient became sick came into the office. No additional adverse events were reported. No further information was provided. No product quality complaint (PQC) was provided. More
2836627 DE 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Headache Headache
head pain; This non-serious case was reported by a consumer via call center representative and descr... head pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Patient had Shingles on head). Previously administered products included varicella zoster vaccine and Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In APR-2025, 7 years after receiving Shingrix, the patient experienced headache (Verbatim: head pain). The outcome of the headache was not resolved. It was unknown if the reporter considered the headache to be related to Shingrix. It was unknown if the company considered the headache to be related to Shingrix. Additional Information: GSK Receipt Date: 08-APR-2025 Patient stated that after having Shingles, on head, they received the old shingles vaccine, then had two-part Shingrix Vaccine approximately 7 years ago. Patient was experiencing head pain for the second day, similar to that of the early days leading up to when they first had Shingles. Also asked if they can take the Shingrix vaccine again. More
2836628 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
was more painful; This non-serious case was reported by a consumer via interactive digital media and... was more painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Tetanus vaccine with an associated reaction of pain (received tetanus shot and was painful). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: was more painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 09-APR-2025 This case was reported by a patient via interactive digital media. The shingles shot was more painful than a tetanus shot for him/her. The patient suggested that took it on a Friday so you have the weekend to recover. More
2836629 M 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. 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. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by the reporter via interactive digital media. The reporter's dad (patient) got shingles from the vaccine, and it was so painful. He was fine before it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This was 1 of the 2 linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR045179:Same reporter/ different patient More
2836630 04/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Diaphragmatic disorder, Ear pain, Neck pain, Pain; Pain of skin Arthralgia, Diaphragmatic disorder, Ear pain, Neck pain, Pain; Pain of skin
disabled diaphragm; I suffered severe pain at left ear, neck, shoulder, scalp; I suffered severe pai... disabled diaphragm; I suffered severe pain at left ear, neck, shoulder, scalp; I suffered severe pain at left ear; severe pain at upper torso; I suffered severe pain at neck; severe pain at scalp; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diaphragmatic disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diaphragmatic disorder (Verbatim: disabled diaphragm), shoulder pain (Verbatim: I suffered severe pain at left ear, neck, shoulder, scalp), ear pain (Verbatim: I suffered severe pain at left ear), pain (Verbatim: severe pain at upper torso), neck pain (Verbatim: I suffered severe pain at neck) and scalp pain (Verbatim: severe pain at scalp). The outcome of the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain were not reported. It was unknown if the reporter considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix. It was unknown if the company considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter suffered severe pain at left ear, neck, shoulder, scalp, upper torso, disabled diaphragm. More
2836631 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
the vaccine is horrid, sick for 4 days; This non-serious case was reported by a consumer via interac... the vaccine is horrid, sick for 4 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: the vaccine is horrid, sick for 4 days). The outcome of the sickness was resolved (duration 4 days). It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine was horrid. The patient was sick for 4 days. The follow-up could not be possible as no contact details were available. More
2836632 04/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; had shingles 3 times after getting the shots; This serious case was r... Suspected vaccination failure; had shingles 3 times after getting the shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times after getting the shots). 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: 12-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the patient (his/her employee's physician) has had the vaccine and had shingles 3 times after getting the shots. 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 about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2836633 04/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Had both doses of the vax and still got a bad case of shingles; This ... Suspected vaccination failure; Had both doses of the vax and still got a bad case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both doses of the vax and still got a bad case of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had both doses of the vaccination and still got a bad case of shingles. This case was considered as suspected vaccination failure as details regarding 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 about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2836634 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
first dose of Shingrix 7 years ago/missed second dose; This non-serious case was reported by a nurse... first dose of Shingrix 7 years ago/missed second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose 7 years ago (2018)). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix 7 years ago/missed second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-APR-2025 The nurse contacted safety team via chat and requested to remain anonymous. The reporter enquired if the patient received first dose of Shingrix 7 years ago, still they just get the second dose or have to restart the series. Till the time of reporting, the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. The agent asked if that actually happened with a patient and the reporter answered it in yes. More
2836635 0.5 M WV 04/17/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Diluent only administered; accidentally received only the diluent portion of Hiberix; This non-serio... Diluent only administered; accidentally received only the diluent portion of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old male patient who received Hib (Hiberix) for prophylaxis. On 20-MAR-2025, the patient received the 3rd dose of Hiberix. On 20-MAR-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent only administered) and inappropriate dose of vaccine administered (Verbatim: accidentally received only the diluent portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 07-APR-2025 A registered nurse reported that a six-month 25 day old patient accidentally received only the diluent portion of Hiberix as their third dose, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. They stated that they did not have the lot number or expiration date of the vaccine as the full vaccine was not administered and declined to received follow up. They requested to have the case escalated to global and, even though only the diluent portion inquiry was reported, an adverse event detail was added for the possible third dose. The vaccine administration facility was the same as primary reporter. More
2836636 11 M SD 04/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
11 year old received Infanrix; This non-serious case was reported by a nurse via call center represe... 11 year old received Infanrix; 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 11-year-old male patient who received DTPa (Infanrix) (batch number 9KB9G) for prophylaxis. On 11-MAR-2025, the patient received Infanrix. On 11-MAR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old received Infanrix). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 08-APR-2025 Other HCP reported that an 11 year old patient was administered Infanrix, which led to inappropriate age at vaccine administration. More
2836637 M NC 04/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Maladministration of a Kinrix vaccine instead of a Pediarix to a 6 month old patient.; a six month o... Maladministration of a Kinrix vaccine instead of a Pediarix to a 6 month old patient.; a six month old male patient was administered a Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 26-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 26-FEB-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of a Kinrix vaccine instead of a Pediarix to a 6 month old patient.) and inappropriate age at vaccine administration (Verbatim: a six month old male patient was administered a Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-APR-2025 The licensed practical nurse called to ask about guidance because a six month old male patient was administered a Kinrix vaccine instead of a Pediarix dose which led to wrong vaccine administered and inappropriate age at vaccine administration. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was provided from the Licensed Practical Nurse end in this call. The vaccine administration facility was the same as primary reporter. More
2836638 F GA 04/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
forgot to get their second dose; This non-serious case was reported by a pharmacist via call center ... forgot to get their second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get their second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-APR-2025 The pharmacist explained that a patient got their first dose of Shingrix on 2021, but they forgot to get their second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2836639 5 M NE 04/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 T343J
Expired product administered Expired product administered
an expired dose of Kinrix was administered; This non-serious case was reported by a nurse via call c... an expired dose of Kinrix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis. On 11-APR-2025, the patient received Kinrix. On 11-APR-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Kinrix was administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-APR-2025 The nurse reported that an expired dose of Kinrix was administered, which led to expired vaccine used More
2836640 M 04/17/2025 COVID19
 MODERNA
Limb discomfort Limb discomfort
the right arm "Completely feels like it's falling apart and coming off."; This sponta... the right arm "Completely feels like it's falling apart and coming off."; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off.") in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off."). At the time of the report, LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off.") had not resolved. No concomitant medications were reported. It was reported that, the patient had 2 more shots in the right arm. Till the reporting date, the right arm completely felt like it was falling apart and coming off. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-784670 (Patient Link). Reporter did not allow further contact More
2836641 M 04/17/2025 COVID19
 MODERNA
Pain in extremity Pain in extremity
One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit; Thi... One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit). At the time of the report, PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had received one shot of Moderna in the left arm about 4 or 5 years ago. Then had two more shots in right arm. To this day, the left arm was still hurting a little bit. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-784675 (Patient Link). Reporter did not allow further contact More
2836642 56 M 04/17/2025 COVID19
 MODERNA
 039A21A
Post-acute COVID-19 syndrome, Therapeutic response unexpected Post-acute COVID-19 syndrome, Therapeutic response unexpected
The first vaccine made my symptoms 30% better. I definitely felt 30% better; I had long COVID for an... The first vaccine made my symptoms 30% better. I definitely felt 30% better; I had long COVID for an entire year before I got the vaccine/previous symptoms came rushing back/I progressively got worse and worse to where my pain; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I had long COVID for an entire year before I got the vaccine/previous symptoms came rushing back/I progressively got worse and worse to where my pain) and THERAPEUTIC RESPONSE UNEXPECTED (The first vaccine made my symptoms 30% better. I definitely felt 30% better) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 prophylaxis. Concurrent medical conditions included Long COVID (Patient caught COVID on 16-Mar-2020. Patient did get the Moderna vaccine but had long COVID for an entire year before got the vaccine. At the time of reporting, long COVID symptoms were mild comparatively) since 16-Mar-2020. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced POST-ACUTE COVID-19 SYNDROME (I had long COVID for an entire year before I got the vaccine/previous symptoms came rushing back/I progressively got worse and worse to where my pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The first vaccine made my symptoms 30% better. I definitely felt 30% better). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I had long COVID for an entire year before I got the vaccine/previous symptoms came rushing back/I progressively got worse and worse to where my pain) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (The first vaccine made my symptoms 30% better. I definitely felt 30% better) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No other vaccines were given to the patient within the 4 weeks. At the time of reporting, patient's long COVID symptoms were mild comparatively. To what happened to him after he got the vaccine and just to be specific, the first vaccine made his symptoms 30 percent better and definitely felt 30 percent better. Patient got the first vaccine and woke up 24 hours later, his symptoms were 30 percent better. After getting the second vaccine, within 24 hours all those previous symptoms came rushing back and over the course of the next couple of months, he progressively got worse and worse to where his pain and the new symptoms that he acquired. Patient was so debilitating like it progressively led to him having to stop working. Patient went on disability and had been treating this ever since. The first day patient felt symptoms was on 16-Mar-2020. Patient was an athlete, he ran up, up to like between 5 and 10 miles a week, depending on how much time he had. Patient swam a few miles every week. Patient was very extremely active and physical; he hadn't been the same ever since. There was evidence that it was viral persistence. Patient was living with his 81-year-old mother. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment information was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2836643 F TX 04/17/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Immunodeficiency, Influenza like illness, Muscular weakness, Pyrexia... Arthralgia, Immunodeficiency, Influenza like illness, Muscular weakness, Pyrexia; Skin discolouration, Skin disorder More
She is immuno compromised; Skin totally came off with her left elbow exposing the bones and tendons;... She is immuno compromised; Skin totally came off with her left elbow exposing the bones and tendons; Flu like symptoms; Low grade fever; Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns; Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns; Severe weakness in her left arm; pain associated with the shoulder in the arm; Severe weakness in her left arm; pain associated with the shoulder in the arm; This is a spontaneous report received from an Other HCP. A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertensive" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), administration date: 2024, for Covid-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "She is immuno compromised"; SKIN EXFOLIATION (medically significant), outcome "unknown", described as "Skin totally came off with her left elbow exposing the bones and tendons"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; SKIN DISORDER (non-serious), SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "Does start to get breaking out these patches; Almost look like burns in her arms and her legs; Nasty burns"; MUSCULAR WEAKNESS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Severe weakness in her left arm; pain associated with the shoulder in the arm". The patient underwent the following laboratory tests and procedures: Body temperature: Low grade. Therapeutic measures were taken as a result of skin exfoliation, muscular weakness, arthralgia. Clinical course: The caller reported for his wife. They had the first two covid vaccines a year and a half ago when it first came out and then they got the two boosters in the springtime six months later which was about a year ago. He was fine but his wife had flu-like symptoms almost immediately that same day and low-grade fever. She did start to get breaking out patches that almost looked like burns on her arms and her legs. They opened up and looked like nasty burns. The big problem was on her left elbow, the skin totally came off with her left elbow exposing the bones and tendons. She had five surgeries on her left elbow to repair it. They placed a skin grip from her left thigh over it and that seems to help the problem. She did talk to her primary care Physician who have heard several numerous adverse reactions of different place of people who had the covid vaccine. The MD was attributing it as well as they were to the booster and her adverse reaction to it because the caller did not have it, but the wife did. She is now immunocompromised; she was not supposed to get any more vaccines. She was supposed to take extremely good care of herself, not to get ill because that could be dangerous for her. The caller clarified that this was after the second booster, after the first two doses. The caller also added that his wife also had severe weakness in her left arm and pain associated with the shoulder in the same arm. She takes over-the-counter medications for that. The caller was a Dentist, and his wife was a Nurse anesthetist. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMI XBB.1.5 administration cannot be completely excluded. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. More
2836644 M MD 04/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; used Paxlovid in th... used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; This is a spontaneous report received from a Physician. A male patient in his 80's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient just turned 92 now. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202500043227 Same reporter/ drug/ event for different patients.; More
2836645 04/17/2025 COVID19
 PFIZER\BIONTECH
Upper limb fracture Upper limb fracture
broke arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identi... broke arm; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-784109 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Spikevax (dose number unknown, intramuscular), for COVID-19 prophylaxis, reaction(s): "a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna". The following information was reported: UPPER LIMB FRACTURE (medically significant), outcome "unknown", described as "broke arm". Clinical course: The reporter informed that date of administration was 2020, 2021, and 2022 in years. It was reported that so if wanted to believe that it's, that it was dangerous, then they went for research that. And if wanted to believe in the power of whatever, getting immunized and was doing what's best for country, and then making that into some sort of judgment on somebody's Character for personality, testing and 23 and testing, those were all the side effects of that. It was also added "That was a side effect of Moderna and Johnson and Johnson and Pfizer. That's also an ethical and compliance concern, Patient stated (redacted) had "numerous vaccines. that's a really negative side effect." Patient broke arm and patient wanted to learn how to write with left hand. (redacted) added, "(redacted) didn't go with Johnson Johnson." It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. Batch/lot number is not provided, and it cannot be obtained. More
2836647 F MD 04/17/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; used Paxlovid in th... used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it; This is a spontaneous report received from a Physician. A 72-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "used Paxlovid in the past. were positive/ 3 years ago...2021, that they took it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded. The patient's predispositions such as old age associated immunosenescence may contribute to suboptimal response after vaccination.,Linked Report(s) : US-PFIZER INC-202500076435 Same reporter/ drug/ event for different patients.; More
2836648 54 M CA 04/17/2025 RAB
 SANOFI PASTEUR
Chest discomfort, Epistaxis, Palpitations Chest discomfort, Epistaxis, Palpitations
Later that day he woke up at 2100 to use the bathroom and had to clear his throat and spit up blood ... Later that day he woke up at 2100 to use the bathroom and had to clear his throat and spit up blood tainted mucus. He said he had fresh blood in his nose but not a nose bleed. After awakening later that morning the blood tinged mucus; had heart palpitations; chest tightness; Initial information received on 15-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 54 years old male patient who woke up at 21:00 hours to use the bathroom and had to clear his throat and spit up blood tainted mucus, patient said he had fresh blood in his nose but not a nose bleed, after awakening later that morning the blood tinged mucus, had heart palpitations and chest tightness after receiving rabies (HDC) vaccine [Imovax Rabies]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Apr-2025, the patient received an unknown dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 13-Apr-2025 at 21:00 hours, the patient woke up to use the bathroom and had to clear his throat and spit up blood tainted mucus, he said he had fresh blood in his nose but not a nose bleed, after awakening later that morning the blood tinged mucus (epistaxis) (latency- 1 day) following the administration of rabies (HDC) vaccine. On an unknown date in APR-2025 the patient had heart palpitations (palpitations) and chest tightness (chest discomfort) (unknown latency) following the administration of rabies (HDC) vaccine. Reportedly, patient had the Imovax at a local ER (Emergency room) but switched to RabaVert at urgent care location for his second injection. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in April 2025 for the event (epistaxis) and was Unknown for rest of the events. More
2836649 65 F SD 04/17/2025 HEPAB
HEPAB
HEPAB
HEPAB
PNC21
PNC21
PNC21
PNC21
TDAP
TDAP
TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 324BY
324BY
324BY
324BY
E75E5
E75E5
E75E5
E75E5
AK334
AK334
AK334
AK334
Acute myocardial infarction, Asthenia, Depressed level of consciousness, Echocar... Acute myocardial infarction, Asthenia, Depressed level of consciousness, Echocardiogram, Ejection fraction normal; Endotracheal intubation, Hyperglycaemia, Intensive care, Mechanical ventilation, Mental status changes; Moraxella test positive, Pulmonary oedema, Pulseless electrical activity, Respiratory arrest, Resuscitation; Troponin increased; Acute myocardial infarction, Asthenia, Depressed level of consciousness, Echocardiogram, Ejection fraction normal; Endotracheal intubation, Hyperglycaemia, Intensive care, Mechanical ventilation, Mental status changes; Moraxella test positive, Pulmonary oedema, Pulseless electrical activity, Respiratory arrest, Resuscitation; Troponin increased; Acute myocardial infarction, Asthenia, Depressed level of consciousness, Echocardiogram, Ejection fraction normal; Endotracheal intubation, Hyperglycaemia, Intensive care, Mechanical ventilation, Mental status changes; Moraxella test positive, Pulmonary oedema, Pulseless electrical activity, Respiratory arrest, Resuscitation; Troponin increased More
The patient was seen in ED 3/25/25 with weakness and altered mental status stating that she received... The patient was seen in ED 3/25/25 with weakness and altered mental status stating that she received the Hep B/A shot Thursday and hasn't been the same since Sunday Night. She was admitted with hyperglycemia and blood culture returned positive for Moraxella osloensis. She was discharged on 4/2/25 and saw PCP on 4/9/25. She then presented to ED with altered mental status and developed PEA arrest and was admitted to ICU intubated on invasive vent support. Per ED note: patient appeared obtunded initially with respiratory arrest followed by cardiac arrest. CPR was initiated immediately. IO access obtained and patient received epinephrine. On rhythm check, patient appeared to be in PEA. CPR was continued and patient received additional dose of epinephrine. Patient intubated and continuous compressions performed. Patient had return of spontaneous circulation after approximately 7-10 minutes of CPR. Blood pressure 70s/50s; vasopressors (Levophed) initiated along with IV fluid resuscitation. Patient received calcium chloride/magnesium sulfate and sodium bicarbonate. Subsequently she was found to have a NON-STEMI with elevated troponin and on heparin gtt. Extubated 4/16 with recurrent bouts of pulmonary edema requiring lasix and noninvasive vent support. More
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2836650 69 F CO 04/17/2025 PNC21
 MERCK & CO. INC.
Dizziness, Fatigue, Injection site pain, Nausea Dizziness, Fatigue, Injection site pain, Nausea
Dizziness, nausea, fatigue, sore arm at injection site Dizziness, nausea, fatigue, sore arm at injection site
2836651 52 F NY 04/17/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013009
Y013009
Chest discomfort, Feeling abnormal, Injected limb mobility decreased, Neck pain,... Chest discomfort, Feeling abnormal, Injected limb mobility decreased, Neck pain, Pain in extremity; Skin discolouration More
04/10/25 (Thr Apr 10) 02:05 PM Pt called stating she is not reacting well to the shot she got yest... 04/10/25 (Thr Apr 10) 02:05 PM Pt called stating she is not reacting well to the shot she got yesterday. pt states her left arm is in so much pain and it is going to her neck, pt states she can barley move her arm. pt states she knows she is going to be sore but this is more then that pt states she took Advil as the day has gone by it has gotten better but she wanted to inform us. 04/10/25 (Thr Apr 10) 02:05 PM Sent to PA-C 04/11/25 (Fri Apr 11) 11:13 AM PA-C can you call and see how she is today 04/11/25 (Fri Apr 11) 11:13 AM PA-C Forwarded 04/11/25 (Fri Apr 11) 11:26 AM lvm for pt to call office back 04/14/25 (Mon Apr 14) 10:18 AM lvm for pt to call office back 04/14/25 (Mon Apr 14) 10:38 AM pt called back relayed above pt states she feels better now she has full range of motion in her arm pt states she started feeling better on Saturday. pt states she believes she had an allergic reaction pt states her arm was in so much pain she could not even work. 04/14/25 (Mon Apr 14) 10:38 AM Forwarded 04/15/25 (Tue Apr 15) 07:05 AM PA-C Closed 04/15/25 (Tue Apr 15) 03:21 PM LPN Opened 04/15/25 (Tue Apr 15) 03:32 PM LPN Patient called, states that she is "having severe reaction to pneumonia vaccine", states that it was "akin to paralysis" on her left arm and entire left side. States that she has regained mobility. Still has pain in left shoulder, but skin still has discoloration. Reports that she was bed ridden throughout the weekend. Patient wants this reported to CDC for negative vaccine reaction. Do you want me to add vaccine to allergy list?? After talking to patient, states that she felt "weird", after getting vaccine, states that she sat in her car and believed it to be vasovagal. After discussing reactions with her, patient states that she felt chest tightness immediately after. 04/15/25 (Tue Apr 15) 03:41 PM Employee discussed this with me. If pt wants us to report an adverse reaction to the vaccine we need to report on VAERS (Vaccine Adverse Event Reporting System). This can be done online. I will use the information in this triage to report it. I haven't had to report before so Im not sure of the follow up but the process seems pretty simple. 04/15/25 (Tue Apr 15) 03:46 PM PA-C the story is so inconsistent. But yes seems like we should report.... hopefully you can free text what pt stated. With the arm pain I don't suspect it to be an allergic reaction but more so the needle could have hit a nerve or gone into bursa/muscle. Let me know what other info you may need, TY 04/15/25 (Tue Apr 15) 03:46 PM PA-C Forwarded More
2836652 7 F DC 04/17/2025 COVID19
 MODERNA
 3044143
No adverse event, Product storage error No adverse event, Product storage error
No adverse event occurred. Patient tolerated vaccine well. This report is being written due to a dis... No adverse event occurred. Patient tolerated vaccine well. This report is being written due to a discovery that the vaccines given may have been improperly stored in the fridge at some point. The freezer at the facility began malfunctioning for short periods of time in December 20214 and January 2025. The temperature excursions were discovered and vaccines were moved to the fridge while repairs were being made in February. Vaccines were administered between January and march. Upon inquiry with the manufacturers, vaccines were deemed viable at the time of administration because Moderna vaccines can be used within 60 days if stored in the fridge. We were asked to submit this report by the DOH after the fact More
2836653 75 F OH 04/17/2025 COVID19
PNC20
 PFIZER\BIONTECH
PFIZER\WYETH
 MD3414
LJ5284
Erythema, Pruritus, Rash, Skin irritation; Erythema, Pruritus, Rash, Skin irrita... Erythema, Pruritus, Rash, Skin irritation; Erythema, Pruritus, Rash, Skin irritation More
Redness of the left arm. Itching and irritation of arm. Rash spread further over and down arm over t... Redness of the left arm. Itching and irritation of arm. Rash spread further over and down arm over the course of 3 days from 4/15/25 to 4/17/25. More
2836654 6 F DC 04/17/2025 COVID19
 MODERNA
 3044143
Product storage error Product storage error
none- This report is being written due to a discovery that the vaccines given may have been improper... none- This report is being written due to a discovery that the vaccines given may have been improperly stored in the fridge at some point. The freezer at the facility began malfunctioning for short periods of time in December 20214 and January 2025. The temperature excursions were discovered and vaccines were moved to the fridge while repairs were being made in February. Vaccines were administered between January and March. Upon inquiry with the manufacturers, vaccines were deemed viable at the time of administration because Moderna vaccines can be used within 60 days if stored in the fridge. We were asked to submit this report by the DOH after the fact More
2836655 4 M DC 04/17/2025 COVID19
 MODERNA
 3044143
Product storage error Product storage error
none-This report is being written due to a discovery that the vaccines given may have been improperl... none-This report is being written due to a discovery that the vaccines given may have been improperly stored in the fridge at some point. The freezer at the facility began malfunctioning for short periods of time in December 20214 and January 2025. The temperature excursions were discovered and vaccines were moved to the fridge while repairs were being made in February. Vaccines were administered between January and March. Upon inquiry with the manufacturers, vaccines were deemed viable at the time of administration because Moderna vaccines can be used within 60 days if stored in the fridge. We were asked to submit this report by the DOH after the fact. More
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