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
2861935 F CA 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received the first dose of Shingrix a year ago; This non-serious case was reported by a pharmacist v... received the first dose of Shingrix a year ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose a year ago). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix a year ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-SEP-2025 The pharmacist enquired if a patient skipped the second dose, and comes back after 6 months from the first dose, does she need to start all over The pharmacist stated that some insurance plans do not cover more than 2 doses. More
2861936 F IL 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
now wants to receive the second dose; This non-serious case was reported by a pharmacist via call ce... now wants to receive the 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 62-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got their first dose of Shingrix on 26th DEC 2024). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: now wants to receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 09-SEP-2025 On 9 September 2025 a pharmacy student called to report that a patient got their first dose of Shingrix on 26th DEC 2024, it had been 9 months since the first dose. More
2861937 1 M AZ 09/29/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Twinrix administration under the 18 years of age; This non-serious case was reported by a other heal... Twinrix administration under the 18 years of age; 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 18-month-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 05-SEP-2025, the patient received Twinrix. On 05-SEP-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix administration under the 18 years of age). 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: 10-SEP-2025 A health care provider wanted to get safety information on the administration of Twinrix in five patients below 18 years of age. The vaccine administration facility was the same as primary reporter. This was 1 of 5 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025116673:same reporter US-GSK-US2025116669:same reporter US-GSK-US2025116668:same reporter US-GSK-US2025116676:same reporter More
2861938 62 M TN 09/29/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 946607
Expired product administered Expired product administered
Flulaval expired dose administration/ 30 days between the expiration and the administration date; Th... Flulaval expired dose administration/ 30 days between the expiration and the administration date; 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 62-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 946607, expiry date 30-JUN-2025) for prophylaxis. On 27-AUG-2025, the patient received FluLaval 2024-2025 season. On 27-AUG-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: Flulaval expired dose administration/ 30 days between the expiration and the administration date). 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: 12-SEP-2025 A health care provider wanted to get information on the administration of a Flulaval expired dose with more than 30 days difference between the expiration and the administration date. The vaccine administration facility was the same as primary reporter. More
2861939 M NY 09/29/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Patient received 2 doses of Arexvy in a 1 year span; This non-serious case was reported by a pharmac... Patient received 2 doses of Arexvy in a 1 year span; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (The 1st does was given on 21 Feb 2024). On 10-SEP-2025, the patient received the 2nd dose of Arexvy. On 10-SEP-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Patient received 2 doses of Arexvy in a 1 year span). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 Pharmacist called to report that an 83 years old male patient received two doses of Arexvy on a 1 year span. The 1st does was given on 21 Feb 2024. The 2nd dose was given on 10 Sep 2025. More
2861940 66 M OH 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received a dose of Shingrix on 2-Feb-2024 and a second on 23-Feb-2024; This non-serious case was re... received a dose of Shingrix on 2-Feb-2024 and a second on 23-Feb-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 23-FEB-2024, the patient received the 2nd dose of Shingrix. On 23-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received a dose of Shingrix on 2-Feb-2024 and a second on 23-Feb-2024). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK receipt date: 16-SEP-2025 Registered pharmacist would like to be contacted via email. More
2861941 18 F OH 09/29/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB072A
Product preparation error Product preparation error
Menveo administration with a non-approved diluent; Inappropriate dose of vaccine administered; This ... Menveo administration with a non-approved diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB072A, expiry date 30-APR-2026) for prophylaxis. On 15-SEP-2025, the patient received Menveo. On 15-SEP-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo administration with a non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 16-SEP-2025 The pharmacist sought guidance on the appropriate course of action after having administered the lyophilized vial of Menveo reconstituted with a diluent other than the one provided by the manufacturer. More
2861942 M LA 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not received the second dose yet; This non-serious case was reported by a pharmacist via call ce... has not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2023). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: has not received the second dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-SEP-2025 More
2861943 NM 09/29/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
Temperature excursion: ipol- Duration: 1 Hour and 54 Minutes, Maximum/minimum temperaturereached: 53... Temperature excursion: ipol- Duration: 1 Hour and 54 Minutes, Maximum/minimum temperaturereached: 53.6๏ฟฝF and administered after the excursion with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to IPV (Vero) [IPOL] which had temperature excursion- duration: 1 hour and 54 minutes, maximum/minimum temperature reached: 53.6๏ฟฝF with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (Vero), Suspension for injectionl (lot number, expiry date and strength not reported) via unknown route in unknown administration site or Immunization and temperature excursion: duration: 1 hour and 54 minutes, maximum/minimum temperature reached: 53.6๏ฟฝF and administered after the excursion with no reported adverse event (poor quality product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, human error occurred as somebody left the door open. No other vaccines. Action taken was not applicable. 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
2861944 52 F CA 09/29/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT7383
UT7383
Arthralgia, Ligament sprain, Musculoskeletal stiffness, Pain, Pain in extremity;... Arthralgia, Ligament sprain, Musculoskeletal stiffness, Pain, Pain in extremity; Sleep disorder More
left shoulder pain; Sprain of the left shoulder; neck pain; Stiff neck which over time went "to... left shoulder pain; Sprain of the left shoulder; neck pain; Stiff neck which over time went "to the back of [their] ears, going to their shoulders; experiencing difficulty in lying on their left side; left arm was killing [them] so bad," describing it as a "constant throbbing"NULL; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 52 years old female patient who had left arm was killing [them] so bad, describing it as a constant throbbing null, experiencing difficulty in lying on their left side, stiff neck which over time went to the back of [their] ears, going to their shoulders, left shoulder pain, sprain of the left shoulder and neck pain after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone]. The patient's past medical history included Patella fracture. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Bronchitis chronic. On 11-Nov-2021, the patient received an unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot UT7383, expiry date and strength not reported) via intramuscular route in the left deltoid for Immunisation. On an unknown date in 2021, the patient developed left arm was killing [them] so bad, describing it as a constant throbbing null (pain) (latency approximately few months) following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. On an unknown date in Oct-2022, the patient developed experiencing difficulty in lying on their left side (sleep disorder due to a general medical condition) (latency approximatlet 11 months) following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. On an unknown date in Nov-2023, the patient developed stiff neck which over time went to the back of [their] ears, going to their shoulders (musculoskeletal stiffness) (latency approximately two years) following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. On an unknown date, the patient developed left shoulder pain (arthralgia), sprain of the left shoulder (ligament sprain) and neck pain (latency unknown) following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. 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 Not Recovered / Not Resolved for all the events. More
2861945 65 TX 09/29/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
they administered Fluzone to a 65 year old patient instead of Fluzone HD with no adverse event; Init... they administered Fluzone to a 65 year old patient instead of Fluzone HD with no adverse event; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 year old and unknown gender patient was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] Instead Of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine with no adverse event (wrong product administered) (latency-same day). Action taken was not applicable. 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
2861946 83 F IL 09/29/2025 COVID19
FLU3
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
U8855BA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
received two FLUZONE HD by mistake instead of getting one flu and one COVID vaccine with no reported... received two FLUZONE HD by mistake instead of getting one flu and one COVID vaccine with no reported adverse event; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 83 years old female patient who received two Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] by mistake instead of getting one flu and one Covid-19 Vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Sep-2025, the patient received two doses of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (lot U8855BA and expiry date-unknown) via unknown route in unknown administration site by mistake instead of getting one flu and one Covid-19 Vaccine with no reported adverse event (extra dose administered) (latency-same day). Action taken was not applicable. 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
2861947 76 F PA 09/29/2025 FLU3
FLU3
FLU4
FLU4
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR

u8837da
u8837da
Injection site pain, Malaise, Myalgia, Pain in extremity; Injection site pain; I... Injection site pain, Malaise, Myalgia, Pain in extremity; Injection site pain; Injection site pain, Malaise, Myalgia, Pain in extremity; Injection site pain More
arm is sore, arm hurts; She's also a little bit not feeling good; muscle and her arm were sore;... arm is sore, arm hurts; She's also a little bit not feeling good; muscle and her arm were sore; there's a burning sensation on the injection site; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 76 years old female patient (79 kg) who had burning sensation on the injection site , muscle and her arm soreness, arm hurts, and also a little bit not feeling good, muscle after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Influenza immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 22-Sep-2025 the patient had a burning sensation on the injection site (vaccination site pain) ,arm is sore, arm hurts (pain in extremity), she's also a little bit not feeling good (feeling abnormal) and muscle and her arm were sore (myalgia) (latency: same day). Reportedly,had high dose flu shot because she's a senior. When the pharmacist was going to give it to her, she noticed that the patient was squeamish because of the needle. So, the pharmacist used a smaller needle (5/8''). When she went home, she was told by her daughter that a 1'' or 1.5'' needle should've been used to her to make sure it's intramuscular. Patient cannot provide the brand name, but she was told by the pharmacy the name of the company which is Sanofi and she took our high dose flu shot. she should contact her pharmacy to make sure that it's the one she received. Her question is that how would she know if she got the flu shot into the muscle or fat. She said that it won't be effective if it got on the fat. When she went back to the pharmacy, it was confirmed by them that they should've used 1'' or 1 1/2'' needle for the patient. 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 Unknown for all the events More
2861948 52 F MN 09/29/2025 UNK
 UNKNOWN MANUFACTURER
 U8832AA
Injection site discharge Injection site discharge
given immunization and it leaked back out of her arm after the injection. with no reported adverse e... given immunization and it leaked back out of her arm after the injection. with no reported adverse event; given immunization and it leaked back out of her arm after the injection. with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old female patient who was given immunization with Influenza Trivalent Recombinant Vaccine [Flublok Tiv] and it leaked back out of her arm after the injection with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot U8832AA, Expiry: 31-May-2026, Strength: standard, Frequency: once) via unknown route in the arm nos (not otherwise specified) as immunization that leaked back out of her arm after the injection with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: same day). Reportedly, reporter wanted to know if the patient should be given another dose. Action taken: not applicable. 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
2861950 13 F VA 09/29/2025 FLU3
 SANOFI PASTEUR
 U8837AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administration of fluzone hd to pediatric patient with no reported ae; Initial information received ... administration of fluzone hd to pediatric patient with no reported ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old female patient who had administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the 13 year old patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe once (lot U8837AA, expiry: 30-Jun-2026) via unknown route in unknown administration site as immunization with no reported ae (product administered to patient of inappropriate age) (latency: same day). Action taken: not applicable. 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. Sender's comment: Still using product : No More
2861951 6 M TX 09/29/2025 FLUN3
IPV
 MEDIMMUNE VACCINES, INC.
SANOFI PASTEUR

Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
administration of extra dose of ipol with no reported ae; supposed to receive the flumist however, h... administration of extra dose of ipol with no reported ae; supposed to receive the flumist however, he and his 6-year-old brother switched places in the grandma's lap, so when she turned around, the 6-year-old brother was given with ipol with no reported ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old male patient who had administration of extra dose of IPV (Vero) [IPOL] and supposed to receive the flumist however, he and his 6-year-old brother switched places in the grandma's lap, so when she turned around with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 5 of suspect IPV (VERO) Suspension for injection via unknown route in unknown administration site and 4 other doses were administered on unknown dates for suspect IPV (VERO) (strength, expiry date and lot number not reported for all regimens) for prophylactic vaccination (immunization) instead of flumist with no reported ae (extra dose administered) (wrong product administered) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: not applicable. 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
2861952 49 F NY 09/29/2025 FLU3
 SANOFI PASTEUR
 U8764AB
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
accidentally administered with FLUZONE HD with no reported adverse event; Initial information receiv... accidentally administered with FLUZONE HD with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old female patient who was accidentally administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8764AB, expiry date 30-Jun-2026, frequency once and strength standard) via intramuscular route in the right deltoid for Influenza and accidentally administered with fluzone hd with no reported adverse event (vaccination error) (latency same day). Reportedly, the patient was immunocompromised with Lupus and Sjogren's Syndrome taking multiple medications that suppresses the immune system who was accidentally administered with Fluzone HD. Action taken was not applicable. 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
2861953 75 F PA 09/29/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8837DA
U8837DA
Chills, Dizziness, Fatigue, Malaise, Mobility decreased; Muscular weakness, Naus... Chills, Dizziness, Fatigue, Malaise, Mobility decreased; Muscular weakness, Nausea, Pyrexia, Sleep disorder More
lack of sleep; When she woke up, she felt very tired; chills/teeth-chattering; nausea; feeling light... lack of sleep; When she woke up, she felt very tired; chills/teeth-chattering; nausea; feeling light-headed; fever; sick; weak muscles; unable to get up from the sofa; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 75 years old female patient who experienced sick, weak muscles, unable to get up from the sofa, lack of sleep, chills/teeth-chattering, nausea, feeling light-headed and fever after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] and while treated with Lidocaine. The patient's past medical history included Appendicitis perforated. The patient's past medical treatment(s) and family history were not provided. The patient past vaccination involves Shingles shot before and she felt sick too. On 23-Sep-2025 at 11:00 am, the patient started taking Lidocaine 2 DF (dosage form) (unknown strength, indication, form and expiry) On 23-Sep-2025 at 12:30 PM, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe once (lot U8837DA, with unknown expiry) (Strength: High Dose) via intramuscular route in the left arm as influenza. On 23-Sep-2025 at 6:15 PM, her sever side effects kicked in. She experienced chills that lasted for almost 5 hours, teeth-chattering (chills), nausea, feeling light-headed (dizziness), sick (illness), weak muscles (muscular weakness), and her fever hit 102.9F (pyrexia). She was unable to get up from the sofa (movement disorder) (Latency: 5 hrs 45 min) from Influenza Usp Trival A-B High Dose Subvirion Vaccine and (Latency: 7 hrs 15 min) from lidocaine. She added that she had medical issues before wherein her appendix burst and she experienced close to what she experienced now. Patient said that around 1:30 AM the next day, she started to calm down and she got her sleep. When she woke up, she felt very tired (fatigue) and she said that it may be due to lack of sleep (sleep deficit) (Latency: 1 day) from both suspects. She added that she had a shingles shot before and she felt sick too, but it's no big deal. She's been having this flu shot for years and she never had this issue until her most recent one.Patient came from her dentist that day and she had two lidocaine shots in her gums an hour and a half before having the FLUZONE HD. She asked if there's interaction between the two which is why she experienced all of these side effects. Reportedly, Patient said that she's okay now. Relevant laboratory test results included: Body temperature - On 23-Sep-2025: 102.9 F Action taken with Lidocaine was unknown. Action taken with INFLUENZA VACCINE TRIVALENT was not applicable. The patient was treated with Paracetamol (Tylenol) for Chills, Nausea, Dizziness, Illness, Muscular weakness and Pyrexia. At time of reporting, the outcome was Recovered / Resolved on 23-Sep-2025 for the event chills/teeth-chattering, was Recovered / Resolved on an unknown date in Sep-2025 for all events. More
2861954 GA 09/29/2025 FLU3
 SANOFI PASTEUR
 UT8820CA
Extra dose administered, No adverse event Extra dose administered, No adverse event
administering FLUZONE HD to a patient who has already received a high-dose flu shot with no reporte... administering FLUZONE HD to a patient who has already received a high-dose flu shot with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administering fluzone hd and has already received a high-dose flu shot with no reported adverse event The patient's past vaccination(s) included FLUZONE HIGH DOSE on 28-JUL-2025. The patient's past medical history, medical treatment(s) and family history were not provided. On 20-Sep-2025, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe by another pharmacist (lot UT8820CA, Expiry date: 30-Jun-2026, dose, strength, route, administration site (extra dose administered; latency: same day). Action taken was not applicable. 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
2861955 M FL 09/29/2025 MNQ
 SANOFI PASTEUR
 U6920AA
Expired product administered, No adverse event Expired product administered, No adverse event
stated that in the record, it says the vaccine expired 6 years prior to when it was given with no ad... stated that in the record, it says the vaccine expired 6 years prior to when it was given with no adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who administered expired meningococcal a-c-y-w135 (d conj) vaccine [menactra] 6 years prior to when it was given with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided On an unknown date in 2021, the patient received a dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot U6920AA, expiry date: 22-Apr-2015) (dose, strength, route, administration site was unknown) as prophylactic vaccination and in the record, it says the vaccine expired 6 years prior to when it was given with no adverse event (expired product administered) (latency: same day). Action taken was not applicable. 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
2861956 GA 09/29/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
Ipol was administered it to the patient, and they just forgot the vial back in the refrigerator/Conf... Ipol was administered it to the patient, and they just forgot the vial back in the refrigerator/Confirmed the vial has not been used since the excursion with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who had administered with IPV (Vero) [IPOL] and they just forgot the vial back in the refrigerator/confirmed the vial has not been used since the excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (Vero) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) and they just forgot the vial back in the refrigerator/confirmed the vial has not been used since the excursion with no reported adverse event (product storage error) (same day latency). Reportedly, Negative Advice - Yes, Human Error - Yes. The caller reported a temperature excursion on a punctured MDV of IPOL and wanted to know if the product is still suitable for use. The caller reported that the products were exposed to a temperature of 74.2 degrees Fahrenheit and were out of range for a total of about 3 hours. Confirmed the vial has not been used since the excursion. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. Action taken: not applicable. 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
2861957 60 F OH 09/29/2025 FLU3
 SANOFI PASTEUR
 U8859CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
inadvertently administered FLUZONE HD to 60 year old patient with no reported adverse event; Initial... inadvertently administered FLUZONE HD to 60 year old patient with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who had inadvertently administered Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to 60 year old patient 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 Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation. On 25-Sep-2025, the 60 years old female patient received a 0.5 ml (dose 1) dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength: standard, frequency: once, expiry date: 30-Jun-2026 and lot U8859CA) via intramuscular route in the left deltoid as immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken: not applicable. 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
2861966 09/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure
suspected vaccination failure; on right side of the ear; on the right side of head, neck and shoulde... suspected vaccination failure; on right side of the ear; on the right side of head, neck and shoulder; 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 (patient had shingles on thigh in 2006). On an unknown date, the patient received Shingles vaccine. On 05-SEP-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: on right side of the ear) (serious criteria GSK medically significant) and shingles (Verbatim: on the right side of head, neck and shoulder). The outcome of the vaccination failure, herpes zoster oticus and shingles were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster oticus and shingles to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster oticus 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: 22-SEP-2025 This case was reported by a patient via interactive digital media. The patient got the shot and got the shingles again on the right side of head, ear, neck and shoulder. The patient stated that it was so painful even three weeks later. The patient took antiviral medicine which helped them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Herpes zoster, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2861967 M FL 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 AS4G9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... Late second dose; 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 70-year-old male patient who received Herpes zoster (Shingrix) (batch number AS4G9) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 1st JAN 2018). On 29-SEP-2022, the patient received the 2nd dose of Shingrix. On 29-SEP-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 09-SEP-2025 Pharmacist wanted to know if they have to revaccinate/restart patient's vaccination schedule or what to do in this case. The patient was planning on receiving another dose at the time of reporting or day after reporting. Vaccination dates, vaccine detail (only lot number was provided for dose administered on twenty twenty-two) and patient demographics were obtained in this call. No further information was obtained in this call. More
2861971 65 M NV 09/29/2025 COVID19
 MODERNA
 007B21A
Chills, Headache, Myalgia, Pain, Pyrexia Chills, Headache, Myalgia, Pain, Pyrexia
Reported Symptoms: 10008531:CHILLS; 10016558:FEVER; 10019211:HEADACHE; 10028322:MUSCLE PAIN; 1002841... Reported Symptoms: 10008531:CHILLS; 10016558:FEVER; 10019211:HEADACHE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Patient reports 2 days of headache, body ache, muscle aches in fingers, chills and fever @ 100.2F. 03/26/2021 Dose #2 The patient received Moderna COVID-19 Vaccine 0.5 ml IM. Other Relevant HX: Other MUSCLE PAIN (3/27/21@06:00); FEVER (3/27/21@06:00); CHILL (3/27/21@06:00) More
2861972 68 M NV 09/29/2025 COVID19
 MODERNA
 026A21A
Fatigue Fatigue
Reported Symptoms: 10016256:FATIGUE; Narrative: Other Relevant HX: Other: FATIGUE Reported Symptoms: 10016256:FATIGUE; Narrative: Other Relevant HX: Other: FATIGUE
2861973 23 M NV 09/29/2025 PPV
 MERCK & CO. INC.
 uo28160
Hypoaesthesia, Paraesthesia, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia Hypoaesthesia, Paraesthesia, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Reported Symptoms: 10029829:NUMBNESS; 10043876:TINGLING; Narrative: Developed tingling and numbness ... Reported Symptoms: 10029829:NUMBNESS; 10043876:TINGLING; Narrative: Developed tingling and numbness on face and throat, but no shortness of breath, no swelling, no rash, no dysphagia. Treated with diphenhydramine and discharged home from Ambulatory Care clinic. Other Relevant HX: Other: NUMBNESS, TINGLING ON FACE AND THROAT More
2861974 93 M NV 09/29/2025 FLUA4
FLUA4
 SEQIRUS, INC.
SEQIRUS, INC.
 352490
352490
Asthenia, Failure to thrive, Fall, Malaise, Nausea; Pneumonia, Skin laceration, ... Asthenia, Failure to thrive, Fall, Malaise, Nausea; Pneumonia, Skin laceration, Urinary tract infection, Vomiting More
Reported Symptoms: 10047862:WEAKNESS; Narrative: Patient had felt sick and weak since received both ... Reported Symptoms: 10047862:WEAKNESS; Narrative: Patient had felt sick and weak since received both COVID and influenza vaccine 17 days prior to presenting to E.D. Was hospitalized for pneumonia, uti, failure to thrive, generalized weakness, nausea/vomiting, fall with skin tear, possible nasal malignancy. Other Relevant HX: WEAKNESS (2/4/23@09:08) More
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2861975 71 M NV 09/29/2025 COVID19
 MODERNA
 006B21A
Azotaemia, Blood creatinine increased, Renal failure, Renal transplant Azotaemia, Blood creatinine increased, Renal failure, Renal transplant
Reported Symptoms: 10003889:AZOTEMIA RENAL; 10038435:RENAL FAILURE; 10062237:RENAL TRANSPLANT; Narra... Reported Symptoms: 10003889:AZOTEMIA RENAL; 10038435:RENAL FAILURE; 10062237:RENAL TRANSPLANT; Narrative: Patient with mild sustained increase in baseline serum creatinine after vaccines. Unclear if related to other etiology. Serum Creatinine range was 1.3 to 1.7 before injection and increased to 1.7-2.0 range after. Other Relevant HX: Other: RENAL AZOTEMIA; RENAL FAILURE SYNDROME; RENAL TRANSPLANT More
2861976 50 F WV 09/29/2025 PPV
 UNKNOWN MANUFACTURER
Pruritus, Rash Pruritus, Rash
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
2861977 56 M WV 09/29/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Paraesthesia Paraesthesia
Reported Symptoms: 10033987:PARESTHESIA; Narrative: Other Relevant HX: Other: parathesia Reported Symptoms: 10033987:PARESTHESIA; Narrative: Other Relevant HX: Other: parathesia
2861978 M VA 09/29/2025 JEV1
 INTERCELL AG
 JEV24B20E
Pruritus Pruritus
Reported Symptoms: 10037087:PRURITUS; Narrative: Other Relevant HX: Other: PRURITUS Reported Symptoms: 10037087:PRURITUS; Narrative: Other Relevant HX: Other: PRURITUS
2861979 75 M CA 09/29/2025 COVID19
 MODERNA
 007B21A
Asthenia Asthenia
Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: O... Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS More
2861980 59 M MN 09/29/2025 COVID19-2
 MODERNA
Blister Blister
Reported Symptoms: 10005216:BLISTERS; Narrative: Did not receive from the facility Other Relevant HX... Reported Symptoms: 10005216:BLISTERS; Narrative: Did not receive from the facility Other Relevant HX: Other: BLISTER More
2861981 65 M CA 09/29/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
MG5S9
MG5S9
Full blood count normal, HIV test negative, Hepatitis C test negative, Hypersens... Full blood count normal, HIV test negative, Hepatitis C test negative, Hypersensitivity vasculitis, Joint swelling; Metabolic function test normal, Peripheral swelling, Petechiae, Rash, Rash erythematous; Rash macular, Syphilis test negative More
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10042674:SWELLING; Narrative: Per provider note... Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10042674:SWELLING; Narrative: Per provider note on 9/10/25 65 year old MALE with DM on insulin, active smoking, and HL, with today's door visit to follow-up ED visit for rash patients concern re reaction to shingles vaccine ## LE Rash and swelling - reports developing red dots on the distal LE beginning early July followed by swelling of the ankle and feet. - 8/15/2025 ED for bilateral LE rash. vitals normal. No description of rash. Negative ROS. CBC and CMP unremarkable, syphilis nonreactive, HIV negative, HCV negative. Unclear A/P in JLV but ICD diagnosis petechial rash and Rx'd loratadine. - he went to hospital 2 days later, disappointed w lack of tx at other hospital. This note is not avail. He was rx'd prednisone 60mg daily x 7 days. - The rash improved during the steroid course and the swelling completely resolved. - Today he has some residual rash which is flat/nonpalpable and remains nonpainful and nonpruritic - no focal or systemic illness preceding the onset of rash. - shingles vaccine delivered June 24, 2025. apart from that, there were no new medicines. - no travel, new pets, new bath/laundry products. No EtOH. A/P Erythematous macular rash (likely petechial in mid August per ED ICD 10), with edema, of unclear cause. The one potential inciting factor is the Shingrix vaccine/24. Hypersensitivity vasculitis seems likely, given the clear response to steroids. This is relatively long post Shingrix vaccine, but still plausible. Reassuring that there were no systemic More
2861982 58 M NJ 09/29/2025 FLU3
 SEQIRUS, INC.
 AX5590A
Dizziness, Rash, Rash pruritic Dizziness, Rash, Rash pruritic
Reported Symptoms: 10013573:DIZZINESS; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient presen... Reported Symptoms: 10013573:DIZZINESS; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient presented to ED with chief complaint of pruritic rash to bilateral upper extremities and dizziness approximately 30 minutes after receiving Influenza, Trivalent, Preservative Free (Afluria-Syringe), administered intramuscular to left deltoid. He was elevated by the ED attending, no airway involvement or signs of anaphylaxis were noted, and symptoms resolved after administration of diphenhydramine, methylprednisolone, famotidine, and IV fluids. Vitals were stable during ED course. Patient was discharged home. Reaction was considered mild by ED attending. Patient reports tolerating flu vaccines in the past with no noted reactions. Other Relevant HX: Patient present to ED 9/24/25 with chief complain of pruritic rash to bilateral upper extremities and dizziness approximately 30 minutes after receiving Influenza, Trivalent, Preservative Free (Afluria-Syringe), administered intramuscular to left deltoid. He was evaluated by the ED attending, no airway involvement or signs of anaphylaxis were noted, and symptoms resolved after administration of diphenhydramine, methylprednisolone, famotidine, and IV fluids. Vitals were stable during ED course. Patient was discharged home. Reaction was considered mild by ED attending. Patient reports tolerating flu vaccines in the past with no noted reactions. Other: More
2862014 39 F GA 09/29/2025 HEP
 MERCK & CO. INC.
Maternal exposure before pregnancy Maternal exposure before pregnancy
no additional AE; " Consumer confirmed that they were not pregnant when they were administered ... no additional AE; " Consumer confirmed that they were not pregnant when they were administered their first dose of RECOMBIVAX HB; This spontaneous prospective pregnancy report was received from a Consumer or other non health professional (patient) and refers to a(n) 39-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On Apr-2025, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose 0.5 mL (three dose series), (lot # and expiration date were not reported) as prophylaxis (Maternal exposure before pregnancy). Patient has not been able to follow up with other doses of the vaccine since. She recently found out that she was pregnant in July 2025 and I did not have any medical concerns. She confirmed that she was not pregnant when she was administered with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), as well as confirmed she had not experienced any medical concerns or symptoms as a result of this report. She confirmed she was not pregnant when they she was administered the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). The patient experienced no additional AE. This pregnancy involved 1 fetus. At the reporting time, the outcome of the events was unknown. The outcome of the pregnancy, pregnancy due date and last menstrual period were unknown. Causality was not reported. More
2862015 IN 09/29/2025 MMRV
 MERCK & CO. INC.
 Z008221
Device leakage, No adverse event Device leakage, No adverse event
No additional AE; The leaking product did not get on the patient. Leaking product did get on the glo... No additional AE; The leaking product did not get on the patient. Leaking product did get on the gloved hand of the HCP, but did not get on the HCP's skin; reconstituted vaccine came out between the hub and the leur lock; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-SEP-2025, when attempting to administer Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z008221, expiration date: 27-OCT-2026) reconstituted with sterile diluent (lot # 1973253, expiration date: 22-FEB-2026), the plunger was pushed and reconstituted vaccine came out between the hub and the luer lock (Device connection issue). The leaking product did not get on the patient who was to be vaccinated, but did get on the gloved hand of the HCP, but did not get on the HCP's skin (Accidental exposure to product). The patient did not get any of the vaccine from this dose. A different dose was given to the patient so that he received his vaccine. No symptoms and no additional adverse event were reported. More
2862016 F CT 09/29/2025 HPV9
 MERCK & CO. INC.
 2018414
Exposure during pregnancy, No adverse event, Product use issue Exposure during pregnancy, No adverse event, Product use issue
The patient has not report any medical concerns or symptoms after being administered the dose of GAR... The patient has not report any medical concerns or symptoms after being administered the dose of GARDASIL 9; A patient who was 8 months pregnant was administered their first dose of GARDASIL 9 on 9/15/2025; This spontaneous report was received from a nurse prescriber and refers to an 8-months pregnant 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 15-Sep-2025, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #2018414, expiration date: 11-Dec-2025) 0.5 mL, two or three dose series, for prophylaxis (Exposure during pregnancy). The healthcare worker who administered the dose was not aware the patient was pregnant. The patient had not reported any medical concerns or symptoms after being administered the dose of vaccine. More
2862017 1.75 M WA 09/29/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y018157
Y013348
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
no adverse event; product storage error; patient received PROQUAD in April or May of 2025, VARIVAX o... no adverse event; product storage error; patient received PROQUAD in April or May of 2025, VARIVAX on 22-May-2025; product storage error; This spontaneous report was received from a medical assistant and a clinic manager referring to a 1-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in April or May of 2025, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (0.5 mL total, lot #Y018157, expiration date: 29-Apr-2026; rout of administration and vaccination site were not reported) for prophylaxis (Temperature: 14.85C for 30 minutes, reported by medical assistant) (Product storage error). On 22-May-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (1 dosage form total, lot #Y013348, expiration date: 02-Aug-2026; rout of administration and vaccination site were not reported) for prophylaxis (reported by clinic manager during follow up) (Inappropriate schedule of product administration, Product storage error) (clarify pending). As it was reported, vaccine was administered after contacting the manufacturer, and Clinic staff thought vaccine was viable. No adverse reaction was reported from patient/family. The case became valid with new information date 16-Sep-2025 due to lack of patient's identifier in previous version. More
2862018 TX 09/29/2025 PPV
 MERCK & CO. INC.
 X023559
Expired product administered, No adverse event Expired product administered, No adverse event
no patient symptoms have been reported; expired dose of PNEUMOVAX 23 was inadvertently administered;... no patient symptoms have been reported; expired dose of PNEUMOVAX 23 was inadvertently administered; This spontaneous report was received from a Licensed Vocational Nurse and refers to a identified 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 24-Sep-2025, the patient was inadvertently vaccinated with 1 dose of Pneumococcal Vaccine, Polyvalent (23-valent) (lot #X023559) which had expired on 24-Nov-2024. The product was never involved in a temperature excursion. The patient had no symptoms to report. At the reporting time, the outcome of the event was unknown. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) was determined as not applicable. More
2862019 9 F CA 09/29/2025 HPV9
 MERCK & CO. INC.
 Y013768
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No adverse effects reported; patient received her 2nd dose of GARDASIL 9 too early; This spontaneous... No adverse effects reported; patient received her 2nd dose of GARDASIL 9 too early; This spontaneous report was received from a Certified Medical Assistant (CMA) and refers to a 9-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The CMA reported the patient received her 2nd 0.5ml dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y013768, expiration date: 12-Feb-2025), too early. Patient received it on 23-Sep-2025 instead of 06-Nov-2025. No adverse effects were reported. At the reporting time, the outcome of patient received her 2nd dose of GARDASIL 9 too early and No adverse effects reported was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was determined as not applicable. More
2862020 MO 09/29/2025 HBHEPB
 MERCK & CO. INC.
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; temperature excursion and reports that a dose of PEDVAX HIB was administered; This... No additional AE; temperature excursion and reports that a dose of PEDVAX HIB was administered; This spontaneous report was received from an Other health professional 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 24-Sep-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot # and expiration date were not reported) for prophylaxis. The temperature excursion vaccine's temperature was 11.1 degree and time frame was 168 hours (product storage error). No additional adverse event (no adverse event). Lot # is being requested and will be submitted if received. More
2862021 F IL 09/29/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
Y010802
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
no adverse event; inappropriate schedule; This spontaneous report was received from an Other health ... no adverse event; inappropriate schedule; This spontaneous report was received from an Other health professional and refers to a 31-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Sep-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant Injection, dose number 1, (lot # and expiration date were not reported). On 26-Sep-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #Y010802, expiration date: 01-Jan-2027), dose number 2 (Inappropriate schedule of vaccine administered). No adverse event was reported. More
2862022 CA 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received the Jynneos dose three weeks instead of four weeks apart; Case reference number... The patient received the Jynneos dose three weeks instead of four weeks apart; Case reference number US-BN-2025-000192 is a spontaneous case initially received from nurse via agency (reference number: USBAV25-0253) on 04-Feb-2025 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with first and second dose (to be confirmed) of Jynneos (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. As reported, the patient received the Jynneos dose three weeks instead of four weeks apart (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos. No further information was provided.; Reporter's Comments: This case report concerns a patient of unknown age and gender. Reportedly, the patient was vaccinated with first and second dose (to be confirmed) of Jynneos, at an unknown dose, route and site of administration for unknown indication and the patient received Jynneos dose three weeks instead of four weeks apart, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns a patient of unknown age and gender. Reportedly, the patient was vaccinated with first and second dose (to be confirmed) of Jynneos, at an unknown dose, route and site of administration for unknown indication and the patient received Jynneos dose three weeks instead of four weeks apart, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2862023 M MA 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 unknown
Inappropriate schedule of product administration, Incorrect route of product adm... Inappropriate schedule of product administration, Incorrect route of product administration More
The first dose of Jynneos was administered intramuscularly rather than subcutaneously; The patient r... The first dose of Jynneos was administered intramuscularly rather than subcutaneously; The patient received the second dose of Jynneos four months and 10 days after the first dose; Case reference number US-BN-2025-000311 is a spontaneous case initially received from pharmacist via agency (reference number: US-BN-2025-000311) on 04-Mar-2025 and concerns a 37-year-old, male patient. The patient's medical history and concomitant medication details were not provided. On 19-Oct-2024, the patient was vaccinated with first dose of Jynneos (batch number: unknown) intramuscularly, at unknown dose, site of administration, for unknown indication (explicitly coded as 'intradermal injection'). On 01-Mar-2025, after four months and 10 days from the first dose, the patient was vaccinated with second dose of Jynneos (batch number: unknown) subcutanously, at unknown dose and site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due Jynneos. No further information was provided.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos intramuscularly for unknown indication, which is considered as intradermal injection. Reportedly, after four months and 10 days from the first dose, the patient was vaccinated with the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos intramuscularly for unknown indication, which is considered as intradermal injection. Reportedly, after four months and 10 days from the first dose, the patient was vaccinated with the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2862024 F RI 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
Incomplete course of vaccination, Incorrect route of product administration Incomplete course of vaccination, Incorrect route of product administration
The patient received the first dose of Jynneos on 24-Nov-2024 and didn't receive the second dos... The patient received the first dose of Jynneos on 24-Nov-2024 and didn't receive the second dose still; Patient received Jynneos vaccine intramuscularly; Case reference number US-BN-2025-000353 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV25-0565) on 12-Mar-2025 and concerns a 28-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 24-Nov-2024, the patient took the first dose of Jynneos (batch number: 96867; expiration date: 30-Apr-2026) intramuscularly, at unknown dose, site of administration for travel. (explicitly coded as 'Incorrect route of product administration') The patient hasn't received the second dose yet (explicitly coded as 'Incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any of the adverse events due to Jynneos. No further information was provided.; Reporter's Comments: A 28-year-old, female patient took the first dose of Jynneos, intramuscularly, at unknown dose and site of administration for travel which is considered as incorrect route of product administration. The patient hasn't received the second dose yet which is considered as incomplete course of vaccination. Incorrect route of product administration and incomplete course of vaccination are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of the adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 28-year-old, female patient took the first dose of Jynneos, intramuscularly, at unknown dose and site of administration for travel which is considered as incorrect route of product administration. The patient hasn't received the second dose yet which is considered as incomplete course of vaccination. Incorrect route of product administration and incomplete course of vaccination are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of the adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are both assessed as not related to suspect product but to human factor. The case is non-serious. More
2862025 M CA 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient received the first dose of Jynneos six months ago, and did not receive the second dose s... The patient received the first dose of Jynneos six months ago, and did not receive the second dose still; Case reference number US-BN-2025-000441 is a spontaneous case initially received from pharmacist via agency (reference number: USBAV25-0775) on 07-Apr-2025 and concerns a male patient of unspecified age born. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported also as Oct and six months ago, the patient was vaccinated with Jynneos vaccine (batch number: unknown) at unknown dose, route or site of administration for unknown indication. As reported, the patient didn't receive the second dose yet (explicitly coded as 'Incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due Jynneos. No further information was provided.; Reporter's Comments: This case concerns an adult male patient of unknown age, who had received the first dose of Jynneos vaccine on unknown date (6 months ago) for unknown indication. As reported, the patient didn't receive the second dose yet, which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed as per company convention. Patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns an adult male patient of unknown age, who had received the first dose of Jynneos vaccine on unknown date (6 months ago) for unknown indication. As reported, the patient didn't receive the second dose yet, which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination is considered as listed as per company convention. Patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2862026 M OH 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 Unknown
Expired product administered Expired product administered
The patient was given a seven-day expired m-pox vaccine; Case reference number US-BN-2025-000843 is ... The patient was given a seven-day expired m-pox vaccine; Case reference number US-BN-2025-000843 is a spontaneous case report initially received from an other health professional via Communication (reference number: USBAV25-0846) on 16-APR-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received seven days expired dose of Jynneos vaccines (batch number: unknown) at unknown dose, route or site administration for unknown indication (explicitly coded as 'expired vaccine used'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. No further information provided.; Reporter's Comments: A male patient of unspecified age received seven days expired dose of Jynneos vaccines, at unknown dose, route or site administration for unknown indication which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age received seven days expired dose of Jynneos vaccines, at unknown dose, route or site administration for unknown indication which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2862027 M OR 09/29/2025 SMALLMNK
 BAVARIAN NORDIC
 96868
Incomplete course of vaccination, Incorrect route of product administration, No ... Incomplete course of vaccination, Incorrect route of product administration, No adverse event More
The Jynneos vaccine was administered intramuscularly instead of subcutaneously; Patient received fir... The Jynneos vaccine was administered intramuscularly instead of subcutaneously; Patient received first dose (only one dose) of Jynneos vaccine on 08-Apr-2025; Case reference number US-BN-2025-000922 is a spontaneous case initially received from pharmacist via Manufacturer (reference number: BN_2025_00130) on 08-May-2025 and concerns a 27-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 08-Apr-2025, the patient received Jynneos vaccine (batch number: 96868; expiration date: 30-Apr-2026) at 0.5 dose, intramuscularly, in the left deltoid for smallpox (monkey pox) prevention (explicitly coded as 'Inappropriate route of vaccine administered' and 'Incomplete course of vaccination'). At the time of initial report, the patient had not experienced any adverse events due to Jynneos, reported as none reported. Follow-up information received from pharmacist on 21-May-2025 included: Jynneos vaccine administration information, patient information and confirmation that patient did not experience any adverse event.; Reporter's Comments: A 27-year-old male patient received only one dose of Jynneos vaccine intramuscularly instead of subcutaneously, for smallpox (monkey pox) prevention, which is considered as incorrect route of product administration and incomplete course of vaccination. The patient had not experienced any adverse events due to Jynneos. Incorrect route of product administration and incomplete course of vaccination are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 27-year-old male patient received only one dose of Jynneos vaccine intramuscularly instead of subcutaneously, for smallpox (monkey pox) prevention, which is considered as incorrect route of product administration and incomplete course of vaccination. The patient had not experienced any adverse events due to Jynneos. Incorrect route of product administration and incomplete course of vaccination are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
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