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
2855983 10 F CA 08/28/2025 COVID19
 MODERNA
 3046979
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the... Vaccine administration error. Patient was given moderna covid vaccine 12yrs and older instead of the 6 months- 11 years old. Provider was notified and stated that there is no adverse reaction and that it is still FDA approved. Parent was notified and was explained that the child will be okay. More
2855984 12 M PA 08/28/2025 MNP
 GLAXOSMITHKLINE BIOLOGICALS
 GB73Y
Erythema, Tenderness Erythema, Tenderness
Erythema to left shoulder 9 cm diameter, tender , second day after injection Erythema to left shoulder 9 cm diameter, tender , second day after injection
2855985 26 M CA 08/28/2025 COVID19
COVID19
 JANSSEN
JANSSEN

Asthenia, Brain fog, Chest discomfort, Chest pain, Heart rate irregular; Influen... Asthenia, Brain fog, Chest discomfort, Chest pain, Heart rate irregular; Influenza, Myocarditis, Palpitations More
AT THE TIME OF INJECTION: FLU SYMPTOMS, MYOCARDITIS SYMPTOMS, PALPITATIONS, IRREGULAR HEARTBEAT, CHE... AT THE TIME OF INJECTION: FLU SYMPTOMS, MYOCARDITIS SYMPTOMS, PALPITATIONS, IRREGULAR HEARTBEAT, CHEST PAIN/TIGHTNESS, BRAIN FOG, LOW ENERGY; PROLONGED SYMPTOMS: MYOCARDITIS SYMPTOMS, PALPITATIONS, IRREGULAR HEARTBEAT, BRAIN FOG, LOW ENERGY More
2855986 5 M MT 08/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 Y020518
Extra dose administered Extra dose administered
Patient was administered one additional dose of MMR, (total of 4) Patient was administered one additional dose of MMR, (total of 4)
2855987 52 F CT 08/28/2025 PNC20
 PFIZER\WYETH
 LP4948
Pharyngeal swelling, Urticaria Pharyngeal swelling, Urticaria
Reaction: hives, throat swelling; went to ED - treated with pepcid, benadryl, decadron; outcome - he... Reaction: hives, throat swelling; went to ED - treated with pepcid, benadryl, decadron; outcome - hemodynamically stable and cleared for discharge by ED More
2855988 19 F GA 08/28/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 PX7E2
Interchange of vaccine products, No adverse event Interchange of vaccine products, No adverse event
Patient received Trumenba as 1st dose of Men B on 10/28/2022. Bexsero is not interchangeable with Tr... Patient received Trumenba as 1st dose of Men B on 10/28/2022. Bexsero is not interchangeable with Trumenba. No other reaction noted. More
2855989 54 F FL 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3E27G
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Patient came on 08/27/25 stating she received second dose of shingle dose on 08/25/25 in evening and... Patient came on 08/27/25 stating she received second dose of shingle dose on 08/25/25 in evening and subsequently developed swelling and redness at site of injection. She stated feeling her shot might have been administered too low on her arm and was concerned about cellulitis More
2855990 32 M TX 08/28/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FWO178
FWO178
FWO178
Antinuclear antibody negative, Biopsy peripheral nerve, Blood pressure fluctuati... Antinuclear antibody negative, Biopsy peripheral nerve, Blood pressure fluctuation, Borrelia test negative, Brain fog; Chest X-ray normal, Computerised tomogram head normal, Fatigue, Hyperacusis, Joint swelling; Peripheral swelling, Postural orthostatic tachycardia syndrome, SARS-CoV-2 antibody test positive, Tremor More
Arm, wrist, leg swelling that comes and goes and has persisted to this day. Brain fog, very sensiti... Arm, wrist, leg swelling that comes and goes and has persisted to this day. Brain fog, very sensitive to noise. very fatigued. Occasional tremors. Fluctation in blood pressure, POTS More
โœ“
2855991 0.5 M WI 08/28/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 9C295
Y013911
LN4931
2096657
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; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Patient received dose of Hib vaccine earlier than recommended. No symptoms were observed at the time... Patient received dose of Hib vaccine earlier than recommended. No symptoms were observed at the time. More
2855992 65 F TX 08/28/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 407242
LJ5283
Cellulitis, Erythema, Pruritus; Cellulitis, Erythema, Pruritus Cellulitis, Erythema, Pruritus; Cellulitis, Erythema, Pruritus
Patient received a Fluad and Prevnar shot on August 23rd. She returned today to get an antibiotic th... Patient received a Fluad and Prevnar shot on August 23rd. She returned today to get an antibiotic that her doctor sent in. He said she probably has cellulitis. Her arm was red and she said it was itchy. More
2855993 52 F FL 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 nr4t5
Erythema, Skin infection, Skin warm, Urticaria Erythema, Skin infection, Skin warm, Urticaria
Patient had large red and warm welt on arm below the deltoid that did not get better with benadryl. ... Patient had large red and warm welt on arm below the deltoid that did not get better with benadryl. The patient went to the ER on 8/28 where she was given Bactrim DS for a diagnosed skin infection. More
2855994 8 F CO 08/28/2025 DTAP
 SANOFI PASTEUR
 3CA11C1
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Wrong vaccine for age TDaP vs DTaP Wrong vaccine for age TDaP vs DTaP
2855995 63 F AL 08/28/2025 PNC20
 PFIZER\WYETH
 lx4482
Injection site erythema, Injection site swelling, Rash Injection site erythema, Injection site swelling, Rash
Red swelling area at injection site with a rash leading up to the neck; patient's PCP is handli... Red swelling area at injection site with a rash leading up to the neck; patient's PCP is handling treatment More
2855996 7 M CT 08/28/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 FH4YR
Cellulitis, Injection site pain, Injection site pruritus, Injection site swellin... Cellulitis, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction More
Swollen left upper arm extending from shoulder top all the way down to elbow. Itchy and painful. Swollen left upper arm extending from shoulder top all the way down to elbow. Itchy and painful.
2856002 M IN 08/28/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Z003309
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 additional AE/PQC.; HCP called to report TE occurring on 8/21/2025 for VARIVAX and PROQUAD. PROQU... No additional AE/PQC.; HCP called to report TE occurring on 8/21/2025 for VARIVAX and PROQUAD. PROQUAD was administered after the TE on 8/22/2025. No additional AE/PQC. PROQUAD Lot Z003309, exp 7/21/2026 Prior: (-12.6C) for 2 hours, 31 minutes, 0 seconds Current excursi; This spontaneous report was received from other health professional and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date of 2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Z003309, expiration date: 21-Jul-2026, reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) administered for prophylaxis (dose, route of administration and anatomical site of injection were not provided). The vaccine was administered after a temperature excursion which occurred on 22-Aug-2025. A prior excursion occurred at a temperature of -12.6๏ฟฝC for 2 hours, 31 minutes, and 0 seconds, and a current excursion at a temperature of -15.6๏ฟฝC for 1 hour, 3 minutes, and 0 seconds (Product storage error). No additional adverse event was reported (No adverse event). More
2856003 45 M OH 08/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4mg3e
Product preparation issue Product preparation issue
received only the sterile water component; received only the sterile water component; This non-serio... received only the sterile water component; received only the sterile water component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old male patient who received MMR (Priorix) (batch number 4mg3e, expiry date 01-DEC-2026) for prophylaxis. On 08-AUG-2025, the patient received Priorix (intramuscular, left arm). On 08-AUG-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: received only the sterile water component) and inappropriate dose of vaccine administered (Verbatim: received only the sterile water component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 11-AUG-2025 The pharmacist mentioned that a patient received only the sterile water component of which led to inappropriate preparation of medication and inappropriate dose of vaccine administered More
2856004 M NY 08/28/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
A patient received 1st dose of Twinrix in February and did not came back to the second dose.; This n... A patient received 1st dose of Twinrix in February and did not came back to 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 adult male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (first dose of Twinrix in February 2025). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: A patient received 1st dose of Twinrix in February and did not came back to the second dose.). The outcome of the incomplete course of vaccination 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: 06-AUG-2025 Pharmacist called to report that an adult male patient got the first dose of Twinrix in February 2025 but he did not receive the second dose one month later. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2856005 0.17 M CA 08/28/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK342AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
only administered with the dtap-ipv component as it was not reconstituted with the dtap-ipv componen... only administered with the dtap-ipv component as it was not reconstituted with the dtap-ipv component with the hib powder component before administration with no reported adverse event; Initial information received on 25-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who was only administered with the dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] as it was not reconstituted with the dtap-ipv component with the hib powder component before administration with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine live reassort oral 5v (Rotateq) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 21-Aug-2025, the patient received 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,Powder and suspension for suspension for injection (lot UK342AA, expiry date 31-AUG-2026; strength not reported) via intramuscular route in the left thigh and only administered with the dtap-ipv component as it was not reconstituted with the dtap-ipv component with the hib powder component before administration with no reported adverse event (single component of a two-component product administered) (latency same day). Reportedly, they inquired on behalf of the doctor if Hib portion can be administered alone or should the entire Pentacel dose be repeated. 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
2856006 FL 08/28/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation issue No adverse event, Product preparation issue
administered the solution portion of the vaccine and not the powder with no reported adverse event; ... administered the solution portion of the vaccine and not the powder with no reported adverse event; Initial information received on 26-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who experienced administered the solution portion of the vaccine and not the powder with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2025, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and administered the solution portion of the vaccine and not the powder with no reported adverse event (single component of a two-component product administered) (latency same day). Reportedly, she said that it was only the 0.4% sodium chloride diluent that was administered and the powder was not mixed with it and wanted to know if the solution will have adverse effects to the patient. 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
2856007 NY 08/28/2025 TDAP
 SANOFI PASTEUR
 U8122AA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion: adacel was administered afterwards with no reported adverse event; Initial in... temperature excursion: adacel was administered afterwards with no reported adverse event; Initial information received on 26-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient with unknown age and gender who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] and there was temperature excursion: negative disposition 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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot U8122AA, expiry date 30-Apr-2026 and U8366AA, expiry date : 31-Jan-2027, strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and was administered afterwards with no reported adverse event (poor quality product administered) (latency same day). Reportedly, the temperature reached as a low of 31.9F for 2 hours & 18 mins and 46.9F for an hour due to someone changing the temperature range of the fridge. There was no previous excursion. 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
2856008 PA 08/28/2025 HIBV
 SANOFI PASTEUR
 UK210AA
No adverse event, Product preparation error No adverse event, Product preparation error
staff member may have given the ACTHIB with sterile water instead of the diluent, with no reported a... staff member may have given the ACTHIB with sterile water instead of the diluent, with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] With sterile water instead of the diluent, 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 unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength) with lot UK210AA and expiry date 28-FEB-2026 via unknown route in unknown administration site for Immunization With sterile water instead of the diluent, with no reported adverse event (product preparation error) (Latency same day) Reportedly, Reporter stated that 1 of the 4 people that they administered ACTHIB to, was given that vaccine. reported that at the time of this call they are not sure if the ACTHIB was prepared and given; that they are looking into the charts to see if a possible medication error took place; that something may have happened to the ACTHIB powder vial and not used or another reason that the diluent was left alone. 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
2856009 1.33 F MI 08/28/2025 DTAP
HEPA
HIBV
IPV
MMR
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 5KR3R
3255P
Y007178
Y1A201M
Y013172
LN4931
Y020586
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Child's parents offered but declined a 4th dose of Pentacel, requesting that Hib and Dtap be ad... Child's parents offered but declined a 4th dose of Pentacel, requesting that Hib and Dtap be administered separately to avoid the extra dose of polio. An extra dose of polio was administered in error, as a separate injection. Parents notified of error. Child observed for 15 minutes- no adverse effects noted. More
2856010 66 F SC 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75D3A
Injection site discomfort, Injection site pain Injection site discomfort, Injection site pain
Painful and tender to touch in the upper right arm. This started after receiving the vaccine and has... Painful and tender to touch in the upper right arm. This started after receiving the vaccine and has persisted since that day, 5/17/25. It has been 102 days (as of today, 8/28/25) since I got the vaccine, and I still experience discomfort and pain. More
2856011 59 M FL 08/28/2025 COVID19
 MODERNA
Acoustic stimulation tests, Computerised tomogram, Tinnitus Acoustic stimulation tests, Computerised tomogram, Tinnitus
Ringing in left ear began roughly 3 months after the second moderna vaccine shot. Currently a consta... Ringing in left ear began roughly 3 months after the second moderna vaccine shot. Currently a constant ringing in both ears daily, non stop. Never had ringing in the ears prior to vaccine. More
2856012 73 M NC 08/28/2025 PNC21
 MERCK & CO. INC.
 Y019157
Erythema, Pruritus Erythema, Pruritus
patients has multiple red areas on right arm and they are itching, patient has taken two 25mg diph... patients has multiple red areas on right arm and they are itching, patient has taken two 25mg diphenhydramine tablets and a famotidine More
2856013 73 F NC 08/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 K73J3
Immediate post-injection reaction, Injection site bruising, Injection site haema... Immediate post-injection reaction, Injection site bruising, Injection site haematoma, Injection site haemorrhage, Injection site swelling More
Patient developed a hematoma immediately after vaccination of Arexvy in the left arm. Patient had b... Patient developed a hematoma immediately after vaccination of Arexvy in the left arm. Patient had bleeding and slight bruising to the area of the vaccination site in deltoid region. Bleeding stopped after one minute. Skin around area was raised in diameter around one inch. Patient's arm was cleaned with cotton ball and a standard bandage was applied. More
2856014 0.17 M MI 08/28/2025 DTAPHEPBIP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 9C295
Y2DX4
LN4932
Cyanosis, Infantile apnoea, Intensive care, Oxygen saturation decreased, Resusci... Cyanosis, Infantile apnoea, Intensive care, Oxygen saturation decreased, Resuscitation; Cyanosis, Infantile apnoea, Intensive care, Oxygen saturation decreased, Resuscitation; Cyanosis, Infantile apnoea, Intensive care, Oxygen saturation decreased, Resuscitation More
Infant was apneic, cyanotic, with no respiratory effort. Oxygen saturation was recorded at 11% at th... Infant was apneic, cyanotic, with no respiratory effort. Oxygen saturation was recorded at 11% at the lowest, heart rate 30 beats per minute. Infant required resuscitation with positive pressure ventilation, brief chest compressions for 30 seconds, and suctioning. Event lasted 6 minutes. Infant recovered, was returned to previous respiratory support of 2L 21% hiflo nasal cannula and monitored closely in the NICU overnight. More
2856021 67 F DC 08/28/2025 COVID19
FLU3
RSV
 PFIZER\BIONTECH
SANOFI PASTEUR
PFIZER\WYETH
 ME6072
U8830CA
LN5492
Anaphylactic reaction, Swollen tongue, Throat tightness; Anaphylactic reaction, ... Anaphylactic reaction, Swollen tongue, Throat tightness; Anaphylactic reaction, Swollen tongue, Throat tightness; Anaphylactic reaction, Swollen tongue, Throat tightness More
PROPERLY ADMINISTERED FLUZONE HD, ABRYSVO, AND COMIRNATY TO PATIENT ON 8/27/25 AT 1:15PM AND PATIENT... PROPERLY ADMINISTERED FLUZONE HD, ABRYSVO, AND COMIRNATY TO PATIENT ON 8/27/25 AT 1:15PM AND PATIENT CALLED BACK AFTER 6:00PM TO COMPLAIN OF ANAPHYLACTIC LIKE REACTION : TONGUE SWELLING UP AND THROAT CLOSING IN. TOLD PATIENT TO HEAD TO ER. PATIENT WAS FINE ON 8/28/25 More
2856022 72 F NJ 08/28/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.
 407242
Z002626
Limb mass, Pruritus, Urticaria; Limb mass, Pruritus, Urticaria Limb mass, Pruritus, Urticaria; Limb mass, Pruritus, Urticaria
Patient reported a small itchy lump that started on arm. When she presented to the pharmacy her arm ... Patient reported a small itchy lump that started on arm. When she presented to the pharmacy her arm looked like one large hive and patient stated she was very itchy. She was going to be seen by her physician the next day so wanted record of the vaccines she received. She showed me the mark and wanted me to report it. More
2856023 64 F OR 08/28/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Headache, Musculoskeletal stiffness, Neck pain, X-ray normal Headache, Musculoskeletal stiffness, Neck pain, X-ray normal
Constant Headache (Waves), Stiff Neck (Constant) -- Symptoms appeared within 1 hour. Similar to p... Constant Headache (Waves), Stiff Neck (Constant) -- Symptoms appeared within 1 hour. Similar to pain on back of neck. More
2856024 59 M CA 08/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 N733B
Extra dose administered Extra dose administered
Medical Assistant administered vaccine without provider's order. Patient had already received 2... Medical Assistant administered vaccine without provider's order. Patient had already received 2 full doses of the vaccine. More
2856025 45 F CO 08/28/2025 PNC13
 PFIZER\WYETH
Rash, Rash papular, Skin warm Rash, Rash papular, Skin warm
raised hot rash across the entire upper arm raised hot rash across the entire upper arm
2856026 72 F TN 08/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 gj952
Hypersensitivity, Pruritus, Urticaria Hypersensitivity, Pruritus, Urticaria
pt reported a few hours after vaccination hives and itching, hives were present on stomach, back, ar... pt reported a few hours after vaccination hives and itching, hives were present on stomach, back, arm and neck or injection site, no fever or trouble breathing. More
2856027 71 F FL 08/28/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 u8764db
u8764db
Erythema, Eye swelling, Pain of skin, Pruritus, Skin swelling; Urticaria Erythema, Eye swelling, Pain of skin, Pruritus, Skin swelling; Urticaria
a little less than two days after vaccine pt started with hives on forehead into scalp and down the ... a little less than two days after vaccine pt started with hives on forehead into scalp and down the side of her cheek. Hives were red, raised, itchy and painful. One sided eye swelling. pt is using hydrocortisone cream. vitals are ok More
2856028 73 F AL 08/28/2025 PNC20
 PFIZER\WYETH
 LN4927
Extra dose administered Extra dose administered
Pt received pneumonia vaccine a second time 1st time 07/31/2023 - at (withheld pharmacy name) as wel... Pt received pneumonia vaccine a second time 1st time 07/31/2023 - at (withheld pharmacy name) as well, records only go back 2 years at the store level and this was not on (state system) imprint when we checked- reporting that next - pt requested the vaccine. More
2856029 45 F WA 08/28/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9jt4s
23ah3
Contusion, Erythema, Injection site pain, Pruritus; Contusion, Erythema, Injecti... Contusion, Erythema, Injection site pain, Pruritus; Contusion, Erythema, Injection site pain, Pruritus More
pt reports red, bruising, and itchiness for 8 days following vaccination and extreme pain in injecti... pt reports red, bruising, and itchiness for 8 days following vaccination and extreme pain in injection site More
2856030 36 M NC 08/28/2025 HPV9
 MERCK & CO. INC.
Arthralgia, Pain, Sleep disorder Arthralgia, Pain, Sleep disorder
Constant throbbing and intense shoulder pain constantly throughout the day and delays me from fallin... Constant throbbing and intense shoulder pain constantly throughout the day and delays me from falling asleep on a regular basis More
2856041 15 M NE 08/28/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 G334J
DL4YY
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
None Vaccines were not to be given until Age 16 None Vaccines were not to be given until Age 16
2855735 TX 08/27/2025 UNK
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
 Y008282
X023323
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AEs were reported; Medical assistant reported that a patient received two doses of VAR... No additional AEs were reported; Medical assistant reported that a patient received two doses of VARIVAX on the same day. First dose was (lot y008282, exp 10/21/2025) and second dose was (lot x023323, exp 9/20/2025). No additional AEs were reported, no further information provi; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-AUG-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (valid lot #Y008282, expiration date: 21-Oct-2025) for prophylaxis. The vaccine was reconscitiuted with sterile diluent (lot # and expiration date was not provided). On 01-AUG-2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X023323, expiration date: 20-Sep-2025) for prophylaxis. The vaccine was reconscitiuted with sterile diluent (lot # and expiration date was not provided) (overdose). No additional adverse events (AEs) were reported. This case was considered as invalid due to lack of patient's identifiers. More
2855736 VA 08/27/2025 HPV9
 MERCK & CO. INC.
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received a dose of GARDASIL 9 on 5/15/2025 and is in the pharmacy to receive the another dos... patient received a dose of GARDASIL 9 on 5/15/2025 and is in the pharmacy to receive the another dose today/pharmacist mentioned that patient might have already received unspecified number of doses outside of recommended schedule in the past; No additional AEs were reported; This spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 15-May-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (dosage regimen, anatomical location, route of administration, batch/lot # and expiration date were not reported) administered as prophylaxis. It was reported that on 08-Aug-2025 (reported as "today"), the patient was in the pharmacy to receive another dose. The pharmacist mentioned that this patient might have already received unspecified number of doses outside of recommended schedule in the past (inappropriate schedule of product administration). The pharmacist did not have the detailed vaccination record for this patient. No additional adverse events (AEs) were reported (no adverse event). No further information was provided. Batch/lot# is being requested and will be submitted if received. More
2855737 12 F 08/27/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Acne, Blood test, Fatigue, Hormone analysis, Ovarian failure; Weight decreased; ... Acne, Blood test, Fatigue, Hormone analysis, Ovarian failure; Weight decreased; Acne, Blood test, Fatigue, Hormone analysis, Ovarian failure; Weight decreased More
the patient has also lost a lot of weight; has developed a lot of acne; is very fatigued; the patien... the patient has also lost a lot of weight; has developed a lot of acne; is very fatigued; the patient was diagnosed with "Primary Ovarian Insufficiency''; patient received her first dosage of GARDASIL 9 in 2020, and then her second dosage was administered in 2022; This spontaneous report was received from a consumer concerning her daughter as a 17-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On unspecified date in 2020, the patient was vaccinated with the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL administered by intramuscular (IM) route as prophylaxis (anatomical location, batch/lot # and expiration date were not reported). Then, on unspecified date in 2022, the patient was vaccinated with the 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL administered by IM route as prophylaxis (anatomical location, batch/lot # and expiration date were not reported) (inappropriate schedule of product administration). Reporter confirmed that the patient did not receive the 3-dose series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9.) On unspecified date in June 2025, the patient was diagnosed with primary ovarian insufficiency (ovarian failure). Reporter stated that this had been occurring for "a long time", but the patient's health care professional (HCP) finally diagnosed it. Also, on unspecified date (s) the patient had lost a lot of weight (weight decreased), developed a lot of acne, and was very fatigued (fatigue). Unspecified hormone tests and bloodwork were performed (results were not provided), There were no other symptoms or side effects reported by the patient's mother. At the reporting time, the patient had not recovered from the events and was receiving hormone replacement treatment. The causal relationship between ovarian failure, weight decreased, acne, fatigue and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Additional information was not expected. More
2855738 27 F IN 08/27/2025 PPV
 MERCK & CO. INC.
 Y016291
Arrhythmia, Injected limb mobility decreased, Injection site oedema, Pain in ext... Arrhythmia, Injected limb mobility decreased, Injection site oedema, Pain in extremity More
patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection ... patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; This spontaneous report was received from an Office manager and refers to a 27-year-old female patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were reported as none. On 03-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE 0.5 mL administered by Intramuscular route, lot # Y016291 has been verified to be valid, expiration date reported as 31-DEC-2026 but upon internal validation established as 06-DEC-2026, given for Low IG level ๏ฟฝ vaccination [Immunoglobulins decreased (Considered as concurrent condition)]. On 05-Jun-2025, the patient was evaluated at an urgent care clinic on with arrythmia, edema at the injection site (Vaccination site edema), and arm soreness (Vaccination site pain) to the point the patient could not lift their arm (Injected limb mobility decreased). Unspecified treatment was given for the adverse events and on an unspecified date in 2025, the patient recovered from all the events. The causal relationship between all the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE was not reported. Upon internal review, the event of arrythmia was considered medically significant. This is one of four reports from the same reporter. More
2855740 SC 08/27/2025 PNC21
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AEs were reported,; Field employee called to report an AE on behalf of a nurse. The n... No additional AEs were reported,; Field employee called to report an AE on behalf of a nurse. The nurse told the field employee that a 4 year old patient was administered with CAPVAXIVE. Date rep learned of AE confirmed to be 08/20/2025. No additional AEs were reported, no further; This spontaneous report was received from a Registered Nurse 21-Aug-2025 and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Aug-2025, the was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 1 dosage form (1 dose), (dose, dose number, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse events were reported. Lot # will be requested and will be submitted if received. More
2855741 NJ 08/27/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Extra dose administered, Inappropriate schedule of product administration Extra dose administered, Inappropriate schedule of product administration
Inappropriate schedule of product administration; accidentally received a 4th dose of VAXELIS; This ... Inappropriate schedule of product administration; accidentally received a 4th dose of VAXELIS; This non-serious spontaneous safety report, with reference number 02806767, was received by the partner on 16-MAY-2025 and forwarded to agency on 19-MAY-2025, from an other health professional. Due to the nature of the events, the causality between the events "Extra dose administered and Inappropriate schedule of product administration" and Vaxelis was not applicable. Further information is expected. More
2855749 9 M WA 08/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Chills, Decreased appetite, Fatigue, Oropharyngeal pain, Pain in extremity; Pyre... Chills, Decreased appetite, Fatigue, Oropharyngeal pain, Pain in extremity; Pyrexia, Tonsillitis, Vomiting More
High fever, chills, tonsillitis, soar throat, vomitting, loss of appetite, fatigue, & leg pain. ... High fever, chills, tonsillitis, soar throat, vomitting, loss of appetite, fatigue, & leg pain. Symptoms started Monday evening when we were getting ready for bed. Fever & chills went on for three days every 5 hours. The fever slightly decreased on day 3 but he was still getting chills. Vomitting started on Wednesday (day 2.) He had no appetite the days he was sick and was only able to drink fluids. These symptoms stopped on Thursday but he was afraid to become sick again and has had anxiety ever since. The doctors office had told me this vaccine was required for school and I wasn t provided any information about it. After researching online I read it was given at ages 11-13 not sure why it was given so early to my child. If they would have explained to me I would have said no and waited until he was older. Please also note no one in our family was sick or contracted what he had, this was the most concerning part. According to the urgent care doctors it was a virus. The question is HOW did he contract that virus if he was perfectly fine. He has also never had a reaction this severe to a vaccine. More
2855750 19 F 08/27/2025 TYP
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 X1A261M
UK134AA
Injection site erythema, Injection site urticaria; Injection site erythema, Inje... Injection site erythema, Injection site urticaria; Injection site erythema, Injection site urticaria More
ERYTHEMA AND URTICARIA OF APPROX 14CM DIAMETER TO SITE OF VACCINATION (LEFT ARM). FULL RESOLUTION OF... ERYTHEMA AND URTICARIA OF APPROX 14CM DIAMETER TO SITE OF VACCINATION (LEFT ARM). FULL RESOLUTION OF SYMPTOMS AFTER TAKING 25MG OF DIPHENHYDRAMINE AND 650MG OF APAP. More
2855752 CA 08/27/2025 MMR
 MERCK & CO. INC.
 X019101
Expired product administered, No adverse event Expired product administered, No adverse event
No effects reported. No additional AE; HBP calling to report an expired dose of MMR II was inadverte... No effects reported. No additional AE; HBP calling to report an expired dose of MMR II was inadvertently administered to a patient. HBP reports the MMR II had expired on 07/16/2025 and was administered to the patient on 07/25/2025. Confirmed no TE. No effects reported. No additional AE/No; This spontaneous report was received from the Office Manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 25-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X019101, expiration date: 16-Jul-2025) administered by unknown route as prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided). No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect vaccine was not applicable. More
2855753 63 F FL 08/27/2025 TDAP
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 4CA04C1
332L4
Rash; Rash Rash; Rash
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
2855779 F IN 08/27/2025 PPV
 MERCK & CO. INC.
 Y016291
Hypoaesthesia, Mobility decreased, Pain in extremity, Peripheral swelling Hypoaesthesia, Mobility decreased, Pain in extremity, Peripheral swelling
Pain in arm; their whole arm was in pain, hurting, and swollen; their fingers were numb; they could ... Pain in arm; their whole arm was in pain, hurting, and swollen; their fingers were numb; they could not lift their arm; This spontaneous report was received from the Office Manager and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 31-Jul-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (lot #Y016291, expiration date: 06-Dec-2026) 0.5 mL, administered by intramuscular route as a vaccine due to IG levels low. On an unspecified dates in 2025, the patient's whole arm was in pain, hurting, and swollen, she could not lift her arm, her fingers were numb, and that it was the most (severe) pain that she ever experienced. She sought medical attention. It was told to her to ice the arm and to take ibuprofen. On an unspecified dates in 2025, the patient recovered from all of the events. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not applicable. The causal relationship between the events and the suspect vaccine was not provided (it was also reported that "the facility had 4 patients who reported adverse issues related to the suspect vaccine", but it was not clear whose assessment it was, and then as "an additional AE related to this case", discrepancy). This is one of 4 reports from the same reporter. More
2855780 20 08/27/2025 HEP
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
Caller did not report any side effects; Caller called to report that they received a pediatric dose ... Caller did not report any side effects; Caller called to report that they received a pediatric dose of RECOMBIVAX on 7/13 and they are 20 years old. Caller stated that for them to go to store to get an adult dose on 8/15. Caller did not report any side effects. Permission to contact HCP was; This spontaneous report was received from a 20-year-old consumer referring to themself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Jul-2025, the patient was vaccinated with a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), dose number 1, (lot # and expiration date were not reported) for prophylaxis (underdose). No adverse event was reported. More
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