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
1494298 34 M AZ 07/22/2021 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
EW0217
ew0217
Anaphylactic reaction, Dysphagia; Anaphylactic reaction, Angioedema, Dyspnoea, U... Anaphylactic reaction, Dysphagia; Anaphylactic reaction, Angioedema, Dyspnoea, Urticaria More
RN administered Epi pen at 1059 r/t PT demonstrating difficulty swallowing/anaphylatic reaction. Ra... RN administered Epi pen at 1059 r/t PT demonstrating difficulty swallowing/anaphylatic reaction. Rapid Response was called. PT stated he was feeling better as demonstrated by breathing and swallowing without difficulty, pulse WNL. PT was taken to the ED by RR Team for further assessment/observation. Was DC'd from ED after reassured that was feeling fine. Solumedrol adn benadryl given in ED. DC'd with epipen, benadryl, prednisone, and famotidine. More
2847416 0.33 M PA 06/26/2025 DTPPVHBHPB
RV5
MSP VACCINE COMPANY
MERCK & CO. INC.
U7767AA
X026988
Circumstance or information capable of leading to medication error; Circumstance... Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error More
We believe an error in vaccine administration was made at pt.'s most recent well visit on 6/20/... We believe an error in vaccine administration was made at pt.'s most recent well visit on 6/20/25. Dr. was the provider who ordered the vaccines at that visit and the baby should have received Vaxelis, PCV15 and Rotavirus vaccines. After reviewing our vaccine inventory on 6/23/25, it was discovered that most likely the pt received an HPV vaccine instead of the PCV15 vaccine that was ordered. The MA who administered the vaccines was interviewed and she does not recollect making the error. More
2847417 43 F NM 06/26/2025 TDAP
TDAP
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PG3RP
PG3RP
Abdominal pain, Injection site erythema, Injection site induration, Injection si... Abdominal pain, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus; Injection site warmth, Pyrexia More
Site developed a hard, red lump that became itchy, red, and warm to touch. Subjective fever and abdo... Site developed a hard, red lump that became itchy, red, and warm to touch. Subjective fever and abdominal pain approx 36 hours later. Redness surrounding hard lump not receeding after 48 hours. Site remains hard and red. More
2847418 57 M WI 06/26/2025 HEPA
TDAP
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
Z27PB
9YB4G
Back injury, Dizziness, Fall, Visual impairment; Back injury, Dizziness, Fall, V... Back injury, Dizziness, Fall, Visual impairment; Back injury, Dizziness, Fall, Visual impairment More
Patient had an episode of dizziness that lasted approximately 3-5 minutes and visual disturbances. T... Patient had an episode of dizziness that lasted approximately 3-5 minutes and visual disturbances. This event was at 7:45 a.m. It caused him to fall into a piece of equipment and hurt his right-side mid back. At 07:48 BP was 152/88. He denied chest pain, shortness of breath and was not diaphoretic. He did state that he had not had anything to eat this morning. At 07:50 BP was 148/88, RR 16, Oxygen saturation was 99%, heart rate was 88. Patient was provided a snack and water. 07:55 he says that he is no longer dizzy and just says his back hurts. Ice was provided for his back. More
2847419 36 M MI 06/26/2025 HEPA
HPV9
PNC20
TDAP
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
Z27PB
Z002580
LK6655
AK334
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Patient was seen for a provider visit today. During the visit it was recommended that patient receiv... Patient was seen for a provider visit today. During the visit it was recommended that patient receive HPV vaccine. The HPV vaccine was ordered by PA. MA pulled PCV20 vaccine out of the fridge and MA signed off on PCV20 vaccine. MA then administered PCV20 and realized after injecting the vaccine that the wrong vaccine had been pulled/checked off on/administered to patient. Patient was still in clinic, thus, PA and I brought patient back to exam room to explain what happened. We advised patient that he receive PCV20 vaccine instead of the agreed upon HPV9 vaccine. We advised him that there is no true risk to him receiving this vaccine in error as he is of age to receive PCV20, it is just not something that PA recommended due to him not having additional risk factors for vaccination against pneumonia. We than advised patient that he could still receive HPV9 vaccine if he wished to do so before leaving clinic since this is what was intended. Patient was agreeable to receive HPV9 and received vaccine before being discharged home. Patient did not have any medical adverse reaction to PCV20 vaccine. More
2847420 57 F CA 06/26/2025 PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH
LN4929
LN4929
Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, In... Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Injection site warmth More
Patient received Pneumonia vaccine on 6/22/25; came in on 6/26/25, complaining about red itchy area ... Patient received Pneumonia vaccine on 6/22/25; came in on 6/26/25, complaining about red itchy area on left arm where vaccination was administered. Patient stated that symptoms (redness, swelling, warmth, pain, itching) started on the day of administration, and have continued since then; patient also claimed she had high heart rate and was having trouble breathing for about 2 days after administration. She had gone to see her doctor on morning of 6/22/25, who told her to take Ibuprofen, and return in 8 days if symptoms continued. I confirmed with patient that she had no fever since vaccine administration. I told her to try taking OTC claritin, benadryl, and/or apply topical cortizone or benadryl cream, and to see her doctor (even before 8 days) if symptoms get worse. More
2847421 15 M AL 06/26/2025 MNQ
VARCEL
SANOFI PASTEUR
MERCK & CO. INC.
U8369BA
Y015108
Cold sweat, Dizziness, Eye movement disorder, Pallor; Cold sweat, Dizziness, Eye... Cold sweat, Dizziness, Eye movement disorder, Pallor; Cold sweat, Dizziness, Eye movement disorder, Pallor More
15 year old male patient presented today for vaccine administration. Received Meningococcal (left de... 15 year old male patient presented today for vaccine administration. Received Meningococcal (left deltoid) and varicella (left arm) at 1333 while seated. While sitting in chair after administration, patient became pale. Asked patient how he was feeling, he stated- dizzy. At 1337, His eyes began to roll back and head started to bobble. I helped patient to the floor and called for additional nursing staff. Once on the floor patient began to speak and said he was okay. Patient's aunt (who was in the room and translating) asked patient if he had eaten anything today and he stated no. Patient given cool rags and granola bar to eat along with water. After 15 mins, patient moved from floor back to chair and allowed to eat a popsicle. Patient skin returned to normal color. Patient reported no longer feeling dizzy. At 1405, patient allowed to leave with Aunt, who was advised to have patient eat a meal and to take patient to ER and/or follow up with pediatrician should any other events occur. Patient and aunt acknowledged and verbalized understanding. Vitals: 1337- episode 1342- 110/75, HR 83 Skin clammy, RR 14 1347- 113/80 HR 83, RR 14 1352- 119/82 HR 108 RR 14 1357- 116/69 HR 85 RR 14 1402- 114/67 HR 83 RR 14 Skin warm and dry. More
2847422 83 F AK 06/26/2025 COVID19
PNC20
PFIZER\BIONTECH
PFIZER\WYETH
MD3414
Y019157
Injection site erythema, Injection site pruritus, Injection site swelling; Injec... Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling More
Patient experienced redness and itchiness at the injection site of her Covid shot the next day on 04... Patient experienced redness and itchiness at the injection site of her Covid shot the next day on 04/10/2025. It resolved soon after but then again on 04/15/2025 the patient reports that both of her injection sites were bothering her but the left deltoid (PCV21 injection) was red, itchy, and swollen. More
2847423 61 F AK 06/26/2025 FLU3
PNC20
SEQIRUS, INC.
PFIZER\WYETH
p100713529
LJ5284
Influenza virus test, Injection site reaction, Migraine, SARS-CoV-2 test, Urine ... Influenza virus test, Injection site reaction, Migraine, SARS-CoV-2 test, Urine analysis; Influenza virus test, Injection site reaction, Migraine, SARS-CoV-2 test, Urine analysis More
Patient had a swollen right deltoid the next morning when she woke up and a severe migraine that las... Patient had a swollen right deltoid the next morning when she woke up and a severe migraine that lasted about a week. She eventually went to the emergency room and was treated for her migraine with fluids and medications More
2847424 F GA 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
39H2S
Product preparation issue Product preparation issue
potentially received only the adjuvant of Shingrix a as a first dose; potentially received only the ... potentially received only the adjuvant of Shingrix a as a first dose; potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate dose of vaccine administered (Verbatim: potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 18-JUN-2025 The licensed practical nurse called to report that they might had accidentally administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was the first dose of Shingrix for all patients involved. There was no immunity screening or titers test available for Shingrix. This was 1 of 7 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient More
2847425 69 F TX 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
35a77
Erythema, Induration, Pyrexia, Skin warm Erythema, Induration, Pyrexia, Skin warm
Patient reported left arm red area is very hard swollen and very warm when I touch it. In addition I... Patient reported left arm red area is very hard swollen and very warm when I touch it. In addition I had a temperature for a few days. More
2847426 12 F NV 06/26/2025 DTAP
SANOFI PASTEUR
3ca20c1
Wrong product administered Wrong product administered
The provider ordered Dtap instead of Tdap, and MA did not catch it. The provider ordered Dtap instead of Tdap, and MA did not catch it.
2847427 71 F WA 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
NDC:58160-0823-
Electrocardiogram normal, Night sweats, Sleep study normal Electrocardiogram normal, Night sweats, Sleep study normal
After Vaccine I started having night sweats. Had vaccine #2 on May 7, 2024 and the night sweats incr... After Vaccine I started having night sweats. Had vaccine #2 on May 7, 2024 and the night sweats increased to where I had to change my night clothes 2-3 times/night and change my sheets at least 3 times a week. This lasted for at least six months and finally subsided. I will do a separate report for the May 7 vaccine. More
2847428 15 M CA 06/26/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.
Z002580
Z002580
Cold sweat, Contusion, Depressed level of consciousness, Electrocardiogram, Fall... Cold sweat, Contusion, Depressed level of consciousness, Electrocardiogram, Fall; Head injury, Hyperhidrosis, Nausea, Pallor, Tremor More
Treatment RN were called in to the room for syncope patient. Patient collapsed after receiving HPV ... Treatment RN were called in to the room for syncope patient. Patient collapsed after receiving HPV vaccine. Per parent describing the situation, patient had and episode of shaking before falling and hitting the floor head first. CN was already in the room attending to patient with father by patient's side. Pale color, clammy skin, and sweaty, half awake and nauseous. Legs were elevated on chair. VS were taken at 10:42 97/54, HR 55, Temp 96.7 100% O2; BSG result at 79 10:45 - DOD attended and examined the patient. Ordered an EKG. EKG result were shown to PCP and DOD. 10:55 - Dr. examined and talked to patient (no further instruction given). Patient complains of neck pain (MD's aware) due to impact sustained. Dr. reported mild contusion to right forehead and pain of left neck, pale, clammy. FROM of neck. Patient was given water, juice, vitals done. 11:00 - BP retaken 94/52; HR 52, O2 100% 11:25 - BP 105/67 (BP Location: Right arm, Pt Position: Lying, Cuff Size: Medium) | Pulse (!) 57 | Temp 97 ๏ฟฝF (36.1 ๏ฟฝC) (Temporal) | Resp 18 | Ht 1.803 m (5' 11") | Wt 138 lb 10.7 oz (62.9 kg) | SpO2 98% | BMI 19.34 kg/m๏ฟฝ Dr. noted patient recovered after about 20 minutes and was able to walk out. More
2847429 22 F CA 06/26/2025 HPV9
MERCK & CO. INC.
X026926
Injection site bruising, Injection site indentation Injection site bruising, Injection site indentation
After getting my second dose I went home was bruised when I went back on September 5, 2024 for my de... After getting my second dose I went home was bruised when I went back on September 5, 2024 for my depo shot I told the nurse that I still had a dent in my arm where I got the last gardicil vaccine by them and was told to give it some time that it might be that it was still bruised. Since then I have stated to them it won't go away its been almost a year and my arm still has the dent and won't go away More
2847430 43 F WA 06/26/2025 COVID19
COVID19
MODERNA
MODERNA
039021A
039021A
Arthralgia, Asthenia, Brain fog, Fatigue, Herpes zoster; Pain, Tenderness Arthralgia, Asthenia, Brain fog, Fatigue, Herpes zoster; Pain, Tenderness
Brain fog; physical strength gone; my feet are tender; Extreme fatigue/fatigue; Chronic Pain Joints;... Brain fog; physical strength gone; my feet are tender; Extreme fatigue/fatigue; Chronic Pain Joints; I deal with chronic pain in my body everyday all day/chronic pain joints; shingles on legs; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on legs), BRAIN FOG (Brain fog), ASTHENIA (physical strength gone), PAIN (I deal with chronic pain in my body everyday all day/chronic pain joints) and TENDERNESS (my feet are tender) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hysterectomy on 22-Mar-2021 and Neck surgery (Neck surgery z discs) on 21-Dec-2023. Concomitant products included Duloxetine hydrochloride (Cymbalta) for an unknown indication. On 25-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021 at 12:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (shingles on legs). On 15-Oct-2024, the patient experienced PAIN (I deal with chronic pain in my body everyday all day/chronic pain joints), FATIGUE (Extreme fatigue/fatigue) and ARTHRALGIA (Chronic Pain Joints). On an unknown date, the patient experienced BRAIN FOG (Brain fog), ASTHENIA (physical strength gone) and TENDERNESS (my feet are tender). On 13-Nov-2021, HERPES ZOSTER (shingles on legs) had resolved. At the time of the report, BRAIN FOG (Brain fog), ASTHENIA (physical strength gone), PAIN (I deal with chronic pain in my body everyday all day/chronic pain joints), TENDERNESS (my feet are tender), FATIGUE (Extreme fatigue/fatigue) and ARTHRALGIA (Chronic Pain Joints) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had received the vaccine and shortly afterwards, she experienced shingles. Following the vaccine administration, her quality of life deteriorated. Her life was severely impacted, as getting out of bed and beginning the day became more painful. She had chronic pain in her body everyday, all day. She also experienced brain fog and extreme fatigue. She had been seeing specialists, but no one could figure out what was happening to her. With each passing day, her limitations increased. Opening her water bottle became a struggle for her, her feet grew tender, and her physical strength was gone. The events of chronic joint pain, fatigue and shingles on legs caused the patient to seek medical care. There were no other factors that could have led to the adverse events of chronic joint pain and fatigue. The patient did not experience similar events like chronic joint pain, fatigue and shingles on legs in the past. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2024-779510 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2025: Follow-up received that contains significant information and Reporter details updated, patient details updated, medical history added, suspect start date updated, suspect anatomical location updated, suspect lot number updated, case validity updated, concomitant medication added, new events added, narrative updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2024-779510:Master Case (Husband case) More
2847431 77 F 06/26/2025 COVID19
PNC21
MODERNA
MERCK & CO. INC.
3042648
Y019157
Vaccination site erythema, Vaccination site induration, Vaccination site pain, V... Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site reaction, Vaccination site vesicles; Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site reaction, Vaccination site vesicles More
Injection site reaction; Injection site vesicles; Injection site induration; Complaining of arm pain... Injection site reaction; Injection site vesicles; Injection site induration; Complaining of arm pain; Area was hard, red, induration present and large blister present (size of a quarter); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042648) for COVID-19 prophylaxis. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Concurrent medical conditions included Diabetes. Concomitant products included Amlodipine besilate, Benazepril hydrochloride (Lotrel), Atenolol, Insulin aspart (Novolog), Empagliflozin, Metformin hydrochloride (Synjardy), Esomeprazole magnesium (Nexium) and Tirzepatide (Mounjaro) for an unknown indication. On 18-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 20-Apr-2025, the patient experienced VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE VESICLES (Injection site vesicles), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE PAIN (Complaining of arm pain) and VACCINATION SITE ERYTHEMA (Area was hard, red, induration present and large blister present (size of a quarter)) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. On 23-Apr-2025, the patient visited the clinic due to complaints of arm pain after receiving vaccines from the pharmacy. There was no fever, and pain occurred only when the area was palpated. Antibiotics were prescribed by the physician, and a follow-up was scheduled for 28-Apr-2025. More
2847432 M 06/26/2025 COVID19
MODERNA
004F21A
Eye haemorrhage Eye haemorrhage
My husband had the same batch given and also had an eye bleed; This spontaneous case was reported by... My husband had the same batch given and also had an eye bleed; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed). At the time of the report, EYE HAEMORRHAGE (My husband had the same batch given and also had an eye bleed) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided by the reporter. Patient was cleared up with symptom but was of concern for a while. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-787613 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787613:Patient (case for husband) More
2847433 68 F 06/26/2025 COVID19
MODERNA

COVID-19 COVID-19
she had caught COVID-19; This spontaneous case was reported by a consumer and describes the occurren... she had caught COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she had caught COVID-19) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine. On 19-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (she had caught COVID-19). At the time of the report, COVID-19 (she had caught COVID-19) outcome was unknown. No concomitant medication was reported. The patient had all the Moderna shots, and at the time of reporting, she was due for another one. She went to four pharmacies, but nobody had the Moderna COVID-19 vaccine. She even went to the facilities listed on website (which state they had the Moderna COVID-19 vaccine), but nobody had it. She was off schedule because she had caught COVID-19, which resulted in her being recommended to wait for 6 months. She had all her Moderna COVID-19 vaccine (5 or 6 shots), the last one before she caught infected with COVID-19. She took her mask off to go to the dentist and then the dermatologist. One week after, she got COVID. The facility where she got her latest Modena COVID-19 vaccine currently did not have the vaccine, as they said they can't get it. The pharmacy only had Pfizer, but she didn't want to switch if she could get Moderna. She and her husband searched for the vaccine in several pharmacies without any result and believe they will not purchase the vaccine just for her. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact More
2847434 M 06/26/2025 COVID19
MODERNA

Malaise, Pyrexia Malaise, Pyrexia
He is still not right and got real sick with fever and "everything"; He is still not right... He is still not right and got real sick with fever and "everything"; He is still not right and got real sick with fever and "everything"; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything") in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything"). At the time of the report, MALAISE (He is still not right and got real sick with fever and "everything") and PYREXIA (He is still not right and got real sick with fever and "everything") had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient received the moderna vaccine the previous Thursday but did not specify the exact date. He added that he was still not feeling well and had become very sick with fever and other symptoms. He then inquired whether those were side effects of the vaccine and whether it usually took a while to recover from them. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported. Reporter did not allow further contact More
2847435 MA 06/26/2025 IPV
SANOFI PASTEUR

Product storage error Product storage error
First excursion was at 9.8C for 25 minutes while the second excursion was at 8.7C for minutes due to... First excursion was at 9.8C for 25 minutes while the second excursion was at 8.7C for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event; Initial information received on 23-Jun-2025 (with live follow-up information received on 23-Jun-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 was administered with IPV (VERO) [IPOL] vaccine that had first excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory 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 0.5ml dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization that had a temperature excursion was at 9.8c for 25 minutes while the second excursion was at 8.7c for minutes due to one of the employees returning vaccines and doing inventory with no reported adverse event (product storage error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- extended stability data does not cover the excursion, human error was involved, The product was administered 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
2847436 CA 06/26/2025 HIBV
SANOFI PASTEUR

No adverse event, Product preparation error No adverse event, Product preparation error
administered act-hib that was reconstituted with sterile water instead of sodium chloride with no re... administered act-hib that was reconstituted with sterile water instead of sodium chloride with no reported adverse event; Initial information received on 24-Jun-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 was administered with HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water instead of sodium chloride 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 HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Immunization reconstituted with sterile water instead of sodium chloride with no reported adverse event (product preparation error). Information on the batch number was requested corresponding to the one at time of event occurrence 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
2847438 F NY 06/26/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.


Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that a 42 year old female... HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that a 42 year old female patient received two doses of the GARDASIL 9 vaccine three years ago. HCP stated that the patient did not complete the vaccination series for the GAR; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist and refers to a 42-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (reported as 3 years ago), the patient was vaccinated with the first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), administered for prophylaxis (doses, lot #s, expiration dates, route of administration and anatomical site of injection were not reported). The reporter stated that the patient did not complete the vaccination series for the Human Papillomavirus 9-valent Vaccine, Recombinant vaccine (GARDASIL๏ฟฝ9) and has not yet received her third dose of the vaccine. The reporter did not provide the reason for the missed dose of the vaccine (Product dose omission issue). No additional adverse event was provided (no adverse event). More
2847439 06/26/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Discomfort, Pain, Pruritus Discomfort, Pain, Pruritus
so painful; itching; uncomfortable; This non-serious case was reported by a consumer via interactive... so painful; itching; uncomfortable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: so painful), pruritus (Verbatim: itching) and discomfort (Verbatim: uncomfortable). The outcome of the pain, pruritus and discomfort were not reported. It was unknown if the reporter considered the pain, pruritus and discomfort to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain, pruritus and discomfort to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had ever had something so painful and uncomfortable and thought he/she had ever been so miserable and then the itch and itching was uncomfortable. Nighttime was the worst. More
2847441 18 M CA 06/26/2025 HEPA
GLAXOSMITHKLINE BIOLOGICALS
Z27PB
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient was given Havrix adult dosage at at 18. Patient was monitored and informed about the error a... Patient was given Havrix adult dosage at at 18. Patient was monitored and informed about the error and the patient will need to be revaccinated when the patient turns 19 years old. No adverse reactions. More
2847442 72 F WA 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
NDC:58160-0823-
General physical health deterioration, Night sweats General physical health deterioration, Night sweats
First Shingrix on January 31, 2024 and Second Shingrix on May 7, 2024. After first vaccine I started... First Shingrix on January 31, 2024 and Second Shingrix on May 7, 2024. After first vaccine I started having night sweats and they got worse after second vaccine. Changed night clothes 2/3 times nightly and sheets at least 3 times a week. Stopped after six months but my general health is poor, and I attribute it to the Shingrix vaccines. More
2847443 66 M CA 06/26/2025 PNC21
MERCK & CO. INC.
y019158
Cellulitis, Injection site pain, Pain in extremity, Serum sickness Cellulitis, Injection site pain, Pain in extremity, Serum sickness
Patient had significant soreness of the injection site for days afterwards. He was seen in urgent c... Patient had significant soreness of the injection site for days afterwards. He was seen in urgent care 03/31/2025 and was diagnosed with pain in upper arm, cellulitis in left upper limb and other serum reaction due to vaccination. Patient was given antibiotics and short course of oral steroid. More
2847444 16 M OR 06/26/2025 HEP
GLAXOSMITHKLINE BIOLOGICALS
95BJ9
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Patient came in for vaccinations, when vaccines were reviewed this writer did not realize that the p... Patient came in for vaccinations, when vaccines were reviewed this writer did not realize that the patient had two accounts in database after vaccines were given this writer noticed that there was another account for the same patient with additional vaccines. This writer confirmed name with parent and the two accounts matched the patient's demographics. More
2847456 21 M CA 06/26/2025 HPV9
MERCK & CO. INC.
X023318
Arthralgia, X-ray limb Arthralgia, X-ray limb
patient was seen in clinic today, 6/26/25, and reports persistent right shoulder pain since receivin... patient was seen in clinic today, 6/26/25, and reports persistent right shoulder pain since receiving the HPV vaccine on 6/9/25. Treatment: treat with NSAIDs and referred to orthopedics and physical therapy More
2847457 1.5 F GA 06/26/2025 HEPA
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
Y008338
Y014511
Discomfort, Rash, Rash erythematous, Rash papular, Rash pruritic; Discomfort, Ra... Discomfort, Rash, Rash erythematous, Rash papular, Rash pruritic; Discomfort, Rash, Rash erythematous, Rash papular, Rash pruritic More
Onset of unilateral thoracic rash (from just above nipple line to just above groin, small red raised... Onset of unilateral thoracic rash (from just above nipple line to just above groin, small red raised spots (papules), itchy and uncomfortable; 6 week duration; treated with topical colloidal oatmeal and Benadryl cream More
2847458 51 F PA 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
55TH4
Injection site mass, Peripheral swelling Injection site mass, Peripheral swelling
Left arm swollen with baseball size lump in arm at injection site. Have been taking Tylenol and ici... Left arm swollen with baseball size lump in arm at injection site. Have been taking Tylenol and icing with no improvement More
2847459 16 F ID 06/26/2025 MNP
MNP
PFIZER\WYETH
PFIZER\WYETH
LJ007
LJ007
Headache, Pain, Pain in extremity, Periorbital swelling, Peripheral swelling; Pr... Headache, Pain, Pain in extremity, Periorbital swelling, Peripheral swelling; Pruritus, Rash, Urticaria More
Pt c/o left arm pain and body aches about 2 hours after vaccine was given. She woke up next morning ... Pt c/o left arm pain and body aches about 2 hours after vaccine was given. She woke up next morning with body hives and itching and headache. She called office at 716am and was advised to take Benadryl and Motrin. Mom worried it is an allergic reaction and will get worse. F/u call 3 hrs later. Pt was able to go back to sleep. Mom states the last time she got vaccines her arm was swollen and very painful. This was in 2020 and she received Tdap and Menveo. Mm also states pt has seasonal allergies and some "weird ones". She can not use most face makeup product d/t reactions. Another f/u 3 hors later now Hives have blended together, but body aches and H/a is gone. No fevers. Hives/rash started on feet and legs. Then arms and neck no facial hives. No difficulty breathing. No vomiting no lip or tongue swelling. Advised to continue Benadryl every 6 hrs. and ER if needed. Now 3 days later mom calls states pt eyes are swollen. Appt made for today. Pt seen no rash or hive present. No acute distress. v/s wnl. arm is not swollen. Eyes are slightly puffy but no redness or drainage. Will continue to monitor can change to Zyrtec if needed and VAERS form filled out on line. Penbraya information package insert given to Dad. F/u as needed More
2847460 62 M NC 06/26/2025 COVID19
COVID19
MODERNA
MODERNA
014C21A
014C21A
Arthralgia, Sleep disorder; Arthralgia, Sleep disorder Arthralgia, Sleep disorder; Arthralgia, Sleep disorder
8/3/21- Days after first Covid shot in left arm, pain in left shoulder began and has continued unaba... 8/3/21- Days after first Covid shot in left arm, pain in left shoulder began and has continued unabated ever since. Had second Covid shot on 8/25/21 this time in right arm because of pain on left shoulder. Just a few days later, 9/1, right shoulder exhibited pain very similar to pain in left shoulder following first shot. This pain has continued to this day, most times requiring acetaminophen and naproxen at bedtime to control the pain so I can get to sleep. More
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2847461 38 F MD 06/26/2025 MMR
MERCK & CO. INC.
C38299
Bacterial vaginosis, Injection site rash, Laboratory test abnormal, Rash Bacterial vaginosis, Injection site rash, Laboratory test abnormal, Rash
6/18 vaccine 6/21 started Flagyl for bacterial vaginosis 6/24 rash began @ injection site 6/26 rash ... 6/18 vaccine 6/21 started Flagyl for bacterial vaginosis 6/24 rash began @ injection site 6/26 rash all over body More
2847462 84 F AZ 06/26/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Eye disorder Eye disorder
THIS VACCINE HAS PUT ME BACK ONE YEAR. NEVER WILL I GET ANOTHER VACCINE AGAIN NOT EVEN THE FLU IT EF... THIS VACCINE HAS PUT ME BACK ONE YEAR. NEVER WILL I GET ANOTHER VACCINE AGAIN NOT EVEN THE FLU IT EFFECTED MY EYES. THATS ALL I HAVE TO SAY. More
2847151 M NJ 06/25/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION

Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Received Heplisav-B first dose received on 1/29/2025, then patient received Engerix on 2/17/2025, an... Received Heplisav-B first dose received on 1/29/2025, then patient received Engerix on 2/17/2025, and then received Heplisav-B on 2/26/2025.; Received Heplisav-B first dose received on 1/29/2025, then patient received Engerix on 2/17/2025, and then received Heplisav-B on 2/26/2025.; Initial report received on 27-May-2025. A medical assistant reported that a male patient received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, then received ENGERIX-B, and then received the second dose of HEPLISAV-B four weeks after the first. No medical history or concomitant medications were reported. On 29-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #,expiration date, NDC #, route, and site not available)]. On 17-Feb-2025, 19 days after receiving dose 1 of HEPLISAV-B, the patient received a dose of a hepatitis b vaccine [ENGERIX-B (lot #, expiration date, NDC #, route, and site not available)]. On 26-Feb-2025, 28 days after receiving dose 1 of HEPLISAV-B, the patient received dose 2 of a HEPLISAV-B (lot #, expiration date, NDC #). No adverse reactions were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2847152 LA 06/25/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION

Interchange of vaccine products Interchange of vaccine products
First Dose Received HEPLISAV-B and Second Dose ENGERIX-B; Initial report received on 04-Jun-2025. A... First Dose Received HEPLISAV-B and Second Dose ENGERIX-B; Initial report received on 04-Jun-2025. A nurse reported that a patient (age and gender not reported) received HEPLISAV-B (hepatitis B vaccine) as the first dose of hepatitis B immunization and the second dose received was ENGERIX-B. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, after having been vaccinated with HEPLISAV-B, the patient received the second dose of hepatitis B vaccine [ENGERIX-B (lot number and expiration date not reported)]. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2847168 OK 06/25/2025 UNK
VARCEL
UNKNOWN MANUFACTURER
MERCK & CO. INC.
Y015022
Z004454
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
No symptomatic events were reported. No additional AE; MMR II and VARIVAX were administered to a pat... No symptomatic events were reported. No additional AE; MMR II and VARIVAX were administered to a patient when they did not need to receive it.; 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 and concomitant therapies were not reported. On 19-JUN-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, lot #Z004454 [which has been verified to be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 13-FEB-2027 and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, lot #Y015022 [which has been verified to be valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live], expiration date reported and upon internal validation establish as 05-SEP-2026. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) and were administered for prophylaxis (strength, dosage, route and anatomical site of administration were not reported). It was reported that the vaccines were administered although the patient did not need to receive them (Wrong product administered). No symptomatic events were reported (No adverse event). More
2847194 43 F MS 06/25/2025 RAB
NOVARTIS VACCINES AND DIAGNOSTICS

Heavy menstrual bleeding, Menstruation irregular Heavy menstrual bleeding, Menstruation irregular
Period began 12 days early (on day 17 of her cycle) and was heavy. Patient's cycle has been irr... Period began 12 days early (on day 17 of her cycle) and was heavy. Patient's cycle has been irregular since with the next cycle beginning 20 days later. This is outside of the norm for this patient. More
2847195 0.5 M AL 06/25/2025 DTAPIPVHIB
PNC20
RV5
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
UK329AA
LN4931
Y014321
Cyanosis, Injection site reaction, Vaccine positive rechallenge; Cyanosis, Injec... Cyanosis, Injection site reaction, Vaccine positive rechallenge; Cyanosis, Injection site reaction, Vaccine positive rechallenge; Cyanosis, Injection site reaction, Vaccine positive rechallenge More
Both legs (thighs down to feet) turned blue at daycare the day after the 6 month old vaccines as wel... Both legs (thighs down to feet) turned blue at daycare the day after the 6 month old vaccines as well as the day after the 4 month vaccines. Pulses were still normal, patient was still moving all extremities normally, and it self-resolved within 2 hours. No swelling or pain or erythema at the injection sites. More
2847196 72 M FL 06/25/2025 RSV
PFIZER\WYETH

Extra dose administered Extra dose administered
Not exactly an adverse event. Patient received the RSV vaccine and they had already received it a fe... Not exactly an adverse event. Patient received the RSV vaccine and they had already received it a few months back. More
2847197 17 M TN 06/25/2025 MENB
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
YA377
u8494aa
Dyskinesia, Loss of consciousness, Muscle contracture; Dyskinesia, Loss of consc... Dyskinesia, Loss of consciousness, Muscle contracture; Dyskinesia, Loss of consciousness, Muscle contracture More
Gave patient menquadfi in Rt deltoid then gave Men B in Lt deltoid when patient started passing ou... Gave patient menquadfi in Rt deltoid then gave Men B in Lt deltoid when patient started passing out I started fanning patient and mom grabbed wet paper towel and placed on forehead patient then started jerking all over with hands contracting I opened clinic door and called for help other nurses came we raised foot of chair I ran and got two bite size kit kats patient ate after coming too drank apple juice x2 and crackers took blood pressure 107/73 and blood sugar 93. RN Supervisor came down and talked to patients mom. Patient alert and oriented approximately 40 seconds after passing out started More
2847198 81 F CO 06/25/2025 COVID19
COVID19
MODERNA
MODERNA
EW0167
EW0167
Anxiety, Contusion, Pain in extremity, Rash, Rash erythematous; Sensory disturba... Anxiety, Contusion, Pain in extremity, Rash, Rash erythematous; Sensory disturbance More
Rash to left side of her neck/chest. It is intermittent since 2021. Has tried Eucerin, Sarna which h... Rash to left side of her neck/chest. It is intermittent since 2021. Has tried Eucerin, Sarna which helps a little but it doesnt get it to completely go away. When it flares it lasts for 3 weeks then goes away for 1-2 weeks. The more she remembers to put the sarna on the better it is. Gets anxious and it flares the rash. Has a purple/red undertone to it. Daughter says almost like purpura but not that intense. No real crusting drainage or bleeding to it. Tried triamcinolone cream and it didnt help Historically sees a hematoma/bruising to R outer ankle or L inner ankle. No known injuries over the years. SIL feels like it looks like pooling. No swelling. No pain. lasts a couple weeks too. Has not seen it anywhere else. No supplements that increase her More
2847199 4 F NV 06/25/2025 VARCEL
MERCK & CO. INC.
z003767
Extra dose administered Extra dose administered
The state record did not indicate any other dose of Varicella. The provider had the medical assistan... The state record did not indicate any other dose of Varicella. The provider had the medical assistant administer an extra dose of varicella because she thought the series was not complete. The previous varicella was not on the state record but has now been added and corrected. More
2847200 33 F WV 06/25/2025 HEPA
GLAXOSMITHKLINE BIOLOGICALS
772YT
Asthenia, Dizziness, Hyperhidrosis, Nausea Asthenia, Dizziness, Hyperhidrosis, Nausea
Within 5 minutes of vaccine, pt became extremely nauseated, diaphoretic, dizzy, and weak. Symptoms ... Within 5 minutes of vaccine, pt became extremely nauseated, diaphoretic, dizzy, and weak. Symptoms lasted for 30 minutes. Was treated with supportive care. More
2847201 58 M WV 06/25/2025 COVID19
PFIZER\BIONTECH
3015584
Depression, Suicidal ideation Depression, Suicidal ideation
None at the time None at the time
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2847202 50 M NY 06/25/2025 COVID19
COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
ER2613
ER2613
ER8733
ER8733
Autopsy, Cardiac arrest, Death, Gastrooesophageal reflux disease, Granuloma; Liv... Autopsy, Cardiac arrest, Death, Gastrooesophageal reflux disease, Granuloma; Liver sarcoidosis, Myocarditis, Pulmonary sarcoidosis, Sarcoidosis of lymph node, Splenic sarcoidosis; Autopsy, Cardiac arrest, Death, Gastrooesophageal reflux disease, Granuloma; Liver sarcoidosis, Myocarditis, Pulmonary sarcoidosis, Sarcoidosis of lymph node, Splenic sarcoidosis More
Patient suffered cardiac arrest on 10/23/23 and did not survive. Prior to his death he worked in th... Patient suffered cardiac arrest on 10/23/23 and did not survive. Prior to his death he worked in the (redacted) state during and after 911 attacks More
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2847203 53 F MO 06/25/2025 CHOL
DTAP
TYP
PAXVAX
SANOFI PASTEUR
SANOFI PASTEUR
50632001502
58160064252
49281-0790-51
Dyspnoea, Lung disorder, Rash, Rash vesicular, Tinnitus; Dyspnoea, Lung disorder... Dyspnoea, Lung disorder, Rash, Rash vesicular, Tinnitus; Dyspnoea, Lung disorder, Rash, Rash vesicular, Tinnitus; Dyspnoea, Lung disorder, Rash, Rash vesicular, Tinnitus More
5 days after vaccine both me and my husband have blister like rash all over the body. More concentra... 5 days after vaccine both me and my husband have blister like rash all over the body. More concentrated on belly but down the legs back and feet. I personally have been in the ER twice once on 6/20/25 for rash and difficulty breathing. Steroids and benedryl was given the 1st time. Repeat ER visit 6/22/25 given Epi , & Steroids. Found spots on my lungs unclear why. More
2847204 1.08 F SC 06/25/2025 DTPPVHBHPB
MSP VACCINE COMPANY

Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Adverse Event(s): On May 20, 2025, while I was present with my child, a potential vaccine administra... Adverse Event(s): On May 20, 2025, while I was present with my child, a potential vaccine administration error occurred. I was informed by staff member that the vaccine being administered was Vaxelis, despite previous documentation from an April 29 visit indicating my child was due for the Hepatitis A (Hep A) vaccine. I voiced this concern directly before administration, but provider proceeded with the vaccination regardless. Treatment: A vaccine was administered?initial documentation identified it as Vaxelis. This was later revised to show that Hep A had been given, but the patient portal still lists Vaxelis. No immediate physical symptoms or adverse reactions were observed following the vaccination. Outcome(s): The conflicting verbal and written information created significant confusion and concern about the accuracy of medical records and the vaccine received. While no physical symptoms have been reported to date, the documentation conflict and lack of confirmation procedures present a serious risk to patient safety and future care decisions. The issue remains unresolved in the digital health chart. More
2847205 12 M OH 06/25/2025 MNQ
TDAP
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
U8369BA
XN575
Fall, Loss of consciousness; Fall, Loss of consciousness Fall, Loss of consciousness; Fall, Loss of consciousness
AFTER GETTING THE 2ND SHOT, PT PASSED OUT FORWARD OFF THE EXAM TABLE. AFTER GETTING THE 2ND SHOT, PT PASSED OUT FORWARD OFF THE EXAM TABLE.