🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • ✅ Early warning system for potential safety signals
  • ✅ Open and transparent - publicly accessible
  • ✅ Accepts all reports regardless of likelihood of causation
  • ✅ Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2851698 07/29/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Limb injury, Nerve injury Limb injury, Nerve injury
I have my injured arm; I've had a nerve rubbed; This non-serious case was reported by a consume... I have my injured arm; I've had a nerve rubbed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm injury in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced arm injury (Verbatim: I have my injured arm) and nerve injury (Verbatim: I've had a nerve rubbed). The outcome of the arm injury and nerve injury were not reported. It was unknown if the reporter considered the arm injury and nerve injury to be related to RSV vaccine. It was unknown if the company considered the arm injury and nerve injury to be related to RSV vaccine. Additional Information: GSK Receipt Date: 21-JUL-2025 Reporter reported that the vaccines were pure tricks. Thanks to them, patient had injured arm he/she had a nerve rubbed and they wanted to be on pure therapy. You heal not clear that not the therapies were not at all. More
2851699 07/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; I never had Shingles until I got the Shingles shot; This serious case... Suspected Vaccination failure; I never had Shingles until I got the Shingles shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I never had Shingles until I got the Shingles shot). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until he/she got the Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2851700 CA 07/29/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
UNK
UNK
3374s
3374s
3374s
3s354
3s354
3s354
Herpes zoster, Vaccination failure; Back pain, Blister, Herpes zoster, Pain, Pos... Herpes zoster, Vaccination failure; Back pain, Blister, Herpes zoster, Pain, Post herpetic neuralgia; Rash, Skin haemorrhage, Vaccination failure; Herpes zoster, Vaccination failure; Back pain, Blister, Herpes zoster, Pain, Post herpetic neuralgia; Rash, Skin haemorrhage, Vaccination failure; Herpes zoster, Vaccination failure; Back pain, Blister, Herpes zoster, Pain, Post herpetic neuralgia; Rash, Skin haemorrhage, Vaccination failure; Herpes zoster, Vaccination failure; Back pain, Blister, Herpes zoster, Pain, Post herpetic neuralgia; Rash, Skin haemorrhage, Vaccination failure More
Suspected Vaccination failure; I was told that I have shingles.; This serious case was reported by a... Suspected Vaccination failure; I was told that I have shingles.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2018, the patient received the 2nd dose of Shingrix. In APR-2018, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I was told that I have shingles.). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-JUL-2025 The patient got two shots of Shingrix in April and July 2018 then on the day of reporting the patient was told that he/she had shingles. Reporter questioned that should he/she had gotten an extra show since he/she was 77 years old. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2851701 M AZ 07/29/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Maladministration of DTAP (Infanrix... Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Maladministration of DTAP (Infanrix); This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-JUL-2025, the patient received Infanrix. The patient did not receive Boostrix. On 16-JUL-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix)) and inappropriate age at vaccine administration (Verbatim: Maladministration of DTAP (Infanrix)). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 18-JUL-2025 Registered nurse called to report that the maladministration of the wrong vaccine diphtheria, tetanus, and pertussis (Infanrix) instead of tetanus, diphtheria, and pertussis vaccine (Boostrix) to twin brothers, which led to wrong vaccine administered. The patient received Infanrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter wants guidance on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. This is 2 of 2 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025092569:case for twin brother More
2851702 FL 07/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
incomplete course of vaccine administration; This non-serious case was reported by a other health pr... incomplete course of vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: incomplete course of vaccine administration). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 18-JUL-2025 The reporter had a question that if patient had first dose of Shingrix last in 2023, and willing to re comply this year, will 2 doses be approved this year? Or was it even safe to give another series (2-6 months apart). What was your recommendation for those that had one dose and then never followed up to complete the series? Till the time of reporting the patient did not receive the second dose which led to incomplete course of vaccination. More
2851703 F 07/29/2025 COVID19
 MODERNA
Myalgia, Pain in extremity Myalgia, Pain in extremity
so her arm would be pretty sore; she'd have muscle aches, particularly around her thumbs, the w... so her arm would be pretty sore; she'd have muscle aches, particularly around her thumbs, the wrist muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles). At the time of the report, PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles) had resolved. Concomitant medication was not reported. The caller described that with previous vaccinations, after about 48 hours or so her arm would be pretty sore, and she had muscle aches, particularly around her thumbs, the wrist muscles, but she did not have that now. All her vaccines have been Moderna so far. Started in 2021 and has had a total of 9 vaccines including the dose on 22-Jul-2025. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2025-788313 (Patient Link). Reporter did not allow further contact More
2851704 F 07/29/2025 COVID19
 MODERNA
Myalgia, Pain in extremity Myalgia, Pain in extremity
arm would be pretty sore; muscle aches, particularly around thumbs, the wrist muscles; This spontane... arm would be pretty sore; muscle aches, particularly around thumbs, the wrist muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles). At the time of the report, PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. With the previous vaccinations, after about 48 hours or so arm would be pretty sore, and had muscle aches, particularly around thumbs, the wrist muscles, but not had that now. All the vaccines have been Moderna so far. Started in 2021 and has had a total of 9 vaccines including the dose on 22-Jul-2025. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2025-788315 (Patient Link). Reporter did not allow further contact More
2851705 F 07/29/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Fatigue, Influenza like illness; Fatigue, Influenza like illness Fatigue, Influenza like illness; Fatigue, Influenza like illness
had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year; ha... had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year; had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year; This is a spontaneous report received from an Other HCP from a sales representative. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in 2025 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), FATIGUE (non-serious) all with onset 2025, outcome "recovered" (2025) and all described as "had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year". Therapeutic measures were not taken as a result of influenza like illness, fatigue. Additional information: Person mentioned that she had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year. Person did not know which Covid vaccine she received and received a flu vaccine the same day. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2851706 07/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blindness, Blood cholesterol, Blood cholesterol increased, Blood pressure measur... Blindness, Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Diabetes mellitus; Hypertension More
My eye went blind; It raised up diabetes; high blood pressure, cholesterol; high blood pressure, cho... My eye went blind; It raised up diabetes; high blood pressure, cholesterol; high blood pressure, cholesterol; This is a spontaneous report received from a Consumer or other non HCP. An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "My eye went blind"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "It raised up diabetes"; HYPERTENSION (non-serious), BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown" and all described as "high blood pressure, cholesterol". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high; Diabetes mellitus: raised up. Clinical course: Consumer stated, "I would like to talk to someone about the COVID shot (Pfizer COVID-19 Vaccine). I have had 5 of them and they have done me in. I am not myself. They (COVID-19 Vaccine) have created a lot of heath issue for me now and I just came out from the hospital last night. I am tired of going in the hospital because of the COVID shot. I am trying to get back to my son in, from (withheld) to (withheld) and try to get in, my eye went blind. It raised up diabetes, high blood pressure, cholesterol. I have never experienced these things in my entire life and I have been trying to get the help and I cannot get any form of help because nobody, some people just only got two shots, some did not take any but most of the people that I have talked to, had bad reactions and mine seems to be getting worse. Now, I need Pfizer to come up with something to help me. I have no money. I have spent all the money I have had on trying to get myself well in another naturopathic stuff. I am a naturopathic person". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2851707 F 07/29/2025 COVID19
FLUX
RSV
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgi... Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus More
Sore arms; Chills, especially at night; Muscle aches; Headache; Some itching on top of her head; Thi... Sore arms; Chills, especially at night; Muscle aches; Headache; Some itching on top of her head; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRAZODONE HCL; CLONAZEPAM; PROZAC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; CALCIUM. The following information was reported: CHILLS (non-serious) with onset 16Dec2024, described as "Chills, especially at night"; HEADACHE (non-serious) with onset 16Dec2024; MYALGIA (non-serious) with onset 16Dec2024, described as "Muscle aches"; PRURITUS (non-serious) with onset 16Dec2024, described as "Some itching on top of her head"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2024, described as "Sore arms". Amendment: This follow-up report is being submitted to amend previous information: adding case identifiers, classification (At Risk) deleted. More
2851708 F TX 07/29/2025 COVID19
 PFIZER\BIONTECH
Autonomic failure syndrome, Encephalitis autoimmune, Headache, Orthostatic hypot... Autonomic failure syndrome, Encephalitis autoimmune, Headache, Orthostatic hypotension More
Pure Autonomic Failure; Autoimmune Encephalitis; orthostatic hypotension; head pain; This is a spont... Pure Autonomic Failure; Autoimmune Encephalitis; orthostatic hypotension; head pain; This is a spontaneous report received from a Consumer or other non HCP. A 20-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: AUTONOMIC FAILURE SYNDROME (disability, medically significant), outcome "not recovered", described as "Pure Autonomic Failure"; ENCEPHALITIS AUTOIMMUNE (disability, medically significant), outcome "not recovered", described as "Autoimmune Encephalitis"; ORTHOSTATIC HYPOTENSION (disability), outcome "not recovered"; HEADACHE (disability), outcome "not recovered", described as "head pain". Event information: It was reported that the patient has been diagnosed with Pure Autonomic Failure and Autoimmune Encephalitis. She has chronic, daily head pain, orthostatic hypotension also a list of other symptoms. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
✓
2851709 1.33 M VA 07/29/2025 DTAPIPV
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
patient of 16-month-old adminitered with Quadracel with no reported adverse event; Initial informati... patient of 16-month-old adminitered with Quadracel with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old male patient who was inappropriately administered with Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jul-2025, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, Suspension for injection, (lot number, expiry date and strength not reported),frequency:once via intramuscular route in unknown administration site for Prophylactic vaccination (immunisation) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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
2851710 64 M MA 07/29/2025 TD
 SANOFI PASTEUR
 2CA91C1
Expired product administered, No adverse event Expired product administered, No adverse event
had administered an expired TENIVAC with no reported adverse event; Initial information received on ... had administered an expired TENIVAC with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 64 years old male patient who received an expired diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] with no reported adverse event. The patient's past vaccination(s) included TDAP (diphtheria vaccine toxoid pertussis vaccine acellular tetanus vaccine toxoid) The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included varicella zoster vaccine RGE (CHO) (shingrix) for Immunisation. On 22-Jul-2025, the patient received Dose 1 of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength, frequency once with 2CA91C1 and expiry date 04-Jul-2025 via intramuscular route in the right deltoid for immunization (expired product administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851711 12 F TX 07/29/2025 MEN
TDAP
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
 U8370AA
3CA30C1
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
temperature excursion: negative disposition, administered menquadfi with no reported adverse event; ... temperature excursion: negative disposition, administered menquadfi with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional (Live follow up processed together on the same day). This case involves a 12 years old female patient who had received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] And Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] after 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 19-Jul-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (expiry date: 30-APR-2028 and lot U8370AA) (strength: standard and frequency: once) via intramuscular route in the left deltoid; On the same day, also received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (expiry date: 30-APR-2026 and lot 3CA30C1) via intramuscular route in the right deltoid as immunization and temperature excursion: negative disposition, administered menquadfi with no reported adverse event (poor quality product administered) (latency: smae day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851712 0.33 M CA 07/29/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK216AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
administered PENTACEL without reconstituting the HIB with no reported adverse event; Initial informa... administered PENTACEL without reconstituting the HIB with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without reconstituting the HIB 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 Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance); and rotavirus vaccine live reassort oral 5V [Rotateq] as both for Immunisation. On 17-Jul-2025, the patient received 0.5 ml of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date- 31-JUL-2026 and lot UK216AB) once via unknown route in the right vastus lateralis for Immunization without reconstituting the HIB with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, caller was looking for any guidance and asked if they could give the patient ACTHIB to make up for the HIB. 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
2851713 57 F IA 07/29/2025 IPV
 SANOFI PASTEUR
 Y1A212M
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
receiving the 2nd dose 7-days too early with no reported adverse event; Initial information received... receiving the 2nd dose 7-days too early with no reported adverse event; Initial information received on 24-Jul-2025 (live follow-up processed together) regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 57 years old female patient who received the 2nd dose of IPV (Vero) [Ipol] 7-days too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jul-2025, the patient received 0.5ml dose 1 of suspect IPV (Vero) (once), Strength Standard, lot Y1A212M and expiry date 31-Jan-2027 via unknown route in unknown administration site for immunisation On 23-Jul-2025 she also received second 0.5ml dose 2 of suspect IPV (Vero) (once), Strength Standard, lot Y1A212M and expiry date Jan-2027 via unknown route in unknown administration site for immigration, 7-days early with no reported adverse event (inappropriate schedule of product administration) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851714 60 M WA 07/29/2025 PNC20
 PFIZER\WYETH
Dizziness, Impaired driving ability, Influenza, Nausea, Vertigo Dizziness, Impaired driving ability, Influenza, Nausea, Vertigo
While I had regular flu symptoms later in the evening from the vaccine, that's normal for me. H... While I had regular flu symptoms later in the evening from the vaccine, that's normal for me. However, this morning I woke up with severe vertigo... The house was spinning... Dizziness, nausea. I got a co-worker to pick me up for work and after a few blocks of driving the movement of the car got me severely. Nauseous and I went home and I spent most the day on the better couch. Sometimes on the couch it feels like I'm going to fall off so I've been staying in the bed when it feels that way. My symptoms have declined from a 10 down to about a five or six through the day.. at time of reporting, it's been now about 8 hours since the severe dizziness when I woke up. More
2851715 70 F TX 07/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9n2r2
Injection site pain, Injection site swelling, Injection site warmth Injection site pain, Injection site swelling, Injection site warmth
Per patient experienced swelling, pain and warmth in arm radiating from injection site to elbow Per patient experienced swelling, pain and warmth in arm radiating from injection site to elbow
2851716 13 F 07/29/2025 HPV4
 MERCK & CO. INC.
Pain, Vulvovaginal burning sensation, Vulvovaginal pain, Vulvovaginal swelling Pain, Vulvovaginal burning sensation, Vulvovaginal pain, Vulvovaginal swelling
Within a week of receiving the first dose, my vaginal opening felt like it had suddenly ripped in ha... Within a week of receiving the first dose, my vaginal opening felt like it had suddenly ripped in half while walking normally. Over the course of the next few weeks to months my vaginal opening began to hurt in a plethora of ways while performing every day tasks. My symptoms included burning, stinging, the feeling of tearing, swelling, and about half a dozen other ways that caused me pain. After about two months, my mother took me to the hospital to see what was wrong. The doctor could not diagnose me and said I was being dramatic, she offered no further assistance. I received the second dose of Gardasil not knowing this was what caused my problem at the time. Around the time of the second dose, my symptoms increased 10x. Over the course of the next 8 years my symptoms remained the same, no doctor or research of my own could find out what was wrong with me. When I was 20 and in college, I had an episode where my pain was so intense it felt as though someone was pouring acid on my vaginal opening. I went to a gynecologist in 2017 that was finally able to diagnose my problem as Vulvodynia. I only realized my symptoms started immediately after my Gardasil vaccine when the Covid vaccine came out and I was looking for my shot records and realized the date of the first vaccine coincided with my pain starting. My condition is chronic and there is no permanent solution. More
✓
2851717 52 F WY 07/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Headache, Malaise Arthralgia, Headache, Malaise
JOINT PAIN, HEAD ACHES, FEELING UNWELL SINCE JOINT PAIN, HEAD ACHES, FEELING UNWELL SINCE
2851718 0.42 M TX 07/29/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
 9359n
uk227ac
ln4932
2096662
Crying, Infant irritability; Crying, Infant irritability; Crying, Infant irritab... Crying, Infant irritability; Crying, Infant irritability; Crying, Infant irritability; Crying, Infant irritability More
patient being very fussy and crying a lot patient being very fussy and crying a lot
2851727 0.75 M CA 07/29/2025 HIBV
 SANOFI PASTEUR
 UK093AB
No adverse event, Product preparation error No adverse event, Product preparation error
patient did not have any reaction but the vaccine was reconstituted with wrong diluent ( sterile wat... patient did not have any reaction but the vaccine was reconstituted with wrong diluent ( sterile water instead of actHIB diluent) More
2851728 57 M FL 07/29/2025 COVID19
FLU3
TDAP
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 8080799
A555J
9YB4G
Injected limb mobility decreased; Injected limb mobility decreased; Injected lim... Injected limb mobility decreased; Injected limb mobility decreased; Injected limb mobility decreased More
Left Arm loss of motion Left Arm loss of motion
2851729 38 F IL 07/29/2025 HEPAB
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 P2443
Y015180
Dizziness, Dizziness postural, Immediate post-injection reaction, Syncope; Dizzi... Dizziness, Dizziness postural, Immediate post-injection reaction, Syncope; Dizziness, Dizziness postural, Immediate post-injection reaction, Syncope More
Patient felt light headed and dizzy immediately after HPV vaccine and fainted for about 10 seconds a... Patient felt light headed and dizzy immediately after HPV vaccine and fainted for about 10 seconds and became alert. The tech applied a cool damp cloth, but she became alert prior to application. We also gave her cold pack, she had a piece of chocolate, and some cool drink of choice, blue powerade. She stated that she did not eat much during the day, sometimes has anxiety with vaccines (but declined any adverse reactions on form and upon review), the weather has been unseasonably hot, and she had an intense workout during the day which patient commented as possible contributing factors. She felt fine after 15/20 minutes and wanted to finish her 2nd Twinrix dose and asked the vaccinating tech to administer. Again, she waited 20 minutes and felt good with no reactions or feeling faint, scheduled her 3rd dose, and left by her own choice, stating she felt good. More
2851730 73 M NV 07/29/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 23ah3
23ah3
Abdominal pain upper, Asthenia, Diarrhoea, Dizziness, Hypotension; Nausea, Pain,... Abdominal pain upper, Asthenia, Diarrhoea, Dizziness, Hypotension; Nausea, Pain, Pain in extremity More
Patient woke up around 3am on 7/29/25 with dizziness, aches/pain, severe diarrhea, nausea, weakness,... Patient woke up around 3am on 7/29/25 with dizziness, aches/pain, severe diarrhea, nausea, weakness, 99.9 degrees F temperature, and low blood pressure (89/59mmHg). Patient took tylenol, immodium, and coffee to raise BP. He also used a heating pad for his stomach pain and an ice pack for the arm pain. He called his doctor in the morning to report the issue. Patient called the pharmacy at 4:45pm on 7/29/25 to also report the side effects. He is still complaining of weakness, dizziness, and nausea. Patient was only able to eat a banana and some toast. Patient advised to follow up with doctor and continue monitoring blood pressure. More
2851731 84 F FL 07/29/2025 PNC20
 PFIZER\WYETH
 LN4927
Extra dose administered Extra dose administered
Additional dose given. A technician checked immunization record database but didn't realize the... Additional dose given. A technician checked immunization record database but didn't realize there were two profiles for the same patient. The profile chosen showed she had not received a pneumonia PCV vaccine and a second dose was given. First PCV20 given 10/12/2024. More
2851732 3 F CA 07/29/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site pain, Injection site swelling, Pyrexia Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
fever, red, painful, swollen arm, went to ER got antibiotic for the swelling. fever, red, painful, swollen arm, went to ER got antibiotic for the swelling.
2851733 13 M 07/29/2025 HPV9
IPV
 MERCK & CO. INC.
SANOFI PASTEUR

Fatigue, Feeling hot, Headache, Nausea, Vomiting; Fatigue, Feeling hot, Headache... Fatigue, Feeling hot, Headache, Nausea, Vomiting; Fatigue, Feeling hot, Headache, Nausea, Vomiting More
Rapid onset of headache approximately 20 hours post injections. Nausea and vomiting. Fatigue. Experi... Rapid onset of headache approximately 20 hours post injections. Nausea and vomiting. Fatigue. Experienced the feeling of being hot while temporal temperature is 96.8. More
2851734 56 F MO 07/29/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Asthenia, Chills, Consciousness fluctuating, Pain, Pain in extremity; Rash macul... Asthenia, Chills, Consciousness fluctuating, Pain, Pain in extremity; Rash macular, Sleep disorder, Tooth fracture More
Received the shot in the morning, arm was sore and had red splotches on upper arm. Other than that, ... Received the shot in the morning, arm was sore and had red splotches on upper arm. Other than that, the rest of the day was fine. Woke in the middle of the night, very achy, no energy to role over and couldn't role over due to pain. My teeth were chattering so much that I couldn't stop it. It continued and I ended up breaking teeth. I felt like I was in a fever dream or in and out of consciousness throughout the night. I stayed in bed until noon and started to feel better later in the day and felt fine the next day. More
2851365 M WA 07/28/2025 HPV9
 MERCK & CO. INC.
 Y008640
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
no adverse event; a 10-month-old male patient was accidentally given a Gardasil 9 vaccination in the... no adverse event; a 10-month-old male patient was accidentally given a Gardasil 9 vaccination in their right leg on 15Jul2025 by mistake; This spontaneous report was received from a nurse referring to a 10-month-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 15-Jul-2025, the patient was accidentally vaccinated by mistake with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y008640 has been verified to be a valid lot # for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date not reported but upon internal validation established as 24-May-2026), administered in right leg as prophylaxis (product administered to patient of inappropriate age). No other adverse events or unwanted effects have been reported at this time (no adverse event). More
2851366 WA 07/28/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y002062
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 AEs were reported; patient received improperly stored vaccine; This spontaneous report... No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the vaccine experienced a temperature excursion (TE), at -9.6C for 40 minutes. On 09-Jul-2025, the patient started therapy with one dose of the vaccine involved in the TE Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y002062 has been verified to be valid, expiration date reported and confirmed as 09-Jan-2026), as prophylaxis; reconstituted with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Product storage error). No additional AEs were reported (No adverse event). At the reporting time, the outcome of patient received improperly stored vaccine and No additional AEs were reported was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable. More
2851367 F NY 07/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration Inappropriate schedule of product administration
Received First dose In May 2023, and the 2nd Dose July 2023, and Another Dose June 10, 2025; Initial... Received First dose In May 2023, and the 2nd Dose July 2023, and Another Dose June 10, 2025; Initial report received on 10-Jul-2025. A pharmacy intern in the reported that a 27-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in May-2023, the second dose in Jul-2023, and a third dose on 10-Jun-2025. No medical history or concomitant medications were reported. In May-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). In Jul-2023, the patient received dose 2 of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). On 10-Jun-2025, after receiving the second dose of HEPLISAV-B, the patient received dose 3 of a HEPLISAV-B (lot number 945665, expiration date 31-Jan-2027, NDC number 43528-003-05) intramuscularly in the left arm. Previous doses were received at a different pharmacy than the third dose. 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
2851368 82 F OH 07/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Oral herpes, Pain, Pain in extremity Herpes zoster, Oral herpes, Pain, Pain in extremity
Shingles; had left arm pain; This non-serious case was reported by a consumer via call center repre... Shingles; had left arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cancer (cancer survivor) and zoster vaccination live-attenuated (Zoster vaccination live-attenuated several years ago). Concurrent medical conditions included cardiac failure (Heart failure). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 03-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 03-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: had left arm pain). On 06-JUL-2025, the patient experienced shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the shingles and pain in arm were not resolved. It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 09-JUL-2025 The reporter was the patient. She received her first Shingrix dose in Mar or Apr 2025 and had no problems. On 3rd July 2025 she received her second Shingrix dose in her left arm. She has had left arm pain since then. On 4th July she developed body aches that lasted through 5th July. On 6th July she developed shingles on her left lower abdomen and back. On 6th July she developed pain to the left side of her body. On 6th July she developed a cold sore). She had no prior history of shingles or cold sores. On 7th Jul 2025 she saw her doctor and started treatment with Valtrex and gabapentin. Nothing else was reported. More
2851369 51 M CA 07/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Myalgia, Pain, Rhinorrhoea, Sneezing Injection site pain, Myalgia, Pain, Rhinorrhoea, Sneezing
Injection site very sore; generalized achiness; muscle pain; runny nose; sneezing; This non-serious ... Injection site very sore; generalized achiness; muscle pain; runny nose; sneezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 15-JUL-2025 11:30, the patient received the 2nd dose of Shingrix (left arm). On 15-JUL-2025 19:45, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site very sore), generalized aching (Verbatim: generalized achiness), muscle pain (Verbatim: muscle pain), runny nose (Verbatim: runny nose) and sneezing (Verbatim: sneezing). The outcome of the injection site pain, generalized aching, muscle pain, runny nose and sneezing were not resolved. It was unknown if the reporter considered the injection site pain, generalized aching, muscle pain, runny nose and sneezing to be related to Shingrix. It was unknown if the company considered the injection site pain, generalized aching, muscle pain, runny nose and sneezing to be related to Shingrix. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter is the patient who received his second dose of Shingrix yesterday and at 7:45 pm he developed generalized achiness, muscle pains, injection site very sore, runny nose, and sneezing. Then at 2:30 am his body aches became severe. The reporter stated that he did not have a fever, and all of the symptoms were persisting. More
2851370 11 M IL 07/28/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 55N34
Wrong product administered Wrong product administered
that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo; This non-... that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 55N34, expiry date 30-SEP-2027) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis. On 17-JUL-2025, the patient received Bexsero. The patient did not receive Menveo. On 17-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo). The outcome of the wrong vaccine administered 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: 17-JUL-2025 The reporter stated that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo, which led to wrong vaccine administered. More
2851371 F 07/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
My second one made me so sick; This non-serious case was reported by a consumer via interactive digi... My second one made me so sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: My second one made me so sick). The outcome of the sickness was not reported. The reporter considered the sickness to be related to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUL-2025 This case was reported by a patient via interactive digital media. Reporter reported that her second one made her so sick that her husband refused to get vaccinated and ended up with long term issues with a case of shingles. More than six million later and he was still in pain, but because of the lies that they had been told about the jab, they did not ever want another vaccine because they did not trust that it was not going to do more harm than good. More
2851372 M 07/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; got them last year, almost 12 weeks; This serious case was reported ... suspected vaccination failure; got them last year, almost 12 weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them last year, almost 12 weeks). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 12 weeks). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUL-2025 This case was reported by a wife of the patient via interactive digital media. The reporter's husband (patient) got them (shingles) last year in 2024. Almost for 12 weeks. Reporter indicated that he had so bad, also shot did not work good for him. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR094238 reported by same reporter.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." US-GSK-US2025AMR094238:same reporter More
2851373 07/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Terrible pain and still dealing with them; This serious case was repo... Suspected vaccination failure; Terrible pain and still dealing with them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Terrible pain and still dealing with them). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date:18-JUL-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had the shingles twice and also got the vaccination. Consumer mentioned terrible pain and still he/she was dealing with them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2851374 M WI 07/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered, Inappropriate schedule of product administration Expired product administered, Inappropriate schedule of product administration
Shingrix expired dose; received first dose of Shingrix on February 4, 2021 and second dose (expired ... Shingrix expired dose; received first dose of Shingrix on February 4, 2021 and second dose (expired dose) on July 15, 2025.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received Herpes zoster (Shingrix) (expiry date 13-JUL-2025) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 04-FEB-2021). On 15-JUL-2025, the patient received the 2nd dose of Shingrix. On 15-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix expired dose) and drug dose administration interval too long (Verbatim: received first dose of Shingrix on February 4, 2021 and second dose (expired dose) on July 15, 2025.). The outcome of the expired vaccine used and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that a patient received an expired dose of the Shingrix vaccine and while gathering details of this event it was discovered that the dose would also be a late second dose, which led to drug dose administration interval too long. The reporter stated a patient received the first dose of Shingrix on 4th February 2021 and then the second dose (expired dose) on 15th July 2025, which led to expired vaccine used. More
2851375 F HI 07/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered, No adverse event Expired product administered, No adverse event
gave an expired vaccination to a patient by accident; This non-serious case was reported by a pharma... gave an expired vaccination to a patient by accident; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: gave an expired vaccination to a patient by accident). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 17-JUL-2025 The pharmacist was 6 hours behind and they have a question in regard to a vaccination they gave, an expired vaccination to a patient by accident obviously and it was 7-days expired, and the vaccination was Arexvy, which led to expired vaccine used. Everything on that was fine, the patient had no complaints, and they just obviously reversed it in the system, so she did not get billed, obviously she needs to get reinoculated. The reporter asked that how long they should wait before they re-do this shot. The reporter provided telephone and cellphone number just in case you can call early your time. One, they want to know if the lady would be okay, they were pretty sure that she was and two, they thought they should re-do the vaccination, three, how long should be wait before they do ahead and re-vaccination. No additional information was available regarding administration of Arexvy as information was obtained via afterhours VM message. More
2851376 89 F FL 07/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4LM9F
Product preparation issue Product preparation issue
didn't get the antigen of Arexvy, that is that only the diluent portion was injected to the pat... didn't get the antigen of Arexvy, that is that only the diluent portion was injected to the patient./ administered the Adjuvant portion of AREXVY only; didn't get the antigen of Arexvy, that is that only the diluent portion was injected to the patient./ administered the Adjuvant portion of AREXVY only; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4LM9F, expiry date 10-OCT-2026) for prophylaxis. On 17-JUL-2025, the patient received Arexvy. On 17-JUL-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: didn't get the antigen of Arexvy, that is that only the diluent portion was injected to the patient./ administered the Adjuvant portion of AREXVY only) and inappropriate dose of vaccine administered (Verbatim: didn't get the antigen of Arexvy, that is that only the diluent portion was injected to the patient./ administered the Adjuvant portion of AREXVY only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUL-2025 The patient was administered the Adjuvant portion of Arexvy only, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The lot number provided was from the adjuvant. The reporter did not have the lot from the antigen. More
2851377 66 F NJ 07/28/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 HA9CH
Expired product administered Expired product administered
Boostrix expired dose administration; This non-serious case was reported by a pharmacist via call c... Boostrix expired dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HA9CH, expiry date 13-JUL-2025) for prophylaxis. On 21-JUL-2025, the patient received Boostrix. On 21-JUL-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix expired dose administration). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-JUL-2025 The pharmacist had wanted to receive information regarding the administration of a Boostrix dose that had expired less than 30 days prior, which led to Expired vaccine used. He then inquired about the risk of administering another shot that day, so the call had been transferred to the second line More
2851378 16 M IA 07/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9N2R2
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 16 years old male patient received a dose of Shingrix.; This non-serious case was reported by a ot... A 16 years old male patient received a dose of Shingrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received Herpes zoster (Shingrix) (batch number 9N2R2, expiry date 25-APR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 16 years old male patient received a dose of Shingrix.). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 22-JUL-2025 The clinic administrator reported that they administered a dose of Shingrix to a 16 year old patient, which led to inappropriate age at vaccine administration. The reporter asked that there were any long-term side effects for the patient and there was any safety information available. More
2851379 29 M TX 07/28/2025 DTAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 3CA11C1
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
patient was supposed to received ADACEL but received DAPTACEL instead with no reported adverse event... patient was supposed to received ADACEL but received DAPTACEL instead with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 29 years old male patient who was supposed to received diphtheria-2/tetanus/5 Ac pertussis vaccine [Adacel] but instead received diphtheria-15/tetanus/5 Ac pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. No other vaccine. On 22-Jul-2025 at 08:55 AM, the patient supposed to received diphtheria-2/tetanus/5 Ac pertussis vaccine but instead received 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength, frequency once with lot 3CA11C1 and expiry date 31-Dec-2025 via intramuscular route in the left deltoid for immunization with no reported adverse event (wrong product administered) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2851380 WV 07/28/2025 RAB
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
patient who is due to receive their second dose today, on day 7 of the series, but they may not be a... patient who is due to receive their second dose today, on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was due to receive their second dose rabies (HDC) vaccine [Imovax rabies] today, on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient who was due to receive their second dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (Unknown strength, lot and expiry date) for Immunization on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event (routine immunisation schedule not 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
2851381 51 M TN 07/28/2025 TD
 SANOFI PASTEUR
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
inappropriate use due to administration with incorrect route (iv push instead of im) with no adverse... inappropriate use due to administration with incorrect route (iv push instead of im) with no adverse event; surgery; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old male patient who was inappropriately administrated to Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with incorrect route (iv push instead of im) with no adverse event during surgery. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jul-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (strength standard and frequency once) (lot number and expiry date not reported) via iv push route in unknown administration site for Immunization and administrated with incorrect route (iv push instead of im) with no adverse event (incorrect route of product administration) and during surgery (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, the reporter stated someone called regarding the situation but that was several hours ago and they have not had a callback yet. The patient needed it for an emergent situation and he was at surgery. 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
2851385 5 CA 07/28/2025 HEPA
 MERCK & CO. INC.
 X025485
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; Expired dose of VAQTA was administered to a patient.; This spontaneous report was ... No additional AE; Expired dose of VAQTA was administered to a patient.; This spontaneous report was received from a consumer (HBP) refers to a 5-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant therapies was not reported. On 11-JUL-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) as a prefilled syringe, at a dose of 0.5 ml (lot #X025485 who had been verified to be a valid lot number, expiration date reported and validated as 13-MAY-2025) (anatomical route of administration was not reported) as prophylaxis (Expired product administered). No additional adverse events reported. More
2851386 F MO 07/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
She received first dose of September 13 2024, and has not had the second dose; Initial report receiv... She received first dose of September 13 2024, and has not had the second dose; Initial report received on 15-Jul-2025. A pharmacist reported that a 55-year-old female (race, ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 13-Sep-2024 and had not yet received the second dose. No medical history or concomitant medications were reported. On 13-Sep-2024, the patient received dose 1 of a hepatitis B vaccine ([HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). At the time of reporting, the patient had not received the second dose yet. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2851387 ME 07/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 947931
No adverse event, Product storage error No adverse event, Product storage error
Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initia... Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had a temperature excursion for a total of 6 days. No medical history or concomitant medications were reported. On 20-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were 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
2851388 ME 07/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 947931
No adverse event, Product storage error No adverse event, Product storage error
Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initia... Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had a temperature excursion for a total of 6 days. No medical history or concomitant medications were reported. On 20-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were 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
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