🏥 VAERS Vaccine Data Browser

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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:

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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.

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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)
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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)

⚠️ 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

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 22,301 to 22,350 of 34,052 reports (Page 447 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	♿
2837318	57	F	CO	04/22/2025	TDAP TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	m2g3z m2g3z	Arthralgia, Back pain, Cough, Fatigue, Headache; Injection site bruising, Neck p... Arthralgia, Back pain, Cough, Fatigue, Headache; Injection site bruising, Neck pain, Pain More	Patient reports pain in the neck area (left side), pain radiating down left shoulder, pain down back... Patient reports pain in the neck area (left side), pain radiating down left shoulder, pain down back , hip and knee. Lasted for about 12 days. Bruising on the injection site. Looks better today. Sudden random coughing. Headche and fatigue More
2837319	70	F	WA	04/22/2025	COVID19	MODERNA	80777-0110-96	Fatigue, Rash, Rash erythematous, Somnolence Fatigue, Rash, Rash erythematous, Somnolence	After I had my vaccine, I went home and felt so tired that I had to take a nap. I never nap during ... After I had my vaccine, I went home and felt so tired that I had to take a nap. I never nap during the day. The next morning, as I was getting into the shower, I noticed a bright red rash on the trunk of my body (chest, abdomen, back and lower back). I felt extremely tired in spite of getting over 8 hours of sleep the night before. I ended up sleeping most of the day. The rash continued to spread up to my neck and into my arm pits. Before I went to bed, I took a Benadryl tablet, hoping it would clear up the rash. The next morning, the rash was even worse. Bright red, like a sunburn. I took Benadryl that night and the following night. On the 4th day after my vaccine, the rash started to subside. It is now completely gone. I have always kept current with covid vaccines, getting boosters every six months. Most of my prior vaccines were manufactured by Pfizer. I got the Spikevax vaccine because the FDA says it is the most effective for people my age. I'm afraid to get another Spikevax vaccine. More
2837320	0.67	M	MN	04/22/2025	HEP HEP PNC13 PNC13	MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH	L044694 L044694 M98916 M98916	Abnormal behaviour, Balance disorder, Crying, Developmental delay, Ear infection... Abnormal behaviour, Balance disorder, Crying, Developmental delay, Ear infection; Eye infection, Fall, Mobility decreased, Motor dysfunction, Strabismus; Abnormal behaviour, Balance disorder, Crying, Developmental delay, Ear infection; Eye infection, Fall, Mobility decreased, Motor dysfunction, Strabismus More	Child began to lose a lot of his intended motor function. He lost his ability to roll over and woul... Child began to lose a lot of his intended motor function. He lost his ability to roll over and would 'crappy flop' on the floor when he tried to roll over. He started exhibiting new hand biting behaviors. He was having feeding issues and biting the breast while nursing which got much worse after this round. Repetitive hand motions and hand flapping began to get really obvious after this. His eyes would start to intermittently cross and he would then lose his balance and fall over if he was in the sitting position. He was inconsolable many nights and a lot during the daytime. Shortly after he got ear and eye infection that would require drops. He hasn't reached many developmental milestones since this last round. More	✓
2837321	79	F	MI	04/22/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	333SK	Injection site bruising, Pain in extremity Injection site bruising, Pain in extremity	Patient came in on 4/22/2025 concerned of a injection site reaction. Patient got a TDAP vaccine on 4... Patient came in on 4/22/2025 concerned of a injection site reaction. Patient got a TDAP vaccine on 4/18/2025. She is concerned because her arm is still sore and injection site has a small bruise. I informed patient to apply a cold compress to the site for 15 minutes at a time. I also recommended an analgesic and to follow up if she has any other changes or to go to the emergency room if it is only getting worse. More
2837322	12	M	CA	04/22/2025	MMR	MERCK & CO. INC.	X019107	No adverse event, Wrong product administered No adverse event, Wrong product administered	No adverse events. Reporting wrong vaccine administered by the provider. No adverse events. Reporting wrong vaccine administered by the provider.
2837323	70	F	CO	04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	A5T73	Hypoaesthesia, Neuropathy peripheral Hypoaesthesia, Neuropathy peripheral	I had a pre-existing scheduled appt with NP, who is part of the practice. I told her about the marke... I had a pre-existing scheduled appt with NP, who is part of the practice. I told her about the markedly worse numbness & now the swelling in my feet & ankles (peripheral neuropathy) & showed her my feet and ankles. These conditions are still present. More
2837324	5	M	CA	04/22/2025	PNC20	PFIZER\WYETH	HN5980	No adverse event, Wrong product administered No adverse event, Wrong product administered	NO ADVERSE EVENTS. REPORTING WRONG VACCINE ADMINISTERED BY PROVIDER. NO ADVERSE EVENTS. REPORTING WRONG VACCINE ADMINISTERED BY PROVIDER.
2837325	16	M	CO	04/22/2025	COVID19 FLU3 HPV9 MNP TDAP	PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR	ln0591 u8442aa y012508 lj0077 3ca22c1	Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea; Abdominal pain, Agi... Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea; Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea; Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea; Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea; Abdominal pain, Agitation, Dizziness, Hyperhidrosis, Nausea More	Dizziness, abdominal pain, nausea, diaphoresis, agitation, in and out of responsiveness post vaccina... Dizziness, abdominal pain, nausea, diaphoresis, agitation, in and out of responsiveness post vaccination. EMS called and transported to hospital. More
2837327	1	F	MI	04/22/2025	HEPA	MERCK & CO. INC.	Y015027	No adverse event, Product storage error No adverse event, Product storage error	No additional adverse event; they did administer a dose of VAQTA to a patient the next clinic day af... No additional adverse event; they did administer a dose of VAQTA to a patient the next clinic day after the needle had been attached; they did administer a dose of VAQTA to a patient the next clinic day after the needle had been attached; This spontaneous report was received from a nurse on 03-Mar-2025 and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The vaccine was primed to administer on 27-Feb-2025 (Thursday) at 02:21 pm. I was a pre-filled syringe primed with a needle. It was not administered so it was kept at appropriate temperatures to be used by the end of the day. It wasn't used by the end of that Thursday and should have been wasted but wasn't. On 28-Feb-2025, at 09:19 am, the patient was vaccinated with first dose of Hepatitis A Vaccine, Inactivated (lot #Y015027, expiration date: 06-Feb-2026), administered by intramuscular route in right thigh as prophylaxis. The vaccine was administered to the patient the next clinic day after the needle had been attached. It had been stored in the refrigerator with the needle attached for approximately 19 hours prior to being administered to a patient (Product use issue, Product preparation issue). There was no patient symptoms have been reported. No additional AE (no adverse event). The office policy was to waste any primed vaccines at end of day, and staff education was done. The vaccine was kept at appropriate temperatures that whole time. More
2837329			VA	04/22/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More	consumer received 3 doses of GARDASIL-9 at 8 years old, 8 years and 6 months old, and 9 year and 7 m... consumer received 3 doses of GARDASIL-9 at 8 years old, 8 years and 6 months old, and 9 year and 7 months old.; No additional AE reported; d 3 doses of GARDASIL-9 at 8 years old, 8 years and 6 months old, and 9 year and 7 months old; d 3 doses of GARDASIL-9 at 8 years old, 8 years and 6 months old, and 9 year and 7 months old; This spontaneous report was received from a pharmacist and refers to a child of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, reported as at 8 years old, the patient was vaccinate with the first dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Product administered to patient of inappropriate age). On an unknown date in 2023, reported as at 8 years and 6 months old the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration). On an unknown date in 2024, reported as at 9 years and 7 months old, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported. More
2837330			TX	04/22/2025	VARCEL	MERCK & CO. INC.	X006982	Expired product administered, No adverse event Expired product administered, No adverse event	No additional AE/PQC; HCP called and reported inadvertent administration of expired VARIVAX to a pat... No additional AE/PQC; HCP called and reported inadvertent administration of expired VARIVAX to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Limited patient demographics were provided The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Mar-2025, the patient was inadvertently administration a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot# X006982 and expiration date reported as and upon internal review confirmed as 07-Mar-2025 (dose, route of administration and vaccination site were not reported) administered for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2837331			ID	04/22/2025	VARCEL VARCEL HIBV HIBV	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y013350 Y013350 X022981 X022981	No adverse event, Product storage error; Product storage error; No adverse event... No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error More	No additional AEs were reported; The nurse is reporting that a patient received improperly stored va... No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VARIVAX (y013350 8/2/2026) Temperature: 14.92F Time frame:; This spontaneous report was received from a Nurse and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 26-Mar-2025, the patient was vaccinated with improper storage 1 dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), lot #Y013350, expiration date: 02-Aug-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown exact date, administered dose of vaccine was exposed to the temperature excursion of 14.92 degrees Fahrenheit for 1 hour and 40 minutes (product storage error). No previous temperature excursions had occurred. No additional adverse event reported (no adverse event). More
2837332				04/22/2025	RV5 RV5	MERCK & CO. INC. MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	HCP reported that patient was administered the 1st and 2nd dose of ROTATEQ, but has not yet been adm... HCP reported that patient was administered the 1st and 2nd dose of ROTATEQ, but has not yet been administered the 3rd dose; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown gender, 34-weeks-old at the time of reporting. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first and the second doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Oral solution, 2 mL (route of administration, lot # and expiration date were not reported) for prophylaxis. Heath care professional (HCP) reported, that patient was administered the 1st and 2nd dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) on an unknown dates, but had not yet been administered the 3rd dose. At the time of reporting, the patient was beyond the recommended dosing age to be able to complete the series (inappropriate schedule of product administration). No symptoms reported, no additional adverse event (AE) was reported (no adverse event). Additional information is not expected. More
2837333	3		NY	04/22/2025	VARCEL	MERCK & CO. INC.	Y015557	No adverse event, Product storage error No adverse event, Product storage error	No additional AE /PQC reported; HCP calling to report T/E; Information has been received from Busine... No additional AE /PQC reported; HCP calling to report T/E; Information has been received from Business Partner/CRO on 10-Apr-2025. This spontaneous report was received from a Nurse and refers to a 3-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Mar-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y015557, expiration date: 16-Sep-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis; The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (details not provided). The temperature excursion was: -7.8�C, time frame: 36 minutes and there was a previous temperature excursion as. (-14.4�C up to -10.4�C) -14.0C 13 minutes No adverse event provided. More
2837334			MO	04/22/2025	VARCEL	MERCK & CO. INC.	X010526	Expired product administered, No adverse event Expired product administered, No adverse event	Patient involved has not reported any medical concerns or symptoms/ No additional AE/PQC.; Expired d... Patient involved has not reported any medical concerns or symptoms/ No additional AE/PQC.; Expired dose of VARIVAX that was administered; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (BAXTER STERILE DILUENT) . On 21-Apr-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 mL (Two dose series) as prophylaxis (lot number: X010526, which was determined to be valid, with an expiration date on 11-Apr-2025) (strength, scheme, route and anatomical location of administration were not reported) (Product use issue) The patient did not reported any medical concerns or symptoms/ No additional AE/PQC. More
2837335			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication: The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837336			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837337			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction Drug interaction	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837338			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837339			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837340			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837341			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837342			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837343			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837344			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837345			MD	04/22/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Drug interaction, Inappropriate schedule of product administration Drug interaction, Inappropriate schedule of product administration	Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 m... Drug Interaction with Burton tyrosine kinase inhibitors (BTKi's); HEPLISAV-B given at 0 and 3 months; Median anti-HBS titer was 0.05 mIU/mL with BTKi treatment; Initial report received on 21-Mar-2025. This report was retrieved from a publication. The patient was enrolled in an open-label, phase 2 clinical trial of recombinant adjuvanted hepatitis B vaccine (HEPLISAV-B) in patients with treatment na�ve (TN) chronic lymphocytic leukemia (CLL) or those on Bruton tyrosine kinase inhibitors (BTKi's) for >= 6 months frontline treatment or for relapsed disease. The patient did not have a history of hepatitis B infection nor immunization confirmed by negative hepatitis B surface antibodies (anti-HBs) and hepatitis B core antibodies. Concomitant medications included BTKi treatment with either ibrutinib or acalabrutinib. Hepatitis B serologic titer was measured at baseline, prior to receiving the first dose of HEPLISAV-B. On an unknown date, the patient received dose 1 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, three (3) months after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot #, expiration date, site and route not reported). On an unknown date, six (6) months after receiving the first dose of HEPLISAV-B, serologic titers were measured. The patient experienced did not respond to HEPLISAV-B vaccination. The study confirmed that HEPLISAV-B administration is safe for patients with CLL, with similar rates of adverse events compared with healthy individuals. At baseline, comparing TN vs BTKi groups, the median absolute lymphocyte count was 23.0 (11.72-57.59) vs 4.14 (1.86-7.33) k/microL; immunoglobulin IgG was 652 (535-782) vs 474 (417-759) mg/dL, and beta-2-microglobulin was 2.1 (1.7-2.4) vs 2.0 (1.68-2.33) mg/L. Only 1 patient on BTKi responded, whereas 9 patients who were TN responded to HepB-CpG. It was noted that at six months, the median anti-HBS titer was 0.05 mIU/mL (interquartile range [IQR], 0.00-0.43 mIU/mL} in the BTKi group and 1.30 mIU/mL (IQR, 0.15-43.78 mIU/mL} in patients who were TN. No difference was noted between serum anti-gE antibody titer at baseline or at 6 months between patients who were BTK-treated and TN. BTKi's, a standard treatment in B-cell malignancies, were associated with near absence of de novo humoral immune response to HEPLISAV-B. In summary, CLL patients have impaired vaccine responses compared with the general population. The humoral immune response to novel antigens is abrogated by BTKi's. Vaccination against novel antigens would ideally be scheduled early in the disease course and before starting BTKi. No additional information was reported. Company Comment: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses.; Sender's Comments: The company assessed the events as non-serious. The event of vaccination failure was not immunologically confirmed as the dosing schedule of vaccine administration was not according to schedule. Although there is a virtual absence of a de novo humoral response to HepB-CpG on BTKi therapy, patients with TN CLL could be more immunocompetent because of less advanced disease (time to onset of disease 58 months for TN vs 104 months for those on BTKi therapy), permitting more effective immune responses. More
2837346		M	FL	04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incorrect dose administered Incorrect dose administered	never received the second dose; This non-serious case was reported by a consumer via call center rep... never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on August 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The reporter was patient that stated that he received the first dose of Shingrix in August 2024 and he never received the second dose. The patient reported that his pharmacist at his pharmacy administered the vaccine. The reporter had reported all that was provided about this adverse event. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2837347		F		04/22/2025	MEN	UNKNOWN MANUFACTURER	UNK	Pain in extremity Pain in extremity	Arm was really sore; This non-serious case was reported by a other health professional via sales rep... Arm was really sore; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 25-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced pain in arm (Verbatim: Arm was really sore). The outcome of the pain in arm was resolved. The reporter considered the pain in arm to be related to Meningococcal B vaccine. The company considered the pain in arm to be related to Meningococcal B vaccine. Additional Information: GSK Receipt Date : 14-APR-2025 Patient reported that due to her arm being so sore with the first dose, she never received the second dose. More
2837348		F	TX	04/22/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	75GZ7 UNK	Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More	received third dose of Shingrix; 2nd dose administered on 31 January 2025; This non-serious case was... received third dose of Shingrix; 2nd dose administered on 31 January 2025; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 75GZ7) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 04th April 2019). Concurrent medical conditions included diabetes. Concomitant products included metformin hydrochloride (Metformin). On 07-APR-2025, the patient received the 3rd dose of Shingrix. On 31-JAN-2025, the patient received the 2nd dose of Shingrix. On 31-JAN-2025, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered on 31 January 2025). On 07-APR-2025, the patient experienced extra dose administered (Verbatim: received third dose of Shingrix). The outcome of the extra dose administered and drug dose administration interval too long were not applicable. Additional Information: GSK receipt date: 14-APR-2025 The patient took 3 doses of Shingrix. The first one was administered on 04th April 2019 and the second dose on 31st January 2025 which led to drug dose administration interval too long. The third dose of vaccine was administered on 07th April 2025 which led to extra dose administration. More
2837349	64	F	NY	04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	99HE4	Inappropriate schedule of product administration Inappropriate schedule of product administration	patient received the first dose of SHINGRIX 29 DEC 2022 and the second dose of SHINGRIX 11 APR 2025;... patient received the first dose of SHINGRIX 29 DEC 2022 and the second dose of SHINGRIX 11 APR 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 99HE4, expiry date 29-MAR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 29-DEC-2022). On 11-APR-2025, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of SHINGRIX 29 DEC 2022 and the second dose of SHINGRIX 11 APR 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 17-APR-2025 The pharmacist reported that the patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacist reported that a first dose at Month 0 followed by a second dose administered 2 to 6 months later is recommended dose schedule as per PI. More
2837350		F		04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	two days later got a horrific case of shingles all over her mouth; This non-serious case was reporte... two days later got a horrific case of shingles all over her mouth; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: two days later got a horrific case of shingles all over her mouth). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 The reporter reported he/she know someone who got the vaccine and two days later got a horrific case of shingles all over her mouth.; Sender's Comments: US-GSK-US2025AMR046310:Same Reporter US-GSK-US2025AMR046310:Same reporter More
2837351				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Fatigue, Injection site discomfort Fatigue, Injection site discomfort	mild discomfort at injection site; some mild fatigue for a day or two; This non-serious case was rep... mild discomfort at injection site; some mild fatigue for a day or two; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site discomfort in a 64-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles and post herpetic neuralgia. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site discomfort (Verbatim: mild discomfort at injection site) and fatigue (Verbatim: some mild fatigue for a day or two). The outcome of the injection site discomfort and fatigue were resolved. It was unknown if the reporter considered the injection site discomfort and fatigue to be related to Shingles vaccine. It was unknown if the company considered the injection site discomfort and fatigue to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media Consumer reported that he/she 64 years old and had shingles over a year ago. But still had nerve pain (post herpetic neuralgia) from the shingles even though the blisters had been long gone. Physician was advised to patient take the vaccine to reduce the chances of having the shingles a second time. Patient had the vaccine and had very few side effects, mild discomfort at injection site and some mild fatigue for a day or two, but nothing. The follow-up could not be possible as no contact details were available. More
2837352				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Feeling abnormal Feeling abnormal	I didn't realize it would feel like crap; This non-serious case was reported by a consumer via ... I didn't realize it would feel like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: I didn't realize it would feel like crap). The outcome of the feeling abnormal was not reported. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the first shot put patient out the next day. Patient did not realize it was feel like crap. But it was better than having the shingles. The patient cannot wait for the second shot. More
2837353				04/22/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	suspected vaccination failure; got shingles vaccine both shots and still got shingles; This serious ... suspected vaccination failure; got shingles vaccine both shots and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles vaccine both shots and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient got shingles vaccine of both shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2) More
2837354		M		04/22/2025	RVX	UNKNOWN MANUFACTURER	UNK	Aphonia, Cough, Fatigue, Malaise Aphonia, Cough, Fatigue, Malaise	lost voice; coughing; exhausted; sick; This non-serious case was reported by a consumer via interact... lost voice; coughing; exhausted; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of loss of voice in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2024, the patient received RSV vaccine. On an unknown date, 2 days after receiving RSV vaccine, the patient experienced loss of voice (Verbatim: lost voice), cough (Verbatim: coughing), exhaustion (Verbatim: exhausted) and sickness (Verbatim: sick). The outcome of the loss of voice was resolving and the outcome of the cough, exhaustion and sickness were not reported. It was unknown if the reporter considered the loss of voice, cough, exhaustion and sickness to be related to RSV vaccine. It was unknown if the company considered the loss of voice, cough, exhaustion and sickness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. Patient got the RSV shot in October and 2 days later he got very sick, he lost his voice and stated that it is just now coming Back. Patient was, coughing, sick and exhausted for more than 6 months. This case is linked with case US2025AMR048219, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR048219: More
2837355				04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Product preparation issue Product preparation issue	adjuvant portion of the Shingrix vaccine was administered; adjuvant portion of the Shingrix vaccine ... adjuvant portion of the Shingrix vaccine was administered; adjuvant portion of the Shingrix vaccine was administered; 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 patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant portion of the Shingrix vaccine was administered) and inappropriate dose of vaccine administered (Verbatim: adjuvant portion of the Shingrix vaccine was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 14-APR-2025 The pharmacy assistant reported that the adjuvant portion of the Shingrix vaccine was administered to the patient which led to, Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter mentioned that the vaccination date, batch number and expiry date were unknown. This case had been link with US2025AMR046764, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR046764:Original Case : US2025AMR046764 More
2837356				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pain Pain	shot stings; This non-serious case was reported by a consumer via interactive digital media and desc... shot stings; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot stings). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-APR-2025 This case was reported by a patient via interactive digital media. The patient said that the shot stings. More
2837357		M		04/22/2025	RVX	UNKNOWN MANUFACTURER	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	Suspected vaccination failure; still got RSV; This serious case was reported by a consumer via inter... Suspected vaccination failure; still got RSV; 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 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still got RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by the wife of the patient via interactive digital media. The reporter stated, her husband (patient) got the RSV vaccine but still got RSV (respiratory syncytial virus infection). The reporter reported what a nightmare the patient went through. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2837358				04/22/2025	RVX	UNKNOWN MANUFACTURER	UNK	Fatigue, Pain in extremity Fatigue, Pain in extremity	sore arm; tired for a day; This non-serious case was reported by a consumer via interactive digital ... sore arm; tired for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tired for a day). The outcome of the pain in arm was not reported and the outcome of the tiredness was resolved (duration 1 day). It was unknown if the reporter considered the pain in arm and tiredness to be related to RSV vaccine. It was unknown if the company considered the pain in arm and tiredness to be related to RSV vaccine. Additional Information: GSK receipt date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient had very little reaction to all the vaccines such as just too sore arm and tired for a day. More
2837359		M		04/22/2025	RVX	UNKNOWN MANUFACTURER	UNK	Gait inability Gait inability	no longer he can walk; This non-serious case was reported by a consumer via interactive digital medi... no longer he can walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unable to walk in a male 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 unable to walk (Verbatim: no longer he can walk). The outcome of the unable to walk was not resolved. It was unknown if the reporter considered the unable to walk to be related to RSV vaccine. It was unknown if the company considered the unable to walk to be related to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. Reporter's husband got the vaccines that came out, and now he can no longer walk. They did everything to him, and they did not even tell him that he had. More
2837360	59	F		04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	EK225	Herpes zoster Herpes zoster	acute shingles; This non-serious case was reported by a physician via sales rep and described the oc... acute shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225) for prophylaxis. The patient's past medical history included stye (seen in the office on 14th March 2025 with stye on the right eye and referred to ophthalmologist). On 27-MAR-2025, the patient received the 1st dose of Shingrix (right deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: acute shingles). The patient was treated with prednisone acetate (Prednisone), hydrocodone bitartrate (Hydrocodone), valaciclovir hydrochloride (Valacyclovir) and gabapentin. The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 16-APR-2025 The first dose of vaccine was given on 27th March 2025 in the right deltoid. The patient was seen the urgent care on 2nd April 2025 and was diagnosed with acute shingles. She was previously seen in the office on 14th March 2025 with complaints of a stye on the right eye and referred to ophthalmologist. The shingles rash was actually on the left side of the face and the neck and then the urgent care on 2nd April 2025 was prescribed prednisone, hydrocodone, and valacyclovir and also gabapentin. She was 59 years old, and she was not having any further complications at this time the last office visit again was 2nd April 2025. More
2837361				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; still get outbreaks; This serious case was reported by a consumer via... Suspected vaccination failure; still get outbreaks; 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: still get outbreaks). 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: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had gotten the vaccine but still got outbreaks. They were devastating. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2837362				04/22/2025	FLUX VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Dizziness; Dizziness Dizziness; Dizziness	got so sick the one time; This non-serious case was reported by a consumer via interactive digital m... got so sick the one time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received Shingles vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got so sick the one time). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 This case was reported by a patient via interactive digital media. Hard pass on these vaccines patient body rejects them horrible got so sick the one time. Had the flu shot, prayed that God would bring him/her home. The patient stated be very careful if you suffer from auto immune disease. Vaccines can trigger much worse than what they were trying to prevent. It was unknown if the reporter considered the sickness to be related to flu shot. More
2837363				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; I had all the vaccines, but still was attacked by it; This serious ca... Suspected vaccination failure; I had all the vaccines, but still was attacked by it; 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 had all the vaccines, but still was attacked by it). 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 : 18-APR-2025 This case was reported by a patient via interactive digital media. He/she had all the vaccines, but still was attacked by it. Luckily, he/she caught on right away, and his/her doctor was able to prescribe an antiviral med, the size of a horse pill, that he/she took three times a day, for 10 days, but it could had been worsened. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2837364		F		04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. 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: 18-APR-2025 This case was reported by a consumer via interactive digital media. Reporter was just curious because his/her physician had told him/her that he/she could still have gotten shingles after the vaccine, it was just less likely. Reporter's friend had gotten shingles after she had gotten the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2837365				04/22/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure	suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 87-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. 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: 17-APR-2025 This case was reported by a patient via interactive digital media. Patient had the vaccine but got the shingles and was having lots of pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: 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
2837366		F	NC	04/22/2025	HEP HEPA	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Incomplete course of vaccination; Incomplete course of vaccination Incomplete course of vaccination; Incomplete course of vaccination	Incomplete Series; This non-serious case was reported by a pharmacist via call center representative... Incomplete Series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis A vaccine and Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced incomplete dose administered (Verbatim: Incomplete Series). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK Receipt Date: 10-APR-2025 The pharmacist stated that a patient had received random doses of Hepatitis A and Hepatitis B in the early 90s but had not completed either series, which led to Incomplete dose administered. More
2837367				04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Patient only received one dose of Shingrix; This non-serious case was reported by a pharmacist via c... Patient only received one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient only received one dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-APR-2025 The pharmacist stated a patient only received one dose of Shingrix. Thee pharmacist states a prescriber just asked her to call with the question about the efficacy of only one dose. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. More
2837368		F	TX	04/22/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS		Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue	Administration of Arexvy in pregnant patient; Administration of Arexvy in pregnant patient; This non... Administration of Arexvy in pregnant patient; Administration of Arexvy in pregnant patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 14-APR-2025, the patient received Arexvy. On 14-APR-2025, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Administration of Arexvy in pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Administration of Arexvy in pregnant patient). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 14-APR-2025 The supervisor reported that a pregnant women received Arexvy by error on 4/14/2025, which led to drug used in unapproved population and vaccine exposure during pregnancy. This case is linked with US2025AMR046693, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR046693: More
2837369		F		04/22/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	they never got their Second dose; This non-serious case was reported by a pharmacist via call center... they never got their Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient that received their First Shingrix dose on April, 2014). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they never got their Second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 Pharmacist called to report the following that he/she had a couple of questions such as patient that received their First Shingrix dose in April 2014 and they never got their Second dose, which led to Incomplete course of vaccination. Pharmacist wants to ask is ok to go ahead and take their Second Dose now or not. This is 1 out of 2 AE reported. Health care professional stated that she did not received the First dose on their clinic therefore HCP did not have much information. This case has been linked with US2025047471, reported by the same reporter.; Sender's Comments: US-GSK-US2025047471:same reporter US-GSK-US2025AMR046222:same reporter More

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