🏥 VAERS Vaccine Data Browser

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About This Site

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

Data Source & Accuracy

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

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Medical Disclaimer

Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
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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)
State: Enter 2-letter state code (e.g., CA, NY, TX)
Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

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

⚠️ 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 28,351 to 28,400 of 34,052 reports (Page 568 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥
2828124	28	M	ME	02/25/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	U8115AA	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828125	40	M	ME	02/25/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	U7929AA	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828126	71	F	ME	02/25/2025	FLU3	SANOFI PASTEUR	UT8409EA	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828127	75	F	ME	02/25/2025	FLU3	SANOFI PASTEUR	UT8409EA	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828128	24	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	K9XL5	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828129	48	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	K9XL5	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828130	4	F		02/25/2025	DTAPIPV DTAPIPV MMRV MMRV	SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC.		Cyanosis, Dizziness, Eye movement disorder, Malaise, Pallor; Presyncope, Vomitin... Cyanosis, Dizziness, Eye movement disorder, Malaise, Pallor; Presyncope, Vomiting; Cyanosis, Dizziness, Eye movement disorder, Malaise, Pallor; Presyncope, Vomiting More	About 30-40 minutes after vaccination patient stood up and while walking started feeling dizzy and s... About 30-40 minutes after vaccination patient stood up and while walking started feeling dizzy and sick, threw up, and almost passed out. She was immediately picked up and put in trendelenburg, her face/lips turned pale and was green/blue around her mouth, eyes rolling into the back of her head, but did not entirely lose consciousness. About 10-15 minutes after the event she felt better. She ate a full breakfast an hour before her appointment and has never passed out from vaccines in the past. Her doctor?s office was notified and said this was a ?very common adrenaline reaction,? which seems inaccurate as it did not occur immediately after vaccination, and should not be a common reaction. I want to make sure the reaction is reported accurately. More
2828131	24	F	ME	02/25/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	U8115AA	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828132	23	F	ME	02/25/2025	HPV9	MERCK & CO. INC.	X019862	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828133	30	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	DA7P5	Exposure during pregnancy, Product storage error Exposure during pregnancy, Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant with EDD of 6/20/2025 More
2828134	36	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	K9XL5	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828135	1.33	F	CO	02/25/2025	UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	79K45 Y003146 5YB7L LC5484	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More	Accidental third dose of Influenza (flulaval) IZ administered to pt. No adverse reaction occured - d... Accidental third dose of Influenza (flulaval) IZ administered to pt. No adverse reaction occured - did call mother of patient followind day, 02/25/2025 and ask how patient was doing, MOC (speaking) notified that pt was doing well and had no side effects or adverse reaction. Did speak with provider of visit and supervisors of incident day of (02/24/2025) - notified by supvervisor to report incident. More
2828136	1	M		02/25/2025	DTPPVHBHPB MMR	MSP VACCINE COMPANY MERCK & CO. INC.	U7947AA Y008290	Rash; Rash Rash; Rash	Rash beginning day after vaccine administration. Resolved over next few days. Per nursing note &q... Rash beginning day after vaccine administration. Resolved over next few days. Per nursing note "Mom called to clinic stating child had a well check on 2/19. At appt he received two vaccines (MMR and vaxelis). The next day mom noted a rash and by Friday rash seemed worse. Improved over the weekend and has completely resolved today." More
2828137	55	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	K9XL5	Product storage error Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. More
2828138	25	F	ME	02/25/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	K9XL5	Exposure during pregnancy, Product storage error Exposure during pregnancy, Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant and EDD is 4/10/25 More
2828139	25	F	ME	02/25/2025	TDAP	SANOFI PASTEUR	U7999AA	Exposure during pregnancy, Product storage error Exposure during pregnancy, Product storage error	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant and EDD is 4/10/25 More
2828140	32	F	ME	02/25/2025	RSV TDAP	PFIZER\WYETH SANOFI PASTEUR	LN5502 U7999AA	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828141	0.17	M	NY	02/25/2025	UNK	UNKNOWN MANUFACTURER	U8265AA	Circumstance or information capable of leading to medication error, Skin abrasio... Circumstance or information capable of leading to medication error, Skin abrasion, Skin haemorrhage More	Vaccine administered by LPN and when vaccine was administered, needle was removed but patient moved ... Vaccine administered by LPN and when vaccine was administered, needle was removed but patient moved his leg and needle did hit his upper left knee leaving a small abrasion. Bleeding was controlled and bandaid was applied More
2828142	31	F	ME	02/25/2025	RSV TDAP	PFIZER\WYETH SANOFI PASTEUR	LN5502 U7999AA	Exposure during pregnancy, Product storage error; Exposure during pregnancy, Pro... Exposure during pregnancy, Product storage error; Exposure during pregnancy, Product storage error More	It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperatu... It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered. Patient is pregnant EDD is 3/9/25 More
2828143	34	F	ME	02/25/2025	FLU3 TDAP	GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR	K9XL5 U7999AA	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828144	5	F	NM	02/25/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	m4834	No adverse event, Wrong product administered No adverse event, Wrong product administered	pt was given twinrex instead of hep a hep b separately...no symptoms pt was given twinrex instead of hep a hep b separately...no symptoms
2828145	13	M	SC	02/25/2025	HEPA HPV9	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	TF27T 1965035	Pallor, Syncope; Pallor, Syncope Pallor, Syncope; Pallor, Syncope	Following administration of vaccines, client slid from chair onto floor. Client s father was seated ... Following administration of vaccines, client slid from chair onto floor. Client s father was seated on chair beside client. Client appeared pale and experienced a brief period of syncope. Client placed in supine position with legs elevated. Vital signs monitored. Client returned to consciousness within a few seconds. Vital signs stable and pupils equal, round, reactive, to light and accommodation. Father voiced concern for possible allergic reaction. Client s shirt removed, cool cloths and fan provided and tolerated well. Client s skin tone returned to baseline coloration within minutes. Continued to monitor client and vital signs. No symptoms of localized or anaphylactic reaction present. Within minutes client stated no dizziness, nausea, or other symptoms. No vomiting present. Client denied pain. Cool water provided and tolerated well; snack offered but declined. Continued to monitor client who was able to sit, stand, and walk around room without difficulty. Vital signs stable, activity and water tolerated well. Two small areas of redness present to intact skin of nose. Client denied pain and tenderness; no injury or bleeding present. Client s father denied concerns and declined emergency medical response. Client denied symptoms. Father encouraged to have client follow up with primary medical provider and to seek medical attention for client with concerns or changes in condition. Father voiced understanding. Client and parent encouraged to notify providers of syncopal episode prior to future injections or procedures. Client and parent voiced understanding. Regional medical director notified by telephone. Per regional medical director no further intervention indicated, no orders received. Regional immunization program manager notified by telephone. Client ambulatory with steady gait without assistance, accompanied by father. No symptoms or distress present at time of discharge from clinic. More
2828146	19	F	ME	02/25/2025	TDAP	SANOFI PASTEUR		Exposure during pregnancy, No adverse event, Product storage error Exposure during pregnancy, No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828147	25	F	ME	02/25/2025	FLU3 RSV TDAP	GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH SANOFI PASTEUR		No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828148	13	M	KY	02/25/2025	VARCEL VARCEL	MERCK & CO. INC. MERCK & CO. INC.	Y014868 Y014868	Incorrect route of product administration, Injection site erythema, Injection si... Incorrect route of product administration, Injection site erythema, Injection site pruritus, Injection site swelling, Product administered at inappropriate site; Urticaria More	Per the 02/19/2025 triage note from RN, "After 20 minutes, sight of shot displayed redness and ... Per the 02/19/2025 triage note from RN, "After 20 minutes, sight of shot displayed redness and mild swelling and itchiness. Dr. checked spot with patient and advised that is possible natural reaction from the injection given in the subcutaneous tissue of the lower forearm and stated benadryl would be prescribed for symptomatic relief and patient and mother acknowledged information." Patient and patient's mother left the medical office before receiving the benadryl from the Health Center pharmacy. Later that evening, the patient's parents took the patient to the Hospital emergency room. Per provider encounter note on 02/21/2025, "here to follow up ER visit. seen at facility 2 days ago after local reaction to the varicella vaccine. doing better, redness is smaller and not itchy, but hurts a lot. note reviewed, got benadryl, has been taking 25 mg every hours." "Current Medications Discontinued Benadryl Allergy 12.5 MG/5ML Liquid 5 ml Orally every 6 hrs prn , stop date 03/12/2025 Treatment 1. Acute urticaria Start diphenhydrAMINE HCl Capsule, 25 MG, 1 capsule, Orally, every 6 hours As needed, 7 days, 28 Capsule, Refills 1 Start predniSONE Tablet, 5 MG, 1 tablet, Orally, Once a day, 3 days, 3 Tablet, Refills 0 Notes: Nursing supervisor spoke with manufacturer and advised will need to repeat the dose due to not being given IM or SQ and to wait 30 days. will have patient return to see me after 30 days and update all vaccines and repeat the varicella. 2. Others Start Ibuprofen Tablet, 200 MG, 2 tablets, Orally, every 8 hours As needed, 7 days, 42 Tablet, Refills 1 On 02/20/2025, RN "Spoke to Merck Sharp & Dohme LLC. Spoke with representative. Case #02756830. Per Merck and CDC vaccine is invalid because there are no studies on vaccine efficacy when given in forearm. Per Merck, titers may be drawn to determine immunity. Based on results of titers, provider may decide to offer additional dose of Varivax. Merck states that immunity cannot be guaranteed with current second dose. Per Merck, should wait at least 28 days prior to administering additional dose. Reaction reported to Merck (Merck stated that they report all reactions to VAERS)". More
2828149	22	F	ME	02/25/2025	TDAP	SANOFI PASTEUR	U7929AA	Exposure during pregnancy, No adverse event, Product storage error Exposure during pregnancy, No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828150	67	F	AL	02/25/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	F42B2	Paraesthesia oral Paraesthesia oral	Patient said she had tingling of the tongue/mouth area that started about 5 to 10 minutes after the ... Patient said she had tingling of the tongue/mouth area that started about 5 to 10 minutes after the vaccine. Symptoms resolved within about 30 minutes. No medical care sought More
2828151	21	F	ME	02/25/2025	FLU3 TDAP	GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR	K9XL5 U7924AA	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828152	22	F	ME	02/25/2025	TDAP	SANOFI PASTEUR	3CA07C1	Exposure during pregnancy, No adverse event, Product storage error Exposure during pregnancy, No adverse event, Product storage error	Out of range temperature for refrigerator. No adverse reactions Out of range temperature for refrigerator. No adverse reactions
2828153	0.42	F	MI	02/25/2025	DTAPIPVHIB IPV PNC20	SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH	UK023AA X1D141M LG5574	Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered	Dtap-Hib-IPV administered at the same time as single antigen IPV. Dtap-Hib-IPV administered at the same time as single antigen IPV.
2828154	29	M	MI	02/25/2025	COVID19	PFIZER\BIONTECH		Alopecia Alopecia	Hair loss 2 months post vaccination. No personal history and No family history of alopecia or male p... Hair loss 2 months post vaccination. No personal history and No family history of alopecia or male pattern baldness. Episodes have come in waves over the last 3-4 years. Always patchy and different areas of body. permanent hair loss on crown of head More
2828155	1.33	F	TX	02/25/2025	MMR	MERCK & CO. INC.	X024178	No adverse event No adverse event	Nurse didn't realize the child had an egg allergy until after giving the vaccine. Parnts and ch... Nurse didn't realize the child had an egg allergy until after giving the vaccine. Parnts and child waiting in clinic 10 minutes before leaving. No reaction was noted. More
2828156	1.33	F	TX	02/25/2025	MMR	MERCK & CO. INC.	X024178	No adverse event No adverse event	Nurse didn't realize the child had an egg allergy until after giving the vaccine. Parnts and ch... Nurse didn't realize the child had an egg allergy until after giving the vaccine. Parnts and child waiting in clinic 10 minutes before leaving. No reaction was noted. More
2828157	18	F	IL	02/25/2025	MENB MENB	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	PX7E2 PX7E2	Oral pruritus, Rash, Rash erythematous, Rash macular, Rash pruritic; Skin warm Oral pruritus, Rash, Rash erythematous, Rash macular, Rash pruritic; Skin warm	Pt describes feeling itchiness around mouth within 1 hour of vaccine administration. Within next 3 ... Pt describes feeling itchiness around mouth within 1 hour of vaccine administration. Within next 3 hours complained of facial itching and also facial redness, rash and blotchiness. Returned to clinic within 5 hours to get evaluated and noted to have facial itchiness with rash and redness/warmth, without any respiratory or other complaints. Received oral Prednisone 20 mL (15 mg/mL) suspension and oral Children's Allegra Allergy liquid 25 ml. Within 1 hour itchiness decreased and facial rash noticeably less reddened. Was sent home on oral Prednisone 40 mg 2x's/day x 5 days and also Allegra Allergy liquid. Per patient next day 2/25/25 reports facial complaints improved, slight itchiness, no increased redness. More
2828158	0.83	M	PA	02/25/2025	UNK	UNKNOWN MANUFACTURER	W1A191M	Expired product administered Expired product administered	Vaccine administered past manufacturer expiration date. Printed expiration date lists 02/16/2025. Va... Vaccine administered past manufacturer expiration date. Printed expiration date lists 02/16/2025. Vaccine administered to patient on 02/25/2025 More
2828159	67	M	NJ	02/25/2025	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		Atrial fibrillation, Blood creatinine increased, Blood immunoglobulin G decrease... Atrial fibrillation, Blood creatinine increased, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Cardiac failure congestive; Chills, Epstein-Barr virus antibody, Fatigue, Glomerular filtration rate decreased, Headache; Hyperhidrosis, Infectious mononucleosis, Pain, Renal impairment More	Developed mononucleosis, atrial fibrillation and congestive heart failure. Hospitalized for 11 days... Developed mononucleosis, atrial fibrillation and congestive heart failure. Hospitalized for 11 days. Major mono symptoms lasted about 2 weeks, and included painful headaches, body aches, chills, sweats and fatigue. Today (six weeks later) the fatigue is still severe. Heart failure was treated with diuretics. Also developed under-performing kidneys, possibly from diuretics. More	✓
2828160	1	F	WA	02/25/2025	HIBV	SANOFI PASTEUR	UK042AA	No adverse event, Product preparation error No adverse event, Product preparation error	There was no adverse reaction. The patient received this vaccine diluted with the wrong diluent. Ste... There was no adverse reaction. The patient received this vaccine diluted with the wrong diluent. Sterile water was used instead of the supplied diluent of 0.4% sodium chloride. More
2828161	23	M	AK	02/25/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	B0005 UT8415MA	Arthralgia, Mobility decreased, Pain; Arthralgia, Mobility decreased, Pain Arthralgia, Mobility decreased, Pain; Arthralgia, Mobility decreased, Pain	Complains of 3 weeks of intermittent radiating pain originating in left shoulder with limited mobili... Complains of 3 weeks of intermittent radiating pain originating in left shoulder with limited mobility that started after the COVID vaccine. Reported it lasted 2 days after administration, resolved, and then returned. Complains of episodes of right hand limited mobility over 3 weeks since flu vaccine administration. 3 weeks later he reported "my right hand still hurts at the wrist". Client wanted to see if symptoms improved after completion of course of antibiotics. More
2828174		F	AZ	02/25/2025	PPV PPV PPV PPV	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Extra dose administered, Product administered to patient of inappropriate age; E... Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age More	patient vaccinated with the fourth dose of pneumococcal vaccine on 17-FEB-2006 at the age reported a... patient vaccinated with the fourth dose of pneumococcal vaccine on 17-FEB-2006 at the age reported as 1y0mo; patient vaccinated with the fourth dose of pneumococcal vaccine on 17-FEB-2006 at the age reported as 1y0mo; patient vaccinated with the third dose pneumococcal vaccine on 16-AUG-2005 at the age reported as 6m3do; patient vaccinated with the third dose pneumococcal vaccine on 16-AUG-2005 at the age reported as 6m3do; patient vaccinated with the second dose of pneumococcal vaccine on 14-JUN-2005 at the age reported as 4m1do; patient vaccinated with the second dose of pneumococcal vaccine on 14-JUN-2005 at the age reported as 4m1do; patient vaccinated with the first dose of pneumococcal vaccine on 12-APR-2005 at the age reported as 1m30do; This spontaneous report, which is a split case from a case in litigation for human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (case ID in previous safety database: 2501USA003441; current case ID: 2249222), has been received via medical records from a physician and refers to a 1-month-old female patient. The patient's medical history, current conditions and concomitant therapies have already been reported in the above-mentioned case in litigation. On 12-Apr-2005, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection, provided as "pneumococcal" vaccine (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "1m30do" (Inappropriate age at vaccine administration). On 14-Jun-2005, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "4m1do" (Inappropriate age at vaccine administration, Extra dose administered). On 16-Aug-2005, the patient was vaccinated with the third dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "6m3do" (Inappropriate age at vaccine administration, Extra dose administered). On 17-Feb-2006, the patient was vaccinated with the fourth dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) solution for injection (exact dose, lot #, expiration date, route of administration and anatomical location not reported), for prophylaxis, at the age reported as "1y0mo" (Inappropriate age at vaccine administration, Extra dose administered). This is one of several reports pertaining to the same patient (cross-referenced with case # US-009507513-2501USA003441). All available medical records will be provided upon request. More
2828175			NJ	02/25/2025	RV5	MERCK & CO. INC.		Rotavirus infection Rotavirus infection	3-month-old child was admitted with Rotavirus 2/7/2025. Child was supposed to receive ROTATEQ today,... 3-month-old child was admitted with Rotavirus 2/7/2025. Child was supposed to receive ROTATEQ today, but did not; This spontaneous report was received from a Nurse and refers to a 3-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral solution, reported as "ROTATEQ VIAL 2", administered by oral route for prophylaxis (lot # and expiration date were not reported). On 07-FEB-2025, the patient was admitted due to Rotavirus, diagnosed on 20-FEB-2025. Child was supposed to receive Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) that day, but did not. At the reporting time, the outcome of Rotavirus was not known. The action taken with the suspect vaccine regarding the event was not reported but established as not applicable. The causal relationship between the event of Rotavirus and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided. More	✓
2828176		F	FL	02/25/2025	HPV9	MERCK & CO. INC.		Injection site nodule, Pain in extremity Injection site nodule, Pain in extremity	A patient experienced a nodule at the injection site after receiving their second dose of GARDASIL 9... A patient experienced a nodule at the injection site after receiving their second dose of GARDASIL 9 that lasted approximately a week.; After the nodule went away, the patient has still been experiencing arm pain; This spontaneous report was received from a Physician regarding a 45-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date in November 2024 (reported as at the end of November), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, 0.5 mL, administered Intramuscularly for vaccination (lot number, expiration date and anatomical site of injection were not reported). After receiving the mentioned dose, the patient experienced a nodule at the injection site (Vaccination site nodule) that lasted approximately a week. After the patient recovered from the vaccination site nodule on an unknown date in November 2024 (reported as after the nodule went away), the patient has still been experiencing arm pain (Pain in extremity). The reporter stated that due to the event of Vaccination site nodule, they decided not to administer the third dose of the vaccine. At the time of the report, the patient was recovered from the event of Vaccination site nodule and was not recovered from the event of Pain in extremity. The action taken with the suspect vaccine regarding the events was reported as drug withdrawn. Dechallenge and rechallenge were not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. More
2828177	64	M	KS	02/25/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	24M7E	Inappropriate schedule of product administration Inappropriate schedule of product administration	patient had received two shots of Shingrix, but they were more; This non-serious case was reported b... patient had received two shots of Shingrix, but they were more; 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 male patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 02-APR-2026) for prophylaxis. Previously administered products included Shingrix (1st dose received on 22-NOV-2021). On 03-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 03-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had received two shots of Shingrix, but they were more). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 21-FEB-2025 Reporter did not had access saw this in registry first dose was not administered at their pharmacy. The reporter stated that although the pharmacy has email it was for internal use only. She reported to the GRC on 21 February 2025 that a patient had received a shots of Shingrix, but they were more than 6 months apart. Reporter did not have access to the lot number for dose #1 which was given at a different facility in 2021. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2828178				02/25/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Mal... Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Malaise More	received my first Shingrix shot in July 2024 and I have been sick; have not gotten my second shot, i... received my first Shingrix shot in July 2024 and I have been sick; have not gotten my second shot, is it too late; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: received my first Shingrix shot in July 2024 and I have been sick) and incomplete course of vaccination (Verbatim: have not gotten my second shot, is it too late). The outcome of the sickness was not reported and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 13-FEB-2025 This case was reported by a patient via interactive digital media. The patient received first Shingrix shot and had been sick on and off and have not got the second shot, was it too late to get it now or did have to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2828179				02/25/2025	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; 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. 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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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-FEB-2025 This case was reported by a patient via interactive digital media. The patient had both shingles vaccines and continue to get shingles. The patient also stated that vaccines have not protected them at all and was just getting over the worst outbreak so far. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st and 2nd dose) More
2828180				02/25/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination failure; Everyone I know got shingles from the vaccination; This serious case ... Suspected Vaccination failure; Everyone I know got shingles from the vaccination; 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: Everyone I know got shingles from the vaccination). 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date 14-FEB-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got shingles from the vaccination. Sorry he/she will take chances. Zinc had helped me ward off viruses. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2828181				02/25/2025	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; diagnosed with shingles last week; This serious case was reported by ... Suspected vaccination failure; diagnosed with shingles last week; 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. In FEB-2025, 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: diagnosed with shingles last week). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. The patient just had the vaccine last year in 2024 and was a two part shot and was just diagnosed with shingles last week. The patient didn't knew what to think about any vaccines as they were shooting in everyone's bodies. This case was considered as suspected vaccination failure since the details regarding the time to onset and lanboratory confirmation of 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 Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2828182				02/25/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Hypersensitivity Hypersensitivity	I had a allergic reaction; This non-serious case was reported by a consumer via interactive digital ... I had a allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction (Verbatim: I had a allergic reaction). The outcome of the allergic reaction was resolved. The reporter considered the allergic reaction to be related to Shingrix. The company considered the allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported that he/she had an allergic reaction to what they suspect was the vaccine, and would be available for questions if anyone was interested. The reporter saw that allergic reactions were rare with this vaccine, and thought the reporter would offer if interested. All was well now. More
2828184		F	OR	02/25/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	patient received a dose of Twinrix and then she came back two months later for the second dose; This... patient received a dose of Twinrix and then she came back two months later for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received a dose of Twinrix and then she came back two months later for the second dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-JAN-2025 The reporter called to report that a patient received a dose of Twinrix and then she came back two months later for the second dose. The reporter enquired does the patient needs a booster dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. More
2828185		F	PA	02/25/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Chills, Headache, Hyperhidrosis, Oral mucosal eruption, Pain Chills, Headache, Hyperhidrosis, Oral mucosal eruption, Pain	body ache; Headache; broke out with a rash in the mouth; Chills; Sweating; This non-serious case was... body ache; Headache; broke out with a rash in the mouth; Chills; Sweating; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (Had vaccine 12 years ago). Concurrent medical conditions included diabetes. Additional patient notes included The patient had sensitive system and react bad to all vaccines/medications. She takes medications for diabetes.. On 03-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills), sweating (Verbatim: Sweating), general body pain (Verbatim: body ache), headache (Verbatim: Headache) and rash mouth (Verbatim: broke out with a rash in the mouth). The outcome of the chills and sweating were resolved (duration 1 week) and the outcome of the general body pain and headache were resolved and the outcome of the rash mouth was not resolved. It was unknown if the reporter considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix. It was unknown if the company considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JAN-2025 The patient was diabetic and that takes medications for diabetes. She had the Zostavax vaccine 12 years ago. She reported that she got her 1st dose of Shingrix on 03 August 2024. The patient received the vaccine at a local pharmacy, and it was administered in the left arm. The patient reported that she had headache and body aches. She had sweating and chills that lasted for a week. These events have been resolved. The patient concerned about getting the 2nd dose because had a sensitive system and react bad to all vaccines/medications. The patient inquired Shingrix related to Likens planus. She broke out with a rash in the mouth a few days ago. The patient was not sure what it was and was concerned about getting the 2nd dose of Shingrix because she was told that this condition and Shingrix were related. No additional events were reported. Did not given consent to follow up. More
2828186			SC	02/25/2025	DTAP DTAPHEPBIP FLU3 MNQ RV1 TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	M52GG 2G273 J5T9Z 9M2R7 HP495 3335K	Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More	Vaccines administered after above and below temperature excursion; This non-serious case was reporte... Vaccines administered after above and below temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 3335K, expiry date 28-SEP-2025) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number M52GG, expiry date 07-SEP-2026) for prophylaxis, Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number 9M2R7, expiry date 31-DEC-2025) for prophylaxis. On an unknown date, the patient received Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo. On an unknown date, an unknown time after receiving Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccines administered after above and below temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-FEB-2025 The physician called to report a temperature excursion that happened during 22 hours 50 minutes with a maximum temperature of 10.22 degree Celsius for Bexsero, Boostrix, Engerix-B, FluLaval, Havrix, Infanrix, Kinrix, Menveo (1-vial), Pediarix and Rotarix (liquid). Those vaccines experienced two prior excursions, one of them during 32 hours 6 minutes with maximum temperature of 21.92 degree Celsius, and the other one during 9 hours 45 minutes with a minimum temperature of 1.53 degree Celsius. Physician mentioned that after those temperature excursions, some of the vaccines were administered to patients 1 dose of Menveo (1-vial presentation), 2 doses of FluLaval, 3 doses of Pediarix, 3 doses of Rotarix (liquid presentation), 2 doses of Infanrix, and 1 dose of Boostrix, which led incorrect storage of drug. The reporter did not have any patient demographics, but mentioned that vaccines were administered between February 3rd and 4th 2025. The reporter consented to follow up. More

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