🏥 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 9,801 to 9,850 of 34,052 reports (Page 197 of 682)

« First ‹ Prev 1 ... 194 195 196 197 198 199 200 ... 682 Next › Last »

ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2857890	5	M	NY	09/10/2025	DTAP DTAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	Y7JC3 Y7JC3	Eye irritation, Injection site erythema, Injection site swelling, Lethargy, Phot... Eye irritation, Injection site erythema, Injection site swelling, Lethargy, Photophobia; Pyrexia More	My son became very lethargic shortly after receiving the vaccine. By the next morning, he spiked a h... My son became very lethargic shortly after receiving the vaccine. By the next morning, he spiked a high fever of 104.7, which lasted for three days. During this time, I gave him Motrin and used cold compresses to help bring his temperature down. While the fever persisted, his eyes were burning and very sensitive to light, which was alarming. In addition, there was redness and swelling at the injection site that lasted several days. To manage this, I continued with cold compresses and Motrin, but the reaction was concerning given the severity and duration of his symptoms. More
2857891	69	M	TX	09/10/2025	FLU3	SANOFI PASTEUR	49281-0125-65	Pruritus, Skin burning sensation, Urticaria Pruritus, Skin burning sensation, Urticaria	Hives, severe itching and burning in skin of neck, upper arms and chest and abdomen (both sides). Hives, severe itching and burning in skin of neck, upper arms and chest and abdomen (both sides).
2857892	57	F	NY	09/10/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS		No adverse event, Wrong product administered No adverse event, Wrong product administered	Influenza vaccine was ordered by provider, Tdap was given by nurse. Patient was made aware and calle... Influenza vaccine was ordered by provider, Tdap was given by nurse. Patient was made aware and called back to office. Influenza vaccine was given as ordered. No adverse reaction to date. More
2857893	60	F	CA	09/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	93N4J	No adverse event, Product preparation issue No adverse event, Product preparation issue	Vaccine/component omission - Diluent given without the vaccine: only the adjuvant suspension compone... Vaccine/component omission - Diluent given without the vaccine: only the adjuvant suspension component (vial 1 of 2) was administered to the patient. It was not reconstituted with the Lyophilized gE Antigen component (vial 2 of 2) as indicated. The patient did not receive the entire dosage of the Shingrix as a result. No Adverse reactions were reported by the patient. More
2857894	16	F	FL	09/10/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	NA0589 NA0589	Disorientation, Headache, Immediate post-injection reaction, Loss of consciousne... Disorientation, Headache, Immediate post-injection reaction, Loss of consciousness, Nausea; Pallor, Syncope More	Immediately after injection, patient had syncopal episode in the chair and lost consciousness for ap... Immediately after injection, patient had syncopal episode in the chair and lost consciousness for approximately 5 seconds. Patient was slightly disoriented and pale. Quickly became reoriented once it was explained what happened and felt nauseas with a slight headache. Placed pulsox on the patient which read a pulse of 41 and O2 of 98%. BP was taken with automatic cuff and read 62/28 (patient sitting up and talking at this time). Vital signs repeated every 2-5 minutes for next 20 minutes with oxygen staying stable at 98-99%, HR readings were as follows: 55, 68, 77. Blood pressure readings were as follows: 77/55, 88/62, 106/72. Patient's mentation and constitution returned to normal and was able to walk out of clinic with mother and siblings. More
2857895	67	F	FL	09/10/2025	FLU3	SANOFI PASTEUR	U8764BB	Syringe issue, Underdose Syringe issue, Underdose	Tech was administering the vaccine, while pushing down on the plunger, half of the dose was administ... Tech was administering the vaccine, while pushing down on the plunger, half of the dose was administered and the rest spilled out from the syringe. Patient saw the event occur, was calm, Clinical services and Pharmacy Supervisor was notified to see what were the next steps. According to the CDC, if patient got half of the dose and left the clinic, a full dose must be readministered. More
2857896	11	M		09/10/2025	TDAP	SANOFI PASTEUR	2CA94C1	Expired product administered Expired product administered	Patient was given a Tdap vaccine that expired on 08/31/2025. Patient was given a Tdap vaccine that expired on 08/31/2025.
2857897	52	F	CO	09/10/2025	COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	FG3527 FG3527 FG3527	Abdominal pain, Arthralgia, C-reactive protein, Computerised tomogram abdomen, D... Abdominal pain, Arthralgia, C-reactive protein, Computerised tomogram abdomen, Diarrhoea; Fatigue, Liver function test, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test; Myalgia, Pyrexia, Ultrasound Doppler, Ultrasound abdomen, Urine analysis More	Fatigue; fever, diarrhea, muscle pain, joint pain, abdominal pain Fatigue; fever, diarrhea, muscle pain, joint pain, abdominal pain	✓	✓
2857898	31	M	OH	09/10/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Autoimmune disorder, Bursitis, Condition aggravated, Hepatic cyst, Inflammation;... Autoimmune disorder, Bursitis, Condition aggravated, Hepatic cyst, Inflammation; Pain, Tendonitis, Vitiligo More	Various Autoimmune issues developed. Vitiligo, Liver Cysts, Inflamation throughout body, tendenitis... Various Autoimmune issues developed. Vitiligo, Liver Cysts, Inflamation throughout body, tendenitis, bursitis, Chronic Pain. More		✓
2857899	0.33	M	TX	09/10/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	4L454	Wrong product administered Wrong product administered	PATIENT WAS GIVEN THE WRONG VACCINE PATIENT WAS GIVEN THE WRONG VACCINE
2857900	18	F	MI	09/10/2025	MMRV MNQ TDAP	MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS	Y013571 U8370AA 333SK	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	It was discovered that patient received a vaccine that was not age appropriate. Patient received a d... It was discovered that patient received a vaccine that was not age appropriate. Patient received a dose of proquad which should only be administered to children 12 months through the age of 12. To date, patient has not had any adverse reactions to the vaccine that was administered. More
2857901	1.5	M	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	772YT	Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857902	65	F	CA	09/10/2025	COVID19 COVID19 COVID19 FLU3 FLU3 FLU3	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC.	NA0587 NA0587 NA0587 407241 407241 407241	Asthenia, Chills, Disorientation, Dizziness, Fatigue; Gait disturbance, Gastroin... Asthenia, Chills, Disorientation, Dizziness, Fatigue; Gait disturbance, Gastrointestinal pain, Myalgia, Pain, Sluggishness; Somnolence, Walking aid user; Asthenia, Chills, Disorientation, Dizziness, Fatigue; Gait disturbance, Gastrointestinal pain, Myalgia, Pain, Sluggishness; Somnolence, Walking aid user More	Mid afternoon I began to feel very tired and sluggish. I experienced some light-headedness. I fell a... Mid afternoon I began to feel very tired and sluggish. I experienced some light-headedness. I fell asleep watching tv around 6:30 pm. I became even sleepier through the evening. I had some intestinal cramping and my muscles began feeling achey. In the night I woke shivering. I added a blanket and went back to sleep. In the morning I was in a lot of pain and it hurt to move my hands or shift my body. I had pain in all of my muscles and I was weak. I was unable to walk to the bathroom without a cane. I was light-headed and disoriented. More
2857903	2	M	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	3j9g4	Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857904	60	F	ID	09/10/2025	TDAP	SANOFI PASTEUR	U8564AA	Injection site erythema, Injection site swelling, Injection site warmth, Lymphad... Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy More	pt who reported getting a tDap vaccine on 8/8/25 and now the site is red, warm, and swollen. Pt als... pt who reported getting a tDap vaccine on 8/8/25 and now the site is red, warm, and swollen. Pt also reports lymph node swelling both cervical and supraclavicular on the left. More
2857905	1.08	F	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	4t93r	Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857906	12	M	VA	09/10/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	m2rh3	Extra dose administered Extra dose administered	On 9/9/25, additional dose of Hep B vaccine was administered. This would be the child's 4th dos... On 9/9/25, additional dose of Hep B vaccine was administered. This would be the child's 4th dose of Hep B. Father was called with a interpreter to explain the error. More
2857907	8	M	NV	09/10/2025	DTAP	SANOFI PASTEUR	3CA55C1	Product prescribing error Product prescribing error	Provider ordered Dtap instead of Tdap. Provider ordered Dtap instead of Tdap.
2857908	59	M	CA	09/10/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	n/a n/a	Injection site muscle weakness, Injection site pain, Injection site paraesthesia... Injection site muscle weakness, Injection site pain, Injection site paraesthesia, Injection site rash, Magnetic resonance imaging spinal; Spinal X-ray More	Pain, paresthesia, rash, and weakness in Lt. biceps and deltoid muscles starting just after the inje... Pain, paresthesia, rash, and weakness in Lt. biceps and deltoid muscles starting just after the injections. More		✓
2857909	75	F		09/10/2025	TDAP	SANOFI PASTEUR		Arthralgia Arthralgia	Patinent states started feeling pain in knuckle of right hand on 9/3, with continued, worsening pain... Patinent states started feeling pain in knuckle of right hand on 9/3, with continued, worsening pain at date of report 9/10. Patient reports she is sure this is secondary to vaccine. Declines further evaluation. Insistent that this author make report. More
2857910	48	F	FL	09/10/2025	FLU3	SANOFI PASTEUR	U8823AA	Injection site paraesthesia, Paraesthesia Injection site paraesthesia, Paraesthesia	PATIENT CALLED ABOUT 30 MINUTES AFTER RECEIVING VACCINE SAYING THAT SHE WAS EXPERIENCING TINGLING ON... PATIENT CALLED ABOUT 30 MINUTES AFTER RECEIVING VACCINE SAYING THAT SHE WAS EXPERIENCING TINGLING ON HER LEFT ARM FROM HER SHOULDER DOWN TO THE ELBOW. SHE ALSO WAS EXPERIENCING TINGLING ON HER FACE AROUND HER CHEEK AREA. More
2857911	77	M	FL	09/10/2025	FLU3	SANOFI PASTEUR	UT8781AA	Vaccination site mass Vaccination site mass	Pt got small bump or lump on the vaccination site. Pt got small bump or lump on the vaccination site.
2857912	79	F	OR	09/10/2025	RSV	PFIZER\WYETH	LG9828	Arthralgia, Injection site inflammation, Injection site irritation, Injection si... Arthralgia, Injection site inflammation, Injection site irritation, Injection site scab More	Patient received vaccine. Next day patient left for travel. The site became inflamed and irritated. ... Patient received vaccine. Next day patient left for travel. The site became inflamed and irritated. Patient still has pain in shoulder and site is inflamed and scabbed More
2857913	79	M	DC	09/10/2025	DTAPHEPBIP DTAPHEPBIP IPV IPV PNC20 PNC20	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH		Blister, Condition aggravated, Epistaxis, Haematuria, Haemorrhage intracranial; ... Blister, Condition aggravated, Epistaxis, Haematuria, Haemorrhage intracranial; Injection site haemorrhage, Platelet count decreased, Thrombocytopenia; Blister, Condition aggravated, Epistaxis, Haematuria, Haemorrhage intracranial; Injection site haemorrhage, Platelet count decreased, Thrombocytopenia; Blister, Condition aggravated, Epistaxis, Haematuria, Haemorrhage intracranial; Injection site haemorrhage, Platelet count decreased, Thrombocytopenia More	? 2 Sep 2025 (evening): Petechiae noted around vaccination sites. ? 8 Sep 2025: Severe thrombocytope... ? 2 Sep 2025 (evening): Petechiae noted around vaccination sites. ? 8 Sep 2025: Severe thrombocytopenia (life-threatening) diagnosed; patient developed intracranial hemorrhage (brain bleed). ? Intervening symptoms: Epistaxis (bloody nose), gross hematuria, new blisters on arms and face. More	✓
2857914	76	M	GA	09/10/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	5f5xk	Asthenia, Dizziness, Fall, Malaise Asthenia, Dizziness, Fall, Malaise	patient was sick the next day and was very week. he fell due to dizziness and went to emergency room... patient was sick the next day and was very week. he fell due to dizziness and went to emergency room. after getting I.V. he is feeling better More
2857915	1	M	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	4t93r	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857916	4	M	ID	09/10/2025	DTAPIPV MMRV	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	4L454 Z008220	Injection site pain, Injection site swelling, Local reaction; Injection site pai... Injection site pain, Injection site swelling, Local reaction; Injection site pain, Injection site swelling, Local reaction More	Local reaction to Dtap-polio Kinrix pain and swelling at site Local reaction to Dtap-polio Kinrix pain and swelling at site
2857917	1	F	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	z27pb	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857918	1.42	M	CA	09/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	4t93r	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	On 8/11/25, the nurse manager received an email from the billing department reporting there were som... On 8/11/25, the nurse manager received an email from the billing department reporting there were some Hep A vaccines that seemed had been given in error to the incorrect patient age. The nurse manager reviewed the list of patients and compared this with the documentation in their individual charts. There seemed to not be any discrepancies between provider orders and the immunization documentation via MAR. The nurse manager asked the nurse who administered the vaccines about this at which time they did not disclose that she had made changes to the unit number of the vaccines in Apex. The nurse manager asked the nurse to show her how to pull the vaccine from the pyxis. The nurse then told the manager that they were unaware there were two different bins (one for peds and one for adults) on separate shelves. Upon further review, IT pulled a report from Apex MAR scanning and showed that the nurse had pulled the adult Hep A vaccine (1440 1 mL dose), but had overridden the unit number to reflect the pediatric number (720 0.5 mL dose). The nurse later acknowledged that she had overrose the warning message and gave the entire adult dose (1 mL) to the pediatric patients. Providers have contacted each patient to disclose the error and at this time, there have been no reports of patient adverse effects. The clinic is working with the ambulatory and patient safety team to ensure safety practices are in place to prevent additional errors from occurring. The nurse was released from probation. Clinical leadership is reminding all clinical staff to scan medications before administering them to each patient. Do not override warning messages. If a warning appears, take the time to question it and discuss it with your colleagues and the leadership team before proceeding. More
2857919	1	M	AZ	09/10/2025	HEPA MMR	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	L4EA4 Y013132	Rash; Rash Rash; Rash	5 minutes after administering immunization patient father discover a rash on patient's back. Dr... 5 minutes after administering immunization patient father discover a rash on patient's back. Dr check on patient and spoke with parents. She doesn't think rash was related to vaccines. Injection site was no red, swollen or warm. After making sure patient was okay, she let me know patient was okay to go home. More
2857920	41	F	MI	09/10/2025	FLU3	SEQIRUS, INC.	407004	Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain, Pro... Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain, Product administered at inappropriate site More	Pain that MD states was from injection going into bursa sac in right shoulder. MD prescribed meloxic... Pain that MD states was from injection going into bursa sac in right shoulder. MD prescribed meloxicam 7.5mg twice daily More
2857921	26	M	NE	09/10/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	73BN2	Dizziness, Feeling abnormal, Injection site haemorrhage, Nausea, Retching Dizziness, Feeling abnormal, Injection site haemorrhage, Nausea, Retching	Vaccine given in right deltoid at 1415. When activating the safety of the needle while in the arm it... Vaccine given in right deltoid at 1415. When activating the safety of the needle while in the arm it began bleeding requiring a bandaid change. Patient did not report any other effects at that time. Shortly before 1530 patient reports feeling nauseous and began dry heaving, began feeling lightheaded and fuzzy about 1530 and returned to the employee health clinic. BP checked and allowed patient to lay down to rest. After about an hour and 15 mins patient reported lightheadedness and nausea improved. More
2857922	91		PA	09/10/2025	FLU3	SANOFI PASTEUR	u8800ca	Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error	Pt weight was 115lb and attempted to use 1 inch needle tip. Pt had very little muscle mass upon stic... Pt weight was 115lb and attempted to use 1 inch needle tip. Pt had very little muscle mass upon sticking her so I removed the needle and replaced it with a 5/8 in needle to make pt more comfortable. Pt was double stuck but vaccine only administered once. More
2857930	13	M	GA	09/10/2025	HPV9	MERCK & CO. INC.		Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More	No additional AE; HCP called to report that a patient in their office received only half of the dose... No additional AE; HCP called to report that a patient in their office received only half of the dose of GARDASIL-9 due to mishandling. The caller stated that the patient tensed the arm muscle which caused the nurse to pulled out the needle.; Patient received only half of the dose of Gardasil 9 due to mishandling. Patient tightened arm muscle and which caused the nurse to pulled out the needle, therefore, the vaccine was not completely administered; This spontaneous report was received from a Physician Assistant (reported as certified medical assistant [C.M.A.]) and refers to an unknown patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 25-JUL-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered for prophylaxis in the arm muscle (exact dose, route of administration, lot number and expiration date were not provided). It was reported that the patient only received half the dose due to mishandling, since the patient tensed the arm muscle, which caused the nurse to pull out the needle (Accidental underdose, Wrong technique in product usage process). No additional adverse event was reported for the patient. This report was considered as non-valid due to the lack of patient�s identifiers. Follow up information has been received from the physician assistant (medical assistant) on 05-SEP-2025. It was reported that this report concerns a 13-year-old male patient (therefore, case is no longer considered as non-valid). His medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. The previously reported dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was the first dose of this vaccine ever received by the patient. The causal relationship between the events and the suspect vaccine was reported as related, but upon internal guidelines it was established as not assessed. More
2857931		F	MS	09/10/2025	HPV9	MERCK & CO. INC.		No adverse event, Product dose omission issue No adverse event, Product dose omission issue	No adverse event; HCP called to report that a patient missed/delayed her second dose of GARDASIL 9. ... No adverse event; HCP called to report that a patient missed/delayed her second dose of GARDASIL 9. HCP was made aware of the missed/delayed dose today, 08/26/2025, when the patient arrived at the pharmacy to receive her second dose. The patient was 12 years old when; This spontaneous report was received from a pharmacist and refers to a 23-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unspecified date in 2014, when the patient was 12 years old was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), at a dose of 0.5 mL for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On 26-AGO-2025, the health care progressional was aware of the missed/delayed dose, when the patient arrived at the pharmacy to receive her second dose, the patient was 23-year-old now. No symptoms reported. Lot # is being requested and will be submitted if received. More
2857932			TX	09/10/2025	RV5	MERCK & CO. INC.	Y018378	No adverse event, Product storage error No adverse event, Product storage error	a TE for ROTATEQ; no additional AE; This spontaneous report was received from an other health profes... a TE for ROTATEQ; no additional AE; This spontaneous report was received from an other health professional on 05-Sep-2025, referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinate with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) orally, (lot #Y018378, expiration date: 10-May-2026) (strength, dose, formulation were unknown) as prophylaxis after temperature excursion (TE) due to being improperly stored (Product storage error). No reported adverse effects (no adverse event). More
2857933	1		PA	09/10/2025	FLU3 MMR VARCEL	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	5Ef45 Z003401 Z008197	No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue More	No additional AE reported; HCP calling to state MMR II and VARIVAX were not mixed with the STERILE D... No additional AE reported; HCP calling to state MMR II and VARIVAX were not mixed with the STERILE DILUENT instead they believe it was inadvertently mix with FLU-LAVAL; This spontaneous report was received from a Nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-SEP-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 1 dosage form (lot number Z003401 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date not provided but upon internal validation was established as 23-JAN-2027) and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 1 dosage form (lot number Z008197 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date not reported but upon internal validation was established as, expiration date: 30-Apr-2027); both vaccines were administered as prophylaxis (exact dose, formulation, route of administration, anatomical site of injection and dose number were not provided) after inadvertently being reconstituted with Influenza vaccine inact split 3v (FLULAVAL) (lot number reported as 5Ef45; dose, expiration date, formulation, route of administration, anatomical site and indication and were not reported) instead being mixed with sterile diluent (Hollister-Stier STERILE DILUENT) (lot number and expiration date not provided) (Product preparation error). No additional adverse event was reported for the patient. No other information was provided. More
2857934			TX	09/10/2025	RVX	UNKNOWN MANUFACTURER	2096661	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	No additional AE; 1st dose of ROTATEQ was given to a 7 month old patient.; This spontaneous report w... No additional AE; 1st dose of ROTATEQ was given to a 7 month old patient.; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 09-SEP-2025, the patient was vaccinated with the first dose of rotavirus vaccine (ROTATEQ) 2 ml orally, lot # 2096661 verified as valid, expiration date 07-MAR-2026 for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. More
2857935		F	TX	09/10/2025	PNC21	MERCK & CO. INC.		Fatigue, Headache Fatigue, Headache	fatigue; headache; This spontaneous report was received from a patient refers to herself (64-year-ol... fatigue; headache; This spontaneous report was received from a patient refers to herself (64-year-old female patient). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Sep-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 ml, administered by intravenous route (lot # and expiration date were not reported) as pneumococcal vaccination On 08-Sep-2025, the patient experienced headache and fatigue. Consumer did not report any additional side effects. Consumer stated that the side effects went away the following day. The patient recovered from the events of headache and fatigue on 09-Sep-2025. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the event of headache and fatigue and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received. More
2857936		F		09/10/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Angina pectoris, Arteriosclerosis coronary artery, Blister, Blood test, Computer... Angina pectoris, Arteriosclerosis coronary artery, Blister, Blood test, Computerised tomogram heart abnormal; Ear pain, Neck pain, Pain More	she had blisters and a circle around her left lower leg above the ankle; Pain in ears radiating down... she had blisters and a circle around her left lower leg above the ankle; Pain in ears radiating down neck; Pain in ears radiating down neck; Pain in ears radiating down neck; sudden stabbing pain in her heart; This serious case was reported by a nurse via other manufacturer and described the occurrence of chest pain - cardiac in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Concurrent medical conditions included blood cholesterol increased, allergy to vaccine (She had experienced a reaction to tetanus toxoid and was advised not to receive any vaccines containing it due to her allergy) and food allergy (reaction she gets from food allergies). Concomitant products included rosuvastatin. In DEC-2019, the patient received the 1st dose of Shingrix (intramuscular, right arm) and the 1st dose of COVID-19 vaccine (intramuscular, right arm). In DEC-2019, an unknown time after receiving Shingrix and 20 min after receiving COVID-19 vaccine, the patient experienced chest pain - cardiac (Verbatim: sudden stabbing pain in her heart) (serious criteria GSK medically significant), ear pain (Verbatim: Pain in ears radiating down neck), radiating pain (Verbatim: Pain in ears radiating down neck) and neck pain (Verbatim: Pain in ears radiating down neck). On an unknown date, the patient experienced blister (Verbatim: she had blisters and a circle around her left lower leg above the ankle). The outcome of the chest pain - cardiac, blister, ear pain, radiating pain and neck pain were not reported. It was unknown if the reporter considered the chest pain - cardiac, ear pain, radiating pain and neck pain to be related to Shingrix and COVID-19 vaccine. The reporter considered the blister to be related to Shingrix. The company considered the chest pain - cardiac to be unrelated to Shingrix. The company considered the blister to be related to Shingrix. It was unknown if the company considered the ear pain, radiating pain and neck pain to be related to Shingrix and COVID-19 vaccine. It was unknown if the company considered the chest pain - cardiac to be related to COVID-19 vaccine. Linked case(s) involving the same patient: US2025AMR116309 Additional Information: GSK Receipt Date: 26-AUG-2025 The patient was the reporter. The reporter, a pediatric registered nurse, had given consent to be contacted. The COVID-19 vaccine was confirmed to be another company product, although the specific manufacturer was not identified. The consumer stated that she had spoken with company regarding a reaction she experienced from the Shingrix vaccine. During that conversation, she also mentioned her reaction to the COVID-19 vaccine. The pharmacist at company advised her to contact another company directly, explaining that the companies might not share information. The consumer had previously reported her reaction to VAERS, as her symptoms were not listed among the known side effects in the vaccine documentation. As a nurse, she had access to all relevant paperwork from the hospital where she worked and was among the first to receive the vaccine. She clarified that she had not received any company vaccine on the same day or within four weeks of the Shingrix vaccine. Her hospital had offered the COVID-19 vaccine, but she was initially hesitant due to her known allergy to Tetanus Toxoid. She feared an allergic reaction similar to one she had experienced after a previous vaccine. She explained that she had received the Shingrix vaccine in 2019, with blisters forming in a circular pattern around her ankle after the first dose, and around her right arm after the second dose. She had received two doses of the Shingrix vaccine from company. After the first dose, she developed blisters and a circular rash around her left lower leg above the ankle. After the second dose, she had a similar blister below the injection site on her right arm. She stated that she had received the Shingrix vaccine approximately 1.5 years before the COVID vaccine. As a healthcare worker, she was prioritized for early vaccination and received two doses of the COVID-19 vaccine. She experienced a reaction to the first dose, which was not listed in the side effect documentation. She reported it to VAERS but later learned she should have contacted company directly. She described the reaction as frightening. She did not experience any side effects from the second dose. Regarding her age at the time of the event, she was unsure but believed it was around December 2019 or 2020, when the first COVID vaccines were being administered. She described her ethnicity as mixed, with over ten nationalities in her family. She noted that many of her relatives had dark skin and that she herself had blue eyes, making it difficult to categorize her ethnicity. The vaccination took place in a hospital at around 5 pm. She believed the first dose was administered in December 2019, and the second dose in January 2020. She did not have her vaccination card available due to her house being flooded and was staying in a hotel at the time of the call. She explained that her passport and vaccine documentation were at her flooded home, and she expected to return in several weeks. She had been displaced for nine weeks. At the time of vaccination, she was not taking any medications. She later began taking Rosuvastatin for elevated cholesterol, which had since improved. A CT scan of her heart conducted about 1.5 years ago revealed calcium buildup in two arteries, including the widowmaker. Her daughter and husband had similar findings and were also prescribed statins. She had undergone lab work about a month prior but had not had any tests in the past two weeks. She had completed bloodwork the previous month and saw her physician for physical exams twice a year. She reported that she did not receive any treatment for the reaction to the Shingrix vaccine. The pharmacy did not advise any action, but she later reported the incident to company. She attributed the blisters to the Shingrix vaccine. Regarding the COVID-19 vaccine, she experienced symptoms within 20 minutes of receiving the first dose, including stabbing pain in her heart and ears, radiating down her neck. She did not receive treatment and reported the reaction to VAERS, noting that her symptoms were not listed in their database. She stated that the vaccine was administered in her right arm, as she always preferred that side. Although she was unsure of the exact route of administration due to her fear of needles, she believed it was likely intramuscular (IM), based on how the injection was given. She confirmed that the reaction did not result in hospitalization. She had asked what to do in case of a reaction due to her tetanus allergy, especially since she was working with premature infants at the time. She was advised to call for help if needed. When asked if she wanted to know what to do for future reactions, she agreed. The nurse reported that she had experienced an adverse reaction to the company COVID-19 vaccine in December 2019, during its initial release when it was only available to hospital staff. She recalled receiving the vaccine around 5 pm at the hospital where she worked. Within 20 minutes, while using the stairs, she had to sit down due to a sudden stabbing pain in her heart. She described the sensation as similar to a knife stabbing her heart and ears, with pain radiating down her neck, comparable to reactions she had experienced from food allergies. She likened it to the sting of a jellyfish. She also shared her history with other vaccines. She had experienced a reaction to tetanus toxoid and was advised not to receive any vaccines containing it due to her allergy. She clarified that these reactions were unrelated to the COVID-19 vaccine and were mentioned only for context. The caller expressed that she had been terrified to receive the COVID-19 vaccine and had asked her coworkers why she should get it. They told her it could help prevent hospitalization or the need for a respirator, so she agreed to take it. After experiencing the reaction, she reported it to VAERS, as her symptoms were not listed in the vaccine's documentation. She was later advised to contact another company, which she had not known was necessary until speaking with a pharmacist at company. She stated that she only had a reaction to the first dose of the COVID-19 vaccine. For the second dose, which she received around January, she was given Tylenol and did not experience any side effects. She had asked what she should have done during her initial reaction and was told to call the rapid response team, but she did not do so. Instead, she continued working and cared for the infants in her unit. Her healthcare provider had not mentioned any further vaccinations, but she wanted to ensure her provider could evaluate her before making any decisions. She was informed about company medical information and provided with the contact number. She was informed about the risks associated with Comirnaty, including myocarditis and pericarditis, and was advised to seek medical attention if symptoms such as chest pain, shortness of breath, or a fast-beating heart occurred within two weeks of vaccination. The caller had not known that another company might not receive information from VAERS and appreciated the guidance provided.; Sender's Comments: A case of Angina pectoris, an unknown time after receiving Shingrix, in a female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (high blood cholesterol) and Co-suspect products included COVID-19 vaccine. More
2857937	64	F		09/10/2025	UNK UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Alanine aminotransferase normal, Aspartate aminotransferase normal, Atrial fibri... Alanine aminotransferase normal, Aspartate aminotransferase normal, Atrial fibrillation, Basophil percentage, Blood albumin decreased; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride increased, Blood creatinine increased; Blood glucose normal, Blood magnesium normal, Blood potassium decreased, Blood sodium normal, Blood urea normal; Carbon dioxide decreased, Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea; Echocardiogram normal, Electrocardiogram abnormal, Eosinophil percentage, Haematocrit normal, Haemoglobin normal; Hyperhidrosis, International normalised ratio increased, Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal; Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage increased, Neutrophil percentage; PO2 decreased, Platelet count normal, Protein total normal, Red blood cell count normal, Red cell distribution width normal; Troponin I normal, Ventricular extrasystoles, White blood cell count normal More	Atrial Fibrillation; This 64-year-old female subject was enrolled in a blinded study. The subject re... Atrial Fibrillation; This 64-year-old female subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 13-JUL-2021, for prophylaxis. Co-suspect products included losartan potassium for hypertension. The subject's past medical history included ex-smoker (Previous). Concurrent medical conditions included hypertension and obesity. Concomitant products included amlodipine, losartan and warfarin. On 24-JUL-2021, 11 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with bisacodyl, acetylsalicylic acid (Aspirin), potassium chloride, sodium chloride, diltiazem hydrochloride (Cardizem) and metoprolol. The outcome of atrial fibrillation was resolved on 26-JUL-2021. Relevant Tests: On 24-Jul-2021 Echo was done, no diagnostical findings On 24-Jul-2021 and 25-Jul-2021 Subject received a ecg On 24-Jul-2021 subject received an chest xray On Unk-Jul-2021 ECG showed NSR with PVC On Unk-Jul-2021 XRAY was normal. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 24-JUL-2021 17 intlUnit/l (15.00-37.00). Aspartate aminotransferase- 24-JUL-2021 12 intlUnit/l (15.00-37.00). Basophil percentage- 24-JUL-2021 0.8 percent and 25-JUL-2021 0.6 percent. Blood albumin- 24-JUL-2021 2.9 g/dL, (3.40-5.00). Blood alkaline phosphatase- 24-JUL-2021 62 unit/litre, (46.00-116.00). Blood bilirubin- 24-JUL-2021 0.3 mg/dL, (0.20-1.00). Blood calcium- 24-JUL-2021 8.0 mg/dL, (8.50-10.10) and 25-JUL-2021 8.5 mg/dL, (8.50-10.10). Blood chloride- 24-JUL-2021 108 mmol/L, (98.00-107.00) and 25-JUL-2021 109 mmol/L, (98.00-107.00). Blood creatinine- 24-JUL-2021 1.20 mg/dL, (0.55-1.02) and 25-JUL-2021 0.87 mg/dL, (0.55-1.02). Blood glucose- 24-JUL-2021 142 mg/dL, (65.00-99.00) and 25-JUL-2021 99 mg/dL, (65.00-99.00). Blood magnesium- 24-JUL-2021 2.0 mg/dL, (1.60-2.40). Blood potassium- 24-JUL-2021 3.3 mmol/L, (3.50-5.10) and 25-JUL-2021 4.1 mmol/L, (3.50-5.10). Blood sodium- 24-JUL-2021 141 mmol/L, (136.00-145.00) and 25-JUL-2021 138 mmol/L, (136.00-145.00). Blood urea- 24-JUL-2021 15 mg/dL, (7.00-18.00) and 25-JUL-2021 11 mg/dL, (7.00-18.00). Carbon dioxide- 24-JUL-2021 21.9 mmol/L, (21-32) and 25-JUL-2021 21.3 mmol/L, (21-32). Eosinophil percentage- 24-JUL-2021 2.5 percent and 25-JUL-2021 2.6 percent. Haematocrit- 24-JUL-2021 42.7 percent, (31.70-42.50) and 25-JUL-2021 39.4 percent, (31.70-42.50). Haemoglobin- 24-JUL-2021 14.0 g/dL, (11.10-14.40) and 25-JUL-2021 12.6 g/dL, (11.10-14.40). International normalised ratio- 24-JUL-2021 1.25 (0.90-1.10): 25-JUL-2021 1.39 (0.90-1.10) and 26-JUL-2021 1.62 (0.90-1.10). Lipase- 24-JUL-2021 104 intlunit/l (73.00-393.00). Lymphocyte percentage- 24-JUL-2021 40.0 percent and 25-JUL-2021 40.2 percent. Mean cell haemoglobin- 24-JUL-2021 30.0 pg, (26.90-33.20) and 25-JUL-2021 29.9 pg, (26.90-33.20). Mean cell haemoglobin concentration- 24-JUL-2021 32.8 g/dL, (31.80-36.00) and 25-JUL-2021 32.0 g/dL, (31.80-36.00). Mean cell volume- 24-JUL-2021 91.4 fL, (79.50-98.90) and 25-JUL-2021 93.6 fL, (79.50-98.90). Mean platelet volume- 24-JUL-2021 9.2 fL, (7.40-12.30) and 25-JUL-2021 9.4 fL, (7.40-12.30). Monocyte percentage- 24-JUL-2021 9.2 percent and 25-JUL-2021 10.5 percent. Neutrophil percentage- 24-JUL-2021 47.2 percent and 25-JUL-2021 45.9 percent. PO2- 24-JUL-2021 Less than 40 mmHg, (38.00-42.00). Platelet count- 24-JUL-2021 300 x10e3/mcL, (159.00-386.00) and 25-JUL-2021 246 x10e3/mcL, (159.00-386.00). Protein total- 24-JUL-2021 6.4 g/dL, (6.40-8.20). Prothrombin time- 24-JUL-2021 13.5 seconds, (9.40-11.50): 25-JUL-2021 13.8 seconds, (9.40-11.50) and 26-JUL-2021 17.3 seconds, (9.40-11.50). Red blood cell count- 24-JUL-2021 4.67 X10e6/uL, (3.64-5.00) and 25-JUL-2021 4.21 X10e6/uL, (3.64-5.00). Red cell distribution width- 24-JUL-2021 13.1 percent, (12.10-17.20) and 25-JUL-2021 13.2 percent, (12.10-17.20). Troponin I- 24-JUL-2021 22.8 pg/mL, (0-51.40): 24-JUL-2021 13.0 pg/mL, (0-51.40) and 25-JUL-2021 19.1 pg/mL, (0-51.40). White blood cell count- 24-JUL-2021 7.3 x10e3/mcL, (3.60-11.30) and 25-JUL-2021 6.2 x10e3/mcL, (3.60-11.30). The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Other possible cause(s) of the atrial fibrillation included concurrent medication. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Subject contacted site to notify of hospitalization that occurred 7/24-26/2021. Subject states around noon on 7/24/2021 she felt suddenly dizzy an sweaty. Subject contacted 911 and was transported via ambulance to Emergency room. Subject states the doctor believes she was on too much Losartan which caused the Atrial Fibrillation. Subject notified site of medication changes and discharged home in stable condition on 7/26/2021. Site has mailed ROR to subject and will update report upon receipt of new information. Subject went to the hospital on 7/24/21 due to feeling dizzy, chest tightness and shortness of air. EMS noted subject to be in A-Fib with RVR rate in the 170's. Subject was given Cardizem and normal sinus was noted. Subject also started metoprolol which caused subject to be bradycardic. The medication was stopped due to the bradycardia and the dizziness. Subject received PT and OT as well as medication changes before being discharged to home on 7/26/21 once the SOA, chest tightness and dizziness had resolved. The subject is not a part of reactogenicity and immunoigenicity subset. The event was unanticipated and unexpected. This event was not related or possibly related to reasearch. This event does not suggest that research places subject or others at new or increased risk of harm. Follow-up information received on 23-Nov-2022 Investigator comment: On 24th July 2021, more than 2 years after 1st dose of Losartan potassium (non GSK product, taken for hypertension), the subject experienced Atrial fibrillation. Summary of changes: The medication details were updated. Follow-up information received on 14-Dec-2022. Summary of changes: Only lab data X-ray and ECG updated. Follow-up information received on 22-DEC-2022. Summary of changes: co-suspect medication (Amlodipine) has been updated to concomitant medication. Follow-up information received on 03-NOV-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Event term Mitral valve calcification, Tricuspid regurgitation, Aortic valve regurgitation, Hiatal hernia, Cen tribular Emphysema, Chest pain NOS, Bradycardia, Hypotension deleted, AESI sentence updated. Follow up information receive don 08-Nov-2023. Summary of changes: Medical history added. Narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation, 11 days after receiving 1st dose of RSVPreF3 vaccine, in a 64-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factors (h/o hypertension, obesity, ex-smoker) based on medical history. More	✓
2857938	64	M		09/10/2025	UNK	UNKNOWN MANUFACTURER		Atrial fibrillation, Chest pain, Echocardiogram abnormal, Electrocardiogram abno... Atrial fibrillation, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Hyperhidrosis More	New onset of atrial fibrillation; This 64-year-old male subject was enrolled in a blinded study. The... New onset of atrial fibrillation; This 64-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 21-JUL-2021, for prophylaxis. Concurrent medical conditions included hyperlipidemia, diabetes mellitus, coronary artery disease and hypertension. Concomitant products included amlodipine besilate (Norvasc), atorvastatin calcium (Lipitor) and aspirin. On 13-AUG-2021, 23 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: New onset of atrial fibrillation). Serious criteria included hospitalization. The subject was treated with heparin, diltiazem (Cardizem), metoprolol succinate, apixaban (Eliquis) and amiodarone hydrochloride (Pacerone). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was resolved on 15-AUG-2021. Relevant Tests: On 13-Aug-20221 ECG showed atrial fibrillation 13AUG2021 echocardiogram showed significant finding.. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2021175285, US2021175286 Subject presented to site for Visit 2. Reported that he was in the hospital due to waking up with chest pain and very sweaty. Went to ER on Friday 13 Aug 2021 via ambulance and after several tests and blood work Atrial Fibrillation was diagnosed. Admitted until 15AUG 2021, upon discharge stated felt much better an went home with increased Metoprolol, new RX Amiodarone, new RX of Eliquis. Medications prior to hospitalization aspirin, amlodipine, diuretics, atorvastatin Hospital records obtained and reviewed with subject. PI performed a physical exam and deemed no relationship to the vaccine. Follow-up information received on 03-MAY-2023. Summary of changes: action taken updated. Follow-up information received on 10-MAY-2023. Summary of changes: Narrative updated. Follow-up information received on 19-Sep-2023. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: Lab data, AESI sentence and treatment medication added. Follow up information received on 07-Nov-2023. Summary of changes: Concomitant products added. Narrative updated. Follow up information received on 28-MAY-2024 Summary of changes: Treatment medication metoprolol succinate ER (Toprol-xl), amiodarone (pacerone) Continuing at the end of the study updated as Yes, Treatment medication apixaban (eliquis) End date updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation, 23 days after receiving 1st dose of RSVPreF3 vaccine, in a 64-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (hyperlipidemia, diabetes mellitus, coronary artery disease and hypertension) as risk factors based on medical history. US-GLAXOSMITHKLINE-US2021175285: US-GLAXOSMITHKLINE-US2021175286: More	✓
2857939	71	F		09/10/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Atrial fibrillation, Cardiac monitoring abnormal, Cardiac pacemaker insertion, C... Atrial fibrillation, Cardiac monitoring abnormal, Cardiac pacemaker insertion, Cardiac stress test normal, Chest pain; Echocardiogram abnormal, Ejection fraction normal, Sinus arrest, Venogram normal More	Sinus Pause; atrial fibrillation; This 71-year-old female subject was enrolled in an open label stud... Sinus Pause; atrial fibrillation; This 71-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 22-MAR-2021, for prophylaxis. Concurrent medical conditions included hypothyroidism, hypertension, left bundle branch block, obesity and knee osteoarthritis (bilateral knees). On 01-JUN-2021, 71 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 sinus pause (Verbatim: Sinus Pause). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation) on 01-JUN-2021 with serious criteria of hospitalization. The subject was treated with warfarin. The action taken with RSVPreF3 vaccine + AS01E was no change. The outcome of sinus pause was resolved on 07-JUL-2021 10:47. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 07-JUL-2021 10:47). Relevant Tests: On 06JUL2021 Left subclavian venogram showed revealing patency and course of venous structure.. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In JUL-2021 124 bpm. The investigator considered that there was no reasonable possibility that the sinus pause and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the sinus pause and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 30-SEP-2021 Subject was a 71-year-old female with history of left bundle branch block, obesity, hypothyroidism, hypertension, and osteoarthritis. Subject was seen in cardiology outpatient in May for atypical chest pain, and stress test and echocardiogram performed. Echo showed normal EF with normal wall motion but did have septal motion abnormal due to LBBB. Stress test was felt to be low risk. She wore a MCT monitor which showed the subject had atrial fibrillation with a 4 second pause. She was started on warfarin and referred to electrophysiology. Subject proceeded to elective permanent pacemaker implantation and received a dual chamber Medtronic device on 06JUL2021. Subject was admitted for procedure on 06JUL2021 and discharged in stable condition on 07JUL2021. subject enrolled into study on 22MAR2021 and received vaccine on 22MAR2021. This meets an AESI criteria per new protocol. Follow-up information received on 19-JUL-2022. This follow up was considered non-significant. Summary of Changes: Treatment product stop date updated Follow-up information received on 10-JUL-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Summary of changes: General narrative comments were updated.; Sender's Comments: A case of Atrial fibrillation and sinus arrest, 71 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 71-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (hypertension, left bundle branch block and obesity) based on medical history. More	✓
2857940	62	M		09/10/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Atrial fibrillation, Condition aggravated, Dermatitis contact, Electrocardiogram... Atrial fibrillation, Condition aggravated, Dermatitis contact, Electrocardiogram ambulatory abnormal, Hepatic steatosis; Hypertransaminasaemia, Leukocytosis More	Worsening of A-Fib; This 62-year-old male subject was enrolled in a blinded study. The subject recei... Worsening of A-Fib; This 62-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 09-SEP-2021, for prophylaxis. Concurrent medical conditions included hypertension and atrial fibrillation. On 09-SEP-2021, less than a day after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation aggravated (Verbatim: Worsening of A-Fib). Serious criteria included hospitalization. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation aggravated was resolved on 11-SEP-2021. The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date : 08-OCT-2021 Subject reported at Visit 2 that they were hospitalized for an A-Fib episode and monitored for 2 days. They stated that no meds were given. States the E is now resolved as of 11SEP2021. AE was reported to site staff on 07OCT2021. Medical records were requested. Patient also experienced the following AEs. Leukocytosis, contact dermatitis , Transaminitis ,Fatty liver. Patient has a history of atrial fibrillation, hypertension. Patient has a Holter monitor and was called to ED after an arrhythmia was noted and found to be in Afib. Admit Date: 10SEP2021 Discharge Date: 11SEP2021 This case contains an event assessed by the investigator as a adverse event of special interest (AESI) Follow up information received on 27-APR-2023. Summary of changes: Action taken and narrative updated. Follow up information received on 08-Jun-2023. Summary of changes: Medical history (atrial fibrillation and hypertension) added. Follow up information received on 15-Jun-2023. Summary of changes: Hospitalization details updated Follow up information received on 19-JUN-2023. Summary of changes: Event term changed from A-Fib Epipode to worsening of A-Fib. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation aggravated less than a day after receiving 1st dose of RSVPreF3 vs Placebo in a 62-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (atrial fibrillation and hypertension as risk factors) based on medical history. More	✓
2857941	63	M		09/10/2025	UNK UNK UNK UNK UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK UNK UNK UNK UNK UNK UNK	Alanine aminotransferase increased, Aspartate aminotransferase increased, Atrial... Alanine aminotransferase increased, Aspartate aminotransferase increased, Atrial fibrillation, Basophil percentage increased, Blindness unilateral; Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium normal, Blood chloride normal; Blood creatine increased, Blood creatinine increased, Blood potassium normal, Blood sodium normal, Blood urea increased; Carbon dioxide decreased, Eosinophil percentage decreased, Fall, Granulocyte count, Haematocrit normal; Haemoglobin normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal; Mean platelet volume normal, Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Platelet count increased; Protein total, Red blood cell count normal, Red cell distribution width normal, Troponin I increased, White blood cell count increased; pH urine decreased More	Atrial Fibrillation; This 63-year-old male subject was enrolled in an open label study. The subject ... Atrial Fibrillation; This 63-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) on 15-APR-2021, for prophylaxis. Concurrent medical conditions included hypertension. On 15-OCT-2021, 183 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with diltiazem, salicylic acid and metoprolol. The outcome of atrial fibrillation was resolved on 17-OCT-2021. Diagnostic results (reference ranges are provided in parenthesis if available): Alanine aminotransferase- 15-OCT-2021 98 u/L, (0.00-55.00). Aspartate aminotransferase- 15-OCT-2021 55 u/L, (5.00-34.00). Basophil percentage- 15-OCT-2021 5 percent, (0.20-1.20). Blood albumin- 15-OCT-2021 4.5 g/dL, (3.20-4.60). Blood alkaline phosphatase- 15-OCT-2021 140 u/L, (40.00-150.00). Blood bilirubin- 15-OCT-2021 1.2 mg/dL, (0.20-1.20). Blood calcium- 15-OCT-2021 10.1 mg/dL, (7.70-10.10). Blood chloride- 15-OCT-2021 106 mmol/L, (98.00-107.00). Blood creatine- 15-OCT-2021 266.4 mg/dL, (0.00-108.00). Blood creatinine- 15-OCT-2021 1.6 mg/dL, (0.70-1.30). Blood potassium- 15-OCT-2021 4.9 mmol/L, (3.50-5.10). Blood sodium- 15-OCT-2021 142 mmol/L, (131.00-143.00). Blood urea- 15-OCT-2021 24 mmol/L, (7.00-21.00). Carbon dioxide- 15-OCT-2021 22 mmol/L, (17.00-31.00). Eosinophil percentage- 15-OCT-2021 0.1 percent, (0.80-7.00). Granulocyte percentage- 15-OCT-2021 0.4 percent, (0.00-0.40). Haematocrit- 15-OCT-2021 46.8 percent, (40.10-51.00). Haemoglobin- 15-OCT-2021 15.8 g/dL, (11.20-15.70). Lymphocyte percentage- 15-OCT-2021 21.8 percent, (21.80-53.10). Mean cell haemoglobin- 15-OCT-2021 29.4 pg, (25.70-32.20). Mean cell haemoglobin concentration- 15-OCT-2021 33.8 g/dL, (32.30-36.50). Mean cell volume- 15-OCT-2021 87.0 fL, (79.00-92.20). Mean platelet volume- 15-OCT-2021 9.3 fL, (9.00-12.00). Monocyte percentage- 15-OCT-2021 6.5 percent, (5.30-12.20). Neutrophil count- 15-OCT-2021 10.4 x10e3/mm3, (1.78-5.38). Neutrophil percentage- 15-OCT-2021 70.7 percent, (34.00-67.90). Platelet count- 15-OCT-2021 378 x10e3/mm3, (157.00-380.00). Protein total- 15-OCT-2021 39 mg/dL, (0.00-174.00). Red blood cell count- 15-OCT-2021 5.38 x10E6/mm3, (4.63-6.08). Red cell distribution width- 15-OCT-2021 13.2 percent, (11.60-14.40). Troponin I- 15-OCT-2021 .05 ng/mL, (0.00-0.03). White blood cell count- 15-OCT-2021 14.7 x10e3/mm3, (4.20-9.10). pH urine- 15-OCT-2021 6.0 (4.50-8.00). The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2022GSK148515 GSK Receipt Date: 19-OCT-2021 Subject called office and told coordinator at work he lost vision in his eye and fell. Subject drove to hospital where they admitted him from 15OCT2021 to 17OCT2021. Upon arrival, he was in Atrial Fibrillation. Subject was admitted to IMCU (Intermediate Care unit) in which Cardizem was given intravenously but a dose was not given in the medical record. Subject would follow up with his Dr. Subject had a history of smoking cigarettes from 19991-1996. No other information received for this event. This was an AESI. Follow-up information received on 18-APR-2022. This follow-up was considered non-significant. Summary of Changes: No new information. Follow-up information received on 10-JUL-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Summary of changes: General narrative comments were updated. Follow-up information received on 18-JUL-2024 Summary of changes: General narrative comments were updated. Follow-up information received on 15-AUG-2024 Summary of changes Lab test added.; Sender's Comments: A case of Atrial fibrillation, 183 days after receiving 1st dose ofRSVPreF3 vaccine + AS01E, in a 63-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (known case of hypertension). US-GSK-US2022GSK148515: More	✓
2857942	61	M		09/10/2025	UNK	UNKNOWN MANUFACTURER		Cardiomegaly, Chest X-ray abnormal, Electrocardiogram ST segment abnormal, Palpi... Cardiomegaly, Chest X-ray abnormal, Electrocardiogram ST segment abnormal, Palpitations, Supraventricular tachycardia More	Supraventricular Tachycardia; This 61-year-old male subject was enrolled in a blinded study. The sub... Supraventricular Tachycardia; This 61-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular) on 7th July 2021, for prophylaxis. Concurrent medical conditions included sleep apnea, atrial fibrillation and congestive heart failure. On 12th November 2021, 128 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 supraventricular tachycardia. Serious criteria included hospitalization. The subject was treated with metoprolol, adenosine and sotalol. The outcome of supraventricular tachycardia was recovered/resolved on 18th November 2021. The investigator considered that there was no reasonable possibility that the supraventricular tachycardia may have been caused by RSVPreF3 vs Placebo. Relevant Tests: In Nov-2021, EKG showed ST abnormality, possible inferolateral subendocardial injury, HR 193, Rhythm SVT, Diagnostic results (unless otherwise stated, normal values were not provided): In November 2021, Chest X-ray result was enlarged cardiac silhouette, Electrocardiogram result was see text and Heart rate result was 193. Linked case(s) involving the same subject: US2021199058 INVESTIGATOR TEXT pt went to er on 11/12/2021 with reports of palpitations and heart racing. he was found to be in tachycardia. pt was admitted to the hospital for treatment. Labs and ekg were performed. pt. has a documented medical history of: congestive heart failure, a-fib, allergies, sleep apnea, former smoker, and pt is obese. pt was discharged on 11/18/2021 Follow-up information received on 14-Oct-2022 Summary of changes: Demographic details (height and weight) and Treatment details updated (Treatment sotalol marked as ongoing) Follow up information received on 04-Jul-2024 End of study Unblinding completed. Upon internal review the case was updated on 20-Aug-2024. Correct suspect product added summary of change: Product tab updated.; Sender's Comments: A case of Supraventricular tachycardia, 128 days after receiving 1st dose of RSVPreF3 vs Placebo , in a 61-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor (h/o atrial fibrillation and congestive heart failure). US-GLAXOSMITHKLINE-US2021199058: More	✓
2857943	74	M		09/10/2025	UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Atrial fibrillation, Blood sodium decreased, Condition aggravated, Haematocrit n... Atrial fibrillation, Blood sodium decreased, Condition aggravated, Haematocrit normal, Haemoglobin normal; Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin normal, Mean cell volume normal, Neutrophil percentage increased; Red blood cell count normal, White blood cell count normal More	SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE; This 74-year-old male subject was enrol... SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE; This 74-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 19-JUL-2021, for prophylaxis. The subject's past medical history included ex-smoker (Previous smoker status). Concurrent medical conditions included thrombosis, congestive heart failure, hypertension and atrial fibrillation. Concomitant products included apixaban (Eliquis), diltiazem and furosemide (Lasix). On 29-DEC-2021, 163 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation with rapid ventricular response (Verbatim: SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE). Serious criteria included hospitalization. The outcome of atrial fibrillation with rapid ventricular response was resolved on 31-DEC-2021. Diagnostic results (reference ranges are provided in parenthesis if available): Blood sodium- 29-DEC-2021 135 mmol/L, (136.00-146.00). Haematocrit- 29-DEC-2021 45.2 percent, (40.50-52.50). Haemoglobin- 29-DEC-2021 15.1 g/dL, (13.50-17.50). Lymphocyte count- 29-DEC-2021 14.7 percent, (25.00-40.00). Lymphocyte percentage- 29-DEC-2021 14.7 percent, (25.00-40.00). Mean cell haemoglobin- 29-DEC-2021 29.8 pg, (28.00-33.00). Mean cell volume- 29-DEC-2021 89 fL, (83.00-97.00). Neutrophil percentage- 29-DEC-2021 74.6 percent, (50.00-70.00). Red blood cell count- 29-DEC-2021 5.06 million per microlitre, (4.05-5.64). White blood cell count- 29-DEC-2021 7.7 million per microlitre, (5.10-10.80). The investigator considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022040213 GSK receipt date: 05-JAN-2022 The subject informed the agency today during the phone contact that on 28Dec2021 the subject started feeling sick and per PCP recommendation the subject went to the ER. Medical Records were requested today. Any new information regarding the SAE will be provided once available. After review of the medical records received, the subject was admitted to the hospital on 29-DEC-2021 for symptomatic atrial fibrillation and discharged on 31-DEC-2021. Follow-up information received on 28-SEP-2022. This follow-up was considered significant. Summary of Changes: SAE outcome updated Follow-up information received on 07-OCT-2022. This follow-up was considered significant. Summary of Changes: Event outcome updated. Follow-up information received on 12-OCT-2022 Summary of changes: Investigator Text updated, Event term Symptomatic atrial fibrillation with rapid ventricular rate updated, Event outcome date updated, Lab data updated. Follow-up information received on 10-NOV-2023. Summary of changes: Relevant medical condition added. Upon internal review the case was amended on 29-NOV-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI sentence updated Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation, 163 days after receiving 1st dose of RSVPreF3 vaccine, in a 74-year old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, presence of risk factor that may contribute to the exacerbation of the pre-existing medical condition (heart failure), and alternative etiology (known atrial fibrillation) based on medical history. US-GLAXOSMITHKLINE-US2022040213: More	✓
2857944	73	M		09/10/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Aortic valve incompetence, Atrial fibrillation, Cardiac stress test, Colonoscopy... Aortic valve incompetence, Atrial fibrillation, Cardiac stress test, Colonoscopy abnormal, Dizziness; Hypotension, Left atrial dilatation, Polypectomy, Tricuspid valve incompetence More	Atrial Fibrillation; This 73-year-old male subject was enrolled in a blinded study. The subject rece... Atrial Fibrillation; This 73-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 04-NOV-2021, for prophylaxis. The subject's past medical history included coronary stent placement. Concurrent medical conditions included coronary artery disease and hypertension. Concomitant products included irbesartan and amlodipine. On 13-JAN-2022 06:31, 70 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with calcium chloride;potassium chloride;sodium lactate (Lactated Ringers), diphenhydramine and diltiazem. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was resolved on 22-APR-2022 11:21. Relevant Tests: On 13-JAN-2021 Ekg (electrocardiogram) confirmed Atrial Fibrillation in the ER (Emergency Room). On UNK-JAN-2022 Echocardiogram shows the following abnormal findings, left atrium mildly dilated, mild to moderate aortic valve regurgitation, mild tricupsid valve regurgitation. Diagnostic results (reference ranges are provided in parenthesis if available): Blood pressure measurement-In JAN-2022 148/83. Body temperature-In JAN-2022 97.5. Cardiac stress test-In AUG-2022 Not provided. Heart rate-In JAN-2022 116. Respiratory rate-In JAN-2022 15. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022135753 GSK Receipt Date: 14-JAN-2022. 13Jan2022, subject underwent a colonoscopy/polypectomy. During procedure it was noted that the subject had become hypotensive. Subject was admitted to the hospital for hypotension and was found to be in Atrial Fibrillation. Subject had complained of feeling light headed the night prior but thought it was from the colonoscopy prep. Subject had not been started on anticoagulation currently, due to his history of severe epistaxis. Subject currently still admitted to the hospital awaiting plan of care. Subject had a history of coronary artery disease but not atrial fibrillation. Subject was discharged from the hospital on 15Jan2022. This event was documented and assessed by PI as a AESI. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 28-SEP-2022. This follow-up was considered significant. Summary of changes: SAE outcome updated. SAE end date added. Follow-up information received on 03-Oct-2022. This follow-up was considered significant. Summary of changes: Other relevant history updated. Follow-up information received on 27-APR-2023 Summary of changes: Action taken updated. Follow-up information received on 24-OCT-2023 Summary of changes: Relevant medical condition updated. Follow-up information received on 30-OCT-2023 Summary of changes: Concurrent and past medical condition start date, lab result, past medical condition (coronary stents) were updated. Follow-up information received on 2-Nov-2023 Summary of changes: Start date of historical condition updated as hypertension Follow-up information received on 13-NOV-2023 Summary of changes: Concomitant products Irbesartan, Amlodipine were updated. Follow-up information received on 27-NOV-2023. The medication name reported as "IV diltiazem". Summary of changes: Narrative was updated. Follow-up information received on 21-MAY-2024, 28-MAY-2024. Summary of changes: Start date and ongoing check updated for concomitant product IRBESARTAN. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 70 days after receiving the 1st dose of RSVPreF3, in a 73-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (concurrent hypertension and coronary artery disease). US-GSK-US2022135753: More	✓
2857945	80	M		09/10/2025	UNK UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Abdominal pain, Acute respiratory failure, Ageusia, Anosmia, Atrial fibrillation... Abdominal pain, Acute respiratory failure, Ageusia, Anosmia, Atrial fibrillation; COVID-19, Chest X-ray abnormal, Cough, Decreased appetite, Diarrhoea; Dyspnoea, Echocardiogram abnormal, Fatigue, Nausea, Oropharyngeal pain; Pyrexia, SARS-CoV-2 test positive, Vomiting More	Atrial Fibrillation; COVID 19; This 80-year-old male subject was enrolled in a blinded study. The su... Atrial Fibrillation; COVID 19; This 80-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 11-OCT-2021, for prophylaxis. The subject's past medical history included sleep apnea. Concurrent medical conditions included dyslipidemia, type ii diabetes mellitus and blood pressure high. Concomitant products included clopidogrel, rosuvastatin, acetylsalicylic acid (Bayer Aspirin), metoprolol, metformin, dextromethorphan hydrobromide;guaifenesin;paracetamol;pseudoephedrine hydrochloride (Dayquil) and losartan. On 19-OCT-2021, 8 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 covid-19 (Verbatim: COVID 19). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation) on 23-OCT-2021 with serious criteria of hospitalization. The action taken with RSVPreF3 vs Placebo was no change. The outcome of covid-19 was resolved with sequelae on 05-DEC-2021. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 05-DEC-2021). Relevant Tests: On 23-OCT-2021 X-ray chest showed Covid-19 infection and Acute respiratory failure. On 23-OCT-2021 Echo showed Atrial fibrillation new onset On an unknown date in Oct-2021, Covid-19 test showed Positive. The investigator considered that there was no reasonable possibility that the covid-19 and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the covid-19 and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK receipt date:17-FEB-2022 Medical records Admitted on 23OCT2021 Discharged on 25OCT2021 Agency was no longer on site and subject was not seen in the clinic for this ARI Addition information: subject had underlying condition of hypertension (high blood pressure), sleep apnea and type 2 diabetes which are potential risk factors for atrial fibrillation. Medications for these are added to medication line. Per query, dyslipidemia also considered a risk factor Cough and fatigue were lingering sequelae symptoms of covid-19 that were reported as complications. They are updated in database. The case was diagnosed positive for COVID-19. The subject had unknown history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset. The subject visit any health care facility in the 14 days prior to symptom onset was unknown. The concomitant medications was taken by the subject, including experimental medications, to treat COVID-19. The subject had a Cough, Shortness of breath, Sore throat, Loss of appetite, Fatigue The subject had fever, Nausea, Vomiting, Diarrhea, Abdominal pain, Loss of smell, Loss of taste was unknown. The subject was not asymptomatic. The subject was not contact with a confirmed or probable case in the 14 days prior to symptom onset was unknown. The subject was in home quarantine or isolation was unknown. Follow-up information received on 11-APR-2022. This follow-up was considered significant Summary of Changes: Lab data updated, Investigator text updated Follow-up information received on 11-APR-2022 This follow-up was considered non significant Summary of Changes: No new significant information was received. Follow-up information received on 23-DEC-2022. Summary of changes: The additional event were added. Follow-up information was received on 18-Jan-2023 Summary of changes: Action taken of study vaccine updated, event start date of atrial fibrillation updated, Narrative updated. Follow-up information was received on 20-Jan-2023 Summary of changes: Onset date of Atrial Fibrillation updated, narrative updated. Follow-up information was received on 28-APR-2023 Summary of changes: Outcome with end date of event term Atrial Fibrillation and action taken was updated. Follow-up information was received on 03-NOV-2023, 08-NOV-2023 and 10-NOV-2023 On 10-NOV-2023 the case US2022GSK030666 was identified as duplicate case of US2022033440. All the future correspondence will be added to US2022033440. Summary of changes: Concomitant drugs Metoprolol ER, Metformin, Dayquil/Nyquil, Losartan, relevant test updated, merging performed and general narrative comments were updated. Follow-up information was received on14-NOV-2023 and 17-NOV-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The Concomitant medication reported as Dayquil/Nyquil and Metoprolol ER Summary of changes : The outcome Recovered/Resolved with sequelae changed to Recovered/Resolved for COVID 19 and Concurrent medical conditions dyslipidemia and Concomitant medication bayer aspirin added, general narrative comments were updated. Follow-up information was received on 27-NOV-2023 The medication name reported as Metoprolol ER, Dayquil/nyquil Summary of changes: concurrent and medical condition was updated. Follow-up information was received on 13-Dec-2023 Summary of changes: Outcome of COVID-19 updated from Recovered/Resolved to Resolved with Sequelae and narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of COVID-19 and atrial fibrillation, 8 days after receiving the 1st dose of RSVPreF3 , in a 80-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factor (h/o hypertension, dyslipidemia, sleep apnea and type 2 diabetes) based on medical history. More	✓
2857946	76	M		09/10/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Arteriogram carotid, Atrial fibrillation, Computerised tomogram head normal, Com... Arteriogram carotid, Atrial fibrillation, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Magnetic resonance imaging head normal; Pneumonia aspiration, Pulmonary embolism, Scan with contrast normal, Swallow study More	Paroxysmal Atrial Fibrillation; Aspiration Pneumonia; This 76-year-old male subject was enrolled in ... Paroxysmal Atrial Fibrillation; Aspiration Pneumonia; This 76-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 28-SEP-2021, for prophylaxis. The subject's past medical history included tobacco abuse. On 28-NOV-2021, 61 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 paroxysmal atrial fibrillation (Verbatim: Paroxysmal Atrial Fibrillation). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 aspiration pneumonia (Verbatim: Aspiration Pneumonia) on 28-NOV-2021 with serious criteria of hospitalization. The subject was treated with metoprolol succinate and apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of paroxysmal atrial fibrillation was resolved with sequelae on 01-DEC-2021. The outcome(s) of the additional event(s) included aspiration pneumonia (resolved on 01-DEC-2021). Relevant Tests: On 29-Nov-2021 CT chest w/o contrast RLL/RUL PNA On 29-Nov-2021 CT Brain Neg result On 28-Nov-2021 CT neck w/ contrast On 28-Nov-2021 CT Brain w/ contrast Quest perfusion (L) Cerebellum On 29 and 30-Nov-2023 MRI Brain w/w/o contrast showed Negative result G.I swallow x-ray negative result.. The investigator considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and aspiration pneumonia may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and aspiration pneumonia may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022033223, US2023004717 Additional Information: GSK Receipt Date: 12-APR-2022, 21-APR-2022. This follow-up was considered significant. Site was conducting safety call and asked subject start date of medication Eliquis ( blood clot preventative) and reply was DEC2021and subject reported SAE of Aspiration Pneumonia associated with blood clots that occurred around 10DEc2021. Subject was unsure of how many days he stayed admitted. Site requested for medical records and will update SAE upon receipt of records. Thank you. Med records reviewed on 01APR2022. Dates of admission updated. Subject had slurred speech in ER - admitted for neuro work up - negative. Subject had aspiration PNA - cleared by pulm - D/C on antibiotics. Also had new onset of paroxysmal A-Fib - started on Eliquis. D/C home in good condition. subject was admitted on 28NOV2021 and was discharged 01DEC2021 per records. Follow-up information received on 06-May-2022, 09-May-2022, 10-May-2022, 13-May-2022. This follow-up was considered significant. Summary of changes: The SAE Aspiration Pneumonia with associated blood clot start date and stop date updated. Laboratory data, concomitant medication and Investigator text updated. Follow-up information received on 27-May-2022. This follow-up was considered -significant Summary of Changes: SAE term updated to Aspiration Pneumonia from Aspiration Pneumonia with associated blood clot. Lab data updated. Follow-up information received on 30-Jun-2022. This follow-up was considered significant. Summary of changes: Lab data added, Investigator text updated, Treatment medication updated. Follow-up information received on 24-apr-2023. Summary of changes: action taken updated. Follow-up information received on 01-MAY-2023. Sumary of changes: Product Metoprolol Succinate updated as treatment medication. Follow up information received on 16-May-2023. Summary of changes: Event paroxysmal atrial fibrillation added. Follow up information received on 03-NOV-2023. Summary of changes: The relevant medical history were updated. Upon internal review the case was updated on: 03-DEC-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI Sentence updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation and pneumonia aspiration, 61 days after receiving 1st dose of RSVPreF3 in a 76-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (multiple chronic comorbidities; small cell lung cancer with brain metastasis, diagnosed later, as given in linked cases). US-GLAXOSMITHKLINE-US2022033223: US-GSK-US2023004717: US-GSK-US2022033223: More	✓

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