🏥 VAERS Vaccine Data Browser

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

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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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 26,701 to 26,750 of 34,052 reports (Page 535 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2830468	24	F	PA	03/10/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.	Y012864 Y012864	Gaze palsy, Hyperhidrosis, Loss of consciousness, Malaise, Seizure like phenomen... Gaze palsy, Hyperhidrosis, Loss of consciousness, Malaise, Seizure like phenomena; Tremor, Urinary incontinence More	Pt presented to the office for TDAP vaccine and HPV vaccine. Prior to administration, pt stated tha... Pt presented to the office for TDAP vaccine and HPV vaccine. Prior to administration, pt stated that she has not ever passed out after a vaccine or had any adverse reactions. Vaccine were given by someone under my supervision. With in 30 seconds of receiving the HPV vaccine patient let us know she was not feeling well. The patient then passed out, eyes rolled back in her head, started having seizure like activity, loss of bladder control, sweating, shaking. This lasted about 60 seconds. The call bell was pulled, Person went to get the BP cart and doctor. We moved the patient to the table and her BP was taken. Doctor did an exam. Pt was given water and graham cracker. Vital signs were stable. Doctor discussed symptoms with another provider, and was decided that she should be sent to the ED for evaluation, due to seizure like activity. Pt was agreeable, and her mother in law came to get her. Pt was wheeled out to mother in laws vehicle. Pt was transferred to vehicle and they are going to hospital. More
2830469	74	F	PA	03/10/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH		Acoustic stimulation tests abnormal, Deafness unilateral, Herpes zoster, Hordeol... Acoustic stimulation tests abnormal, Deafness unilateral, Herpes zoster, Hordeolum, Magnetic resonance imaging head normal; Viral infection More	Loss of hearing in my left ear, had MRI, normal, took steriod, had steriod injection in my left ear.... Loss of hearing in my left ear, had MRI, normal, took steriod, had steriod injection in my left ear. Follow up visit scheduled for 3/26. I am not noticing any difference, still cannot hear in my left ear. On February 20, I got shingles. On February 24, I started with a viral infection. On March 7, 2025, I started with a stye in my right eye More
2830470	32	F	MO	03/10/2025	HEPA MMR	MERCK & CO. INC. MERCK & CO. INC.	X026485	Exposure during pregnancy, No adverse event; Exposure during pregnancy, No adver... Exposure during pregnancy, No adverse event; Exposure during pregnancy, No adverse event More	Patient presented in our office requesting vaccinations for her nursing school. Patient was 18 week... Patient presented in our office requesting vaccinations for her nursing school. Patient was 18 weeks pregnant. Nurse Practitioner ordered the vaccines. Patient was given consent forms and signed for both vaccines. Patient received vaccines. Patient was instructed to return in 1 month for the second MMR. Patient returned on 2/24/25. Patient again was given consent and signed for vaccine. Received second MMR. Patients OB/GYN notified us of error. Advised that fetus appears to be fine. Patient advised of symptoms to be aware of. Patient states she is fine also. Followed up with patient to assure no adverse reactions. Primary Care advised of error. Staff educated on policy and protocol regarding live vaccines and women of childbearing age. More
2830471	40	M	NM	03/10/2025	HEPAB MMR TDAP	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR	m4b34 y013172 U8352AA	Loss of consciousness; Loss of consciousness; Loss of consciousness Loss of consciousness; Loss of consciousness; Loss of consciousness	patient experience possible panic or seizure attack during vaccination. loss conscious for few secon... patient experience possible panic or seizure attack during vaccination. loss conscious for few second and recover afterward. no medication was used. More
2830472	67	M	IL	03/10/2025	FLU3 PNC21	SANOFI PASTEUR MERCK & CO. INC.		Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More	REDNESS, SORENESS AND PAINFULL AT THE INJECTION SITE REDNESS, SORENESS AND PAINFULL AT THE INJECTION SITE
2830473	28	M	TX	03/10/2025	RAB	NOVARTIS VACCINES AND DIAGNOSTICS	FDP00613	Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling	SYMPTOM REPORTED INCLUDE MILD SKIN REDNESS AND MILD SWELLING TO LEFT DELTOID AT INJECTION SITE. NO F... SYMPTOM REPORTED INCLUDE MILD SKIN REDNESS AND MILD SWELLING TO LEFT DELTOID AT INJECTION SITE. NO FURTHER SYMPTOMS. TREATMENT PROVIDED ICE PACK WAS APPLIED TO LEFT DELTOID BY INJECTION SITE. More
2830474	18	F	TN	03/10/2025	MMR TDAP VARCEL	MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	X025827 4799G Y011019	Rash, Rash pruritic; Rash, Rash pruritic; Rash, Rash pruritic Rash, Rash pruritic; Rash, Rash pruritic; Rash, Rash pruritic	PT received vaccines on 02/25/25 and reported to clinic today (3/10/25) with a rash noted all over f... PT received vaccines on 02/25/25 and reported to clinic today (3/10/25) with a rash noted all over face and scattered on her back. Pt states the rash is itchy and painful at times. Pt was at school and seen school nurse whom she told that she had recently received vaccines and the nurse sent her to this clinic where she received them. This nurse consulted with regional medical director, who stated patient needs to be seen by her PCP or pediatrician. Referred family to pediatrician. More
2830475	4	F	AZ	03/10/2025	DTAPIPV MMRV	SANOFI PASTEUR MERCK & CO. INC.	U7908AA Y008786	Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More	Patient developed red swollen left arm, warm to touch, the next day following vaccines. Instructed ... Patient developed red swollen left arm, warm to touch, the next day following vaccines. Instructed parent to apply a cool compress to child's arm and if it does not subside within a few days, take child in to get checked by a medical provider. More
2830476	19	M	FL	03/10/2025	HEP TDAP	DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS	944917 3zh27	Head injury, Loss of consciousness; Head injury, Loss of consciousness Head injury, Loss of consciousness; Head injury, Loss of consciousness	Patient administered two vaccines. 2nd hepB vax and boostrix. Approximately 2mins after administra... Patient administered two vaccines. 2nd hepB vax and boostrix. Approximately 2mins after administration pt was standing and conversing with pharmacist and technician then suddenly lost consciousness. Patient mildly/moderately struck head on wall while being caught by technician and another patient standing by. Patient was caught before falling to ground with no skin broken and no bleeding observed or reported by patient. 911 was called and ambulance team arrived. Patient refused further medical attention and exited on his own volition. More
2830477	53	F	MI	03/10/2025	PNC20	PFIZER\WYETH	LK6655	Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose	pt only got a partial does of the pneumococcal PVC 20 vaccine. the pt flinched while getting the vac... pt only got a partial does of the pneumococcal PVC 20 vaccine. the pt flinched while getting the vaccine and only have of a dose went it. pt will have to return to get another dose since this one is considered not a real dose according to the manufacturer. More
2830479	5	F	AK	03/10/2025	DTAPIPV MMR	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	7D2Y4 X013193	Dyspnoea, Feeling abnormal, Injection site erythema, Injection site pruritus; Dy... Dyspnoea, Feeling abnormal, Injection site erythema, Injection site pruritus; Dyspnoea, Feeling abnormal, Injection site erythema, Injection site pruritus More	On 3/6/25 patient developed a 2 inch diameter itchy, raised reddened bump. Mother gave patient bena... On 3/6/25 patient developed a 2 inch diameter itchy, raised reddened bump. Mother gave patient benadryl. Patient had no systemic signs. On 3/7/25 mother reported breathing difficulties and patient felt warm to the touch as well as reddened and itchy area going around patient's thigh. Mother gave patient tylenol and took patient to the ER. ER found circumferential area of erythema, nontender and some surrounding scattered area of urticaria. ER found no respiratory abnormality. ER gave prednisolone and benadryl and observed patient for improvement and discharged patient home. More
2830480	15	F	KS	03/10/2025	HPV9	MERCK & CO. INC.	Y018389	Hypertonia, Syncope Hypertonia, Syncope	The patient's face became void of expression and she started tipping over. Her mother was with ... The patient's face became void of expression and she started tipping over. Her mother was with her and she came to pretty soon after fainting. The patient remembered the pharmacist leaving the room and she remembered sitting back up after fainting, but she does not remember the time (less than 5-10 seconds) during which the fainting spell occurred. She was shaken up afterward, but no more episodes occurred. Water was offered but not accepted. The patient stayed in the vaccine room for 20 more minutes and felt back normal during that time. More
2830481	20	M	OH	03/10/2025	HEPA HPV9 MENB	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS	Z27PB Y000206 DD72H	Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Vomiting; Hyperhidrosis, L... Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Vomiting; Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Vomiting; Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Vomiting More	Approximately 11:15 am-Patient became pale, diaphoretic and passed out. Patient aroused quickly afte... Approximately 11:15 am-Patient became pale, diaphoretic and passed out. Patient aroused quickly after smelling alcohol pad. Patient reclined back with feet elevated. Cool cloth to forehead and back of neck. Complained of nausea with small clear, watery emesis. Water given and refused food. States he did not eat before appointment. Alert and oriented x 3. Refused to go to the ER. Instructed to seek medical attention if need and patient verbalized understanding. Stayed in facility x 25 minutes after adverse event. Patient left facility ambulating with steady gait. Skin W/D/Pale Pink. Denies issues/concerns upon exiting the building. More
2830482	57	F	TN	03/10/2025	PNC20	PFIZER\WYETH	lk6651	Extra dose administered Extra dose administered	Patient has received prevnar 20 on 11/22/2023 and 03/08/2025 Patient has received prevnar 20 on 11/22/2023 and 03/08/2025
2830483	42	F	TX	03/10/2025	HIBV	GLAXOSMITHKLINE BIOLOGICALS	4J452	Product preparation issue Product preparation issue	None- reporting as patient was only administered the prefilled sterile saline diluent without first... None- reporting as patient was only administered the prefilled sterile saline diluent without first mixing it with the lyophilized antigen component. Patient left clinic. Mistake was noticed within the hour by another Medical Assistant. Patient and Quality Nurse were notified. Medical Assistant called vaccine manufacturer and was told there was nothing to worry about since it was the sterile diluent and the vaccine could be immediately correctly administered. Medical Assistant shared info with patient and patient is to call back to come in for vaccine. More
2830484	78	F	WA	03/10/2025	COVID19	MODERNA		Blood pressure increased, Chest pain Blood pressure increased, Chest pain	After the vaccine admin and in less than 5 minutes I began to feel a substernal pain and it worsened... After the vaccine admin and in less than 5 minutes I began to feel a substernal pain and it worsened as I drove the 5-10 home. My husband whose injection followed mine was experiencing the same but less severe. We both took.a Benadryl. I got the EpiPens out, having has anaphylaxis before. I used my albuterol inhaler. The pain persisted. Finally used the pulse ox and it was 98% so not respiratory. Took my BP and it was 203/176. Never had BP elevated to that level before. It is controlled at 125-130/70. The feelings continued for 2 hrs. I have had multiple Pfizer covid vaccine injections with no side effects. This is the first time for any post vaccine effects. Concerning for me as an RN with multi drug allergies. More
2830493			NY	03/10/2025	VARCEL	MERCK & CO. INC.	W003820	Expired product administered, No adverse event Expired product administered, No adverse event	No additional AE/PQC reported.; Nurse calling to report an expired dose of VARIVAX was inadvertently... No additional AE/PQC reported.; Nurse calling to report an expired dose of VARIVAX was inadvertently administered to a patient. Caller confirmed product did not undergo any temperature excursions and was not supported per Post-Expiry Memo. Permission to contact HCP was granted. No; This spontaneous report was received from an other health professional and refers 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 14-FEB-2025, the patient was vaccinated with expired dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (administered with sterile diluent (MERCK STERILE DILUENT)), lot #W003820, expiration date: 02-FEB-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired vaccine administered). Caller confirmed product did not undergo any temperature excursions and was not supported per Post-Expiry Memo. No additional information provided. No additional adverse event/product quality complaint reported (no adverse event) More
2830494			CA	03/10/2025	HPV9	MERCK & CO. INC.	Y010466	No adverse event, Product storage error No adverse event, Product storage error	No symptoms reported; administered improperly stored GARDASIL 9; This spontaneous report was receive... No symptoms reported; administered improperly stored GARDASIL 9; This spontaneous report was received from nurse and refers 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. Previous temperature excursion: None. On 13-Feb-2025, the patient was vaccinated with improperly stored (temperature drift, occurred on 12-FEB-2025, Temperature: 46.9F; Time frame: 1 Hour 45 Minutes 0 Seconds) Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL/dose for prophylaxis by Health Professional (lot #Y010466, expiration date: 29-Oct-2026) (product storage error). No symptoms reported (no adverse event). More
2830495	1.25		TX	03/10/2025	VARCEL	MERCK & CO. INC.	Y010374	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; while the dose was being administered to the patient the vaccine began leaking out... No additional AE; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe and splattered everywhere; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe "and splattered everywhere".; patient received no more than 25% of the recommended dose; This spontaneous report was received from a Physician Assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 25-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) into the patient's thigh intramuscularly, (vaccination scheme, dose description not provided, lot #Y010374, expiration date: 05-JUN-2026) with sterile diluent syringe (dose description not provided, lot # 2050911, expiration date: 11-FEB-2027) for the treatment of prophylaxis, it was states that the medical assistant reconstituted the vaccine with no issues or concerns and while the dose was being administered to the patient the vaccine began leaking out of the diluent syringe and splattered everywhere (Poor quality device used, Syringe leak); they estimate that the patient received no more than 25% of the recommended dose (Accidental underdose). No additional adverse events were reported. Follow up was received from the Physician Assistant on 05-MAR-2025. The vaccine was administered by health professional. The operator was trained. More
2830497	6	M	ND	03/10/2025	HEPA UNK	GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER	Y017208	No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error	No adverse effects reported; patient received improperly stored Proquad; This spontaneous report was... No adverse effects reported; patient received improperly stored Proquad; This spontaneous report was received from a Nurse and refers to a 5-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Jan-2025, the vaccine arrived at the facility. It was assumed that the vaccine could be refrigerated at 36 to 46 degrees Fahrenheit. On 07-Feb-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) administered by Subcutaneous route in Left Thigh (formulation, strength, frequency, and vaccination scheme were not provided; lot # Y017208 which has been verified as a valid number, and expiration date was not reported); this vaccine was dissolved in a sterile diluent as a prophylaxis (improper storage of product in use). On an unknown date, the patient started therapy with HEO A (HAVRIX)) (Left thigh, dose 1), administered by Intramuscular route (Lot# T5727; indication, expiration date and lot # were not reported). It was unknown if a data logger was used. The patient had No adverse effects reported. More
2830498	5	M	ND	03/10/2025	UNK	UNKNOWN MANUFACTURER	X012418	No adverse event, Product storage error No adverse event, Product storage error	No additional adverse event; ProQuad were moved to the refrigerators where they remained withing nor... No additional adverse event; ProQuad were moved to the refrigerators where they remained withing normal refrigerated temperature range until administration. The dose administered to this client was one that was removed from the freezer to the refrigerator on October 1, 2024.; This spontaneous report was received from a Nurse regarding a 5-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 01-OCT-2024, a temperature excursion (TE) occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) after the doses were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (RHA)(PROQUAD), dose 2, administered by Subcutaneous route in Left Thigh for prophylaxis (formulation and dose were not reported; lot number X012418 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date was not reported but upon internal validation it was established as 28-OCT-2024), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT). It was reported that the TE for this dose was in the range of 15 to 46 degree Fahrenheit (-9 to 8 degree Celsius) during 552 (units not provided). No additional adverse event was reported for the patient. More
2830499	2	M	ND	03/10/2025	UNK	UNKNOWN MANUFACTURER	Y013583	No adverse event No adverse event	No additional adverse event; Proquad were moved to the refrigerators where they remained whthin norm... No additional adverse event; Proquad were moved to the refrigerators where they remained whthin normal refrigerated temperature range (36 to 46 degrees fahrenheit) from 01-OCT-2024 until administration on 20-NOV-2024; This spontaneous report was received from a Nurse regarding a 2-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Influenza vaccine live reassort 4v (FLUMIST QUADRIVALENT), Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), Hepatitis a vaccine inact (HAVRIX) and DTAP IPV HEP B HIB VACCINE Injection (VAXELIS). On 01-OCT-2024, a temperature excursion (TE) occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) after the doses were moved to the refrigerator where they remained within normal refrigerated temperature range (36 to 46 degree Fahrenheit) until administration. On 20-NOV-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose 1, administered by Subcutaneous route in Left Thigh as prophylaxis (lot number Y013583 has been verified to be a valid number for Measles, Mumps, Rubella and Varicella [Oka-Merck] Virus Vaccine Live [PROQUAD], expiration date 03-FEB-2026; dose and formulation were not reported). No adverse event was reported for the patient. This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/15/2022 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830500			OK	03/10/2025	HEPA	MERCK & CO. INC.	Y008483	No adverse event, Product storage error No adverse event, Product storage error	No additional AE cases; T/E for VAQTA that was administered; This spontaneous report was received fr... No additional AE cases; T/E for VAQTA that was administered; This spontaneous report was received from a Nurse and refers 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 18-FEB-2025, there was a temperature excursion of Hepatitis A Vaccine, Inactivated (VAQTA) with 32.0�F during 2 hours 12 minutes 0 seconds. Then on 03-Mar-2025, the patient was vaccinated with that dose (second dose) of Hepatitis A Vaccine, Inactivated (VAQTA) lot #Y008483, expiration date: 26-Nov-2025 (strength, dose, route and anatomical location were not provided) for prophylaxis. There was no previous temperature excursion. No adverse events reported. More
2830501			OK	03/10/2025	HIBV PNC15 RV5	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y006393 Y005465 Y009341	No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More	No additional AE reported; improperly stored temperature excursion; This spontaneous report was rece... No additional AE reported; improperly stored temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-FEB-2025, the vaccines of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), and Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) experienced improperly stored temperature excursion, with temperature of 32.0 Fahrenheit (F) and time frame of 2 hours 12 minutes. There was no previous temperature excursion. On 03-MAR-2025, the patient was vaccinated with these vaccines of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) injection strength 0.5ml (2nd dose, lot #Y005465, expiration date: 08-JAN-2027; dose and route were not reported); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (2nd dose, lot #Y006393, expiration date: 07-NOV-2026; strength, dose, and route were not reported); Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2nd dose, lot #Y009341, expiration date: 24-NOV-2025, via orally; strength and dose were not reported), all for prophylaxis (Product storage error). No additional AE was reported. More
2830502		F	MD	03/10/2025	UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More	3rd dose 9 months old; This spontaneous report was received from a physician and refers to a 9-month... 3rd dose 9 months old; This spontaneous report was received from a physician and refers to a 9-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-MAY-2003, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection (reported as Hep B, adolescent or pediatric) (dose, route of administration, anatomical location, lot number and expiration date were not reported), on 30-JUN-2003, the patient the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and on 05-MAR-2004, she received the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) for prophylaxis (inappropriate schedule of product administration). The pt additionally received unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 26-MAR-2021, 02-MAR-2020, 07-JUL-2014, 26-JUL-2007, 23-NOV-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified immunoglobulin antihepatitis a (HEPATITIS A VACCINE) (reported as Hep A, ped/adol, 2 dose) (on 02-MAY-2006 and 29-JUN-2005), unspecified hib vaccine (reported as HIB) (on 30-AUG-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 02-MAR-2020 and 07-JUL-2014); unspecified polio vaccine (reported as IPV) (on 26-JUL-2007, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003); unspecified varicella zoster vaccine (reported as varicella) (on 26-JUL-2007 and 11-JUN-2004); unspecified measles vaccine, mumps vaccine, rubella vaccine (MMR) (on 26-JUL-2007 and 11-JUN-2004): unspecified pneumococcal vaccine (reported as pneumococcal conjugate PCV 7) (on 29-JUN-2005, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003), unspecified influenza vaccine (reported as Influenza, seasonal, injectable, presentative free) (on 22-OCT-2013), unspecified tuberculin PPD (reported as TST-PPD intradermal) (on 11-JUN-2013); quadrivalent human papillomavirus (GARDASIL) (on 18-AUG-2015) (captured in case 2262110) and human papillomavirus, recombinant (GARDASIL 9) (captured in case 2221838) (on 26-MAR-2021). More
2830503			MI	03/10/2025	VARCEL	MERCK & CO. INC.	Y015559	No adverse event, Product storage error No adverse event, Product storage error	No symptoms reported. No additional AE details reported.; a patient who was administered improperly ... No symptoms reported. No additional AE details reported.; a patient who was administered improperly stored VARIVAX on 2/17/2025; This spontaneous report was received from an Other health professional and referred to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Feb-2025, the patient was vaccinated with the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015559, expiration date: 16-Sep-2026) (0.5ml/dose) for prophylaxis; The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). It was reported that the suspect vaccine was underwent temperature excursions (minus 13.9C or minus 14C up to minus 10C) for 10 Minutes on 14-Feb-2025 (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event). More
2830504		F	TN	03/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Injection site erythema, Injection site pain Injection site erythema, Injection site pain	pain and redness at the injection site; pain and redness at the injection site; This non-serious cas... pain and redness at the injection site; pain and redness at the injection site; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In SEP-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain and redness at the injection site) and injection site erythema (Verbatim: pain and redness at the injection site). The outcome of the injection site pain and injection site erythema were not reported. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient was a 55-year-old female that received her first Shingrix vaccine in September 2024 (unsure of exact date). The reporter stated that after the first vaccination she had mild common symptoms as far as pain and redness at the injection site. More
2830505	89	F	GA	03/10/2025	RVX	UNKNOWN MANUFACTURER	UNK	Injection site discolouration, Injection site erythema, Injection site irritatio... Injection site discolouration, Injection site erythema, Injection site irritation More	that the vaccine ate her flesh and that her flesh turned black; She said that initially it was a lar... that the vaccine ate her flesh and that her flesh turned black; She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot; But then the patient put an unspecified salve on it and it is now irritated again; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 90-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 29-JAN-2025, the patient received RSV vaccine (left arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site discoloration (Verbatim: that the vaccine ate her flesh and that her flesh turned black), injection site erythema (Verbatim: She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot) and injection site irritation (Verbatim: But then the patient put an unspecified salve on it and it is now irritated again). The outcome of the injection site discoloration, injection site erythema and injection site irritation were not resolved. It was unknown if the reporter considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine. It was unknown if the company considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine. Additional Information: GSK receipt date: 28-FEB-2025 The reporter was the granddaughter of the patient. The reporter reported that her grandmother was 90 years old and received the �RSV vaccine made by Glasosmithkline on 29th January 2025. The brand name of the vaccine could not be confirmed and the lot number was not available. The reporter provided the name of the pharmacy (and location) of where the pharmacy where the shot was administered. The reporter could not find the pharmacy receipt to confirm the name of the product or the lot number though the pharmacy told her that it was the RSV vaccine that Glasosmithkline makes. The expiry date was not provided. The reporter stated that she had already reported the "site reaction" adverse event to the pharmacy. It was unknown if the pharmacy reported this event or not. The reporter states, that her grandmother's arm which received the injection was "rotting" and that the vaccine "ate her flesh" and that her flesh "turned black." She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot. It was treated with A&D ointment and covered. When the bandage was taken off it was healing and had a scab. But then the patient put an unspecified salve on it and it was now irritated again and had left a "valley/indent" on the injected arm. More
2830506	11	F	AR	03/10/2025	DTAPIPV DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	34mf9 UNK	Extra dose administered, Product administered to patient of inappropriate age, W... Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered More	patient received their first dose of KINRIX when they were 7 years old; another nurse accidentally a... patient received their first dose of KINRIX when they were 7 years old; another nurse accidentally administered KINRIX today to a patient instead of BOOSTRIX.; Extra dose administerd; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: another nurse accidentally administered KINRIX today to a patient instead of BOOSTRIX.) and extra dose administered (Verbatim: Extra dose administerd). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: patient received their first dose of KINRIX when they were 7 years old). The outcome of the wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:28-FEB-2025 The another nurse accidentally administered Kinrix at the time of reporting to a patient instead of Boostrix , which led to wrong vaccine administered and extra dose administered. The patient received their first dose of Kinrix when they were 7 years old,which led to inappropriate age at vaccine administration This case was two of the three cases reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025025487:same reporter US-GSK-US2025025495:same reporter More
2830507	11	F	AR	03/10/2025	DTAPIPV DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	34mf9 UNK	Extra dose administered, Product administered to patient of inappropriate age, W... Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered; Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered More	received their first dose of KINRIX when they were 7 years old; nurse accidentally administered KINR... received their first dose of KINRIX when they were 7 years old; nurse accidentally administered KINRIX today to a patient instead of Boostrix; Extra dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: nurse accidentally administered KINRIX today to a patient instead of Boostrix) and extra dose administered (Verbatim: Extra dose administered). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: received their first dose of KINRIX when they were 7 years old). The outcome of the wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:28-FEB-2025 The another nurse accidentally administered Kinrix at the time of reporting to a patient instead of Boostrix , which led to wrong vaccine administered and extra dose administered. The patient received their first dose of Kinrix when they were 7 years old, which led to inappropriate age at vaccine administration This case was two of the three cases reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025025491:same reporter US-GSK-US2025025487:same reporter More
2830508		M		03/10/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Arthralgia, Pain, Pruritus; Arthralgia, Pain, Pruritus Arthralgia, Pain, Pruritus; Arthralgia, Pain, Pruritus	sore shoulder; This non-serious case was reported by a consumer via interactive digital media and de... sore shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced shoulder soreness (Verbatim: sore shoulder). The outcome of the shoulder soreness was not reported. The reporter considered the shoulder soreness to be related to Shingles vaccine and Shingles vaccine. The company considered the shoulder soreness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 02-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he was 50 plus, had it for a month or so in his hair, on his head. He reported that he found a medicine that would work, for pain and itch it was dried up. The reporter reported that he got the two shots no side effects, except very sore shoulder, no fever, nothing else. But very minor compared to the Shingles. The reporter mentioned that if you were 50 plus, old dudes, ask your doctor, if okay for you to get the two shot series. More
2830509		F		03/10/2025	MENB MENB MENB	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	UNK UNK UNK	Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, Product administered to patient of inappropriate age More	with the wrong dosage schedule; vaccine with the wrong dosage schedule; Mydaughter was born; This no... with the wrong dosage schedule; vaccine with the wrong dosage schedule; Mydaughter was born; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men B NVS (Bexsero) for prophylaxis. On 11-AUG-2023, the patient received the 3rd dose of Bexsero. On 24-MAY-2023, the patient received the 2nd dose of Bexsero. On 12-AUG-2022, the patient received the 1st dose of Bexsero. On 12-AUG-2022, an unknown time after receiving Bexsero, Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Mydaughter was born). On 24-MAY-2023, the patient experienced drug dose administration interval too long (Verbatim: vaccine with the wrong dosage schedule). On 11-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: with the wrong dosage schedule). The outcome of the drug dose administration interval too short, drug dose administration interval too long and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 The reporter reported that the patient was given Bexsero vaccine with wrong dosage schedule. The patient was born. She administered 1st dose on August 12, 22, the 2nd dose on May 24, 2023 and the third dose on August 11, 2023, which led to inappropriate age at vaccine administration, drug dose administration interval too long and drug dose administration interval too short. The reporter asked that had she developed enough immunity. More
2830510				03/10/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Viral infection Viral infection	currently going through the virus; This non-serious case was reported by a consumer via interactive ... currently going through the virus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of viral infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced viral infection (Verbatim: currently going through the virus). The outcome of the viral infection was not resolved. It was unknown if the reporter considered the viral infection to be related to Shingles vaccine. It was unknown if the company considered the viral infection to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAR-2025 This case was reported by a patient via interactive digital media. The patient had gotten the shingles shot years ago and was currently going thru the virus. It was extremely painful. More
2830511				03/10/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got a shingles shot and10 days later got shingles. Patient was over 80 years old. More
2830512				03/10/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; had shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 The case was received from the patient via interactive digital media. The patient had shingles after the vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2830513	19	F	TX	03/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster Herpes zoster	having an outbreak; Well she's 19 years old; This non-serious case was reported by a consumer a... having an outbreak; Well she's 19 years old; This non-serious case was reported by a consumer and described the occurrence of herpes zoster in a 19-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes zoster (Verbatim: having an outbreak) and inappropriate age at vaccine administration (Verbatim: Well she's 19 years old). The outcome of the herpes zoster was not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the herpes zoster to be related to Shingrix. It was unknown if the company considered the herpes zoster to be related to Shingrix. Linked case(s) involving the same patient: US2025024809 Additional Information: GSK Receipt Date: 27-FEB-2025 The patient was 19 years old. The other health professional reported that some idiot at a drugstore administered the second shot while the patient was having an outbreak. The patient received first dose of Shingrix outside the recommended age which led to inappropriate age at vaccine administration. For tolerance to 2nd dose, refer case US2025024809.; Sender's Comments: US-GSK-US2025024809:Same patient ,2nd dose More
2830514	16	M	WI	03/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	Y3ME2	Expired product administered Expired product administered	patients were administered with expired doses of Havrix; This non-serious case was reported by a oth... patients were administered with expired doses of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HAV (Havrix pediatric) (batch number Y3ME2, expiry date 23-FEB-2025) for an unknown indication. On 27-FEB-2025, the patient received the 1st dose of Havrix pediatric. On 23-FEB-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: patients were administered with expired doses of Havrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 The patient was administered with expired dose which led expired vaccine used. This was the first Hepatitis A vaccine for the patient. The reporter consented to follow up. This case was linked with case US2025025535 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025025535:Same reporter/Different patient More
2830515		M	CO	03/10/2025	HEPAB HEPAB	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	4DS4N 4DS4N	Angioedema, Discomfort, Feeling hot, Irritability, Lip dry; Lip swelling, Mouth ... Angioedema, Discomfort, Feeling hot, Irritability, Lip dry; Lip swelling, Mouth swelling, Oropharyngeal pain, Skin discolouration, Swollen tongue More	Angioedema; Irritation; Sore throat; This serious case was reported by a nurse via call center repre... Angioedema; Irritation; Sore throat; This serious case was reported by a nurse via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis. Additional patient notes included no allergies. On 07-FEB-2025, the patient received Twinrix. On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced angioedema (Verbatim: Angioedema) (serious criteria GSK medically significant). In FEB-2025, the patient experienced irritability (Verbatim: Irritation) and sore throat (Verbatim: Sore throat). The patient was treated with prednisone. The outcome of the angioedema was not resolved and the outcome of the irritability and sore throat were resolving. It was unknown if the reporter considered the angioedema, irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. The company considered the angioedema to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 Nurse called to report that patient received the Twinrix vaccine on 07 February 2025. The symptoms started on 10 February 2025 presented angioedema and he was seen in the office on 12 February 2025 with swollen mouth, Irritation, sore throat, dry lips, no fever but feeling warm. Patient was treated with prednisone 40mg for 5 days and symptoms went away for the most part but on 28 February 2025 at 3am it reoccurs, and patient presented lip and tongue swelling, jaw line was white and feels a pressure from the inside of his mouth. Nurse comments patient had no allergies at all that he knows of. Did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No route for prednisone reported.; Sender's Comments: Angioedema is a listed event which is considered related to GSK vaccine Twinrix and Twinrix Pre-Filled Syringe Device. More
2830516		F	NC	03/10/2025	VARZOS	UNKNOWN MANUFACTURER		Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete	suspected vaccination failure; suspected Zoster Sine Herpete (ZSH); flank pain /the patient had this... suspected vaccination failure; suspected Zoster Sine Herpete (ZSH); flank pain /the patient had this severe pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In JAN-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: suspected Zoster Sine Herpete (ZSH)) and flank pain (Verbatim: flank pain /the patient had this severe pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine. The company considered the vaccination failure, zoster sine herpete and flank pain to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 The reporter called to speak with someone regarding Shingrix and Zoster sine herpete (ZSH) and was asking whether there was an increased reaction of Zoster Sine Herpete (ZSH) in patient who were vaccinated (not acutely/recently) with Shingrix. The reporter stated two months ago a patient probably 50 s in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. She had no proof of Zoster Sine Herpete (ZSH), just a clinical suspicion because all the workup was negative but the patient had this severe pain that she could not account for. Now, in retrospect she thought it was Zoster Sine Herpete (ZSH). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Zoster Sine Herpete (shingles) and laboratory confirmation regarding Zoster Sine Herpete (shingles) were unknown at the time of reporting. This case was one of the three case reported by the same reporter for different patient; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Zoster sine herpete and Flank pain are unlisted events which are considered unrelated to GSK Shingles vaccine. US-GSK-US2025026200:same reporter/Different patient US-GSK-US2025026208:Same reporter/Different patient More
2830517		F	NC	03/10/2025	VARZOS	UNKNOWN MANUFACTURER		Antibody test positive, Flank pain, Vaccination failure, Zoster sine herpete Antibody test positive, Flank pain, Vaccination failure, Zoster sine herpete	suspected vaccination failure; potential zoster sine herpete (ZSH); flank pain; This serious case wa... suspected vaccination failure; potential zoster sine herpete (ZSH); flank pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: potential zoster sine herpete (ZSH)) and flank pain (Verbatim: flank pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete and flank pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 Reporter called to speak with someone regarding Shingrix and zoster sine herpete (ZSH) and was asking whether there was an increased reaction of zoster sine herpete (ZSH) in patients who were vaccinated (not acutely/recently) with Shingrix. In February 2025, 1 month ago, a female patient (also a doctor) probably 70ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. This was the only one of the 3 patients the caller had potential confirmation of zoster sine herpete (ZSH) for. The patient said zoster sine herpete (ZSH) was evidently more common in vaccinated patients and the patient's zoster antibody levels were high. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is one of the three linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025026210:Same reporter/Different patient US-GSK-US2025026200:Same reporter/Different patient More
2830518			IL	03/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration Inappropriate schedule of product administration	Llss than recommended interval/patient received the second dose a month later; This non-serious case... Llss than recommended interval/patient received the second dose a month later; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Llss than recommended interval/patient received the second dose a month later). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK receipt date: 04-MAR-2025 The physician asked if the patient received the second dose of Shingrix a month later which led to, drug dose administration interval too short. The reporter reported that the patient was not immunocompromised. The reporter had a questioned did they need to get a third dose. The Vaccine Administration Facility is the same as Primary Reporter. More
2830519			CA	03/10/2025	RSV	PFIZER\WYETH	HN8090	Syringe issue Syringe issue	looked like they were leaking; The initial case was missing the following minimum criteria: Invalid ... looked like they were leaking; The initial case was missing the following minimum criteria: Invalid due to other - info not qualifying for AE reporting - Product complaint. Upon receipt of follow-up information on 05Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Other HCPs from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HN8090, Expiration Date: 31May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "looked like they were leaking". Additional information: The Medical Assistant/office supervisor informed that they have two defective vials. The reporter clarified that there was no patient involvement with these defective vials. They were going to be given to patients, once they were defective, they were not able to be give to patients, looked like they were leaking. It seemed like 1 was fine, had 1 defective one, the other one seemed to have a little crack inside of case, could see the fluid. The reporter clarified, specific presentation of Abrysvo involved has, part supposed to be screwed on, with plastic adapter piece, with powder in vial and syringe with liquid. Only has 1 of the syringes, has both vials. The reporter clarified, second vial and all components for second vial, including, carton, diluent syringe and carton, all have same NDC, LOT, EXP, Manufacturer, as provided for first kit. Causality for "looked like they were leaking" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. More
2830520			CA	03/10/2025	RSV	PFIZER\WYETH	HN8090	Device breakage, Device leakage Device breakage, Device leakage	2 defective vials, looked like they were leaking; the other one seemed to have a little crack in sid... 2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; 2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; This is a spontaneous report and received from Other HCPs from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HN8090, Expiration Date: Aug2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid". Causality for "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). More
2830522	17	F	MD	03/10/2025	MENB	PFIZER\WYETH		Dizziness, Fatigue, Headache, Loss of consciousness, Nausea Dizziness, Fatigue, Headache, Loss of consciousness, Nausea	passed out; Light headed/Dizzy; headache; fatigue; nausea; This is a spontaneous report received fro... passed out; Light headed/Dizzy; headache; fatigue; nausea; This is a spontaneous report received from a Consumer or other non HCP. A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 05Mar2025 at 14:45 as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in left arm for immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: PROZAC, start date: 01Nov2024. No other vaccine was received on the same day. No other vaccine was received on in four weeks. Vaccination history included: Meningococcal vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering", described as "Light headed/Dizzy"; FATIGUE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; HEADACHE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; LOSS OF CONSCIOUSNESS (medically significant) with onset 05Mar2025 at 19:00, outcome "recovering", described as "passed out". Therapeutic measures were not taken as a result of loss of consciousness, dizziness, headache, fatigue, nausea. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received. More
2830523	84	F	FL	03/10/2025	PNC20 PNC20	PFIZER\WYETH PFIZER\WYETH	LC9348 LC9348	Discomfort, Erythema, Inflammation, Magnetic resonance imaging, Pain; Pain in ex... Discomfort, Erythema, Inflammation, Magnetic resonance imaging, Pain; Pain in extremity, Peripheral swelling More	swelling in the second toe (index)/The top part of foot was starting to swell; toe is swollen and it... swelling in the second toe (index)/The top part of foot was starting to swell; toe is swollen and it hurts/painful to walk; it sometimes spreads to the top of her foot; toe next to big toe on right foot is inflamed; discomfort; she is just injured; It was kind of a dark pink; This is a spontaneous report received from a Nurse from medical information team. An 84-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Feb2025 as dose number unknown, 0.5 ml single (Lot number: LC9348, Expiration Date: 30Jan2026) at the age of 84 years intramuscular for immunisation. The patient's relevant medical history included: "Broken hip", start date: Apr2024 (unspecified if ongoing), notes: Broken hip Right hip, all healed up now; "clot" (unspecified if ongoing); "flu" (unspecified if ongoing); "lungs were damaged" (unspecified if ongoing), notes: in an accident 20 years ago. Concomitant medication(s) included: XARELTO taken for thrombosis (ongoing). The following information was reported: ERYTHEMA (non-serious) with onset 26Feb2025, outcome "unknown", described as "It was kind of a dark pink"; DISCOMFORT (non-serious) with onset 26Feb2025, outcome "unknown"; PAIN (non-serious) with onset 26Feb2025, outcome "not recovered", described as "it sometimes spreads to the top of her foot"; INJURY (non-serious) with onset 26Feb2025, outcome "unknown", described as "she is just injured"; PERIPHERAL SWELLING (non-serious) with onset 26Feb2025, outcome "not recovered", described as "swelling in the second toe (index)/The top part of foot was starting to swell"; PAIN IN EXTREMITY (non-serious) with onset 26Feb2025, outcome "not recovered", described as "toe is swollen and it hurts/painful to walk"; INFLAMMATION (non-serious) with onset 26Feb2025, outcome "unknown", described as "toe next to big toe on right foot is inflamed". The events "swelling in the second toe (index)/the top part of foot was starting to swell", "toe is swollen and it hurts/painful to walk", "it sometimes spreads to the top of her foot", "toe next to big toe on right foot is inflamed", "discomfort", "she is just injured" and "it was kind of a dark pink" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, pain in extremity. Additional information: Caller mentioned her toe was swollen and it hurts. It's painful to walk and it doesn't go away. She has tried using Epsom salts and it just helps her for 30 minutes. She has also noticed that it sometimes spreads to the top of her foot. Neither her foot doctor nor her primary doctor know what to do about it. Caller was called in regard to the Prevnar 20 vaccine. On 25Feb2025, received it, arm was fine but toe next to big toe was inflamed. Clarified as on the right foot. It was swollen and very sore. It was kind of a dark pink. Used Epsom salt, stated she was a retired nurse. It occurred the day after got the vaccine. Went to a foot doctor and she didn't quite know and now caller was kind of stuck. Calling to report it and ask has anyone reporting has a reaction like this. It was very painful. She has never had anything like this happen. She would guess she was pretty healthy; she was just injured. Started as very little discomfort, as days went by it got more uncomfortable and started swelling. It was the toe next to the big toe, usually was tall and skinny, looks more like a thumb now. It has gotten a little worse. The top part of foot was starting to swell. Noticed because wears open toe sandals, they are marking the foot now. No interventions besides seeing the foot doctor. More
2830524		M		03/10/2025	PNC20	PFIZER\WYETH		Lymphadenopathy Lymphadenopathy	lymph nodes were swollen; This is a spontaneous report received from a Consumer or other non HCP. A... lymph nodes were swollen; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Feb2025 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Mar2025, outcome "not recovered", described as "lymph nodes were swollen". Therapeutic measures were not taken as a result of lymphadenopathy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830525		F		03/10/2025	COVID19	PFIZER\BIONTECH		Exposure during pregnancy Exposure during pregnancy	she had it while she was pregnant; This is a spontaneous report received from a Consumer or other no... she had it while she was pregnant; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient (pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "she had it while she was pregnant". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830526	40	F	TX	03/10/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	EL0140 EL0140 EL0140 EL0140 EL0140 EL0140 EL0140	Anaphylactic reaction, Blood calcium, Blood creatine phosphokinase, Blood lactic... Anaphylactic reaction, Blood calcium, Blood creatine phosphokinase, Blood lactic acid, Blood magnesium; Blood potassium, Blood pressure measurement, Body mass index, Body temperature, Cardiac telemetry; Chills, Dehydration, Disturbance in attention, Dizziness, Fatigue; Full blood count, Headache, Heart rate, Hypokalaemia, Loss of consciousness; Memory impairment, Metabolic function test, Nausea, Oxygen saturation, Physical examination; Respiratory rate, Seizure, Speech disorder, Syncope, Tachypnoea; Tremor, Vomiting, White blood cell count More	a major episode; concentration issues; fatigue; forgetfulness; speech issues; seizure activity/witne... a major episode; concentration issues; fatigue; forgetfulness; speech issues; seizure activity/witnessed syncopal episode with convulsive spells; loss of consciousness; dizzy/lightheaded/light headedness; nausea; vomiting; witnessed syncopal episode with convulsive spells/problem with concentration fainting; Allergic reaction/anaphylaxis; tachypneic; rigors; electrolyte abnormality/mild hypokalemia; dehydration; headache; tremors; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 05Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician, Program ID. A 40-year-old female patient received BNT162b2 (BNT162B2), on 05Jan2021 (reported as am) as dose 1, single (Lot number: EL0140) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Achilles tendinitis" (unspecified if ongoing); "Contracture of left Achilles tendon", start date: 2017 (unspecified if ongoing); "Depression" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Gastrocnemius equinus" (unspecified if ongoing); "GERD (gastroesophageal reflux disease)" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing), notes: with body mass index (BMI) of 40.0 or higher (HCC); "Peripheral sensory neuropathy" (unspecified if ongoing); "Rheumatoid arthritis (714.0)" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Cholecystectomy" (unspecified if ongoing); "Carpal tunnel release" (unspecified if ongoing); "Foot ganglion excision" (unspecified if ongoing); "Knee Arthroscopy" (unspecified if ongoing), notes: Literality: Bilateral, Literality: Right; "Thyroidectomy, partial" (unspecified if ongoing), notes: Literality: Right; "Tonsillectomy" (unspecified if ongoing); "Wisdom tooth extraction" (unspecified if ongoing); "Tobacco use" (unspecified if ongoing); "Never smoker" (unspecified if ongoing), notes: Smokeless tobacco: Never used, Substance use topics; "Alcohol use: Yes" (unspecified if ongoing), notes: Frequency: Monthly or less, Drinks per session: 1 or 2; "arthritis" (unspecified if ongoing); "low vitamin D levels" (unspecified if ongoing). No Known Drug Allergies reported for patient. Never binge frequency. Never drug use. The patient's family history includes hypertension, lupus, clotting disorder, heart disease, mitral valve prolapse, and type II diabetes in the father; hypertension, osteoporosis, heart disease, and mitral valve prolapse in the mother; hypertension and type II diabetes in the brother; breast cancer, hypertension, and type II diabetes in the maternal aunt; breast cancer in a cousin; and hypertension and type II diabetes in the maternal uncle. Concomitant medication(s) included: ZOLOFT taken for depression; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; MOBIC taken for arthritis; NORVASC taken for hypertension; VITAMIN D2 taken for vitamin d deficiency. The following information was reported: ANAPHYLACTIC REACTION (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "Allergic reaction/anaphylaxis"; DEHYDRATION (disability) with onset 05Jan2021, outcome "recovered with sequelae"; DIZZINESS (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "dizzy/lightheaded/light headedness"; HYPOKALAEMIA (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "electrolyte abnormality/mild hypokalemia"; LOSS OF CONSCIOUSNESS (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae"; NAUSEA (disability) with onset 05Jan2021, outcome "recovered with sequelae"; CHILLS (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "rigors"; SEIZURE (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae", described as "seizure activity/witnessed syncopal episode with convulsive spells"; TACHYPNOEA (disability) with onset 05Jan2021, outcome "recovered with sequelae", described as "tachypneic"; VOMITING (disability) with onset 05Jan2021, outcome "recovered with sequelae"; SYNCOPE (disability, medically significant) with onset 05Jan2021, outcome "recovered with sequelae", described as "witnessed syncopal episode with convulsive spells/problem with concentration fainting"; HEADACHE (disability) with onset Jan2021, outcome "recovered with sequelae"; TREMOR (disability) with onset Jan2021, outcome "recovered with sequelae", described as "tremors"; SEIZURE (hospitalization, disability) with onset Sep2021, outcome "recovered with sequelae", described as "a major episode"; SPEECH DISORDER (disability), outcome "recovered with sequelae", described as "speech issues"; DISTURBANCE IN ATTENTION (disability), outcome "recovered with sequelae", described as "concentration issues"; FATIGUE (disability), outcome "recovered with sequelae"; MEMORY IMPAIRMENT (disability), outcome "recovered with sequelae", described as "forgetfulness". The event "seizure activity/witnessed syncopal episode with convulsive spells" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood calcium: (unspecified date) 8.5; Blood creatine phosphokinase: (unspecified date) normal; Blood lactic acid: (unspecified date) normal; Blood magnesium: (unspecified date) within normal limits; Blood potassium: (unspecified date) 3.2, notes: mild hypokalemia; Blood pressure measurement: (unspecified date) 150/97; (unspecified date) 111/64; (unspecified date) 116/69, notes: lying; (unspecified date) 127/77, notes: sitting; (unspecified date) 136/64, notes: standing; (05Jan2021) 111/64, notes: 12:00; (05Jan2021) 111/74, notes: 11:30; (05Jan2021) 113/65, notes: 11:10; (05Jan2021) 130/72, notes: 10:45; (05Jan2021) 130/72, notes: 10:20; (05Jan2021) 138/74, notes: 10:00; (05Jan2021) 134/76, notes: 09:50; (05Jan2021) 154/80, notes: 09:30; (05Jan2021) 150/97, notes: 09:00; Body mass index: (unspecified date) 40.0, notes: or higher (HCC); Body temperature: (unspecified date) 97.4, notes: degree F/36.3 degree C; (05Jan2021) 97.4, notes: degree F (36.3 degree C) at 09:22; Cardiac telemetry: (unspecified date) Unknown results, notes: Bedside Telemetry interpreted by patient in real time. Rate: 68. Rhythm: normal sinus rhythm. Premature Beats: None grossly Seen. A order for cardiac telemetry was ordered. Clinical reason for order: Other potential cardiac emergency not otherwise specified. with a general concern for dysrhythmia or cardiac abnormality. A general review of the patient's telemetry during this included encounter was consistent with normal sinus rhythm AND did not reveal any obvious clinically significant events, alarms or pertinent rhythms affecting outcomes; Full blood count: (unspecified date) Abnormal; Heart rate: (unspecified date) 84; (unspecified date) 64, notes: per minute; (unspecified date) 71, notes: per minute; (unspecified date) 82, notes: per minute; (unspecified date) 84; (05Jan2021) 84, notes: 12:00; (05Jan2021) 72, notes: 11:30; (05Jan2021) 61, notes: 11:10; (05Jan2021) 62, notes: 10:45; (05Jan2021) 67, notes: 10:20; (05Jan2021) 74, notes: 10:00; (05Jan2021) 76, notes: 09:51; (05Jan2021) 67, notes: 09:30; (05Jan2021) 84, notes: 09:00; Metabolic function test: (unspecified date) Abnormal; Oxygen saturation: (unspecified date) Unknown results, notes: An order for general oxygen monitoring and oximetry was ordered. Clinical reason for order was for potential for hypoxia, respiratory insufficiency due to potential emergent conditions being evaluated for or being treated for. A general review of the patient's oximetry during this included encounter did not reveal any clinically pertinent hypoxic events affecting clinical outcome or requiring intervention; Oxygen saturation: (unspecified date) 100 %; (unspecified date) 100 %; (05Jan2021) 100 %, notes: 12:00; (05Jan2021) 99 %, notes: 11:30; (05Jan2021) 98 %, notes: 11:10; (05Jan2021) 100 %, notes: 10:45; (05Jan2021) 100 %, notes: 10:20; (05Jan2021) 100 %, notes: 10:00; (05Jan2021) 97 %, notes: 09:51; (05Jan2021) 98 %, notes: 09:50; (05Jan2021) 96 %, notes: 09:30; (05Jan2021) 100 %, notes: 09:22; HENT: (unspecified date) Head: Normocephalic and atraumatic, notes: Mouth/Throat: Oropharynx is clear and moist. Eyes: Pupils are equal, round, and reactive to light. No scleral icterus. Neck: Normal range of motion. Neck supple. Cardiovascular: Normal rate, regular rhythm, normal heart sounds and intact distal pulses. Pulmonary/Chest: Effort normal and breath sounds normal. Tachypnea noted. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. There is no rebound. Musculoskeletal: Normal range of motion. No tenderness or edema. Neurological: She is alert and oriented to person, place, and time. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6. Following commands and responding to verbal stimuli. Skin: Skin is warm and dry. No rash noted. Psychiatric: She has a normal mood and affect. Her behavior is normal; Respiratory rate: (unspecified date) 38; (unspecified date) 18; (05Jan2021) 18, notes: 12:00; (05Jan2021) 26, notes: 11:30; (05Jan2021) 15, notes: 11:10; (05Jan2021) 23, notes: 10:45; (05Jan2021) 20, notes: 10:20; (05Jan2021) 23, notes: 10:00; (05Jan2021) 15, notes: 09:51; (05Jan2021) 17, notes: 09:30; (05Jan2021) 38, notes: 09:22; White blood cell count: (unspecified date) 11.5; (unspecified date) Constitutional: appears morbidly Obese. No distress. Clinical course included: the patient had been having issues ever since vaccination. Within minutes after receiving the vaccine the patient started having seizure activity and ended up in the emergency room. Everything was witnessed by hospital employees. The patient continued to be uncontrolled seizure activity that medication is not helping. She was unable to work because of this beside seizure activity, the patient had forgetfulness, speech issues, fatigue, concentration issues and more. The brief event was reported as Allergic reaction, loss of consciousness, past injection dizzy, nausea lightheaded, witnessed syncopal episode with convulsive spells and vomiting. This event happened in Jan2021 and continue to have issues like, tremors, headache, light headedness, problem with concentration fainting, speech problems and etc. In Sep2021 while at work finishing up her shift she had a major episode of the nurses station which end up with hospital admission of 4 to 5. The patient had not being able to work since. The patient presenting to the ED (Emergency Department) as rapid Response with c/o (complaining of) allergic reaction which began just pta (prior to arrival). The patient is an employee at this hospital. The received Covid vaccination this morning and began feeling dizzy, lightheaded and then had an unanticipated medical event. The patient had a witnessed syncopal episode with seizure-like activity with convulsive spells and vomiting. She was moved from chair onto floor as precautions. She also began feeling nauseous with emesis. She was then moved into the emergency room as part of the rapid response protocol. Patient denies any h/o (history of) seizure. Patient was in process of talking with mother over the phone before demonstrating seizure-like activity again while in ED room. Allergic Reaction: The illness progression has not changed. The symptoms are associated with new medications. The associated symptoms include nausea and vomiting. The vomiting frequency was once. The vomit appearance was stomach contents. No treatments have been tried. The patient has no history of similar symptoms previously. There are no sick contacts. The patient has not received any recent medical care. The patient presented to the ED for evaluation of potential reaction following Covid-19 vaccination. Symptoms were onset almost immediately after the shot. She had loss of consciousness with seizure like activity and vomiting. Patient brought to ER (emergency room) where convulsive like behavior is ongoing. VS tachypneic but improved. Upon examination, patient arrives nauseous with rigors and convulsions but still able to follow commands and respond to verbal stimuli. Appropriate PPE worn throughout patient encounter. Differential diagnosis includes allergic reaction, anaphylaxis, epilepsy, electrolyte abnormality, dehydration among others. Seizure precautions: IV Ativan, Benadryl; IV LR bolus infusion. Lab work grossly WNCL with the exception of mild hypokalemia. Lactate and CK normal. 10:25 AM: Patient feeling significantly improved and resting comfortably in no distress after ativan and benadryl. No more convulsions or seizure like activity after the fluids, ativan and benadryl. 1:28 pm: Patient feeling at baseline. No reoccurrence during ED observation. No evidence of dehydration. No respiratory distress. Tolerating PO. No focal neuro deficits. She is ambulatory at this time and again feeling much better and back to baseline. Patient in no distress, and stable for dispo home. Patient nontoxic appearing, afebrile. Not sure if after this reaction to the 1st covid 19 vaccine shot she will be allowed to get the 2nd shot. Final diagnoses reported as Vaccine reaction, initial encounter. S/P (Status Post) Vaccination to the Covid-19 Virus. It was reported that the events resulted in disability or permanent damage. Outcome provided as Recovered/Resolved with lasting effects. ED Interventions included: Medications: LORazepam (ATMAN) injection 1 mg (has no administration in time range); LORazepam (ATIVAN) 2 mg/ml- injection -ADS; Override Pull (override Pull 05Jan2021 09:19); diphenhydramine (BENADRYL) 50 mg/mL; injection -ADS Override Pull (Override Pull 05Jan2021 09:20); Lorazepam (ATIVAN) injection 2 mg (2 mg Intravenous Given 05Jan2021 09:00); diphenhydramine (BENADRYL) injection 50 mg (50 mg Intravenous Given 05Jan2021 09:00); 0.9% sodium chloride (NaCl) 1,000 mL bolus (Intravenous Completed 05Jan2021 11:00); lactated ringers (LR) IV 500 mL (0 mLs Intravenous Completed 05Jan2021 12:02); potassium bicarbonate (K-LYTE) 25 MEQ disintegrating tablet 25 mEq (25 mEq Oral Given 05Jan2021 12:01).; Sender's Comments: There is a reasonable possibility that the events dizziness, nausea, vomiting, syncope, anaphylactic reaction, headache, chills, and fatigue were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More	✓	✓
2830527		F	IL	03/10/2025	COVID19	PFIZER\BIONTECH		COVID-19, Disease recurrence, Drug ineffective COVID-19, Disease recurrence, Drug ineffective	This is the fourth time I've had COVID; This is the fourth time I've had COVID; This is th... This is the fourth time I've had COVID; This is the fourth time I've had COVID; This is the fourth time I've had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 64-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "This is the fourth time I've had COVID". She did not remember it was the 4th or 5th time (as reported). She had all of the Pfizer vaccines. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence, included Pfizer medication for COVID. On another occasion, they gave the patient Pfizer medication for COVID. The patient said that she did not remember the name of medication for COVID, but on one of those occasions, she got sick with COVID, and they gave her COVID medication. The patient stated that this would be the second time she took COVID medicine. The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received. More
2830528	2	F	CA	03/10/2025	HIBV	SANOFI PASTEUR	UK016AC	Expired product administered, No adverse event Expired product administered, No adverse event	administration of an expired product to a patient (with no reported adverse event); Initial informat... administration of an expired product to a patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 2 years,8 months old female patient to whom administered expired Hib (PRP/T) Vaccine [Act-Hib]with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Mar-2025, the patient received a 0.5 ml dose of suspect Hib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot UK016AC , unknown strength, expiry date:28-feb-2025, via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More

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