🏥 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 33,201 to 33,250 of 34,052 reports (Page 665 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2820095	1.33	M		01/09/2025	COVID19	PFIZER\BIONTECH		Irritability, Product preparation issue Irritability, Product preparation issue	An 16 month patient received 3 doses (3 ml undiluted) of COVID 19 vaccine instead of a single dose ... An 16 month patient received 3 doses (3 ml undiluted) of COVID 19 vaccine instead of a single dose appropriate for age. PCP was informed and called pt's mother 2 days after the incident and child was doing fine. Mom stayed he was fussy after injection but otherwise he was fine. More
2820096	50	F	IA	01/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	JS3S4	Erythema, Musculoskeletal stiffness, Pain, Swelling Erythema, Musculoskeletal stiffness, Pain, Swelling	Pain, diffuse redness, swelling, body aches, arm stiffness lasting more than 3 days Pain, diffuse redness, swelling, body aches, arm stiffness lasting more than 3 days
2820097	42	M	TX	01/09/2025	COVID19 COVID19	MODERNA MODERNA	AS7163B AS7163B	Bell's palsy, Computerised tomogram, Eyelid weights application, Facial par... Bell's palsy, Computerised tomogram, Eyelid weights application, Facial paralysis, Facial reanimation operation; Herpes zoster oticus, Magnetic resonance imaging, Muscle flap operation, Nerve graft, Nerve stimulation test More	Facial paralysis. Bell's Palsy or Ramsay Hunt, the physicians I've seen IM, ENT, neurolog... Facial paralysis. Bell's Palsy or Ramsay Hunt, the physicians I've seen IM, ENT, neurologist, are not sure. I had no improvement. After a year, I had an eyelid weight implanted and a facial nerve graft. I've had two other surgeries (nerve grafts, nerve transfers, and muscle flap) for the reanimation. My medical care began at hospital and continues at second hospital for facial reanimation. My internal medicine diagnosed me on 12/15/21. My first surgery was 2/20/23. My second 9/11/23. My third 9/18/24. I get more MRIs in March 2025. First surgery had 2 inpatient overnights, second also had two overnights inpatient, third surgery was five inpatient days. More	✓	✓
2820098	73	F	FL	01/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS		Erythema of eyelid, Periorbital swelling Erythema of eyelid, Periorbital swelling	patient woke up the morning after her RSV vaccine experiencing puffy red under eyelids. stable condi... patient woke up the morning after her RSV vaccine experiencing puffy red under eyelids. stable condition 4 hours later. pharmacist has been in contact. told her to take benadryl and monitor condition worsening. did not present with any other symptoms More
2820099	3	F	MN	01/09/2025	COVID19 COVID19	MODERNA MODERNA		Blood thyroid stimulating hormone normal, Cyanosis, Full blood count normal, Met... Blood thyroid stimulating hormone normal, Cyanosis, Full blood count normal, Metabolic function test normal, Rash; Urticaria More	Severe hives from scalp to toes. All extremities turned blue and are currently blue. Hands and feet ... Severe hives from scalp to toes. All extremities turned blue and are currently blue. Hands and feet are more blue. More
2820100	0.5	M	MI	01/09/2025	RSV	PFIZER\WYETH	HY1813	No adverse event, Wrong product administered No adverse event, Wrong product administered	NO ADVERSE EVENT, GAVE WRONG VACCINE TYPE NO ADVERSE EVENT, GAVE WRONG VACCINE TYPE
2820101	75	M	OR	01/09/2025	FLU3 FLU3	SANOFI PASTEUR SANOFI PASTEUR	U8489CA U8489CA	Constipation, Dysuria, Grip strength decreased, Guillain-Barre syndrome, Laborat... Constipation, Dysuria, Grip strength decreased, Guillain-Barre syndrome, Laboratory test; Loss of bladder sensation, Muscular weakness More	Resident sent from skilled nursing facility (SNF) to hospital with progressive, ascending muscle wea... Resident sent from skilled nursing facility (SNF) to hospital with progressive, ascending muscle weakness and lessened sense to urinate. From day of admission to SNF 12/31 to hospitalization on 1/7/25, "ascending weakness that started in their legs and has reached their arms. Quad 1/5 and grip strength 2-3/5 per a PT and it has been worsening since he was admitted to the facility. The patient claims that it is steadily progressing, experiencing constipation, and difficulty urinating along with lessened sense to urinate." Quoted from NP'S progress note. Influenza vaccine administered within 48 hours of admission to SNF. GBS within differential at current hospital stay. This reporter uncertain of current treatments/outcome while hospitalized. More	✓
2820102	11	M	SC	01/09/2025	MNQ MNQ TDAP TDAP	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	3E99M 3E99M 333SK 333SK	Erythema, Injection site erythema, Injection site swelling, Pain, Peripheral swe... Erythema, Injection site erythema, Injection site swelling, Pain, Peripheral swelling; Swelling; Erythema, Injection site erythema, Injection site swelling, Pain, Peripheral swelling; Swelling More	Redness and swelling that started on 1/6/2025 on upper deltoid area , seen in MD office on 1/7/25 ... Redness and swelling that started on 1/6/2025 on upper deltoid area , seen in MD office on 1/7/25 and 1/8/25. Now redness and swelling is worsening and is extending to the lower arm involving the right elbow and developing on the right upper back. Patient having pain but no fever. Patient was started on cephalexin. More
2820103	70	F	FL	01/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	255t2	Extra dose administered, No adverse event Extra dose administered, No adverse event	Patient received vaccine twice. 1st was 10/24/23. Contacted patients md office to report the fact th... Patient received vaccine twice. 1st was 10/24/23. Contacted patients md office to report the fact that the patient received a second dose by accident. She expresses no adverse effects but counseled her on signs and symptoms of an allergic reaction and when to follow up with MD. Dr's employee said she would inform provider and will advise pharmacy and patient on further steps if needed More
2820104	2	M	VA	01/09/2025	MMR	MERCK & CO. INC.	X022411	Body temperature increased, Influenza virus test negative, Respiratory syncytial... Body temperature increased, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative More	On 1/8/25 patient had a temperature of 105.8F without any other symptoms. Influenza, Covid, RSV, Str... On 1/8/25 patient had a temperature of 105.8F without any other symptoms. Influenza, Covid, RSV, Strep swabs were all negative. Patient was treated with motrin at home. More
2820106	65	F	WI	01/09/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	58160-0823-11 58160-0823-11	Chills, Headache, Injection site erythema, Injection site swelling, Injection si... Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth; Lip blister, Lip swelling, Pain More	headache, body aches evening of; worsened next day with added swelling, redness and hot to touch at ... headache, body aches evening of; worsened next day with added swelling, redness and hot to touch at injection site; adding chills but no fever in the evening; same next day with worsening of the injection site; the symptoms were improving on 3rd day post injection however started developing blisters around lower lip-like fever blisters (cold sores); by this morning my lip was full of blisters and quite swollen and they have begun to spread up the left upper lip. The only other symptom that remains is slight headache off & on; pain to touch at injection site but much better. More
2820144	37	M	CA	01/09/2025	COVID19 FLU3	MODERNA GLAXOSMITHKLINE BIOLOGICALS	B0003 N737Y	Euphoric mood, Feeling abnormal; Euphoric mood, Feeling abnormal Euphoric mood, Feeling abnormal; Euphoric mood, Feeling abnormal	At 10:54 am patient received Spikevax Moderna COVID vaccine lot # B0003 BUD 2/11/2025 in the right ... At 10:54 am patient received Spikevax Moderna COVID vaccine lot # B0003 BUD 2/11/2025 in the right deltoid, IM. Patient also received Fluarix lot # N737Y exp 6/30/2025 in the left deltoid, IM. At 11:00 am patient reported feeling "loopy." PHN, sat patient down and gave him water to drink. Patient denied feeling dizzy, denied pain, denied headache or nausea, denied itchiness or trouble breathing. Patient described sensation as "floating." At 11:05 am PHN, palpated radial pulse. Pulse was rhythmic and measured at 80 beats per minute. Patient's skin was dry and color was appropriate to Ethnicity. Patient consented to vitals being taken at 11:10: blood pressure 108/70, RR 16, pulse was 84 beats per minute, 98% SPo2. PHN, gave patient more water to drink and talked with patient for emotional support. Patient stated he was feeling better and at 11:15 am symptom was resolved. Patient reported history of high blood pressure, no medication and has not seen a doctor in a while. PHN, educated patient about signs and symptoms of an emergency and referred patient to Family Healthcare centers street team tonight at 5:30 pm by needle exchange to follow up for primary care. Van drove away at 11:25 am, patient sitting up, organizing his belongings. More
2820145	16	F	FL	01/09/2025	MENB MNP	NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH		Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Pt received 2 injections of Men B due to receiving Bexsero & Penbraya Pt received 2 injections of Men B due to receiving Bexsero & Penbraya
2820146	5	M	OR	01/09/2025	DTAPIPV MMRV	SANOFI PASTEUR MERCK & CO. INC.	U7838AA Y015989	Cellulitis; Cellulitis Cellulitis; Cellulitis	Patient started showing signs of cellulitis on 01/09/25. They sought treatment from an Urgent care, ... Patient started showing signs of cellulitis on 01/09/25. They sought treatment from an Urgent care, they prescribed Cephalexin, Mom then brought patient into our office for a second opinion of cellulitis. More
2820147	76	M	FL	01/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	52Z52	Extra dose administered, No adverse event Extra dose administered, No adverse event	PATIENT MISTAKENLY RECEIVED 2 AREXY VACCINES ON 11/13/23 AND 1/7/25. NO ADVERSE EFFECTS PATIENT MISTAKENLY RECEIVED 2 AREXY VACCINES ON 11/13/23 AND 1/7/25. NO ADVERSE EFFECTS
2820148	20	F	OR	01/09/2025	COVID19 FLU3	PFIZER\BIONTECH SANOFI PASTEUR	LP1780 TFAA2442	Dizziness, Feeling hot, Nausea; Dizziness, Feeling hot, Nausea Dizziness, Feeling hot, Nausea; Dizziness, Feeling hot, Nausea	Patient was advised to remain in the pharmacy waiting area for 15 minutes after her vaccines for mon... Patient was advised to remain in the pharmacy waiting area for 15 minutes after her vaccines for monitoring. Shortly after receiving both vaccines patient reported feeling very warm, light headed and nauseas. Patient was brought back in to the vaccine room and monitored for a reaction. EMS was called right away and patient reported feeling better in about 3 minutes time. The fire department arrived and assessed patient and she was able to be picked up by her mom. More
2820162	33	F	CA	01/09/2025	VARCEL	MERCK & CO. INC.		Extra dose administered, No adverse event, Product storage error Extra dose administered, No adverse event, Product storage error	No other AE./ no adverse drug reaction (NADR); Customer reported an AE for VARIVAX. The caller said ... No other AE./ no adverse drug reaction (NADR); Customer reported an AE for VARIVAX. The caller said the product was administered after a temperature excursion. Caller did not have patient information, but said there was only 1 patient that received the product. AE letter sent to caller. No other; was the vaccine resumed? - yes; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date) for prophylaxis (product storage error). No adverse event was reported (no adverse event). The vaccine underwent a temperature excursion of 4 degrees Celsius. Lot # is being requested and will be submitted if received. Follow-up information has been received from a consumer (vaccine provider) on 30-DEC-2024. The report became valid as the patient's identifiers were provided. The patient was a 33-year-old female patient (age reported as 34 years, but calculated as 33 years at the time of the vaccination and the event based on DOB and onset dates), with pre-existing allergies to milk and to penicillin (PCN); historcal drug included PCN. The improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with the reported lot # Y003891 and expiration date of 06-FEB-2026 (both confirmed as valid for the suspect vaccine) was administered to the patient subcutaneously (SQ) into right (R) arm on 28-JUN-2024 as the first dose (no previous doses), at a private doctor's office/hospital, purchased with private funds. It was reported that the vaccines were stored in clinical practice at 2-8 degrees Celsius (C) instead of the recommended temperature. The action that was taken with the suspect vaccine was provided as "patient notified, vaccine doses wasted" (entered as not applicable in field). The patient had no adverse drug reaction (NADR). The vaccine was not available for return/evaluation, as it was discarded after the single use. The operator of the vaccine was a trained healthcare professional. Addiitonally, it was reported that on an unknown date in 2024, the suspect vaccine varicella virus vaccine live (oka/merck)(VARIVAX) was resumed (strength, dose, formulation, route and site of administration, lot # and expiration date not reported), but no specific date or any further details were provided (extra dose administered). Lot # is being requested and will be submitted if received. More
2820163	18	U	VA	01/09/2025	HEPA	MERCK & CO. INC.	X026485	No adverse event No adverse event	No additional AEs; Caller reported adult dose of VAQTA administered to 18 year old patient. No othe... No additional AEs; Caller reported adult dose of VAQTA administered to 18 year old patient. No other information provided. No additional AEs or PQC reported.; patient received 1mL instead of 0.5 mL; This spontaneous report was received from a registered pharmacist referring to a 18-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 15-JUL-2024, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) lot # X026485, expiration date 11-MAY-2025, 1 milliliter, intramuscular for prophylaxis (product administered to patient of inappropriate age and overdose). No adverse event was reported. More
2820165	0.25	F	TX	01/09/2025	PNC15 RV5 UNK	MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER	Y005351 2037483	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 adverse events were reported; HCP called to report TE where ROTATEQ, VAXELIS and VAXNE... No additional adverse events were reported; HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient. No side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC. ROTATEQ: 2037483 exp: 02/23/2026 VAXELIS (pfs) :; This spontaneous report was received from medical assistant and refers to a 3-month-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-JAN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #2037483, expiration date: 23-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #Y005351, expiration date: 08-JAN-2027, administered for prophylaxis (strength, and route of administration were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Those vaccines underwent temperature excursion in 49.22 degree Farenheit for 1 hour (Product storage error). No additional adverse event was reported. More
2820166	57	F		01/09/2025	HEP HEP	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Colonoscopy abnormal, Colorectal adenoma, Large intestine polyp, Nasal septum de... Colonoscopy abnormal, Colorectal adenoma, Large intestine polyp, Nasal septum deviation, Polypectomy; Tumour excision More	tubulovillous adenoma; Bilateral Deviated septum; This non-serious case was reported by a nurse via ... tubulovillous adenoma; Bilateral Deviated septum; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of nasal septum deviation in a 67-year-old female patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included appendectomy (in 1959), tobacco user (1 pack per day (40.0 pack per yrs), Years since quitting: 8.6, Cigarette pack per day 5), knee arthroplasty (in 1980 and 2003), tubal ligation (in 1980), abdominal hernia repair (in 1981), carpal tunnel decompression (in 1988), uterine dilation and curettage (in 1994), rotator cuff repair (in 2003 and 2005), joint arthroplasty (in 2004), macular degeneration (Bilateral eyes in 2007), cesarean section (3 times, not ongoing), degenerative joint disease (in 1996), pure hypercholesterolemia, anesthetic complication, tonsillectomy (not ongoing), adenoidectomy (not ongoing), wheezing, shortness of breath, insomnia and phlebitis. Previously administered products included Influenza vaccine (received a dose on 10-JAN-2010), Hepatitis A vaccine (in 1980), Tdap (received on 09-NOV-2009), Hepatitis b vaccine (received on 13-NOV-2009), Influenza vaccine (received on 13-NOV-2009) and Hepatitis b vaccine (received on 14-DEC-2009). Concurrent medical conditions included type ii diabetes mellitus (without long-term current use Of insulin (HOC)), obstructive sleep apnea (in 1995, not interested in using CPAP, uses mouth guard), osteoarthritis (in 1996), chronic pain (Plan follow-up pain specialist, upcoming injections SI joint on right, right shoulder), constipation, contact lens wearer, hyperlipidemia, shoulder pain (chronic pain in shoulder joint), osteoporosis, seasonal allergy and environmental allergy. On 20-MAY-2010, the patient received the 3rd dose of Hepatitis B vaccine. In JAN-2011, between 7 and 9 months after receiving Hepatitis B vaccine, the patient experienced nasal septum deviation (Verbatim: Bilateral Deviated septum). On an unknown date, the patient experienced colonic tubulovillous adenoma (Verbatim: tubulovillous adenoma). The outcome of the nasal septum deviation and colonic tubulovillous adenoma were not reported. It was unknown if the reporter considered the nasal septum deviation and colonic tubulovillous adenoma to be related to Hepatitis B vaccine. It was unknown if the company considered the nasal septum deviation and colonic tubulovillous adenoma to be related to Hepatitis B vaccine. Linked case(s) involving the same patient: US2024AMR135366, US2024AMR165841 Additional Information: GSK Receipt Date: 30-OCT-2024 The nurse reported that a patient received 3rd dose of Hepatitis B vaccine and experienced nasal septum deviation in January 2011, colorectal adenoma and tubolovillous adenoma polyp of colon in 2010. The colonoscopy performed and it was flexible with respect of removal of tumors, polyps or other lesions.; Sender's Comments: US-GSK-US2024AMR135366:same patient US-GSK-US2024AMR165841: US-GSK-US2024AMR135366: More
2820167		M		01/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; ended up getting shingles from the shot twice; This serious case was ... Suspected vaccination failure; ended up getting shingles from the shot twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: ended up getting shingles from the shot twice). The outcome of the vaccination failure and shingles were not reported. 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. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the shot and ended up getting shingles from the shot twice. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2820168		M	NY	01/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Not received the 2n dose; This non-serious case was reported by a physician via call center represen... Not received the 2n dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in MAR-2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received the 2n dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: Follow up information received on: 11-DEC-2024 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was ask should restart the series. More
2820169	1	M	MO	01/09/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	95DB2	Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More	18-month-old patient received an adult dose; 18-month-old patient received an adult dose; Drug dose ... 18-month-old patient received an adult dose; 18-month-old patient received an adult dose; Drug dose administration interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old male patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. Previously administered products included Havrix (received first dose of Havrix on 11-JUN-2024). On 02-DEC-2024, the patient received the 2nd dose of Havrix 1440 1 ml. On 02-DEC-2024, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: 18-month-old patient received an adult dose), adult product administered to child (Verbatim: 18-month-old patient received an adult dose) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the overdose, adult product administered to child and drug dose administration interval too short were unknown. 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: 12-DEC-2024 The other health professional reported that the18-month-old patient received an adult dose (1.0 ml) of Havrix which led to overdose and adult product administered to child. The Vaccine Administration Facility was the same as Primary Reporter. The patient received second dose of Havrix shorter than the recommended interval which led to shortening of vaccination schedule. More
2820170	50	F	GA	01/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Pain in extremity Pain in extremity	soreness in her arm; This non-serious case was reported by a consumer via call center representative... soreness in her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 10-OCT-2024, the patient received the 1st dose of Shingrix. On 10-OCT-2024, 4 hrs after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness in her arm ). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2024157530 Additional Information: GSK Receipt Date: 13-DEC-2024 The patient self-reported this case. The patient received her first Shingrix dose and that after the first dose she experienced soreness in her arm which resolved quickly. This case is linked with US2024157530, reported by same reporter.; Sender's Comments: US-GSK-US2024157530:Same patient/ Dose 2 More
2820171	50	F	GA	01/09/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Chills, Fatigue, Influenza like illness, Injection site pain, Malaise; Musculosk... Chills, Fatigue, Influenza like illness, Injection site pain, Malaise; Musculoskeletal stiffness, Myalgia, Pain, Pyrexia More	stiffness in arms and legs; chills; fatigue; Soreness at injection site; Fever of 100.4�F/low grad... stiffness in arms and legs; chills; fatigue; Soreness at injection site; Fever of 100.4�F/low grade fever; my body hurts; I feel like I have the flu,; don't fell well; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of first dose refer case US2024157532). On 12-DEC-2024, the patient received the 2nd dose of Shingrix. On 12-DEC-2024, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Soreness at injection site). On 13-DEC-2024, the patient experienced limbs stiffness (Verbatim: stiffness in arms and legs), chills (Verbatim: chills) and fatigue (Verbatim: fatigue). In DEC-2024, the patient experienced fever (Verbatim: Fever of 100.4�F/low grade fever), general body pain (Verbatim: my body hurts), influenza like illness (Verbatim: I feel like I have the flu,), unwell (Verbatim: don't fell well) and myalgia (Verbatim: Myalgia). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, general body pain, influenza like illness and unwell were not reported and the outcome of the fever was resolving and the outcome of the myalgia, limbs stiffness, chills and fatigue were unknown. It was unknown if the reporter considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix. It was unknown if the company considered the injection site pain, fever, general body pain, influenza like illness, unwell, myalgia, limbs stiffness, chills and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2024157532 Additional Information: GSK Receipt Date: 13-DEC-2024 The patient self-reported this case for herself. The patient took the Shingrix vaccine day before reporting and I'm trying to figure out if this was normal stuff. The patient had a fever of 100.4 and she was, she took Tylenol at 7 o'clock and she rarely had a fever, her body hurts, she feel like she had the flu, honestly, she just don't feel well. After the second dose, the patient did experience soreness at the injection site which began a few hours after the vaccination. The patient reported that she awoke with fatigue, stiffness in arms and legs, chills and low-grade fever, even after having taken acetaminophen.; Sender's Comments: US-GSK-US2024157532:Sae patient/ Dose 1 More
2820172	0.5	M	IA	01/09/2025	DTAPHEPBIP	GLAXOSMITHKLINE BIOLOGICALS	7592L	Expired product administered Expired product administered	6 months old patient received, on 12/12/2024, a Pediarix expired dose; This non-serious case was rep... 6 months old patient received, on 12/12/2024, a Pediarix expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7592L, expiry date 03-DEC-2024) for prophylaxis. On 12-DEC-2024, the patient received Pediarix. On 12-DEC-2024, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: 6 months old patient received, on 12/12/2024, a Pediarix expired dose). The outcome of the expired vaccine used was unknown. 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: 13-DEC-2024 The patient received an expired dose of Pediarix, which led to expired vaccine used. More
2820173		M	CA	01/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS		Extra dose administered Extra dose administered	received Arexvy sometime last year and forgot and received another dose; This non-serious case was r... received Arexvy sometime last year and forgot and received another dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (Patient received first dose of Arexvy in 2023). Concurrent medical conditions included alzheimer's disease. In NOV-2024, the patient received the 2nd dose of Arexvy. In NOV-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy sometime last year and forgot and received another dose). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date:07-JAN-2025 Reporter stated his 63-year-old father who has Alzheimer's disease received Arexvy sometime last year and forgot and received another dose in November this year. Reporter did not have product lot numbers or any further details. Patient received another dose of Arexvy which led to extra dose administered. More
2820174		F	TX	01/09/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	95D74	Underdose Underdose	An adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B.; unde... An adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B.; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 65-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: An adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B.) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown. 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: 16-DEC-2024 The medical assistant called to report that an adult patient received a pediatric dose of Engerix-B instead of an adult dose of Engerix-B which led to, adult use of a child product and underdose. More
2820175	55	M	PA	01/09/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS	47XP4	Underdose Underdose	Engerix-B pediatric dose administered to an Adult; Engerix-B pediatric dose administered to an Adult... Engerix-B pediatric dose administered to an Adult; Engerix-B pediatric dose administered to an Adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 55-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 17-DEC-2024, the patient received the 2nd dose of Engerix B pediatric. On 17-DEC-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose administered to an Adult) and underdose (Verbatim: Engerix-B pediatric dose administered to an Adult). The outcome of the adult use of a child product and underdose were unknown. Additional Information: GSK Receipt Date: 17-DEC-2024 The nurse reported that the adult patient received Engerix-B second dose pediatric formulation, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter. More
2820176		M		01/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Rash Rash	Rash on hands; This non-serious case was reported by a consumer via call center representative and d... Rash on hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced rash (Verbatim: Rash on hands). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 17-DEC-2024 The patient self-reported this case. The patient received the 1st dose of Shingrix vaccine and a week after getting the 1st dose, he developed a rash on his hands The date of the vaccination and the facility location was not provided and it was unknown in which arm the vaccine was administered. The patient did not provided lot and expiry date information. More
2820177		M	IL	01/09/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS		Underdose Underdose	they administered a pediatric dose of Havrix to an adult patient; pediatric dose of Havrix to an adu... they administered a pediatric dose of Havrix to an adult patient; pediatric dose of Havrix to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 26-year-old male patient who received HAV (Havrix pediatric) for prophylaxis. On 13-DEC-2024, the patient received the 1st dose of Havrix pediatric. On 13-DEC-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: they administered a pediatric dose of Havrix to an adult patient) and underdose (Verbatim: pediatric dose of Havrix to an adult patient). The outcome of the adult use of a child product and underdose were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-DEC-2024 The pharmacist stated they administered a pediatric dose of Havrix to an adult patient back on 13th December 2024 which led to adult use of a child product and underdose. This was the first Hepatitis A dose that patient received so far. The reporter did not have lot number or expiration date for the vaccine. The vaccine administration facility was the same as primary reporter. More
2820178	1	M	UT	01/09/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	4T93R	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	Havrix 1440 adult administered to a 1-year-old; Possible Overdose/Havrix 1440 adult administered to ... Havrix 1440 adult administered to a 1-year-old; Possible Overdose/Havrix 1440 adult administered to a 1-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. On 19-DEC-2024, the patient received the 1st dose of Havrix 1440 adult. On 19-DEC-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Havrix 1440 adult administered to a 1-year-old ) and overdose (Verbatim: Possible Overdose/Havrix 1440 adult administered to a 1-year-old ). The outcome of the adult product administered to child and overdose were unknown. 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:19-DEC-2025 Reporter stated Havrix was administered to a 1-year-old patient, and it expired on13-DEC-2024. The lot number provided by the HCP had a different expiration date (11-JUL-2026) when looked it up in the batch number identifier and also identified as an adult dose. The 1 year old patient received Havrix adult vaccine which led adult product administered to child and overdose. More
2820179		M	NY	01/09/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	MZ474	Inappropriate schedule of product administration Inappropriate schedule of product administration	Early second dose; This non-serious case was reported by a nurse via call center representative and ... Early second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old male patient who received HAV (Havrix pediatric) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis. Concomitant products included Hepatitis a vaccine inact (Havrix junior). On 24-DEC-2024, the patient received Havrix pediatric. On 24-DEC-2024, an unknown time after receiving Havrix pediatric, the patient experienced drug dose administration interval too short (Verbatim: Early second dose). The outcome of the drug dose administration interval too short was unknown. 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:24-DEC-2024 Nurse reported that a 12-year-old patient received Havrix pediatric early second dose which led to drug dose administration interval too short. The first dose was on November 1st, 2024, and the 2nd dose was on December 24th 2024. HCP was asking if the patient should return on 6 months for the second dose to be valid. More
2820180	60	F	NM	01/09/2025	COVID19	MODERNA		Pruritus, Rash Pruritus, Rash	rash; Itch; This spontaneous case was reported by a patient and describes the occurrence of RASH (ra... rash; Itch; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and PRURITUS (Itch) in a 60-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Prophylactic vaccination. Co-suspect product included non-company product Dupilumab (Dupixent) for Atopic dermatitis. Concurrent medical conditions included Atopic dermatitis (Rashes with bumpy blisters that pop and scab, face was blood red & dried out from the scalp down. Rash was grown for past 2 years.). On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and Dupilumab (Dupixent) (Subcutaneous use) 300 milligram. On an unknown date, the patient experienced RASH (rash) and PRURITUS (Itch). At the time of the report, RASH (rash) and PRURITUS (Itch) was resolving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No Concomitant medications provided by the reporter. It was reported that patient experienced rash and which grew for past 2 years due to Atopic dermatitis. And patient's current condition improved since patient was received Dupixent medication and symptom was not got worse. Patient asked if Dupixent medication was supposed to recover from symptom. Because patient experienced Rashes with bumpy blisters that pop and scab, face was blood red & dried out from the scalp down. On an unknown date Patient was received the first dose intake of Dupixent medication and following the first dose intake of Elasomeran (Moderna -Covid-19 Vaccine). Post Moderna -Covid-19 Vaccine patient experienced symptom of Rash with itches and it hurt the Patient. It was hard to shower for patient. However, patient's symptom improved since patient was received Dupixent dose regimen. Now for patient there were little dots around the edges instead of solid blood red. No treatment medications provided by the reporter. More
2820181		M		01/09/2025	COVID19	MODERNA		Vaccination site pain Vaccination site pain	he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing... he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain). At the time of the report, VACCINATION SITE PAIN (he received a second Moderna covid-19 shot on his left arm on 24FEB2021, and that he is experiencing injection site pain) had not resolved. The patient had no medical history, concomitant disease or risk factor. Concomitant medication was not reported. The pain was ongoing, and patient had seen numerous doctors who have all been unable to help him. Patient stated the following, "It hurts me all the time. I'm tired of being in pain all the time and it hurts". It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported. More
2820183		F	FL	01/09/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP from me... had covid; had covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 71-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose 1, single (Batch/Lot number: unknown) and in 2023 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had covid". Clinical course: The patient had been inoculated 2 years ago when it first came out and didn't get a reaction or anything. Her doctor said to get the booster this year so that's when the patient made the appointment with (withheld) and got it done on 21Oct2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2820185		U		01/09/2025	COVID19	PFIZER\BIONTECH		Allergy to vaccine, Rash Allergy to vaccine, Rash	Allergy; rash; This is a spontaneous report received from a Consumer or other non HCP from License P... Allergy; rash; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017247 (BioNTech). A patient (age and gender not provided) 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. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy"; RASH (non-serious), outcome "unknown". Additional information: The patient had experienced some problems in their body after taking Pfizer vaccine, allergy, rash, etc. BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE. More
2820186		M		01/09/2025	FLUX	UNKNOWN MANUFACTURER		Unevaluable event Unevaluable event	Flu shots don't usually work; weaken your immune system; Initial information received on 29-Dec... Flu shots don't usually work; weaken your immune system; Initial information received on 29-Dec-2024 regarding an unsolicited valid social media serious case received from a Patient. This case involves Adult male patient who reported flu shots don't usually work and weaken your immune system after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization). On an unknown date the patient reported flu shots don't usually work (vaccination failure) and weaken your immune system (immune system disorder) (unknown latency) following the administration of Influenza Vaccine. Reportedly, Had the flue three times in life. Flu shots don't usually work. Most times they weaken your immune system. Seriousness criteria: The event vaccination failure was assessed as medically significant. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events.; Sender's Comments: Sanofi company comment dated 06-Jan-2025: This case involves Adult male patient who reported flu shots don't usually work and weaken your immune system after receiving Influenza Vaccine.The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2820187	9	F	NJ	01/09/2025	MEN MMR	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	U8271AB	No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More	patient was intended to receive MMR, however, menquadfi was inadvertently used as a diluent with MMR... patient was intended to receive MMR, however, menquadfi was inadvertently used as a diluent with MMR administered to a patient with no reported adverse event; Initial information received on 06-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 9-year-old female patient who was intended to receive measles vaccine, mumps vaccine, rubella vaccine [MMR], however, meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was inadvertently used as a diluent with MMR administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Jan-2025, patient was intended to receive MMR not produced by Sanofi Pasteur however, 0.5 ml dose suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection strength: standard of lot U8271AB and expiry date: 31-Jan-2028 via intramuscular route in the right deltoid for immunisation was inadvertently used as a diluent with mmr administered to a patient with no reported adverse event (product preparation error) (latency: on same day). 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
2820189	1	F	PA	01/09/2025	FLU3	SANOFI PASTEUR	U8486AA	Extra dose administered, No adverse event Extra dose administered, No adverse event	3 doses of the FLUZONE was given to a 1 year old patient, patient received the extra dose 3 months l... 3 doses of the FLUZONE was given to a 1 year old patient, patient received the extra dose 3 months later with no reported adverse event; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient who received 3 doses of the influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone], patient received the extra dose 3 months later with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella zoster vaccine (Varicella vaccine); measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; and Hepatitis a vaccine (Hepatitis A) as all for Immunisation. On an unknown date in 2024, the patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot U8486AA) and she also received an unknown dose 1 of same vaccine (lot U8486AA) both via unknown route in unknown administration site. On 02-Jan-2025 she also received 0.5 ml of dose 3 of same vaccine (expiry date- 30-JUN-2025 and lot U8486AA) via intramuscular route in the right deltoid as prophylactic vaccination (Immunization), patient received the extra dose 3 months later with no reported adverse event (inappropriate schedule of product administration) (latency- same day). 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
2820190	0.33	F	FL	01/09/2025	FLU3	SANOFI PASTEUR	UT8485NA	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	inadvertently administered FLUZONE NP to a 4-month-old child with no reported AE; Initial informatio... inadvertently administered FLUZONE NP to a 4-month-old child with no reported AE; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who had inadvertently administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 07-Jan-2025, the patient received a unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) lot UT8485NA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in unknown administration site for Immunization and inadvertently administered fluzone np to a 4-month-old child with no reported ae (product administered to patient of inappropriate age) (latency : same day). 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
2820191	0.33	F	TX	01/09/2025	DTAPIPVHIB	SANOFI PASTEUR	UK044AA	Product preparation issue Product preparation issue	the last PENTACEL they gave, only the DTaP-IPV was administered and the ACTHIB component was not rec... the last PENTACEL they gave, only the DTaP-IPV was administered and the ACTHIB component was not reconstituted with no reported AE; Initial information received on 07-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient to whom the last Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel(VERO)] they gave, only the dtap-ipv was administered and the acthib component was not reconstituted with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine (Rotavirus vaccine)and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 07-Jan-2024, the patient to whom last Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Strength = standard) 1x(once) 0.5 ml Suspension for injection lot UK044AA expiry-31-Aug-2025 via intramuscular route in the left vastus lateralis for immunization only the dtap-ipv was administered and the acthib component was not reconstituted with no reported ae (single component of a two-component product administered) (latency same day). 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
2820196		U	GA	01/09/2025	HEPA	MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event, Product admi... Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age More	FBE called reporting a child under the age of 12 months given VAQTA and given the 2nd dose too early... FBE called reporting a child under the age of 12 months given VAQTA and given the 2nd dose too early (before 6 months from the 1st dose). FBE did not have patient information at the time of the call. Consent to contact is yes. No adverse side effect; FBE called reporting a child under the age of 12 months given VAQTA and given the 2nd dose too early (before 6 months from the 1st dose). FBE did not have patient information at the time of the call. Consent to contact is yes. No adverse side effect; No adverse event; This spontaneous report was received from physician via a company representative, concerning a child under the age of 12 year old of unknown gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date, the reporter called reporting a child under the age of 12 months (Inappropriate age at vaccine administration) given hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). and given the 2nd dose too early (before 6 months from the 1st dose) (Inappropriate schedule of product administration). The reporter did not have patient information at the time of the call. No adverse side effects were reported. No additional information available at this time. More
2820197		U	CA	01/09/2025	MMRV	MERCK & CO. INC.	Y015991	Device connection issue, No adverse event, Underdose Device connection issue, No adverse event, Underdose	Caller has not reported any symptoms. No additional AE/PQC report; Nurse calling to report patient o... Caller has not reported any symptoms. No additional AE/PQC report; Nurse calling to report patient only received half a dose PROQUAD due to syringe improperly attached.; Nurse calling to report patient only received half a dose PROQUAD due to syringe improperly attached. Caller confirmed syringe attachment was due to user error and no PQC was reported.; This spontaneous report has been received from a nurse, regarding a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported. On 08-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot number Y015991, expiration date: 23-MAR-2026, administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not provided). On that date, the patient experienced only received half a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (accidental underdose) due to syringe improperly attached. The reporter confirmed syringe attachment was due to user error (device use issue). There was not reported symptoms, adverse events or product quality complaints reported (no adverse event). More
2820198		F	PA	01/09/2025	COVID19	PFIZER\BIONTECH		COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure	Got COVID after receiving the COVID vaccine; Got COVID after receiving the COVID vaccine; This is a ... Got COVID after receiving the COVID vaccine; Got COVID after receiving the COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2025, outcome "unknown" and all described as "Got COVID after receiving the COVID vaccine". The clinical course was reported as follows: The patient indicated she just got vaccinated this past fall and confirmed receiving the Pfizer COVID vaccine. She also mentioned that on 30Nov2024 she and her sister got exposed to COVID. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2025) Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2820199		U	FL	01/09/2025	COVID19	PFIZER\BIONTECH		Myalgia, Pruritus Myalgia, Pruritus	Muscle pain and itching in right arm and shoulder; Muscle pain and itching in right arm and shoulder... Muscle pain and itching in right arm and shoulder; Muscle pain and itching in right arm and shoulder; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Nov2024 at 10:01 as dose 1, 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "Muscle pain and itching in right arm and shoulder". Additional information: Muscle pain and itching in right arm and shoulder that will not go away More
2820200		F		01/09/2025	COVID19 UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	No batch number No batch number	Cerebrovascular accident, Hemiplegia, Physiotherapy, Speech-language therapy, Th... Cerebrovascular accident, Hemiplegia, Physiotherapy, Speech-language therapy, Thrombosis; Cerebrovascular accident, Hemiplegia, Physiotherapy, Speech-language therapy, Thrombosis More	Stroke; Blood clot developed in the back of my head; Cannot use my left side; I have to go to speech... Stroke; Blood clot developed in the back of my head; Cannot use my left side; I have to go to speech therapy; I am in physical therapy; This spontaneous case, initially received on 24-Dec-2024, was reported by a non-health professional and concerns an adult female patient. Height: 155 cm, Weight: 188.5 lb At the time of the event the patient had Diabetes. Concomitant medication: unspecified diabetes medication, unspecified heart medication and 12 unspecified medicines. Administration of company suspect drug(s): On 06-Nov-2024, the patient received Flucelvax (TIV) for an unknown indication., Dose regimen: not reported, Route of administration: not reported, Site of administration: not reported, Lot number: No batch number available and will be requested upon follow-up Non-company suspect drugs: On 06-Nov-2024, the patient received COVID-19 vaccine (COVID-19 vaccine) for an indication not reported, Dose regimen: not reported, Route of administration: not reported, Site of administration: right arm, Lot number: Not reported. Adverse reactions/events and outcomes: On 22-Nov-2024, the patient experienced Stroke (Medically Significant, outcome: Unknown), Blood clot developed in the back of my head (Medically Significant, outcome: Unknown), Cannot use my left side (Medically Significant, outcome: Unknown), I have to go to speech therapy (outcome: Unknown), I am in physical therapy. (outcome: Unknown), Consumer stated, she had a blood clot developed in the backed of her head, then she had the stroke two weeks after she had the vaccine. Consumer stated, she had never had the pfizer vaccine. When requested for former probing, consumer stated, she had it. That was the paperwork that she had, but she just needed to know what that adverse event was. She was not sure what that was, but she still answered the questions. When probed if the vaccination card was handy, consumer stated, they did not gave a vaccination card. Date of vaccination: 06-Nov-2024, Site of administration: right arm, shoulder. Route of administration: intramuscular 4 weeks prior vaccination. The patient took the flu shot on the same day, name of the flu shot: flucelvax 0. 5 milligram Flucelvax (TIV) action taken: Not Applicable Reporter Assessment: The reporter did not provide the seriousness and causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related. Of note covid-19 vaccine can be considered as confounder. More
2820201	49	F	AZ	01/09/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	3S54K	No adverse event No adverse event	no symptoms per son today 1/9/25 no symptoms per son today 1/9/25
2820202	71	M	NC	01/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	255T2	Extra dose administered, No adverse event Extra dose administered, No adverse event	Patient made appointment online for RSV vaccine. No history of RSV vaccination in registry and no is... Patient made appointment online for RSV vaccine. No history of RSV vaccination in registry and no issues billing through insurance. Patient said he did not get it yet. PharmD administered Arexvy to patient on 01/06/2025. Clinical Service department contacted pharmacy about possible duplicate claim / issue. After further investigation, it was realized the patient did receive Arexvy back on 10/20/2023 at a different location, but it was far back in pharmacy records and was not entered on registry. PharmD left message for patient requesting return call. On 01/08/2025, PharmD contacted original pharmacy (other Pharmacy location) to please update record for patient regarding this vaccine, which has been completed. Patient and PharmD spoke on 01/09/2025 at 05:04 pm for about 15 minutes. PharmD explained the situation to patient, reviewed information needed to complete VAERS form and discussed how the patient is feeling and any side effects he already experienced. Pharmacist counseled patient on what to expect, common side effects, possible adverse reactions, and reviewed possible risks and outcomes of the additional vaccination. Patient stated he had some soreness around injection site for one to two days after administration but took no additional medication or other interventions; he has experienced the same aftereffects following prior vaccines and does not consider it an adverse event. He stated he "experienced no adverse events and feels fine." PharmD also counseled patient on new documentation / warning regarding Guillain-Barre syndrome seen in post-marketing data and what signs and symptoms to monitor for. He appreciated the information but is not concerned further. Over the phone, patient verbalized understanding of the situation, answered questions easily, and said he would contact pharmacy with any further questions. More
2820203	20	M	OR	01/09/2025	COVID19 HPV9 MNQ VARCEL	NOVAVAX MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC.	6024MF016A 1957404 U8370AA Y005919	No adverse event; No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event; No adverse event	Patient arrived for his 2nd dose of the HPV vaccine on 1/7/25. He notified me when reviewing the vac... Patient arrived for his 2nd dose of the HPV vaccine on 1/7/25. He notified me when reviewing the vaccine administration record consent and screener that after his last visit on 11/26/24, he developed hives on his right thigh and lower leg about 24 hours after receiving vaccines. He took a zyrtec and the hives resolved. On 11/26/24, Patient received the HPV vaccine (Gardasil), Meningococcal ACWY (Menquadfi), Varicella (Varivax), and 2024-2025 Novavax COVID-19 vaccine. Upon further review of the vaccines administered on 11/26/24, it appears that the reaction is likely due to the Novavax vaccine as that is the only vaccine listing hives as a known side effect during clinical trials. I discussed the risk and benefit of administering the 2nd dose of HPV vaccine during the visit and he was agreeable based on the information provided. I ensured he had an antihistamine available at home to take if he has another reaction and educated him on signs of an allergic reaction and when to seek medical care. He verbalized understanding. After the administration of the HPV dose, there were no side effects observed during the 15 minute wait post-vaccination. More

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