🏥 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 19,801 to 19,850 of 34,052 reports (Page 397 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	🚑	♿	⚠️
1889603	12	M	AL	11/22/2021	COVID19 TDAP TDAP	PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	y3z9p y3z9p	Epistaxis; Asthenia, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli, ... Epistaxis; Asthenia, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli, Vomiting More	2 nose bleeds over the course of two days, following Covid vaccine 2 nose bleeds over the course of two days, following Covid vaccine
2841474	64	M	AR	05/18/2025	DTAP DTAP	SANOFI PASTEUR SANOFI PASTEUR		Blood test normal, Dizziness, Hypoacusis, Irritability, Pain; Somnolence, Vertig... Blood test normal, Dizziness, Hypoacusis, Irritability, Pain; Somnolence, Vertigo, Visual impairment, Vomiting More	Dizziness, sleepiness, aches/pains, throwing up, followed by Vertigo. Eyesight issues, hearing issue... Dizziness, sleepiness, aches/pains, throwing up, followed by Vertigo. Eyesight issues, hearing issues. Saw Dr on 5/2/25, conducted exam and bloodwork. Outcome: fussiness, eyesight, hearing and irritability persist. More
2841475	65	M	MD	05/18/2025	COVID19	PFIZER\BIONTECH	LM2221	Rash Rash	Patient developed a severe rash later in the day and went to the emergency room Patient developed a severe rash later in the day and went to the emergency room
2841476	65	M	SC	05/18/2025	PNC21	MERCK & CO. INC.	Y013009	Dyspnoea, Mobility decreased Dyspnoea, Mobility decreased	Pt received the vaccine and had trouble breathing and going up stairs. Pt received the vaccine and had trouble breathing and going up stairs.
2841477	69	M	TN	05/18/2025	COVID19 VARZOS	PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS	LM2224 74NC9	Injection site paraesthesia, Paraesthesia; Injection site paraesthesia, Paraesth... Injection site paraesthesia, Paraesthesia; Injection site paraesthesia, Paraesthesia More	After vaccination, patient has experienced tingling from his upper arm at the vaccination site down... After vaccination, patient has experienced tingling from his upper arm at the vaccination site down to his wrist More
2841478	48	M	PA	05/18/2025	HEPAB PNC20 TDAP	GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH SANOFI PASTEUR	324by lx4482 2ca56c1	Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain; A... Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain; Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain; Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain More	Patient stated he experienced right shoulder pain for a week, then after that, stiffness in the arm ... Patient stated he experienced right shoulder pain for a week, then after that, stiffness in the arm and decreased range of motion. He states that if he tries to stretch further out, he experiences some pain More
2841523	19	F	AZ	05/18/2025	MNP	PFIZER\WYETH		Dermal filler reaction, Lip swelling, Pain, Swelling Dermal filler reaction, Lip swelling, Pain, Swelling	Localized swelling and pain, then patient developed granuloma-like swelling in one area of her lip w... Localized swelling and pain, then patient developed granuloma-like swelling in one area of her lip where she had filler previously the following Sunday AM. More
2841431		F	NJ	05/17/2025	UNK	UNKNOWN MANUFACTURER		Antibody test abnormal Antibody test abnormal	Antibody test abnormal; This spontaneous report was received from a Physician and refers to an Elder... Antibody test abnormal; This spontaneous report was received from a Physician and refers to an Elderly female patient in her 70's. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) (lot #, expiration date, strength, route of administration, anatomical location not provided) as "routinely pneumonia" (pneumonia immunization). On an unknown date, the patient had low antibody results with the vaccine (Antibody test abnormal), as the test showed "low" for 20 of serotypes and "low-normal" for serotypes 34, 43 and 57. At the reporting time, the outcome of Antibody test abnormal was unknown. It was stated that was unclear if there were any other adverse effects. The causal relationship between the event of Antibody test abnormal and Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02794485-02794481 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZHRHRYA5\|25042025160011\|8489 , Central date : 2025-04-25 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2280124 , MNSC case number : 02794485 , MNSC interaction number : 02794481 , Integration log UniqueID : 500UW00000ZHRHRYA5\|25042025160011\|8489 , Service cloud CaseID : 500UW00000ZHRHRYA5 More
2841432	20	M	PA	05/17/2025	HEP HEP	MERCK & CO. INC. MERCK & CO. INC.	X023303	Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More	No symptomatic Adverse Events were reported.; received his first dose of RECOMBIVAX HB at 20 years o... No symptomatic Adverse Events were reported.; received his first dose of RECOMBIVAX HB at 20 years old (2 years ago, exact date unknown). The patient did not receive their second dose until yesterday (04/30/2025); This spontaneous report was received from a healthcare professional (HCP, also reported as "physician assistant") concerning an approximately 22-year-old male patient. His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. The patient was previously unvaccinated as a child. On unspecified date in approximately 2023 (reported as "2 years ago"), at 20-year-old, he was vaccinated with the 1st dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 1 dosage form (anatomical location, route of administration, lot # and expiration date were not reported). The patient did not receive his 2nd vaccination until 30-Apr-2025 (also reported as "yesterday"), when he was vaccinated with Hepatitis B Vaccine (Recombinant) injection pre-filled syringe (batch/lot number X023303 has been verified to be a valid batch lot number for Hepatitis B Vaccine [Recombinant], expiration date reported and upon internal validation established as 17-May-2026), dose number 2, 1 mL administered by a health professional (anatomical location and route of administration were not provided) (inappropriate schedule of product administration). Both doses were administered as prophylaxis. No symptomatic adverse events were reported (no adverse event). No additional information reported. Lot # is being requested and will be submitted if received. More
2841433			NY	05/17/2025	HEPA HEPA	MERCK & CO. INC. MERCK & CO. INC.	Y007472	Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More	No additional AEs; Caller reported a Patient received her 1st dose of VAQTA on 5/21/2024 and 2nd dos... No additional AEs; Caller reported a Patient received her 1st dose of VAQTA on 5/21/2024 and 2nd dose on 11/14/2024. The 2nd dose was administered 1 week too early. The Lot and expiration information under product tab is for the 2nd dose as that is the dose involved; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 21-May-2024, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (Lot No., expiration date, exact quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On 14-Nov-2024, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 mL, strength reported as 25/0.5, administered intramuscular on the left thigh as prophylaxis (Lot No. Y007472 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported and upon internal validation established as 19-Oct-2025) (vaccination scheme frequency was not provided). It was stated that the second dose was administered 1 week too early (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event). More
2841434	12	M	KS	05/17/2025	MEN MMRV	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	U8375AA	No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More	MENQUADFI was reconstituted with an MMR Varicella vaccine's diluent and was given to a patient ... MENQUADFI was reconstituted with an MMR Varicella vaccine's diluent and was given to a patient with no AE; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was reconstituted with measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine diluent 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and HPV vaccine both for Immunisation. On 13-May-2025, the patient received 0.5 ml of dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- standard, expiry date- 30-APR-2028 and lot U8375AA) once via intramuscular route in the left deltoid for Immunization was reconstituted with measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) diluent with no reported adverse event (product preparation error) (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
2841435	11	M	NC	05/17/2025	TDAP	SANOFI PASTEUR	2CA56C1	Expired product administered Expired product administered	11-year-old patient received an expired ADACEL, with no reported adverse event; Initial information ... 11-year-old patient received an expired ADACEL, with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old male patient who received an expired diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel], 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 meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi); and hpv vaccine vlp rl1 4v (yeast) (gardasil) for Immunisation. On 13-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (Strength- standard and frequency- once) lot 2CA56C1 and expiry date- 12-MAY-2025 via intramuscular route in the left deltoid for Immunisation with no reported adverse event (expired product administered) (latency- same day). Action taken- 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
2841436	11	M	NE	05/17/2025	TDAP	SANOFI PASTEUR	3CA17C1	Exposure via skin contact, No adverse event, Syringe issue, Underdose Exposure via skin contact, No adverse event, Syringe issue, Underdose	patient was not given the full dose, as some of the medication spilled down the arm of the patient w... patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who had experienced an event was not given the full dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] vaccine, as some of the medication spilled down the arm of the patient 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 Meningococcal vaccine A/C/Y/W conj (tet tox), (Menquadfi); and HPV vaccine VLP rL1 4v (yeast) (Gardasil). On 14-May-2025, the patient received a less than 0.5 ml dose once (1x) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (batch number: 3CA17C1, expiry date: 28-Feb-2026) via intramuscular route in the left deltoid for prophylactic vaccination. On 14-MAY-2025 the patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: 1 day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Action taken: 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. 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
2841447	72	M	WA	05/17/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	MD3414 MD3414	Blood pressure fluctuation, Computerised tomogram abnormal, Hypoaesthesia, Magne... Blood pressure fluctuation, Computerised tomogram abnormal, Hypoaesthesia, Magnetic resonance imaging head abnormal, Transient ischaemic attack; Vertigo More	Pt received the covid vaccine on 4/17/2025. She had some vertigo starting on 4/18. On 4/24 She wen... Pt received the covid vaccine on 4/17/2025. She had some vertigo starting on 4/18. On 4/24 She went to the Emergency Department on 4/24 with numbness in left arm, up through her face near her eye. Her blood pressure was fluctuated very widely. She was diagnosed with a TIA, and possibly 2 earlier mini stokes found on Catscan and MRI. On 5/8 she had a follow up with neurology, but we did not received a further update. More
2841449	68	F	OH	05/17/2025	PNC20	PFIZER\WYETH	mf0416	Eye pruritus, Lip swelling Eye pruritus, Lip swelling	Swollen Lips/eyes itchiness Swollen Lips/eyes itchiness
2841450	72	F	MO	05/17/2025	CHIK	VALNEVA USA, INC.		Arthralgia, Headache, Malaise, Pyrexia Arthralgia, Headache, Malaise, Pyrexia	fever up to 104 x 2 days; joint aches; headaches; malaise fever up to 104 x 2 days; joint aches; headaches; malaise
2841451	78	F	WI	05/17/2025	PNC21 RSV	MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS	y019157 255t2	Cellulitis, Erythema, Peripheral swelling; Cellulitis, Erythema, Peripheral swel... Cellulitis, Erythema, Peripheral swelling; Cellulitis, Erythema, Peripheral swelling More	Patient called pharmacy reporting that her arm was red and swelling. Eventually, patient went to the... Patient called pharmacy reporting that her arm was red and swelling. Eventually, patient went to the ER where she was provided with an Rx sent to my pharmacy for cephalexin 500 mg (1 QID for 7 days). It appears patient was being treated for cellulitis. More
2841452	1.25	M	TX	05/17/2025	DTAP HIBV	SANOFI PASTEUR SANOFI PASTEUR	3CA25C1 UK198AA	Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus t... Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative; Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative More	Febrile seizure on 5/16/25 at 9:30. Febrile seizure on 5/16/25 at 9:30.
2841453	4	M		05/17/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS		Febrile convulsion Febrile convulsion	Complex Febrile Seizure Complex Febrile Seizure	✓
2841454	75	F	MI	05/17/2025	COVID19	MODERNA		Fatigue, Heart rate irregular Fatigue, Heart rate irregular	About 9 hours after vaccination my heart beat became very erratic. It bounced from 120s to 50s and b... About 9 hours after vaccination my heart beat became very erratic. It bounced from 120s to 50s and back within a couple minutes, and did so for 5 hours (7 pm - midnight). When I realized why it was happening, likely vaccine reaction, I decided to wait and see what happened. I had just received thorough heart tests in March with good results. But if it had gone on for much longer I would have gone to ER. Told my family doctor, Dr, at appointment this week. Plan to talk with cardiologist at next appointment. Concerned about future vaccinations, especially another Moderna COVID. It took the next day and a half to recover from extreme fatigue caused by erratic heart beat. More
2841455	5	M	PA	05/17/2025	DTAPHEPBIP MMR	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	K25M5 Y020516	Cellulitis, Local reaction, Skin warm, Swelling; Cellulitis, Local reaction, Ski... Cellulitis, Local reaction, Skin warm, Swelling; Cellulitis, Local reaction, Skin warm, Swelling More	Mild swelling and warmth started the night after getting vaccines. Seen two days later, local reacti... Mild swelling and warmth started the night after getting vaccines. Seen two days later, local reaction vs. cellulitis. Started on cephelexin and cetirizine. More
2841456	86	F	FL	05/17/2025	UNK	UNKNOWN MANUFACTURER	LN5486	Decreased appetite, Pain Decreased appetite, Pain	PT REPORTED SIDE EFFECTS 2 WEEKS AFTER RECEIVING THE VACCINES; LOSS OF APETITE & BODY ACHES PT REPORTED SIDE EFFECTS 2 WEEKS AFTER RECEIVING THE VACCINES; LOSS OF APETITE & BODY ACHES
2841458	68	F	FL	05/17/2025	DTAP DTAP	SANOFI PASTEUR SANOFI PASTEUR		Injection site pain, Injection site paraesthesia, Pain, Pain in extremity, Parae... Injection site pain, Injection site paraesthesia, Pain, Pain in extremity, Paraesthesia; Peripheral coldness, Sleep disorder, Tenderness More	Patient contacted us to evaluate her for left upper extremity pain and paresthesias that started les... Patient contacted us to evaluate her for left upper extremity pain and paresthesias that started less than 24 hours after she received dtap in her left deltoid region. Symptoms started the day after the shot and initially involved her entire arm from site to her fingers and interrupted her sleep, not relieved with Tylenol. She states it does not feel like the CRPS symptoms she tends to get in her right hand. Does not feel like neuropathy she gets in her right foot. After 24 hours she reports it improved somewhat and only now involves her forearm and hand on the left. She has waited 4 days to see if it got better and it is not improving now. She is concerned it is related to the dtap injection as it started shortly after receiving it. She had pain to touch in the left arm and forearm, pain with movement of the extremity. She was able to move through a rom but painful. Temperature difference is present with the left upper extremity cooler than the right upper extremity. Strength is hindered by pain. Prescribed Prednisone 20mg qd x 5 days, Tylenol. More
2841459	19	M	CA	05/17/2025	YF	SANOFI PASTEUR	UK134AA	Dizziness, Dysarthria, Hypotonia, Unresponsive to stimuli Dizziness, Dysarthria, Hypotonia, Unresponsive to stimuli	About 1 to 2 minutes after vaccine administration, pt reported feeling dizzy. As we spoke to him fur... About 1 to 2 minutes after vaccine administration, pt reported feeling dizzy. As we spoke to him further, pt slumped over and started slurring his words. Then he stopped responding altogether and passed out. I heard hard breathing from him and pt became very pale. I administered an Epipen 0.3mg to patient and within 30 seconds or so, pt became responsive and woke up again. Pt immediately questioned what was going on and said he remembered nothing after feeling like he was going to pass out. Paramedics were called and by the time paramedics came, pt was fully responsive. Pt had started shivering from Epipen use. Pt was taken to hospital and I spoke to pt's father today and he states pt is back to normal and no further adverse effects were noted. More
2841460	59	F	MA	05/17/2025	COVID19 COVID19	NOVAVAX NOVAVAX		Arthralgia, Fatigue, Headache, Myalgia, Peripheral swelling; Pyrexia, Vomiting Arthralgia, Fatigue, Headache, Myalgia, Peripheral swelling; Pyrexia, Vomiting	Less than 24 hours after vaccine - fatigue vomiting, severe joint pain, fever, headache, muscle ac... Less than 24 hours after vaccine - fatigue vomiting, severe joint pain, fever, headache, muscle aches, swelling in legs and feet. More
2841461	31	F	CO	05/17/2025	RAB	NOVARTIS VACCINES AND DIAGNOSTICS	fdp00527	Arthralgia Arthralgia	Patient was describing shoulder joint pain around 24 hours after receiving dose 1. She stated that t... Patient was describing shoulder joint pain around 24 hours after receiving dose 1. She stated that the pain has not subsided in seven days. The patient has not used any over the counter medications to help with the pain. The patient also stated that it didn't seem like the vaccine was given too high based on the bandage placement. More
2841462	79	M	MO	05/17/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	9L944	Chills, Fatigue, Myalgia Chills, Fatigue, Myalgia	Temperature 99.4, stream fatigue, throughout body, muscle aches, shivering at bedtime. Temperature 99.4, stream fatigue, throughout body, muscle aches, shivering at bedtime.
2841463	77	F	MS	05/17/2025	PNC21	MERCK & CO. INC.	Y044819	Peripheral swelling, Pruritus Peripheral swelling, Pruritus	Patient called 5.17.25 and stated that they got the Capvaxive vaccine 5.10.25 and by 5.13.25 the pat... Patient called 5.17.25 and stated that they got the Capvaxive vaccine 5.10.25 and by 5.13.25 the patient said her arm started swelling and itching - patient states it is still swollen and itching as of today - patient has only tried rubbing alcohol on the spot, but will try some itching cream, benadryl, and a cold compress. I told patient that if it got worse, spread, or did not resolve to go visit PCP for follow-up More
2841464	84	F	CO	05/17/2025	COVID19	PFIZER\BIONTECH	md3414	Injection site erythema, Injection site induration, Injection site warmth Injection site erythema, Injection site induration, Injection site warmth	Patient called the pharmacy on 5/16/25 worried that her arm was infected. She complained of warmth a... Patient called the pharmacy on 5/16/25 worried that her arm was infected. She complained of warmth at the injection site, a hard lump, and pink color. I asked if she had tried ice or Tylenol and she had not. She stated that she had never had a reaction before. I suggested she call her primary care if it got worse and asked her to call us and follow up if anything changed. I did not hear back from her. More
2841465	73	M	TX	05/17/2025	COVID19	PFIZER\BIONTECH	MD3414	Injection site erythema, Injection site pain Injection site erythema, Injection site pain	Redness and soreness at injection site even after 25 days Redness and soreness at injection site even after 25 days
2841466	50	M	AZ	05/17/2025	PNC21 PNC21 TDAP TDAP VARZOS VARZOS	MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	Y019158 Y019158 Eb499 Eb499 5y9ca 5y9ca	Cough, Headache, Oropharyngeal discomfort, Pain, Pyrexia; Throat irritation; Cou... Cough, Headache, Oropharyngeal discomfort, Pain, Pyrexia; Throat irritation; Cough, Headache, Oropharyngeal discomfort, Pain, Pyrexia; Throat irritation; Cough, Headache, Oropharyngeal discomfort, Pain, Pyrexia; Throat irritation More	Fevers up to 103, chills, systemic body aches, headache, tickle/burn down throat/ some coughing. Th... Fevers up to 103, chills, systemic body aches, headache, tickle/burn down throat/ some coughing. These come and go, with me feeling fairly normal part of the day, then fever spikes, seeming to be getting worse every day. With it going up to 103� today, this is quite concerning More
2841467	66	F	UT	05/17/2025	HEPAB VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	324BY SJ2S2	Rash, Rash erythematous, Skin warm; Rash, Rash erythematous, Skin warm Rash, Rash erythematous, Skin warm; Rash, Rash erythematous, Skin warm	Red, hot painful rash began shortly after shot and has continued for 3 days, increasing in severity.... Red, hot painful rash began shortly after shot and has continued for 3 days, increasing in severity. Rash on right bicep, approx fist size. More
2841468	0.42	F	WI	05/17/2025	DTAP PNC20 RV5	GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC.		Diarrhoea, Infant irritability, Pyrexia; Diarrhoea, Infant irritability, Pyrexia... Diarrhoea, Infant irritability, Pyrexia; Diarrhoea, Infant irritability, Pyrexia; Diarrhoea, Infant irritability, Pyrexia More	Fever 5/15 starting 7pm that resolved by 5/16 9am. Mild diarrhea during fever. Fussy 5/17 after 7pm. Fever 5/15 starting 7pm that resolved by 5/16 9am. Mild diarrhea during fever. Fussy 5/17 after 7pm.
2841204	1		PA	05/16/2025	VARCEL	MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	No additional AE; the 12 month old patient was administered MMR II on 1/20/2025 (1st dose) and on 2... No additional AE; the 12 month old patient was administered MMR II on 1/20/2025 (1st dose) and on 2/3/2025 the 12 month old patient was administered VARIVAX (1st dose).; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Jan-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 1, then, on 03-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), dose number 1, both as prophylaxis, the vaccines were reconstituted with sterile diluent (dose, route of administration lot # and expiration date were not reported) (Inappropriate schedule of product administration). No other information was provided. No additional adverse event. Lot # is being requested and will be submitted if received. More
2841205	18	F	MI	05/16/2025	MMRV MMRV	MERCK & CO. INC. MERCK & CO. INC.	Y008283	No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More	No additional AE; HCP called to report PROQUAD was given to an 18 year old female on 3/26/2025. No s... No additional AE; HCP called to report PROQUAD was given to an 18 year old female on 3/26/2025. No side effects or symptoms. HCP gave the combination accidentally instead of MMRII and VARIVAX separate. No additional AE/no PQC.; This spontaneous report was received from a Licensed Nurse Practitioner and refers to a 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008283, expiration date: 21-Oct-2025) 0.5 mL administered by Unknown route for prophylaxis. The vaccine was prepared with a Sterile Diluent (lot# and expiration date not reported). The healthcare professional gave the combination accidentally instead of Measles, Mumps, and Rubella (MMRII) and varicella virus vaccine life (VARIVAX) separate. No side effects or symptoms. More
2841206		F	NY	05/16/2025	MMR	MERCK & CO. INC.		Condition aggravated, Graves' disease Condition aggravated, Graves' disease	Within 2-3 months of receiving the vaccine, the daughter had "full blown Graves"; thyroid ... Within 2-3 months of receiving the vaccine, the daughter had "full blown Graves"; thyroid disease; This spontaneous report was received from a Pharmacist (the patient's mother or grandmother, discrepancy) and refers to an Adult female patient (exact age unknown). The patient's medical history was not reported. The patient's concurrent conditions included Grave's disease. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, formulation, route and site of administration, lot # and expiration date were not reported) administered with a sterile diluent (MERCK STERILE DILUENT) (strength, dose, formulation, route and site of administration, lot # and expiration date were not reported) for prophylaxis. It was stated that the patient, who was the reporter's daughter, who had been diagnosed with Grave's disease (concurrent condition), had to get the with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine when she went to college. Then, on an unknown date, reported as within 2-3 months of receiving the suspect vaccine, the daughter had "full blown Grave's". The reporter did not provide any further details on when this happened. She also asked if single measles and mumps vaccines were available, because her granddaughter (conflicting information) had thyroid disease (since unknown date), and showed signs of Graves. For this reason, she was unable to get the shot. The reporting pharmacist also mentioned that the Rubella portion is contraindicated in pregnancy and mentioned being allergic to components in Rubella. For this reason, the reporter was not able to get the shot. She said it would be beneficial if the single measles and mumps vaccines were still available, and that there were benefits to having access to the single components so that people with issues to Rubella could get vaccinated. The reporter mentioned being a registered pharmacist and would like to be contacted regarding her feedback. She was hoping the Company would reconsider the decision to discontinue the monovalent components as she could not get the vaccine because she was allergic. She asked why should MMR be given if people only need to get vaccinated against measles, the Rubella was causing the issues. At the reporting time, the outcome of the events was not reported. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. Upon internal review, the event of Grave's disease was determined to be medically significant. Lot # is being requested and will be submitted if received.; Sender's Comments: Based on the clinical information currently available for this individual case, there is no sufficient evidence to suggest a reasonable possibility for a causal relationship between M-M-R II vaccine and the adverse event of Grave�s disease. More information regarding if the vaccine was administered and the exact date of administration (if administered), the clinical course and relevant diagnostic evaluation is needed for further assessment. No changes to the product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product. More
2841207	18	M	OR	05/16/2025	HPV9	MERCK & CO. INC.	Y007197	Immediate post-injection reaction, Syncope Immediate post-injection reaction, Syncope	Immediate syncope; This spontaneous report was received from a Physician Assistant and refers to an ... Immediate syncope; This spontaneous report was received from a Physician Assistant and refers to an 18-year-old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included Diphtheria tetanus pertussis vaccine (TDAP) and Meningococcal vaccine ("GFK"). On 06-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y007197 confirmed as valid, expiration date: 18-Aug-2026), administered Intramuscularly (anatomical location not provided) as human papillomavirus (HPV) prevention. On the same date after vaccination, the patient experienced Immediate syncope. Therefore, the patient was laid down and the event recovered within 15 minutes. It was reported that the aforementioned concomitant vaccines were administered few minutes before Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), and the patient did not experience any immediate symptoms. Also, it was stated that there was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they had given 3 doses out of this box and had had the same issue with each patient. Patient had not experienced any other issues. The causal relationship between Immediate syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Upon internal review, the event of Immediate syncope was determined to be medically significant. This is one of several cases reported by the same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-05-08 , MNSC number : 02802186 , CLIC number : , ESTAR number : , IRMS number : 02802186 , Central date : 2025-05-08 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2841208		F	WI	05/16/2025	DTAPIPVHIB	SANOFI PASTEUR		No adverse event, Product preparation issue No adverse event, Product preparation issue	administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial ... administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA135316 and US-SA-2025SA138691 This case involves an unknown age female patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only the DTAP-IPV dose was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of Pentacel was administered. She further asked if they had to revaccinate or when can they give the Hib component. 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.; Sender's Comments: US-SA-2025SA135316: US-SA-2025SA138691: More
2841209		M	WI	05/16/2025	DTAPIPVHIB	SANOFI PASTEUR		No adverse event, Product preparation issue No adverse event, Product preparation issue	Nurse reported administering pentacel but only the Dtap-IPV dose was given with no reported adverse ... Nurse reported administering pentacel but only the Dtap-IPV dose was given with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age male patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only the DTAP-IPV dose was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of Pentacel was administered. She further asked if they had to revaccinate or when can they give the Hib component. Information on the batch number was requested corresponding to the one at time of event occurrence. 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.; Sender's Comments: US-SA-2025SA138519: More
2841210	0.58			05/16/2025	DTAPIPVHIB	SANOFI PASTEUR		No adverse event, Product preparation issue No adverse event, Product preparation issue	patient was administered the liquid DTaP-IPV component of Pentacel without mixing it with the Hib co... patient was administered the liquid DTaP-IPV component of Pentacel without mixing it with the Hib component of the vaccine with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old patient with unknown gender who was administered with the liquid dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without mixing it with the hib component of the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-May-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization (Immunisation) and was administered the liquid dtap-ipv component of pentacel without mixing it with the hib component of the vaccine with no reported adverse event (single component of a two-component product administered). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, caller stated that she accidentally gave only the liquid DTaP-IPV component of the Pentacel vaccine to a 7-month-old baby, without first mixing it with the Hib component of the vaccine, and she is asking for information on that. 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
2841211			CA	05/16/2025	IPV	SANOFI PASTEUR		No adverse event, Product storage error No adverse event, Product storage error	product administered after the excursion with no reported adverse event; Initial information receive... product administered after the excursion with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received after the excursion with no reported adverse event IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) after the excursion with no reported adverse event (poor quality product administered) (Latency same day) Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Max/low temperature reached: Lowest temperature reached was 21.7F and maximum was 43.2F. Duration out of labelled range: 15 minutes. Human error not involved, but caller is unsure which vaccines were administered and will follow up if they decide to deem the products not viable. Caller stated that their back up log showed a 43.5 F maximum temperature and a 39.0F minimum temperature. 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
2841212	1	M	NY	05/16/2025	DTAPIPVHIB	SANOFI PASTEUR	UKO15AA	Crying, Extra dose administered, No adverse event Crying, Extra dose administered, No adverse event	pentacel was administered twice (in one day),the first vaccination, only the diluent was administere... pentacel was administered twice (in one day),the first vaccination, only the diluent was administered,in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered an extra dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered 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 pneumococcal vaccine conj 15v (CRM197) for Immunisation. On 07-May-2025, the patient received an extra (dose 3) of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Powder and suspension for suspension for injection, lot UKO15AA,expiry date: 31-May2025, Frequency = once, Strength:Standard, via intramuscular route in the left thigh for prophylactic vaccination (immunization) which was administered twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event (extra dose administered) (latency:same day). Reportedly,patient was reported waking up crying and was holding his head and no treatment given. 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
2841219	2	F	CA	05/16/2025	PNC21 PNC21	MERCK & CO. INC. MERCK & CO. INC.		Gait inability, Injection site rash, Injection site reaction, Musculoskeletal st... Gait inability, Injection site rash, Injection site reaction, Musculoskeletal stiffness, Pain in extremity; Pyrexia, Rash, Staring, Vomiting, Weight bearing difficulty More	Injection was done at 9:50a on Tuesday morning. within 15 minutes of her injection a very thick puff... Injection was done at 9:50a on Tuesday morning. within 15 minutes of her injection a very thick puffy rash along her leg beginning from injection site up towards her mid belly began. Leg stiffness, leg pain, and inability to walk due to her leg not being able to have weight on it happened immediately following her rash appearing. We placed warm compresses and gentle circular motions to the leg, gave Benadryl and a topical antihistamine to her leg. At 9:15pm that night, she spike a high fever of 104.1 that was not responsive for several hours to tylenol or ibuprofen to drop the fever. It took several hours of cold baths and rags to get the fever down. She had a blank stare in her face and didn't seem as though she was hearing us. At 2:30a her fever finally dropped to 102.6 and stayed there the remaining of the day (even with around the clock ibuprofen and tylenol in her system). She began vomiting off and on until 5pm that Wednesday night. Her rash spread and her leg remained stiff and painful to touch. By day 3 (Thursday) her fever is completely gone and despite the rash and her leg having a hard time walking from the vaccine site, she is otherwise okay. More
2841220	46	F	TX	05/16/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	ER8737 ER8737 ER8737 8736 8736 8736 0183 0183 0183	Chronic fatigue syndrome, Condition aggravated, Dyspnoea, Gastrooesophageal refl... Chronic fatigue syndrome, Condition aggravated, Dyspnoea, Gastrooesophageal reflux disease, Hypertension; Intervertebral disc protrusion, Laboratory test, Lumbar spinal stenosis, Migraine, Multisystem inflammatory syndrome in adults; Nausea, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Vomiting, X-ray; Chronic fatigue syndrome, Condition aggravated, Dyspnoea, Gastrooesophageal reflux disease, Hypertension; Intervertebral disc protrusion, Laboratory test, Lumbar spinal stenosis, Migraine, Multisystem inflammatory syndrome in adults; Nausea, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Vomiting, X-ray; Chronic fatigue syndrome, Condition aggravated, Dyspnoea, Gastrooesophageal reflux disease, Hypertension; Intervertebral disc protrusion, Laboratory test, Lumbar spinal stenosis, Migraine, Multisystem inflammatory syndrome in adults; Nausea, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Vomiting, X-ray More	?????????????????? (Post-COVID) 5. Migraines 6. POTS 7. HTN 8. GERD 9. MIS-A 10. L4-S1 stenosi... ?????????????????? (Post-COVID) 5. Migraines 6. POTS 7. HTN 8. GERD 9. MIS-A 10. L4-S1 stenosis, bulging discs 11. N/V prn 12. Intermittent Sob 13. Myalgic Encephalomyelitis More	✓		✓	✓
2841222				05/16/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Hypoaesthesia, Vaccination failure Herpes zoster, Hypoaesthesia, Vaccination failure	Suspected vaccination failure; Shingles; I have no feeling on side where I had it bad; This serious ... Suspected vaccination failure; Shingles; I have no feeling on side where I had it bad; 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. The patient's past medical history included shingles (patient had it bad out of the blue, but once he/she got over it). 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), shingles (Verbatim: Shingles) and numbness (Verbatim: I have no feeling on side where I had it bad). The outcome of the vaccination failure, shingles and numbness were not reported. It was unknown if the reporter considered the vaccination failure, shingles and numbness to be related to Shingles vaccine. The company considered the vaccination failure, shingles and numbness to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media Patient had it bad out of the blue. Once he/she was over it, he/she got the shots and later ended up getting it again. The second time was at least mild. He/she lost feeling on the side where he/she had it bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Hypoaesthesia are unlisted events which are considered unrelated to GSK Shingles vaccine" More
2841223	2	F	MN	05/16/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	Y49BZ	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	a dose of Kinrix vaccine was administered to a 2-year-old patient; This non-serious case was reporte... a dose of Kinrix vaccine was administered to a 2-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 05-MAY-2025, the patient received Kinrix. On 05-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a dose of Kinrix vaccine was administered to a 2-year-old patient). The outcome of the inappropriate age at vaccine administration 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 :05-MAY-2025 Nurse called to report a dose of Kinrix vaccine was administered to a 2-year-old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up. More
2841224		M	VA	05/16/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS		Product preparation issue Product preparation issue	Menveo, Administration of only the diluent portion; Menveo, Administration of only the diluent porti... Menveo, Administration of only the diluent portion; Menveo, Administration of only the diluent portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 07-MAY-2025, the patient received Menveo. On 07-MAY-2025, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Menveo, Administration of only the diluent portion) and inappropriate preparation of medication (Verbatim: Menveo, Administration of only the diluent portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported about administration of only the diluent portion of Menveo (2 vial) to a patient, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The pharmacist asked if the patient should be re vaccinated. The pharmacist did not provide patient identifiers (initials, age), and did not had the information about Menveo dose(lot number, expiration date). Consented to follow up. More
2841225				05/16/2025	COVID19	MODERNA	3043838	Pain in extremity Pain in extremity	Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported... Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. This case contains information for the 2nd of 5 patients described by the reporter. No concomitant medication was reported. The reporter checked to see if Spikevax lot 3043838 had any quality issues or concerns. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added. On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786107:Master case More
2841226				05/16/2025	COVID19	MODERNA	3043838	Pain in extremity Pain in extremity	Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported... Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. This case contains information for the 1st of 5 patients described by the reporter. No concomitant medication was reported. The reporter checked to see if Spikevax lot 3043838 had any quality issues or concerns. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786120, US-MODERNATX, INC.-MOD-2025-786122, US-MODERNATX, INC.-MOD-2025-786123, US-MODERNATX, INC.-MOD-2025-786125 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added. On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786120:Patient 2 US-MODERNATX, INC.-MOD-2025-786122:Patient 3 US-MODERNATX, INC.-MOD-2025-786125:Patient 5 US-MODERNATX, INC.-MOD-2025-786123:Patient 4 More
2841230	2	F	MS	05/16/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	22GP3	Swelling, Swelling face Swelling, Swelling face	Swelling on left side of face and neck. Swelling on left side of face and neck.		✓

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