chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious clinical trial report of Grade 3 osteomyelitis was received from a physician concerning a five-year-old female, who was enrolled in a study. The subject's past medical history included born at 35 weeks gestational age, ear infection, and no hospitalization. Her family history included arthritis, skin cancer and Sjogren's disease (all maternal grandmother). The subject has three siblings and the subject is one in a set of triplets. Her concomitant medication included amoxicillin approximately 1 month prior for treatment of an ear infection. The subject received one dose of MEDI3414 on 19-Aug-2009 intranasally, and the second dose of MEDI3414 was administered intranasally on 16-Sep-2009. The subject's mother reported progressive right leg pain for 2 days that resulted in the subject becoming unable to bear weight on the leg. The subject had several days of fevers (up to 102 F) at home prior to being evaluated in the Emergency Room. The mother reported that her daughter had a slight scratch by pet on 15-Jan-2010. Two siblings at home experienced fever, diarrhea and vomiting, and her older sister had a streptococcal infection of the throat which was treated approximately 2 weeks prior. On 28-Jan-2010, the subject presented to the Emergency Room with fever and pain in the right-knee-region. Blood work was performed, and she was sent home. The blood work revealed staphylococcus infection, and the subject was recalled to return to the hospital. On 29-Jan-2010, she was admitted to the hospital. Her vital signs were within normal limits with the exception of a fever of 39.4C. The subject was in no acute distress, and had no tenderness to palpation along the entire leg and specifically in the hip, greater trochanter, knee joint, and ankle. She had painless active and passive range of motion of the hip and ankle. The right knee was slightly warm to touch, and there was no clear effusion on examination, but was described as slightly puffy in the knee region. The subject was started on intravenous antibiotics. On 29-Jan-2010, magnetic resonance imaging (MRI) of the right lower extremity was done. The results of MRI were following: abnormal signal and enhancement of involving the distal femur and adjacent soft tissues, no focal bony lesion, and normal femorotibial alignment. On 02-Feb-2010, ultrasound and fluoroscopic guided placement of a four-French-single-lumen peripherally ventral catheter were performed successfully. on 02-Feb-2010, the subject was discharged from the hospital. The event of osteomyelitis was reported as recovered on 12-Feb-2010. The Study Investigator reported the causality of the osteomyelitis to MEDI3414 as none. Alternative etiology provided was bacterial infection. The sponsor assessed the causality of the osteomyelitis to MEDI-3414 as none. Follow-up information, changed onset date, was received on 24-Feb-2010. Follow-up information, subject's medical records, was received on 15-Mar-2010.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 01-JUN-2015, the patient was vaccinated with an expired dose (exp. date: 15-MAY-2015) of PNEUMOVAX 23 (lot number or batch number unspecified) 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was reported. Additional information has been requested.
On  3rd night after receiving my 2nd dose of the Moderna Covid vaccine, I noticed a red rash on and surrounding the injection site on my upper left arm.  As of today  (5th day), the rash hasn?t changed and remains on my arm.  It is moderately itchy, and feels warm (in comparison to right upper arm).  I have not treated it and have showered regularly,.
Chronic spontaneous urticaria occurring daily. Dermatographia, pruritus, hives, erythema. Zyrtec improves symptoms within 30 minutes- more severe symptoms occur if Zyrtec is skipped. Occurs on scalp, face, neck, trunk, legs. Often worse at night
Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added Reporter's Email address, Updated PT term of the event.
3 minutes after injection, mild tongue and lip swelling, running nose, itchy throat, red splotches and hives on chest and arms, mental confusion, and sudden extreme fatigue
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (lot/batch#, expiration dates, dose and dose numbers were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Menveo given first, followed by Boostrix in the LD.  HPV was then entered in the RD.  Shortly after dose was administered, patient passed out for about 5-10 seconds and she jerked 2-3 times.  Patient then came to, set up and then passed out again (5-10) seconds.  Once patient awakened, she turned ashen in color & got cold and clammy.  Kept patient laying down on table & took VS:  B/P-82/44 R-brachial, T-97.4, P-54.   Cold rag was applied to forehead.   Asked patient if she had eating anything that morning & she stated that she had eaten an orange before coming to her Dr. appt.   Had patient eat a granola bar and gave her some apple juice.  Took B/P again after 10 minutes & it was up to 92/58 R-brachial.  Patient no longer cold/clammy & her color had returned.  Kept patient (along with her mother) in the office for at least an hour.  She was feeling better after eating the granola bar & drinking the orange juice.  Mother stated to this nurse that she thinks it was due to her daughter having some anxiety about getting 3 shots.
This spontaneous report as received from a registered nurse refers to a 29 years old female patient. The patient was vaccinated with a dose of M-M-R II (lot # 669017/1250Z) on 12-OCT-2012 that expired on 28-SEP-2012. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Typical expected side effects but were very SEVERE and UNable to function normally- headache, fatigue, nausea, vomiting, diarrhea, Dizziness, Chills, Cold Sweats, Pain and soreness especially in lower back, and throat hurt when swallow.  These persisted for 7+ days.  The abnormal side effects included Yellow Vision that persisted for around 2 days, eyes felt hot, and heart rate shot up to 175 and then would drop to 70's.  Went to doctor on 1/14/2021 and was found to have A-fib.  had previously received a heart evaluation in 8/2020 and did not show any signs of this nor any signs on reading prior with an Apple watch.  A-Fib is persisting and heart rate continues to be elevated and shoot up often even with Metapropol.  As of this report on 1/20/2021 the heart rate is still varying from 80-150 and it normally runs around 50-60, has always been low.  Blood pressure also dropped precipitously during this event and was as low as 80/50 so blood pressure medicines were discontinued to try and stabilize.
Patient has white crusting around area of vaccination. Pt states he is experiencing pain from injection from injection site down arm. States pain from injection site to neck.
Felt dizzy; Headache; Felt nauseous; Body ached all over; Fatigued; Got a fever in the middle of the day for an hour or two; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 at 17:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, sulfonamide allergy, traumatic arthritis, nerve pain, migraine and insomnia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), suvorexant (BELSOMRA), topiramate (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO); all on an unknown date, for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.  On 21Apr2021 at 07:00, after 2nd dose, the patient felt dizzy, had a headache, felt nauseous, her body ached all over.  She also got fever in the middle of the day for an hour or two. She was also fatigued. The next day she was still little achy, fatigued and nauseous but was feeling lot better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt dizzy, headache, fever was recovered on an unknown date in Apr2021 whereas, body ached all over, felt nauseous, fatigued was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed fever, body aches and cough within several hours of receiving vaccine; this continued into fever of greater than 102, intractable cough, body aches and laryngitis.
12-year-old male with hx of asthma presented with 7 hours of chest pain 3 days after 2nd dose of Pfizer Covid-19 mRNA vaccine now admitted for monitoring in the setting of myocarditis.   # Myocarditis Admit troponin elevated to 7354 and EKG with evidence of early repolarization. ECHO performed 6/7 was normal.  Cardiac MRI 6/7 was consistent with pericarditis.  Patient was admitted for observation and close monitoring. EKG and troponin were trended every 8 hours and were overall down trending by the day of discharge. Chest pain was managed with ibuprofen every 6 hours.     ID was following patient throughout admission and recommended COVID Ab that resulted negative and  Anti SARS COv 2 Ab; Lyme Ab; CMV, EBV, Adeno PCR/Antibody; which were all pending at the time of discharge.    The patient remained afebrile and hemodynamically stable throughout admission with appropriate cardiology follow-up. Adverse vaccine event was appropriately reported to the CDC via the VAERS passive reporting system
route subcutaneous; Dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid 19 Vaccine, formulation: Solution for injection, batch/lot number and expiry date not reported), via subcutaneous route of administration on 26Feb2021 (at the age of 62-years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and ttreprostinil sodium (REMODULIN, formulation: Injection, batch/lot number: 2101788, Expiry date: 30Nov2021), via subcutaneous route of administration from 04Feb2005 to an unspecified date, at 2.5 mg/ml, subcutaneous from an unspecified date and ongoing, the current dose is 0.0115 ug/kg, continuous for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included sildenafil citrate (REVATIO) taken for an unspecified indication, start and stop date were not reported. The patient experienced dizziness in 2021. The patient received vaccine in an inappropriate route of administration (subcutaneous). The outcome of the event is unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt sick to stomach; Headache; Bodyache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 67-Years-old elderly non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6200 and expiration date not provided) dose 1 on right arm via an unspecified route on Mar2021 at 14:00 (at the age of 67-years-old) as a single dose for COVID-19 vaccination (COVID-19 Immunisation). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past medical history included High blood pressure, Thyroid, allergy to antibiotics, morphine and codeine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications received within 2 weeks of vaccination included Vitamin D, sertraline, Vitamin A, Olmesartan, Esterol and Levothi. The first day and the next patient had headache and was tired. One week later to the day and time of the Covid shot the patient felt sick to stomach, headache, body aches, and tired. The onset date of the events was 15Mar2021 at 14:30. No therapeutic measures were taken in response to the event. The clinical outcome of the events Headache, stomach discomfort, General body pain, tiredness was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
Three hours after the second vaccine there was a soreness in my left arm, followed by a headache. The next day around 12:00pm, I started to experience swelling in my throat. The swelling made it difficult to breathe. About an hour later I experienced tightness in my chest, making it difficult to breathe again. I experienced shortness of breath and the tightening in my chest did not leave. I was able to make it more bearable by taking my inhaler, used for my asthma. Today (5/17), I am still experiencing tightness in my chest, although it is not as severe as it was yesterday. The swelling in my throat as disappeared today (5/17).
12 year old patient mistakenly received Moderna COVID-19 vaccine instead of Pfizer BioNTech.
hives on my arm around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient experienced hives on my arm around the injection site on an unspecified date. Consumer had something might be a reaction to the virus but patient did not know for sure. 19 days after second virus shot. Patient did not have problems with the first two virus shots and 19 days after second shot patient had like hives on arm around the injection site. So, patient did not know if it was just side effect to the shot or if it was just totally different thing but patient wanted to call. Outcome of the event was unknown.  No follow-up attempts are completed; information about batch/lot cannot be obtained
3 months (01/17/2022) later participant experienced heart palpitations. PCP put on an antidepressant and anxiety medicine. EKG was done it was normal. Also, put on heart monitor for a week.
Information has been received from an office manager concerning a female who on 09-NOV-2006 was vaccinated with a dose of Pneumovax 23.  Subsequently the patient developed redness and a swollen arm.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Patient did not reported any adverse event.  No treatment medications were provided.
BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad headache was not reported. This report was non-serious.
(L) arm redness, pain - instructed to follow-up in 48 hours if not better, sooner if worse. NSAIDS, ice/heat, rest, elevate.
The evening of receiving the flu vaccine, the individual developed soreness in her left arm. Now, 9 days later, the arm is still sore, approximately 2" posterior to the injection site. The pain covers are area of near her left shoulder to her left elbow. The individual states that she has used hot packs and Tylenol for discomfort, but that she cannot sleep on the arm. She states that she can raise her arm to the side and back, but it is too painful to lift her arm forward. She has not experienced this pain following an injection before, and states that it feel like pain in the joint to the bone. There is no redness, swelling, warmth or hardness around the injection site.
HCF administered over 1000 that are now considered unreliable due to missing DDL information. The vaccination sites occurred at approximately 109 sites for a total of 1455 vaccines administered from July 17 to Sep 9th, 2021. The vaccination sites has not yet filed the required VAERS reports for these admiistrative events, or contacted the clients who recieved unreliable vaccines to inform them of the reccomendation to be re-vaccinated the unreliable dose. This report is being filed to alert VAERS reps in order to trigger requests for information from the vaccination sites regarding this vaccines for proper reporting and more importantly- client notification. Mutliple reports have already been filed by myself without action. Please don't hesitate to reach out for more information. I have additional spreadsheets with dates, addresses, and vaccine counts for each site. I called your site number and was advised to use this form as a means to initiate a reporting process for this concern.  (NAME), listed above, is the lead vaccination site representative working the analysis of the HCF vaccines and the required documentation. The analysis has been currupted and requires and external and unbiased second review to ensure all the clients that need to be notified are. The CDC has not responded to my email from 11 days ago, and the lack of urgency is concerning  This issue is most noted with the HCF vendor, but is a continual problem with additional unreliable vaccines being administered by the vaccination sites and clinical compliance willfully ignored. The public is at great risk and the response to clinical concerns has been to remove clinicians and complaince assessments from oversight of the vax sites. Any assistance is appreciated.
I had the typical 2nd day fatigue, low grade fever, chills, and lack of appetite, but that passed by the next day. However I also had this odd pain at the top of both my legs and into my hips. That has never stopped. Several weeks later the pain became intense in my R buttock and down the back of my leg. That was followed by an outbreak of HSV2, which I have never had ever before (13 years married and monogamous, only known exposure was in 1999-2005). The GYN and an immunologist friend said they thought the HSV was likely dormant for many years and brought out/triggered by the immune reaction to the vaccine. I've read about shingles occurring this way, so I guess this would make  sense.
Severe back and abdominal pain, pain in left leg, pain in neck, hives on upper extremities 6 hours after shot, general malaise