chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical assistant administered flublok instead of standard dose to patient/no AE; Medical assistant administered flublok instead of standard dose to patient/no AE; Medical assistant administered flublok instead of standard dose to patient/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case involves Child female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported.  It was of actual medication error due to Inappropriate age at vaccine administration, incorrect dose administered and off label use..Medical assistant administered flublok instead of standard dose to patient.  It was unknown whether adverse event was noted or not.   Information on the batch number was requested.   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 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.  List of documents held by sender: none.
Intervertebral disc replacement; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Lumbar discectomy in July 2022. Concurrent medical conditions included Rheumatoid arthritis.   In July 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In July 2022, the patient experienced INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) (seriousness criterion medically significant). At the time of the report, INTERVERTEBRAL DISC OPERATION (Intervertebral disc replacement) was resolving.            It was not known if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medication information was reported.  The causality of co-suspect product RINVOQ with respect to adverse event was reported as not related.  Company Comment: This spontaneous case concerns a 55-year-old female patient with a medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Intervertebral disc operation that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had a surgery to replace the disc on an unknow date in Jul 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as resolving. Patients' medical history of Rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with a medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Intervertebral disc operation that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had a surgery to replace the disc on an unknow date in Jul 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as resolving. Patients' medical history of Rheumatoid arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
next wk from receiving vax pt lifted arm to get dressed, felt sharp pain in site well above inject site; thereafter arm becoming black & blue & swollen;
Later that night I felt strange and the next day I woke up with dizziness.  It has gotten worse, feels like the room is spinning.
15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away; 8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts; Horrible breath taking heartburn; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jan2022 at 10:00 (Lot number: 33030BD) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: PCN and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: TYLENOL; VIT D3; VITAMIN K2 and B COMPLEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Anatomical Location: Left arm; Administration time: 10:00), administration date: 07Aug2021, when the patient was 59 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FD8448; Anatomical Location: Left arm; Administration time: 10:00), administration date: 28Aug2021, when the patient was 59 years old, for COVID-19 immunisation.  The following information was reported: RASH PAPULAR (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away"; URTICARIA (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts"; DYSPEPSIA (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "Horrible breath taking heartburn". The events "15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away", "8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts" and "Horrible breath taking heartburn" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash papular, urticaria and dyspepsia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment for the reported events included Xyzal, Benadryl, Steroids, Pepcid, Singular, Hydroxyzine. Since the vaccination, the patient had been tested for COVID-19.
65-year old man with PMH notable for CAD s/p 3v CABG 2015, HFrEF (EF 54% 11/2020), CKD, T2DM (A1c 7.5% 9/2020), and OSA, presenting with 2 days of weakness, malaise, difficulties getting out of bed and walking. The patient was in his normal state of health until he got the 2nd dose of the moderna covid vaccine two days ago; since then he has been somnolent, weak, not eating or drink much, and slid out of his bed and woke up on the floor once. He came to the ED because he was so weak that he couldn't walk. He furthermore endorses suprapubic and generalized right-sided abdominal tenderness that started after two episodes of nonbloody emesis and chills while waiting in the ED. He denies fevers, chest pain, dyspnea, orthopnea, lower extremity swelling, palpitations, brbpr, melena, dysuria, rash, easy brusing/bleeeing, headache, vision changes, and sensory changes.
Moderna COVID- 19 Vaccine EUA: One day after vaccination patient presented to the emergency department with fever, chills, myalgias, diarrhea, flank pain, blurry vision, and feeling of almost passing out. All vital signs within normal ranges and stable, including temperature of 36.8 degrees Celsius. No abnormal findings on physical examination. Patient received intravenous fluids, symptoms improved, and discharged to home.
Three -four days after receiving shot, the injection site started itching and became painful again. At the same time I experienced acute and chronic diarrhea that lasted for 6 days. The last instance was after lunch yesterday (April 10th).
after recv vax pt exp 10 cm circle of erythema 7 swelling around site, temp 100 by mouth. had night sweats & body aches.
Vial was not diluted, stronger dose given. Mom notified at 9am to monitor. Mom stated child was playing and injection site OK.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 30Dec2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 09Mar2023 to 13Mar2023.  Clinical course: The patient finished Paxlovid on the 13th - felt better. Started getting symptomatic again on 20Mar2023. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported serious events cannot be excluded for the suspect drug BNT162b2.  The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
PFIZER 12+ VACCINES DOSE ADMINISTERED PAST APPROVED EUA EXPIRATION/BEYOND USED DATE
Tired at first, woke up hot and sweaty at 2:00 am, body ache, injection site very tender.  Nausea off and on all day and very tired, not with it
A report has been received from a Study investigator concerning a 15 year old, female subject, Height: 5.1 inches; Weight: 140.0 Pounds, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 19-Oct-2013. The patient experienced suicide/intentional self-harm with a firearm which started on 04-May-2014. The patient died from the event of suicide/intentional self-harm with a firearm on 04-May-2014. Assessment of the Serious criteria for the report was as follows: Death. The patient died on 04-May-2014. The cause(s) of death was/were suicide/intentional self-harm with a firearm and gunshot wound of head. The investigator considered that there was no causal relationship between suicide/intentional self-harm with a firearm and FLUMIST QUADRIVALENT.
started out as rash then spread to all over the body,  looks like shingles, hives and reg. rash.  Body Aches and feels like pulled muscles in chest, tingling left arm and sore neck
Initial unsolicited case received from a pharmacist via other company Novartis (under the case ID: PUS2016US185481) on 16 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient experienced difficulty moving arm and lump in arm, she had trouble lifting her arm, she also has a lump in her arm in the area where the vaccine was received. The patient lab tests and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Day 1: Very sore red arm, excessive tiredness, by evening feeling sick. Day 2: Muscles and joints of arms, legs, back, chest - very sore. Arm (where received shot) aching, red and very sensitive to touch. Headache. Feeling ill all day. Dizzy, Stomach hurt (similar to when I had shingles last year). Day 3: Felt better than day 2, but still sick. Upper arm still red and swollen. Very tired in the afternoon. Day 4: (today) still feeling unwell, arm still red and swollen. Feeling dizzy and tired. Began researching the shot's side effects because I didn't expect to have any reaction.... especially one that is lasting so long.
Fever; Chills; Vomiting; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose number unknown (orange cap; booster), single (Lot number: FL8095, Expiration Date: 30Aug2022) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The report was not related to a study or programme. The patient is not also the reporter. The person that reported it to caller is a doctor and it was the doctor's child that had an adverse event. The adverse events that were reported were fever, chills, and vomiting that lasted a day and a half and then resolved. This was the patient's booster dose. It was given on 17Jun2022. Caller states he is unsure when the fever, chills, and vomiting started, but he assumes it started the same day the patient got the booster dose, but reporter doesn't know for sure. The reporter clarified that the patient received the Pfizer BioNTech Covid Vaccine, orange cap. The reporter stated he also had product misuse or product storage issue to report for the Pfizer BioNTech Covid Vaccine. The reporter's office was told by the Health Department that once they get it shipped to them it could stay in freezer for 2 weeks and then be use after that. The reporter stated the product can't be frozen. The office was going to probably have to discard everything. The office called the person at the Health Department who thought the office's freezer was an ultra-low freezer, but it wasn't. Someone had told them it was good for 2 weeks in freezer. The reporter stated that it was specifically the orange cap Pfizer BioNTech Covid Vaccine, but may have effected the maroon cap, and possibly the purple and gray cap too. Basically anything they had. Patient Involvement: it is all of the doctor's patients and reporter didn't have a number. The reporter is not sure how many they gave. The doctor's daughter who had the adverse events of fever, chills, and vomiting would have been one of the patients involved. The doctor tested her daughter for antibodies and her daughter did have antibodies.
SCHOOL BOOSTERS GIVEN ON 5/1/12 IN R UPPER ARM. RIGHT UPPER ARM RED, HOT, AND SWOLLEN 5/3/12.
Uncontrollable chills for one hour, soreness at injection site, head and body aches, tiredness - treated with ibuprofen
pt recvd 3 dose of of Engerix-B vax; pt reports a pos titer for hep BS antigen; this was determined from blood that was taken from pt 2 days p/3rd vax; not titer, antigenemia;
LEFT THIGH 3 X 2.5 CM RED AND WARM TO TOUCH.
Three days after receiving 2nd dose the injection site of the 1st dose became swollen, red and itching. The swollen/red area is the size of 50 cent coin. No pain. Today it has been a week since the 2nd dose and it is still swollen and red, but no itching or pain felt.
Severe chest pain graduated to the right side of my body. Right arm and leg numbness, tingling and weakness.
This spontaneous report as received from a licensed practical nurse refers to an 18 years old male patient with no known drug allergies. The patient was vaccinated IM with a dose of GARDASIL, 0.5 ml, on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012, minutes after receiving the GARDASIL, the patient felt faint. The patient did not lose consciousness, but he felt lousy for better than an hour. No treatment information was reported. No lab diagnostic studies were performed. The patient was observed for one hour. The patient will not receive any more doses of GARDASIL. The patient was recovered on 11--JUL-2012. Additional information has been requested.
Ringing both ears Narrative: Employee reported ringing in both ears post Pfizer vaccine !st dose on September 1, 2021. Employee ringing is consistent t date. Advised to schedule appoint with Primary Care Provider.
I had chills, body aches, and fatigue  the next day for 10 hrs or so.  11 days later I developed patches of hives all over my body. Benadryl initially stopped the itching for awhile, but now after 4 days of hives it barely works. I went to Dr. on the second day of hives and he prescribed a 5 day dose of steroids. I have taken two doses now, each at night. I wake up in the morning with virtually no rash or itching, but after about half an hour of activity the hives return in full force. Also the hives come and go in the same areas and patches in new areas spring up daily. Many have a wheel like shape, and others grow together to form huge red patches. At one point my ears were affected and my ear and jaw swelled to the point where I couldn't fully close my jaw for a whole day. Also, several hours before taking my first dose of steroids, I noticed a burning kind of pain going from my lower jaw/throat area down to my sternum area. It feels like reflux, but I have only ever had that once as a child and for a month or so 13 yrs ago when I was 8-9 mo pregnant with my oldest child. The burning pain seems to be coming mainly in the afternoon and evening.
fast heart rate for weeks, tired, dizzy, nervous , could not raise my arm that had the injection for two days and still sore. I have a hard time breathing after walking a short distance.
BOTH FEET GOT NUMB; FELL DOWN; NERVE DAMAGE; ONE LEG QUITE WORKING; SEVER LEG PAIN ON THE BOTTOM OF THE FOOT; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included sick, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced both feet got numb, fell down, nerve damage, one leg quite working, and sever leg pain on the bottom of the foot. Treatment medications (dates unspecified) included: naproxen sodium, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both feet got numb, and sever leg pain on the bottom of the foot, and the outcome of nerve damage, one leg quite working and fell down was not reported. This report was non-serious.
I was very achy, had a headache and sore throat. I was about to travel so I took a home COVID-19 test that came back positive. I isolated from everyone, on day seven I had a lot of heart palpitations that scared me, it felt like A-fib and I felt very weak. i went to the emergency room. They had me on a heart monitor, EKG, X- ray of my lungs and heart. They found nothing and said they felt it was part of the symptoms of COVID-19.  I am still very tired and testing positive, I am not back to feeling like myself, I do not have my sense of taste or smell back yet.
Low grade fever; Chills; Cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
did not feel very well; felt draggy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy). At the time of the report, MALAISE (did not feel very well) and FEELING ABNORMAL (felt draggy) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-419213 (Patient Link).
Patient reports that she had swelling and discoloration from top of left arm to elbow, which her primary provider described as a cellulitis. Also her smallpox vaccination site became gray and scaly. 2 months duration. Seen and evaluated by primary provider, no medication treatment.
Red swelling hard at site of injection (Subq) 10cm x 15cm fever 101.  Nausea.  No vomit.
The patient reported facial numbing for about 10 minutes, as well as head/clavical pain that lasted hours, and a swollen lymph node and that lasted a day.