chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEFT EYE STARTED GETTING MUSCLE SPASMS; KEPT UP AT NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced left eye started getting muscle spasms, and kept up at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left eye started getting muscle spasms and kept up at night was not reported. This report was non-serious.
Pt informed the Pharmacy on 4/21/22 that 2 days after he received his third shot of Pfizer 3/22/22, his eyes started to water and then after another day, his right eye was very swollen and then his face started to swell.  Pt went to see a doctor and they gave him benadryl and steroids injection.  Half his face and right eye were swollen for about a week.  Pt did not have any of these problems with the first two series.  He said he just had sore arms, and tiredness.
Headache, nausea, fatigue, fever, pain at site of shot & rash at site of shot.
Symptoms started approximately 10 days after 1st dose, red burning rash starting on bottom of my feet working up to my head.Over about a two week period I had to cover my entire head with steroid cream 4-5 times. I am still taking antihistimes and use steroid cream on
Fever, chills, pain to the touch, Bilate Flank pain. headaches, fatigue
In Feb. 2022, my daughter came to me to tell me she could not wrinkle her nose of move the side of her face. I called the doctor the next morning. She had noticed she had that longer than that night. She for sure had it a week before and just thought to finally tell me. The doctor was not sure if it was due to infection on a tooth. He gave her an antibiotic and acyclovir and prednisone. She is good now and it took about a week to clear up from that date. She has braces, also so I called her dentist to see if something of that nature could have created that effect.
positive for covid; This is a spontaneous report from a contactable consumer or other non hcp.A 19-year-male patient  received first dose of bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 Vaccine,Batch/Lot number and Expiry date: not reported), via an unspecified route of administration on 14Mar2021 as 1ST Dose, Single Dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021.On 19Mar2021 the patient experienced positive for covid sars-cov-2 test positive. patient stated that he had received his first dose on14Mar2021and was tested sars-cov-2 test positive on 19Mar2021 he came out of quarantine on an unspecified date. The patient stated that his second dose was scheduled on 10Apr2021,he wanted to know whether he could receive the second dose or not.The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
developed Shingles 10 days after vaccine and was   treated with Valcyclovir
Bloody nose in L nostril on 10-8-09 and 10-10-09, mod amount bleeding then stopped. C/o bubbly feeling in bridge of nose when nose stopped bleeding-10/12/09 bubbly.
Slight arm pain; Flu-like symptoms; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Left Arm on 11Feb2021 12:45 pm at a SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Penicillin, prostate cancer, IBS, skin cancer and Allergies. If Covid prior vaccination: No, If Covid tested post vaccination: No. Concomitant medication(s) included atorvastatin (LIPITOR), loratadine (CLARITIN), fluticasone propionate (FLONASE), atropine sulfate, diphenoxylate hydrochloride (LOMOTIL). The patient previously took historical vaccine, first dose of BNT162B2 (lot number: EL9262) for COVID-19 immunisation on 21Jan2021 01:00 PM on Left arm. Facility type vaccine was Other. If other vaccine in four weeks: No. The patient experienced flu-like symptoms (non-serious) on 11Feb2021, slight arm pain (non-serious) on 12Feb2021. After second dose, slight arm pain following morning which dissipated in 4 hours. Flu-like symptoms the day following the 2nd dose but no fever and Ok the next day. The outcome of event slight arm pain recovered on 12Feb2021.
pt recv vax 5JUL96 & was found to be pregnant (LMP 4MAY96) f/u indicated that pregnancy was terminated by an induced abortion which was the pt choice;it was noted that pt decision was r/t vax;
Immediately after receiving the shot, her heart rate went up to 154 bpm. She mentioned that her heart was beating very fast and the technician responded that she would pass out. She was monitored at the facility for 15 minutes until her heart rate lowered to 90 bpm. The raised heart rate lasted for approximately 12 hours following dose #1.
Patient developed a rash at the actual site of injection, that spread to her trunk. Also complained of itching, headache, mouth pain, and some shortness of breath.
Fever; Sore; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired). At the time of the report, PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired) outcome was unknown. Not Provided    No relevant concomitant medications were reported.  No treatment information was provided.
When pt received her chicken pox vaccine the first few nights she was very restless in her sleep waking up crying as in pain putting her hand up toward her head. In the day I felt her neck and the glands on each side felt like hard rocks. On Feb 7th in the evening she felt itchy and uncomfortable. On the morning of Feb 8th you could see she had broken out with chickenpox on her stomach, under arm, back, legs, arms. She also had a large rectangular welt on her lower left back. Feb 9th new spots on stomach,neck, arms, scalp, hands. Large spot in genital area so it burns when she urinates. Feb 10th broke out more. Feb 11 just a few more breakouts. She at least ended up with 60 spots. During the break out time in the evening or during the night she would be screaming and crying in pain that her throat hurt. It was extremely difficult to give her a drink or pain medicine because it hurt so bad. She didn't want to swallow. Eating citrus bothered her also. On Monday Feb 12 Took her to Dr at advanced pediatrics. She said she had a significant reaction to the shot and would turn in a form to the health department. Pt had complained of her ear the day before. She confirmed an ear infection but since pt was not running a fever she said to wait a few days before antibiotics to see if she still complained of the pain and had a fever. Pt did not complain the rest of the week about her ear and did not run a fever so I didn't need to give prescribed medicine. The doctor felt the ear infection was part of the chickenpox virus she was sick with.
Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the next day only), and tiredness (for a couple days). However, I have experienced tinnitus starting the evening of injection, and it hasn't disappeared or even dampened since.
Burning & itching sensation on chest. Mom saw 3 red hives running mid-chest down to abdomen. Gave Benedryl.
4"X 1" red, warm when touch, rash on left arm where the needle went in for my shingles shot on F 14 Sept 2012 16:00 EST.
Fever to 106 & mild irritability several hrs p/immun; Given acetaminophen; In office the following morning temp 101, exam otherwise normal;
Redness, heat, very large swelling and itchiness at the site of flu shot injection.
On 12-14-14, pt developed arthralgia both knees (Lt) > (Rt) and purpuric rash on legs. Was hospitalized with a diagnosis of Henoch Schonlein Purpura. CBC WNL, ESR 21, CRP 17, U/A 3 RBC. Pt had abd. pain. Abdominal sonogram was WNL. Pt was discharged on 12-16-14 as she was feeling better. As pt developed extensive purpuric lesions on legs, arms, feet, body she was readmitted on 12-18-14. Had Rheumatology consult. Was placed on naproxen PRN. IgA WNL. Coag profile WNL. Pt continued to get new purpuric rash until 12-30-14.
22 yo female in the parking structure post 2nd moderna vaccine with a c/c of dizziness. Assessment performed and normal with stable vital signs. Pt improved and refused transport to er, and signed release.
collapses with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media non-serious case from was received from a consumer/non-healthcare professional.  This case involves a 33 years old patient of unknown gender, who collapsed with heart problems, while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for flu. Information on batch number was requested.   On an unknown date, the patient collapsed with heart problems (cardiac disorder) (unknown latency) following the administration of influenza vaccine. There were no lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac disorder).  At time of reporting, the outcome was Unknown for the event of cardiac disorder.
The Morning after the vaccine I woke up with extreme fatigue and body aches.  It lasted about 8 hours. I still was tired at night and woke up 2 days after the vaccine and felt fine.
Vaccine given on 3/12/01. Pt's mom states this morning, she noticed a rash patch on left thigh and right arm. Now she has "patchy" rash all over her body except her face. Mom doesn't recall the temperature last night. States "not that high".
History of recent subdural hematoma status post evacuation/craniotomy and subsequent admission to rehab who was discharged nearly 1 week ago to home presented complaining of worsening shortness of breath and cough. Hx of CHF. COVID-19 PNA w/ acute hypoxemic respiratory failure at presentation. Tx w/ steroids, remdesivir and supportive therapy.  Weaned off oxygen, on RA at time of DC.DC'd to home w/home health.
Pt recieved vaccine.Immediate BP after vaccine 200/90. PT refused ER, co of being tired.  monitored BP 208/104.Pt coontinued  refused EMS, pt became more upset  BP 214/112. pt called husband and he picked her up.  Attempts to call EMS refused by patient multiple times.  Husband advised to take her to ED.  Went to ER.
Arm was red and swollen with about a 3 inch diameter from point of injection. Patient was counseled to take 2 ibuprofen with food every 4-6 hours and ice the area with a cold compress for about 20 minutes on/off. Planning to follow up with patient on 10/31/18.
Tingling tongue, trouble swallowing starting at about 30-35 minutes after injection. Symptoms lasted about 1 hours. I had a similar, though more severe reaction to the flu vaccine about 4-5 years ago.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Antibiotics for known allergies: Antibiotics. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VACCINE GAVE BACK PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine gave back problems. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine give back problems was not reported. This report was non-serious.
Patient reports a rash that started all over his body. Rash comes and goes away. He also reports stiffness in the shoulder and is hard to mobilize. He has pain up his left arm to his shoulder blade and neck. symptoms began the same day as his shot
2 weeks after the injection i started developing a rash on the inside of both elbows and at the injection site.
Uncomplicated first pregnancy, due Oct 12, 2021. Second Pfizer vaccine 7/30/21, began contracting on 8/8/21, admitted to hospital 8/9/21, and delivered 31wk viable infant on 8/10/21. Pt states had high fever after second vaccine.
Experienced spotting and bleeding and it was not supposed to be my normal cycle; Experienced spotting and bleeding and it was not supposed to be my normal cycle; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0198) via Intramuscular in right arm on 01Jul2021 (in the afternoon probably a little closer to 2 O'clock) as single dose (at the age of 45-year-old) for COVID-19 immunisation at pharmacy. Medical history and concomitant medications were none. Patient was healthy, and don't take any other prescriptions. No other vaccination received 4 weeks prior to COVID 19 Vaccine. Patient received vaccine on 01Jul2021 on Thursday and a week after that she experienced spotting and bleeding and it was not supposed to be her normal cycle, so she found that a little odd on 08Jul2021. She was still experiencing, it's been, let's see Thursday Friday Saturday Sunday and yeah, it's almost been five days now. She stated it looks like it was starting to Improve. The second one is coming up on Thursday it's going to be 22Jul2021. Patient not had physical yet so it's been a year. No treatment was received. The outcome of events was recovering.
Information has been received from a registered nurse concerning a female patient with gastrooesophageal reflux who on 19-JAN-2009 was vaccinated with a first dose of ROTATEQ, lot # 663638/1706X.  A lot check has been initiated.  Concomitant therapy included ZANTAC.  On 19-JAN-2009 the patient experienced 6-8 episodes of emesis after receiving her first dose of the ROTATEQ vaccine.  The nurse stated that the parents of the patient contacted the office by phone and PEDIALYTE was suggested.  Patient fully recovered.   This is one of several reports from the same source.  Additional information has been requested.
Developed an erythematous papular rash 8 days after varicella vaccine suspicious for vaccine related varicella.
fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued). At the time of the report, FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Phone call received from reception. Mom brought pt back inside building after immunizations because she is having a hard time breathing. 1457: pt in room, audible wheezing heard. Mom states that she gave her a puff of albuterol in the car but didn't have a mask/spacer. O2 Sat 82-88 %, pt coughing and nauseous. 1459: Dr. notified and in room with pt. Pt vomiting. 1505: 10 mg Dexamethasone given IM per MA, O2 Sat 100% on room air, pulse 146. 1510: pt continues to vomit. Mom at beside. 1515: pulse OX 97, pulse 112. No further vomiting noted. Mom at bedside. Pt is starting to itch. 1530: 25 mg BENADRYL given orally. 1600: pt continues to itch. 0.15 mg EPI given IM per RN.; RN at bedside. Ambulance called per protocol. 1605: ambulance here, report given. Mom and dad at bedside and going to ER with pt.
He got his vaccine, and he was feeling great.  He didn't feel well that night, and then the next morning he called for his wife and said that he could not get out of bed, his joints.  He was like a turtle on his back and not able to move his arms or legs like they seazed up on him.  He was taken to the doctor and they told her that what happened and said that they felt it was from the shot, and she believes that it was as well.  She started him on steroids and said that he could not stay on them forever.  His jaws could not open either the first day to eat.  She put him on the steroids and that night he was able to move his arms, legs and able to eat.  Then he was on them for a long while, and then she was worried about him and took him off of the steroids and tried everything.  When they got out of his systems he ceased up again and then put him back on the steroids.  They did a biopsy of him on the hospital last week and the results stated that he had a fatty liver due to the steroids from the vaccine.    He also has something wrong in his esophagus, a built up on his esophagus, a hiatal hernia and a mass at the bottom that goes into the stomach and all due to steroid use.  He is still on steroids as if he does not take them then he's not able to move.  His doctor said that if he does not get the steroids then he's not going to be able to eat or move and just live in the bed.    Due to pain and they thought that he was having a heart attack he was taken by ambulance to the hospital.  He had a catheterization and he had no blockages and the next day he had the endscope and found the findings from his esopahgus.  When he does not take the steroids he is not able to drive and cannot hold the steering wheel to grip it.    The doctor said that the vaccine has literally ruined his health.  He did not have any issues prior to his vaccine.  The one day he was fine, the next day he was not able to move or get out of the bed.  They called pharmacy that day as he has had flu shots for many years, and they informed her that there was something extra in it for over the 65 vaccine.
11/6 Flu like symptoms. Fever body aches and chills.  11/8 A.M.- 1 hour into exercising felt light headed, heart racing, shortness of breath, chest tightness and left arm felt swollen/ engorged with blood. Rushed to the ER. Multiple EKG's were performed showing normal heart function.  Blood Work was performed twice showing no negative effects.   11/11 A.M. While performing low intensity weight lifting felt light headed, fatigued and shortness of breath. Not as intense as the symptoms experienced on 11/8.
delayed shipment vaccine of Fluzone Quadrivalent was given to a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent was given to a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311023, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 46 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 04-Nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  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.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL (Lot #, dose and route not reported). The physician reported that the patient was using GARDASIL and experienced seizures. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review, seizures were considered to be an other important medical event. Additional information has been requested.
ON 01/15/2021, WAS PLACED ON THE COVID VACCINE SCHEDULE. WE HAD ?NO SHOWS? DURING THE CLINIC WHICH WARRANTED ADDITIONAL PATIENTS/ EMPLOYEES BEING PLACED ON THE SCHEDULE THE SAME DAY. WAS CHECKED IN BY THE PSR. I INSTRUCTED HIM TO BE SEATED IN THE WAITING ROOM WHERE HE WAS TO RECEIVE HIS VACCINE. I ASKED PATIENT TO VERIFY HIS NAME AND DATE OF BIRTH FOR THE PURPOSES OF ?DOUBLE IDENTIFICATION?. UNFORTUNATELY, I DID NOT RECOGNIZE THAT HE WAS UNDER THE AGE OF 18, AS I WAS WORKING UNDER THE UNDERSTANDING THAT ONLY ADULTS WERE BEING PLACED ON THE SCHEDULE FOR COVID VACCINE. DURING THE VACCINE CLINIC I AM NOT ACCESSING PATIENT CHARTS IN ECW, WHERE THE AGE OF THE PATIENT IS CLEARLY VISIBLE IN THE CHART. I DISCOVERED THIS MISTAKE ON 01/18/2021 WHILE WORKING FROM HOME. I HAPPENED TO BE REVIEWING THE SCHEDULE FROM 01/15/2021 AND DISCOVERED THE PATIENTS AGE. I IMMEDIATELY REACHED OUT TO MY SUPERVISOR.