chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from healthcare workers refers to multiple unspecified patients of unknown age and gender. No information regarding the patients medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ, orally, lot # K013861, expiration date: 18-MAY-2016, Lot # K011947, expiration date: 07-JUN-2016, lot # K020183, expiration date: 25-JUN-2016 and lot # L004466, expiration date: 02-AUG-2016, (dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, rash on arm, soreness of arm, tiredness, nausea , lack of appetite
I check my blood pressure periodically to monitor hypertension.  I was feeling fine except for sore arm when I checked my bp.  On Thursday, 10/13, bp was elevated to 154/95.  Next morning 10/14 was still elevated 147/98.  I went to dr's office 10/14 to discuss. She said if it goes over 145/90 to take half or whole losartan, in addition to whole 25 mg losartan in evening.  I started taking half pill 10/17, and had to increase to whole pill 10/19 (in morning).  BP improved but was still elevated higher than normal.  10/28 bp started improving to about 125/86, and by 10/30, 11/2, 11/3, it has been under 120/80 most of the time.
050806 Client called and reported that she had her MMR and within 1 hour she had hives on her hands and feet and then took 1 tablet of Benadryl and the hives resolved.  She was attending a potluck food event and thought the hives could have been due to something she ate.  The next day 050606, almost 24 hours after the shot was given, she noted at the injection site she had a red, raised welt,which was painful to the touch.  The welt was about 2 inches across.  Area didn't itch.  Area on 050906 was less red and continued to be tender to the touch.  RN called client at work and she indicated the redness was much better and in fact the area was only slightly discolored and the tenderness was better, but still somewhat present.  051006 1325 PM Client called and reported she experienced Left eye pain on 050906 and went to an Eye Doctor on 051006 and had an MRI on 051206 and was diagnosed with optic neuritis.  On 051506 she noted loss of visual clarity and contrast and her vision in the left eye was hazy.  Client saw Neurologist and was given IV steroids on 051506 followed by oral steroids until 052006.  Vision improving, but still experiencing visual problems and is being followed by doctor.
Patient reports she felt like her throat was closing up, felt like she was having asthma attack , she had cough, she was anxious. Patient was assessed by  and monitored by EMS. Patient reports symptoms improved , she felt better and was cleared by EMS. BP 160/90, pulse 70, Spo2 99%
Patient received vaccine at clinic, waited the 15 minutes and was released.  Passenger in car, wife driving shortly after departing from clinic - wife state he passed out in the car for approximately 10 seconds, no loss of bowel, or bladder control.  Had some UE jerking movements, he was quite awake and alert once he woke up and did not exhibit and post-ictal symptoms.  Synocpal episode at 1300 was in Vtac per Boston Scientific Reading.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LATANOPROST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive, notes: Antigen test on night of 21st turned positive quickly; (26Aug2022) Positive, notes: Still positive on antigen test 26th; (13Aug2022) Positive, notes: Original positive on the 13th felt as bad as originally minus a fever for about 3 days then symptoms improving. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Not totally clear that adverse reaction was related to the vaccine, but temporally related. Two days after receiving COVID vaccine, pt developed acute loss of vision in right eye. Awoke with vision loss. Seen initially by general ophthalmology and then by retinal specialist. Diagnosed with BRAO (Branch Retinal Artery Occlusion)
On 8/2/00 at 23:00, child vomited, had fever of 104F, headache and was very sleepy. Gave Motrin at 02:00 on 8/3/00 and she felt better. At 13:00 on 8/3/00, fever was 105F with headache and lethargy. Mom called Pediatrician who said it was a reaction and to call health dept.
high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Mar-2021, the patient experienced PYREXIA (high fever). At the time of the report, PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous case initially received from other non-health professional on 02-Nov-2018, concerning a 46-year-old, adult, female patient. The patient's historical medication included influenza vaccine during last year (as reported) and did not experienced any adverse reaction. The patient's concomitant medications included: RUBRACA for malignant neoplasm of unspecified ovary, cyclobenzaprine, COLACE, NEXIUM, Acyclovir, venlafaxine and Aspirin. On an unspecified date, the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, frequency, expiry date, trade name and manufacturer: not reported]. On an unspecified date, within three hours of administration of flu shot, the patient experienced chills and aches all over the body. The patient went to bed because she was not feeling well. The patient stated that she woke up fine the next morning. The patient questioned that the reaction was due to a concomitant drug RUBRACA in her system. The patient asserted that she was not taking RUBRACA for very long prior to the flu shot. At the time of report, the patient had recovered from the events. The reporter assessed this case as non-serious.
A territory representative reported that a 13 month old female received an injection of Hib-Titer. Seven to 9 days post immunization, she developed an injection site reaction characterized by induration and redness. She recovered. This is 1 of 2 patients from this facility who experienced this event following receipt of Hib-Titer lot # 468-488.
pt recv vax 15FEB96 & 4MAR96 pt devel one vesicle @ the inj site;it was reported that the pt sister (WAES96030581) devel one vesicle @ the inj site on the same day
Patient upset because they had given them an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
Patient email reads, " area is reddened swollen with some pain.  My legs feel wobbly and weak at times.  In addition she has a migraine that her regular medication is not helping.  Attempted to follow up with email employee not responding to call or email.
Respiratory failure; Shortness of breath; A spontaneous report was received from a health care professional (physician) concerning a 64 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath and respiratory failure.  The patient's medical history was not provided. Concomitant medications included amiodarone, apixaban, atorvastatin calcium, vitamin D, dulaglutide, furosemide, hydralazine, insulin, nifedipine and glyceryl trinitrate.  On 02-Mar-2021, the patient received his first dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 09-Mar-2021, the patient started to experience shortness of breath and had respiratory failure. Patient was admitted to the ICU.   The patient was treated with antibiotics, IV fluids, paralytics, sedation medications and cardiac medications.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (dyspnea), a causal relationship cannot be excluded. Very limited information regarding respiratory failure has been provided at this time.
This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 76-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 10Feb2021 (76-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 10Feb2021, the patient experienced little pain in middle of his back, Arm started hurting a little bit. On 11Feb2021, the patient Not feeling so good and Temperature of a hundred" [100 degrees F]. It was reported that, no reaction on Thursday (10Feb2021) but "later that day there was some pain in the back". Later in the day on 10Feb2021 he had a little pain in middle of his back; but was not really sure if from that or something else. He went to bed last night and while sleeping his arm started hurting a little bit. he heard that could happen and it was not too bad. When he woke up this morning he was not feeling so good, and has a temperature of 100-units of measurement such as degrees Fahrenheit/Celsius not clarified. He called because he did not know if he should take Tylenol or if there was something more appropriate he should take instead of Tylenol after the vaccine; he wanted to check that information with Pfizer before taking anything. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Started having a surge/relapse of symptoms associated with Meniere's Disease. Vertigo, nystagmus, loss of balance, bobble-headedness, headaches . Lasted over 5 weeks. Had to restrict driving and physical activities.
Patient was fatigued a few hours after the injection.  About 6 hrs after injections, there was a small rash around area.  Fever started @ 10:pm, patient c/o his leg hurt.  Injection site next day hot, swollen and painful.
I have rheumatoid arthritis that was controlled by methotrexate.  Following my booster shot I began to have rather severe pain in multiple joints.  One month later the symptoms are still occurring.
Pt recvd 3 doses of Hep-B vax, 3rd dose on 23JAN89 & p/the completion of the series, it was determined tha pt was a non responder & was not protected against HBV;
Fever of 100, muscle aches, bones aches, fatigue. I took acetaminophen a couple of times. Symptoms lasted 36 hours.
Hospitalized 10/27/2021; COVID-19 positive 10/28/2021; fully vaccinated  BRIEF OVERVIEW Discharge Provider: Doctor Primary Care Provider at Discharge: Doctor Admission Date: 10/27/2021 Discharge Date: 10/29/2021 DETAILS OF HOSPITAL STAY PRESENTING PROBLEM: COVID-19 virus infection COVID-19   HOSPITAL COURSE: Patient is a 63 y.o. male with a past medical history of type 2 diabetes, stroke, persistent atrial fibrillation, obstructive sleep apnea, hyperlipidemia, hypertension, and chronic kidney disease stage 3 who presents today with shortness of Breath.   the emergency department patient was afebrile, and tachypneic.  He was hypoxic and did require supplemental oxygen support 2 L via nasal cannula.  Pertinent lab findings include elevated lactic acid at 2.1 which decreased to 1.2 at recheck.  No leukocytosis noted at 8.9.  Sodium was low at 131, potassium was elevated at 5.4.  BNP was 208. Troponins were normal at 21 and then 20 at recheck.  EKG showed normal sinus rhythm.  D-dimer was noted to be elevated at 14 70.  Due to concerns of a pulmonary embolism, CT angiogram was ordered which showed no pulmonary embolism, no pericardial effusion, no thoracic aortic dissection.  Lungs did show patchy areas of peripherally located areas of ground-glass areas of parenchymal opacification comparable with does commonly associated COVID pneumonitis.  No pleural effusion no pneumothorax.  Patient was given fluids and initiated on steroids.  Due to concerns of acute respiratory failure secondary to COVID-19 pneumonia, patient was admitted to hospitalist service.  He was placed on remdesivir/dexamethasone.  He was placed on supplemental oxygen and over the course of hospitalization improved.  The patient was afebrile, hemodynamically stable and normoxic on room air.  He was discharged home on 10/29/2021 with follow-up with his cardiologist and primary care physician.
pt had ITP w/plalelet count dec to 1K-9 days p/vax;
Red M and M sized dot on her right arm/It was red; It is red and swollen but not as big as the first time; In the afternoon it was so itchy where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red M and M sized dot on her right arm/It was red), INJECTION SITE SWELLING (It is red and swollen but not as big as the first time) and INJECTION SITE PRURITUS (In the afternoon it was so itchy where she got the shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy NOS (Hysterectomy) and Parathyroid gland operation (Parathyroid surgery). Previously administered products included for Product used for unknown indication: Flu vaccine (It was reported that the last time the patient took flu vaccine was years ago.). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Itchy (Patient is generally an itchy person so she takes antihistamines daily.), Blood pressure high (High blood pressure), Hypercholesteraemia (High cholesterol), Penicillin allergy (Penicillin (anaphylactic allergic reaction)), Drug allergy (Nystatin (anaphylactic allergic reaction)), Allergy to antibiotic (Flagyl (anaphylactic allergic reaction)), Allergy to antibiotic (Ciprofloxacin (anaphylactic allergic reaction)), Allergy to antibiotic (Bactrim (anaphylactic allergic reaction)), Allergy to nuts (Tree nuts (anaphylactic allergic reaction)) and Allergy to plants (Sesame (anaphylactic allergic reaction)). Concomitant products included IRBESARTAN, ROSUVASTATIN, PROBIOTICS NOS, ZOLPIDEM and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced INJECTION SITE SWELLING (It is red and swollen but not as big as the first time) and INJECTION SITE PRURITUS (In the afternoon it was so itchy where she got the shot). On 22-Mar-2022, the patient experienced INJECTION SITE ERYTHEMA (Red M and M sized dot on her right arm/It was red). The patient was treated with HYDROXYZINE ongoing since an unknown date for Itchy, at a dose of 25 milligram. At the time of the report, INJECTION SITE ERYTHEMA (Red M and M sized dot on her right arm/It was red), INJECTION SITE SWELLING (It is red and swollen but not as big as the first time) and INJECTION SITE PRURITUS (In the afternoon it was so itchy where she got the shot) outcome was unknown.            Concomitant medications also included unspecified allergy shots and Cranberry supplement. It was also reported that the patient was generally an itchy person and so the patient took antihistamines (hydroxyzine) daily. It was reported that the patient had never tested positive for COVID-19. It was reported that the patient got a reaction to all 3 shots and it had got progressively worse each time.   This case was linked to MOD-2021-358365, MOD-2021-358382 (Patient Link).
Approx 8 hours after the first vaccine shot, I felt like I had mild flu like symptoms without a fever:  body aches, and headache
pt recv vax; fever & sz that lasted 10 mins;to hosp via amb;T inc to 102;tx w/ ATBs & released; to f/u on Friday;MD felt sz related to virus & fever;
Pt had red rash approx 2" diameter with 1 welt. Instructed to use BENADRYL oint.
Employee feels that injection was given too high and posterior to correct placement in deltoid.  She noticed a tingling sensation, pain and numbness within a few hours after receiving the injection.  These symptoms continue today. Employee does not plan to seek treatment at this time.
Stroke like symptoms, severe headaches, elevate blood pressure, tingling and numbness around mouth, right side of body was sore and numb, right side of neck was sore
This spontaneous report was received from a registered nurse referring to a 15 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
6/22: fever, 6/23: rash on face/ fussiness, 6/24: eczema patches appeared on shoulder, back of legs, chin. Rash on face worsened, 6/25: rash worsened. Became very itchy. EXTREME fussiness. Sleep changed - went from one wakeup a night to 5-10. 6/28: hives on chest and neck, 6/30: hives reappeared on chest and neck, 7/5: hives reappeared on chest and neck, started showing signs of breathing difficulties. Grabbing at throat, gasping. Rash reappeared on face and itchiness.
Child was  colicky  24/7 for her first year of life. She developed a sensitivity to gluten and asthma  in her second year as well as frequent and severe stomach aches and head aches.
Patient had a rash at injection site after 2nd hepatitis B vaccine. Received 3rd hepatitis B vaccine and months later he developed severe chronic hives with occipital joint stiffness. He must be on antihistamines to control the hives.
Suspected varicella zoster outbreak 2 weeks after vaccination - typical appearing lesions NOT appearing like ?covid arm?
the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area.; miserable; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 92-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as dose 2, single for COVID-19 immunization. Medical history included measles from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiry date: Unknown was not reported) on middle of Feb2021 Covid-19 immunization. On an unspecified date Apr2021 the patient experienced the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area, drug reaction, miserable. The patient underwent lab tests and procedures which included biopsy: drug reaction on biopsy of the rash done by the dermatologist came back as a drug reaction. Therapeutic measures were taken as a result of the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area, miserable rash did not go away and not gone away treatment included with steroid shots and prescription creams. The outcome of events was unknown.  Additional information has been requested and will be provided as it becomes available.
Subject reported chest pain on Sunday evening and again on Monday afternoon. Pain made worse by deep breathing but not shortness of breath reported. No other symptoms apart from low grade fever of 99.1.  Physical exam and EKG at local walk-in clinic could not determine cause and referral to local ER suggested. ER conducted chest x-ray which was unremarkable and blood tests with no unusual elevations. Second EKG at hospital generally normal but did indicate prolonged PR interval. Patient was released and encouraged to treat with over the counter pain medicine but to return to ER if other symptoms progressed. Mild chest pain still present at this time.
5 days after my 1st shot, I experienced general redness and soreness on my left arm pit and breast. It felt like it was infected, and it felt really painful. I called my doctor and went in for observation and the doctor said it was probably the lymph node was inflamed as well as the breast. She advised to do hot compress on the areas affected and if it didn't get better, I would need to come back again, but it worked after 5 days of continuous hot compress.
I have a redish area on my bicep, below the injection site, but not in the area of the injection. It feels hard under the skin and is hot to the touch. I has been getting progressively bigger since I first noticed it on 4/10/2021, the day after the injection.