chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
PT REPORTS EXTREME PAIN IN ARM SHOULDER AND NECK STARTING EVENING OF RECEIVING SHOT. LASTED APPROXIMATELY 24 HOURS. ONLY OTHER SYMPTOM REPORTED IS FEVER.
Immediately became weak, passed out when released to walk to car, vomited. Had an epileptic episode. Pharmacy staff asked me to stay or go by ambulance to hospital.
heart issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "potential binge drinker" (unspecified if ongoing), notes: implicating her as a potential binge drinker. The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues".  Additional information: Activity Category was withheld Services, Activity Subject was reported as No Subject. Activity Body reported as I am seeking a payment for evidence disproving a lawsuit by a withheld of Withheld on Withheld. She claims that your COVID vaccination caused her health issues, specifically heart issues. Reach me at Withheld As my information that I have gathered amounts even greater, I will detail what I know as follows: I have evidence of her gross irresponsibility, implicating her as a potential binge drinker and "party girl." Evidence of gross irresponsibility on day of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within less than one minute of vaccination, client became dizzy and had blurry vision. Was laid down with cool packs and improved. Attempted a couple of times to have client sit up, but with any movement continued to get dizzy without change in vision, but eyes would appear glazed over. After approximately 20 minutes client complained of mild headache to right brow area of forehead. Symptoms continued for at least 45 minutes without full recovery and EMS was notified and transported client to Health Center ER.
This spontaneous report as received from a reporter (role unspecified) via a company representative refers to a 5 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, at the age of 5, the patient was vaccinated subcutaneously with an adult dose of the chicken pox vaccine (manufacturer unknown) injection (dose, lot # and expiration date were not reported). The patient did not experience an adverse event. The relatedness between the event and the chicken pox vaccine (manufacturer unknown) was not reported. Additional information is not expected as no contact details were provided.
Crying nightly for 10-13 nights. Left thigh with 1 cm erythema, 1/2cm nodule. Right thigh with 2cm erythema and 1cm nodule. No previous problems with same shots 5/9/03 and 7/8/03.
Diarrhea , 7 days after receiving the second dose; Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose; Chills , 7 days after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose). At the time of the report, DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.
COVID tongue. Patchy red and raised off white/beige tongue with scrapeable off white thick substance. Inflamed papillae along the tongue edge where it meets the teeth on the front 1/3. Sparse inflamed papillae along the top of the tongue over the front 1/3.  Feels coated and bad breath. No matter how much I brush, floss and scrape I feel like I'm tasting garlic. Also very sore injection site. I know this is common.
Pain upper right arm, lethargy, malaise, head-ache. Aspirin, bed rest.
Controlled Type 2 diabetes w/o complications became uncontrolled with erratic blood sugars causing nausea, weakness, involuntary shaking. Circulation to fingers and toes was affected by turning white, cold,  becoming numb, then burning and tingling when warmed and turned dusky and purple. Diagnosed with Raynaud's Syndrome.
High blood pressure, heart palpitations, light headed, numbness and tingling in arms, cotton-mouth, feverish very hot, shakey
Post vax, the pt complained of feeling dizzy and nauseated. No fainting or vomiting; blood pressure and pulse were stable.
pt descrives onset of redness @ inject site, LD w/rash occuring & spread to forearms, shoulder, chest, groins; denies fever or rash on face, no resp distress, no neuro deficit; rash described as, prickly, raised, dry, rough & itchy;
Chills started around 11pm - took Tylenol and went to bed Stayed in bed for 18 hours - took a total of 3 rounds of Tylenol - every six hours Fever was around 101 - and it dropped and spiked again about 3 times Lymph nodes in my right armpit were swollen Headache and nausea most of the day on Saturday April 10, along with fevers and chills; cold compress and Ibuprofen helped. Around 6 or 6:30 I was up and moving slowly. Fine this morning after another night of sleep.
unable to move; extreme fatigue; body feels heavy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy) outcome was unknown.            Concomitant medications include Memory pill
CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. 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 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 chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210623950.
Tinnitus in my right ear; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Feb2021 at 12:45 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, esophageal acid reflux (acid reflux disease) and the patient had known allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included losartan potassium (LOSARTIN), omeprazole (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. On 01Mar2021, the patient experienced tinnitus in the right ear. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus in the right ear was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Adverse event nos; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event nos) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event nos). At the time of the report, ADVERSE EVENT (Adverse event nos) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-302036 (Patient Link).
In the year 2007, I received the 3 doses of the shot GARDASIL. In the year 2015, I was diagnosed with Multiple Sclerosis. Now, there is no family history of MS in my family. So it had to come from somewhere. I recently saw a few articles on how bad this shot is and most recently I read an article and MS was the first side effect to GARDASIL. So now my assumption of maybe the shot caused the MS has now turned into IT DEFINITELY DID.
Upper body aches: throughout arms, fingers, shoulders, chest, lower torso. Muscle weakness. Shortness of breath. Rapid exhaustion. Tiredness. I felt like I was coming down with the flu or a cold.
1/2 hour after shot my upper arms, chest and back broke out in rash and slight itching. Approximately 9 hours later (at 1am) I noticed my face was very swollen. The rash was very red, not too itchy. Face no rash slight red and rash on legs also. Doctor gave me a cortisone shot and Benadryl shot to take once / day.  Face and arms, chest back to normal
Patient's husband called about 30 minutes after she had received her Pfizer vaccination.  He said she had developed a pill sized blue/purple lump on the vein of her wrist that was on the same arm that the vaccine was administered on.  It was advised he take her to seek medical attention, preferable the ER. Patient's husband agreed to take her to seek medical attention and to update us on her status.
16AUG92 pt had not eaten very well for a few days & very lethargic not even enough energy to walk; 17AUG92 started throwing up when ate anything; lost over 10% of body weight; seen by MD 18AUG92; dx as diabetic;
10am - Felt Dizzy & Flushed 10:15am along with Dizzy & Flushed I felt sick at my stomach with  headache. This feeling continued off and on for several hours.  Around 2pm I started to feel body aches and low grade fever . A few times the feeling of off balance happened. This continued throughout the day. 9pm - Low grade fever of 99.2. Body aches more severe and headache mild. The nausea was off & on still. Also a runny nose started.
Patient received dose #1 of TwinRix Hep A/B and passed out for approximately 5 seconds. Developed nausea with emesis, was dizzy. Was supine for observation for one hour, but still unable to ambulate without nausea and emesis. Was sent to ER via EMT/ambulance for evaluation.
tired; slight fever; back pain; This is a spontaneous report from a contactable consumer (patient's wife). This case is for dose 1. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 15:00 (at the age of 46-Years-old) (Batch/Lot Number: ER8731) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history included Sinus surgery in Dec2014, covid-19 from 11Jan2021 and was recovered on an unknown date in 2021, ongoing Cholesterol, ongoing Blood pressure, ongoing Hair loss. Concomitant medication included propranolol taken for Blood pressure, rosuvastatin taken for cholesterol, finasteride taken for hair loss and ongoing multivitamins. On an unknown date in 2021, the patient experienced tired, slight fever, back pain. The patient underwent lab tests and procedures which included acoustic stimulation tests and showed results on 10May2021 with High frequency SNHL RSL muffled hearing, sars-cov-2 test was positive on 11Jan2021. At the time of this report, the outcome of events was unknown.  Follow-up attempts completed. No further information expected.
throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable consumer. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan2021 10:15 at single dose on Left arm for covid-19 immunisation. Medical history included has a lot of allergies, reactions to honey and penicillin, She experienced neck swelling after receiving penicillin. Caller took the 1st dose last 26Jan2021. she and her husband got the Covid-19 vaccine yesterday. While reporting on her husband, caller states she had a reaction to the vaccine. After receiving the shot, Caller was put on the side for half hour and 15 min later, she experienced her throat tightening on 26Jan2021. Caller was given Benadryl and observed for 10 min. Her husband received his shot but "he did not feel the needle going into his arm. Weight is between 120-123lbs. Caller mentioned that she has a lot of allergies. They watched her for 30 minutes after getting the vaccine. Within 15 minutes her throat was feeling a little tight. It cleared after about 10 minutes. Her vital signs were checked and were fine. Thy also gave her some Benadryl. She takes vitamins and minerals because she believes in them. Outcome of the event throat tightening recovered on 26Jan2021 and events was unknown.
Sore/tender arm at injection site beginning in about 2hrs after injection. Entire upper arm hot, red, swollen about 10 hrs - very itchy at 24 hrs. Remained extremely tender and red, itchy for a week. Still slightly sore, tender at 9 days. Had a fever of almost 100 starting next day following  injection and continued for a total of 3 days. Fever accompanied by chills. Decreased appetite and extremely fatigued.  Appetite now back to normal but still somewhat fatigued.
Pt came in 3/4/10 reported the evening of the shot her arm was sore with erythema under arm the shot was given (Left Deltoid) on 3/2/10. The swelling & warmth has decreased according to the pt. Reported event to the MD & informed pt. to take BENADRYL 50mg q 6 hr x 3 doses & call MD/EMG if sx worsen. Erythema going down when pt seen.
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering.  Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm.  diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
Patient felt light chest heaviness, difficulty breathing and nausea approx 10 minutes after receiving vaccine and in warm waiting room.  No syncope, felt better after legs elevated.  Food and drink given.   t = 97.4.  bp = 120/80.  hr = 103.  oxygen = 98%.  blood sugar = 138 mg/dl.  patient reports vaccination site felt 'warm' during episode but went back to normal shortly afterwards.    Chest pressure remained, bp remained stable, heart rate went down to 91.  chest pressure 2/10.  patient evaluated by dr and advised to see pcp next day.  Discharged after approx 45 minutes ambulatory.
This spontaneous report was received from a physician via a company representative and refers to two female patients (sisters) of unknown age. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated intramuscularly with unidentified Merck HPV vaccine (name, lot number, expiration date and dose were not provided). It was unspecified whether the patients received GARDASIL or GARDASIL 9 and how many doses they received. Concomitant therapy was not reported. On unknown dates, while receiving unidentified Merck HPV vaccine, the patients were diagnosed with reflex sympathetic dystrophy syndrome. The outcome of the events was not reported. The relatedness between the events and unidentified Merck HPV vaccine was not reported. Additional information has been requested.
a patient had been given an expired Tenivac vaccination with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00323975) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 31 year old male patient who received an 0.5 ml expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6021AA, expiry date: 22-Jul-2020) via Intramuscular route in the right deltoid site on 20-Oct-2020  for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the expired vaccine used (same day).  At the time of report, no adverse event was reported.  Disclaimer: 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.  No further relevant information was reported.
Information has been received from a physician concerning a 64 year old female with a history of hyperlipidaemia, allergic rhinitis, osteoarthritis, irritable bowel syndrome, cervical disc degeneration disease, glucose intolerance and drug reactions/allergies to anesthetics, who on 17-OCT-2007 was vaccinated with a dose of ZOSTAVAX (lot number: 658085/0882U).  Concomitant therapy included multi-vitamins daily, calcium 600mg twice daily, vitamin D 400 IU daily, cyanocobalamin 500mg daily, ibuprofen as needed and "amitriptyline" 10mg daily.  On 24-OCT-2007 the patient developed varicella lesions on both her thighs and legs after receiving the vaccine.  No further information was available.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought via the telephone.  The outcome was reported as recovering.  There was no product quality complaint.  The physician is not interested in the VZV analysis by PCR (Polymerase Chain Reaction).  Additional information has been requested.
Beginning 2-3 hours after injection on September 16, arm became painful and I began to feel poorly.  Basically went to bed for next 48 hours.  First evening and next day suffered chills and temperature reached 100 degrees.  By September 18 fever and chills had gone, but felt weak.  By September 19, was feeling pretty good until mid-afternoon when I felt quite nauseous and rested the remainder of the day.  OK today.
After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was getting a cold, my face was hot. I went to the station to take my temperature, it was 98.4F and then I did a re-check 15 minutes later it was 97.2F. I was still feeling under the weather and left work a little before 5pm. I started to drive to the pharmacy when I got there I felt dizzy, I still went in and bought Tylenol cold and flu PM. When I got home, I still was feeling bad, I had severe headaches, migraines and also pain to base of my neck and my chest felt very heavy, like someone was sitting on top of me. I then went to bed early, was lying flat on my bed when I started to feel my heart, shaking my whole body. I felt really scared, these were strong palpitations. I then woke up around 3am, still having persistent headaches 10/10 pain level. I woke up because I could  not sleep and went to my living room, still having chest pain and pain in my neck with headaches that did not go away. My BP in the morning was high for me was 132/96, then 133/98 and at 730am it was 137/100 with a pulse of 80. I went to the emergency room where  I received IV medication, blood tests, triponents and EKG were performed which came back negative.  After an hour of my iv medication, I still continued with headaches, neck pain and my blood pressure was still high.  My doctor said that i had a severe reaction to the vaccine. I was discharged to go home after a few hours and I rested then I slowly started to fee better.
Pfizer-BioNTech COVID19 dose #1 given IM LD at 10:30AM 1/27/21. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting. While seated, vital signs were taken- BP 148/76, HR 73, O2 98%. No falls or medication administered. EMS arrived around 11:10am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on EMS assessment, recommenedation was to go to the ER.  Patient brought to Sharp Memorial Hospital by EMS staff at 11:20am, spouse was present and in agreement.