chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11:15am patient is a 25 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - diffused pruritis . Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  Patient states 15 minutes after she received the vaccine, she started feeling itchy on her right arm where the vaccine was given. Then itchiness has gradually moved to her left arm and now her face. Concerned that she has facial itching as this is new to her.  She reports no difficulty breathing, shortness of breath, chest pain, dizziness, headache. States she does have a hx of mild seafood allergy, has never needed to use an epi pen.   BP 114/76  | Pulse 97  | Resp 16  | SpO2 96%   General:  alert, well appearing, no acute distress Eyes:  no erythema or discharge  Mouth/Throat:  no erythema or lesions, no signs of angioedema Neck:  supple, no significant adenopathy Lungs:  clear to auscultation, no wheezes  CV:  normal, regular rate and rhythm, regular rhythm, no murmur Skin:  no hives, + generalized  Eczematous patches throughout both arms   11:45am  Spoke with MD from Urgent Care - agree to monitor for 30-45 minutes with administering benadryl po. If Patient symptoms worsen, will transfer to EMERGENCY DEPARTMENT for observation.   Action(s) taken: Another drug administered - Benardryl 50 mg Allergy to COVID-19 vaccine documented in Allergies activity: No, Referred to Advice MD Allergy   12:25 PM Patient states pruritis  has improved and ready to go home. Patient is alert , awake and oriented. She is no distress, no angioedema, no visible rash or hives.  Vitals within normal limits.  I discussed the  possible sedative effects of benadryl- states she is not drowsy and able to drive herself home. EMERGENCY DEPARTMENT precautions discussed- if symptoms worsen, call 911 or EMERGENCY DEPARTMENT.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 44 year old female. 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, intramuscular, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Day of injection: Shivering/shaking, fever, arm pain at site of injection, nausea, lack of appetite  Day 1-14: severe chest pain, difficulty breathing, arm pain at site of injection  Month 0-4 (Sept2021-Jan2022): continued chest pain that is enhanced by any form of exercise, arm pain at the site of injection
Let me preface that I have never felt pain from a broken bone before so I am not sure how it should feel, but my left leg randomly gets these intense intermittent stabbing pains like the bone is being chopped at.  I don?t know how else to describe it other than that. When it happens it is some of the most intense pain I?ve ever experienced. I called my doctor and am waiting to get in to see them so no resolution yet.
Around 1 hr after vaccines pt developed urticaria on face, chest, back. Presp distress. Given Benadryl in office. No new lesions noted, pruritis improved.
adverse event began 2 hours post vaccination swollen left arm around injection site, redness and bruising that lasted 2-3 days and then left a scab after and started peeling, patient describes it as a skin burn. She self treated with hydrocortisone cream and vitamin E. Patient states not experiencing pain.
I ended up getting a fever of 101 and body aches for the next 2 days after the vaccine. I took some extra strength Tylenol that helped with my symptoms. I did not go to a doctor for care.
Patient began complaining of an itchy and tingling throat about 2-3minutes after vaccine given. A minute later stated it had stopped. Her HR was found to be 150 and B/P 140/ 98 with O2 sat of 97% on RA.  Had patient deep breath with mask off and after about two minutes complained her throat was tingling again and Benadryl 50 mg was given IM. Stat team was called and took her to treatment area. Pt. talked on her phone throughout the incident and denied shortness of breath or discomfort.
5 days after the vaccine I woke up with severe vertigo and earache which improved later that day.  I went to my provider's clinic on Sunday in the afternoon and the PA said I had fluid in both ears.
Information has been received from a physician concerning a patient who was vaccinated with mumps virus vaccine live (Jeryl Lynn). Three years after receiving virus vaccine (Jeryl Lynn), the patient has "low titers.' The outcome was not reported. The patient's twin sibling had a similar experience (WAES#0609USA08026). Additional information has been requested.
Day 1 - headache starting in the evening; notable soreness at injection site. Day 2 - headache continued throughout the day; muscle aches; continued soreness at injection site. Day 3 - some achiness; significant chills in the evening; soreness at injection site. Day 4 - slight remaining headache.
Within 15-minutes of vaccination, the patient reported palpitations and feeling lightheaded.  EMS evaluated the patient on-site. The patient was hypertensive and transported to Emergency Department. In the ED, the patient remained hypertensive (199/95). Patient was administered clonidine and reported feeling improved. They were discharged with palpitations and hypertensive urgency.
Rash on chest and back on the side where vaccine administered, terrible headaches and neck aches
RASH STARTED ABOUT A WEEK AFTER THE 2ND SHOT. BUMPS ON LEFT UPPER ARM AND BACK OF NECK, THEN BUMPS STARTED ON RIGHT ARM. TOOK BENADRYL FOR THE ITCHING AND RUBBED CALAMINE LOTION ON THE BUMPS. BUMPS WOULD STOP ITCHING BUT COME BACK. COULD NOT CONTINUE TAKING BENADRYL BECAUSE IT CAUSES MY HEART TO RACE. STOPPED USIG THE CALAMINE BECAUSE IT WAS NOT HELPING. TRIED RUBBING ALCOHOL AND IT GAVE SOME RELIEF. THIS IS THIRD WEEK AND STILL GETTING NEW BUMPS ON MY ARMS AND NOW MY LEGS. I HAVE NOT BEEN TO A DOCTOR YET BUT DID REPORT IT TO MY SUPERVISOR AT WORK BECAUSE I HAVE TAKEN TIME OFF DUE TO THE PAIN.
Client received 4 doses of Janssen covid vaccine and 2 doses of Moderna covid vaccine a total of 6 using alias names.   J&J (3/11/21) Moderna (3/19/21) J&J (4/9/21) Moderna (4/16/21) J&J (6/3/21) J&J (6/20/21)
Pt recvd 3 doses of Hep B vax JAN91, FEB91, & JUL91 & titer performed in NOV91 failed to seroconvert;
pt recvd vax in the Am that afternoon pt had an episode of paleness & listlessness, irritable, inject site painful;
COUGH, RUNNY NOSE, FOR TWO WEEKS, GENERAL MALSIE, BODY ACHE
HAVE NOT FELT THE SAME SINCE RECEIVED VACCINE; This spontaneous report received from a patient concerned a male 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, and batch number were not reported) 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 patient experienced have not felt the same since received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have not felt the same since received vaccine. This report was non-serious.
This spontaneous report as received via company representative from female physician assistant refers to herself (age unknown). The patient's medical history included eczema. On an unknown date (when she turned 60) the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot # were not provided). The physician assistant reported that 3 months later she developed rash on her hand and her skin was peeling off. The patient saw her healthcare provider who placed her on unspecified antibiotics which didn't work. The patient then saw 3 unspecified dermatologists who could not figure out what it was. The patient reported that the rash went away completely after a year. The outcome of her skin was peeling off was unknown. Relatedness between rash on her hand, her skin was peeling off and ZOSTAVAX was unknown. Additional information has been requested.
8/10/17 - 10 months - Vaccine reaction to prevnar 13 3rd dose- fever of 102, high pitched crying for over a week, especially at night, lost all sounds, became non verbal, lost eye contact, would not respond appropriately to stimuli.  1/24/18 - 15 months - Complained to Dr. about his ?regression? with sounds and speech. Said it happened after his last immunization and he never regained his sounds.  4/23/18 - 18 months - Complained to Dr. about his limited eating. He ate everything up until recently and was self limiting to about 5 foods at this time. Asked about getting speech therapy. Was told he still had time to catch up. But I pressed her because he was making NO SOUNDS anymore. She referred him for an Speech evaluation.  5/14/18 - 19 months- Evaluated for speech, scored at a 10month old level.  5/16/18 - 19 months - TDAP vaccine 3rd dose, stopped eating all foods but quinoa and almond milk post vaccination. Became chronically constipated. 6/1/18 - 20 months - Began speech therapy.  6/4/2018 - Appoint with MD, ENT- Concerns about speech, hearing and swallowing. Had Audiometric test. Tympanograms normal, Type A bilaterally. Diagnosed with Dysphagia.  7/10/18 - 21 months - Meeting with Early Intervention System. Had a 25% deficit an was approved for Early intervention services. In home speech and OT once a month. 10/1/2018- MD, ENT- Follow up for issues with related to Dysphagia, performed Laryngoscopy. Enlarged inflamed adenoidal tissue. Referred to Pediatric Gastroenterologist.  10/30/2018 24 months - Upper and Lower Frenectomy Laser Revision 11/21/2018-  MD, ENT Six week follow up.  11/28/18 - 25 months - MD - Upper GI Endoscopy - Diagnosed with Reflux Esophagitis, prescibled 40mg of Nexium 12/6/2018 - MD - Sleep Study Consult  12/17/18 - 26 months - Evaluated for Occupational Therapy. Scored 15months on grasping and 21months on visual motor integration. Started weekly OT.  1/9/2019 - Failed Sleep Study. 1/30/2019 -  MD, ENT - Follow up. Discuss and schedule adenoidectomy and tympanostomy tubes. 2/8/19 - 28 months - MD, ENT-  adenoidectomy and tympanostomy tubes. 2/23/19 - 28 months -  Implemented Cod Liver Oil- Significant improve in eye contact and speech and overall behavior 2/27/2019 - MD- GI Post op follow up. Instructed to do milk and molasses enemas for constipation. Prescribed Generlac.  3/21/2019 -MD, ENT- Post op follow up. Audiometric test. 5/16/19 - 30 months -  Extensive Labs done, high thyroid, low iron, high urea  9/4/2019 -  Evaluated at School for integration into school systems Special Needs program out of early intervention.
After administration of the vaccine into patient's deltoid, the needle became dislodged from the syringe and stuck into the patient's arm. This was not a human error as the needle/syringe device comes pre-assembled. The name brand of this device is Haiku retractable needle safety syringe.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received for immunization, a single dose of PREVNAR 13 on an unknown date in 2017 and a single dose of PNEUMOVAX 23 on 23Sep2018. The patient medical history and concomitant medications were not reported. The patient experienced signs of pneumonia on an unspecified date. She took antibiotics but was not 100% well yet. Planning to go to the hospital to see a doctor. Final outcome of the event was recovering. Information on the batch number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded towards the onset of pneumonia.
Pt presented in office with rash, began 7/10/08 with fever. Rash began on face and has spread to neck and trunk, arms. On exam rash consists of multiple red, raised bumps. No other symptoms.
Severe headache , chills, body aches, nausea.  Lasted approximately 36 hours.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting
Vaccines at 4:30 pm, given tylenol at 4:45.  Awoke with chills at 9:50, gave ibuprofen, but fever immediately rose-last measured at 103.3 but still rose higher within approx. 5-10 minutes.  Then breathing was labored & he had a grand mal seizure, lost consciousness and stopped breathing.  Per 911, put on left side & undressed, & he regained consciousness & breathing.  Ambulance arrived at 10:02-gave O2, checked blood sugar & vitals, took to ER.  ER Dr. gave more ibuprofen & tylenol & told us to alternate doses & increase dose we were normally giving.  Next day at Peds office, checked vitals & reflexes- felt certain seizure brought on by fever caused by vaccinations.
felt tired (2nd dose); chills (2nd dose); a little more pain in joints (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Cancer (NOS) (Cancer Survivor-No recent change in status such as improvement or worsening) and Cancer surgery (Precancerous polyps removed-No recent change in status like improvement or worsening). Concurrent medical conditions included Seasonal allergy, Fruit allergy (Multiple allergies including grapes) and Drug allergy (Allergic to the colonoscopy "Prep" medication). Concomitant products included VITAMINS NOS, VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-May-2021, the patient experienced FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)). At the time of the report, FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Tested negative in September 2021 she thinks..         Lot number of dose 1 was said to be illegible, caller reported it as 039B2?D Treatment information was not provided.   This case was linked to MOD-2022-559967, MOD-2022-559987, MOD-2022-559986 (Patient Link).
COVID Arm. It?s big and Red Swollen about 4 inches tall it?s Friday night. I got the shot Tuesday around 2:30pm
Patient received shot on 9/16/14, and on 9/17/2014 woke up feeling sick. Extremely weak, had to crawl to the restroom, rapid heart beat, shortness of breath, no appetite, heavy sweats, rash on the left arm and sore for 2 days could even use rt, arm was hot to the touch.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history.  The patient's past medical history included Hypertension since an unknown date and Hypothyroidism since an unknown date. Concomitant products included POTASSIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-056895 (Patient Link).   Reporter did not allow further contact
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/27/2021 COVID-19 PNEUMONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/19/2021 COVID-19 PNEUMONIA
Hives, rash on face, torso, arms, groin, legs. High temperature 101 F Tool Benadryl, tyelenol. Symptoms return after 8 hrs. Symptoms lasted 4 days post vaccination.
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
Initial spontaneous report received from a physician on 27 May 2010. A 48-year-old female patient with a history of diabetes received an intramuscular left arm injection of ADACEL (sanofi pasteur inc lot number UF544CA, sanofi pasteur ltd lot number C3109) on 21 May 2010. Concomitant medication included metformin. Approximately 24 hours after vaccination she began having body aches. Her left arm became red, warm and painful from the deltoid to 2 inches below the elbow. She was seen by her physician on 26 May 2010, at which time the redness extended outward on the borders, with central clearing noted. She was treated with BENADRYL and prednisone, and the event remained ongoing at the time of the report. Documents held by sender: None.
This patient had a local reaction, pain, swelling, erythema, large area of upper arm, affected strength and ROM, and numbness persisted over 48 hours. Treatment was Ibuprofen, cold compresses, diphenhydramine HCL; also had systematic reaction, myalgia, and arthralgia.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding the administration of Prevnar that was exposed to -8 degrees C. The dates of administration was not specified. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. it was reported that Prevnar was exposed to 8 degrees C, the vaccine was administered (medication error). The number of patients who experienced this event was not specified. Additional reports will be generated when identifying information is provided.
Constant palpitations, chest pain, decreased heart rate. Currently on Metoprolol and being evaluated for an ablation.
Extremely sore arm following day (3/25/21), worsening throughout the day, could hardly lift. Nose bleed early in the morning and about mid day. Two days after (3/26) no nose bleeds, arm is tender and red at injection site with knot, but overall feeling much better.
Pt vaccinated with MMR/TD  Post vaccination hypotension & bradycardia 30 seconds after MMR 90 seconds after TD.
The left arm was with a large area of cellulitis that is hot to touch with no pustules. There is a puncture site from vaccine to the superior, proximal boarder of cellulitis to the deltoid region.
Admitted 9/23 for fevers, N/V, diarrhea, HA. Seen by infectious disease, received IV fluids and discharged home 9/24.
Muscle aches head to toe, headache, fatigue, nausea, loss of appetite. Symptoms persisted for two days, slightly less severe on day two. Patient completely recovered on day three. Patient did not seek medical treatment.
This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left deltoid on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 26Jan2021. When he came home that day his left arm swelled up and had a knot at the injection site. States he went right out, clarifies he went to sleep for hours. The next day (27Jan2021) when he woke up, he rubbed the area and it was sore. Three days ago (30Jan2021), he started running out of breath, he would walk to the mailbox and have to stop since he was out of breath. He never had that happen before. He was not sure what it was or if something else going on. He would have no breath whatsoever if he gets up to walk. When he was sitting still he was ok. If he gets up to walk to the bathroom, he was out of breath by the time he gets to the bathroom. States he was not short of breath as long as he was not doing anything. States it was crazy though when he starts walking and he gets out of breath. This has never happened to him before. He does not know if it was the vaccine or something else. He saw the shortness of breath was one of the side effects. He wants to find out what he should do and if he should go to the hospital. Advised to contact hcp. He asks if he was supposed to go back for the second shot. He has an appointment with his doctor in the next two weeks for all the medications he takes. The outcome of the events was unknown.