chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back in April, I was meditating, and I started to have heart palpitations. Which was like a fluttering in my chest and being out of breath even though I wasn't moving. It felt like my heart skipped a beat and my heart was racing. It happened from 7PM-4AM every few minutes. I've had these feelings before where it would happen once or twice. But because this happened over and over again for many hours, that's why I contacted my doctor. These palpitations were happening for several hours for 2-3 minutes. I remember it kept me from being able to go to sleep. For the next week, I had them intermittently so it didn't happen often, but it would happen a few times a day for a few weeks. I was told to cut out the protein supplements by my doctor. But the palpitations wouldn't go away and eventually went away after a month. I still have them occasionally, but not as frequent and intense. For treatment, I went in for a EKG and that came back normal. They had me wear a heart monitor for 2 weeks and sent it in. The heart monitor helped with diagnosis of atrial fibrillation, but the monitor showed that it was less than 1% of the time. Taking a low dose aspirin daily to prevent stroke and blood clots.
Patients reports red, swollen area above left eye 2 x 3 centimeters which appeared shortly after vaccination.  Area continued to become larger and patient returned to clinic after hours for evaluation.  No doctor or physician extender was present and patient was counseled on adverse reactions by nurse.  He followed up with primary medical doctor which prescribed Zyrtec.  Patient reports that swelling is decreasing and he is to follow up with physician again if symptoms do not resolve.  Patient reports past similiar reactions after taking unrelated medications.
t102, congestion that evening, cough inc, runny nose, won't eat; seen @ hosp; had rash on chest; cried 2-3 hrs high pitch @ times; white as a sheet for 1 wk;  screamed cont; MD order ped DT;
Within 3 minutes, scratchy throat dissipated within 7 minutes, probably. Within 1/2 hour runny nose and 4 hours later dry cough.  Approximately 18 hours later all symptoms stopped.  I did take a couple of zinc cough drops and used saline nasal spray thinking this may help.
Pt. rec. vaccine on 02/01/16, tolerated well. The following morning she awoke with severe pain, redness and puffiness to (L) arm. Redness and pain with swelling continued and pt. returned to the office on 02/03/16 with concerns of adverse rxn warmth, redness and swelling documented throughout entire Lt upper arm. Pt advised to do BENADRYL, MOTRIL for 48 hours.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
pt presents to hosp via EMS with fever, cough, chills, worsening SOB; EMS recorded O2 sats at 48% on RA; pt placed on CPAP and brought to ED; placed on BiPAP in ED; family member positive for COVID; pt had a positive COVID test in ED; treated with dexamethasone, remdesivir, Olumiant, Heparin drip, Vitamins C, D, and zinc, ABX; pt's condition worsened with severe hypotension and multiple organ system failure; pt intubated; transferred to ICU; pt had a code blue called and family later requested DNR; as the day went on the pt's condition worsened and he passed away in the hospital
pain in shoulder , hard to lift her arm , doctor says she has sirva , still has issues 3 months later , saw doctor seen ortho doctor , got cortazole and physical therapy
The morning after the first dose (taken on 1/20/2021) I threw up and have felt dizzy/nauseous frequently. The throwing up only happened that morning but the dizziness continued. The dizziness happened when I turned my head to quickly or bent over.   After the second dose (taken at 2:30pm on 2/11/2021) I have dry heaved nearly every morning since. I'm not throwing up anything but the dry heaving happens nearly every morning and continues to even today (3/2/2021). I don't feel nauseous even though I dry heave... which seems strange. I still feel like I have vertigo, which I did not have prior to taking the COVID19 vaccine.
Fever; chills; nausea-vomiting; nausea-vomiting; aches/pain; low oxygen level. 92; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration in the left arm, on 29Sep2021 13:00 (lot number: FF8839), at age 71 years old, as dose number unknown, single, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Relevant medical history included Graves' disease, high BP, and thyroid disease from unknown dates, not reported if ongoing or not. Concomitant medications included levothyroxine sodium, aloe barbadensis and vitamin b nos all taken for unknown indications, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks. The patient previously took erythromycin and had an allergy. On 29Sep2021 19:00, the patient experienced fever, chills, nausea, vomiting, aches/pain, and low oxygen level at 92. On the same day, the patient's heart rate was 96. The events resulted to physician's office visit. Treatment for the events included unspecified nausea medications (as reported). The outcome of the events was not resolved.
12/18, 0905: metallic taste in mouth lasting all day 12/19: fatigue all day, 2200-nausea and low grade fever 12/20: fatigue lasting all day 12/21: woke up at 0400 with congestion  and sore throat. Swollen lymph nodes and swollen glands over right clavicle.  12/22: congestion, drainage, sore throat, swollen glands/lymph nodes as described yesterday and fatigue
Pt vaccinated with Pneumovax 23 developed fever 104, & localized tenderness at the site of the injection.
Got very ill; High fever; Dizzy; Diarrhea; Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "brain fog", "diarrhea", "dizzy", "got very ill", "High fever". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got very ill"; PYREXIA (non-serious), outcome "unknown", described as "High fever"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; BRAIN FOG (non-serious), outcome "unknown". Additional information: The patient got very ill after the second and third shot. The patient also experienced high fever, dizzy, diarrhea, and brain fog. The patient has avoided getting a fourth shot. The patient would like to know if the vaccines are improved enough that they won't make him/her sick.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151989 same patient and drug, similar event (separated by time), different dose;
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On unknown dates, the patient was vaccinated with improperly stored doses of ZOSTAVAX lot # reported as N012615, expiration date reported as 16-MAR-2018 (dose, route and site of administration were not reported) for prophylaxis. ZOSTAVAX underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Some part of the vaccine spilled out from the plunger with no AE; Some part of the vaccine spilled out from the plunger with no AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 76 years old female patient whom while administrating 0.7 mL once suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot UJ467AB, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination (syringe issue) (vaccine underdose) some part of the vaccine spilled out from the plunger on 08-Sep-2020.  Medical history, past medical treatments, past vaccinations and family history were not provided.  This was actual medication error case due to vaccine underdose and Syringe issue.  Reporter reported that as soon as he started pushing down on the plunger, as he was pushing it into patient, the stuff came leaking out. He states that the liquid seemed to be coming from the syringe itself, a crack in the area of the 'shoulder' of the syringe (the barrel of the syringe, "2 or 3 centimeters from the needle") (syringe issue).  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
COLD LIKE SYMPTOMS; STUFFY NOSE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, 1 total administered on an unspecified date in APR-2021 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. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received booster Pfizer Biontech Covid-19 vaccine (Tozinameran) (Dose number in series 2) (form of admin not reported, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, administered on an unspecified date in NOV-2021 for prophylactic vaccination. On 25-APR-2022, the patient experienced stuffy nose (Dose number in series 2). Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 26-APR-2022, the patient experienced cold-like symptoms (Dose number in series 2). The outcome of the stuffy nose, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was non serious.
One week after vaccine I began having high pitch tinnitus in left ear.  It is so loud and has not resolved!
Initial report was received from a health care professional on 24 January 2011. A 13 year-old patient with no reported past medical history, had received ADACEL, lot number U3051CA (sanofi pasteur Ltd lot number CC3312, route and site of administration not reported) on 14 July 2010 and approximately six months later on 18 January 2011, had a positive B pertussis IgM Ab of 1.3 (minimal and maximum values that establish the normal range were not reported). No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received on 07 March 2011 from a health care professional who provided the normal range values of B pertussis IgM Ab which were a negative of less than 1.0 and a positive of greater than 1.1. The patient's B pertussis IgM Ab was 1.3. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The female patient who had no reported illness at the time of vaccination, had received a left deltoid injection of ADACEL on 14 July 2010. She presented with a persistent productive cough for six weeks on 10 January 2011. She had a confirmed positive B pertussis IgM Ab result on 18 January 2011. She was treated with Cefdinir, MYTUSSIN AC, Prednisone and Fluticasone. Concomitant medications were listed as none. Her vaccine history included: Five doses of DTaP (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998, 23/Jul/2002); Four doses of OPVor IPV (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 23/Jul/2002); Two doses of MMR (01/May/1998, 23/July/2002); Four doses of HIB (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998); Three doses of Hepatitis B (28/Apr/1997, 30/Jun/1997, 29/Oct/1997) and a dose of Varicella (01/May/1998). No further information was provided at the time of this report. The patient's outcome was reported as recovered. Documents held by sender: none.
approx 4 hrs p/immun pt a fussier than usual, then fell asleep; ashen, gray, hypotonic, poorly responsive; t99.5; BP 52/40, pale, diminished peripheral perfusion;
jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4, treated with steroids, supportive care , pressors,  pt died 2/20/21
Persistent high fever lasting until present time. Hives on cheeks beginning 08/05/2010 at 6 PM lasting until present time. Also accompanied by rash on trunk, legs, feet and genitals.
Patient was experiencing localized swelling and redness; moderate to severe in intensity. Patient reports some weakness in affected arm and edematous area has relocated from the deltoid area (site of injection) to back side of the arm. Visibly edematous and red upon inspection. Currently taking Benadryl and Naprosyn as instructed by an allergist; patient reports that symptoms have improved but not resolved in entirety.
Patients wife stated he was found  dead on floor the morning of 6/1/21 and exact time of death was unknown.  It sounded like cause was unknown.
Double vaccinated (Name withheld) tests positive for Covid.; Double vaccinated (Name withheld) tests positive for Covid.; The initial case was missing the following minimum criteria. Upon receipt of follow-up information on [04Jan2022], this case now contains all required information to be considered valid.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Double vaccinated (Name withheld) tests positive for Covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tests positive for Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
died the beginning of this month because of blood clots because of vaccine.; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer reported for a patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced died the beginning of this month because of blood clots because of vaccine on an unspecified date. The patient died in Sep2021. It was not reported if an autopsy was performed.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died the beginning of this month because of blood clots because of vaccine.
Patient received second vaccine on 3/15/2021. Today she feels dizzy ( but stated she has history of Vertigo) and feels like she has the flu. She denies any other symptoms.
Patient was seen by this physician three days after administration of Menactra.  He was complaining of back pain, shoulder pain, headache, lightheadedness, tactile temperature, heart racing, mild neck stiffness and rash starting one hour post vaccine administration. He was recommended to control fever and pain with tylenol, maintain hydration, rest and obtain labs (CBC and CMP).  I assume that the patient recovered because he never returned to this clinic with persisting symptoms.
COVID and Shot has left an awful taste in my mouth; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "COVID and Shot has left an awful taste in my mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On February 16, 2018 patient came in requesting MMR and Hepatitis B vaccines as he had chicken pox illness as child. Received Hepatitis B vaccine in left arm. MMRV vaccine given in right arm. Noted immediately after dose given. Informed client of error, reviewed and provided copy of VIS for MMRV and reviewed the side effects. Client was understanding of error saying "mistakes happen." Follow up phone call placed 2/20/2018 on patient's voice mail to check if concerns. Called again on 2/26/2018 and spoke with patient. He stated the only side effect was site being "a bit sore" but otherwise no adverse reaction.
Vaccine administered 10/6/15 approximately 9 AM. Four and a half hours later pt felt ill, cold sweat/shivering, nausea, diarrhea x 2. Right arm became swollen "like a balloon", shoulder hurt and difficult to lift arm. Pt used Bayer ASA and APAP, ADVIL OTC and ice x 3 days.
Pt vaccinated with FLU/TYPHOID developed nausea, vomiting, diarrhea, temp 103, WBC decreased, hypertension, chills, liver function test elevated.
chills; fever; muscle pain; fatigue; headache; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: 23/JUNE/2021) .5 ml, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced muscle pain. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain, fatigue, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210437057.
Pt felt dizzy, nauseated s/p vaccination.  Placed in supine position and given water, symptoms subsided.  Pt left clinic with mother in ambulatory condition. Mother called the next day stating pt still felt nauseated/dizzy/headache & was experiencing some diarrhea.
No additional AEs; Caller reports vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies, and concomitant medications were not provided.  On 18-MAY-2022, the patient was administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (ml) subcutaneously (valid lot number U031560 [expiration date 06-APR-2023]) for prophylaxis, after a temperature excursion of 10 degrees Fahrenheit (F) for 14 minutes (min) (product storage error) (dose number, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Post vax, two  pts experienced fevers of 102 and 103 degrees. The other two pts developed large red lumps from shoulder to elbow with intense pain.
proton therapy to right ear; right ear canal resection; Adenoid cystic carcinoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site Arm upper, Batch/lot number: EN6208), administration date: 16Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site Arm upper, Batch/lot number: EW0153), administration date: 13Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ADENOID CYSTIC CARCINOMA (medically significant) with onset Dec2021, outcome "not recovered"; EAR OPERATION (medically significant) with onset 15Feb2022, outcome "unknown", described as "right ear canal resection"; RADIOTHERAPY TO EAR (medically significant) with onset 28Mar2022, outcome "recovered" (10May2022), described as "proton therapy to right ear". Clinical Course: It was reported that patient received Pfizer/BioNTech COVID-19 Vaccine Details: Dose: 4, Date: 01Apr2021, Anatomical site of injection: Arm- Upper, Batch/lot number: FJ6369, Vaccination Facility type: Hospital, 4th dose/booster. Prior vaccinations (within 4 weeks): Vaccine Name: Shingrix, Route: Injection, Anatomical site: Arm-upper, Date: 04Dec2021 and 01Oct2021.Prior vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
mom describes low grade fever (100), whelps which started on neck then spread to head then spread to stomach & groin region;also whelps on tongue;no resp problems seen by mom;mom said same type of rxn when given infant shots;not seen by MD;