chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of vaccination March 2, 2021, about 20min later a metal mouth taste and excessive salivation was identified by the patient.  Signs last for about 2 hours. The following day headaches, muscle pain at the site of infection and left side of the neck area, tiredness . Signs last for three days.  No signs for the following days until March 10  where a red, swollen area  (golf size) appears at the site of infection, area itches and is hot to the touch.  Also headaches and tiredness reappears.   Patient took 1 Acetaminophen tablet on March 11 AM. Headache got better but the arm lesion still present and do not appears to get better with the treatment.
Chills, Body Aches, Diarrhea, Nausea, Dry Heaving, Weakness, Dizziness, Fatigue, Loss of Appetite
LOW GRADE FEVER; BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced low grade fever. On 06-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, and body aches. This report was non-serious.
anaphylactic reaction/rash /itching; difficulty breathing; allergic reaction; This is a spontaneous report from a contactable consumer or other non-health care professional via Medical Information Team. A female patient of an unspecified age received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On an unspecified date, the patient experienced anaphylactic reaction/rash /itching, difficulty breathing and allergic reaction. The events resulted in emergency room visit. The patient was told that she was not a candidate for the second dose. The patient wanted to know that for how long it was supposed to last. The outcome of the events was unknown.  Information about batch/lot number has been requested.
minor arm pain like a flu shot, aches, chills, fatigue--generally flu-like symptoms lasting 1 day after shot.  Second day felt just fine.
Atrial Fibrillation 3 days post injection.  Elevated heart rate prior to a-fib
Booster; Severe chills; Fever; Fatigue; Body ache; Even more rapid heartbeat (approx. 140-150 bpm when resting); Even more rapid heartbeat (approx. 140-150 bpm when resting); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing), notes: Other medical history: Bicuspid aortic valve. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Drug allergy", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose no: 1, Anatomical location: Left arm), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache"; Bnt162b2 (Dose no: 2, Anatomical location: Left arm), administration date: 11Apr2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Very rapid heartbeat (approx. 120-130 bpm when resting)", "Body ache". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Severe chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body ache"; HEART RATE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Even more rapid heartbeat (approx. 140-150 bpm when resting)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, fatigue, pain, heart rate increased, condition aggravated.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Additional information:  The rapid heartbeat continued for 24 hours before it stopped. For female 3rd dose, patient took Propanalol to regulate it. If Covid prior vaccination: No, if Covid tested post vaccination: Yes. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR, Covid test date: 03Nov2021, Covid test result: Negative. if other vaccine in four weeks: No, other medications in two weeks: No
Patient had pain when she was getting the Flu shot and the pain never goes away. She can hardly move her arm.
LEG GIVING OUT; HEADACHE; FEVER OF 101 F; This spontaneous report received from a patient concerned a 67 year old male. 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: 207A21a, expiry: 07-AUG-2021) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced fever of 101 f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-JUL-2021, the subject experienced leg giving out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg giving out, and the outcome of headache and fever of 101 f was not reported. This report was non-serious.
Sudden fever - causing febrile seizure. Patient has had 2 previous febrile seizures. The last one occurring in May 2010 after Hand, Foot and Mouth Disease.
Fever, difficulty breathing  (Oximeter  89-92, pulse 42-50), fatigue.  7/4/21, O2 still  95-97 and severe fatigue, heaviness in lungs
Days post vaccination 9cm round indurated felt non tender rash at MMR injection site. Panniculitis.
Constant feeling of ears being plugged, ''I'' would describe it as when you are taking off on a airplane; This is a spontaneous report from a contactable nurse, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included known allergies to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021, the patient had a constant feeling of her ears being plugged since receiving her second dose. The patient would describe it as while taking off on an airplane. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event constant feeling of ears being plugged was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hot/Cold flashes, fever, stomach pain when urinating, nausea, swelling at the injection site, bruising at the injection site, body aches, head/neck aches, muscle pain in upper chest, headache, migraine, extreme fatigue, excessive sweating, swollen lymph nodes, dizziness
This case involves a 67 years old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered). The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) and POLIO VACCINE (POLIO) (lot number and expiration date not reported) via unknown route and unknown site of administration for  prophylactic vaccination. On 12-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (total, lot UJ359AA and expiry date: 11-Jul-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration (product administered to patient of inappropriate age and expired product administered, latency: same day). The reporter was with the question that what does she do. At the time of reporting, it was unknown 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 holder's compliance with the requirements set out in the 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.
Nurse drew up monovalent covid pfizer vaccine and accidently labeled it with bivalent label. Paitent was ordered to recieve Bivalent covid Pfizer booster and was administered monovalnet instead. Patient and provoider were notifed immediately about error. Vaccines were immediately seperately into two seperate fridges to prevent this error from occuring in the future. No effects were noted by patient. Patient educated that he could recieve the bivalent vaccine booster in the future but would need to wait at least two months from this injection.
Patient complained about a sore throat about 5 minutes after her vaccine.  She carries an Epi-pen with her regularly due to allergies.  She said she did not "feel" like she needed to use the epi-pen, she did accept some water to drink,   During her 30 minute wait time we checked in with her several times and there were no changes other than her arm being sore.  After her wait time, she said she felt well enough to leave but still had a sore throat and sore arm.   We discussed making sure her epi-pen was available if she started to feel worse.  She left the pharmacy.  About 10-15 minutes later we found out she was slumped over the steering wheel in her vehicle and EMS had been called.  We saw the ambulance outside and took her vaccine consent form to the EMS.  She was taken to the ER.  I followed up with her on 4/18/2021 and she said she was given benadryl and steroids to treat the reaction and was still recovering from the reaction.
Arthritis and joint pain/swelling, cognitive impairment, extreme fatigue, others. This pt developed severe fibromyalgia and chronic fatigue syndrome with symptoms developing with 6 weeks of Lymerix vaccinations. She has been very ill since. I take this from her history but do not have records close to the event.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included MENACTRA. On an unknown date, the patient experienced  a "bad reaction" (adverse event) after administration of PROQUAD and MENACTRA. The outcome of adverse event was unknown. Additional information is not expected, since no consent to contact the reporter was provided.
pt recv 2nd dose of vax;devel itchy hives;joint pain;erythema,inability to freely bend joints;ear drums appeared retracted,bilateral low admittance & high gradient on the rt;redness & swelling on palmer surface of indexes;inc WBC=15.6K/MM3
Was vaccinated 10/11/03. 36 hours later had fever of 101.01; called ER at hospital and nurse said spit not colored; he has virus and to give Tylenol every 4 hours. Called nurse 2 times daily. Pulmonary doctor Monday, Tuesday, and Wednesday and they all said the same (virus). Wednesday night, fever 103.1, lost 10 pounds, weak and could not get out of bed. Had pneumonia and in hospital for 8 days. The hospital discharge summary received on 1/13/04 states dyspnea. 60-day follow up on 01/29/04: "Pt has recovered from adverse events."
Dizziness after the 1st dose; Lightheaded after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027821a) for COVID-19 vaccination.     The patient's past medical history included Amputation and Phantom pain. Concomitant products included GABAPENTIN.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose). At the time of the report, DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant products included blood thinner and gabapentin.
Shot was administered high on arm. Within 8 hours pain in back of shoulder, down back of arm, in elbow, and across upper arm.  Pain continues to be an issue along with swelling of arm.  Sought medical attention 6 weeks later when pain persisted with activity and interrupted sleep. Saw Dr who diagnosed me with rotator cuff tendinitis. He prescribed physical therapy and Naproxen for pain.  I?m attending physical therapy but still in considerable pain.
pt does not use lt leg when crawling moves rt leg et drags lt;pt stand on both legs et does not cry when mom feel leg;
The CMA did not check patients age and gave the patient the wrong age vaccine which was pfizer up tp 11 years old.
SKIN REDNESS; VOMITING; JOINT PAIN; CHILLS; MUSCLE PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned an 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included pleurisy, fibromyalgia, and worsened asthma. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin redness. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, muscle pain, joint pain, vomiting, chills, headache and skin redness was not reported. This report was non-serious.
patient was passed out for a few second. p/t states that this is common side effects whenever he received a vaccine
Fever, swelling, redness at site. Dx with cellulitis in ER. No evidence on f/u.
pt recv vax JUL95 & in JAN97 pt devel gen chickenpox;another pt was reported as well (WAES 97020807);
Initial information received on 01-Nov-2018 and additional information on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 01-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 54G45, expiry date 30-jun-2019 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient age 4-month old was given a FLUZONE QUADRIVALENT vaccine. The patient did not experience any adverse reaction after the injection. 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. Follow-up report was received from a nurse on 05-Nov-2018. No new information was reported. List of documents held by sender- none.
Confirmed Breakthrough case  COVID-19 (Janssen) 1 03/25/2021  Janssen 1802068   COVID-19 (Janssen) 2 01/05/2022  Janssen 1855191
Information has been received from a physician via a consumer who provided the physician with a link to a forum. The information was received from the patient's mother, from the link, concerning her healthy 14 year old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a first, second and third dose of GARDASIL (lot # not provided). It was reported that the patient experienced several symptoms including numbness and tingling in her fingers and toes, fatigue, a really hard time falling asleep, urinary tract infections, ovarian cyst, moody, trouble getting out of bed and seizures. The patient had had upwards of 150 seizures following her third shot in June 2008. During her seizures she stopped breathing for periods of 30 to 40 seconds. The patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported that the patient died due to ovarian cyst. The reporter felt that the patient's symptoms were related to vaccination with GARDASIL. Upon internal review, the seizures were considered to be other important medical events "seizures" as an other important medical event. No further information is available.
INTRAFLU - I received the flu intradermal shot and later that evening the site started to itch. There was pain and swelling. The area around the shot site was bright red and itchy as well as hard to the touch. It was also very warm. It is now Nov. 30th and it has not resolved. I did see the doctor and he claimed "You are fine."
Body aches, joint pain, headache present upon waking at approximately 8:15 am on 4/14.  Fever developed approximately 11:00 am (100 degrees).  Took 500 mg Tylenol late morning. All symptoms decreased as the day progressed but were still present at bedtime (approximately 11:00 pm).  Upon awakening 4/15 symptoms were gone.
Flu; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care profession.  This case involves Adult (unknown gender) patient who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Gave me the FLU for 4 days!"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  At the time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014100: US-009507513-1905USA014101: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014106: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014102:
Pt rcv'd COVID vaccine Moderna 1st dose 01/28/2021, 2nd Moderna 02/25/2021, then rcv'd in error Pfizer for 3rd dose on 10/05/2021. Pt then seen here at clinic on 10/09/2021 with what provider states trigger of pt' s arthritis inflammation response. Hands swollen, pain in joints especially hands and knees. Pt rcv'd RX prednisone and toradol for inflammation and pain.