chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has mild redness and swelling at the injection site with nausea. Her mother's home health nurse advised her to call the office since this has been going on for two days. Spoke with Dr. and she states that we will inform the CDC about the reaction and recommended pt use TYLENOL or ALEVE for pain and swelling. Patient was also recommended that the pt use a cold compress at injection site to help with the heat at the injection site. Pt was advised that if symptoms worsen or progress to call for appt or go to urgent care center. Nausea could be from chemotherapy pt is getting.
I have a lot of pain on my left side, where I got the vaccine, and it radiates from my neck to my shoulder and especially in my shoulder blade.
Patient had the reaction a few hours after the getting the vaccine. She experienced a headache, fever of 102F, and a large lump at the site of injection.
Within 5-7 days of DTaP and OPV vaccines in 05/98 had complete regression. Lost speech. Was pouting and grunting. Appeared not to hear or respond. Ear infections as well. Since has had neurological exam, EEG, MRI, CT. Taken to ER x 2 on Memorial day wknd. Possible PPD. On Augmentin for ear infection. Also diagnosed with #7 Flattened R Parieto-occipatal calvarium
The patient was given second dose of Moderna Covid-19 vaccine 21 days after receiving the first dose.
The patient tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (The patient tested positive for COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced COVID-19 (The patient tested positive for COVID-19). At the time of the report, COVID-19 (The patient tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
has a fever in it; started to itch; spreaded like a rash; started to swell/swollen for the past three days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE RASH (spreaded like a rash), VACCINATION SITE SWELLING (started to swell/swollen for the past three days) and PYREXIA (has a fever in it) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0G2B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE RASH (spreaded like a rash) and VACCINATION SITE SWELLING (started to swell/swollen for the past three days). On an unknown date, the patient experienced PYREXIA (has a fever in it). At the time of the report, VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE RASH (spreaded like a rash), VACCINATION SITE SWELLING (started to swell/swollen for the past three days) and PYREXIA (has a fever in it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Took acetaminophen and used an ice pack.  Relevant concomitant medications were not provided by the reporter.
grandma called pt had temp of 104.3 R 2hrs p/vax;fever remained approx 100-101 R for 24hrs w/APAP, lukewarm baths & inc water & diluted apple juice;
Sudden onset of crying, welts (size of bee stings) over body, ocular edema; 2-3 min later wheezing, cyanosis of lips, quivering of lips, pt went limp; Mom called 911 by time pt arrived @ ER (20 min later) sx resolved; no temp;
Two hours post vax, the pt "started with problems". Approximately four hours post vax, the pt experienced a wheal the size of a dinner plate and could not raise her arm above her head. This was considered a "severe reaction". On 10/7/00, the pt went to the ER and was given hydroxyzine hydrochloride (Atarax). The pt was able to go to work on 10/10/00, however the arm was still sore. She was able to raise her arm. The pt's experiences were considered significant medical events. No further information is available.
Patient had bumps- Red on arm and legs. Itching and spreading, no fevers. Cramping two weeks ago. Dx Erythema Multiforme.
Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient.  A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination.  Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg.  The patient had not received any other vaccine within 4 weeks prior to the vaccine.  On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.
Patient has PNA vaccine three days ago and started to have redness and pain at area. 24 hours after he had some mild chills and probable fever. His redness has bene extended but no more chills and fever. He does not recall allergy to any foods except PCN and even for this one he is not sure. In exam there is extended area of erythema circle around left arm down to elbow. Mild TTP at area of vaccination. Although it is less likely but I feel more comfortable to treat the skin redness as cellulitis with short course of antibiotic. No need for Histamine blocker.
Patient received 1st dose (Pfizer) on 1/2/21, and later received another  1st dose (Moderna) on 1/7/21
When I would exercise, I would get a strong tightness in the center of my chest. After I warmed up a little, it would kind of subside. It was a symptom I have never had. It would occur at my regular exercise class. Probably a month after I noticed the symptoms, I saw a doctor. I kept thinking it was temporary from the vaccine and that it would go away. There was no change in the symptoms, so I went to see my doctor. I had an operation after testing to put in a stent. I will have a re-check in a year. It took care of my symptom of tightness with exercise.
Day 1: Sore arm, mild fever, general fatigue Day 2: Sore arm Day 3: Sore arm Day 4: Chest pain (stabbing) Day 5: Chest pain (tightness) Day 6: Chest pain (tightness) Day 7: Chest pain (tightness) Day 8: Chest pain (tightness) Day 9: Chest pain (tightness)
Case number PHEH2012US013311 is an initial spontaneous report received from a nurse on 03 Jul 2012: This case refers to an unknown age and gender patient. This patient was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10049), intramuscularly without being reconstituted with Men A component, sometime between 31 May 2012 and 11 Jun 2012. No adverse reaction occurred following this administration error.
No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4-year-old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.    On 21-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(dosage schedule, route, anatomical location were not reported)(it cannot be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006331: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
This spontaneous report as received from a medical assistant refers to a 79 year old female patient with COPD (Chronic obstructive pulmonary disease), emphysema, hypertension and hyperlipidaemia (unspecified). The patient had a history of nausea from BIAXIN (reported as BIAXCI) and erythromycin. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (in the arm, lot # J014401, expiry date: 26-NOV-2014, dose, units, route of administration were not reported). Concomitant therapies included SPIRIVA, ZOCOR and hydrochlorothiazide. In September 2014 (exact date unspecified), the patient experienced a swollen arm from the deltoid to the elbow. There was no treatment given for the adverse event. None lab diagnostics studies were performed. The patient sought medical attention via visiting the physician. The outcome of event was reported as recovering. The relatedness between event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Felt like I had the flu, back pain, headache for over 12 hours Tylenol did cure. Muscle soreness all over as well.
Patient received vaccine on Sunday. On Monday, symptoms developed which included aches in joints and muscles, headache, fever (99.8), swelling, itch and pain at site of injection; some loss of appetite. Cognitive functions were also affected which patient describes as being slow and low in energy. Patient took 1 or 2 ibuprofen 200mg on Monday. Symptoms are getting better as of today when she called me (Wednesday).
Left Arm Pain; arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her; Pain going up the back of her neck; Pain going up the back of her neck; Feels like a muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: ER8735) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID taken for thyroid atrophy. Vaccination history included: Bnt162b2 (Lot number:ER8737, Dose:1, start date:01Apr2021), administration date: 01Apr2021, for COVID-19 Immunization, reaction(s): "Pain in arm"; measels (verbatim: Caller states as a kid, she had the Measles vaccine and then after that she got the Measles. NDC, Lot, and Expiration Unknown. Caller states it happened once before with the flu vaccine too, but she thinks the virus was already in her body. NDC, Lot, Expiration Unknown.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Left Arm Pain; arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 25Apr2021, outcome "not recovered" and all described as "Pain going up the back of her neck"; MUSCLE SPASMS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Feels like a muscle spasm". Therapeutic measures were taken as a result of pain in extremity, back pain, neck pain, muscle spasms.  Additional information: Caller states the vaccine was administered 22Apr2021, her second shot. Caller states she had her first shot in her right arm and it was sore, but it went away after 3 days. Caller states with the second vaccine she got it in her left arm. States the paper said after 10 days it should go away, but her arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her.   No follow-up attempts are possible. No further information is expected.
Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy to nuts and Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Caller states that her son had a fever for one or two days after receiving his primary series of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.   The reporter did not remember fully, but might have given Tylenol to her son for the fever.   Reporter did not allow further contact
Fever, Chills, Nausea, Diarrhea, Vomiting, Severe Headache, Pain in Right Upper Thigh (femoral area)
Four patients received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072336:Same reporter. US-GLAXOSMITHKLINE-US2022071926:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072338:Same reporter.
Loss consciousness; Tiredness; Nausea; Headache; Feeling weak; BP dropped; Extremities were weak; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 25Aug2021 at 10:15 AM (at the age of 47 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulfa. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 27Aug2021 at 11:00 PM (2 days post-vaccination), the patient was feeling mild side effects such as tiredness, nausea, and headache and later that day, she had a sudden onset of feeling weak and loss consciousness for a few seconds. The patient's blood pressure (BP) dropped and her extremities were weak, and she became very tired afterwards (27Aug2021 at 11:00 PM). No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events in Aug2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a 16 year old female who on 27-NOV-2007 was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported).  There was no concomitant medication.  In January 2008, the patient experienced mono-like symptoms.  The patient's mono-like symptoms persisted.  The patient had blood work conducted and sought unspecified medical attention.  Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 3/14/2008. Initial information and follow up has been received from a physician and nurse concerning a 15 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left arm with her third dose of GARDASIL (lot# 657621/0387U). There was no concomitant medication. On 15-JAN-2008 the patient had a sore throat. She went to the ER and was prescribed amoxicillin. On 30-JAN-2008 the patient had another sore throat and was prescribed EMYCIN. On 04-FEB-2008 the patient experienced near syncopal episode at school. On 05-FEB-2008 the patient had an ECG-orthostatic. On 12-FEB-2008 the patient experienced a sore, swollen throat. On 13-FEB-2008 the patient had a neck CT done. On 27-FEB-2008 the patient experienced recurrent tonsillitis. On 17-APR-2008 the patient had a tonsillectomy. The patient had blood work conducted and sought unspecified medical attention. The patient did recover from her sore throat, near syncopal episode, tonsillitis and tonsillectomy. No additional information is expected.
Received H1N1 inactive vaccination on 1/13/10. C/o myalgia and chills (mild) 1/13 and 1/14 with improvement 1/15/10. On 1/16/10 temperature elevated to 100.5 degrees F. c/o sore throat. dry cough, diarrhea, clear nasal drainage. with improvement 1/21/10.
PRESENTED ON 5/14 WITH PETECHIAE AND PLATELET COUNT OF 1,000.  CLINICALLY STABLE BUT REQUIRED URGENT MEDEVAC DURING OVERSEAS DEPLOYMENT.
O had the vaccine at 9 am this morning waited 15 mins after vaccine before leaving while driving I had a pounding heart rate and hot I rolled down the window felt better. 1 hour later while at home.e started with nausea diarrhea rapid heart rate headed to medical office while in care tongue swelled I called 911 pulled over when the ambulance got to me my throat swelled and I had hives on chest they took me emergency while there I had sever pounding heart and vomiting treated with meds sent home with medication and benadryl
heart palpitations; a rapid heartbeat; I had an acute case of diarrhea/diarrhea; I was achy/full body aching; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 040A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac catheterization (6-7 yrs ago). Concurrent medical conditions included Stress.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site). On 09-Nov-2021, the patient experienced DIARRHOEA (I had an acute case of diarrhea/diarrhea). On 10-Nov-2021, the patient experienced PALPITATIONS (heart palpitations) and TACHYCARDIA (a rapid heartbeat). At the time of the report, DIARRHOEA (I had an acute case of diarrhea/diarrhea), PALPITATIONS (heart palpitations), TACHYCARDIA (a rapid heartbeat), MYALGIA (I was achy/full body aching) and VACCINATION SITE PAIN (arm was sore at the injection site) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat. On 11-Nov-2021, Heart rate: rapid (abnormal) a rapid heartbeat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had no history of myo/pericarditis and COVID-19. On 09 Nov 2021. patient had an acute case of diarrhea and full body aching. On 10 Nov and 11 Nov 2021 patient had one episode of heart palpitations & rapid heartbeat,  On 11Nov 2021, patient had diarrhea until 2:30pm On 12 Nov 2021, patient felt fine.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-386518 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient 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; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "gallbladder surgery" (unspecified if ongoing), notes: gallbladder surgery. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.