chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 74 y/o female with PMH significant for meningitis at age 2 resulting in developmental delay (non-verbal at baseline and seizure disorder) who presented for poor oral intake, dysphagia, and inability walk due to increased lower extremity weakness that has been occurring since April 9th. The patient is typically ambulatory but needs significant assistance with ADLs. She is able to feed herself (tends to eat baby food). Eventually, the patient was admitted for sepsis 2/2 UTI and now with concerns for remote stroke with persistent dysphagia and acute encephalopathy.   Since April 9th, the family has noted that the patient has had difficulty swallowing baby food and seems to be uncomfortable; she is able to make a couple of audible sounds or gestures that suggest pain and that is why they brought her. The family also reports that the patient received her second dose of the Pfizer-BioNTech COVID-19 vaccine on 04/07/2021.   On 04/08/2021, the patient had one staring episode, but then returned to baseline. She was at baseline during breakfast on the morning on 04/09/2021, but around lunchtime, she had another staring spell and was unable to swallow food as well as unable to walk, stand, or move her lower extremities. The patient has limited language at baseline but also has not been able to say the few words she used to communicate with her family, only moaning and grunting since that time. Since 04/09, she has not been able to consume any solid foods, only eating a very small amount of smashed/liquified fruit and drinking Pedialyte. Sister has been massaging her legs regularly in hopes of re-establishing movement but saw nothing until yesterday (05/05/2021) when the patient moved toes bilaterally and briefly lifted her right leg.    Neurology Consult on 05/05/2021:  The patient had mildly bradycardiac and hypertensive (170s/80s). Labs reviewed and showed mildly elevated WBC (i.e., 12.9 K/MM3) and urinalysis was consistent with UTI.  Imaging was reviewed and consistent with chronic CVA, likely occurring on 04/09/2021 while the patient was in hypercoagulable post-COVID vaccine state.   Neurology recommends CT angio head and neck, TTE w/ bubble, A1c, fasting lipid panel, DVT prophylaxis via lovenox 40mg SC daily, D-dimer levels, EKG, PT/OT?Speech therapy evals, BP control via lisinopril 10mg daily w/ goal of < 140/90, and ASA 81mg daily
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: treatment of Paxlovid received. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), single (Lot number: Gh9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23May2022 as dose number unknown, single (Lot number: Fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Premature ventricular contractions" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was COVID 19 Treatment, brand: Pfizer, from 10Feb2023 to 14Feb2023.
covid 19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (covid 19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: postive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medication: Regeneron therapy
Developed a sore on my lip that kept increasing in size and discomfort.  I've never had this before.
a rash all over body and now face; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 09:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced a rash all over body and now face. The patient did not receive treatment for the event. Patient stated that she didn't handle anything that was out of the usual or eat anything new. Also, stated she was going to try over the counter BENADRYL and see if it relieved the symptoms. Patient questioned was that something she should be alarmed about, and is it possible this was an effect caused by the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash all over body and now face was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 21Dec2020 04:00 PM at a single dose on left arm for COVID-19 immunization. On Tuesday morning, 12Jan2021, patient woke up in excruciating pain. She had fever, joint and muscle pain. The outcome of the events was recovering. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing.  This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
Headache, Myalgia, SITE OF INJECTION PAIN, FATIGUE, MUSCLE ACHES, CHILLS Narrative:
Sensitive skin from upper waist down, numbness in legs and feet, loss of muscle tone in legs, light headedness upon standing, tiredness, increased hunger and thirst, loss of 20 lbs since vacination.
sore injection site (the injection itself didn't hurt, though).; Mild dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, 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: COUGH (non-serious) with onset Mar2021, outcome "recovered", described as "Mild dry cough"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "sore injection site (the injection itself didn't hurt, though).". It was unknown if therapeutic measures were taken as a result of vaccination site pain, cough.  Additional information: It was unknown if any other vaccine in four weeks. It was unknown If covid prior vaccination and if covid tested post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
INFLAMMATION BEHIND THE EAR - LEFT; TIREDNESS; LEFT ARM SORENESS; NECK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain. On 12-MAR-2021, the subject experienced left arm soreness. On 23-MAR-2021, the subject experienced tiredness. On 29-MAR-2021, the subject experienced inflammation behind the ear - left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation behind the ear - left, had not recovered from tiredness, and left arm soreness, and the outcome of neck pain was not reported. This report was non-serious.
1045AM- Patient started to slide down his mother's leg, got up and held onto the back of mother's chair, where he started to faint. I caught the patient and laid him on the floor. Patient awake immediately. Called for doctor. Patient was given crackers and apple juice. MD discharged patient to parents.
The vaccine wasn?t put  in the system and was accidentally given a second Mmrv  at another clinic
Pt vaccinated with DTP/OPV symptoms started approx 10PM 31JUL90; listlesssness, loss of appetite, gagging, paleness, seen at  ER, condition improved upon arrival- no treatment necessary.
Patient experienced significant redness and swelling at injection site along with pain for several days after vaccine given. Resolved within a week.
Went for prenatal visit at 19 weeks, no heart beat - fetal demise. Induced and delivered Dec 15. D&C to follow.
The patient is a 59 y male with past medical history of essential hypertension,diabetes mellitus, dyslipidemia diabetic neuropathy, morbid obesity, GERD, obstructive sleep apnea intolerant to CPAP who was admitted on 12/28/2021 because of complaints of vomiting and midepigastric abdominal pain.  Patient also reports fatigue and lying in the bed most of the time.  Also describes funny taste going on for past several days.  In the ED, he was noted to be COVID-19 positive. Assessment lung bases shows covid infiltrates.  No pleural fluid or pericardial effusion. Patient did not have any respiratory symptoms from covid 19 and was on room air throughout his stay. Diet was advanced as tolerated. Patient improved and was discharge. He was given covid 19 kit and will monitor his sats.
Extreme blood loss through my rear end, Passed out on the toilet and had to call the ambulance to go to the hospital. Had to receive 7 pints of blood and then over the summer I had to receive 4 different iron infusions.
53 year old. was given a Fluzone HD today S.C/no AE; 53 year old. was given a Fluzone HD today S.C/no AE; 53 year old. was given a Fluzone HD today S.C/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 53 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AA via subcutaneous route in the right deltoid.  It was of actual medication error due to Inappropriate route of vaccination, overdose NOS, Inappropriate age at vaccine administration.  It was reported that no adverse event was noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from an employee health nurse concerning a 38 year old female employee with measles titer 0.82, no drug allergies, and "she does have medical problems": list not provided, who on 07-JUL-2009 was vaccinated with the last of two ATTENUVAX vaccine (Enders-Edmonston) (lot#659617/0187X), SC. There was concomitant medication according to the reporter that "I'm sure she is but I don't have a list". Within 6 hours the patient experienced fever of 102 degrees F, diarrhea and fatigue. The patient made a phone call to seek medical attention. The patient had not recovered at the time of report. Additional information has been requested.
pt recv vax 15JUN95 & 20JUN97 pt devel a breakthrough rash;it was reported that pt mom had shingles;
Pt c/o chest pain starting on 01 or 02 JUN; he came in today 15JUN when he realized the chest pain was not resolving; symptoms were classic pericarditis with worse with laying down and resolved with leaning forward; ecg confirms pericarditis; he was sent directly to cardiology from primary care
Patient had itchiness, redness, and warmth surrounding injection site in a 2 inch diameter surrounding site.
Headache, fatigue, chills began 11 hrs. after injection. Chills ended by following morning. Headache pain increased through out the night. Headache manageable aprox 30 hrs after injection after 2 doses of Ibuprofen. 1/29/21 8am 1/29/21 12p
Information has been received from a health care professional concerning a 46 year old male pt who was vaccinated with a 3rd dose of Hep-B vaccine. Subsequently, the pt experienced flu-like symptoms. Unspecified medical attention was sought. Additional information has been requested.
8x7 cm area of induration and erythema, warm and tender feels flushed but no reported fevers.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2016, the patient was inadvertently vaccinated with expired ROTATEQ (orally, lot # K007246, expiration date 17-MAR-2016, dose was not provided). No adverse effect was reported. Additional information has been requested.
Left deltoid pain began at about 2:30 pm, approximately 3 hours after vaccine was administered in that arm. Pain progressed throughout the next few hours but was moderate. Around 11:30 pm the pain became more severe, to the point where any deltoid movement caused extreme pain. I used an ice pack to try to alleviate the pain but it only provided mild relief. When changing my shirt around this time I touched the area lightly and saw it was slightly swollen with fluid around the site of vaccination. Continued using ice because I had not eaten recently and did not want to take ibuprofen on an empty stomach and cause heartburn. I was unable to sleep on my left side and woke up around 4:30 am in severe pain, put ice on it again and fell back asleep. I had a low grade fever of about 99.4 F at this time and some chills. On 3/16 I woke up around 9:30 am and pain was still fairly moderate-severe and swelling was present but less than the night before. Around 10:00 am I ate breakfast and took ibuprofen, and the pain and swelling have been more moderate since.
Narrative:  71yr patient transferred from one hospital to another hospital for further management of severe AS s/p TAVR via the left femoral artery 7/21 c/b LLE CFA pseudoaneurysm and pseudomonas infection of the left groin access site and COVID-19 infection with increasing oxygen requirements from baseline along with persistent fevers (101-102F) despite despite broad spectrum abx. COVID symptoms started on 9/29/2021 Oxygen Requirements: Baseline 3-4L NC 10/2 ED: 5L NC SpO2 90% Pertinent Medical History: COPD and chronic hypoxemic respiratory failure on 3-4L O2 at baseline CAD s/p CABG 2006 L MCA CVA with residual expressive aphasia & right hemiparesis HFpEF HTN HLD T2DM Pertinent Labs (10/2/2021): COVID-19 Positive (9/30/2021) AST/ALT: 27/19 WNL CRP: 7.47 H eGFR: 63ml/min (>30ml/min CFU) COVID Vaccination Status: Moderna x 2 (Feb and March 2021) COVID Therapeutics during hospitalization: dexamethasone 6mg daily and remdesivir IV x 5 days. By day 13 of hospitalization was back to baseline O2 requirement/ stable. Was discharged at day 18 in stable condition.
Body aches and fatigue set in at approx 15 hours after injection.  Took 3 hour nap.   Approx 24 hours after injection, developed fever and headache.  Fever lasted approx an hour; headache persisted until asleep for night.  Woke up next morning with no symptoms.
felt liquid come out of the injection site; felt liquid come out of the injection site; felt liquid come out of the injection site; did not feel like she got the right amount of vaccine; This is a spontaneous report from a contactable pharmacist (patient). An adult (reported as "30-40") female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 12Jan2021 13:27 at single dose in left deltoid for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 22Dec2020 in left deltoid for COVID-19 immunization and experienced arm was a little sore. The patient had her 2nd vaccine dose today at 1:27pmET. After she received the dose she felt liquid come out of the injection site. The patient did not feel like she got the right amount of vaccine. The reporter wanted to know if there was any information about measuring titers, or if there was any data on getting a third dose, any information about not being immune and asked if the second dose was not administered properly. The outcome of the events was unknown.  Information on lot/batch number has been requested.
who is pregnant has covid; Believe they tested positive; Believe they tested positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101858753 (Pfizer).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovering" and all described as "Believe they tested positive"; MATERNAL EXPOSURE TIMING UNSPECIFIED (medically significant), outcome "unknown", described as "who is pregnant has covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. It was reported that the patient is pregnant and has COVID. The baby is due in Mar. The reporter cannot confirm vaccine status but the patient may be vaccinated (likely). Unsure when or what vaccine. The reporter believe the patient tested positive on an unspecified date in Dec2021. The reporter assessed the case as serious.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101858682 same reporter/drug, different patients, similar events
sore arm; general muscle soreness; slight nausea; lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER8732) via an unspecified route of administration, in Left arm on 26Mar2021 at 11:00 (at the age of 64-year-old) at a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration, in Left arm on 02Mar2021 at 15:00 at a single dose for COVID-19 immunization. The patient was vaccinated at hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient did not have allergies to medications, food or other products. The patient medical history was not reported. The patient received unspecified concomitant medications. The patient experienced sore arm, general muscle soreness, slight nausea and lethargy on 26Mar2021 at 21:00. The events were reported as non serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Oct-2021. On 18-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 18-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.