chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one other arm used has large swollen area; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIPHERAL SWELLING (one other arm used has large swollen area) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (one other arm used has large swollen area). At the time of the report, PERIPHERAL SWELLING (one other arm used has large swollen area) outcome was unknown.            The concomitant history was not reported. The treatment information was not provided.   This case was linked to MOD-2021-293060 (Patient Link).
Rash appear on my arm that Sunday.  The rash was all over my body.   I was on heavy Benadryl for about 1 week.
About 30 hours after the vaccination I experienced dizziness and nausea.  Unable to walk easily.  No appetite.  Gradually the nauseous feeling went away (8-9 hours).  Dizziness decreased gradually.  Within 15 hours most of the dizziness was gone.  Checked blood pressure.  It was always in the normal range. Able to eat after about 14 hours of the onset of symptoms.
My period (which has been normal and on time for years) started  10 days earlier right after I  received the first dose. It was normal the next month...but then after the second shot, I got my period twice in one month and the next month it started a week early. My cycle has been wacky ever since the vaccine.
my arm is still in a lot of pain; 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 36-year-old female patient received BNT162b2 (BNT162B2), on 22Jul2022 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: PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "not recovered", described as "my arm is still in a lot of pain". Additional information: Patient got the Pfizer Biontech COVID-19 vaccine last Friday. She stated that where can I go to get a sick leave because my arm is still in a lot of pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201008173 same  drug/reporter, different patient/AE;
Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The nurse reported that improperly stored vaccines were administered to multiple unspecified patients on unspecified dates (dose, route and injection site not reported). The nurse was unable to provide the lot numbers and expiration dates for the properly stored sterile diluent that were used to reconstitute the vaccines. No adverse effects were reported. No additional information is available. The vaccines included VARIVAX lot M042497, expires 03-AUG-2018, lot M006157, expires 05-FEB-2018, and PROQUAD lot M042497, expires 17-APR-2018. Out of range temperatures and time frame was not specified. There were multiple unspecified excursions reported on data logger. Follow-up information was received on 18-JUL-2017. The nurse called back to provided information that the vaccines were stored in the temperature range of: -9 degrees C to 8 degrees C for 10 consecutive months. No additional information was provided. Additional information is expected. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 at 10:45 as dose 3 (booster), single (Lot number: 30125) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Asthma" (unspecified if ongoing); "blood clotting disorder" (unspecified if ongoing), notes: other medical history: blood clotting disorder. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: on Day 10; (2022) Positive, notes: On Day 13; (2022) Positive, notes: on Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Consumer took all 10 doses of Paxlovid as scheduled. Symptoms mostly resolved. Consumer had a negative antigen test on day 10. On Day 13 upper respiratory symptoms began again and she tested positive on an antigen test. Consumer still testing positive on day 17. Consumer started anti-viral Paxlovid on 15May2022 for COVID 19 Treatment, treatment stop date was 20May2022. Other medication in 2 weeks included Wellbutrin, started on 05May2022.  No follow-up attempts are possible. No further information is expected.
It felt like I developed chronic fatigue, needed to sleep through the day, muscle fatigue, hard time for me to work, and muscle aches. This lasted for a couple of months. This also happened to me on my 3rd dose, but not as severe and only lasted for 3-4 weeks.
5 min. after injection - noticed pressure both ears. Increased to point uncomfortable. Within 30 min buzzing and roaring both ears - Rt worse (roaring at times). Told by PCP and ENT MD - permanent - times mild buzzing - other loud roar. Most of the time. Taking lipo-flavonoid for ear ringing. I am unable to sleep at night - find spicy food make worse. I'm also using TRP ear drops - does give some relief. This is an over the counter product. I am not pleased with my outcome of this vaccine. Have a vestibular problem from car accident 10 years prior. This adverse reaction has at times made this worse.
Diarrhea, nausea, headache, fever, hot flashes, cold flashes, insomnia, fatigue, muscle aches and soreness
Information has been received for a case in litigation from information obtained from a published article regarding a male child (age at AE onset unknown) with autosomal recessive nonsyndromic deafness, who, on an unspecified date was vaccinated with a dose of PEDVAXHIB. Concomitant suspect therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Subsequently, the patient experienced bilateral sensorineural hearing loss. At the time of the report, it was noted that the patient was currently 10 years old but the patient was "so young at the time" of the event and the patient's outcome was unknown. Upon internal review, bilateral sensorineural hearing loss was considered an other important medical event. Additional information is not expected. A copy of the published article is attached as further documentation of the patient's experience.
Patient´s doctor prescribed 2 more doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date) and Shingrix (received 2nd dose on an unknown date). Concurrent medical conditions included shingles (with no rash, internal shingles (life long internal shingles)). Additional patient notes included Patient was immunocompetent.   On an unknown date, the patient received the 3rd dose of Shingrix and the 4th dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced off label use (Verbatim: Patient´s doctor prescribed 2 more doses of Shingrix). The outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter called to request more information about extra doses of Shingrix, because a patient was coming on the reporting day. The reporter had had an immunocompetent patient who already received two doses of Shingrix, however her physician said that she was not cover due her medical history of shingles with no rash, internal shingles (lifelong internal shingles), so patient needs two more doses. The reporter stated that there were no shingles cases reported between doses administered. At the moment of the call, the patient had not received any extra Shingrix dose yet. The reporter did not provided consent for a follow. The reporter intentionally prescribed extra dose of Shingrix to patient, which led to off label use.
I received the injection on a Friday morning.  During the night I had fevers, chills and headache and my arm was sore for about 4 days. In the afternoon on Saturday I broke out in hives.  It started in my knee pits and elbow pits. Latter it moved up the back of my legs, around my leg joints, across my stomach, around my breasts, in my armpits and then a few days later on my lips and neck.  Even to my hands and feet.  It increased in severity in the heat.  I took Benadryl or allergy tablet for days.  I called the Dr on Tuesday and they prescribed a Z-pack with prednisone for 6 days. I still had to take the allergy pills.  When those finished I was not better.  I called the dr. the following week and they put me on 10 mg prednisone for 10 days and 5 mg for another 10 days (I have a few days left of it). It has helped somewhat but then on 7/17/2021 I broke out in hives again, but they have not been as severe, but still have to take a 24- allergy bill about every other day
I am not sure that they are related, but I was recently diagnosed with Meniere's disease. I had body aches, a very slight fever that lasted for about 18 hours. I saw my ENT and that is how I was diagnosed.
rapid heart rate/pounding heart for approximately 15-20 seconds (Very scary); Fatigue; intermittent rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208, Expiry date: not reported, age at vaccination: 59-year-old), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 07:15 AM as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing , penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included dexlansoprazole (DEXILANT) taken for an unspecified indication, start and stop date were not reported. The patient previously took clarithromycin, arythromicin and tylenol and experienced drug allergy. Previously, the patient received first dose bnt162b2 (lot number: EN6201,age at vaccination: 59-year-old), administered in left arm on 05Mar2021 at 07:30 AM for covid-19 immunization and experienced intermittent rapid heart rate, severe migraine and headache. The patient did not receive any other vaccines in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 26Mar2021 evening, the patient experienced rapid heart rate/pounding heart for approximately 15-20 seconds (very scary). Since an unknown date in Mar2021, the patient experienced fatigue, intermittent rapid heart rate. It was reported to physician. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected
collapsed on the field and died due to cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 41-year-old patient (gender: unknown) who was collapsed on the field and died due to cardiac arrest while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, collapsed on the field and died due to cardiac arrest (cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 41 years old collapsed on the field and died due to cardiac arrest. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (fatal) collapsed on the field and died due to cardiac arrest.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapsed on the field and died due to cardiac arrest).  At time of reporting, the outcome was Fatal for the event collapsed on the field and died due to cardiac arrest. It is unknown if an autopsy was done. The cause of death was reported as Cardiac arrest.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 41 year old adult patient who was collapsed on the field and died due to cardiac arrest, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: collapsed on the field and died due to cardiac arrest
got sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 08-Dec-2020.  This case involves a patient of unknown demographics who got sick (Illness), while the patient received Influenza Vaccine. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.   On an unknown date, the patient got sick (Illness) unknown latency after the patient got the shot.  It was not reported if the patient received a corrective treatment. Outcome of the event was unknown, at the time of reporting. There will be no information available on the batch number for this case.
Acute kidney injury; gross hematuria; IgA nephropathy; This is a literature report. This reporter reported 2 reports; this is the 2 of 2 reports. The full publication has been requested.  We also cared for 2 patients who had prior biopsy-proven IgAN, who developed gross hematuria after their second dose of the Pfizer vaccine, without a preceding COVID-19 infection. Table 1 outlines the clinical data. Our first patient presented 5 days after his second dose, with nonspecific myalgias, chills, headache, dysuria, and gross hematuria within 24 hours of initial symptoms. Previous IgAN flares in this patient were precipitated by upper respiratory infections and were limited to gross hematuria with no AKIs and no requirement for steroids in the past. His postvaccine workup was notable for AKI, with a serum creatinine level of 3.53 mg/dl and a urine protein-creatinine ratio of 3.0. He was empirically started on steroids with recovery to baseline renal function at 1 month and recovery to baseline proteinuria within 2 months. Our second patient developed gross hematuria within 24 hours of receiving his second dose. His hematuria resolved after 3 days with supportive therapy only. To our knowledge, we are the first to report an IgAN flare that has led to an AKI that resolved with steroid therapy. We agree that it is not clear how a nonmucosal immune challenge led to an IgAN.; Sender's Comments: Based on  information in the case  a possible causal association between the reported  events IgA nephropathy , Acute kidney injury and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101460758 Same article/drug/event, different patient.
About 1hour after shot, I became extremely cold and smelled a metallic substance I could not identify.  My sense of smell was damaged by an infection about 10 years ago.  after the coldness, I had flu like symptoms.  When I went to bed, I think I had a seizure.  Head was up/down.  Arms were twitching and going up/down.  Back was arching.  Legs were also moving.  All this was involuntary.  I decided to calm down my brain.  I played a game on tablet.  Motion stopped.  I realize it might just have been over.  I drank 1/2 cup of tea and vomited several times.  Just liquid.  Now I feel feverish.
Patient's mom, states she tried to feed her in the AM and she vomited. Vomiting x 3 from 7:30 Am - 12 N. Refuses to eat or drink. No fever or diarrhea or other symptoms. Injection site at arms ok. (L) leg ok (R) leg small red bump. No swelling of injection sites. Patient normal, playing. Advised to monitor temp and watch for other symptoms. Also advised to call pediatrician for consultation.
heart became inflamed; lungs became inflamed; felt weak; Couldn't lay down / she couldn't do anything; hard for her to breath; Could hardly walk; Arm pain; Not like herself; felt wipe out; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (heart became inflamed) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDITIS (heart became inflamed) (seriousness criterion medically significant), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated). On 07-Apr-2021, MYOCARDITIS (heart became inflamed), PNEUMONITIS (lungs became inflamed), ASTHENIA (felt weak), MOBILITY DECREASED (Couldn't lay down / she couldn't do anything), DYSPNOEA (hard for her to breath), GAIT DISTURBANCE (Could hardly walk), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (Not like herself), FATIGUE (felt wipe out) and NAUSEA (Nauseated) had resolved.            Treatment medication were not reported. Concomitant products were not provided.  After the second dose, the patient felt wiped out, weak, couldn't do anything, which was described as "not like herself". At the same time, the patient couldn't lay down.  These symptoms lasted for about five weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Developed severe chills with swelling. right arm is erythematous and warm to touch.
arm swelling below inj site, redness, warmth & tenderness down towards elbow; Pred, warm compresses to site
numbness in left leg; soreness in the left arm; soreness in the left arm was reported as worsened; rush down to her toes on her left side; tingling sensation all the way to my toes; 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 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:20 (Batch/Lot number: unknown, Expiration Date: Jul2021) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: verbatim: Caller states she did have Covid in November. The patient's concomitant medications were not reported.  The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling sensation all the way to my toes"; HYPOAESTHESIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "numbness in left leg"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "not recovered", described as "soreness in the left arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "soreness in the left arm was reported as worsened"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "rush down to her toes on her left side".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a Covid Bivalent vaccine, pt. already had 3 doses of primary vaccine.
very weak/wrung out in morning.  Happened two more mornings over next two weeks.  My heart normally beats irregularly  due to mitral valve prolapse.  But for about 3 weeks lying down particularly on my right side it was practically continual.  Also my back started hurting.  Also there was family stress.  Also I was concerned when they weighed me at the doctor's office that I had lost 3 pounds.  My weight had previously gone down from 130's to 129.  But it went down to 126 at the office.  Doctor did thyroid and liver blood tests.  All was normal and stable.  I have gotten the weight up to almost 128 since then.