chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vax, the pt developed an anaphylaxis response and noted that when she received the vaccine she had a hard time breathing and developed a severe rash and thinks she ended up in the hospital. Follow-up information from physician states that, upon medical review, the pt's experience was considered an "Other Medical Event." Additional information has been requested.
Rec'd. 5 yr. imm. on 8-19-13. FEver (102 max), redness, warmth and pain reported A.M. on 8-20-13. 'Better" per Mom at O.V. 8/21/13. 3" x 2.75" area of mild erythema, mild edema and TTP to (L) arm; 2" x 1" 4" area same s/s/ to (R) arm on exam (Tx: PRN, Ice and TYLENOL).
Vax given about 30min p/became ill inc dizziness, sweats, chills, inc BP, dec bld sugar, tachycardia; sx cont w/dec BP;
I thought I was coming down with a UTI and it kept getting worse so I went to urgent care the weekend before Sept 5th. The doctor gave me antibiotics and said if it doesn't get better go see my doctor. By the time I went to my dr. I was having lower pain in my right quadrant and was feeling nauseous. I went to the ER for a scan and was given antibiotics. I'm feeling much better and watching what I eat.
Client diagnosed with Covid-19 on 8/7/2021, hospitalized with intermittent dyspnea on exertion, cough, LE edema. He was discharged on 8/13/2021 after being treated with IV Decadron and a 5 day course of Remdesivir. He was readmitted on 8/16/2021 with SOB, fevers, cough and weakness.  During this admission, he was given high-dose IV steroids.  He died on 8/20/2021 due to Acute hypoxemic respiratory failure due to severe bilateral COVID pneumonia and suspected superimposed bacterial pneumonia.  Submitter does not have access to full medical record. If further information is required, please contact the admitting hospital.
100 degree fever, chills, muscle aches, and fatigue for the entire next day (20+ hours).  Fatigue lasted for 2-3 days.
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 26-FEB-2013 was administered a dose of GARDASIL (lot # 668261/1397AA and expiration date 09-APR-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from an unspecified source, concerning teenagers from unknown genders and ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that on unspecified dates, an unknown number of patients died due to unknown causes, after vaccination with GARDASIL, reported as "parents and women must know that deaths occurred". It was unknown if autopsies were done. No further information was cited. The relatedness between deaths and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830: Reported Cause(s) of Death.
SWELLING REDNESS AND EXTREME PAIN LEADING TO IMMOBILITY OF THE RIGHT ARM. PAIN HAS CONTINUED IN THE RIGHT ARM SINCE THE INJECTION IN EARLY NOVEMBER. THE NURSING HOME, LISTED EARLIER, KNOWS THE EXACT DATE OF THE INJECTION AND THE DOSE GIVEN. THE REACTION STARTED THE SAME DAY THAT THE VACCINE WAS ADMINISTERED. THE PAIN HAS AFFECTED MY MOTHER'S ABILITY TO DO PHYSICAL THERAPY, AND SHE HAS NOT BEEN ABLE TO ATTAIN THE STRENGTH NEEDED TO RETURN TO INDEPENDENT LIVING BECAUSE OF THE REACTION SHE HAD TO THIS VACCINE. SHE HAS BEEN TOLD PHYSICAL THERAPY WILL BE DISCONTINUED 12-12-18 BECAUSE OF THIS.
fainting; asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainting"; ASTHMA (non-serious), outcome "unknown". Clinical course: The caller said that she was trying to got the Pfizer booster shot, and her last booster was in Dec2022. The caller said that she really needed to got the vaccine. The caller said that she was getting her vaccine in her doctor's office, but they don't had it. The caller wanted to know when her doctor's office would have the vaccine and also their local health department. The caller said the pharmacy in her area that carries the vaccine didn't had a bed to lie down on because she was fainted if she got the vaccine without lying down in the bed. Reporter created the manual AE form because the caller already took the vaccine and had asthma, and she was fainted upon receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized (12.3.21);  COVID-19 positive (12.3.21);  fully vaccinated Admission Date: 12/3/2021 Discharge Date: Dec 9, 2021 PRESENTING PROBLEM: COVID [U07.1] Hospital Course: PT is a 79 y.o. male with pmhx relevant for HTN, CML on bosutinib (follows with UMICH), history of tobacco use and suspected underlying COPD not formally diagnosed who receives most of his care through the VA. Amitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia as well as AKI with metabolic acidosis and hyperkalemia suspected secondary to poor oral intake during acute viral illness. He is vaccinated with J&J x1 August 2021. Symptoms started 11/25. Tested positive 12/3. Received dexamethasone from 12/3, Remdesivir initially held due to AKI and no longer indicated when renal function improved due to recovery to room air. His AKI was initially treated with fluids and bicarb gtt and improved rapidly.  Therapy evaluated and recommended home with home HHC at discharge.symptoms improves and patient was discharged on home O2 in stable condition .
home sick with the flu; home sick with the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case was linked to 2020SA290963, 2020SA291400, 2020SA291402 and 2020SA291094 (same reporter).  This case involved a patient with unknown demographics who was home sick with the flu (Illness and Influenza), while they received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was home sick with the flu (Illness and Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory test data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of both the events were unknown, at the time of reporting.  There will be no information on the batch number for this case.
Information has been received from a nurse concerning a 24 month old patient with no pertinent medical history who on 03-APR-2007 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 656174/1500F) 0.5 mL subcutaneously. there was no concomitant medication. The nurse reported that on 30-SEP-2008 the patient developed "active chickenpox". At time of reporting, the patient had recovered. The patient sought unspecified medical attention. There were no lab diagnostics studies performed. This is one of two reports from the same source. Additional information has been requested.
Extreme pain in the arm of injection right away, the next day low grade fever, headache, confusion dizziness, unable to go to work
dizzy, faint, myoclonic movement, high BP, high pulse, rash on chest, loss of consciousness;other sx over time included partial sx, chronic fatigue, joint pain, anxiety, low energy, h/a, pain upper lt arm & extremities numbness, foot asleep
Fever, headaches, chills, sore arm. Loss of taste that started on day 3  and lasted 24 hours.
after initial shot 4 hours later woke up with a pounding heart for about 1 hour. then moved in to sweats, chills, upset stomach and full body aches. heart did calm down  however, now after second shot and booster I have tachycardia and am being seen by a cardiologist and cardiac electrophysiologist to stabilize my heart rhythm.   I started having irregular heart rhythm stuff in august, which has intensified since the booster. Now i have abnormal heart activity every day and it is affecting my ability to engage with my life.
Patient received the second dose of their vaccine and we were talking. About 1-2 minutes after the vaccination the patient stated that they "didn't feel right" and that their heart was beating really fast. I asked if they felt shortness of breath or difficulty breathing and they said no, just not right and fast heartrate and they wanted an ambulance called. Minutes went by and they still had no difficulty breathing. The ambulance arrived and took the patient out.
This spontaneous report was received from a physician via company representative refers to a 65 year old female patient. On an unknown date in NOV-2012, the patient was vaccinated with 0.65 ml of ZOSTAVAX (lot number and expiry date is not reported, route was subcutaneous). On an unknown date, the patient experienced pain and swelling at injection site. No treatment was provided. The outcome of pain and swelling at injection site was unknown. The patient sought medical attention (spoke with physician). Additional information is not expected.
This is a 73y.o. male who presents to a local HCF ER due to shortness of breath.  He reports that he had recently been treated for pneumonia, and had tested negative for COVID-19 at that time.  He completed his antibiotics, but felt no improvement in his breathing.  In the emergency department he was found to be hypoxic.  COVID-19 testing was positive.  The patient was also noted to have an elevated troponin level.  He was placed on BiPAP for respiratory support.  He was noted to be in atrial fibrillation with rapid ventricular response.  He has been started on IV heparin and has required amiodarone loading, which is in progress, for persistent atrial fibrillation with rapid ventricular response and borderline blood pressures.  Cardiology has already evaluated him and infectious disease has also been consulted.  At the time of my evaluation the patient was a somewhat limited historian due to the BiPAP, but he reports his breathing is improved I am of his admission largely due to to the reduced work of breathing from the BiPAP. still in critical care at this time- he has been here 30 days
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 46-year-old female patient received BNT162b2 (BNT162B2, solution for injection), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "I noticed a ringing in my ear/tinnitus"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "nerve wrecking"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty in sleeping due to the ringing". The event "I noticed a ringing in my ear/tinnitus" required physician office visit. Additional information: Caller wanted to know if Pfizer can compensate her for her medical bills if Tinnitus is a confirmed AE and if Pfizer BioNTech COVID-19 Vaccine is the cause of her tinnitus. Question: Customer asked if Pfizer will be making some changes to address concerns on tinnitus once it is an established and proven AE of the Pfizer BioNTech Covid-19 Vaccine. Question: Customer expressed disappointment over the ringing on her ears symptom and was not yet resolved even after a year. Customer also mentioned that she had some issues sending the safety report through her phone online and was only able to send it via laptop. Question: Customer Verbatim: I will like to report a side effect of the Pfizer COVID vaccine which experienced. Two days after I was vaccinated, I noticed a ringing in my ear. About 1 week later I was advised by my doctor that it should go away within 90days. Unfortunately, it has been a year and the ringing has not stop. I have visited several ENT Specialist and they have not been able to treat it. I strongly advise that your company list this side-effect. Please advise on if your company has any resolution for this issue. AE: Aside from the AE details listed on customer verbatim, patient added that the ringing in her ears have gotten worse and there are some days when the ringing would get so loud. Caller also mentioned that it was "nerve wrecking" and it started out initially mild. Patient also stated that it is causing a domino effect on her and explained that one thing triggers a bunch of other things like difficulty in sleeping due to the ringing. Caller also stated that the level of ringing is not usual and that they tried to find out the cause of the ringing in her ear by process of elimination and only thing that they think is the cause if the Pfizer BioNTech COVID-19 Vaccine. Caller got her first dose on 31Mar2021 and the second dose on 21Apr2021. Caller also got the booster on "June or July" of 2021. Age: 46 Years (turning 47 on November). Warm transferred AE. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
have side effects to the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have side effects to the first 2 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have side effects to the first 2 doses). At the time of the report, VACCINATION COMPLICATION (have side effects to the first 2 doses) outcome was unknown.            The patient reported, she was on a lot of medications, but did not specify which ones.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395848, MOD-2021-395759 (Patient Link).
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced murdered me for 3 days (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient recovered from murdered me for 3 days. This report was non-serious. This case, involving the same patient is linked to 20220107322 (dose number in series 2).
Redness right arm at 9pm 10/04/04.  Followed by pain and swelling on 10/05/04 at 7AM, lasting for 5 days. Decreased redness with some itching as of 10/15/04.
burning and itching rash on hand and wrist (same side as injection); burning and itching rash on hand and wrist (same side as injection); This is a spontaneous report from a contactable physician. A 14-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, age at vaccination 14 years), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient experienced burning and itching rash on hand and wrist (same side as injection) on 16Jun2021. The patient was treated with topical steroid for events. The outcome of the events was not recovered.  Information regarding lot/batch number has been requested ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Itchy rash and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events Burning sensation 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.
Assessment completed by EMS and Dr. 14 minutes after receiving COVID vaccine booster, pt complained of blurry vision. Pt denies further concerns. Blurred vision resolved, pt returned to baseline. Pt left clinic site on her own. Pt was advised to follow up with PCP.
I woke up sometime in the middle of the night on the 12/02 and I had; postnasal drip fatigue, sore/irritated throat, and I had an upset belly. I thought it was just allergies but Saturday as a precaution I started to think I might need to test since I care for the younger grandchildren from time to time. I took a test for COVID-19 it came back positive and to be sure I tested again at home. Later that evening I start having issues although the nasal drip had gone away. I called my doctor and told them about the testing. They called in a prescription for the PAXLOVID, and I started it right away. That night I sparked a fever, cough, body aches and long-lasting fatigue. The medication had the worse taste and I think it also upset my stomach to the point that I actually vomited. Another thing I have noticed was shortness of breath.
Developed blood clot with pain in right lower leg. Seen by provider, confirmed with ultrasound. Developed 2nd clot same leg 5 days later totaling 2 clots.
Rec'd shot 9-9, on 9-10 presented with complaints of swelling, itching, and redness in vaccine arm. On 9-11 she called and said it was worse with the rash spreading all around the arm and that arm was full fluid and she has mouth sores.
pain in the lungs; dry cough; dizziness; high frequency of bathroom use; unsteadiness; mucous; phlegm; arm feeling limp; sharp pain in the left arm/aching in the left arm; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY PAIN (pain in the lungs), COUGH (dry cough), DIZZINESS (dizziness), DIARRHOEA (high frequency of bathroom use) and BALANCE DISORDER (unsteadiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (pain in the lungs), COUGH (dry cough), DIZZINESS (dizziness), DIARRHOEA (high frequency of bathroom use), BALANCE DISORDER (unsteadiness), SECRETION DISCHARGE (mucous), PRODUCTIVE COUGH (phlegm), MUSCULAR WEAKNESS (arm feeling limp), VACCINATION SITE PAIN (sharp pain in the left arm/aching in the left arm) and CHILLS (chills). At the time of the report, PULMONARY PAIN (pain in the lungs), COUGH (dry cough), DIZZINESS (dizziness), DIARRHOEA (high frequency of bathroom use), BALANCE DISORDER (unsteadiness), SECRETION DISCHARGE (mucous), PRODUCTIVE COUGH (phlegm), MUSCULAR WEAKNESS (arm feeling limp), VACCINATION SITE PAIN (sharp pain in the left arm/aching in the left arm) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up added on 15-Apr-2021 here attached the 1st doses Batch No and added the concomitant drug as Calcium, Vitamin D, Vitamin C and So many events was attached.
Headache, Myalgia, RespDepression, Fatigue, chills Narrative:
Shortness of breath, used all of his rescue inhalers, this is a repeat ED visit.
11 days from vax mom called c/o rash started on 8th day in AM;started @ neck area & moved to chest & arms by 2-3day;no marked fever noted;sibling also recv vax w/o rxn noted, on same day per parents via phone call;
*Horrible pain in the back of my head worse than any chiari pain I have ever had. *Blood clots the size of golf balls for 25 days. *A rash occurred at the sit of injection and  a lot of my arm. *Chest pain and heart flutters.
Patient, who has a h/o vasovagal reactions with injections was fine for 15 minutes, then started to feel warm and slightly woozy.  He did not have any loss of consciousness.  VSS and he felt better quickly after placing him in a reclined position.
The pt experienced redness, swelling in the left deltoid 1.5 days post vax. 8 days later the pt experienced a "huge welt" 5 1/2"x6 1/2" in diameter accompanied with 99.6 temp and itching. The pt went to the ER and received IV antibiotics and oral Cipro.
Area where injected became very sore. Area is warm to touch and red. This occurred around 4 hours post vaccination. Iced area - did help reduce redness.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild