chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have idiopathic pulmonary fibrosis; rheumatoid arthritis; heart problems; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation.  The following information was reported: IDIOPATHIC PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "I have idiopathic pulmonary fibrosis"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "rheumatoid arthritis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". It was reported the patient was waiting to have a procedure for a vein that has a little puncture. Therapeutic measures were taken as a result of idiopathic pulmonary fibrosis, rheumatoid arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue, lethargy, change in consciousness, Fever Chills, weakness, loss of appetite, tachypnea  Sent to local ER
Approx 48 hours post DPT injection, swelling, induration and erythema at site in right thigh. Max. diameter 11x11cm.Reaction lasted 7 days locally with gradual decrease in size of indurated area to 1cm diameter.
Fainted approximately 1-2 seconds after flu shot given. Brief LOC. Hit head. Sister fainted right before patient fainted.
Pt recv vax on 3/22/99; on 3/25/99 pt exp red/ painful/ numb/, erythematous/ swollen/ warm LA; dx=lymphadenitis; tx=Keflex, Acetaminophen
Patient started to feel weird a little bit after receiving shot. Patient said it sting where the shot went in. Then patient words started to slur, patient lost consciousness, fell to her left side and onto the floor. Patient hit her left side of her head on the bench as she was going down.  This all happened within a couple minutes of getting the shot. Patient came back to consciousness within 1 minute of passing out. Patient knew what had happened. Kept patient laying on the floor for 5-10 minutes until patient feel ok (seeing no stars and not dizzy). Patient then got cold and shaky but also feel sweaty. Helped patient up onto a chair and after patient feel ok, have patient drink water and GATORADE slowly. After 1 hour, patient feel slightly better and was driven home by a coworker. Checked on the patient at 7:15PM later that night, patient said the cold and shakiness had resolved. She is still experiencing a major headache from where she hit her head. She was advice to monitor for signs/symptoms of concussions (alter mental status, nausea and vomiting, eye issues, etc).
expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine expiry date was on 02 January 2022. Reporter stated that some patients had reported flu like symptoms after receiving the vaccination but she did not have any details.
Headache & NauseaVomiting   Narrative: Employee reports telehealth visit and  Phenergan per LPN   Other Relevant History:
I had an Afib event after the second vaccine.  I have had several since then.    The first event I was unsure what was happening and got to the hospital just as I slipped back into sinus rhythm.  I was admitted into ICU for 2 days for observation.  The second time I went to the ER and they diagnosed Afib.  I have had several events since, am working with a cardiologist and electrophysicologist and will have an ablation within a few days.
calm mind; feeling faint; drinking too much  after her vaccination in April. Patient reports she drank after her vaccine to relieve stress and be sedated; anxiety related to vaccine; stress related to vaccine; rapid heartbeat, elevated heart rate; loss of breath, difficulty breathing, inability to use treadmill for walking exercise due to loss of breath; feeling high, feeling of adrenalin rush through body; whole body feeling alert; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (rapid heartbeat, elevated heart rate), DYSPNOEA (loss of breath, difficulty breathing, inability to use treadmill for walking exercise due to loss of breath), EUPHORIC MOOD (feeling high, feeling of adrenalin rush through body), HYPERVIGILANCE (whole body feeling alert) and FEELING OF RELAXATION (calm mind) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In April 2021, the patient experienced HEART RATE INCREASED (rapid heartbeat, elevated heart rate), DYSPNOEA (loss of breath, difficulty breathing, inability to use treadmill for walking exercise due to loss of breath), EUPHORIC MOOD (feeling high, feeling of adrenalin rush through body), HYPERVIGILANCE (whole body feeling alert), FEELING OF RELAXATION (calm mind), DIZZINESS (feeling faint), ALCOHOL PROBLEM (drinking too much  after her vaccination in April. Patient reports she drank after her vaccine to relieve stress and be sedated), ANXIETY (anxiety related to vaccine) and STRESS (stress related to vaccine). At the time of the report, HEART RATE INCREASED (rapid heartbeat, elevated heart rate), DYSPNOEA (loss of breath, difficulty breathing, inability to use treadmill for walking exercise due to loss of breath), EUPHORIC MOOD (feeling high, feeling of adrenalin rush through body), HYPERVIGILANCE (whole body feeling alert), FEELING OF RELAXATION (calm mind), DIZZINESS (feeling faint), ALCOHOL PROBLEM (drinking too much  after her vaccination in April. Patient reports she drank after her vaccine to relieve stress and be sedated), ANXIETY (anxiety related to vaccine) and STRESS (stress related to vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (High) Patient reports her heart rate is normally below 60 and has been elevated to 81-87 bpm..         No treatment and concomitant drug information provided   Reporter did not allow further contact
Local eruption of Varicella-like lesions at arm of injection with secondary to infection from patient scratching lesion.
Patient fully vaccinated with two vaccines. Developed symptoms of Covid 19 and admitted to hospital  on 8/23/2021. Case expired while still hospitalized on 08/24/2021.
Wheezing, muscle ache, headache, nausea. I took Mucinex and Tylenol and it seemed to help. Still did not feel well on 11/12/2014.
Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021
Extreme diarrhea, decreased appetite, fatigue, abdominal cramping, dehydration, and confusion. ``12/2010 MR and DC summary for 11/12-11/17/2009, Dx Pseudoembranous Colitis  patient with severe diarrhea and dehydration,  B&B incontinence,  PE noted distended abdomen, hyperactive BS, UTI,  tx: IVF, Cipro/Flagyl, patient DC'd to OP Rehab due to deconditioned state
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a  nurse reporting for herself.    A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine  , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis .  Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy  , food allergy  , contrast media allergy (gadolinium).  There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8  on 13Jan2021 with outcome of recovered.  The patient underwent lab tests and procedures which included allergy test: unknown results   on Jan2021   , body temperature: 100.8   on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day.  The patient also received Decadron and  Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions.   Follow up information has been requested.
Swelling -size of  orange/grapefruit, painful - at site of injection.
Extreme illness with fever and muscular pain. Unable to get up and move about.   After the normal symptoms subsided, my ears became clogged on 12/22/21 and have been clogged ever since. Causes ringing, underwater feeling, popping, body imbalance, high pitched sounds, muffling.
Round, red raised rash and hardened area below the injection site, tightness and soreness at the site.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature: This report concerned multiple patients.  The patient's height, and weight were not reported. The patient's concurrent conditions included: non-hodgkin lymphoma, b-cell neoplasm, and chronic lymphocytic leukemia. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced suspected immunological vaccine failure (dose number in series 2). It was reported that 1 (3 percent) of patients were non-responders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. The authors concluded that, findings provide new insight into the nature of humoral and T-cell responses to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) vaccine booster and in vivo cellular dynamics in patients who have chronic B-cell neoplasms. The results support the usefulness of vaccination in patients with CLL (chronic lymphocytic leukemia) to boost anti-viral T cells, even in the absence of antibody responses, and shed new light on the determinants and variability of vaccine response. The differences in vaccine response between disease types warrant further investigation of the biology of adaptive responses in patients with distinct B-cell malignancies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230808152-suspected immunological vaccine failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
HYPOTENSION 10/25/2022 HYPOXIA ACUTE RESPIRATORY FAILURE 10/27/2022 HYPOXIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 HYPOXIA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 HYPOXIA HYPOXIA 10/25/2022 HYPOXIA CARDIOGENIC SHOCK 10/25/2022 HYPOXIA HYPOTENSION 10/25/2022 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 10/27/2022 ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 ACUTE RESPIRATORY FAILURE HYPOXIA 10/25/2022 ACUTE RESPIRATORY FAILURE  CARDIOGENIC SHOCK 10/25/2022 ACUTE RESPIRATORY FAILURE HYPOTENSION 10/25/2022 IMMUNOCOMPROMISED DUE TO MEDICATION ACUTE RESPIRATORY FAILURE 10/27/2022 IMMUNOCOMPROMISED DUE TO MEDICATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 IMMUNOCOMPROMISED DUE TO MEDICATION ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 IMMUNOCOMPROMISED DUE TO MEDICATION HYPOXIA 10/25/2022 IMMUNOCOMPROMISED DUE TO MEDICATION CARDIOGENIC SHOCK 10/25/2022 IMMUNOCOMPROMISED DUE TO MEDICATION HYPOTENSION 10/25/2022 DILATED CARDIOMYOPATHY ACUTE RESPIRATORY FAILURE 10/27/2022 DILATED CARDIOMYOPATHY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 DILATED CARDIOMYOPATHY ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 DILATED CARDIOMYOPATHY HYPOXIA 10/25/2022 DILATED CARDIOMYOPATHY CARDIOGENIC SHOCK 10/25/2022 DILATED CARDIOMYOPATHY HYPOTENSION 10/25/2022 PULMONARY SARCOIDOSIS  ACUTE RESPIRATORY FAILURE 10/27/2022 PULMONARY SARCOIDOSIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 PULMONARY SARCOIDOSIS ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 PULMONARY SARCOIDOSIS HYPOXIA 10/25/2022 PULMONARY SARCOIDOSIS CARDIOGENIC SHOCK 10/25/2022 PULMONARY SARCOIDOSIS HYPOTENSION 10/25/2022 SHORTNESS OF BREATH ACUTE RESPIRATORY FAILURE 10/27/2022 SHORTNESS OF BREATH ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 SHORTNESS OF BREATH ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 SHORTNESS OF BREATH HYPOXIA 10/25/2022 SHORTNESS OF BREATH CARDIOGENIC SHOCK 10/25/2022 SHORTNESS OF BREATH HYPOTENSION 10/25/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 10/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/8/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOXIA 10/25/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 10/25/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Syncopal episode w/prodromal dizziness/mild abd pain. Brief, fine before and after. Will see cardiology.
vaginal spotting and bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal spotting and bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal spotting and bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal spotting and bleeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter'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.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19  immunization. No medical history reported. On Sep 24, 2021, at 14:21, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 24, 2021, at 14:21, patient administered expired product (expired vaccine used). On Sep 24, 2021, at 14:21, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient did not have any adverse event and did not require any medical attention.
Patient stated she had a very large baseball size bump where vaccine as given. She described the bump as being bruised, hot to the touch, hard, painful. She was feeling dizzy, light headed, and had a head ache after getting the vaccine. Her blood pressure increased and she had the EMTs come to her house and she did go to the ER. The doctors stated she had a possible hematoma at the injection site. Doctor stated her side effects could be related to being asymptomatic COVID+ recently thus having an adverse reaction to the vaccine. Patient is feeling better but still a bit dizzy.
Client received the COVID vaccine (Janssen, lot # 206A21A, expiration 9/22) at 1:59. At 1415, RPh  observed the patient standing at her seat in the observation area and asked her if she was ok. The client complained of dizziness and was escorted to a chair by RPh and RN. At that time, the client refused vital signs, snacks, juice, Benadryl, and to be seated in the zero gravity chair. The client was observed to be clammy, with normal skin color, and complained of "the world spinning" and nausea. She denied chest pain, headache, or shortness of breath. She was offered and accepted water. The client stated she has a history of epilepsy, fatty liver, kidney disease, hypertension, and high cholesterol. She stated that she is allergic to gabapentin and that she takes losartin but isn't sure what other medications she takes. The client appeared uncomfortable but was alert and oriented x4. At 1423, the client consented to having her vital signs assessed. At that time, her vital signs were as follows: blood pressure 130/88, heart rate 66, respiratory rate 14, O2 98%. At 1430, the client stated that her dizziness and nausea had resolved. At 1435, the client stated that her blurry vision had resolved and she no longer appeared to be clammy. At 1438, the client stood up and paced around the room. She stated that her dizziness had not resumed but that she "felt better" when standing. The client appeared to be anxious and uncomfortable but denied pain or shortness of breath. At 1443, the client complained of her nausea resuming and began to vomit in an emesis bag. After the episode of emesis, the client stated "I feel so much better now." The client denied any further nausea or dizziness. The client continued to drink water and sit comfortably in her chair. At 1445, the client's vital signs were as follows: blood pressure 128/76, respiratory rate 16, heart rate 72, O2 97%. Education provided regarding AMS activation and primary care follow up. The client denied any further questions and was escorted to her car by her husband, who drove her home.
Heart racing; Thirst; The shot made her so dehydrated.; breathlessness with the increased heart rate; her blood pressure was 166/102 with a heart rate of 130; her blood pressure was 166/102 with a heart rate of 130/The highest her heart rate got was 166. Then, it would go to 130 or 120.; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0175 and expiry dates was not provided, 24-years-old at the time of vaccination) via an unspecified route of administration on left arm on 10Jul2021 (11:40, Saturday), at unknown dose single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient was perfectly fine before the vaccine. Six hours later on 10Jul 2021, her heart started racing, she did not think about it at first. She road it out through the day. The next day, her heart was still racing. She went to Urgent care, and her blood pressure was 166/102 with a heart rate of 130 on an unspecified dated in Jul 2021. It was 100% from the shot. Her doctor downplayed it. He said he hopes it does not stop her from taking the second one, and she said what an idiot. Racing heart has been reported though. The patient did not have a history of high blood pressure or abnormal heart rates. It was sad because she did not get any other side effects. Other than this she feels 100 percent. Heart racing is not a good feeling. she just went to the walk-in pharmacy at the grocery store, she got the vaccine 48 hours ago on the 10Jul2021 at 11:40 am. Last night (on unspecified date), she went to the ER. She was told to drink a lot of water before the shot. Even her pharmacist told her that. The shot made her so dehydrated. She was drinking bottles of water down constantly. She went to the ER, and it looked like she did not drink any water. It depleted her. It made her so thirsty, and her heart was racing. It seemed like it would improve, but it kept spiking. The highest her heart rate got was 166. Then, it would go to 130 or 120. Her blood pressure last night was 105/71. The first and second day the thirst was worse. Today it has improved. She also experienced breathlessness with the increased heart rate. Her mother told her to go to the urgent care, she had an appointment tomorrow (on unspecified date) with her regular physician in the morning, she called drug safety over the weekend but could not understand the agent. The outcome of the event Heart racing, her blood pressure was 166/102 with a heart rate of 130 and Thrist was recovered on unspecified date in Jul2021, the outcome for event breathlessness with the increased heart rate and Dehydration was unknown.  Information on Lot/Batch number was available. Additional information has been requested.