chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt mom states 5AUG98 pt had hives on face, neck, & legs;states pt did not have any breathing problems or itching;6AUG98 hvies were gone but momtook pt to MD;MD states it was probably a rexn to one of the vax;no med given;
Pt took dose of oral typhoid vaccine and the next d developed a rash and nausea. She also had HIB. Sx lasted a little over 1 week. Didn't take doses 2-4
Patient presented to clinic for COVID19 booster following receipt of J&J for primary series. Full-dose Moderna was administered by mistake.  Unable to reach patient by phone to notify of dosing error. RN left voicemail.
1. Gagging, emesis x 3. 2. Fussiness x 1 1/2 hours. 3. Question of apnea x 10 seconds at home 5-6 times.
Nausea and vomiting, ondansetron orally, oral rehydration.
Tachycardia- I have POTS and have intermitent boughts of tachycardia that respond well to Thermotabs.  Since the vaccine, I have had much more persistent tachycardia (100-110 sitting) that is not just triggered by orthostatic changes, and I have had to take nearly double the amount of salt tabs to manage it.  It is now the 7th day of this.  Starting to improve, and having less frequent episodes.
Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284726, 2018SA284727, 2018SA284723, 2018SA284724, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767. This case involves an unknown gender seven year old patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left deltoid) on 02-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range). No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Subsequent to receiving an Acel-Imune injection, pt developed an injection site reaction characterized by swelling, redness and warmth extending to the elbow.
Severe itch at injection site starting 5 days after the injection. No rash but some painful swelling.
I personally know 9 people who died from your vaccination; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 9 patients. This is one of 9 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I personally know 9 people who died from your vaccination. You reported 16,000 people have died even the people who work for the company speaking on this." It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101145863 Same reporter/drug/event, different patient.; Reported Cause(s) of Death: died from your vaccination
Rise in temperature; She had pains in her body; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Rise in temperature) and MYALGIA (She had pains in her body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: EPINEPHRINE (Her doctor prescribed epinephrine injection before she went to take the shot.). Concurrent medical conditions included Drug allergy (Ibuprofen) and Drug allergy (Anesthetic drugs).    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Rise in temperature) and MYALGIA (She had pains in her body). At the time of the report, BODY TEMPERATURE INCREASED (Rise in temperature) and MYALGIA (She had pains in her body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) a rise in temperature..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
could not lift up her injected arm fully; body aches; painful arm; painful arm, radiating to a pain in her back; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased, general body pain, pain in arm and back pain. On an unknown date, the outcome of the injected limb mobility decreased, general body pain, pain in arm and back pain were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, general body pain, pain in arm and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 28th September 2020, the patient received the 1st dose of Shingrix. The patient experienced painful arm, radiating to a pain in her back. She could not lift up her injected arm fully for 2 weeks. The patient also experienced body aches.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR219352, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219352:same reporter
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter. The patient did not receive any adverse events and did not required any medical attention.
Reportedly on 5/27/00, the pt experienced seizure-like activity. No specifics were provided. From follow-up, it was reported per the pt's father that after receiving bottle, pt had foaming milk from mouth. The father laid the pt down, pt turned blue and stopped breathing. The father performed CPR and the pt was revived. The pt was taken to the ER and had a follow-up appointment on 6/2/00. Further information is requested.
On 11/29/01 at 11:00, the pt felt shaky, light-headed, fever and body aches. Seen by MD at 14:40. Pt states she also "feels heavy in my chest".
Day 1 - Fever up to 102, Light red prickly rash on belly, chest, back, neck, and head.   Day 2 - Fever up to 99.9, Darker more extensive red prickly rash on belly, chest, back, neck, head, in and around ears. Lighter red prickly rash on arms and legs. Saw immunologist for scheduled appointment, he said it looked like a text book measles rash.
Child vaccinated 17APR91 developed blisters on lips starting 18APR91; 19APR91 blisters had spread to all around mouth & on inside of mouth;
Approximately 20 - 30 hours following the second dose of Engerix B, the pt developed fever, headache and rash. The pt was treated with Advil and Tylenol. As of 09/14/1999 the fever had abated and the rash persisted.
Swollen and enlarge lymph nodes in axillary left side. Cording from swollen lymph nodes. unable to lift arm above head. Cording and enlargement has gotten worse. Pain from axillary  to wrist on left side. Pain in brachial to radial. The symptoms persist 17 days post vaccination.
Dizzy, lost color in face, fainted (< 5 sec). convulsion (jerk) } per mom * blood pressure was taken 104/70 pulse 75.
Low grade fever (99.5F), shaking chills, body aches, joint pain, fatigue, right arm pain, nausea. Symptoms lasted 24 hours.
Post receiving the Pfizer vaccine within 15 minutes patient had a near syncopal episode (lightheaded, faint, dizzy, with N/V). Patient was put on a stretcher, recumbent position. Feelings of lightheadedness/vertigo almost resolved but with every attempt to elevate the head lightheadedness/vertigo returned (over a span of 45 minutes). Since patient could not be progressed to a sitting position  without being symptomatic 911 was called. EMS evaluated and transported patient to Hospital at 5:50 PM.
prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds); Pfizer vaccine caused the bleeding around the eye/bleeding under her eye; Black eye/left eye was black. It is a purple eggplant in color.; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 30Jun2021), via an unspecified route of administration in the right arm, on 28Feb2021 10:20, as single dose, for Covid protection, at the hospital. Medical history included atrial fibrillation and ablation. Concomitant medication included apixaban (ELIQUIS) taken for atrial fibrillation and to prevent stroke from 2019. The patient did not have prior vaccinations within 4 weeks. It was reported that the patient received the first dose of COVID-19 vaccine on 28Feb2021 and was scheduled to get the second dose on 21Mar2021 (Sunday). On 12Mar2021, her left eye was black, it was a purple eggplant in color. She wondered if she needed to tell the doctor and remembered her mother had blood vessel that burst. The patient clarified that it was to the side of her eye and not in her eye. It was bleeding under her eye. The nurse wanted the patient to stay so she could do some research. The nurse told her that the Pfizer vaccine caused the bleeding around the eye. The patient didn't want to have the second dose of the vaccine. She was told that she needed to report it. The nurse also told her that she needed to have her blood levels checked and that she does not need to take the second dose until she gets her blood levels checked. She went to her doctor's office but her primary care doctor and the other doctor were on vacation. She was seen by the nurse practitioner. The nurse practitioner told her that she had to take the second shot and she might have to come off the blood thinner. She underwent blood work on an unspecified date with unknown results. She was told that the nurse practitioner has to study up on this and might have to come off of the blood thinner in order to get the second dose. She has been on blood thinner since 2019 after having an ablation. She has done wonderful. She is on this to prevent a stroke. She is on Eliquis. She is thankful for it. She has gone in and out of atrial fibrillation while taking Eliquis. The patient didn't want to take a chance on the second dose of the vaccine in case of hemorrhaging and was scared to take the second dose. Her blood clotting time was checked on 17Mar2021 and her prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds). She was hoping that Pfizer could advise her on taking the second dose. She thinks she will cancel her appointment for 21Mar2021. She is afraid to have the vaccine. The outcome of the events "Pfizer vaccine caused the bleeding around the eye/bleeding under her eye" and "Black eye/left eye was black. It is a purple eggplant in color" was not recovered; and "prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds)" was unknown.
Patient is a 96 y.o. male with history of porcelain gallbladder s/p cholecystectomy 2017, glaucoma, arthritis, CKD stage 3a, atrial flutter presented with generalized weakness and shortness of breath. He daughter is present with him in the ED. Patient states that for the past 2 days he has been having shortness of breath, and intermittent mild pleuritic left sided chest discomfort. Daughter reports that 2 days ago he was having some mild respiratory distress at home. He is currently having no shortness of breath, palpitations, chest pain. He is sating 94% on RA without respiratory distressed. Presumed possible exposure during recent admission. He was just recently admitted and discharged from another hospital 2/5 for pancreatitis, MRCP was performed showing area of inflammation, and no mass. It was recommended that he have follow up EUS in 4-6 weeks. He is currently reporting no abdominal pain, no nausea or emesis, has been having regular BM.    In the ED vitals are as follows, temperature 97.9F, blood pressure 138/52, heart rate 48, RR 21, and oxygen saturation of 94% on RA. Labs results were significant for D dimer 1.91, BNP 7521, Hgb 10.0, GFR 56. The rest of the CBC and CMP were within normal limits. Troponin 280 and on repeat 243.. Flu swab negative. Covid positive. Chest x-ray mild diffuse infiltrates overlying chronic emphysematous changes, no acute findings. CT with no evidence of PE, small bilateral pleural effusions with associated compressive atelectasis, mildly enlarged hilar lymphadenopathy. Patient was given 1 dose of paxlovid. Patient admitted for observation.      Clinical Summary Patient was admitted to observation for dyspnea and elevated troponin in the setting of COVID-19.  His troponin was trended and initially decreased and then remained flat at around 205.  Patient had a echocardiogram which showed no regional wall motion abnormality or RV dysfunction.  He was monitored on telemetry and no significant cardiac arrhythmias were noted.  He was seen by cardiology who felt his troponin elevation was most likely related to COVID-19 as well as some mild respiratory distress that he experienced on presentation.  No further cardiac work-up was recommended.  Patient was not noted to be hypoxic during his hospital stay.  On 2/11/2023 the patient has no active chest pain and overall is feeling well in his usual state of health.  He is stable for discharge home.  He was sent a prescription for Paxlovid from the ED.  He should follow-up with his primary care provider within the next 1 week.  Patient will be discharged home with isolation instructions and he should undergo routine COVID isolation as instructed.   Discharge diagnosis COVID 19 Type II NSTEMI - resolved CKD stage IIIa RBBB Hx atrial flutter Sinus bradycardia POA
Patient -- was administed the moderna vaccine one day before his 28th birthday. There was no adverse effect. The patient does not have a family doctor.
Covid19 breakthrough.  1st vaccine received on 02/20/2021.  86 y/o PMH HTN, Vertigo, Neuropathy, Depression, Laminectomy presents to ED with c/o increasing SOB, intemittent fevers, cough and congestion.  Room air sat 84%, O2 2L NC 97%. CXR-clear.  Treated with IV Steroids, IV ABX and Remdesivir.
Official dx: optic neuritis, severe vision loss in left eye (8 days, post vax), joint and muscle pain, dizziness, fatigue, weakness and insomnia.
Progressive drooping right eye, right cheek and right side of mouth/upper lip, decreased sensation right side of face and mouth over the course of two days. Diagnosed as Bell's palsy on ER visit on third day, and treated with course of steriods po. 3/6/06 - review of medical record confirms diagnosis of Bell's Palsy.
Within 4 hrs of second dose, significant rt knee swelling. With restriction of flexion and extension. Swelling still present following morning. Recognized minor knee pain after first shot and received quarterly cortisone injection approx 2 weeks before second dose.  Similar symptoms as published. No PMH of RA like case study.
On Friday, September 25, 2009 at approximately 2:30pm, our family had influenza vaccines administered at the Health Center.  Other person had his vaccine a week or so earlier. That night, around 8pm, 9 year-old patient complained of a headache.  I checked his temperature and he had a fever of about 99.8°.  I gave him children's Motrin and put him to bed.  During the night he got up and vomited 3 times.  In the morning he still had a fever so I gave him another dose of Motrin. Saturday afternoon he was feeling better and his temperature was normal.  He ate a little and had a shower.  After his shower he was cold so he lied down in bed.  At about 5:30pm (after he'd been in bed about an hour), I heard him shout from his bed.  I went to him and he was very pale.  I checked him for fever and it had returned and was about 100°.  I gave him another dose of Motrin.  As I talked to him, he wasn't answering normally and seemed to be acting funny.  I called someone in to look at him.  We tried to talk to patient but he just stared at us like he couldn't hear us.  He was nearly catatonic.  Other person kept saying his name forcefully and tried to get patient to look at him.  Other person held up a couple of fingers and asked patient how many fingers he saw.  Patient didn't answer, he just stared at us.  Other person pressed him to answer how many fingers he was holding up and finally patient said, "What do you mean?"  Patient asked a couple of strange questions:  "Why are you moving so fast?" and "Are we going to do it like we did before? (When we questioned, "Do what?" he answered, "Make smiley faces like you have in your room?"  This had no meaning to us.).  I was terrified because this was so out of character for patient, who is an A+ student while barely trying.  I wanted to take him in to the hospital right away.  Other person persuaded me to watch patient for 30 minutes, however.  He thought he might be disoriented and have low blood sugar from taking an afternoon nap and not eating much that day (other person has experienced something similar).  I got patient some dinner and sat with him on his bed to eat.  He still was not functioning well and when he couldn't pick up his spaghetti with the fork, he asked me to do it for him.  He ate a couple of bites and then said he wasn't hungry and didn't want anymore.  Patient stayed up that night until about 11:45pm.  He slowly seemed to become more cognizant of what was going on, although he remained confused for some time.  Other person kept asking him math questions, which patient was able to answer correctly. We kept patient home all day on Sunday and he remained normal and without fever.  We think he does not have any lasting effects.  We do, however, believe that he had an adverse reaction to the influenza vaccine and are doubtful that we will immunize for influenza in the future.
really bad diarrhea; stomachache; arm was a little swollen; arm was painful; very tired; very tired and weak; fatigue; headache was severe; Felt achy; Dizziness; had chills; Muscle ache; headache; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Muscle ache), HEADACHE, the first episode of FATIGUE (fatigue), DIZZINESS (Dizziness) and CHILLS (had chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (Muscle ache), HEADACHE, the first episode of FATIGUE (fatigue) and the second episode of FATIGUE (fatigue). On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (had chills) and HEADACHE (headache was severe). On 21-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was a little swollen), PAIN IN EXTREMITY (arm was painful), FATIGUE (very tired) and ASTHENIA (very tired and weak). On 22-Feb-2021, the patient experienced DIARRHOEA (really bad diarrhea) and ABDOMINAL PAIN UPPER (stomachache). On an unknown date, the patient experienced PAIN (elt achy). The patient was treated with TRAMADOL for Back ache, at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) for Headache, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN MELT) for Upset stomach, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle ache), HEADACHE, DIZZINESS (Dizziness), CHILLS (had chills), VACCINATION SITE SWELLING (arm was a little swollen), PAIN IN EXTREMITY (arm was painful), DIARRHOEA (really bad diarrhea), ABDOMINAL PAIN UPPER (stomachache), the last episode of FATIGUE (fatigue), HEADACHE (headache was severe), FATIGUE (very tired) and ASTHENIA (very tired and weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were blood pressure medication, anti depressant medications. Medical history information was not provided. No concomitant medication was reported.  Reporter did not provide any causality assessments.
Ears started ringing; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. On 20Apr2021 at 15:00, around day seventeen after the vaccination, the patient's ears started ringing which continues to a really loud level for the last 24 hours from the day of this report. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ears started ringing was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Incarceration (Incarcerated).    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 RASH (Rash all over body). At the time of the report, RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported