chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Adverse reaction: swelling, erythema, induration to right upper extremity at site of injection surrounding area down to anteabitol fossa.  Reaction noticed 11pm on day injections given.  02/10/04: no change today.
Pt received dose # 2 COVID vaccine at approx. 0750. States he began to feel nausea, light headed and heart racing almost immediately. Did not report symptoms and returned to work after 15 minute wait.  At approx. 0847 pt presented to primary care clinic with symptoms continuing.  Vital signs at this time:  125/85 HR 67  SPO2 100% Temp 97.5 oral. ECG indicated mid and precordial left ST elevation. Based on pt history of prolapsing Mitral Valve Leaflet Syndrome, recent COVID vaccine and abnormal ECG, pt was transferred to the ER.  Pt was not provided any medication at ER and was discharged home.
Pt received the pediatric (age 5-11) vaccine of 10mcg instead of the adult (12+ years old) 30mcg dose.
I woke up with excruciating pain the the right scapular area, medial aspect) . Pain was sharp and constant. No fever, nausea or vomiting. The following day, Oct 27, Sunday, on top of the scapular pain I felt pain and heaviness of the right upper arm and forearm. Pain was felt more on abduction of the right arm. There was little pain on elevation of the right arm and pain on elevation of the left arm ( could only go midway). I felt pain on reaching out  forward of the right and left arms.  I applied alternating cold and hot therapy on the right scapular area with massage in between. I took Ibubrofen  500 mg in the morning and 500 mg in the evening.  Today 10/30, the symptoms persist.
15JUL92 pt recvd 1st dose of Engerix-B & that same day devel wheezing, tremors, nausea, mild anaphylactoid reaction; no tx given;
right Facial Numbness; Right Internal Carotid Artery Occlusion; Left Internal Carotid Artery Stenosis; Peripheral Vision Deficit in right eye; Blepharitis; Lower Lid Laxity in both eyes; sebaceous Inclusion Cyst right in the right medial and right lower lid; sebaceous Inclusion Cyst right in the right medial and right lower lid; problems with the left ankle, knee and back; problems with the left ankle, knee and back; hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concomitant medication, current condition and historical condition was unknown. On or around 05-JAN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered numbness in the right side of the head, face, scalp and upper extremity, problems with the left ankle, knee and back, right lower eyelid pain and irritation and hearing loss and was diagnosed with right facial numbness, right internal carotid artery occlusion, left internal carotid artery stenosis, peripheral vision deficit in right eye, blepharitis, lower lid laxity in both eyes, sebaceous inclusion cyst right in the right medial and right lower lid. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     The events of right facial numbness, right internal carotid artery occlusion, left internal carotid artery stenosis, peripheral vision deficit in right eye, blepharitis, lower lid laxity in both eyes, sebaceous inclusion cyst right in the right medial and right lower lid, problems with the left ankle, knee and back and hearing loss were considered as disabling.  Upon internal review, right internal carotid artery occlusion, left internal carotid artery stenosis and hearing loss were considered as medically significant.
Pt. called me crying in pain saying her stomach hurts and she's having trouble walking.  She said she has her menstrual cycle and it has never been this bad. She said she didn't get it last month at all. Prior to this, she said her cycles were normal. She also had pain in her thighs and trouble breathing which resulted in her needing her rescue inhaler.  At this time she has been given ibuprofen and is resting with a heating pad. I as pts. mom am concerned that this may be related to vaccine.
Red, hard (L) upper arm - hot to touch, took 4 days to go away. Severe diarrhea that night. Sore abdomen for 3 weeks. (Hx of leaky gut).
This spontaneous report has been received from a Registered Nurse refers to a 16-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 26-SEP-2017, the 13-year old patient received the improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1710USA004063.
MIgraine; Ear pain/Pain in right ear; Can't open eyes due to migraine/Pain in right eye; Pain on right side of throat, when swallow; Headache; Chills; Felt very painful like all over; Face swollen/Body swollen, like couldn't put rings around finger; Feeling very bad; Woke up full of sweat; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger) and MALAISE (Feeling very bad) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPROXEN SODIUM (ALEVE), MIRABEGRON, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and COLECALCIFEROL (VITAMIN D 3).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad) and HYPERHIDROSIS (Woke up full of sweat). On 01-Mar-2021, the patient experienced MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow). At the time of the report, HEADACHE (Headache), CHILLS (Chills), MYALGIA (Felt very painful like all over), SWELLING (Face swollen/Body swollen, like couldn't put rings around finger), MALAISE (Feeling very bad), HYPERHIDROSIS (Woke up full of sweat), MIGRAINE (MIgraine), EAR PAIN (Ear pain/Pain in right ear), EYE PAIN (Can't open eyes due to migraine/Pain in right eye) and OROPHARYNGEAL PAIN (Pain on right side of throat, when swallow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Aprezin and Tylenol.   This case was linked to MOD-2021-031896 (Patient Link).   Reporter did not allow further contact
pt vax 20JUL95 & pt felt rt arm become sore w/stinging periods shortly afterwards, stated arm became swollen & felt hot; t99, arm itches, feels hot, site rt deltoid same temp as rest of body, 25mm x 10mm firm; lightheaded, firm
almost passed out after vaccination/Still feels like he has to pass out; sick; throw uppy/feeling like he has to throw up but he can't/feeling like have to vomit; He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night; wakes up feels nauseous; achy; he feels this bad; heart racing; headachy; he is pale; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FC 3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jul2021 for Covid-19 Immunisation and experienced got really sick, heart racing, feeling like have to vomit, nauseous and headache. And He spent 3 to 4 days in nursing quarters, sleeping. After the second dose got even sicker. heart racing, feeling like have to vomit, she is concerned that he is having an adverse event. After his 2nd dose he is still sick, almost passed out after vaccination, the pharmacist thought they would have to call an ambulance, but did not call the ambulance. "He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night, wakes up feels nauseous, achy and headachy and throw uppy, not just being teenage lazy, feeling like he has to throw up but he can't he is pale and still aches. Still feels like he has to pass out, he asks to sleep with us, because he feels this bad.She called the Doctor "can't get us in until Thursday. The nurse said he probably had covid when he got his vaccine. They want to test his white, red blood cell hemoglobin and something else and another covid test. "Call back 24Aug2021 at 2:54PM - Left voice mail with telephone number and extension due to call disconnected while on hold.Outcome of achy was not recovered, of others was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909916 same pt, different dose/event
Approximately 1 hour after vaccine, experienced tinnitus in left ear.  Has approx 25 year hx of intermittent tinnitus but usually resolves within 48 hours.  This instance lasted approx 72 hrs then resolved.  Was not overly concerned given history of tinnitus and received 2nd MMR vaccine on 4/14/21.  After 2nd dose, tinnitus developed after approx  15-30 minutes and has continued since then with varying degrees of loudness.
some injection site tenderness; a really bad head ache; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received his first dose 4 days ago and reported some injection site tenderness on 12Jan2021.  He stated that 18 hours after his injection he had "a really bad head ache", fatigue, and joint pain for the remainder of the day on Jan2021. Outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
Information has been received from a receptionist of the registered nurse, concerning rumor going around that a 19 years old girl who on an unspecified date received the first shot of GARDASIL (dose, route and lot # not reported), developed a brain infection, and passed away. The patient died this summer, June/July 2012. The reporter was not even 100% sure if the patient had had the GARDASIL shot because the nurses found that there was no record of the patient in local registry for GARDASIL patients. They were assuming that she was vaccinated out of state because she had joined the military (unspecified). The patient might have gotten vaccinated by the military. Another part of the rumor that was going around was that "the girl was fine one day, not the next, and it must be the GARDASIL shot that did this". The time from receiving the GARDASIL shot to the time of her death was unknown. It was unknown if she had any adverse experience from the GARDASIL or if it caused the brain infection. Additional information has been requested.
Had redness and swelling from right knee to groin. No lymph node enlargement. Mom reports only slightly swelling note on 6/9/04.
Pt came to office to bring her children for their second Pfizer vaccine.  She stated that the day after her vaccine she had a headache and did not feel well.  She described that her chest felt like a "brick" was on it and it was "caving" in.  She passed out and her family called 911.  The paramedics took her temperature and it was "over 103 degrees".  She stated that she did not know she had a temp and did not have a way to check it.  They gave her Tylenol, an inhaler and observed her.  They did not take her to the ER.
Pain in shoulder, weakness in arms and legs, unable to sleep, loss of mobility in arm and shoulder (cannot put on coat or brush hair without help).
Became pale and felt dizzy.  No LOC.  O2 sat 99%.  HR 88.  BP 116/72.  States she became scared after feeling dizzy after receiving vaccination.  Felt better after speaking with RN and drinking 4oz juice.  Color returned to pink quickly.  Vitals stable.  Became talkative and states she feels better after drinking the juice.
So I had intense muscle pain that started about a week after the second vaccine. I saw my PCP and they diagnosed me with polymyalgia rheumatica and they do not know what from. It has been ongoing ever since. I also have a loss of smell, which started about the same time. For the loss of smell I went to see an ENT and he prescribed a eucalyptus thing I swab in my nose once a day. For the polymyalgia I have prednisone and Tylenol now. I also saw a Rheumatologist as well and had a whole bunch of tests.
lung got congested; temperature was 102 degrees for 3 days; Rash; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunization. (Reason for no lot number: of Covid vaccine: Complainant hung up abruptly/transfer incomplete). Medical history included issue with her heart from 2021 to an unknown date (she went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now). The patient's concomitant medications were not reported. This report is related to a study or programme. Patient previously took first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 after second dose of BNT162B2, the patient's lung got congested, temperature was 102 degrees for 3 days and she also experienced rash. The patient reported that she got both doses of the Covid vaccine, but after the second dose, about 20 minutes later her lung got congested. She went out to her vehicle and used her inhaler and still noticed the problem when she went home that night. She got the regular symptoms and her temperature was 102 degrees for 3 days. Patient had a rash and that all got better, but her lung was still congested. She went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now. Patient went to the emergency room and everything checked out to be fine as far as her heart and lungs. She noticed there was Polyethylene Glycol in the Covid vaccine, and she was wanting to know if this could have caused the issues, if someone else had reported this, or if Pfizer had any recommendations on how to get this all fixed. The patient underwent lab tests and procedures which included body temperature: 102 degree for 3 days on an unspecified date in 2021. Therapeutic measures were taken as a result of lung got congested. The outcome of the event lung got congested was not resolved, and rash was resolving, and outcome of the events temperature was 102 degrees for 3 days was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Received 1st & 2nd does of Engerix-B Jun & Jul90. Oct90 hospitalized w/dx of acute hepatitis B.
Vertigo lasting 8 hrs. Nausea Chills Shakes Multiple bowl movements (5)
10AUG93 parent presented pt for vax; 7-8 days later pt exp a full blown sz 3 mins duration; sl URI p/immun;
Patient was < 16 years of age at time of vaccination.  No adverse event just medication error.
Black out, Pasty coloring, nausea, Profuse sweating and hot flashes, loss of large and fine motor control.  Lasted for 30 minutes and then nausea and weakness for the rest of the day until today.
8 days after flu shot (10/01/2020) came down with Shingles. Confirmed by doctor visit 4 days later (on 10/05/2020) and began medication for rash (Valacyclovir) and pain (Gabapenten)
Patient brought to site by father for COVID vaccination. Father completed form and gave incorrect age and DOB of patient in order to have child vaccinated. Patient is 15 years 7 months old, and father wrote he was 16 years 7 months and changed DOB on consent form to reflect this age. Patient only had school ID which has no birth date and vaccine was given. After vaccine given, staff who are responsible for ensuring vaccine transferred to immunization tracking system noticed the patient's DOB was incorrect and notified author. Patient was off site when they noticed and had no reported adverse effects while waiting the recommended 15 minutes.
Around 11:00 in the morning I was starting to feel weak and hard of breathing with a sore arm where the injection site was. As the day went on it progressed to muscle aches and a low fever, I went to bed with chills, muscle pain, heavy breathing, and a 100.8 fever. I work up in the middle of the night to go to the bathroom and felt nauseous, I don?t remember much but I remember waking up on the floor in a cold sweat, so I assume I passed out from the nausea. I went back to bed and I woke up with a 101.8 fever and weakness and muscle pains. My mother told me to take Tylenol every 4 hours and be on top of things, my symptoms have been decreasing since this morning but as I am filling this out at 11:00 at night I?m slowly getting my fever back. I will add this is exactly how I felt when I got covid back in November of 2020.
Hospital Medication Reconciliation: Patient is being admitted to local HOSPITAL Family Care Unit. Patient is a 71 year old MALE who is being admitted to the local Hospital. This patient meets inpatient level of care because needs O2, input monitoring, and IV meds.
Pain at injection site, red Streak running from site to inside of arm. Ice, Benadryl given-for 48 hours. Redness & pain started to diminish after 48 hours of ice & Benadryl q 8 hrs.
Information has been received from a licensed practical nurse concerning a 41 year old female patient with an allergy to acetaminophen, diphenhydramine hydrochloride, reported as developing itchy palms and no other pertinent past medical history who on 08/12/2003 at 12:00PM was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  On 10/17/2003 a laboratory test, VZV AB (IGM), EIA was performed and resulted 0.17 and a VZV AB (IGG), EIA resulted 0.35; both of which were negative.  On 10/22/2003 at 12:00PM she was vaccinated subcutaneously in the right arm with a second dose of varicella virus vaccine live.  On 07/15/2004 a VZV AG (IGG), EIA resulted negative at 0.41, no VZV IgG antibody was detected.  It was noted that the patient was not ill at the time of vaccination.  The reporter indicated that the patient failed to seroconvert.  A pre-vaccination titer VZV AB (IGG) on 10/17/2003 and HB S AB on 07/15/2004.  A product quality complaint was not involved.  Unspecified medical attention was sought.  No additional information is expected.
covid vaccine breakthrough event  Covid booster on 10/30/2021  FH8028
PATIENT RECEIVED COVID 19 VACCINE THAT WAS OUTSIDE TO THE EXPIRATION TIME.  PATIENT DID NOT REPORT ADVERSE REACTION TO THE PHARMACIST WHEN SHE WAS INFORMED OVER THE PHONE. NO ADVERSE REACTION IS KNOWN TO HAVE OCCURRED.
Patient reported numbness of the right side of face and right arm weakness 2 hours after receiving vaccine. Patient didn't take any medication for this occurrence. Symptoms went away after 45 minutes and then returned again on 4/8/2021. Pharmacist on duty recommended patient see a doctor on 4/8/2021
Chills, some nausea, hives around injection site, persistent soreness around injection site.
Vomiting, diarrhea and fever per phone call from pt's mom on 5/12/05.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-NOV-2015, the patient was vaccinated with an expired dose of PROQUAD (Merck) (0.5 ml, subcutaneously, lot # K007158, expiration date 12-NOV-2015). No adverse effects were reported. Additional information has been requested.
Patient with (2) 1 cm- sized red, itchy, areas approximately 4 mm apart. No treatment necessary at this time.
Deep vein thrombosis right gastrocnemius vein and superficial venous thrombosis in right small saphenous vein diagnosed January 15, 2021. Symptoms began with acute onset right lower extremity calf pain and swelling on January 14, 2021.  Treatment with Xarelto began January 15, 2021.
Patient had swelling of the tongue, hives, difficulty breathing and was sent to the ER for treatment.
Shortness of breath, pain in neck, tingling in fingers/toes, chest pain, heaviness in chest.