chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI 11/14/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient fainted for approximately 1-2 minutes, then regained consciously slowly back to a normal state.  She was sweating profusely (visably), lost eye sight briefly when fainting, and had ringing in her ears that lasted while she was regaining full consciousness.  She was pale with whitish lips.
fast heart beat; high blood pressure; my nose and left ear got kind of numb; facial swelling; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (my nose and left ear got kind of numb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient is under medication). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT ALLERGO), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), ATORVASTATIN CALCIUM (LIPITOR), ATORVASTATIN, FAMOTIDINE (PEPCID AC), VITAMIN D3, BIOTIN and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HYPOAESTHESIA (my nose and left ear got kind of numb). At the time of the report, HYPOAESTHESIA (my nose and left ear got kind of numb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Computerised tomogram: normal (normal) Went to ER, they run a CT scan on me because they thought it was a stroke, but they said it was OK. It might have been Bell's Palsy..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-jul-2021 contains No new information
The patient developed redness and swelling in the arm below where the medication was injected. Pt went to doctor and received steroids and prophylaxis ABX.
Fever up to 103.9,extreme joint pain,exhaustion,overall malaise,lack of appetite
Pt reported feeling lightheaded with chills, obserer reported syncopal episode for few seconds and posible seizure activity, no n/o of sezurs per pt, no significant medical history 1st set of vs-hr 42, 9790 02 on recheck hr 54, 8890 02 and final check in medical tent- HR 63, 96902, Bp 106, pt given water and crackers and reported feeling better after about 15 min pt instructed to flat. pt left medical tent at 9:35 am and reported feeling well enough to drive.
Patient lost consciousness and appeared to have a seizure immediately following vaccination.  He came back around within 1 to 2 minutes. EMS was called and attended to him.  Reported as a vasovagal reaction.   Patient left with his mother.
Discomfort, Flu like symptoms, depression, death.  Its been over a year so I am able to try and cough up my data now.  On Friday May 28th, 2021, Patient age 37, got his second dose of Moderna Covid-19 vaccine, at 9:30am.  He left work early that day, sunk into the usual effects the next, so I delivered him pizza. from afar  I was finishing up a job so I was not home that weekend.  He was home alone.   On Sunday May 30th, he started out feeling somewhat better, but was not feeling great.  But then slunk into a depression. By the evening he was drinking and feeling bad.   At any rate, he was found deceased in our home on Tuesday June 2, 2022.
I took a COVID-19 test that was positive due to being exposed to a large group. Then the next, I started getting symptoms of a dry cough. Then the next day I developed sniffles and a runny nose. I contacted my doctor and was prescribed Paxlovid once I developed more symptoms. My symptoms were mild. Congested nose went away the next day after Paxlovid. The cough took a week to go away.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Client received Hepatitis A, Menactra, and Tdap vaccine.  Within one minute of administering the vaccine, client got very light headed and turned white.  He asked for some water, I gave him a bottle of water.  He was sweaty and cold. His dad was there to help.  We kept telling him to take deep breaths and he was.  He stated he felt like he was going to throw up, and he did.  Once he threw up, he felt much better.  He stayed seated for about 10 minutes and color returned to his face.  He waited in our office for about another 20 minutes and stated he felt fine.  He left with his father.  Of note: a very similar incident happened with his older brother when he received a vaccine here about 2 years ago.
Received MMR vaccine 6/21/06 as a result of "equivocal" mumps titer.  On 8/9/06 noted abrupt loss of hearing on right.  Has been evaluated by specialist with dx of sensorineural hearing loss. 8/29/06 Received medical records from ENT specialist which reveal patient received MMR vax (due to outbreak of mumps in Denver VA hospital where patient works as cardiologist) about 7 weeks prior to onset of sudden hearing loss of right ear.  Hearing loss started with tinnitus, dizziness, vertigo, N/V while on vacation.  Audiometry on 8/11 showed profound downsloping hearing loss in right ear & normal left ear.  Tympanogram was WNL.  Acoustic reflexes were absent in right ear by stimulation; present on contralateral responses.  Placed on steroids & improved as for dizziness & gait stability by following week.  Hearing was not improved.  Received 2 doses of intratympanic steroids to complete the labyrinthian perfusion & scheduled to have f/u audiometric testing in 6 weeks./ss. Annual followup 01/4/2010 Continued hearing loss-unilateral.
Arm very red swollen  hot to touch   Very painful.     Raised  red brown splotchy rash completely down arm following injection  site
After my first covid vaccine dose, I slept; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: SOMNOLENCE (non-serious), outcome "unknown", described as "After my first covid vaccine dose, I slept".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
When I was injected w/Flu Vacc. it burned like Acid. I told the Person giving it to me, it hurt then and it has not stopped hurting since, my Left side is weak and I have trouble keeping anything on that side
vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needles effects  Friday 8:00 PM to Saturday 10:00  rash continues but not as severe to currently Tuesday at noon Jaundice, elevated liver enzymes, and elevated billirubin started Saturday to currently Tuesday at noon
Within less than an hour of vaccine started to experience pulsating in hands and feet, then approx half hour later started to have numbness and tingling in hands, feet, arms and legs. Now experiencing numbness and pain, difficulty walking due to pain on bottoms on feet, prescribed Gabapentin for peripheral neuropathy.
Pfizer-BioNTech COVID-19 Vaccine EUA: six months after vaccination patient presents to emergency department reporting fatigue, cough, and abdominal cramping. Diagnosed with COVID-19 pneumonia and pneumoperitoneum. Admitted to hospital, administered steroids and remdesvir, anticoagulated,  underwent small bowel resection for perforated small bowel diverticulum. Discharged to home medically stable and on follow-up continues to improve.
Dizziness, Nasua, Weezing, Difficulty breathing, Weakness, Fast heart beat.
Pt was given a dose of 0.3ml but the vial was not diluted properly, it was only diluted with 0.8mls; Vial was not diluted properly, it was only diluted with 0.8mls; This is a spontaneous report from a non-contactable pharmacist. A 74-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151, 0.3mL) via intramuscular route of administration in the left arm on 09Apr2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  The patient had no known allergies. It was unknown whether the patient had taken any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient was given a dose of 0.3ml but the vial was not diluted properly, it was only diluted with 0.8ml as reported. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the reported events inappropriate dilution of medication and overdose was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Increased Sensitivity to light and sounds, and This causes Headaches, and aching pain to eyes.
Onset of malaise day following vaccinations.  Nasal congestion, persistent nagging cough productive of greenish sputum, pleuritic chest pain, headache.  Unclear if fever d/t self-administered NSAIDs for headache.  Presence of one child with prolonged respiratory clinic on same date as patient vaccination visit.  Presented 3/25/13 with tachypnea, rhonchi on exam, +scattered (nonlobar) infiltrates on CXR.  Pulse ox 96% RA. Sugars 200s. PORT criteria OK for outpatient management.  Started on course of macrolide.  F/u pending. Had to defer planned airline flight.
LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness.  On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
After 5 to 10 minutes of receiving vaccines, she lost consciousness, woke up and went into seizures for duration less than a minute. Emergency Medical Services was contacted; however, patient refused to go to the hospital.
Herpes zoster meningitis; This is a literature report for the following literature source(s):  A 54 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER MENINGITIS (hospitalization, medically significant), outcome "recovered", described as "Herpes zoster meningitis". The event "herpes zoster meningitis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: negative for lymphadenopathy or neoplasm; computerised tomogram head: negative; computerised tomogram pelvis: negative for lymphadenopathy or neoplasm; computerised tomogram thorax: negative for lymphadenopathy or neoplasm; csf lymphocyte count: 89 %; csf white blood cell count: 750 /mm3, notes: with lymphocytic predominance; 200 /mm3; herpes virus test: positive, notes: (in the CSF); negative, notes: (study); lumbar puncture: csf analysis revealed 750, notes: white blood cells per mm3 with lymphocytic predominance; magnetic resonance imaging head: negative; negative; revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; magnetic resonance imaging spinal: revealed multiple small enhancing leptomeningeal, notes: nodules throughout the dorsal cervical and thoracic spinal cord, along with abnormal enhancement involving the cauda equina nerve roots; showed dramatic resolution of the leptomeningeal, notes: nodules; 25 days later. Therapeutic measures were taken as a result of herpes zoster meningitis.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments:  Based on the information in the case report, a possible causal relationship between reported events herpes zoster meningitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200206631 Same article/drug/event; different patient;US-PFIZER INC-202200206630 Same article/drug/event; different patient
nerver got the 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comment:The reporter reported this case via interactive digital media. The reporter asked if a patient received 1st dose of Shingles vaccine in 2019 but never got the second dose what should they do now. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.  The follow-up would not possible, as no contact details were available.
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Rash (red) all over both arms (from armpit to wrist) (starting from left arm and then both arms). Symptom getting worse in 1-2 days and then gradually subsided in Day 3 and Day 4.
administered an expired vaccine to a patient, no AE; Initial information received on 13-May-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via Media Information (inquiry reference number 00600500).  This case involves a patient in his 50s was administered with 0.5 ml expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot c5578aa and expiration date :28-Jan-2021) via unknown route in the deltoid (but not sure which one) for prophylactic vaccination on 13-May-2021 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant or no other vaccines were given to the patient.  It was a case of actual medication error due to expired vaccine used (same day latency).   It was reported that a medical assistant (MA) gave a dose of Tenivac yesterday which had expired. Caller mentioned that she sent an email to Pharmacovigilance about this last night and missed return phone call. The nurse practitioner who was reporting the event is currently at home and does not have the patient initials or dob (date of birth) with her. Reported that the caller did not have this with her today, but stated that it was in her previous web inquiry. The lot information documented here was pulled from that web inquiry-GMI -00600500). And was with the question that what are the effects of an expired vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.
2 hr post inj pt became ill w/nausea, light-headed, palpitations, felt disoriented lasted until following day; pt had no problem w/2nd dose-same lot
Allergic site reaction, possible infection. Site was red, inflamed, swollen, and warm to touch.
Left arm swollen, red, streaked, tender, given 7/3/06 reaction started 7/4/06 Cefzil 250 bid x 10 days. Benadryl, cold compress.
This spontaneous report as received from a pharmacist via company representative refers to three patients of unknown age and gender. The patients' pertinent medical history concurrent condition were unspecified by the reporter. On an unknown date, the patients were vaccinated with ZOSTAVAX (strength, dose, frequency and lot # were unspecified by the reporter). No concomitant medications were reported. Within the last 6 months, in 2015, approximately, the patients returned back to the pharmacy with an "outbreak of shingles". They did not receive treatment for the event. They sought medical attention by going back to pharmacy. The outcome of the event shingles was unknown. There was no product quality complaint involved. Causality assessment was not provided. Additional information has been requested.
Trigger fingers (tenosynovitis) and pain in Both hands, neck stiffness, acute exacerbation of chronic low back pain.
Received on Monday--fine that day.  Arm got reallty sore on Tuesday-Wednesday & Thursday.  On Thursday I had the chills in the afternnon and that evening.  It is 1 week later to the day and I still have a knot in my arm that is a bit tender
Mom brought her two kids in for their Pfizer vaccines and she was to receive the bivalent Moderna booster. Tech went to give the 9 year old his vaccine and he started getting nervous and she ended up giving him the Moderna vaccine. No adverse reactions were noted while the patient was in the pharmacy.
On my left arm it has hurt a lot  I had to put ice and now that pain has reached my shoulder.
3 less then dime size hives on abdomen and left clavicle- itching at hives site after 15 mon of vaccine, monitored for additional 15 min, symptoms improved, no treatment
Headache, Arthralgia, Fever,  Fatigue Narrative: Fever 100.9, took Tylenol
pt recvd vax & exp rt upper quad abdo pain, tenderness & a four pound weight gain; pt was not hospitalized;
Chills, fever headache nausea  Monday evening red rash on arm bumpy hurting Lasted 7 days Tiredness lasted over a week
Moderna COVID-19 Vaccine EUA. Shingles out break on left leg . 4 days after vaccine. Anti-viral and muscle relaxant treatment started 01/18/2021.
Nausea, fever, chills, extreme fatigue.  VERY disoriented, CONFUSION, DIZZINESS.    After the first dose on 2/16/2021, my symptoms were the same as above but were not severe, a bit more than other reportings.   BUT the 2nd dose on 3/16/2021, my dizziness, disorientation, and confusion was severe.  My temperature was 100.3 and didn't subside  until the evening of 3/17.
The patient verbalized experiencing numbness, tingling, and pain in left upper extremity (shoulder and deltoid area).  Symptom onset started as soon as the influenza vaccine injection was administered.  Symptoms increased in intensity over the next several weeks.  Client seen by neurologist and now symptoms are resolving.
Intense, excruiting muscle pain, low grade fever (100 - 101), nausea, headache.  Unable to move arm, shoulder.  More intense pain than childbirth and kidney stones.  Very ill x 2 days now.  No relief in sight.
1 minute generalized seizure. Follow up 12/08/2003: "Occurred while sleeping with mother.  1 min shaking, followed by brief flacid period.  There were no postictal drowsiness.  Child under tx for cough, prurulent runny nose, sinusitis.  During or immediately before the seizure, the patient had a fever.  It is unknown what the temperature was before the seizure.  The seizure lasted approximately 1 minute. Augmentin-started day before.  Tylenol 9 hours before seizure onset.  Date of first clinic/ER hospital visit for the reported seizure: 11/18/2003.  Diagnosis was made by ER physician.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). the nurse reported that the patient was subsequently rushed to the Emergency Room (ER) after developing a high fever. At the time of this report, the patient was noted to be recovering. The nurse considered high fever to be an other important medical event. Additional information has been requested.
Crying, screaming for 45min on 9AUG91; On 10AUG91 would not walk, leg rt knee swollen; Xray on knees all neg; 11AUG91 sl limping on 12AUG91 completely OK; MD said was acting it out;