chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/27/21: Patient brought to the ED via EMS complaining of SOB. He stated his symptoms started 2 days ago and progressively got worse. He also stated his doctor had recently given him diuretics for BLE swelling. When EMS arrived, his O2sat was 81% on room air. They placed him on CPAP 100% and gave him DuoNeb and methylprednisolone for wheezing. In the ED, he was switched to BiPAP 20/12/100%. He was found to be COVID-19 positive. His chest x-ray showed pulmonary edema. He was diuresed with furosemide 40 mg IVP. He will be admitted to the ICU for further monitoring.
Pain, redness and swelling on the entire length of the left arm, loss of appetite, weakness, somnolence.
Pt shared ears became itchy immediately after receiving the vaccine but didn't think much about it. Later the next day (2/7/23) developed hives to knees, feet and eyes. Took Benadryl 25 mg which helped. However, later in the night voice became hoarse and couldn't speak clearly. Called on call nurse and was instructed to take Benadryl, around 2200. Denied feeling SOB or difficulty swallowing. Feels better today. Voice a little hoarse  Dr notified 2/8/23.
Information has been received from a vaccine specialist concerning an unidentified child patient who was vaccinated with varicella virus vaccine live. The serum varicella zoster virus antibody test was done and "the patient failed to seroconvert". Unspecified medical attention was sought. Follow up information from the physician indicated that this is not an adverse experience because "she cannot be sure that that patient did not seroconvert because there is no commercially available test for varicella vaccine antibodies. The commercially available tests test for wild type antibodies." It was reported that a sibling in the patient's household has leukemia. Additional information has been requested.
Site began itching, then when scratching, bump would scab over, 2 months later, still itching with scabs on arms and chest.
Started with muscle aches at 10 pm the 27th. Woke at 2 am with shooting pain down the right-side of my neck, lower back, through my right leg and down to my ankle. I could barely walk. Took 6 ibuprofen and went back to sleep about 4 am. I woke up limping. I still have severe pain down my right-side.
11/13 - Received vaccine, very sore arm  11/14 - Chills + sweats all day 11/15 - Reduces spread from delt down to elbow warm to touch; MD prescribed Keflex 250 mg QD x 5 days
flu like symptoms; fever; chills; headache; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and headache. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter did not consent to follow up.
Information has been received from a physician concerning a 63 year old female with osteoporosis, rosacea, gastrooesophageal reflux disease (GERD), rhinitis allergic, and drug allergies to penicillin and ampicillin (caused blotches on face and fatigue), TRILAFON and COMPAZINE (caused dystonia), CILOXAN and TOBREK (caused eye swelling), CARBOCAINE (caused ear burning and fatigue), alendronate sodium (MSD) (caused some GI distress) (WAES# 0708USA05256) and ACTONEL (caused weakness and presyncope) who on 13-APR-2007 was vaccinated SQ with 0.65 mL Zostavax (Oka/Merck) (lot # 656606/0033U). Concomitant therapy included PREVACID, multivitamin (unspecified) and a calcium carbonate supplement.  On 13-APR-2007 the patient developed a bad earache the night of her injection which lasted for several days.  The earache kept the patient up at nights.  She also experienced an altered taste sensations for a few weeks.  She sought medical attention.  No lab diagnostic studies were performed.  The earache resolved within several days, and the altered taste resolved after 2 to 3 weeks.  Additional information has been requested.
34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and diaphoresis.  She denied difficulty breathing, throat tightness and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and syncope. Patient states she last ate an apple with PB around 1pm today, but has not had much else today. Denies drinking much water today. She was working in surgery a majority of the day.    ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chest tightness, shortness of breath and rash    + diaphoresis:   Previous Reactions: Denies. Got the flu vaccine this year without adverse reactions.    Objective    Vitals Vitals:   01/08/21 1506 01/08/21 1520 01/08/21 1529 BP: (!) 147/92 132/86 (!) 130/90 Pulse: 69 69 75 SpO2: 100% 100% 100%     Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: no therapy. Patient was given a snack and water. Follow up response to treatment: good. Patients symptoms completely resolved before she was discharged. Encouraged her to drink water at home. Her BP improved throughout her visit.  Patient discharge: Stable to go home and follow up with PCP.   ons  After Visit Summary (Automatic SnapShot taken 1/8/2021) Additional Documentation  Vitals:   BP 130/90  Pulse 75 SpO2 100%  More Vitals Encounter Info:   Old Enc Report, History, BestPractice Advisories, OB History Report
Information has been received from an investigator regarding a 75 year old male who received a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation) on 12/1/98 as part of the study, "A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Efficacy of Protection From Natural Influenza Virus Infection of Influenza Virus Vaccine Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) and Inactivated Influenza Virus Vaccine in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Field Trial". On 12/5/98, the pt developed an exacerbation of chronic obstructive pulmonary disease. He recovered by 12/11/98. The investigator believed that exacerbation of chronic obstructive pulmonary disease (unexpected per the investigator brochure) was "Medically Important" and "possibly" related to study vaccine administration. The medical monitor's assessment is unknown. Follow-up information received on 6/14/01, indicated that the pt received an injection of Fluvirin along with a dose of influenza virus vaccine trivalent, types A & B, live, cold adapted (frozen formulation). On 12/5/98, he developed increased shortness of breath. On 12/8/98, the pt experienced palpitations with exertion. He was seen in an ER where a chest x-ray and an EKG show "no acute changes". The assessment remained unchanged. Additional follow-up received on 8/1/01, indicated that the pt was treated with Augmentin (amoxicillin clavulanate) and prednisone. There was no change in the original assessment. This was a nasal solution.
Facial spasms; cold and flu symptoms; flu symptoms (congestion); flu symptoms (congestion); flu symptoms (sneezing, congestion); This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2022, the patient received the 2nd dose of Shingrix. On 2nd March 2022, less than a day after receiving Shingrix, the patient experienced cold symptoms, influenza-like symptoms, nasal congestion and sneezing. On an unknown date, the patient experienced facial spasm. On an unknown date, the outcome of the cold symptoms, influenza-like symptoms, nasal congestion and sneezing were recovered/resolved and the outcome of the facial spasm was not recovered/not resolved.   It was unknown if the reporter considered the cold symptoms, influenza-like symptoms, nasal congestion, sneezing and facial spasm to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The patient self-reported this case. The patient reported side effects of Shingrix. The patient received her second dose of Shingrix and that same day after receiving the vaccine she experienced cold and flu symptoms (sneezing, congestion). This resolved after two weeks but then she noted she started having facial spasms on the left side of her face which had yet to resolve. The reporter consented to follow up.
Redness, swelling about 2 inches long and 1 inch wide that began on Wednesday Oct. 7th warm to touch. Pt denied pain. (L) deltoid treat with BENADRYL and ice to arm.
While under Observation after receiving the vaccine he felt lightheaded and throat tightness. He was found to be diaphoretic and hypotensive by the vaccination staff. He denies similar symptoms with previous injections or vaccinations. Symptoms resolved after a 500 mL fluid bolus given by EMS. Patient felt he was in his normal state of health upon ED arrival
Erythema, swelling, tenderness at L deltoid 5 inches x 4.75 inches in diameter. Rx KEFLEX.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-NOV-2014 the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had LMP on 1/12/21, so was most likely early pregnant at the time of her first vaccine. She then experienced a miscarriage on 3/1/21. She was assessed in the ER and then in our OBGYN office.
The pt called the clinic on 11/6/01 and stated he "has had stiff neck and soreness of head and ears since 11/3/01. He states he has arthritis of neck and he was referred to PMD. Called PMD but the pt did not go. Then PMD's office called and stated the pt was seen on 11/3/01 with no complaints.
pt was at his normal baseline of health the Monday of vaccine. Per sister, he had a fever of 104F, chills and myalgias hte following Saturday. he was not heard from on Sunday therefore on Monday his sister did a forced entry and found him on the ground.
Chills, fever and fatigue for 24 hours. Chills and fever would return every 4 hours once Advil wore off. Arm soreness for 3 days.
FEVER  TYLENOL 12 HOURS CHILLS  TYLENOL 12 HOURS LETHARGY 36 HOURS
no other AE; Patient received doses of GARDASIL 9 outside recommended administration schedule.; This spontaneous report was received from medical assistant concerning a 13 years old patient. No concurrent condition, medical history or concomitant therapy was reported.       On 03-OCT-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 1 injection; lot# T007024, expiration date 23-APR-2022) as prophylaxis. The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was received on 26-MAY-2021 (at the dose of 1 injection; lot# T007024, expiration date 23-APR-2022) as prophylaxis. The patient received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) outside recommended administration schedule. The interval between the first dose and the second dose was long (inappropriate schedule of product administration). No other adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
lt shoulder swollen & reddened @ site of inj & down to the elbow;did not prevent pt from nl use of arm;saw MD 8JAN98 in afternoon;noted a rxn to the vaccine;
Approximately 10 hours after receiving the vaccine, movement of any kind and speaking became very difficult and lead to rapid heart beat and shortness of breath.   I was taken to the ER where they checked vitals including oxygen levels and ran an ECG 12 Lead.  They provided Benadryl.  I was discharged a few hours later; the doctor felt confident my vitals looked good.  During the following 24 hours, I still had difficulty moving and speaking.  I was able to drink water but swallowing anything else seemed too difficult.  After about 24 hours, I was able to sit up and eat a little soup.  In the days that followed, I still had great difficulty eating, I experienced weakness in both arms, nearly constant lateral head pressure on both sides, tremoring, frequent feelings of hypoglycemia, muscle twitches, and what I can best describe as sudden, unsolicited floods of adrenaline, which included rapidly increasing head pressure and rapid heartbeat.  These could occur when doing something as benign as watching a tv show with my kids.  It took about 2.5 months before the head pressure started to subside for any length of time, as well as, some of the other more acute symptoms.  However, I am still experiencing difficulties even now.  I spoke with my primary care doctor multiple times in the aftermath and he has recommended I consult a neurologist and cardiologist.
started seeing "floaters" or "prisms" in his eyes; as if he was looking through a kaleidoscope/impairment or blurred vision elapsed; vision was distorted for a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (started seeing "floaters" or "prisms" in his eyes), VISUAL IMPAIRMENT (as if he was looking through a kaleidoscope/impairment or blurred vision elapsed) and METAMORPHOPSIA (vision was distorted for a little bit) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Seasonal asthma. Concurrent medical conditions included Penicillin allergy, Drug allergy (Cleocin), Drug allergy (Varieties blue cheese) and BPH. Concomitant products included TAMSULOSIN for BPH, FISH OIL and CHOLECALCIFEROL for Nutritional supplement, ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE;SALMETEROL for Seasonal asthma.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VITREOUS FLOATERS (started seeing "floaters" or "prisms" in his eyes), VISUAL IMPAIRMENT (as if he was looking through a kaleidoscope/impairment or blurred vision elapsed) and METAMORPHOPSIA (vision was distorted for a little bit). On 16-Feb-2021, VITREOUS FLOATERS (started seeing "floaters" or "prisms" in his eyes), VISUAL IMPAIRMENT (as if he was looking through a kaleidoscope/impairment or blurred vision elapsed) and METAMORPHOPSIA (vision was distorted for a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: (Follow-up received on 04-MAY-2021)  Reporter contact details updated. On 14-Jul-2021: Follow-up information was received on 14-Jul-2021. Primary reporter details were added. Facility details was added. Patient demographic was added. Historical condition was added. Concomitant medications were added.
Fatigue for 3 months, persistent eczema, chest pains, rashes on stomach and face, sores in mouth, weight loss and irritable bowel syndrome.
Client was given undiluted COVID-19 Pfizer 5-11 vaccine 0.2cc Left Deltoid.  Mother was notified at noon. No problems at that time. Mother interviewed 1-3-22. Mother denies any changes in behavior, no redness or swelling at the site, afebrile. Mother does not feel there were any side effects.
Upper part of her arm is very sore; Upper part of her arm is red; Around the vaccine area is red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper part of her arm is very sore), ERYTHEMA (Upper part of her arm is red) and VACCINATION SITE ERYTHEMA (Around the vaccine area is red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper part of her arm is very sore), ERYTHEMA (Upper part of her arm is red) and VACCINATION SITE ERYTHEMA (Around the vaccine area is red). At the time of the report, PAIN IN EXTREMITY (Upper part of her arm is very sore), ERYTHEMA (Upper part of her arm is red) and VACCINATION SITE ERYTHEMA (Around the vaccine area is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Bruise appeared 5 days after vaccine - 2 days later arm became itchy and red. Bruise still present 10 days after vaccine.
This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives after 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02LM20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy, Fruit allergy (she can only eat berries and citrus fruits) and Allergy to chemicals. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives after 2nd dose). At the time of the report, URTICARIA (hives after 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.No treatment medication use was reported.  This case was linked to MOD-2021-436363 (Patient Link).
The patient describes moderate to severe pain at the site of injection starting one day after the immunization. Patient describes worsening as well as redness and swelling of the arm starting another day after that. I informed him to try BENADRYL, ibuprofen, and icing to try to manage symptoms. I informed the patient to call his  primary care provider if symptoms worsened or did not improve.
on 6/17 patient developed L shoulder pain with progressive cough, SOB, and inspiratory chest pain. ER admission discovered large pericardial effusion, low grade fever, elevated ERS, CRP, WBC.
This case was reported by a physician and described a 6 week old male pt who tested positive for hep B surface antigen after receiving hep B vaccine recombinant (Engerix B) for prophylaxis. The pt's past medical history included prematurity. The pt had received a blood transfusion. The pt's mother tested negative for hep B surface antigen. On 8/15/03 the pt received the 1st dose of Engerix B. Three days post-immunization, on 8/18/03, the pt tested positive for hep B surface antigen. On 8/25/03, testing for hep B surface antigen was "indeterminate." Testing for hep B core antigen was negative. On 10/31/03, the physician reported that lab work for persistent direct hyperbilirubinaemia was performed on 8/18/03, three days post-immunization with hep B vaccine recombinant (Engerix B), and was therefore positive for hep B surface antigen and was unrelated to the use of hep B vaccine recombinant (Engerix B). No adverse effect was reported.
Patient's Daycare called and said patient was lethargic, mild rash, fever of 103.4, seizure, unresponsive, urinated on himself, dizzy, weak, lying on the floor.
Client received flu vaccine 11/07/2001 approximately 2 days later he noted bruising on the inner aspect of left arm where vaccine given, no redness or swelling noted at injection site, upper arm moist heat to affected area.
Had an episode of almost like extreme vertigo; I could not stand and was using the wall to hold myself up; migraine that could not be controlled by medicine; I never have dizziness with my migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Lot number: EL3248) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraine. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Starting with 05Jan2021. I have the Pfizer mRNA vaccine. The LOT# is EL0142. This was administered by the city of [withheld]. I think it was the state combination vaccine."), administration date: 05Jan2021, when the patient was 45-year-old, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "Had an episode of almost like extreme vertigo"; DYSSTASIA (non-serious), outcome "unknown", described as "I could not stand and was using the wall to hold myself up"; MIGRAINE (non-serious), outcome "unknown", described as "migraine that could not be controlled by medicine; I never have dizziness with my migraine". Therapeutic measures were taken as a result of migraine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360561 Same product, patient, different AEs, different dose;