chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed hearing loss; dizziness; Eustachian tube dysfunction; fullness in my ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2021 at 13:00 as dose 2, single (Lot number: EW0168) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number=EW0167,, administration time=12:00PM,, vaccine location=Left arm), administration date: 02May2021, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: EUSTACHIAN TUBE DYSFUNCTION (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered"; DEAFNESS (hospitalization, disability, medically significant) with onset 15Jun2021 at 08:00, outcome "not recovered", described as "I developed hearing loss"; DIZZINESS (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered"; EAR DISCOMFORT (hospitalization, disability) with onset 15Jun2021 at 08:00, outcome "not recovered", described as "fullness in my ears". The patient was hospitalized for deafness, dizziness, eustachian tube dysfunction, ear discomfort (hospitalization duration: 2 day(s)). The events "i developed hearing loss", "dizziness", "eustachian tube dysfunction" and "fullness in my ears" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2021) Negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of deafness, dizziness, eustachian tube dysfunction, ear discomfort.   Clinical course: In Jun2021 shortly after 2nd vaccine in May, patient developed hearing loss, Eustachian tube dysfunction, fullness in ears and dizziness. Currently the dizziness was occasional, but the fullness in ears and hearing loss persists. The patient received Dose 3 (booster) dose on 09Dec2021 at 12:00, on left arm (lot number=33030BD) for covid-19 immunization administered at Pharmacy or Drug Store. No other vaccine were received in four weeks. No covid prior vaccination. And tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
patient worried about a reaction to 2nd dose.  With 1st dose she had a headache, sweaty and nauseous.  Patient sat in recliner for 15 min.  Only symptoms was slight headache BP 128/70 P 59 O2 97
Fatigue; chills; low grade fever (99 degrees F); This is a spontaneous report from a non-contactable consumer (patient).   A 53-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 25Feb2021 11:15, at the age of 53-years-old, (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient medical history was reported as none. The patient did not have COVID-19 prior vaccination. Historical vaccine includes dose 1 of BNT162B2, Lot number: EM9810, on 04Feb2021, 11:15 AM at Left arm. Concomitant medications included paracetamol (TYLENOL); ibuprofen; vitamin d3; pseudoephedrine hydrochloride (SUDAFED); and ascorbic acid (VITAMIN C ACID), all were taken for unspecified indication, start and stop date were not reported.  On 26Feb2021 15:00, the patient experienced fatigue, chills, and low grade fever (99 degrees F).  The patient underwent lab tests and procedures which included body temperature: 99 degrees F.  The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering. No treatment was received for the events.  No follow-up attempts are possible. No further information is expected.
Sudden onset chest pain and headache, seen in ER, dx with pericarditis.  Currently seeing cardiology.
Contacted COVID  04/01/2023.  Symptoms--extremely sore throat, difficulty swallowing, chills, body aches, headache, sinus congestion, plugged ears, difficulty hearing, weakness.  Lasted through 04/22/2023.  Weakness continued for several weeks after symptoms done.  Treatment--Tylenol, amoxicillin 500 mg., Azelastine HCI nasal spray 0.1%, prednisone
Soreness at injection site began about 20 minutes after injection Thigh muscles became very sore about 2 hours after injection; this lasted for about 6 hours before subsiding About 4 hours after injection, got a headache above left eye that pulled up over head and into back of neck; this subsided around noon the next day. (No pain medications were taken)
Vestibular Neuritis (dizzy) stared at 11am on Monday 10/10  Lasted for a week. Vestibular Neuritis Physical therapy exercises helped (I believe).   I was diagnosed with Vestibular Neuritis during the summer of 2017. However, it resolved in 2018 and I haven't been dizzy since 2018 (until May 2021).
rash and big hives in the sking. Itching.  Currently giving benadryl.
booster dose of BNT162B2; off label use; Postive COVID test 01Nov2021; Postive COVID test 01Nov2021; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 47-year-old non-pregnant female patient received booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: 301308A, Expiry date: unknown), (age at the time of vaccination was 47 years, patient was non-pregnant at the time of vaccination) via intramuscular administered in Arm Left on 07Oct2021 at 18:00 as dose 3, booster single for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medication included biotin, vitamin d, Iron and Vegan Omega 3 daily. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247) (age at the time of vaccination was 46 years), via intramuscular, administered in Arm Left on 23Feb2021 at 14:00 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203) (age at the time of vaccination was 46 years), via intramuscular, administered in Arm Left on 16Mar2021 at 14:15 as dose 2, single for COVID-19 immunization. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and tested positive with COVID post vaccination. No known allergies. The patient underwent lab tests and procedures, which included nasal swab real time PCR: positive on 01Nov2021. Treatment received no. The patient visited the physician office. The outcome of the events was resolving at the time of the report.  Follow-up attempts were completed. No further information was expected.
Tested COVID-19 positive, resulted in hospital admission. Symptoms included shortness of breath.
Got very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004006 (Novavax).  A male patient received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got very sick".  Additional information: It was also reported that patient received this vaccination as his first booster dose and got very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was seen for general physical exam.  She felt dizzy and weak approximately 3-5 minutes after the vaccines were administered (Havrix and Gardasil).  She was placed in the exam room on the bed with the head of bed elevated 30 degrees.  Initial Blood Pressure at time of office visit was 110/80; 5 min after vaccine administration was 70/50; 20 min after vaccine administration was 100/80.  No medications were given.  She was sent home after indicating that she felt better (about 15 min after the last BP reading).
Moderna vaccine #1 given 3/2 Pt developed R sided facial pain 3/6 that lasted about 5 or 6 days then resolved 3/10 developed R facial droop diagnosed as Bell's Palsy in ER- normal MRI of brain done Symptoms of facial weakness  persisted till now-day of report being done
Information has been received from a pharmacist concerning her 12 month old daughter with no allergies or medical history who on 05JUN2003 at 5:00pm was vaccinated SC in the arm with a 0.5ml dose of varicella virus vaccine live. Concomitant vaccination on the same day at 5:00p.m included a dose in the arm of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). There was no other concomitant medication. There was no illness at the time of vaccination. The reporter indicated that he kept her daughter home from day care on 17JUN2003 because the child had several red lesions on her body including her legs, neck and torso for a total of about ten. The lesions were described as a "red rash-like bump with no vesicle." Unspecified medical attention was sought and no treatment was required. There  were no diagnositc tests or laboratory results. A product quality complaint was not involved. Additional information was received from the pharmacist which indicated that on 15JUN2003 the child developed a chickenpox like rash with about ten red spots that faded in three days. The pharmacist noted that she was told by her physician that the child was contagious and needed to be kept home form daycare until the event resolved. It was also reported that the child had a fever of 101 degrees Fahrenheit. Subsequently, the child recovered. No further information is expected.
Five or six children devel red, swollen lumps @ the inject site; all the parents called to report the rxn & two of the pts were seen in the office;
It was reported that a male patient received a Fluzone SV vaccination on 10/23/2000. Reportedly 2 days after the injection, the patient developed a persistent tingling sensation from the injection site to his fingers. Further information is requested.
pt recvd vax; devel eczema which persists to the date of this rpt; pt's MD states pt has exacerbations of eczema from oth sources including food & inhaled allergies;
Foot pain after 4 weeks of vaccine and lasted until January of 2022 when I was getting over Covid which I contracted in December of 2021, back pain followed, lasted  8 months.  Right side of face went numb, affected my ear,  gums numb, jaw, eye numb and itchy, loss of taste on right side of mouth and throat, food getting caught in my throat, cold nose and feet. Systems of Guillain Barre Syndrome .
I immediately had numbness in my mouth and face as well as a metallic taste in my mouth. Since receiving the first shot I have had allergic reactions to various foods at an alarmingly increased rate. I have not been able to isolate which foods/ingredients. Symptoms include swollen lips and tongue, splotchy red face and the slight constricting of my esophagus.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:49 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.31. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 3-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 3-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration.   It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Possible syncope event after vaccine on 12/18/2020. Patient fell when exiting the store. She appears to have lost her balance when reaching for the wall/door to help stabilize her. Could have been due to her Parkinson's disease. She fell and the ambulance was called but disregarded and taken to the clinic instead by caregiver.  She did not complain of shortness of breath or loss of consciousness. Only her pain in her arm. A broken arm was confirmed by the caregiver on 12/21/2020.
Was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  hives and itching.   Assessment : Time of assessment 1030. Alert and oriented and Rash, Location:  both arms, across back at bra line, across shoulder blades, back of neck. Patient reported during her 15 minute observation that she started itching to her back and her top lip and the itching stopped to her lip. The itching on her back remained. She came up for check out with the Nurse at the checkout table and informed her of the itching. She was taken to the triage area and given the medications listed below. Vitals taken. After observing her for 15 minutes, she says the itching was getting worse, a 5/10 on the severity scale 1-10 being initially a 4. The redness to her arms, back, back of neck was not fading. Her lips looks puffy. I advised I would need to call for an EMT to come evaluate, she verbalized understanding. I called at 1049 and the EMT arrived to evaluate her at 1100. He noticed swelling to lips, slight tongue swelling and slight swelling to her gums, hives to her bilateral lower legs as well as the redness to her arms, back, back of neck. She mentioned to him the itching to the top lip had resolved. He advised due to her worsening symptoms, he would need to give more medication. At 1108 Benadryl 50 mg IM given; 1115-18 G Saline lock was started in the Rt A/C and he gave her Solumedrol 125 mg IV. He advised she will need to go to the ED for further evaluation and called for an ambulance to transport. Ambulance arrived at 1125 and she was transported to Hospital ED for evaluation. Patient called her father to notify him of the hospital to meet her there.    Actions taken:  Vitals sign taken  EMS called at  1115. Form obtained and completed by Nurse. Hand off to EMS upon arrival at 1130. 1038: BP 114/79 P 75; 1123: BP 118/79 P 65   Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: 1034 (20mg given due to pill not scored and unable to break in half). Administered by Nurse. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1034. Administered by Nurse.    Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1130.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for herself. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date in 2011, at single dose, for immunisation. Relevant medical history included bad allergies. Concomitant medications were not reported. About 4 weeks before she had to bring her great grandson to the hospital and she felt she caught something there. She had bad allergies, so she thought they were just acting up. But it got worse and she was coughing and felt itchy as well. She just did not feel well. So she went to the emergency room on 06Apr2018. Her oxygen level was down in the 70's, they gave her a breathing treatment, told her to take Levaquin and gave her Inhaler. They did an x-ray and she was diagnosed with pneumonia. On 17Apr2018 she was still coughing a lot and coughing up some blood. The patient was aggravating and depressing because she couldn't do what she wanted to do. No follow-up attempts are possible, information about lot number cannot be obtained.
Skin rashes in various places: arm, belly, arm pit, groin area. Not too itchy so does not cause major discomfort or requiring medical treatment Started occurring an hour after shot. Gradually getting better. Still have some rashes on day 3 after the shot. Hopefully will be gone in the next several days.
Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater; Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 12:00 (Lot number: ER8737) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing), notes: Verbatim: I have lupus. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6204, Administration time: 12:00 PM,, Vaccine location: Left arm,), administration date: 25Mar2021, when the patient was 56 years old, for Covid-19 immunisation, reaction(s): "floaters in my right eye", "i had a tear in my retina". The following information was reported: VITREOUS FLOATERS (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "Then i got my second vaccine 19Apr2021 and by that afternoon dark black larger floater". The event "then i got my second vaccine 19apr2021 and by that afternoon dark black larger floater" and "then i got my second vaccine 19apr2021 and by that afternoon dark black larger floater" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vitreous floaters, condition aggravated.  Clinical Course: The patient did not taken other vaccine in four weeks. The patient got second vaccine 19Apr2021 and by that afternoon dark black larger floater returned and wish she would of never got the vaccine retina could of detached. She was worried, she had another tear, lupus and got it to save her life but regret getting looked up clinical trials after this happened and saw it happened to very few people. She was taken treatment of Emergency laser eye surgery.  No follow-up attempts are possible. No further information is expected.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that he had his first dose of the vaccine last 29Mar2021 and he is due to get his second shot on 19Apr2021. The patient would like to know if he still needs to get the second shot because he has tested positive with COVID on an unspecified date. The outcome of events was unknown.   Information about lot/batch number has been requested.
This spontaneous report was received from a pharmacist refers to eight unspecified patients of unknown age and gender with medical history of exposure to shingles. On an unknown date the patients were vaccinated with ZOSTAVAX, vial, 1 injection, subcutaneous, (lot number, expiration date and dosage were not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date the patients that were previously exposed to shingles, had a more pronounced injection site reaction to ZOSTAVAX. There was not treatment given for the adverse event and the patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
5/29/01 pt called with C/O hives on back and sometimes back of legs. Appeared about 3 days ago. Has taken nothing to relieve symptoms. Advised pt to try Benadryl cream topically or oral Benadryl. If symptoms increase see PMD or call.
pt recv vax 23SEP98 & w/in 24hr pt devel an inj site rxn characterized by swelling & itching;pt was evaluated @ ER;WBC count was 6.8;pt was treated w/DPH;
Headache; Last night was throwing up; Dizziness/light headed; nausea; just like overall unwell; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient reported that she received BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medications included bupropion for anxiety. Consumer stated she thought that she was having adverse side effects. Last night (18Dec2020), she was throwing up. She got COVID-19 vaccine yesterday (18Dec2020) around 5' O clock and last night around mid-night she was throwing up and had like dizziness, she was just getting a headache now (19Dec2020), she was light headed last night, just like overall unwell. Regarding treatment, she took like calcium carbonate (TUMS) (antacids) for like nausea and ibuprofen (ADVIL). Outcome of events was unknown.  Information on the lot/batch number has been requested.
Multiple lesions in various stages of papules, blisters and scabs over entire body including palate and genitals.