chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day I received the injection, I started having body aches and joint pains. I became very lethargic, laid down and slept for 3 hours. That night I felt bad like I had the flu. The next day I felt OK but not great. But the whole next week I felt bad-like recovering from the flu with body aches and joint pains. My arm swelled up and I had a lot of pain at the injection site. About 2 weeks later, I developed a rash on the arm where I had received the injection. I also had a rash on my back that itched and stayed on my back for about 4 months. I also developed eye pain and pressure. I developed very dry eyes. I already have thyroid eye disease, and it's like the COVID-19 vaccine kicked all the symptoms from my eye disease back in place. I went to the ophthalmologist/occuloplasty specialist.
Patient said that had his first ever seizure two days after receiving Shingrix vaccine.  He is questioning if it's related and whether or not he should receive his second dose when due.  I don't know where he was treated (i.e. doctor's office, hospital, etc.) after suffering from a seizure.
Swollen, sore arm infection, has dark mark on arm, had to go to infectious disease doctor for further treatment. Still has pain and discoloration
I21.4 ACUTE NON ST ELEVATION MI 12/9/2022 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE J96.00 ACUTE RESPIRATORY FAILURE 12/9/2022 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE J96.10 CHRONIC RESPIRATORY FAILURE 12/27/2022 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE R57.0 CARDIOGENIC SHOCK 12/13/2022 CARDIAC ARREST DUE TO UNSPECIFIED CAUSE I21.4 ACUTE NON ST ELEVATION MI 12/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 12/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.10 CHRONIC RESPIRATORY FAILURE 12/27/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 12/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
inflammatory reaction to old Juvederm facial filler; the inflammation caused vascular dilation and throbbing, pain; the inflammation caused vascular dilation and throbbing, pain; Possible compromise to bony structure of lower face; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 21:30 (Lot number: FE3594) at the age of 48 years as dose 3 (booster), single, administered in arm left, administration date 04May2021 16:45 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 13Apr2021 15:45 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. Relevant medical history included: "old Juvederm facial filler", start date: Jun2018 (unspecified if ongoing), notes: old Juvederm facial filler, known allergies: No. There were no concomitant medications. The following information was reported: INFLAMMATION (disability) with onset Jan2022, outcome "not recovered", described as "inflammatory reaction to old Juvederm facial filler"; ANGIOPATHY (disability), PAIN (disability) all with onset Jan2022, outcome "not recovered" and all described as "the inflammation caused vascular dilation and throbbing, pain"; BONE DISORDER (disability) with onset Jan2022, outcome "not recovered", described as "Possible compromise to bony structure of lower face". The events "inflammatory reaction to old juvederm facial filler", "the inflammation caused vascular dilation and throbbing, pain", "the inflammation caused vascular dilation and throbbing, pain" and "possible compromise to bony structure of lower face" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (08Feb2022) unknown; sars-cov-2 test: (08Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of inflammation, angiopathy, pain, bone disorder.  Clinical course: The patient was not diagnosed with Prior to vaccination COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. treatment received for the adverse event Medrol dose pack, doxycycline, CT facial scan, ASA.  No follow-up attempts are possible. No further information is expected.
Pain in the site for 2 days Swollen area for 8 days  Warm to touch in injection site 7 days (12/30/2020-today).
draining down my throat; it started to hurt a little bit; it's swollen and sore; glands are all swollen; chills; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (draining down my throat), OROPHARYNGEAL PAIN (it started to hurt a little bit), PERIPHERAL SWELLING (it's swollen and sore), LYMPHADENOPATHY (glands are all swollen) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced THROAT IRRITATION (draining down my throat), OROPHARYNGEAL PAIN (it started to hurt a little bit), PERIPHERAL SWELLING (it's swollen and sore), LYMPHADENOPATHY (glands are all swollen) and CHILLS (chills). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) ongoing since an unknown date for Pain relief, at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (draining down my throat), OROPHARYNGEAL PAIN (it started to hurt a little bit), PERIPHERAL SWELLING (it's swollen and sore), LYMPHADENOPATHY (glands are all swollen) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The patient had covid pneumonia in January and received the antibody treatment with that diagnosis.  No concomitant medication provided.
This spontaneous prospective pregnancy report was received from a pharmacist, referring to a 26 year old female patient. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcomes were known at the time of the report. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown dates, the patient was vaccinated with first and second dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot number and expiration date were not reported). Now, on 14-JUN-2018, an email was received in Merck National Service Center (MNSC), with a pharmacist inquiry "Pharmacist was asking if the patient has received her first two doses of GARDASIL 9 and is now pregnant, what would be the recommendation for the third dose?". It was unclear whether the therapy was taken during or before pregnancy.The pregnancy outcome and the gestational age were not reported. No additional information was provided.
From initial information received on 27Apr05 from a health care professional regarding an adverse event occurring, it was reported that a 20 yr old female pt received a second dose of JEVAX, lot number EJN216B, administered in the left arm and a second dose of RABAVERT, lot number 341011 administered in the right deltoid on 25Apr05 at 10:30AM. Routes of administration were not reported. Five hours later, at 03:30PM on 25Apr2005, the pt developed severe pain and burning from shoulder to wrist in her left arm. She also complained of pain and burning of left side of chest and tightness. The duration of these events was approx eight hrs. There was no difficulty breathing. The pt's recovery status is currently unk. The reporter of this case is the same reporter of case 200500727.
Violent shaking, shivering uncontrollable, fever, headache, joint and muscle  intense pain, shortness of breath, ice cold extremities. Flushing.
mild reaction area from the neck to the elbow on the left arm being swollen; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; mild reaction described as the area from the neck to the elbow on the left arm being red and hot; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 67-year-old female patient who had mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medications given.  On 06-Oct-2020, the patient received a dose of 0.7 mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ482AA, expiry date 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 07-Oct-2020, the patient developed non-serious mild reaction described as the area from the neck to the elbow on the left arm being red, swollen, and hot (extensive swelling of vaccinated limb, inflammation and vaccination site reaction) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the patient was not recovered from the events.
Pain in the arm/area where vaccine was given.  Difficulty lifting arm over ahead, bringing arm across chest and chronic ache.  Went to Dr. to diagnosis, xray and Physical Therapy.  Dull ache continues.
1 hour after receiving the vaccine,  my face and neck on the side of the shot started to burn like a nerve issue and then went numb. My arm where I received the shot went cold and burned. A friend came over and took the temperature of my hand because it was cold and it was 15 degrees colder than my other hand. I took 1 Benadryl of 25mg and laid down for a few hours. At around 4 hours after the vaccine my neck went stiff as well as my upper back. I am reporting this because I don't believe the neck and face going numb is a normal thing and it was concerning and had it continued I would have went to the ER. I am not sure if the Benadryl helped but maybe.
I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; This is a spontaneous report from a contactable physician (patient).  A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received the 1st dose vaccine in Dec2020 and 3 days later was diagnosed with Covid on an unknown date.  The patient underwent lab tests and procedures which included Sars-cov-2 test: diagnosed with cCvid in Dec2020. Patient received the monoclonal antibody infusion and has recovered. Patient knew he/she needed to wait 90 days from the MCA infusion before having the second vaccination. Patient queried whether it would be recommended to start the series over with two additional vaccines since the timing between the first and second vaccines will be so long.    Information on the lot/batch number has been requested.; Sender's Comments: The COVID-19 infection occurred 3 days after the injection of suspect vaccine BNT162B2. No complete effect can be achieved against the target disease due to the short time interval. The COVID-19 is more likely pre-existing condition, unrelated to suspect vaccine BNT162b2.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to cases 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289666, 2018SA289688 and 2018SA289702 (same reporter). This case involves a 20 months old male/female patient who was vaccinated with a dose of IPOL (Batch number: N1K931M, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (given opened multidose vial of IPOL after the temperature excursion reached 32.76 F for 19 hours 44 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Two incidents that required treatment: Rash and eye problems.  Rash: Went to Dr (Dematologist) Determination that rash was staph and was treated. Eye: Initially eye was treated with drops and eyesuvis by Dr. (Ophthamologist) before I went to dermatologist.  Returned last week because of continued chalazions, bloodshot eyes, itching; pain; not clearing up.  Received treatment for symptoms and will return in a month for follow up appt.
body pain; sinus issue; feeling week; cough; sore throat; chills; joint pain; tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills) and FATIGUE (tired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced COUGH (cough), CHILLS (chills) and FATIGUE (tired). At the time of the report, COUGH (cough), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment included Motrin to help with pain.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had 2 seizures that we know of at home and then 2 more in the ER; had an infection; wasn't feeling well; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 13Aug2021 16:00 (Lot Number: FC3180) as dose 1, single at the age of 37-year-old for covid-19 immunisation. Medical history included known allergies: latex from an unknown date and unknown if ongoing. The patient was not pregnant. No other vaccine in four weeks. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. She had the dose 1 vaccine Friday (on 13Aug2021) and wasn't feeling well Saturday (on 14Aug2021) and then Sunday  (on 15Aug2021) didn't feel too well, all she remembered was walking up and going in the living room. Then next thing she knew her mom and paramedics were over top of her. She had 2 seizures that they know of at home and then 2 more in the ER. When she went to hospital they said she had an infection and had to get 2 IVs of antibiotics and now she was on seizure meds with no history of seizures. Never had seizures before and no infection prior to the dose 1. Seizures resulted in emergency room/department visit. The seriousness of seizures was hospitalized for 4 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. Treatment received for seizures and infection which included antibiotic and seizure medicine. No COVID prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Aug2021. The outcome of seizures was recovering. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
COVID; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious.
On 07May2021, the patient received the first dose / on 14JUN2021 / received the second dose / too early; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient received first dose of Shingrix. The patient inadvertently received the second dose at shorter than recommended interval, which led to shortening of vaccination schedule.
My heart was heavy; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (My heart was heavy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISCOMFORT (My heart was heavy). At the time of the report, CARDIAC DISCOMFORT (My heart was heavy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood test: normal (normal) normal. On 14-Aug-2021, Chest X-ray: normal (normal) normal. On 14-Aug-2021, Electrocardiogram: normal (normal) normal. On 14-Aug-2021, Heart rate: 100 to 78 (abnormal) 100 to 78. On 30-Aug-2021, Blood test: normal (normal) normal. On 30-Aug-2021, Chest X-ray: normal (normal) normal. On 30-Aug-2021, Electrocardiogram: normal (normal) normal.         Concomitant medications were not provided. Treatment medications were not provided. Patient states that on 12-AUG-2021 she started feeling like her heart was heavy. Her watch read her heart rate and the heart rate increased. Even after getting results as normal for labs, these symptoms continue and she has made an appointment with a cardiologist whom she has not yet seen.
Pt reports she received vaccine, and less than 48hrs later she noticed rash around clavicle, extending to chest and left arm. Arm was itchy, red, swollen at injection site. Pt called and spoke to a nurse who recommended ER visit. Pt given solumedrol, benadryl, and famotidine in ER. Pt given Rx for 3 days of prednisone. Her rash, swelling, and itching resolved in 3 days.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 Degrees F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
they administered a PNEUMOVAX 23 vaccine to a patient and then realized the vaccine had expired.; This spontaneous report was received from an office manager referring to a 39 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S002582, expiration date 10-AUG-2020; dose and route were not reported) for prophylaxis, then realized the vaccine had expired (expired product administered). They were wanting to know if the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine was still viable. No prior excursions. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002582; expirationdate: 10-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient received the injection, grabbed his chest, states it hurt, and put his head down on the desk next to him. This RN went to get a provider and a MA heard me and grabbed MD. Dr. had the patient lie down and elevate feet. She listened to his heart rate, gave a gentle sternal rub and patient's eye fluttered and became aware of his surroundings. VSS, BG 105. EMS called. EMS arrived. Mom declined having patient transported to the hospital. Patient sat up leaning against the wall. VSS. Patient stood and sat in the chair and was doing well.  mmunization list printed and handed to mom. This RN walked patient and mom out.