chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 10:00 as dose 4, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hypercholestemia" (unspecified if ongoing); "Allergy: Eggs" (unspecified if ongoing), notes: known allergies: Eggs. Concomitant medication(s) included: METFORMIN; LANTISEPTIC PROTECTIVE OINTMENT; NOVALINA; ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022 at 13:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Treatment of covid-19 with anti-viral product, brand-paxlovid, treatment start date 08may2022, treatment stop date 13may2022, lot number fl4517, administrator route oral. 10 days post completing treatment employee is having Headache, Nasesa, Diarrhea, and Runny Nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
After the 2nd dose vaccine, I just had a little sore arm and fatigue. A few months later in April 2021, my arthritis and fatigue started to get worse. Since I have a history of psoriatic arthritis and you have been in remission and had no flare ups for 9 years and have not taken any medication for it. I tried to bear with it at first since it comes and go. The arthritis was not getting better, and my fingers started to swell.  I had to get finger splint to keep them isolated and prevent me from using those fingers. It affected my right hand- index and middle finger and also, I had the arthritis flare up in my right foot (4th toe and big toe). On 6/24/2021 I went to see my doctor. I did X-ray (normal) and blood work (decreased kidney filtration). I started back on my methotrexate medication and my kidney numbers normalized. I am still on methotrexate, and I am starting to feel better, getting more energy and my arthritis is improving but I still have some pain. The pain can range from 3-7 out of 10..
3/02/2021 = chills, headache, burning sensation on internal organs, diarrhea and tiredness 3/03/2021 = headache, burning sensation on internal organs, diarrhea and tiredness 3/04/2021 = headache, burning sensation on internal organs, and tiredness 3/05/2021 = headache and tiredness 3/06/2021 = tiredness 3/07/2021 = tiredness
Thursday evening, 7 pm, chills, fever, hip pain, headache, significant weakness B Lower extremities causing difficulty walking. Heaviness and difficulty lifting feet off the ground to take steps. Tingling B lower extremities.  By 3 am-7-am, most symptoms resolved. By 12 pm- all symptoms resolved except decreased bladder and vaginal sensation. Difficulty feeling the need to urinate. No incontinence.  Decreased sensation around vulvar area as well. The sensation is slowly improving, but continues as reduced. ER visit 9/5/21 for eval.
Swollen, red rt deltoid 11 cm by 5 cm erythematous.
From Dr.s notes on 06/16/2023 office visit. HPI The patient was seen 06/07/23 for 16 yo WCC by NP, received MenQuadfi left deltoid and Bexsero right deltoid and patient has been experiencing right upper arm pain since the evening of the immunization. The patient relays that he felt a deeper pain with the administration of the vaccine in his right arm, he describes the needle as being pushed in further. This was different than what he noted for the left upper arm immunization administration.  Update:The patient relays that he continues to experience upper right arm pain, he has a pain level of 3/10 at rest, but when adducts his right arm across his body, the pain increases, he is able to perform daily living tasks, the initial nights after receiving the vaccine in hurt to sleep on his right upper arm, the patient did not note any redness nor swelling at the injection site, no numbness or tingling in his right arm. Used Ibuprofen 400 mg and warm compresses - not much improvement. The patient leaves tomorrow to attend a work training, this summer working at a  barbecue restaurant, so he will doing a number of different tasks. Today is currently 9 days out from the day of the vaccine  Pain over deltoid muscle has patient adducts upper arm across his body, TTP to deep palpation over the deltoid muscle, FROm B shoulder and B elbows, normal internal and external rotation. In assessing the patient's history and symptoms, I do feel that the right upper arm pain is most likely due to a complication with the administration of the Bexsero vaccine and not as likely due to the ingredients in the vaccine, discussed with the patient that the symptoms could arise from inflammation from the muscle area, I would continue to recommend warm compresses, Ibuprofen 600 mg 2-3x/day, taking with food. I would recommend avoiding activity that produces pain in the muscle area involved. I also discussed if pain is persisting at 2-3 weeks out, I would consider an MRI of the soft tissue/muscles and joint space of the right upper arm next.  Recommend submit VAERS form, will have the Triage Nurse submit this with the information obtained at the visit today.
Information has been received from a physician concerning an approx 12 year old female with rhinitis allergic and obesity who on 16-SEP-2008 was vaccinated with a dose of GARDASIL, 0.5 ml, IM (Lot #659184/0843X). There was no concomitant medication. Physician reported that the patient developed a syncopal episode. The physician considered the syncopal episode occurred after the patient left the office. The patient went to the emergency room and was hospitalized for 3 days for her syncopal episode. It is noted on the patient's chart that when she received dose 1, she had a rash (the rash was present before she received Dose 1). She was prescribed hydrocortisone cream and BENADRYL. The patient has not received any additional doses of GARDASIL. At the time of this report, the patient was recovered. This is one of several reports received the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Subsequent to receiving first and second doses of varicella virus vaccine live a serum antibody test in 1995 revealed positive antibody titers. In 10/1998 another serum VZV antibody test revealed negative titers.
Her arm is sore; This is a spontaneous report from a contactable consumer(patient) from a Pfizer sponsored program. A 76-year-old female patient received the first dose of BNT162B2 (lot number: EL8982), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history included asthma and allergy. Concomitant medications included unspecified medication for asthma and allergies. The patient received the first dose of the COVID-19 vaccine and her arm was sore after receiving it, she wanted to know if she can take Tylenol or use an ice pack. The outcome of the event was unknown.
at 56 days since she got the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at 56 days since she got the first dose) had resolved.        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 medications was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
I started getting symptoms 3/23/2023 little cough, sinus pressure, little bit of runny nose, tickle in the back of the throat. By the next day, from that evening to the next morning short of breath, fatigue at the highest temperature of 99.6, but I got sweat sand chills. and body aches by 03/24/2023.  I went to get tested. I call the COVID hotline, they sent me to the PCR test positive and the home test and the results were positive. I called the clinic and was prescribed Paxlovid. I started taking Paxlovid on Monday, 03/27/2023. I started feeling better within 24 hours of taking it. I noticed an improvement. I gradually got better. I had a conference coming up, after finishing the Paxlovid I did serial testing and was able to test negative.  I was testing negative by 03/31/2023 and 04/01/2023. And 04/02/2023, I really started getting sick again. I did not have my home test because I was out of town. And I was not eligible to get more. I flew back home, and I was testing positive again. When I was testing before Paxlovid, and the color was faintly after the Paxlovid the color was more vibrant immediately.  I am still having the activity intolerance and shortness of breath.  My oxidation drops and I am exhausted afterwards. My pulse drops to 90 to 91 with exertion. Normally I am like 97 and 98.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FUROSEMIDE; HYDROXYCHLOROQUINE; IBUPROFEN; OMEPRAZOLE; GENTEAL [HYPROMELLOSE]; POTASSIUM; CYCLOBENZAPRINE; KADCYLA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: Patient's concurrent condition included was not reported. We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with company policies and procedures.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  SUSPECT PRODUCT is under agreement with company.
IM injection was given to the L deltoid. The day after the injection the arm felt sore, red marks appeared, and some decreased range of motion secondary to soreness.  Pt added that he has HA's usually but they seem a little more intense now; and he also felt warm yesterday with some chills. Denies pruritis, throat swelling, SOB, easy bruising or bleeding, N/V/D, numbness, tingling, weakness, seizures, muscle or joint aches. Denies any type of allergic rxn in the past (No drug allergies listed)
Injection Site Pain Information has been received from a health professional concerning a 62 year old white retired female with hyperparathyroidism and no known allergies who on the morning of 27-OCT2005 was vaccinated IM into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #651523/0604R). Concomitant therapy given IM in the morning into right deltoid included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion3v vaccine inactivated( (lot #U1777AA), calcium carbonate (+) cholecalciferol (Caltrate + D) and vitamins (unspecified) On 31-OCT-2005 the patient recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Shingles, on the left breast and going down the left arm. same side as where the vaccine was given. I went to see MD and was started on Valtrex 1000mg three times a day. My body has not been without the painful rash since.
Fever; arm started swelling; arm is swollen and underneath my armpit is so sore, it hurts to move my arm; arm started swelling; arm is swollen and underneath my armpit is so sore, it hurts to move my arm; arm was sore; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number, Expiration date was not provided) via an unspecified route of administration, on 15Mar2021 (age at vaccination 65-years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15mar2021 patient arm was sore. On 16Mar2021 the patient experienced fever arm started swelling, arm was swollen and underneath her armpit was so sore, it hurts to move arm. Clinical course: Patient got her shot Monday and everything was fine but of course her arm was sore. The last night her arm started swelling and she began to run fever and now her is swollen and underneath her armpit is so sore, it hurts to move arm. She just wanted to know what to do and how long she should expect that to be. The outcome of all events was unknown.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Fatigue and all of her joints hurt since the day of the first vaccine.  They have not let up but seem to be getting worse
Received vaccine at 1:06pm. At 3:30pm felt something odd in my mouth. Looked and found left front side of my tongue was reddened and raw looking, no discomfort at all. Kept watching for last couple of days and today it seems alittle better but my doctor felt it should be reported. I do have a picture
My left shoulder hurts where I got it. I can't sleep at night and I already told my doctor she said it's rotator cuff or bursitis did an xray and cannot find anything.
eye quite swollen and red 4 days after covid and flu vaccines.  Self treated with ibuprofen and Benadryl.  Visited Eye doctor on 6th day after (Nov. 1), and am taking predisalone drops 4x daily for 10 days.
This spontaneous report was received from a pharmacist via a company representative and refers to a 71 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in October 2017, the patient was co-administrated a dose (reported as "one shot") PNEUMOVAX 23 (exact dose, route of administration, lot# and expiry date were not reported) for prevention of pneumonia and an unspecified "high dose flu vaccine". On an unknown date in 2017, the patient developed feelings of weakness and achiness as well as red, painful swelling at the injection site. Both vaccines were administered in the same arm, but it was not known by the reporter whether both vaccines were administered in the left arm or the right arm. The patient sought medical attention and was given an unspecified treatment for the events. The patient was not hospitalized. The outcome of the events was unknown. The reporter's causality assessment between the events and the PNEUMOVAX and unspecified flu vaccine was not reported. This is one of the two reports received from the same reporter.
urticaria all over body, and  violent cough, child choking, asthma attacks In 2 days the baby started to take antihistamine syrup, but the syrup doesn't help much.
Was dizzy. Still dizziness a few days after vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on 16Mar2021 at 10:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), atorvastatin calcium (LIPITOR), amlodipine besilate (AMLODIPINE BESYLATE) and losartan (MANUFACTURER UNKNOWN); all from an unknown date and for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Mar2021 at 22:00, the evening after taking the vaccine the patient felt dizzy and still dizziness was there a few days after vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with meclizine (MANUFACTURER UNKNOWN) of 25mg. The clinical outcome of event felt dizzy was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
2.5 days after receiving dose 1 of the Pfizer series patient was admitted to hospital with a closed throat. Pt. reports being told 0.5cm opening is all that remained. During the course of hospitalization patient developed pneumonia and was hospitalized for 10 days.
Rash, swelling and blistering skin at and around injection site on right arm - started Friday, 01/24/2014.
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol  when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
her tinnitus is getting worst; the tinnitus has been affecting her hearing; had a fever that was really bad; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad). At the time of the report, TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad) outcome was unknown.            Other concomitant medication includes estrogen combipatch. No treatment information was reported.   This case was linked to MOD-2021-283150 (Patient Link).
Feeling fatigued, difficulty breathing and chest discomfort, heart palpitations, irregular heart beat with lightheadedness. Early period after vaccine.
Complained of chest pain 7/10.  Contacted nurse. Nurse questioned and stated that she had not taken b/p meds this morning and was experiencing total body weakness.  B/p elevated pulse elevated volunteer MD on site. 911 contacted for further evaluation.  Patient taken to hospital.
HEADACHE; FEVER 38.9 CELSIUS; This spontaneous report received from a patient concerned a female of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on right deltoid on 31-MAR-2021c, 17:10 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 38.9 degree celsius. On 01-APR-2021 08:00, the subject experienced headache. On 01-APR-2021 08:00, the subject experienced fever 38.9 celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever 38.9 celsius. This report was non-serious.
After receipt of SPV in Oct 2018, with normal site progression and healing, patient had "reaction" at SPV site 5-months post-healing. Patient evaluated on 18 Mar 2018 - reported itching at site. No systemic symptoms.  On exam: erythematous, well circumscribed, and raised. Prescribed antihistamines and referred to Dermatologist and Allergist. --------------- 2 Apr 2019, Derm consult, Assessment/Plan: Hypertrophic scar   ///   Unsure what reaction Pt had previously but given its time course (4-5 months after vaccine), it seems more likely a result of the wound healing/scarring process than due to residual vaccinia virions. In any case, lesion on exam is most c/w a mildly hypertrophic scar that is of appropriate size. No indication today for Bx.   Symptoms: PRURITUS, UNSPECIFIED(L299), OTHER ERYTHEMATOUS CONDITIONS(L53).
Information has been received from a Medical Assistant (MA) concerning a 15 year old female with no drug allergies who was vaccinated with a dose of GARDASIL (no lot number was given) 2 years ago. The patient almost passed out after the vaccine. This occurred when the MA was working at a pediatric office. At the time of report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
The arm that had the shot swelled up from the shoulder to the tip of the fingers. It got really hot, red and itchy. The whole arm was very hard and twice the size of normal size. This happened with the first shot as well but not as severe.