chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Face swollen. Eyes almost swollen shut followed by horrible hives 2 days later which have still not stopped on November 3 2016. Dr says it's only coincidental to vaccination. But I believe that not to be true based on the cases I've read and researched.
Pfizer-biontech covid-19 vaccine eua  Dizzy, light headed, hot, ears ringing, mild headache, tiredness, fatigue,
Pt noticed area of injection site warm and possibly swollen. Area is also pink and occasionally itchy. It has not improved since 2/9/16. Pt was advised to see physician.
According to father, had left shoulder twitch and head twitch to left several times a day for 1st 48 hours.  As of today, happens 1 x per day.  EEG normal and neurologist video - no seizure.  Making this report at dad's request.  Also had fever, runny nose, cough.5/15/08-records received for DOS 3/6-3/7/08-DC DX: fever, resolved. Infantile spasms/epilepsy ruled out. Presented with seizure like reaction associated with fever and mild respiratory distress. Had some fever and fussiness several days prior.
Td given left deltoid on 4/3/08 and at time of follow up visit left deltoid area red, warm, swollen
In the early morning hours of Saturday 2/27, Dad woke with severe pain in his right arm, shoulder and shoulder blade.  He realized the right side of his neck was swollen and his throat was swollen as well. He was having trouble swallowing, talking and his breathing felt obstructed. He tried to awaken my Mother but she couldn't understand what he was saying. He finally managed to get up with on walker and make his way to get a drink of water. After that his throat seemed to loosen up some and by later in the morning  the swelling had subsided. He did not inform me until I called later in that morning to check on them and he did not feel he needed to see a doctor.
Patient received her flu shot in the pharmacy on 9/8/20 and went home without event. Two days later, on 9/10/20, patient broke out in hives, which covered her entire body. She did not have trouble breathing, fortunately.  She went to urgent care, where she was prescribed methylprednisolone 4 mg dose pack, levocetirizine 5 mg, and an epinephrine 0.3mg auto-injector for the future. She is reportedly still itching and in a lot of discomfort.  She spoke to me, the pharmacist on 9/13/20 and suspects that she had an allergic reaction to the flu shot.
Shortness of breath; Palpitations; it has been really tough for me to resume with my normal self/got weird toes; D-dimers elevated; Pains to arm; got weird toes, feel exhausted often despite being off work.; Bit of fever; Chills; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopausal hormonal rollercoaster" (unspecified if ongoing), notes: No known health problems other than the rocking menopausal hormonal rollercoaster.; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer after 2 Astra Zeneca. The patient took concomitant medications. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (non-serious), outcome "not recovered", described as "Palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it has been really tough for me to resume with my normal self/got weird toes"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "D-dimers elevated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pains to arm"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Bit of fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Pain at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "got weird toes, feel exhausted often despite being off work.". The events "shortness of breath", "palpitations" and "pains to arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, fibrin d dimer increased.  Additional information: 13 days later, she visited her GP for shortness of breath, palpitations and pains to arm. D-dimers elevated, 5 days of blood thinners. Her GP thought of long covid but for the last 20 months she tested regularly (school teacher) and never had a positive or doubting result.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Experienced a topical reaction; The rash/ hives from the first dose stayed localized (lasted 3 months), it was extremly annoying; Itchy; Rash on arm as "COVID Arm", stretched from shoulder to elbow; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Experienced a topical reaction), URTICARIA (The rash/ hives from the first dose stayed localized (lasted 3 months), it was extremly annoying), PRURITUS (Itchy) and RASH (Rash on arm as "COVID Arm", stretched from shoulder to elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (Autoimmune issue), Myalgia and Hypersensitivity (Hypersensitive to every everything).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced a topical reaction), URTICARIA (The rash/ hives from the first dose stayed localized (lasted 3 months), it was extremly annoying), PRURITUS (Itchy) and RASH (Rash on arm as "COVID Arm", stretched from shoulder to elbow). The patient was treated with PREDNISONE for Adverse event, at a dose of 5 mg once a day. At the time of the report, VACCINATION COMPLICATION (Experienced a topical reaction), URTICARIA (The rash/ hives from the first dose stayed localized (lasted 3 months), it was extremly annoying), PRURITUS (Itchy) and RASH (Rash on arm as "COVID Arm", stretched from shoulder to elbow) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medication also include Topical cream.  Patient took second dose on 16 March 2021(batch no 013A21A) and experienced the same side effects. Patient reported that the prescribed topical cream did not work later her Rheumatologist put her on prednisone.   This case was linked to MOD-2021-309819 (Patient Link).
suffered facial paralysis on the right side; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 13Aug2021 (at the age of 35-years-old) (Batch/Lot Number: FA7484) as dose 1, single for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced facial paralysis on the right side on 18Aug2021. The visited healthcare professional office for Emergency room/department or urgent care . Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. The patient did not have COVID prior and post vaccination. Patient received treatment with unspecified medicine. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Patient presented with a red/swollen arm to our sister store on Easter Sunday, 04/21/2019. After consulting the pharmacist working, the patient followed up at a local clinic. The doctor confirmed that it was probably a reaction to the vaccine but assured her that the reaction was going away. The doctor also advised her against the 2 dose of SHINGRIX vaccine.
dose 1 in 2018 never got the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other detail of patient or vaccine available. The reporter consent to follow up.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020.   No follow-up attempts possible. No further information expected.  Lot/batch number was not provided and unable to obtain
Joint & muscle pain; headache, fever; sweating, diarrhea; stomach pain 24 hours after vaccine - continued for 7 days - treated with BRAT diet; over the counter pain reliever (TYLENOL - ibuprofen).
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Vaccine received on 01/03/2022 at 6:53pm, patient's mother arrived in drive-thru on 01/04/2022 in the afternoon stating that pt had itching and swelling of lips and itchy throat since 01/03/2022 in the evening. Mother had already contacted MD office and was waiting on call back. I told her to call MD office back to express urgency, and for pt to go to urgent care clinic after leaving my pharmacy, and that pt should administer Auvi-Q (on hand) if needed. Attempted to f/u but reached VM.
My left arm became really sore on Friday, the same evening as my shot.  Fever at site if injection.  Used ice pack and then hot pad, alternating.  My husband and I both had chills all night.  By Saturday eve, I began feeling so nauseated that I began wretching over and over, but no vomiting.  I took my temp as I felt so hot.  The temperature was 102.5!  Took 2 Tylenol, and in the early morn8ng in Sunday, was able to go back to bed as the temp had broken and the wretching had stopped.  Migraine took over and continues today, Monday, 3,8,2021.
Information has been received from a RN concerning a healthy 12 month old male with no illness at the time of vaccination, who on 27Sep04 at 13:30 was vaccinated SC with the first dose of varicella virus vaccine live. Concomitant vaccinations included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. On 15Oct04 at 09:00, the pt developed scattered lesions on trunk, neck, thighs and two on his forehead. The pt was seen in the doctor's office on 18Oct2004 with varicella lesions; seven lesions were scattered throughout trunk and 2 on forehead and thighs. Mupirocin (Bactroban) was recommended for lesions which were infected. No laboratory or diagnostic tests were done. Subsequently, the pt recovered. There was no product quality complaint. The nurse initially considered scattered varicella lesions to be an other important medical event; however follow up information from the same nurse indicated that they were not. Additional information is not expected.
soreness increased to redness, hardness and severe itching at the injection site.  Began around 9 days after the shot was given and the hardness under the skin felt like a plate and the skin looks raised and discolored.  The hardness has subsided a little but the itching has gotten progressively worse.
Information has been received from a 55 year old female patient concerning herself. The patient's concurrent conditions included allergy to REGLAN. The patient's historical condition included bladder spasms. Concomitant therapies included CELEBREX, oxybutynin, SYMBICORT, EVISTA and CLARITIN. On 26-JUL-2016, the patient was vaccinated with an unspecified dose of ZOSTAVAX, frequency reported as "vaccine injection" (concentration, route, anatomical location, lot number, and expiration date were not provided), and the same day, she was also vaccinated with and unspecified dose of PNEUMOVAX23, frequency reported as "vaccine injection"(concentration, route, anatomical location, lot number, and expiration date were not provided) which was not indicated on the prescribing information (product use issue). Subsequently, on 26-JUL-2016, the patient experienced numbness in her lips and noticed a fever blister on her mouth. The patient did not seek medical attention, no laboratory studies were performed and no treatment was given for the adverse events. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the numbness lips and the fever blister. The relatedness between the numbness lips and the fever blister psoriasis and the therapy ZOSTAVAX and PNEUMOVAX23 was not reported. Additional information has been requested.
TIA with vertigo and inability to speak for approximately 15 minutes Seen by Dr to determine what tests should be done No other instances of concern since March 17, 2021
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On an unknown date (start date reported as several years ago) patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date, the patient developed a low grade fever after ZOSTAVAX vaccination. The pharmacist stated that he had no other details about the event and patient present status was unknown. This is one of the several reports from same reporter source. Additional information has been requested.
Patient became slightly pale and diaphoretic after vaccines were administered. Patient was advised to lay down and wait in the room with his mom for 15 minutes. After approximately 10 minutes, mom requested if they could finish their "wait time" in the waiting room and was advised by the doctor that that would be OK. While in the waiting room the patient got up from chair and advised mom he needed some water then passed out into his moms arms. He had convulsion like movements for a few seconds then was assisted to the floor by staff. The patient laid supine on the floor. Slowly became aware of his surrounding and fully oriented after about 30-60 seconds. After a few minutes, patient was assisted to a chair in the waiting room and complained of nausea. After a few minutes, the patient was wheeled into an exam room where he layed down and drank water and soda for apporx. another 10 minutes. He then sat up for another 5 minutes. Doctor cleared the patient to leave. Patient was escorted to their car by a staff member. No further symptoms were noted. Child stated he "felt fine".
The wrong Havrix dose was given to the patient.  The adult 1440 unit/1 mL dose was given instead of the 720 unit/0.5 mL dose.
A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres. FLUMIST QUADRIVALENT was given to the patient on 06-Apr-2016. The reporter stated that on 06-Apr-2016 expired FLUMIST was given to patient. The report was considered to be non-serious by company physician.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 6 days post expiry) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011J20A) for COVID-19 immunization. No medical history reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (vaccine given 6 days post expiry). On Nov 12, 2021, administered expired product (vaccine given 6 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
He suffered a pretty significant seizure; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (He suffered a pretty significant seizure) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 10:10 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022 at 12:00 PM, the patient experienced SEIZURE (He suffered a pretty significant seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 24-Sep-2022 to 27-Sep-2022 due to SEIZURE. At the time of the report, SEIZURE (He suffered a pretty significant seizure) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported. No treatment information were reported.  Reporter had to call 911 as the patient (reporter's husband) suffered a pretty significant seizure.  Patient never had seizures before.  Patient had received first, second, as well as 1 booster dose, all Moderna Covid-19 vaccines (Monovalent).  Company comment:  This spontaneous case report concerns a 45-year-old male patient with no medical history provided, who experienced serious (due to hospitalization and medically significance) unexpected event of Seizure. Reportedly, one day after the patient had received the mRNA-1273 vaccine.222 (as fourth dose), he developed significant seizure and was admitted to hospital for four days. No additional details regarding laboratory investigations, diagnostic procedures and treatment medications were provided. The patient was discharged from hospital, however, the outcome of the event remained unknown at the time of this report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 45-year-old male patient with no medical history provided, who experienced serious (due to hospitalization and medically significance) unexpected event of Seizure. Reportedly, one day after the patient had received the mRNA-1273 vaccine.222 (as fourth dose), he developed significant seizure and was admitted to hospital for four days. No additional details regarding laboratory investigations, diagnostic procedures and treatment medications were provided. The patient was discharged from hospital, however, the outcome of the event remained unknown at the time of this report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Information has been received from a physician concerning a male patient who was vaccinated with a 0.5ml dose SC of varicella virus vaccine live (Oka/Merck). On 09-AUG-2005, the patient came to the office with 15-20 varicella lesions that started that day. He did not have fever. He was given diphenhydramine hcl (BENADRYL) to stop the itching. No product quality complaint was involved. Additional information has been requested.