chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds; Passed out for a little; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) and LOSS OF CONSCIOUSNESS (Passed out for a little) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Passed out for a little) (seriousness criterion medically significant). On 04-Jul-2021, SEIZURE (he had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds) and LOSS OF CONSCIOUSNESS (Passed out for a little) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal.         Concomitant product use was not provided by the reporter.   No treatment information was provided.  On 04-Jul-2021, the patient had one episode of seizure where he passed out for a little bit and he started convulsing for 7 seconds. He consulted with a neurologist at the end of Jul-2021.  Company Comment - This case concerns a 50 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of loss of consciousness and seizure. The events occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to (Patient Link).; Sender's Comments: This case concerns a 50 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of loss of consciousness and seizure. The events occurred approximately 3 months after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient experienced localized redness, swelling, and tenderness that started evening of 3/6/11. Swelling got 5cm in diameter so patient went to see her MD.
How Did I Get The Flu Three Times Taking The Flu Shot ?; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who got the flu three times (influenza), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient got the flu three times after taking the INFLUENZA VACCINE (flu shot).   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
01jun90 pt vax hepta B. 02jun90 pt ex dizziness, flulike sx w/ h/a v/ lethargy, sneezing, itching, swollen glands, and joint pain. tx w/ benadryl, tylenol, Dexone.  14jun90 pt devel conjunctival hemorrage in one eye after coughing.
breaking out facial rash; A spontaneous report was received from a consumer or non healthcare professional concerning a female patient who was breaking out in a facial rash/MedDRA PT: rash and felt very itchy/MedDRA PT: Rash pruritic.    The patient's medical history and concomitant medications were not reported.  On 30 Dec 2020, within one day of onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020 or 31-Dec-2020 the patient developed an itchy facial rash and wanted to know if she could treat the event with Claritin.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were unknown.   The reporter did not provide causality for the events.; Reporter'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.
BP (Blood pressure) 188/70 (units not provided); BR (Breathig rate) 25 (units not provided); loss of consciousness; Patient fainted as she was walking out; felt dizzy; Thrown up chocolate; Pale; This spontaneous report was received from a health professional concerning an 11 year old female patient. There was no information about the patient's medical history or concurrent conditions Concomitant vaccines given on the same day included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid,pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP).  On 08-MAY-2019 at 10:45am, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number R00816A, via intramuscular route in the right thigh for prophylaxis (dose and frequency were not provided). On the same date, at 11:00am, the patient fainted as she was walking out (syncope), felt dizzy (dizziness), pale and thrown up chocolate (vomiting) and lost consciousness. Later, at 11:10am, the patient's BP (Blood pressure) was 188/70 (units not provided) (blood pressure abnormal), BR (breathing rate) 25 (units not provided) (respiration abnormal) and HR (Heart rate) 80 (units not provided). The patient received treatment at doctor's office and felt better in supine position. At the reporting time, the patient recovered from the adverse events. The causality assessment between therapy with the suspect therapies and the aforementioned events was not provided.  Upon internal review, the events syncope and loss of consciousness were determined to be medically significant events.
Urticaria pruritus and nausea/vomiting. Diphenhydramine, methylprednisolone.
At site of vaccine (MENACTRA) there was swelling, redness, tenderness and axillary gland on same side tender.
I had trouble after the shot, with a chronic headache that started a couple hours after the shot and wouldn?t break no matter what I took or did.  I also had chest soreness and a reduced heart rate that started about 4 days after the second shot, which was similar to what I felt when I thought I had COVID in 2020 (my doctor denied my request to be tested and told me to just quarantine until my symptoms were gone for 48 hours).  I tried everything to resolve my symptoms.  I could get my heart rate up with vigorous exercise (mountain biking), and it would recover just fine, but the chest soreness and headache persisted.  After a week, I called my doctor?s office to get in for an evaluation, thinking my thyroid medication needed adjustment.  The doctor who saw me sent me to the ER because she had no answers as to the headache and very low heart rate, which kept dropping into the 30?s... normal is around 50 for me.  She thought I could be having a heart attack.  After 4 hours and a couple tests, the ER released me with no trouble found.  I still had the headache, and slow heartrate with mild chest soreness.  The headache subsided about 4 days later, and my heart rate returned to normal.  The chest soreness continued for 4 weeks, and is still present, but slowly improving I think.
Patient broke out in Hives the day after receiving the vaccine. She had itching  all over her arms, legs and breast. The hives were on her legs, arms, and breast. Some swelled, become red, hot, and left bruises.
pt recvd vax 4MAR96 & AM of 10MAR96 had low grade fever of 100.2 oral;highest temp 102 9PM of 10MAR96;was irritable, sleepy, nauseated nl; 10AM 11MAR96 & afeb;
09/19/22 presents to ED for "leg injury, hip injury". PMHx of "ADHD"
On 9-20-2018 patient received flu vaccine while in clinic. On 9-21-18 at 1:30am patient was awake and asked for some milk, then she started drooling, vomited and had started drooling again, her jaw was clenched and lower legs shaking and difficulty breathing. Mother took her to hospital e.r and arrived at 2:39am on 9-21-2018, discahrged at 3:34am and was doing well at that time. she was smiling and playful at the time of discharge. Patient had an appointment today 9-21-2018 to see Dr, pediatrician.
Eight days (to the hour), after my 2nd Moderna Covid-19 shot, I started having chest pains, shortness of breath, accompanied by headache/migraine, racing heart rate at times, and heart skipping beats.  I continue to have problems daily. 12 weeks after the initial episode, I had an Echo Complete Ultrasound that shows my right atrium is enlarged. (I also wore a heart monitor for 5 days, but the results are not in yet.)  Prior to this time, I have NEVER had heart issues. My physician is going to order a heart cath on Monday.  I want someone to know what's going on!
Facial swelling still persists; Severe swelling under left eye, which blocks vision; Swelling under both eyes; Redness on face; dizziness; Injected arm was sore; Chills; fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizziness), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced EYE SWELLING (Swelling under both eyes) and ERYTHEMA (Redness on face). On an unknown date, the patient experienced SWELLING FACE (Facial swelling still persists) and SWELLING (Severe swelling under left eye, which blocks vision). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and FEXOFENADINE at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), EYE SWELLING (Swelling under both eyes), ERYTHEMA (Redness on face), SWELLING FACE (Facial swelling still persists), SWELLING (Severe swelling under left eye, which blocks vision), INJECTION SITE PAIN (Injected arm was sore), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            Treatment information includes Hydrocortisone cream and Fexofenadine   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-may-2021 contain no new information; Reporter's Comments: NA; Sender's Comments: NA
I completely lost my sense of taste and smell; I completely lost my sense of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) with unspecified age and gender received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0162) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA , AGEUSIA  all with onset Apr2021, outcome "not recovered" and all described as "I completely lost my sense of taste and smell".  Additional Information: Case Category: Product Specific Inquiry Case Subcategory: Adverse Event/Product Complaint  Description of Event Outcome I have Pfizer COVID-19 vaccine, EW0162, on 13Apr2021. Approximately four days after I completely lost my sense of taste and smell. It continued and by the time for the second shot, EE0169, 04May2021 I still received my dose. My sense of smell and taste has never returned in any normal or consistent capacity. I did receive one booster, FJ5682, 06Feb2022. I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up. Can you help?  Event Awareness Date: 03Jul2022  No follow-ups attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200926528 same reporter/patient, different drug, similar event;US-PFIZER INC-202200926529 same reporter/patient, different drug, similar event;
30 min after the vaccine I experienced a severe headache on one side. I had a tele-visit w/ my Dr the same day and they advised me to take migraine medicine.
Left upperarm became significantly swollen & erythematons from shoulder to elbow, improved spontaneously without treatment.
The pt experienced a macular/papular rash which was widespread on the arms, legs, neck, face.
pt recv vax;fever of 101;chills,HA,v&sweating,fatigue,blurred vision,aches all over;fever for 10 days;did not see MD;
NEXT MORNING AFTER VAX,NAUSEA. 4-7-90 EVENING EXPER HEART POUNDING WITH HEART RATE IN LOW 90'S TO LOW 100'S; FELT BETTER MORNING OF 4-8-90. PT WILL CONT. VACCINATIONS.
12-7-06 Patient flu shot pain began in right elbow one or two hours after receiving flu vaccine. Patient reports the joint was sensitive to touch and a sharp pain upon movement. Patient reports that the next day 12-8-06 the same pain moved to his left ankle then to the upper part of the Left side of his neck. He reports the pain more severe in this area. Next the pain moved to his Right knee he felt he could not straighten his leg. Patient reports pain then moved to his Left hand between his index and second fingers then to back of neck and it is (12-13-06) in his Left shoulder area. Patient reports pain now as "not bad" with a dull pain when he raises his arm. Patient reports he went to his family physician on 12-11-06 where he was given a steroid shot that "seems to have helped." At that visit to his physician the patient reports that lab work to rule out side effects of the Lipitor he takes was drawn and found to be negative. A flu test was performed and came back positive for flu. Patient reports not having experienced an adverse event with any flu shots in the future.
pt was given vax 5JUN97 130PM & 3PM 5JUN97 woke @ 330AM w/stiff neck & diff walking;no SOB, no diff breathing, no hives, no swelling;seen by MD 7JUN97;MD ? rxn to Td but dx not confirmed;
sore at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ6369) at the age of 78 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had sciatica so bad" (unspecified if ongoing); "Had kidney removed last year", start date: Oct2021 (unspecified if ongoing), notes: Had kidney removed last year; "mass in her kidney" (unspecified if ongoing); "mass in her kidney and looks very cancerous" (unspecified if ongoing); "She had back surgery in the past" (unspecified if ongoing), notes: She had back surgery in the past. The patient's concomitant medications were not reported. Past drug history included: Oxycodeine, reaction(s): "nerve block". Vaccination history included: BNT162b2 (Dose 3 (Booster), Lot number: EW0185, EXP: Unknown, Route of administration: injected into right arm, Time: morning, exact time unknown), administration date: 11Oct2021, when the patient was 77-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; BNT162b2 (Dose 2, single, Lot number: EN9581, Expiry date: May2021, Route of administration: injected into right arm, Time: 10AM), administration date: 08Feb2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; BNT162b2 (Dose 1, Single, Lot number: EL3249, Expiry date: May2021, Route of administration: injected into right arm, Time: around 6-7pm Was a drive-thru vaccine facility), administration date: 18Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; Shingles (Caller and his wife had all vaccines, from shingles to whatever), for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: While she had the sciatica, one weekend she had to go to ER three times in four days. The last time she was there, they did an MRI on her back. Oxycodeine: NDC/LOT/EXP/Manufacturer: Unknown Unable to confirm spelling of product name as she does not have product at time of call. Strength: 5mg, but she did have some of the heavier dose before she could get the nerve block Oxycodeine did not take the pain away, only the nerve block did.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300032197 same patient/drug/event, different dose;US-PFIZER INC-202300032249 same patient/drug/event, different dose;US-PFIZER INC-202300032250 same patient/drug/event, different dose;US-PFIZER INC-202300030721 same patient/drug, different event/dose;US-PFIZER INC-202300030735 same patient/drug/event, different dose;
Information has been received from a consumer concerning her 15 year old daughter, with no pertinent medical history and no drug allergies or reactions, who on approximately 26-APR-2010 was vaccinated with her first dose of GARDASIL (lot # 666595/0096Z, expire date not reported), intramuscularly, 0.5 ml.  On an unspecified date the patient received the second and third doses of GARDASIL (lot # not reported) 0.5mL, intramuscularly.  There was no concomitant medication.  It was reported that her daughter experienced mononucleosis 6 weeks after (on approximately 07-JUN-2010) the first dose of GARDASIL.  On an unspecified date, after the second dose of GARDASIL, she started having heart flutters and palpitations which were still continuing.  On an unspecified date and 2 minutes after the third dose of GARDASIL, her daughter experienced dizziness and a tonic clonic seizure for which she went to the emergency room for.  While in the emergency room, she experienced numbness in her right hand, left hand, the right side of her face, her mouth, her tongue, and then her throat closed and she stopped breathing.  She was given a steroid (unspecified) through IV to restart breathing which was successful.  Nothing else had been administered as of yet for the seizure when the numbness occurred.  She went back to the emergency room two days later for similar symptoms only without the seizure and stopped breathing.  The patient was due to visit a neurologist at some point within the following week.  At the time of the report, the patient had not recovered.  There were no laboratories diagnostics studies performed.  Upon internal review, tonic clonic seizure and stopped breathing were considered to be other important medical events.  Additional information has been requested.
Fever (prolonged) x 14 days starting day of administraiton per parent. Temp 101.1 9/9/2014 - Redness left thigh midly tender. Rx: Cephalexin for possible cellulitis.
These facts were reported to pharmacy by patient on 4/6/2018. PNEUMOVAX was administered to patient at around 3 pm on 4/2/2018. That evening, patient's arm began to get very swollen at injection sight. The swelling spread to his entire Right upper arm. On Tuesday the arm was still swollen and the patient developed a fever. On Wednesday, the patients whole arm turned red and was still swollen. He sought treatment at an urgent care center, where he received steroids and antibiotics to help the reaction subside. On Monday, when he reported to pharmacy, the redness had subsided and swelling had gone down in his arm, but now he had a large bruise slightly larger than 2 quarters on his forearm that he thought was also from the vaccine.
Mild Chest Pain Worse With Deep Breath/chest pain got worse; Felt warm and his temperature was 100 F; Now I have A-Fib; A spontaneous report was received from a consumer concerning a male 76-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, fever, and atrial fibrillation.   The patient's medical history, as provided by the reporter, included coronary artery disease.  Concomitant medications included carvedilol.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient experienced chest pain that got worse when he took a deep breath.  He also felt warm, and his temperature was 100 degrees Fahrenheit.  The patient visited the emergency room where an electrocardiogram (EKG) was normal and his COVID-19 test were negative.  Because of his history of coronary artery disease, he stayed in the hospital overnight.  On 01 Jan 2021, the hospital cardiologist called it a reaction the vaccine, and he was discharged.  On 05 Jan 2021, on a follow-up visit with another cardiologist, another EKG was performed, and the patient was diagnosed with atrial fibrillation.  The cardiologist increased his carvedilol dose to 6.25 milligram from 3.125 milligram and added apixaban, 5 milligram, twice daily.  At the time of the report, he felt fine.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, chest pain and fever, was considered recovered/resolved on 01 Jan 2021.  The outcome of the event, atrial fibrillation, was considered recovering/resolving.; Reporter's Comments: This case concerns a 76-year-old male patient with medical history of coronary artery disease, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of chest pain and atrial fibrillation and the non-serious listed event of fever.  Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. However, the events of chest pain and atrial fibrillation may be explained by the patient's history of coronary artery disease.
Heart arrhythmia with 3-5 palpitations per minute. Condition lessened each day and appears to be completely gone after 10 days.
Developed a thigh cellulitis at site of injection, right thigh.  Treated with 10 days of Keflex.