chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 27-JAN-2017 at 08:19, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000437: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying down. Sudden lightheadedness, seeing stars; tunnel hearing, then tinnitus; leaned forward and lightheadedness continued to worsen, so I laid the car seat back; suddenly felt hot and started sweating profusely; slight nausea; bradycardia (which I never have - I am on a prescription stimulant, and usually run >80 when seated). Called roommate to pick me up and take me back to the vaccine site to check with paramedics there before continuing home.
FLU SYMPTOMS WHICH DIDN'T FEEL SO GOOD / BODY PAIN; INJECTION SITE SORE / PAIN ON THE JAB SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced flu symptoms which didn't feel so good / body pain. On SEP-2021, the patient experienced injection site sore / pain on the jab site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms which didn't feel so good / body pain on 04-SEP-2021, and had not recovered from injection site sore / pain on the jab site. This report was non-serious.
The day I got my vaccine I was doing fine. Later in that day I was lifting my arm open a blind and it was very painful. It was sore and then it has progressed from sore to painful. I have restrictive movement. I have pain when I am sleeping or move in certain ways like lifting up or reaching out. Sometimes I have to ask for help getting clothing off from my spouse. Yesterday I finally reached out to my doctor for help. I had waited so long because I thought it would go away but for the last month I have been worn out and it just hurts all the time. I am seeing the provider later today. I have been taking 600mg ibuprofen and that does help but it just does not cut it and mostly dulls the pain.
Pt devel diabetic neuropathy feet & hands 1995. Tx unsuccessfully w/meds. 1 day post vax, inc sensitivity of fingers,reduced numbness of feet,Cont to inc x3 days,numbness hands/feet returned by Oct 15.
Vax given 04/19/2000, reaction began 04/29/2000, 35 mm raised red area with defined induration. Is warm and tender to touch. Symptoms resolve in 4-5 days.
pt recv vax & devel an inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002491: US-009507513-1808USA002453.
REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED.  PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.
Patient with pallor hypotonia and decreased responsiveness within 1 minute of 2 month vaccines.
Had a seizure the morning after receiving her 1st dose of the Moderna Vaccine. 911 was contacted and she was hospitalized at a local hospital.
stage 2 breast cancer; I got so sick from the shot; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER STAGE II (stage 2 breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In August 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 BREAST CANCER STAGE II (stage 2 breast cancer) (seriousness criterion medically significant) and ILLNESS (I got so sick from the shot). At the time of the report, BREAST CANCER STAGE II (stage 2 breast cancer) had not resolved and ILLNESS (I got so sick from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Patient was prescribed steroids to help.  Company comment. This spontaneous case concerns a female patient, unknown age, with no medical history reported, who received a dose of mRNA  1273 vaccine (reported as first dose of mRNA - 1273) and experienced the unexpected, serious (medically significant) event of breast cancer stage II. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient got so sick from the vaccine that she "could not function for a month" and in an unspecified date she went to urgent care where she was prescribed steroids (unspecified dose and frequency). Laboratory blood tests were performed, and it was mentioned that the oncologist said, "the cancer was environmental". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, unknown age, with no medical history reported, who received a dose of mRNA  1273 vaccine (reported as first dose of mRNA - 1273) and experienced the unexpected, serious (medically significant) event of breast cancer stage II. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient got so sick from the vaccine that she "could not function for a month" and in an unspecified date she went to urgent care where she was prescribed steroids (unspecified dose and frequency). Laboratory blood tests were performed, and it was mentioned that the oncologist said, "the cancer was environmental". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
More than 36 days after the first dose without receiving second dose; Fall; Broke both her legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER LIMB FRACTURE (Broke both her legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported  by reporter.  Concomitant products included INSULIN HUMAN, METHOCARBAMOL, GABAPENTIN, OXYCODONE HYDROCHLORIDE (OXYCONTIN), ONDANSETRON and DULOXETINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced LOWER LIMB FRACTURE (Broke both her legs) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose). The patient was treated with Rehabilitation therapy (she had to get operation and had to attend rehab) for Lower limb fracture. At the time of the report, LOWER LIMB FRACTURE (Broke both her legs) and FALL (Fall) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Patients arm had a welt which she was told would be normal, but the swelling continued and progress to and was very warm and swollen. Required an office visit which she was prescribed an antibiotic and prednisone for suspected cellulitis.
It took about 5 days in and I started having a heavy chest and was congested. On Monday, July 26th, I went to the doctor and was prescribed prednisone. I have not recovered and have been out of work for weeks.
Systemic: runny nose, excess amount of mucus, no fever, cough, muccle pain-Medium, Additional Details: Pt feels sick
No adverse symptoms occurred, but the RN was made aware that the KINRIX was given as DTAP dose #4, instead of as dose #5.
Fatigue, pain in arm radiating to shoulder and neck, stiffness, nausea and anorexia leading to complaint of weight loss.
A report was received from a health care professional on 10/24/03 concerning 3 vaccinees of unknown gender less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date 3 vaccinees less than 4 years of age inadvertently received Fluvirin. It was unknown at the time of the report whether or not the vaccinees had exhibited any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporter's causality assessment. Update 11/24/03: Further information was received from a health care professional on 11/24/03 indicating that the vaccinee was a 27 month old male who inadvertently received 0.25ml Fluvirin vaccine on 11/3/03. On 11/3/03, the vaccinee inadvertently received Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt felt lightheaded and was taken to triage area. vitals taken and were bp 147/83, HR 86, Po2 97. pt had a vasovagal episode and lost consciousness for 1 second. regained consciousness. pt states this has happened before. last time was 1 .5 years ago at work.   pt states he is feeling well and feels fine to go home.
30 y/o male following-up after ED visit at  MEDICAL CENTER d/t adverse allergic reaction to J&J Covid- 19 vaccine. States he experienced hives, rash that extended  from his forearm to the back of his neck on the side where  injection was administered, severe CP, HA, lightheadness, and  BPs=220s/100s within 4 hours of vaccine administration. He was  transported via ambulance to the ED where labs and some "CXR or  EKG" was completed. Per patient, they placed an IV and  administered Benadryl. He denies recieving EPI-PEN at the ED.  He was monitored and subsequently discharged same-day.  Currently, denies rash, CP, HAs, SOB, and lightheadedness.  Continues to have some mild pruritis and localized tenderness  on injection site. Reports BP has return to his baseline.
Five months after vaccination of dose 3 Moderna, on 6-4-2022, I started having a fever (did not check), headache and sore throat. The next day, it was just a sore throat. I called a doctor on 6-5-2022 who sent someone to test me for Covid. It was a positive result. I also made an appointment the see a doctor on 6-7-2022. They did not prescribe anything. They suggested cough drops. I started taking Strepsils (slurbiprofeno) 8.75mg OTC as needed. On 6-8, I developed a slight cough. I am feeling better but have a lingering cough. I am reporting my breakthrough case of Covid.
There was minor arm pain in the area of the shot for about 4-5 days; there is still (5 days) a hardened lump the size of the palm of my hand in the area of the injection site (slowly improving); the upper left arm is swollen (5 days); tiredness; runny nose
2-3 days post injection: arm pain, lethargy, shivering 3-4 days post injection: muscle weakness and pain in upper thighs, limiting ability to walk distances 5 days post injection: intense muscle pain and weakness in upper legs--unable to walk more than 5-7 steps, lightheadedness/nearly passing out. heart racing, dizziness, gasping for breath. Dr. consulted. She ran an EKG which was normal, and referred for echocardiogram, carotid artery scan, blood panel, and referral to cardiologist. Dr. advised me to get plenty of rest and a lot of fluids and hope that the symptoms would subside. Also advised to cancel colonoscopy scheduled for the following week. For the following 3 1/2 weeks: unable to walk more than 5 steps without sitting down to rest for five minutes, very painful nerve pain in upper thigh, serious muscle weakness, heart racing, gasping for breath, but lightheadedness had subsided. Unable to go to work for one month.  Four weeks after the vaccine, the symptoms largely cleared and resumed going to work. Now feeling as normal. This was the scariest health event of my life.
Arm as if I have fire; It hurts but not to the level of my arm; Extreme tiredness; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ARIPIPRAZOLE (ABILIFY) for Blood pressure abnormal.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache). At the time of the report, BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication reported. No treatment information provided.
patient received expired Menactra/ No AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA244699 same reporter.  This case involves a 17 years old female patient who received 0.5 mL dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5835AA, expired date: 17-FEB-2019 (Frequency- once) via intramuscular route in the left deltoid on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Documents held by sender: none.
Received phone call from a medical director that a first year resident was being seen by neurology for possible work up of Guillain Barre Syndrome. Resident first complained of double vision; patient said possible Miller-Fisher Syndrome.
Delusions starting on 10/28/2021, Hallucinations starting a few days later. Pt already had Mild Cognitive Impairment that began several years earlier.
4 inch zone of erythema, induration, and pain. The zone is swollen at his left lateral thigh and.
Information has been received from a registered nurse concerning an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot#, expiration date, dose and route not provided). The reporter asked about the adverse reactions to patient after receiving an expired PNEUMOVAX23 or was it more or less potent. Additional information has been requested.
Report 20010282091 describes burning pain inthe joints of a 68 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other health care professional. The medical history included chronic tennis elbow. There was no history of osoriasis, Crohn's disease, or Lyme disease. There was no family history of rheumatoid arthritis or lunus. Concurrent conditions and medicaitons were not specified. The vaccinee reported that he received three subcutaneous injections of LYMErix. The first injection was administered approx. in 1999, and the last injection was administered approx. in 2000, the dates of immunization were not provided. In July or August of 2001, the vaccinee reportedly began to experience burning pain in te joints of his left hand. He then experienced the burning joint pain in his left elbow, right toe, and right knee. The vaccinee reported that he has not sought medical attention for the burning joint pain, and is receiving no treatment for it. The burning joint pain persisted as of 11/14/2001. On 01/08/2002, additional information was received from the rhematologist who had evaluated the vaccinee. On examination, no joints were warm or swollen. erythrocyte sedimentation rate (ESR), rheumatoid factor, antinuclear antibody (ANA) titer, and C-reactive protein were normal. No problems associated with LYMErix. He is depressed and obsessed about receiving LYMErix, but despite repeated reassurances, continues to obsess about possible long-term effects of vaccine. The adverse event of "burning pain (joints)" does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
I received my vaccine on 04/09/2021, had mild to moderate arm pain and soreness within 24 hours, lasted for about an day and then went away. However on 4/17/21, I was out in the sun for about 20 minutes during the day and that night I had severe arm pain that woke me up from my sleep, the injection site became inflamed, warm and itchy. The pain was so sever that I could not sleep, I also has severe back pain, mainly on my spine and joint swelling and pain all over my body. I was not able to raise my arm and the site of injection was very painful even without touching it, it was sensitive even to light touch of my clothing. I also had severe head ache and myalgias as well. The symptoms have diminished but have not subsided as of today. The site of injection is till painful, swollen and warm, as well as persistent cervical painful adenopathy.
Began feeling nauseated one day after vaccine on 10/8. Had some chills, fevers, mild muscle aches. Also noticed right arm swelling overlying injected area with erythema warmth in area of vaccine. No prior allergic reaction.
64 YO  AA FEMALE PRESENTED WITH ACTIVE VOMITING. PT STATES SHE FELT FINE IMMEDIATELY AFTER RECEIVING THE VACCINE. AFTER WAITING IN OBSERVATION FOR 10 MIN, SHE STARTED TO FEEL A HOT FLASH (CEPHLAD TO CAUDAD), NUMBNESS IN HER JAW; SWELLING IN HER THROAT AND COULD NOT SWALLOW WATER/ KEEP IT DOWN. SHE ADMITS HAVING A DULL FRONTAL HEADACHE. DENIES CHANGES IN VISION, CHEST PAIN OR PRESSURE. BP 150/84 HR 83 SpO2 96% PT APPEARED ALERT AND ORIENTED X 3 WITHOUT VISIBLE NERVE DEFICITS. NO FACIAL SWELLING, LYMPHADENOPATHY, OR DIFFICULTY SWALLING ON EXAMINATION.  SMALL ERYTHEMATOUS HIVE NOTED ON PTS' RT BRACHIAL AND CERVICAL REGION. AFTER 15 MINUTES OF MONITORING, PT SYMPTOMS RESOLVED AND VOMITTING CEASED. PT WAS INSTRUCTED TO REHYDRATE WITH ELECTROLYTE FLUIDS AND RESUME EATING PROGRESSIVELY. NO BENADRYL OR STEROIDS REQUIRED. PT LEFT IN STABLE CONDITION WITH HUSBAND.  PT ADVISED TO F/U WITH PCP.