chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a health 12 month old female who on 10/18/2004 was vaccinated with a dose of varicella virus vaccine live.  On 10/24/2004, the patient developed a varicella like rash.  The rash was on her arms and legs and new deeper lesions were continuing to form.  Unspecified medical attention was sought.  The child had been treated with diphenhydramine hydrochloride and calamine lotion.  The patient's varicella like rash persisted.  A product quality complaint was not involved.  Additional information was received from the physician who indicated that the patient was seen by a dermatologist.  The new diagnosis was papular acrodermatitis which  resolved and then reoccurred one month later, on approximately 11/24/2004.  The physician noted that it did not appear to be vaccine related.  No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 23-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
No symptomatic adverse events reported. No additional AE/PQC reported; HCP calling to report temperature excursion for VARIVAX in which it was administered.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 15-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number X000100 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 09-OCT-2025) as prophylaxis, that experienced a temperature excursion (product storage error). No symptomatic adverse events reported.  The vaccine experienced a temperature excursion at minus 11.5 degrees Celsius (C) for 72 hours. Call was not because of a data logger. There was no previous temperature excursion.
On Monday morning, February 22, 2021, I woke up with my upper left arm seriously itching.  When I looked in the mirror at my upper left arm I saw a red rash about 4 x 3 inches which was also warm to the touch.    Thinking it might be an insect bite I applied some Aloe cream.  On Thursday, February 25, 2021 I had a previously scheduled doctor's appointment.  The nurse practitioner there looked at my arm and said it is Covid Arm.  She suggested I apply cold compresses and said it happens sometimes and no one knows how long it will last and did not have any suggestions for what to do for it but wait it out.   Today, February 26, it is still warm and hurts when it is touched but the redness is less - maybe because I'm trying very hard not to scratch it.
I got a large lump at the injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: En8733 and expiry date was not reported) via unspecified route of administration into the arm left, at the age of 34-year-old, on 04Apr2021 11:00, as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history includes penicillin allergy, high blood pressure and asthma. The patient concomitant medications in two weeks includes cetirizine hydrochloride (ZYRTEC), famotidine, amlodipine, losartan, albumin human (ALBUTEIN). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208 and expiry date was not reported), via an unspecified route of administration into the arm left, on 14Mar2021 11:00, at the age of 34-year-old, as dose 1, single for covid-19 immunization. The patient didn't receive any other vaccine in four weeks. The patient was tested with Covid-19 antigen (nasal swab) and had negative result on 22Nov2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jul2021 01:00, the patient experienced large lump at the injection site 3 months after second dose. The patient didn't receive any treatment in response to the event. The outcome of the event was not recovered at the time of report.
patient fainted within 5 minutes after receiving vaccine; fainting lasted less than 1 minute . patient reporte excessive sweating/feeling hot. patient reported on form no reaction to vaccine on patient questionairre. patient states that fainting happens at the dentist and in the past when getting a vaccine after the episode. patient also reports that he had not eaten all day, had 3 hours of sleep as well. patient remained in vaccine area for 30 minutes after recovery, drank 2 small bottles of water. patient declined additional emergency services . patient stated he was feeling well and left the pharmacy. advised pt to sign up
Day after, 10/16/19 - fever - 101.  Flu-like symptoms - body ache and headache.  Stayed in recliner chair all day. Could not perform normal activities.  Treatment: Tylenol every four hours - didn't help. 10/17/19 - feeling better, still fatigued.  10/19/19 (today); feeling ok.
Severe varicella eruption total body, approximately 3 weeks, post vax. Afebrile. Treated with Zovirax, etc.
2 days p/vax redness & swelling occured @ inject site; now 5 days post inject erythema & swelling down upper arm 7" x 4; no fever;
not being well; difficulty walking; eyesight blurry; Hot/cold sweats; extreme fatigue/bed ridden; Joint pain/ joint aches; lowgrade fever/ fever; body aches/ muscle pain/ muscle aches; migraine/severe all day migraine/ horrible migrane; "during the administation of the vaccine,blood trickled down her arm"; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well) and GAIT DISTURBANCE (difficulty walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by Reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry), HYPERHIDROSIS (Hot/cold sweats), FATIGUE (extreme fatigue/bed ridden), ARTHRALGIA (Joint pain/ joint aches), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches). On an unknown date, the patient experienced MALAISE (not being well). At the time of the report, MIGRAINE (migraine/severe all day migraine/ horrible migrane) and FATIGUE (extreme fatigue/bed ridden) had not resolved, VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry) and ARTHRALGIA (Joint pain/ joint aches) outcome was unknown and HYPERHIDROSIS (Hot/cold sweats), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event start date for feeling unwell reported as unknown day of AUG 2021.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information included patient demographic data, suspect drug batch number, new events blurry vision, walking difficulty, blood trickled down arm  and event outcome updated for fever, body aches, hot/cold sweats.
headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am floating; fever of 101.1; chills; body aches; extreme fatigue; This is a spontaneous report from a contactable other health care professional (patient).   A 23-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EM9810, intramuscular on 12Feb2021 14:15 (at the age of 23-years-old) as a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were none.  Historical vaccine information included BNT162B2 (Pfizer BioNtech), lot unknown False, administration date 22Jan2021 01:45 AM, dose number 1 for COVID-19 immunization (at 23 years old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient reported she was on day 5 post second vaccine and am still experiencing a lingering headache, nausea and spells of dizziness. These ease up some with acetaminophen (TYLENOL), but do not fully go away nor has she noticed any improvement in her symptoms. The headache started approximately 11 hours after her vaccination 13Feb2021 01:15. The following day unspecified date Feb2021, she had fever of 101.1, chills, body aches, extreme fatigue, and a worsening headache. This headache has continued and is still present, coming and going in severity. She had spells where she feels like she was floating on unspecified date in Feb2021 and feeling extremely dizzy while also being nauseated. She has not seen any reports of these symptoms lasting this long after vaccination.  "The adverse events started on 17Feb2021 at 12:00 PM". The patient underwent lab tests and procedures which included body temperature: 101.1 (fever) on 17Feb2021. No treatment was received for feel like I am floating, fever of 101.1, chills, body aches and extreme fatigue. Outcome of the events was recovering.
Information has been received from a nurse concerning a 36 month old patient who at the age of 12 months (date unspecified) was vaccinated with varicella virus vaccine live (Oka/Merck). Two years later (36 months of age, unspecified date), it was reported that the patient developed shingles. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Follow-up information received from a registered nurse indicated that she was called for the original reporter to report that the case was received from a nurse at another physician's office and concerns a patient who was vaccinated with the vaccine at 12 months and developed shingles 2 years later.  The patient's care facility's information was provided.  Please contact for further information.  Additional information has been requested.
shortness of breath on exertion starting early October, progressive, diagnosed with pulmonary embolus on 12/7/21 by CTA, treatment started 12/7/21
sick; could not eat; could not sleep; felt terrible; arm still hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (could not eat), SLEEP DISORDER (could not sleep), FEELING ABNORMAL (felt terrible) and PAIN IN EXTREMITY (arm still hurt) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 27-Apr-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 ILLNESS (sick), DECREASED APPETITE (could not eat), SLEEP DISORDER (could not sleep), FEELING ABNORMAL (felt terrible) and PAIN IN EXTREMITY (arm still hurt). At the time of the report, ILLNESS (sick), DECREASED APPETITE (could not eat) and SLEEP DISORDER (could not sleep) outcome was unknown, FEELING ABNORMAL (felt terrible) had resolved and PAIN IN EXTREMITY (arm still hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
BODY ACHES; DIZZINESS; FEELING WEAK; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 16-MAR-2021 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 16-MAR-2021, the subject experienced body aches. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced feeling weak. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling weak, headache, body aches, and dizziness. This report was non-serious.
Pain and numbness in left arm and tingling in fingers, fatigue and joint pain in elbows and knees.  These lasted 4 days.  Naproxen. Extra rest and sleep.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. On -7-JUN-2000, the patient was vaccinated with first dose of GARDASIL, intramuscular. On 01-JUN-2004 the patient was vaccinated with second dose of GARDASIL. The patient has not received the third dose yet. No adverse effects were reported. Additional information is not expected as reporter denied consent to be contacted for follow up information.
sore arm radiating pain down arm huge welt (red)  starting the next day still continuing 2 weeks and 2 days later
I am breastfeeding my 7 month old son and within hours after my second dose, he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time. He hadn't even had a fever like this; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; This is a spontaneous report from a contactable consumer (patient's mother). A 07-months-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via trans mammary dose 2, single on left arm on 07Jun2021 for Covid-19 immunization. The patient's medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, single for Covid-19 immunization. The concomitant medications were not reported. Patient did not have any covid prior to vaccination. Patient did not have covid test after vaccination. Consumer reported that "I am breastfeeding my 7 months old son and within hours after my second dose, he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time. He hadn't even had a fever like this ever before. I am a stay-at-home mom and he is my only child, so we are pretty isolated from other children. It was strange timing with my shot. My husband is a firefighter/EMT and after reading about Roseola we decided to watch the fever before seeking medical consultation, both because of the time & cost. We were able to break the fever within 24 hours with acetaminophen, the appetite has improved somewhat, and we are waiting on the rash to clear up. Before the shot I was prepared for it to affect me, but I did not expect this for my baby. It was very alarming. The outcome of the events was resolving.  information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684117 same reporter/vaccine different patient/AE
Numbness, pain bilateral lower extremities progressive weakness, tingling, dyesthesias in soles of feet - started on 10/24 seen at clinic on 10/26 - started on LYRICA d/t hx of diabetes seen in ER on 10/31 - with dyesthesias in hands and fingers - transferred to different hospital.
I had the second dose of the COVID shot yesterday and am having symptoms. I started vomiting last night and now have diarrhea as well. I've also had chills and whole body aches. I called into work today 2/3 and wanted to let you know as well. Back to work today 2/4, had vomiting, muscle aches, chills, and diarrhea for one day.
s/p 1st moderna vaccine on day 11 c/o  sensation throat closing, all over body itchiness, rash and bumps on arms and legs. She called her PCP who informed her to take prednisone 40 mg and her symptoms resolved. Patient referred to allergy MD for consult
Pfizer vaccine was administered outside of the clinic - reported by patient     NEUROPATHY 1/11/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE
This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy, drug and allergy history were not reported. On 16-JUN-2017, the patient was vaccinated by a medical assistant with an expired dose of VAQTA intramuscularly, lot number M022556, expiration date 26-MAY-2017, for prophylaxis (dose number was not reported). The physician stated that the medical assistant did not check the expiration date on vial prior to the administration. No adverse effects were reported and no additional information was given.
02/23/21, 7 pm - upset stomach and sore arm at injection site 02/24/21, 7 am to 11 pm - upset stomach, headache, body aches & chills and sore arm at injection site 02/25/21, 7 am to 02/27/21, 7 am - sore and swollen left underarm and breast, itchy rash extending down upper arm from injection site 02/27/21, 7 am to 02/28/21, 11 pm - swelling of left knee and left ankle 03/03/21, 7am to 03/06/21, 10 pm - back pain along bottom of right shoulder blade 03/08/21, 8 pm to 03/18/21, 10 pm - chest pain under right breast, especially with deep breathing, and highly elevated blood pressure
Child's father noticed rash on arms, legs and back 2/22/10. He's had previous H1N1 in another state 1 month prior. Observation: nickel sized flat wheals with red outline on areas mentioned above. Called 2/24 - mother states rash almost completely gone. Never recorded elevated temp. Child did not act ill. Rash dissipated completely 2/23/10
I was fine in the date of 3/25/2021 when I received the vaccine. At about 2:20-2:30, I started with a very soared arm. I took Tylenol for pain. I started to feel my body aching and having shivers. Went to bed at about 10pm and around 3 a.m 3/27/2021 I woke up with a Fever. I have been taking my temperature every six hrs after that, but it does not seem to go away. Right now at 8:19 I contacted the our Nurse in charge  at medical center, Since I been having fever and the latest reached 101.3 she adviced me to report it here.
got vaccine 1/29/21, 2/2/21 developed heaviness, tingling of arms and legs. He developed double vision on 2/4/21, unable to walk by 2/6/21. Was hospitalized. Developed right facial droop on 2/8/21. Had right ptosis on 2/9/21. Started on IVIG with slow resolution of symptoms.  Today feels 70% recovered. He is able to walk unaided but still feel not back to full strength.
Dizziness CHEST PAIN; BODY PAIN; FATIGUE Narrative: STATES NEEDED TO TAKE NITROGLYCERINE FOR RELIEF  Other Relevant History:
Discharge Provider: PA-C Attending Physician: MD Primary Care Provider at Discharge: MD  Admission Date: 10/16/2022 Discharge Date: 10/24/2022  PRESENTING PROBLEM: Generalized weakness [R53.1]   HOSPITAL COURSE: Patient is a 80 y.o. female metastatic breast cancer, chronic diastolic heart failure, permanent atrial fibrillation on Coumadin, hypothyroidism, depression who presented with worsening weakness and multiple falls. She had been seen in ED on 10/13 w/ hallucinations and found to be COVID positive, she was discharged to follow up outpatient. She presented back to ED on 10/16 and was found to be tachcardic and mildly hypotensive. She did have brief episode of severe hypotension and hypoxia which resolved after fluids. CT head was negative. CT thorax/abd/pelvis showed concern for metastatic disease. Care was discussed with oncology who recommended admission to medicine.     Following admission pt completed 5 day course of remdesivir for COVID. She had no further episodes of hypoxia. She was seen by PT/OT with recommendations for SAR.    Regarding her ill defined sclerotic and lytic bone lesions, oncology was consulted. Recommended continue letrozole and holding palbociclib and follow up outpatient. It was recommended she have outpatient MRI brain to evaluate for metastatic disease given hallucinations.    She was note to have new pancytopenia, which stabilized. Peripheral smear without clear etiology for pancytopenia. Possibly related to acute illness. Recommend follow up CBC within 1 week and heme-onc follow up if persistent. She does have a follow up oncology visit scheduled on 10/26.   She was incidentally found to have a thyroid nodule on CT. Ultrasound revealing two thyroid nodules of concern, for which FNA biopsy recommended. Information forwarded to PCP via Epic and discussed with patient/placed on follow up information on discharge paperwork.    Coumadin was also held on admission with concern for recurrent falls. This was discussed with the patient and her son, ultimately felt benefit higher than risk (chadsvsac 4, hasbled 1) especially as plan for rehab and hopeful for LTC following. Alternative agents were discussed with the patient and her son, and she was started on eliquis.   Once cleared from respiratory isolation, she was felt stable to transfer to subacute rehab on 10/24. All follow up recommendations discussed in detail prior to discharge.
Rapid heart beat, shortness of breath, dizziness, rash on face, numbness on face, tongue began swelling. Brought liquid benadryl at store took full cup of it and followed it with water (same as I do if I come into contact with shellfish- I have a level 2 anaphylaxis allergy) it cleared within 20 mins after benadryl at store. It did return but less at home. I had to repeat twice at home.
1. Feelings of having a fast-beating and pounding heart in the night. 2. Sweet often during the day without excise.
Cold sore spread from right to left nostril, circular around nostril instead of bump.  Today 4/3/08 still have it but getting better.
With no previous heart issues.  Heightened hear rate started on evening after the vaccine, topped out at a resting heart rate of over 160bpm.  Went to primary health care physician, he did EKG, then ordered me to Emergency Room.  Was diagnosed with Atrial Fibrillation with RVR, prescribed Apixban (Eliquis) 5mg oral tablet, 1 tab 2 times a day, prescribed Metoprolol (metrolrolol succinate 50mg extended relese) 50mg 1 cap per day. Given diltiaZEM 10mg via IV push while at the hospital.  Continue to have increased heart rate and have not returned to a normal sinus rhythm as of 3/23.  Scheduled for follow-up with EP on 4/9 to review heart rhythms.