chrisvoncsefalvay/vaers-outcomes huggingface dataset:
so weak, even weaker; nose running profusely; almost dropped twice; threw up; a bad reaction; became really weak/since then was very weak; suddenly had to do number one and number two; head was sweating to death; nose running profusely; suddenly had to do number one and number two; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death) and the first episode of RHINORRHOEA (nose running profusely) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, LISINOPRIL and PAROXETINE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), the first episode of RHINORRHOEA (nose running profusely), DEFAECATION URGENCY (suddenly had to do number one and number two) and VOMITING (threw up). On 13-May-2021, the patient experienced ASTHENIA (so weak, even weaker), the second episode of RHINORRHOEA (nose running profusely) and FALL (almost dropped twice). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of three at a time and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of two at a time. At the time of the report, ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), DEFAECATION URGENCY (suddenly had to do number one and number two), ASTHENIA (so weak, even weaker), the last episode of RHINORRHOEA (nose running profusely), FALL (almost dropped twice) and VOMITING (threw up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer reports telling the person who gave the vaccine, of a family history of a mitochondrial condition. Also reported that she has made a decision not to take the second vaccine dose. Treatment included allergy pill two at one.
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and  chest.; Instant hot fire feeling in stomach and  chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported.  The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and  chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event).  Information on the Lot/Batch number has been requested.
easily getting angry or emotional; easily getting angry or emotional; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: ANGER (non-serious), EMOTIONAL DISORDER (non-serious), outcome "unknown" and all described as "easily getting angry or emotional".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid vaccine breakthrough case  dose 1 Moderna 2/13/21 031M20A dose 2 Moderna 3/13/21 040A21A dose 3 Moderna 11/11/21 039F21A
ARM IS SWOLLEN; FACE IS FULL OF RASH; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced arm is swollen. On 05-JUN-2021, the subject experienced face is full of rash. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is swollen and face is full of rash was not reported. This report was non-serious.
Headache,  nausea, body aches, chills and fever (highest 101.1) began around 1am 1/26/21 and continued throughout the day, fever finally breaking around 7pm that night.  I woke the following morning 1/27/21 at 7:20a feeling better,  only slightly tired.  I was awake about 30mins when my husband reported I stated I felt very dizzy while standing in our kitchen, he states I started walking over to our living room when I fainted and fell face first into the side of our sofa.  He stated I came too about 20-30 seconds later.  After awaking my hearing was muffled and my arms were very tingly for about 3 mins.  I felt completely exhausted and slept for a few hours, remaining very  fatigued the rest of the day.  Today, 1/28/21, I woke up feeling tired but tightness to base of my head and neck, no other symptoms.
Patient admitted with vomiting, diarrhea, acute kidney injury, elevated inflammatory markers, but did not have fever so not diagnosed with MISC. Patient also had vomiting and diarrhea so this may have been from another acute illness and had nothing to do with the vaccine.
Pt noticed small red quarter-sized mark soon after vaccination but thought nothing of it; says it spread by the next day and as of today (2 days after vaccine) noticed significant redness and soreness; came into pharmacy at 5:15pm on 2/10/17 to report adverse event; was told to apply ice, take benadryl and ibuprofen for pain (pt has already done this) and monitor; if it worsens to seek medical help and to call us or come by tomorrow to let us know his status.
Headache; This is a Spontaneous report based on the information received by Pfizer from Agency on behalf of Pharmaceuticals, Inc. (Manufacturer Control No: 2021BHV01004) via a contactable consumer (patient).  A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Feb2021 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after second dose of vaccination, patient experienced severe headache. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a 76 year old male patient. Medical history was not specified. On 05-SEP-2013 the patient was vaccinated with ZOSTAVAX. After vaccination patient experienced being increasingly sick, weak, chest consolidation (onset date interpreted as 05-SEP-2013) and elevated white blood counts (onset date interpreted as September 2013). Patient was being treated at oncology clinic for myelodysplastic syndrome. Patient had been to emergency room three times since he received ZOSTAVAX. Since 05-Sep-2013, patient was treated with a ten day course of Valacyclovir. Patient was actively undergoing chemotherapy and received VIDAZA on 06-SEP-2013. White blood count was reported as 0.5 (units not provided), prior to vaccination of ZOSTAVAX, and 7.9 on 23-SEP-2013, 7.1 on 25-SEP-2013 and 6.6 on 26-SEP-2013. Chest x-ray on 26-SEP-2013 showed possible developing hazy infiltrate left lung base. The reporter considered the adverse events to be life threatening and serious due to disability. The outcome of chest consolidation, x-ray showed possible developing hazy infiltrate left lung base, myelodysplastic syndrome, elevated white blood counts, weak and increasingly sick was unknown. Additional information has been requested.
Patient received his first dose at the age of 11. Parents gave wrong date of birth at first appointment. Patient turns 12 in September and will receive the second dose at that time. Error was realized when billing second dose through insurance.
This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # H010915 with expiration date 13-FEB-2015 and lot# K007828 with expiration date 02-MAR-2017, dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were not supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "General Anxiety disorder" (unspecified if ongoing), notes: other medical history: General Anxiety disorder. Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and other medication in 2weeks reported as yes. Antiviral details included COVID 19 Treatment with Paxlovid from 20Nov2022 to 25Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, weak, pale, swollen (very) arm and redness, pain in arm that would awake me at night. Dropped item on porch & when I went to pick it up, the whole porch was spinning. Dizziness & weakness lasted 10 days as well as swollen arm, warm feeling like fever too but chills inside. Returned to Dr's office on 9-17-10 but wait was too long. Sitting in air conditioning made me feel worse - chills inside were worse. Told I was 'probably coming down with something anyway' asked for copy of what I was given & I was mailed the 2 enclosed forms. I phoned and asked 'what type of flu shot I was given' and told the forms sent to me were all I needed for my records. Note: Both flu and pneumonia shots were given in same arm within seconds of each other. Did this cause a problem?
Extended rash - additional sores. Pt with erythema 8cm diameter around wound / small pustule (3mm) on opposite R lat. elbow, questionable lesion on back of R neck.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805529 was crossed linked to original case 201804863 due to same reporter.
This is a 67-year-old gentleman with no significant health problems.  The patient receives annual flu vaccine and is current as of 2012/2013.  On Monday 01/14/2013 patient went to his primary care doctor for the pneumonia vaccine.  One day after vaccine (01/15/2013) he was working out and began feeling short of breath.  He noticed swelling in his throat, started coughing and had facial flushing.  He started to notice swelling around the right eye, and developed hives on the right side of the chest.  Patient then came to emergency room at 9 o'clock that evening.  He was treated with hydrocortisone and diphenhydramine and was given a prescription for prednisone. The swelling and angioedema subsided after treatment and he was discharged that night.  The morning of the 16th patient woke up and felt swelling around the right eye, pruritus, erythema on the palms of his hands, and swelling inside the cheeks.  He took the diphenhydramine for itching but he did not take any prednisone.  He felt dizzy so he sat in a chair and lost consciousness.  His wife grabbed him, put him flat on the ground and called 911.  When the patient arrived at the ER his blood pressure was 70/50.  In the ER he was given IV fluids, epinephrine 0.3, famotidine 20 mg, diphenhydramine 50 mg, and hydrocortisone and was admitted for further evaluation.  Patient was admitted and treated for allergic reaction through the 18th.  He was discharged stable with an active allergic reaction controlled with steroids and diphenhydramine and will be further managed as an outpatient.  Patient home medications include: dutasteride .5 mg daily and Cyclosporine eye drops daily, none of which are new medications.
I originally just had muscular pain at the injection site.  About 36 hours after the vaccine, I woke up in the middle of the night with uncomfortable chest pain, which I have never experienced before.  Not bad enough to go to the doctor or ER, but certainly kept me awake.  It lasted only ~3 hours and was gone after that.  Since then I've just noticed swollen painful lymph  nodes in the L axilla, the same arm that I received the vaccine in.
BEDRIDDEN FOR TWO DAYS; METALLIC COPPERY TASTE; EGGS PORK AND CHICKCEN TASTE AWFUL; HIGH FEVER; 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. The patient's past medical history included: covid-19 infection. 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 MAY-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 an unspecified date, the patient experienced bedridden for two days, metallic coppery taste, eggs pork and chickcen taste awful, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, bedridden for two days, metallic coppery taste and eggs pork and chickcen taste awful was not reported. This report was non-serious.
This spontaneous report as received from a patient's mother concerning to her 16 month old son. Patient's concurrent conditions and relevant medical history was not reported. The reporter stated that the patient was exposed to another unspecified child who had active case of chicken pox. After about 15 days later, the patient developed chickenpox symptoms. The patient sought medical attention by visiting the physician. On 24-JAN-2015 the patient was vaccinated with first dose of VARIVAX (Merck) (lot number, dose and frequency unspecified) (route: injection). Concomitant medications were not reported. On 25-JAN-2015 the patient experienced more chickenpox symptoms and clay colored stools. On an unknown date in January 2015 the patient developed a rash where the band aid was applied after injection of VARIVAX (Merck). The outcome of the events was reported as not recovered/not resolved. The causality of the events with VARIVX (Merck) was not reported). Additional information has been requested.
PATIENT: UNDERAGE 18 YEARS OF AGE  PATIENT IS 16 YEARS OLD AND VACCINATED. PATIENTS MOTHER WAS PRESENT AND CONSENTED TO VACCINE ADMINISTRATION. NO ADVERSE REACTIONS NOTED DURING OBSERVATION.
Arm because red and tender at injection site a few hours following the injection but by the next morning there appeared to be a patchy rash in the surrounding area and my arm was very warm and sore. That evening the red had continued to spread and the rash became itchy. This continued the 2nd day so I reached out to the pharmacy to ask at what point I should be concerned. They asked me to fill out this form and said they would check in with me again tomorrow and May recommend a visit to urgent care  if it hasn't cleared up by morning. I've been recording the growth of the rash by photograph.
Following the Vaccine, That evening I developed a high fever and  mild tingling throughout my body.  The next day I felt unwell with no more fever but the mild tingling sort of developed into a gnawing tingly side pain. Alongside with mild nausea and loss of appetite from the time of the shot on. That remained for the next two days until I finally looked at the area and it was a shingles spot.  there were some other spots of shingles I noticed on my stomach. I determined this 3 days following the shot and went to an urgent care on the Friday to get some medicine, ( Valacyclovir). After taking my first dose Friday evening of that medicine I vomited the entire day Saturday. I no longer took any Valacyclovir as I assumed the vomiting was from the medicine. I went to my family doctor the next week. She stated that the shingles were healing all right and not to take the Valacyclovir. It took another week for the shingles to heal up but my loss of appetite lasted for about another month. I still get side nerve pain ( its been a couple months)and just returned to the MD 10/19 as I have had 2 more episodes of extreme nausea since the initial time following the Valacyclovir.
BP/ 98/60 at time vaccines adminestered. After vaccines patient and mother stayed in the room for 3 to 4 minutes, then walked out to the hallway towards exit door, but patient fell unconcious hit the head against the edge and counter wall. Pt  had a 10 sec seizure and within 30 mins became alert, responsive and not sleepy or drowsy. Pt was taken in a wheelchair back to room and after evaluation - laceration was noticed on scalp. Laceration was treated and successfuly the bleed was stopped. BP was retaken 149/90. Ems was called and patient was taken to the ER for further evaluation.
Patient presented stating that he was here to receive his first dose.  After being vaccinated it was discovered that he had just received a first does at another location 2 days prior.  Patient counseled on the importance of following CDC recommendations for COVID-19 vaccine.  He was advised to not take any more vaccines.  Patient advised to call 911 if he starts experiencing chest pain, SOB, difficulty breathing or a rash develops all over his body.  Patient verbalized understanding.
FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 year old male. 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: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.
Father reported the boy sneezing, coughing, which he stated started 45 min ago (call came in at 4:45 PM) and at the time of the call getting a red and swollen face. Pt's father was given lot number, and expiration date of vaccination and told to take pt to the emergency room.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 17-MAY-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1", DS/VTF" with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for 112 hours (lowest recorded temperature). The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills/Sweats, Fever, Headache, Exhaustion, Nausea, Body Aches