chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 17:45 as dose 3 (booster), single (Lot number: EE2593) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE oral, start date: Jan2022, stop date: 11Jul2022; TURMERIC [CURCUMA LONGA] oral, start date: Jan2022, stop date: 11Jul2022; DEXMETHYLPHENIDATE oral, start date: Jan2022, stop date: 11Jul2022; BUPROPION oral, start date: Jan2022, stop date: 11Jul2022; L-METHYLFOLATE CALCIUM [CALCIUM LEVOMEFOLATE] oral, start date: Jan2022, stop date: 11Jul2022; TRINTELLIX oral, start date: Jan2022, stop date: 11Jul2022; ATORVASTATIN oral, start date: Jan2022, stop date: 27Jun2022; FAMOTIDINE oral, start date: Jan2022, stop date: 11Jul2022; BACLOFEN oral, start date: Jan2022, stop date: 11Jul2022; METOPROLOL XL oral, start date: Jan2022, stop date: 11Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100.7; SARS-CoV-2 test: Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-Viral Details ,Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date was 28Jun2022, Treatment Stop Date was 03Jul2022, Indication was Treatment of COVID-19, Administration route: oral. Adverse Event: Patient completed 5 days of Paxlovid and improved. Last dose 7/3 AM. On 7/6 PM patient started experiencing congestion, runny nose and sneezing. On 07Jul patient developed headache, body aches, and fever of 100.7 and tested positive for COVID. Adverse Event Start Date was 06Jul2022, Adverse Event Start time was 10:00 PM, Patient was Recovered: Recovering.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Information has been received from a healthcare worker referring to 5 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with PEDVAX HIB (lot # L035880, expiration date 11-AUG-2018, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Temperature 102 - 103 x 2 days 4 hours after vaccine. Crying non stop x 4 day. Talked to Pediatrician Dr. Continued TYLENOL, no office visit. Pediatrician recommended doing vaccines indefinitely but do not withhold.
chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Polyethylene glycol.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling). On 19-Mar-2021, CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (bad reaction) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (bad reaction). At the time of the report, vaccination complication (bad reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Patient stated she needs to see a doctor.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L007495, expiration date 24-FEB-2017; lot # 019286, expiration date 14-SEP-2017; lot # 027282, expiration date 21-SEP-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
p/vax pt devel breakthrough chickenpox;started w/ 3 lesions @ the time of report had over 50 lesions distributed over entire body;pt MD office indicated they have no record of an adverse rxn;
Headache, Myalgia, enlarged supraclavicular lymph node, fatigue Narrative:
vertigo; Lightheadedness; tried to stand and couldn't.; flu like symptoms; hot and cold off; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.), INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0161F21A, 013L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Pain. Concomitant products included PRAVASTATIN for Cholesterol, AMLODIPINE for Hypertension, MELOXICAM for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.), INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, VERTIGO (vertigo) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off) had not resolved and DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.   This case was linked to MOD-2021-388271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up document received on 17-NOV-2021 contains patient reported that events (vertigo, hot and cold off) are still ongoing. On 17-Nov-2021: The follow-up document received on 17-NOV-2021 contains no new information.
Abdominal and lower back pain; Abdominal and lower back pain/Major back and muscle pain; felt like a bowel movement that wouldn't happen; Constant feeling of having to pee, and very little urine; Constant feeling of having to pee, and very little urine; Nausea; Major back and muscle pain; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 27Feb2021 10:00 (Lot Number: EN6198, expiration date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported (as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. On 28Feb2021, 01:00, the patient experienced major back and muscle pain, abdominal and lower back pain, and felt like a bowel movement that wouldn't happen, had constant feeling of having to pee, and very little urine and had nausea. The patient recovered. No treatment for any events. Outcome for all events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.
Patient presented to ED on 9/27. Patient recieved booster on 9/25 of Pfizer. Patient with underlying history of MI, atherosclerosis, peripheral artery disease, RA presenting with several days of right toe pain. On physical exam patient does have ulceration to her fourth right toe.  Some surrounding erythema that does not extend into the foot.  Is very tender.  See attached picture otherwise on exam she is tachycardic. Patient was made a sepsis alert on arrival. wound does appear that it may have an infection and may be the etiology of her symptoms.  Patient was provided with ceftriaxone to cover for infectious pathogens. Patient is nonambulatory at baseline, potentially may need placement given her inability to ambulate on her own and current treatment of her cellulitis and wound infection.
Two and a half weeks after the second shot  (around September 21st) I started getting red spots on my back and back of  thighs. The spots have spread and turned dark. They do not itch nor hurt as of yet. They are predominately on my upper back legs and all over my back. A few spots are now appearing under left breast stomach region.  I called a dermatologist and my primary care physician this week. My primary care physician told me over the phone I should go to the emergency room. Since I am not in pain,  I told them an emergency clinic would be a better option.   This evening around 5:00p.m  I visited a clinic and the physician explained to me that he?s seen such skin eruptions before as a result of the Covid vaccine  but never on dark skin as of yet.  He explained that the research is limited as of now as to why some have this reaction.   The timer is running out and I am not able to finish this report, but can explain more details if needed later.
crying for 2hr where leg touched;seen in ER for purple liver leg & foot;inj site nl;
THE DAY AFTER (20 HOURS?) RECEIVING THE INJECTION THE PATIENT BROKE OUT IN A RASH ON THE SHOULDERS BACK AND CHEST.  THERE WAS NO CHEST TIGHTNESS OR SWELLING OF THE THROAT MOUTH LIPS OR TONGUE.  THE RASH FADED AWAY OVER THE COURSE OF THE NEXT 4 DAYS WITHOUT MEDICAL INTERVENTION.
This consumer spontaneous report (initial receipt: 03-NOV-2014) concerns a female patient. On 04-OCT-2014, the patient received intramuscular AFLURIA (batch number T58706) at 0.5 ml. On 07-OCT-2014, the patient developed itchy hives all over her body. The hives completely disappeared on 15-OCT-2014. The outcome was unknown (reported as recovered for the hives). Reporter comments: The reporter assessed the event as non-serious and the Causality as probable to AFLURIA.
difficulty lifting her right arm up; sore right arm 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had a high fever (up and down) for 10 days with COVID-19 infection.14 days to recover from COVID-19) on 16-Aug-2020, Physical therapy and Pain management (on her neck due to COVID-19 infection). Concurrent medical conditions included Sulfonamide allergy and Adhesive tape allergy (adhesive tape).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose). At the time of the report, LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-456401, MOD-2022-456431 (Patient Link).
Profound weakness both legs, very difficult to mobilize myself to get out of bed. With several minutes, concentration and assistance with my arms I was able to mobilize my legs and bear weight. This lasted approximately 3 days. Continued to have significant fatigue for approximately 2 weeks.
Initially fever, ring in my ears the day of the shot and day after. The day after the fever was more persistent and later in the day my stomach was unset. In the evening on the second day I developed a lose of appetite and felt a slight stomach ache. That same evening the stomach pain worsen and I threw up around 4am and again at 6am. On the morning of Oct 25th the stomach pain continued so I when to the emergency room of the Hospital. I was first given an ultra sound of my abdomen which didn't identify any issues. Next I received a CT  which identified a major blood clot in an artery. The blockage was cuting the blood supply to my bowel causing acute Ischemia. A surgery consult determined they would attempt to re-establish blood flow via Heparin  and then evaluate. Fortunately the heparin worked. remained in hospital for 4 days, discharge and now on Xarelto
Pt was feeling tired, sweating, and was pale after 15 minutes post vaccination. EpiPen was not used but an ambulance was called. While waiting he was given Gatorade and an ice pack. He laid on the ground and sat back up. Ambulance took his vitals and stated everything was normal. They concluded that he might have been nervous for the vaccine and recommended to follow up with his PCP.
Pt recvd 3 booster shots of Engerix-B & was determined to be a non-responder;
Patient stated that after vaccines he usually feels a little light headed. A few minutes after the vaccine patient stated that he felt a little fuzzy and out of it. He was not responding to any questions for a minute, however, after a minute he was interacting with us. We gave him water to drink and offered candy which he did not take. We spoke with him for 10 minutes and he felt back to normal. Patient was told to sit outside the pharmacy for 10-15 more minutes after. He felt fine after and left.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient fainted roughly 5 min after vaccine administration and became responsive again in less than a minute. She was monitored for 30 min with frequent blood pressure checks and took two glucose tablets while drinking plenty of water.
Within 24 hour of receiving Varivax booster pt developed redness and swelling from injection site on the back of her left arm to her elbow. Fever 102, no tenderness, but unable to bend elbow, symptoms clearing with another 24 hrs.
Vaccination site started to itch. By Thursday, the area surrounding the site was red and splotchy. Still itchy today (Friday following vaccination).
pt exp urticaria following the administration of tetramune; pt has been referred to allergist; no additional info available @ the time of report;
This spontaneous report as received from a consumer refers to patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was vaccinated with a dose of oral, ROTATEQ, (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. On an unknown date, the patient experienced intussusception and malaise reported as "close relative got intussusception and was very ill". The outcome of malaise and intussusception was unknown. This is a linked case with 1506USA000495 (original case) from the same reporter. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date in 2012 (reported as 3 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported) to prevent. Approximately in 2012 (reported as next two days after vaccination), the patient was awaken with "1" inch blistering circular appearance spots on her arms and legs that would dissipate within few hours. The patient reported that it was not rash. A complete diagnosis was never able to do determined as the area would dissipate before she could reach her physician's office. The patient sought medical attention. The outcome of the event was reported as recovered/resolved. The causality of the event was not reported. Additional information is not expected as the patient declined to participate in the report.
Patient had localized reaction that mother reported looked like a "welt". Mother denied any other signs and symptoms at this time. Nurse consulted Immunization Consultant. Nurse instructed mother to bring patient in to Health Department so nurse could observe reaction. Patient and mother came to Health Department at approximately 3:00 pm. At site of Varicella injection, patient's arm had developed redness, itching and approx. a quarter size area of swelling. Area of swelling was warm to touch. Nurse educated mother to take patient to urgent care so physician could assess site. Nurse asked mother to sign release at urgent care and have report of visit faxed to HD. Per report Urgent Care physician assistant treated patient by prescribing cool compresses as needed and OTC Benadryl 25-50mg PO q6hrs as needed for itching. Nurse spoke with patient's mother on Monday November 2, 2015 at 10:35 am, mother of patient reported that symptoms have resolved and no further adverse events occurred over the weekend.
Chest pain, shortness of Breath, palpitations, headache, head heaviness, fatigue, joint pains, and body pains. Previously had syncopal episode. 1/14/22 Covid-19 positive. 2/4/22 Urgent Care visit.
ITCHY RED RASH ON LEFT SIDE OF FACE.  STARTED ABOVE MY EYE THEN TO CHEEK AND NOW A BIT ON MY CHIN.  NOT PAINFUL JUST ITCHY AND ALMOST GONE BUT FOR A LITTLE ON CHIN NOW.
Fever up to 103.2, body ache, chills. Began 4am the day following the shot, fever broke around 9pm that day.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by the pharmacist in the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered.  The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).
tingling in figures of both arms on and off; injection given to her is little lower and not properly in muscle; Headache; A spontaneous report was received from a dentist concerning a 64-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle.  The patient's medical history was not provided. Concomitant medication included rosuvastatin calcium.  On 01 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle. The treatment information included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The event, injection given to her is little lower and not properly in muscle, was considered resolved on 01 Jan 2021. The outcome for the events, headache and tingling in figured of both arms, was unknown.; Reporter's Comments: This case concerns 64-year-old, female, who experienced the non-serious unexpected events of paraesthesia, a non-serious expected event of headache and incorrect route of product administration for mRNA-1273 (Lot# 011L20A). The events of paraesthesia and headache occurred 1 day after the first dose of mRNA-1273 (Lot# 011L20A). There were no reported AEs associated with this case of incorrect route of product administration. The treatment details were not provided. Based on temporal association between the use of the product and the start date of the events (paraesthesia and headache), a causal relationship cannot be excluded.
Severe aortic stenosis, NSTEMI (non-ST elevated myocardial infarction) , 1Elevated troponin, Essential hypertension. Treated for all and discharged after 3 days. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.