chrisvoncsefalvay/vaers-outcomes huggingface dataset:
68-year-old male with past medical history of AFib previously on warfarin therapy, hypertension, hyperlipidemia, BPH, and history subdural hematoma (SDH) previously on Keppra, who presents to the ER wife his wife and uncle due to a 1 day history of difficulty walking and AMS.  Patient was previously found to have large  SDH w/ 6 mm R to L shift,  2 months ago.  Neurosurgery was consulted and patient  was taken to the OR for burr holes and evacuation of SDH due to brain compression.  Patient was discharged  to encompass and received Keppra for 1 month.  Patient's son was contacted today and states the patient has been home for 1 month, since Dec 2021, and has been working with home health care who come to the patient's house 2 times per week. Last week, the patient's home health nurse tested positive for COVID-19. On Tuesday, the patient developed bad cough and became immobile (restricted in movement), and was not able to get up or use his walker.  Patient Son and the patient's nurse became concerned about patient's recent decline in physical mobility, so the patient was brought to the ER by his wife and Uncle for further evaluation.  In the ER the patient tested positive COVID and CT scan of his head was shown to have a subdural hematoma that had increasing in size since his previous scan.  Patient is currently AOx1.  Complains of recent blurry vision, headache, and difficulty walking.  Patient states he has had a stroke in the past which left him with mild left-sided weakness.  Denies chest pain, SOB, fever chills, nausea, vomiting, numbness and tingling.  Of note:  Patient has stopped taking Coumadin 2 months ago, after the surgery.  Patient has received both COVID vaccine and booster.  Patient lives at home receives  help from Home Health care 2x's per week, as well as assistance from patient son, spouse and family.  Patient's son states that POA is shared between patient is son, daughter, and patient's wife. Baseline: Takes meds, walks with walker and gait belt, AOx3 with slight confusion, requires assistance with eating; diet: solids, heart healthy. PT CONTINUES TO BE INPATIENT AT THIS TIME.
Immediate whole body severe sweating, eye pupils extremely dilated, skin color and lips became very pale, dizziness, disorientation, tremor in the hands, thirst, a bit of nausea, fainting . No treatment received except for ice pack. Neither doctor or nurse was present on the site.
Pt got dizzy after Gardasil injection.  Given ammonia pellet and juice, rested in clinic for 20 minutes.  Left alerted and oriented.  BP  100/60 Pulse 66 Resp 16 even and unlabored.
On 10/14/21 the resident had a change of condition and was unresponsive.  He was pale and lethargic.  He had hypoxia and sats were 58% and supplemental oxygen was increased.  Resident was transferred to the ER.  The resident was treated at the hospital for pulmonary infiltrates, cellulitis LUE, aspiration pneumonia, hypokalemia, hypomagnesis.
Body aches, headache, back pain, chest discomfort, fever, dizziness and fatigue.
24 hours after vaccine was given in the right deltoid Mom noticed it was red then the following day arm was warm to touch, had increased redness to the elbow 15x12 cm.  Patient had no complaint of pain only some itching.  MD prescribed Benadryl.  MD felt it was a local reaction.
jerks or myoclonus-like symptoms; Initial information regarding an unsolicited valid serious case was received from a other health care professional via Information via call-Center (Reference number- 00344462) and transmitted to Sanofi on 03-Nov-2020.  This case involves 41-year-old female patient who experienced jerks or myoclonus-like symptoms (dyskinesia), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing anxiety, depression and hypothyroidism.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious jerks or myoclonus-like symptoms (dyskinesia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.   This event was assessed as medically significant.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for dyskinesia.  Batch number has been requested for suspect product for this case.; Sender's Comments: A 41-years-old female patient who presented with dyskinesia following the vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (HTN, Improved) since 2014, GERD (GERD, Controlled) and Hyperlipidemia. Concomitant products included AMLODIPINE from 2022 to an unknown date and EZETIMIBE, SIMVASTATIN (VYTORIN) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was H 25 MGCTZ and start date of Amlodipine was on 02-2022. The patient ethnicity were reported as Hispanic or Latino and not Hispanic or Latino and allergy reported as no known drug allergies. Patient did not diagnosed or tested positive with COVID-19. The treatment information was unknown.
Swelling of body, feet, hands, legs, fever, full body ache, kidneys inflamed, hurts to move, throat sore, hurts to try and talk, severe head ache, pale, can't keep food down, don't want to eat. Knots and arm turn white at injection site.
Patient reports onset of diarrhea on 11/6/2019.  She had 4 loose stools.
Patient called 7/14/2021 to report that on 7/9/2021 at 11PM he experienced heaviness in chest and trouble breathing that lasted 24-25 hours and went away. Stated he did not go to the hospital or talk to his PCP.
I experienced a breakthrough case of COVID-19 with sneezing, nasal congestion, fatigue, fever and chills.
Narrative:  08/04/2021 Patient received Pfizer COVID dose #1 at non-affiliated site, reports experiencing Patient c/o chest pain (described as pressure sensation with heaviness), sob (feeling as if he has to take an extra deep breath and is conscious of needing to take deep breath) and cold sweats since 10 minutes after receiving first pfizer vaccine on Aug 4th at a pharmacy. States was given benadryl x 2 while at the pharmacy which did not help. Called ambulance yesterday due to intense pain and "pounding out of my chest" with difficulty breathing. Evaluated by ED and advised to f/u with cardiology. Patient states "My heart feels like it's too big and heavy." EKG/lab work with chest x-ray. Evaluation was unrevealing. He was recommended to have cardiology consult. Echo and CT chest WNL 08/27/21 Pt reports continued "chest pressure with sweating, light headedness, really feeling incapacitated"
cold; shivering; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever) outcome was unknown.            Concomitant: Inhaler for asthma No treatment information was provided   This case was linked to MOD-2021-341921 (Patient Link).
Broke out in red blisters on breast 3 days after vaccine, not itchy. Following day blisters resolving. Next  day blisters gone, just red spots.
Depression, anxiety, tinnitus, sore throat loss of taste, earache, cough, rash, fatigue, joint pain, loss of concentration and memory, headache, sleep disturbance, chest tightness, palpitations, nausea, decreased appetite
Vaccines given 8-18-09-reaction started 8/19/09-to outer aspect of Rt arm-red, swollen, measured 11 cm x 12 cm induration. Patient instructed to use warm packs on arm. Area marked by NP with black marker. Patient returned to clinic 8-20-09. Marked decrease in swelling. Returned 8-21-09 prescribed KEFLEX. Returned to clinic 8-24-09, reaction resolved.
Information has been received from a physician referring to a 70 year old female patient with "allergies, hypertension, asthma and hypothyroidism". The patient had no known drug allergies. On 03-SEP-2018 at 14:00, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, batch/lot # and expiration date were not reported) for prophylaxis at an unspecified Pharmacy. On 04-SEP-2018, the patient went to the Emergency Room "with systemic chills, malaise, nausea, the injection site was swollen 12 1/2x7 cm, and was red and hot". The patient received BENADRYL, calamine (manufacturer unknown), and KEFLEX at the Emergency Room. On 06-SEP-2018 the patient was seen in physician's office and "seemed to be better" (the outcome of the events considered to be recovering). The causality between the events and PNEUMOVAX 23 was not reported.
patient was given 1 cc dose instead of 0.5 cc dose pt was monitored 15 mins with no adverse reaction pt was called 3 days after to monitor symptoms, left message for pt
Low blood pressure. Low platelet count (lowest recorded value 13). Weak energy. Tired/lethargic.
vaccinated with an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Follow up received: No new information was received.
Pt was a total hip arthroplasty pt that had been admitted since 2/3.  He complained of some shortness of breath and was tested for COVID prior to discharge and was COVID positive.
Headache chills muscle aches started in the morning after injection. Had to leave work and come home. Pain redness swelling with hard knot injection site. Headache and dizziness persisted 2 days.
Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This is Report 1 of 2. A 52-years-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: EW0179, expiration date: unknown), via an unspecified route of administration, administered in right upper arm on 20May2021 as 2nd dose, single dose; and previously took first dose of BNT162B2(Lot number: EW0172), via an unspecified route of administration, administered in left upper arm on 29Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Depression diagnosed at 4 years old as he was adopted and everything, and had Previously heart attack on 23Oct2003, high cholesterol, and a finger cut off. Patient states it was work related and accidental, he put his hand in the wrong spot, the actuator came down, and took his finger off. States that was years ago, they were able to stitch it back on. Patient reported him and his wife are allergic to cottonwood and he don't know what treatment to take. Patient also reported after forty there is two things that happen, one you start losing your memory, and second you can not remember the other one, and that is exactly what happened to him. Concomitant medications included FLUOXETINE, 40 mg, 2 capsules once a day, every morning, he thinks he takes for cholesterol; ATORVASTATIN, 20 mg daily, he thinks he takes for depression; AMITRIPTYLINE HCL, 25 mg. Takes 3 at night which helps him sleep; LISINOPRIL, 20 mg tablet once daily, taken for an unspecified indication; since 1.5 years and start and stop date of all concomitant medications were not reported. No prior Vaccinations within 4 weeks of vaccination. The patient on an unknown date in May2021, woke up in the middle of the night, he was experiencing restlessness, and not really chest pain, almost like a shoulder pain, up in the shoulder, not like a heart attack or anything and chest pain in the upper right chest which is bearable, but annoying. Patient stated pain comes and goes. Chest pain is still persisting, and started about 2-3 days of second vaccination and has not improved, it is still steady, a burning sensation, and always in the upper right shoulder, above the male breast, up above that, up in the clavicle. The patient underwent lab tests and procedures which included blood cholesterol: only two points up. No investigation assessment. No Emergency Room or Physician Office visits. The outcome of chest pain in the upper right chest was not recovered, upper right shoulder pain was recovering; restlessness and burning sensation was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Pt had redness, swelling, warmth, on upper 1/3 of right thigh. On site rxn to DtaP with  cellulitis. Ceclor liquid TID x 10 days. Warm compresses. To recheck in one week.
Patient was given vaccine around 10:00 am and developed nausea, diarrhea and vomiting in the afternoon. Those symptoms resolved by the next morning.
Severe rash left axilla, right and left groin. Treated with IV prednisone and pain medicine. Hospitalized overnight beginning 48 hrs after vaccine administration.
Patient reports experiencing pain, significant swelling (injection site down to elbow), and redness at injection site the next morning following the vaccination. The area was hot to the touch and patient recorded temperatures of 99.3 that first morning following the vaccination and 99.1 on the second day. Patient reported no systemic temperature, only hot at injection site. Patient noted that it took approximately 3 days for the swelling to subside and several more days before pain resolved.
Fever ranging 101.5-105 for six days. Behavioral changes. Red dotted rash then turned into red raised bumps on body. Sores on throat and mouth. Behavior changes. Drooling. Paleness. Weakness. Lethargic. Rapid breathing. Rapid pulse.
COVID arm - swelling, pain, heat and redness (4 inches by 3 inches) about 7 days after vaccine.  It is not 13 days after my vaccine and the redness, swelling, heat and pain are dissipating.
Sever muscle aches and joint pain, headache radiating down into neck 6/10, sore throat, pain at injection site
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2007 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
This spontaneous report was received from a physician, concerning a female nursing student of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unspecified, patient received in childhood first and second dose of MMR II, (Lot number, expiration date, dose and route were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, after antibody titers were determined to be low for measles, the student received an additional dose of MMR II. After 2-3 months, the antibody titers for measles were found to still be low. An additional dose of MMR II was then administered to student but measles antibody titers did not respond and were still low. The patient sought medication attention (unknown type). At the time of the report, the patient had not recovered from measles antibody test low. The relatedness between measles antibody titers low and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Shaking chills, generalized fatigue, body aches, headache. Took 1500mg Tylenol every 6 hours with relief of chills only. Completely resolved in about 15 hours.
Fever, cold chills, restless sleep, redness at site of injection, right leg soreness-unable to stand on that leg, loss of appetite, moodiness/crying.  After 12 hours of injection
ACHES; DIDN'T SLEEP; TIRED; CHILLS; FEVER; BAD HEADACHE; EYES FELT HEAVY; HOT AND BURNING MOUTH; HOT AND BURNING IN THROAT; BURNING OF EYES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included mild arthritis. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced eyes felt heavy. On 08-APR-2021, the subject experienced hot and burning mouth. On 08-APR-2021, the subject experienced hot and burning in throat. On 08-APR-2021, the subject experienced burning of eyes. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 98.6 unit not reported, 101.6 F. Treatment medications included: ibuprofen. On 09-APR-2021, the subject experienced aches. On 09-APR-2021, the subject experienced didn't sleep. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes felt heavy, hot and burning mouth, hot and burning in throat, burning of eyes, didn't sleep, chills, and fever on 10-APR-2021, had not recovered from bad headache, and tired, and the outcome of aches was not reported. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-FEB-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
16 year old patient received Moderna vaccine due to facility error, Moderna not currently covered under EUA for anyone under the age of 18. Patient reported no adverse reaction or outcome.
Severe Hives/Rash and itchiness. Started slow and isolated and then expanded each day until my entire body was covered including hands and feet. Lasted for a few days and then my entire face swelled. On steroids and antihistamine for weeks until it mostly but not completely went away. Still isolated itching, especially overnight (4 weeks after it began).
(L) arm redness needle mark (grey) evaluated by PCP no diagnosis, no prescribed medication for (L) arm area. Area is still effected.
This spontaneous report was received from a registered nurse refers to a 21 year old female patient with lightheadedness after injection or when blood is drawn. Patient did not have known allergies. On 22-DEC-2014 the patient was vaccinated with an expired dose of GARDASIL lot # 0131AE, expiration date: 26-OCT-2014, dose 1, 0.5 ml, intramuscular in the left arm. There were no concomitant medication. On 22-DEC-2014 experienced lightheadedness after vaccine was administered. The reporter stated that the patient always experience lightheadedness when she get an injection or blood drawn. The patient was monitored and she was given a glass of water. Patient did not receive any treatment for the adverse event. There were no laboratory diagnostics performed. The outcome of lightheadedness was reported as recovered/resolved on 22-DEC-2014. Additional information is not expected due to the reporter did not want to be contacted again.
received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was diagnosed with Covid on 10Jan2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 10Jan2021. She has been back to work on 25Jan2021 and was currently Covid free. The outcome of events was unknown. She was scheduled to take the second dose of the vaccine on 26Jan2021 and wanted to know if she can receive it or would need to wait considering her situation. Filing potential AE report for review.  Lot and batch number has been requested.