chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ENTIRE BODY SORENESS; CHILLS; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 06-APR-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 APR-2021, the subject experienced entire body soreness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the entire body soreness, chills and slight fever was not reported. This report was non-serious.
TIGHTENING OF THROAT, DIZZINESS, RAPID HEARTBEAT, NAUSEA
PCV 13 administered on 4/27 in L arm. Mom returned to clinic 4/30 to have labs drawn. L arm noted to have large, red area around where PCV 13 was given ~ 3 1/2" wide x 3" tall - tender, warm and induration. H1N1 administered on 4/27 in R arm. Small red area ~ 1/2"x1/2" with 2 or 3 pinpoint raised bumps in center. No tenderness or itching. Not warm or tender today (was yesterday).
Migraine. Abdominal pain. Menstrual bleeding. Crhamps. Colic.
bumps on roof of mouth; Tender swollen gums; Tender swollen gums; heart was racing; tender bumps at the roof of the mouth behind her front teeth; itchy and tender 2 inch circle at the injection site; 2 inch circle at the injection site; chills; fever; hands, arms, face and eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth), ERYTHEMA (hands, arms, face and eyes were red), GINGIVAL PAIN (Tender swollen gums) and GINGIVAL SWELLING (Tender swollen gums) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive on 18-Dec-2020.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Jan-2021, the patient experienced ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever). On 17-Jan-2021, the patient experienced PALPITATIONS (heart was racing), ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site). On an unknown date, the patient experienced GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums), ORAL DISORDER (bumps on roof of mouth) and VACCINATION SITE RASH (2 inch circle at the injection site). On 15-Jan-2021, ERYTHEMA (hands, arms, face and eyes were red), CHILLS (chills) and PYREXIA (fever) had resolved. On 17-Jan-2021, PALPITATIONS (heart was racing) had resolved. On 20-Jan-2021, ORAL PAIN (tender bumps at the roof of the mouth behind her front teeth) and VACCINATION SITE PRURITUS (itchy and tender 2 inch circle at the injection site) had resolved. At the time of the report, GINGIVAL PAIN (Tender swollen gums), GINGIVAL SWELLING (Tender swollen gums) and VACCINATION SITE RASH (2 inch circle at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.2-102 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
ACHE IN LEFT ARM AND PAIN RUNNING DOWN TO LEFT ARM; SORE ARM AT INJECTION SITE; REDUCED SLEEP; This spontaneous report received from a patient via a company representative concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included bisacodyl, and docusate sodium. On JUL-2021, the subject experienced reduced sleep. On JUL-2021, the subject experienced sore arm at injection site. On 08-JUL-2021, the subject experienced ache in left arm and pain running down to left arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache in left arm and pain running down to left arm, and sore arm at injection site, and the outcome of reduced sleep was not reported. This report was non-serious.
Left medial deltoid pain-left scalene pain. Left cervical rotation pain. Very apparent neck stiffness started Sunday (11-1-09) AM and has not resolved yet.
death; A spontaneous report was received from a HCP concerning about a 86 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history was not reported. Concomitant medications were not reported.  On 05 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026A21A) via intramuscular in left deltoid for prophylaxis of COVID-19 infection.  On 06 Mar 2021 the patient died next day after vaccination, who left quite well after vaccination from the facility, the reason for death is not known.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event is not applicable.  The outcomes of all the event is not applicable.; Reporter's Comments: This is a case of death in a 86 years old female patient, with unknown past medical hx or current co morbid conditions and concomitant medications, who died one day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
FATIGUE; This spontaneous report received from a vaccine facility via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious.
Stents were placed at the LAD, RDA and the circumflex artery; Heart attack, at hospital 31-MAR-2022 to 2-APR-2022; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537Z, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st October 2021 with batch number 5P9DR and expiry date 20th March 2023).   On 5th January 2022, the patient received the 2nd dose of Shingrix. On 31st March 2022, 85 days after receiving Shingrix, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced stent placement (serious criteria hospitalization). On an unknown date, the outcome of the heart attack and stent placement were unknown.   The reporter considered the heart attack to be related to Shingrix. It was unknown if the reporter considered the stent placement to be related to Shingrix.     Additional Information: GSK receipt date: 13-Apr-2022 Reporter's comment: The patient stated that she had a full workup of her heart last year in July 2021 and she had no issues at the time. The patient received 2 doses of Shingrix prior to discovery of heart attack.  On 31st March 2022, heart attack was discovered, when patient was getting a physical at her doctor's office. The patient was hospitalized on 2 separate occasions from 31st March 2022 to 2nd April 2022 and from 7th April 2022 to 8th April 2022 for placement of 3 stents.  Stents were placed at the LAD, RDA and the circumflex artery.  The patient reported never had any heart issues prior to receiving Shingrix and believed vaccine attributed to heart attack based upon that fact.  The patient reported having results, to support having no previous symptoms or evidence of heart disease/issues.  The patient reported clinic did not perform screening, so they (the patient) would have to provide those results. The reporter consented to follow up with healthcare professional. The reporter did not consent to follow-up.
Back pain from the bottom to the neck, arm pain (more on the right side), leg pain (more on the right side), body sickness, headache (not severe), dizziness, a little nausea and a little stomach ache. I went to the emergency room on 04/15/2021 at 2:51 p.m. I had a laboratory and CT scan prescribed Naproxen 500 and Soma 350mg but until now I still have pain.
She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Patient started itching all over within an hour after receiving a shot of Adacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who experienced itching all over within an hour after receiving a shot of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5560A, expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious itching all over within an hour after receiving a shot of Adacel (Pruritus generalised) within an hour following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests included were not reported.  Final diagnosis was Pruritus generalised.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported.  List of documents held by sender: none.
Local area, 3 inches in diameter flushed and warm, tender to touch on left thigh.
Patient received PNEUMOVAX 23 vaccine in LD and influenza high dose vaccine in RD on 11/13.  On 11/15, patient called office stating "left arm swollen and warm to touch". Patient returned to office complaining of swollen arm, watery eyes, and rash.  Denied SOB, itching, chest pain, abdominal pain, vomiting, or wheezing. Patient stated reaction started on evening of 11/13. Patient noted to have mild redness of proximal left UE, around biceps area. Moderate swelling of upper arm to elbow, no evidence of cellulitis". Patient prescribed cetirizine and diphenhydramine.
Within 1-2 hours I developed migraine, then the injection site erythema, 2nd day all started. Severe pain in left arm NOT at injection site but more medially but nothing there. By 6pm driving home, was febrile, had shaking chills, couldn't keep my eyes open and the L. arm pain was so bad that I had to open and close my car door with the right. At 1:30am was woken up when I rolled on my left arm with sharp pain and that's when I noticed blisters, 2 big ones which confluenced into one HUGE and painful one and numerous small ones. Large one burst when I tried to cover it to go to pharmacy and see the pharmacist, mainly serous fluid drained.  Now area looks like 2nd degree burn and painful. W/ 1st shingrix felt like I had the flu and was in bed for 3 days. Never had a problem w/ Zostovax.
Redness and induration noted to where varicella and meningococcal vaccine was given. Area warm to the touch. No trouble breathing, SOB or other systemic reactions noted.
Intermittent chest pains since 3/24/03.  Has not seen physician yet.  Taking Aciphex & Plendil.  If no improvement, will seek medical attention.
Pt received a full adult (0.5mL) dose of Moderna instead of the pediatric Pfizer vaccine.
mom states approx 1 hr p/vax pt began to cry & hold leg; cont to cry abn cry throughout the noc, sometimes holding head, didn't behave usual self; t100, sl edematous & red approx 1.25 cm in size rt VL;
On March 6, 2021 when I received my first injection of the Pfizer Covid vaccine, I immediately began to feel sick about 5 minutes afterwards. I had instant dizziness, flush feeling, tired, weak and a little nauseated.  When I got home I immediately laid down because I felt like I was going to pass out. I slept the rest of the day. Those exact symptoms lasted from March 6, 2021- March 13th, 2021. They began to dissipate the evening of the 13th. I thought all the symptoms were gone but I began urinating blood on March 18, 2021 and I haven't stopped as of yet. I have had constant kidney paid, leg soreness and cramping, dizziness, low blood pressure, chronic pain in my hands and feet, constant fatigue, intermittent headaches, loss of weight, loss of appetite, pain with urination due to the blood. I had a hysterectomy in 2016 so this is not an issue of a heavy period, I no longer have a uterus.
pt states nausea, fatigue, chilled, lt upper outer arm became swollen, erythemic, warm/hot to touch w/a quarter size blister in erythemic area;T98.6;
Patient reported pain and swelling in left arm within 5 hours from the shoulder to the elbow. Within 24 hours she reported that it became discolored and bruised on the inside and outside of her arm.
Patient c/o tingling in mouth/tongue approximately 15 mins after receiving vaccination.  No difficulty breathing/SOB/difficulty swallowing.  B/P 132/70 HR 80 Resp 16  Medicated with 25mg PO Benadryl
off and on fatigue/ very slight  off and on chest tightness thru out the day
Stroke any medication with sulfa causes her a problem so she doesn't take it, she can't have certain antibiotics such as keflex because of an adverse reaction following catching Cdif in hospital and must be prescribed other antibiotics, she gets a cough from certain heart medications which she does not take, raw onion upsets her stomach, dairy causes her to have a nose bleed
Cellulitis aggravated; Back pain; This is a solicited report from an unspecified marketing program received from a contactable consumer. A 67-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis and moderate to severe chronic plaque psoriasis. Medical history included cellulitis from an unknown date. The patient's concomitant medications were not reported.  The patient experienced cellulitis aggravated and back pain. The action taken in response to the events for bnt162b2 adalimumab was unknown. The event back pain was not recovered and unknown outcome for the event Cellulitis aggravated. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Follow-up attempts are possible; information about lot/batch number not available.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Extensive itchy rash over entire trunk, back and front, including around legs at pubic area.; feeling of unwellness.; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 14:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient medical history included COVID-19 and rash after the first shingles vaccine. The patient did not receive any medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient had extensive itchy rash over entire trunk, back and front, including around legs at pubic area and accompanied by slight feeling of unwellness. It was reported that no treatment measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of extensive itchy rash and feeling of unwellness was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sinus infection, fever, headache, difficulty breathing that led to a brief bout of asthma, coughing that lasted for 6-8 weeks.
Hot a lot; Feeling nausea; Slight elevation in temperature; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot a lot), NAUSEA (Feeling nausea) and PYREXIA (Slight elevation in temperature) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hot a lot), NAUSEA (Feeling nausea) and PYREXIA (Slight elevation in temperature). At the time of the report, FEELING HOT (Hot a lot), NAUSEA (Feeling nausea) and PYREXIA (Slight elevation in temperature) outcome was unknown.            It was reported that the patient was taking other unknown concominant medications which were not provided. Patient stated that on 04/05 Jul-021, she was near someone who is not vaccinated, that had just been out of the hospital. About 4 or 5 days she been feeling nausea, hot a lot, and a slight elevation in temperature. She is wondering if she had a breakthrough. No treatment information was provided.
he "feels heated up, on the inside" from the waist up; This is a spontaneous report from a contactable consumer (spouse). An-82-year-old male patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown), via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan 2021, the patient experienced he "feels heated up, on the inside" from the waist up. The patient did not report fever.  The outcome of the event was unknown.  Information on lot number/batch number was requested.