chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palpitations; fever; Sinus Tachycardia; high chloride 108; high glucose; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: EL9266, Expiration Date: 31May2021) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; Lot: EL9266 and Expiry: 31May2021; administered in arm), administration date: 16Mar2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset 2021, outcome "unknown", described as "myocarditis"; PALPITATIONS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "palpitations"; PYREXIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "fever"; SINUS TACHYCARDIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "Sinus Tachycardia"; BLOOD CHLORIDE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high chloride 108"; BLOOD GLUCOSE INCREASED (non-serious) with onset 08Apr2021, outcome "unknown", described as "high glucose". The events "palpitations" and "fever" were evaluated at the emergency room visit. Course of events: He got both doses of Pfizer vaccine and developed palpitations, fever, and went to the ER. EKG was completed and showed Sinus Tachycardia, a heart rate of 123 bpm with an incomplete bundle branch block, an abnormal EKG; it is possible that patient developed myocarditis relative to the Pfizer Covid-19 Vaccine.  The patient underwent the following laboratory tests and procedures: blood chloride: (08Apr2021) 108, notes: high; blood glucose: (08Apr2021) high, notes: Glucose; brain natriuretic peptide: (unspecified date) unknown result; electrocardiogram: (unspecified date) abnormal; (Oct2020) unknown result; (08Apr2021) ventricular rate 123 bpm, notes: ECG abnormal; (08Apr2021) atrial rate 123 bpm, notes: ECG abnormal; (08Apr2021) p-r interval 152 ms, notes: ECG abnormal; (08Apr2021) qrs duration 94 ms, notes: ECG abnormal; (08Apr2021) qt 320 ms, notes: ECG abnormal; (08Apr2021) qtc 458 ms, notes: ECG abnormal; (08Apr2021) p axis 40 degrees, notes: ECG abnormal; (08Apr2021) r axis 15 degrees, notes: ECG abnormal; (08Apr2021) t axis 21 degrees, notes: ECG abnormal; (08Apr2021) sinus tachycardia, notes: ECG abnormal; (08Apr2021) incomplete right bundle branch block, notes: ECG abnormal; full blood count: (unspecified date) unknown result; heart rate: (unspecified date) 123 bpm; troponin: (unspecified date) unknown result; x-ray: (08Apr2021) no acute pulmonary abnormality.  No follow-up attempts are possible. No further information is expected.
Presented with lethargy, dec appetite;  +Covid test; also dx with GI bleed  Labs: normal; Tx: antibiotics & PPI; remained on room air
Minimum bone pain; Had cramps on that same arm( right one); Felt the pain of the needle on her arm; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Minimum bone pain), MUSCLE SPASMS (Had cramps on that same arm( right one)) and VACCINATION SITE PAIN (Felt the pain of the needle on her arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Felt the pain of the needle on her arm). On 06-Feb-2021, the patient experienced BONE PAIN (Minimum bone pain) and MUSCLE SPASMS (Had cramps on that same arm( right one)). On 05-Feb-2021, VACCINATION SITE PAIN (Felt the pain of the needle on her arm) had resolved. On 06-Feb-2021, BONE PAIN (Minimum bone pain) and MUSCLE SPASMS (Had cramps on that same arm( right one)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant medication included blood pressure medications.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067366 (E2B Linked Report). This case was linked to MOD-2021-067366 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067366:
Tinnitus started day after injection and continues 2 weeks later but possibly lessening over time. I had odd symptoms (excess saliva, teeth chattering lightly) for 6 weeks following my 2nd Moderna. Think all of it inflammatory reaction.
30-second syncopal episode and urinary incontinence while seated--3 minutes after injection. Did not fall or hit head. Regained consciousness without intervention. BP, pulse and respirations wnl.  Positive for diaphoresis. Negative for swelling and shortness of breath. Recovered in 20 minutes and was able to leave clinic site. Provided water and cookies. Employer activated their emergency response system.
Patient is 55 years old and presented to the emergency department for evaluation of chest discomfort.  He said yesterday he was doing minimal work he was on the back of his truck and drinking when he felt his heart racing and some chest tightness and he was short of breath.  He was seen black-and-white he thought he was going to pass out.  He sat down and it was ongoing for 45 minutes to roughly an hour.  He did mention some right shoulder discomfort.  He was seen in the emergency department.  His EKG showed sinus rhythm ST depressions noted but no ST elevations were seen.  His initial troponin was 19 in the subsequent troponin was 105.4.  By the time he was in the ER he was completely symptom-free.  Overnight he has not had any chest discomfort either.  He had mentioned that over the last 1 month going up a flight of stairs he would be short of breath.  He has had always some chest tightness going on for years and he did not notice any worsening.  He had mentioned also that over the last few weeks they have been working up a soft tissue mass in the right upper neck and even had recent MRI of the chest which was otherwise unremarkable.  In the emergency department CT of the brain was performed which was essentially unremarkable.  CTA of the chest was also performed which showed no evidence of acute pulmonary embolism.  No coronary artery calcification.   Risk factor assessment for CAD He states he has hypercholesterolemia has been on medicines for 30 years At one point was hypertensive but diet controlled He was a smoker but quit 20 years ago There is a family history and a brother had a myocardial infarction at 45 years old.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a solicited report from a non-contactable consumer (patient) based on the information received by Pfizer from a company (Mfr. Control No.: 21K-163-4052598-00).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) as dose 2, single; and dose 1 intramuscular on 02Feb2021 (at the age of 74years) as dose 1, single for Covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On 31Jul2021, the patient experienced Covid-19 virus test positive. The outcome of events was unknown.  The reporter's assessment of the causal relationship of the events with BNT162B2 was reported as possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Client C/O itchiness at injection site and left index finger. Full body assessment done, ice pack provided, 3 sets of vital signs done.  At 2:56 pm client took Benadryl 25 mg, p.o.  At 3:20pm client denied any itchiness, no acute distress, leave vaccination site at with daughter and mother. Provided client with education to be alert to any respiratory issues and seek 911 if in respiratory distress.
Pain at injection site, feeling faint, nauseated, injury to right shoulder, X-rays, MRI, decreased range of motion, inability to use arm to push, pull or lift; trouble sleeping, depression, bursitis, tendonitis, rotator cuff tear; physical therapy, cortisone shot, likely surgery will be needed.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, concentration and Lot number not reported). On an unknown date, the patient experienced shingles in the T-10 dermatome on the right flank. The outcome of shingles was unknown. Relatedness between shingles and ZOSTAVAX was not reported. The physician was unable to obtain a sample from the patient for VZVIP (Varicella Zoster Virus Identification Program). Additional information has been requested.
Fingers on left hand numb; Cold; Tingling; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 13:45 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), narcolepsy, aneurysm cerebral, penicillin allergy and COVID-19; all from unknown dates. Concomitant medication were not reported. The patient previously received gentamicin (MANUFACTURER UNKNOWN) on an unknown date for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 07:00, the patient woke up morning after with fingers on left hand numb, tingling and cold. It was unknown if the patient received any therapeutic measures for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fingers on left hand numb, tingling and cold were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
have a rash; has burning like an allergic reaction; has burning like an allergic reaction; has some discomfort from her thighs; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 at 10:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Covid-19 vaccine first dose:, Manufacturer: Pfizer, NDC: Unknown, Lot: EL8982, Expiration: Unknown , Dose given: Unknown, Location: left arm, Time: afternoon, Location given: Civic Center), administration date: 27Jan2021, when the patient was 76-year-old, for COVID-19 immunization; covid-19 vaccine (Covid-19 vaccine second dose:, Manufacturer: Unknown, NDC: Unknown, Lot: EL9264, Expiration: Unknown, Dose given: Unknown, Anatomical Location: Left arm  , Location given: Civic Center , Time: Afternoon around 2:30), administration date: 17Feb2021, when the patient was 76-year-old, for COVID-19 immunization; covid-19 vaccine (Covid-19 vaccine third dose:, Manufacturer: Unknown, NDC: Unknown, Lot: FF2593, Expiration: Unknown, Anatomical Location: Left arm, Time given: Afternoon , Dose given: Unknown, Location given: (Pharmacy name) 17115), administration date: 04Nov2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: BURNING SENSATION (medically significant), HYPERSENSITIVITY (medically significant) all with onset 10May2022, outcome "unknown" and all described as "has burning like an allergic reaction"; DISCOMFORT (medically significant) with onset 10May2022, outcome "unknown", described as "has some discomfort from her thighs"; RASH (medically significant) with onset 10May2022, outcome "unknown", described as "have a rash"; PRURITUS (medically significant) with onset 10May2022, outcome "unknown", described as "itching". Therapeutic measures were taken as a result of rash, burning sensation, hypersensitivity, discomfort, pruritus.   Additional Information: It was reported that She said she seems to have a rash.  She said she has burning like an allergic reaction. Event date: started about 15 to 20 minutes ago.  She had the vaccination about 10:30 this morning on 10May2022.  She took some Benadryl and applied some lidocaine to her face and arms.  She said her symptoms doesn't seem to have worsened but has calmed down but she has some discomfort from her thighs.  She never had this before.  She said this was her fourth vaccine and no problems with the other vaccines. She said symptoms seem to be calming down.   Follow-Up (13May2022): Follow-up attempts are completed. No further information is expected.
Patient described symptoms of very painful, red and itching at the injection site. She also stated that the itching went down her upper arm a little bit. Patient was advised to take benadryl for itching, ibuprofen and/or a cold compress for the pain and inflammation.
Constant headache on (R) side of face started 1-2 weeks after vaccinations with double vision in (R) eye shortly after. Continues to have double vision & headache (R) side. No treatment done, just testing continues - Carotid doppler pending.
Found down - day after vaccination.  Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment.  Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia.  Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday.  On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia.  After several phone calls, her sister went to pt's home and found pt on her bedroom floor.  There was   some blood found, not sure from where.  Sisiter was unable to get pt up so EMS was called and pt was taken to ED.  She was evaluated, her BP was very elevated, she was admitted and testing was done.  Head CT/MRI was unchanged.  X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.
ACUTE NON ST ELEVATION MI 2/12/2023 BILAT CATARACT ACUTE RESPIRATORY FAILURE 2/12/2023 BILAT CATARACT ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/12/2023 BILAT CATARACT RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/13/2023 BILAT CATARACT
Loss of feeling in left leg, bruises rotating on left leg, arthritis flare up in right hand (swollen middle finger) restless
Information has been received from a certified medical assistant concerning a 65 year old male with hypertension, emphysema and hyperlipidaemia and "no known drug allergies" who in 2005 was vaccinated IM with the first 0.5ml dose of PNEUMOVAX 23 (Lot number was unknown). On 28-SEP-2010 the patient was vaccinated IM in his left arm with the second dose of PNEUMOVAX 23 (Lot number 667913/1021Z, expiration date 27-FEB-2012). During the same visit the patient were administered a flu vaccine (manufacturer unknown) in his left arm and Tdap in his right arm. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. On 30-SEP-2010 the patient experienced fever of 99F and swelling of his left arm after administration of his second dose of PNEUMOVAX 23 intramuscularly in his left arm on 28-SEP-2010. He also experienced redness and warmth of his left arm. The patient sought medical attention by office visit. The patient was prescribed OMNICEF. No lab diagnostics studies was performed. At the time of reporting, the patient was recovered (date unknown). Information has been received from medical records and a medical assistant concerning a 65 year old male ex-smoker (90phy, quit in 05), with alcohol use (one drink per day) who in 2005 was vaccinated with PNEUMOVAX 23 (lot # unknown) for the first time. On 31OCT08 the pt was vaccinated for the second time with PNEUMOVAX 23 (lot number unknown). On 28SEP10 he was vaccinated with PNEUMOVAX 23 (lot number unknown) (left deltoid), FLUVIRIN (Novartis, Lot #111807P1, exp 30APR2011) (left deltoid) and ADACEL (Sanofi Pasteur, lot # unknown) (right deltoid). The next day the patient had flu like symptoms, including nausea and joint and muscular pain, that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time 30SEP2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm and forearm and other vaccines and biological substances causing adverse effects in therapeutic use. The pt was to elevate and rest his arm, take ibuprofen 400-600 mg q 6hr prn for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested he take off from work the following day, but the patient did not want to. He was also prescribed OMNICEF 300mg one capsule bid for 10 days. It was reported the patient had recovered by 05OCT2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. This is one of several reports received from the same source. This is an amended report. Vaccinated at: private doctor/hospital and vaccine purchased with: Unknown were added to Therapy. All available medical records will be provided upon request. Additional information is not expected.
Patient described being diagnosed with a Graft vs. Host disease of viral etiology and requires treatment with Prograf. She described onset as a few months after her Shingles vaccine.
Moderna 1/27/21, 2/22/21, 10/28/21. Positive on 11/27/22
Pt with intussusception on 2/18/08. For which she underwent surgery.  03/14/2008 MR received for DOS 2/17-20/2008 with D/C DX: Intussusception.  Infant presented to ER with irritability and crying. Barium enema (+) for IS but unable to fully reduce.  Pt had an Exploratory Lap with manual reduction of Intussusception and appendectomy. Pt taking po well and d/c on POD#3.
Patient reports itchy arm and redness at site of injection. Had a welt the size of a baseball 8 days after administration. Discussed treatment with provider and has taken Benadryl to help with symptoms.
worst seizure; This is a spontaneous report from a non-contactable consumer (patient parent).  A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206 and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 17Mar2021 10:30 at single dose for covid-19 immunisation. The patient's medical history included catamenial epilepsy has been taking 1000 mg Keppra twice daily to help control seizures. The shortest duration between seizures was approximately 1 month, and that was before her epilepsy diagnosis and starting on the Keppra. Additionally, patient's medical history included ADHD. The patient was not pregnant at time of vaccination. The patient's concomitant medications included levetiracetam (KEPPRA) for catamenial epilepsy at 1000 mg, 2x/day,  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and unspecified medication. On 27Mar2021 08:30, the patient experienced her worst seizure ever.  Also reported as suffered a cluster of seizures which is atypical for her. Last night the reporter read an article about some women starting their periods after years of not having it soon after receiving the Covid vaccine, so I looked back at my daughter's seizure record and noticed a potential link. Treatment included increased her Keppra dosage to 1250 mg. The event caused the patient for physician office visit. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
(R) arm cellulitis. KEFLEX, BENADRYL & cool compresses.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-MAY-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 20-DEC-2014 and two more bouts of shingles on 23-FEB-2017 and 09-MAR-2018 respectively. The outcome of the events is unknown. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak, shingles, and shingles were considered to be disabling. Additional information has been requested.
Orthostatic hypotension 10 min after H1N1 vaccine 11:15 resulted in new syncope. Initial pulse 60 after laying supine B/P 80/60 11:16 B/P 122/70 p-78 @ 11:20 - Pt remained supine for 20 min. was given 15 oz O.J. VS: orthostatic.