chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OPTIC NEURITIS; Blurred Vision; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OPTIC NEURITIS (OPTIC NEURITIS) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OPTIC NEURITIS (OPTIC NEURITIS) (seriousness criterion medically significant) and VISION BLURRED (Blurred Vision). At the time of the report, OPTIC NEURITIS (OPTIC NEURITIS) outcome was unknown and VISION BLURRED (Blurred Vision) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: optic neuritis (abnormal) Vaccine triggered Optic Neuritis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product details was not reported.  Treatment details was not reported.  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.  Further information has been requested.; 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.  Further information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of seizure in a male patient who received Hepatitis B vaccine. Concurrent medical conditions included eczema nummular (Discoid eczema), allergic reaction to antibiotics (Neomycin allergy) and rubber sensitivity. On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, less than a day after receiving Hepatitis B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. The reporter considered the seizure to be possibly related to Hepatitis B vaccine. Additional details were provided as follows: This case was previously reported to a doctor. The reporter was the patient's father. The age at vaccination was not reported, but the patient could be 12 or 13 years old. The reporter stated that in 2001, the patient received a Hepatitis B vaccine and experienced a seizure within two hours of getting the vaccination. The reporter was unable to provide any additional information and did not know the name of the product administered. The patient had denied permission to contact their physician.
Shaking episodes, started with slight jerking of her arms. Rapid eye blinking and shoulder shrugging, then whole body jerking.
Significant flare up of psoriasis and psoriatic arthritis initially, followed by extreme fatigue, hair loss, oral sores, blurry vision, overal malaise. Dr visit on May 14, 2021- Topical steroid prescribed, blood work for autoimmune work up. Prescribed Colchicine for possible Bechet?s Disease. Blood work returned showing high fasting glucose level of over 240 on May  26,2021. No history of high glucose levels prior, no family history of diabetes.
Information has been received from a physician concerning a 21 year old female who was vaccinated with a first dose of GARDASIL vaccine. Subsequently, the patient developed generalized body aches, swollen lips and a temperature of 100 which lasted 1-2 days. Additional information has been requested. It was reported that her sister had an experience following vaccination with GARDASIL vaccine (WAES # 0710USA00753). This is in follow-up to report (s) previously submitted on 11/14/2007). Initial and follow up information has been received from a physician and a nurse practitioner, concerning a 21 year old female student, who on 30-AUG-2007, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Subsequently the student developed generalised body aches (date not specified), and on 02-SEP-2009, she devolped swollen lips, swollen eyes, and a fever of 100 degrees. The patient visited the physician or emergency room. Treatment included TYLENOL. The physician noted the symptoms lasted for 1-2 days, but the NP reported that on 04-SEP-2007 ("Tuesday"), the swelling had "decreased." The NP added that the patient's sister had developed "mono" during this time, however the patient tested negative for mono. At the time of this report, the patient had recovered from the events. Additional information is not expected. It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0710USA00753).
This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with RECOMBIVAX HB (dose and route not provided). The reporter stated an unspecified number of patients may have received doses RECOMBIVAX HB (dose in series unspecified) that were exposed to 25 F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source. Additional information has been requested, since can contact the physician.
Tingling down affected arm (LT). Numbness on top of arm and hand. Slight swelling of lymph nodes LT side of neck. Woozy sensation.
phantom smells of cigarette smoke; sore arm; hot flashes; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced a sore arm for a couple of days. On an unknown date in Apr2021, within 24 hours of vaccination, the patient experienced hot flashes and chills. On 17Apr2021, 12 days after the vaccination, the patient experienced phantom smells of cigarette smoke many times in a day. It was reported that no one in the patient's house smokes and this had been going on for at least a week. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, hot flashes, chills and phantom smells of cigarette smoke was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment (26Aug2021): This follow-up report is being submitted to amend previously reported information: Patient's initial added in patient tab. Narrative updated.
sore arm next day; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 18:15 (Lot :EN9581) at single dose for COVID-19 immunisation. Medical history included hepatitis b chronic from 05Sep2002 , high blood pressure from 25Jan1995 , late effect of cardioembolic stroke from 14Jan2005 , nerve entrapment of hand ,neuroma hand from  10Jan2006 , diabetes type 2 without retinopathy from 20Dec2006 , atrial fibrillation from 23Aug2007 , coronary artery disease from 01May2009 , depression from 06Mar2010 , left heart failure from 29Apr2013 , slow heart rate from 18Apr2014 and bradycardia  from 27Apr2014, duodenal ulcer from Apr1997, gallstone and acute cholecystitis with obstruction from 27Jul2016, clotting or bleeding disorder (coagulopathy) from 27Jul2016, lipoma (fatty mass) from 27Aug2016, moderate chronic kidney (disease) from 16Sep2017, left ventricular (hypertrophy) from 16Sep2017, Chronic low back pain with lumbar radiculopathy from 16Jan2019 and lumbar disc herniation with radiculopathy from 17Jan2019, iliac artery aneurysm (left and right) from 27Feb2019, right iliopsoas bursitis from 26Mar2018, Benign prostatic hyperplasia from 11Apr2018, Arthritis of (right and left hand) from 17Apr2018. Concomitant medications included warfarin; entecavir; metoprolol; losartan; bupropion; glipizide; metformin; diltiazem hydrochloride (DILT-XR); atorvastatin, all were ongoing. Patient felt sore arm next day on 28Jan2021. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient received covid-19 pfizer bivalent booster today around 8:46 am in the left arm. A couple minutes later, patient developed a tingling sensation on left side of body. It feels as though there are ants crawling underneath her skin. It started by left underarm and has spread throughout left side of body. The sensation level as remained the same. Patient is also experiencing itchiness of the left side. Denies pain, shortness of breath, tongue swelling, rash, chest pain, feeling warm, and change in vision. Patient stated for previous covid injections, she did not have any reactions.   RN spoke with DO who prescribed patient benadryl and prednisone for 3 days. Patient to take and monitor symptoms. Dr. advised patient to wait in lobby until symptoms resolve.    RN informed patient scripts were sent to pharmacy next door and to wait in lobby until symptoms resolve. Patient stated she was called in to work (which is from home) and cannot stay. RN walked with patient to pharmacy, waited for prescriptions to be filled, and walked patient out. RN advised patient with any change in symptoms, to call office or seek medical attention. Patient verbalized understanding.
Patient left office after getting vaccinated and passed out near the elevator.  She quickly came to and Mom brought her back into the office.
Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficulty getting up from a sitting position.  Missed work on week 3.  Worsened each week until that point.  Improves with rest but worse after on feet more.  Extreme exhaustion.  Some chest pressure started on week 2
COLD LIKE SYMPTOMS; FUNNY TASTE IN MOUTH; SORE THROAT; SLEEPY; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included ruptured disc in back, and concurrent conditions included high blood pressure, seasonal allergies, fluid retention, and sulfa allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced cold like symptoms. On 08-MAR-2021, the subject experienced funny taste in mouth. On 08-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy on 08-MAR-2021, and had not recovered from cold like symptoms, funny taste in mouth, and sore throat. This report was non-serious.
Tinnitus increased from mild/barely noticeable to very noticeable in both ears, with the left ear being louder.
Patient developed chest tightness, shortness of breath, diaphoresis, muscle soreness, subjective fever after receiving the vaccine.  He presented to the hospital and was found to have elevated troponin and ST elevation in inferolateral leads on EKG.  He subsequently had an urgent cardiac angiogram that showed clean coronary arteries.
hx of Hypertension, dyslipidemia, hypothyroid Sx onset 2 weeks ago. nonproductive cough, shortness of breath, nasal congestion, sweats, chills and fever of 101 patient was hypoxic with a po2 of 56  patient also had severe sepsis
83-year-old man comes to an appointment for skin condition - rash. He is currently not on any medications. He does have some swelling in his ankles and a previous years-older history of swelling on his knee. He is diagnosed with scleroderma for the first time and also given his first COVID vaccine, lot #EN6207 on 3/17/21.  He comes back for a return appointment and check up on 4/7/21 and receives his second dose of COVID vaccine, lot #EW015D on 4/7/21. As the months go forward his skin rashes increase, his ankles become more swollen and he has increasingly more difficulty upon swallowing food without large amounts of mucus needing to be coughed up soon afterwards, often bringing some or most of his food back up. This mucus accumulation problem continues, worsening through the months which causes and large amount of weight loss. He visited his doctor around July or August 2021 about the problem. They want to check his heart even though it is made clear that he has a swallowing and mucus problem. He completes a stress test and is scheduled for an angiogram. He schedules with a GI doctor to get an endoscopy to help understand the swallowing and mucus issues as this issues is currently the most distressing and he is losing more weight each week. It is cancelled by the heart doctor until the angiogram takes place. He has a lung evaluation that indicates that his lungs have a lot of scar tissue. He smoked for 20 years, 40 years ago and never had any known pulmonary issues to date. He sees a new doctor regarding the heart angiogram and it is completed - 4 areas where stents could be helpful are recommended but the new heart doctor says he needs to be able to swallow a blood thinner for a few months first so schedules the endoscopy. The endoscopy takes place, no cancerous cells noted and they stretch his esophagus in at least one place. Initially the swallowing is improved but soon, more mucus and difficulty swallowing resumes. He is scheduled for heart stents as his doctor suggests. His ankles and feet are increasingly swollen with pitting edema. His cough is productive but getting weaker and more strained, his weight is dangerously low at 155 for a 6'1" man. He is on a water pill and blood thinners. Just a few days before stent surgery is to be done, he passes away as he wakes in the morning in bed after a night of labored breathing. He was tested 2 times for COVID in the recent months before his passing and both were negative.
8 days after vaccine, arm broke out in a rash. Swollen tender to touch.
muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of the throat; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included has ongoing allergies and has to take an "allergy pill" every day for this condition, diabetes and hypothyroidism. Concomitant medication included levothyroxine, ertugliflozin pidolate (STEGLATRO), loratadine, montelukast, metformin, atorvastatin, lisinopril, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), dulaglutide (TRULICITY) and ongoing allergy pill. She reported that she received her vaccine in a mass Covid vaccination. The reporter stated that she developed muscle pain in her arm where she received the injection, which she states that she understands this is a commonly reported side effect. She also developed a cough, hoarseness in her voice, and noticed that the cough was worse when she went to bed. She mentioned that her cough started on Wednesday, she felt like it was little bit worse on last night (unspecified date), than it was on Saturday, so she means it was only Sunday after that [pending clarification]. The reporter was heard clearing her throat multiple times on the phone during the conversation. She would like to know if the cough, hoarseness and clearing of the throat are commonly reported symptoms. The patient was informed that the injection side pain was reported last on average between 1-3 days. Per the EUA Prescribing Information, "Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days" and that we did not have information on how long her mild respiratory symptoms may last and referred her to her HCP. The patient was encouraged to contact her healthcare professional if her symptoms did not go away or if they became worrisome and she verbalized understanding. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood work showed normal on 15Jan2021. The outcome of the event cough was not recovered while the outcome of the other events was unknown.  Information about Batch/Lot number has been requested.
Irregular menstrual spotting. I have never ever had a single issue with this my entire life, over 38 years.
felt fainting / lightheadedness; stiff neck; back pain; dry mouth; heart palpitation; weak; tingling of limbs; shortness of breath; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 27Feb2021 at 15:45 (Batch/Lot Number: EN 6205) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks were taken. The patient experienced stiff neck, back pain, felt fainting, weak, dry mouth, heart palpitation, tingling of limbs, shortness of breath, chest tightness, lightheadedness on 05Mar2021. The patient had covid tests PCR (Nasal Swab) in Apr2020, May2021 and 20Aug2021 were negative. No treatment received for the events. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Patient had dizziness. BP 134/97 -- > 117/71, HR 50 -- > 57, RR 18 -- > 16, O2 100%. Patient stable, released from vaccination site.
Lymph node pumped up on the side of the neck; This is a spontaneous case initially received from nurse on 03-Dec-2018, concerning a 51-year-old, adult, female patient.  On an unknown date in past, the patient was administered Tdap vaccination and had exact same reaction (lymph node pumped up on the side of the neck). The patient was not taking any concomitant medications.  On 30-Nov-2018, the patient was administered Afluria TIV [Influenza vaccine, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YT38006, expiry date: 30-Nov-2019) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On 01-Dec-2018, 1 day after vaccination, the patient's lymph node pumped up on the side of neck. The patient did not receive any treatment of the event. The patient was better after 2-3 weeks as the major swelling decreased significantly. As of 09-Jan-2019, the patient felt better, but still had minor swelling of the lymph node.  The outcome of the event was recovering.  The reporter assessed the events as non-serious.  Follow up information was received by a other health professional (nurse) on 09-Jan-2019: Secondary reporter details were added in the general tab. It was confirmed that the reporter did not give permission to contact the patient, hence no patient contact information was available. The outcome of the event (lymph node pumped up on the side of the neck) was changed from not recovered to recovering. The narrative was amended accordingly.  Non-significant follow-up received from other heath professional (nurse) on 12-Feb-2019: It was reported that T-dap was not a concomitant medication and no further information was available regarding the T-Dap vaccine. Reference number (info number:SEQ19-00703) was added in the additional information tab. No changes were made in the narrative.  Case re-opened for completion of full data entry: 12-Feb-2019.; Reporter's Comments: A 51-year-old female patient experienced lymph node enlargement one day after administration of Afluria TIV. The company assessed the causality of the event as related to the suspect vaccine, due to plausible temporal relationship between event and suspect vaccine.
numbness in fingers and hands on the right side where she received the vaccine,; Arm was extremely sore; bad headache; This is a spontaneous report from a contactable consumer, the patient.  A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, yesterday evening, on 21Feb2021, she developed numbness in fingers and hands on the right side where she received the vaccine, and one of her fingers felt like rubber, basically had no control over it. On an unspecified date in Feb2021, her arm was extremely sore and she had a bad headache all day, laid down early. She reported that she could not pick up phone in the middle of the night. The outcome of the events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Information was received from a physician via a company representative concerning an unspecified patient who was "greater than 65 years old." Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot number, dosage, and route of administration not provided). The physician reported that at an unspecified time after the patient received PNEUMOVAX 23, the patient developed "a large lump, swelling and redness at injection site that got worse" (clarifying information not provided). The patient was seen at an emergency room on an unspecified date in regards to the reaction and was given unspecified steroids as treatment.  It was not specified if the patient was admitted to the hospital. The patient recovered from the large lump, swelling and redness at injection site. Causality was not assessed by the reporter. Additional information has been requested.
Patient completed her moderna vaccination series on 3/16 and 4/13. On 7/5 he presented to the hospital with 3 days of fever, dyspnea on exertion and generalized weakness after returning from another country, two weeks prior and tested positive for COVID on presentation. He was initially admitted because of an oxygen saturation of 90% on room air. He remained on room air and was treated with supportive care and discharged on 7/8.
Patient was treated for intussusception on 11/8/07.  02/26/2008 MR received for DOS 11/08-09/2007 with D/C DX:  Intussusception. Infant presented to ER with projectile vomiting, fussiness, drawing up of the legs, and decreased UO.  In ER had bloody stool and RUQ pain.  Reduced by Air Enema. Following reduction, pt tolerated po and d/c next day.