chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 11Oct2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; LEXAPRO; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Product: COVID 19 Treatment; (13Jan2023) Negative, notes: She tested negative 2 days after her last dose of paxlovid; (Jan2023) Positive, notes: her symptoms returned and once again she tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023.  Clinical course: The patient tested negative 2 days after her last dose of paxlovid. 3 days following her negative test her symptoms returned and once again she tested positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
atrial fibrillation; hyperthyroidism; This is a literature report.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; HYPERTHYROIDISM (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Negative; Echocardiogram: showed an ejection fraction of 65% with borderline, notes: left ventricular hypertrophy and mild left atrial dilation; Electrocardiogram ambulatory: revealed paroxysmal atrial fibrillation; Heart rate: 160s to 170, notes: Units: beats/min  elevated; laboratory results: An autoimmune response was suspected against the, notes: thyroid gland, confirmed by laboratory results.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
01/22/2021 I had a burning sensation through my heart before the needle was taken out. I slept like the dead for about 12 hours which is uncommon. The next I could not lift my arm and I had a huge welt of about 4" around at the injections site, it was raised, hot and it hurt like a mother and it was still there 2+ weeks after and it was still quite painful. I woke up to a headache, nausea, lymph nodes in left side arm pit enlarged. I had some joint pain and continued fatigue and tiredness for about four days and I saw my naturopath and she gave me supplement SP Cleanse to remove toxins. I took that like 4 times per day and I started to feeling a little better every day. The arm was still sore almost to the time of my second vaccine.
Information has been received from a physician and father of the patient concerning a 4 year old female who on 17-AUG-2010 was vaccinated with a dose of MMR II in the right deltoid. There was no concomitant medication. 10 days later on 27-AUG-2010 the patient developed swelling and discoloration in both ankles. Little tenderness/pain was noted. The patient was brought to the emergency room where labs (serum C-reactive protein test, complete blood cell count, erythrocyte sedimentation rate) were analyzed and all were negative. This presentation persisted. Additional information has been requested.
Fever, chills, severe body aches, fatigue, weakness. 4 days later, severe neck spasms.
Pain at injection site (upper right arm), hardness and swelling at and around injection site in 3" diameter (similar to size and shape of smallpox vaccine scar), pain in right armpit and inside of upper right arm, profound fatigue.
Lightheaded/ Dizziness; Chest Heaviness/ lungs pressure/ lung heaviness; Headache; began to have a washing feeling; This case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   Co-suspect products included AFLURIA for prophylaxis.   Previously administered products included Flu vaccine (never had reaction with previous flu vaccines).   On 18th September 2019, the patient received the 1st dose of Shingrix and the 1st dose of AFLURIA .5 ml. On 18th September 2019, 20 min after receiving Shingrix, the patient experienced light headedness, chest heaviness, headache and feeling abnormal. On 18th September 2019, the outcome of the light headedness, chest heaviness, headache and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the light headedness, chest heaviness, headache and feeling abnormal to be related to Shingrix.  Additional case details were provided as follows: The patient reported the adverse events experienced by herself. The patient received Shingrix and on the same day received a yearly flu vaccine in right gluteus medius. Following vaccination she got into driving and approximately 20 min later, she began to have a washing feeling which she described as a feeling that was rising upwards and enveloping her head, washing over her.  The patient then began to feel lightheaded and dizzy and thought to pull over and find somewhere to park. She arrived to where she needed to be.  She also described her chest and lungs felt heavy and described it as a feeling of knowing exactly where her lungs were similar to if they were outlined on paper due to heaviness feeling.  She did not have shortness of breath or difficulty breathing but described heavy and prominent feeling of her lungs.  The patient stated, lightheaded and dizziness lasted approximately 30 minutes to an hour, chest and lung heaviness approximately 15 to 30 minutes, but the headache lingered around a little longer after an hour but was not bad. The patient consented to follow up.  She stated, she would call back to provide batch number and expiry date of Shingrix vaccine and confirm name and possibly manufacturer of co-suspect flu vaccine and she provided details.
ARM SWELLED, TURNED VERY RED, HOT AND HARD FROM SHOULDER TO ELBOW LASTED ABOUT 2 FULL DAYS BEFORE IT STARTED TO RESOLVE
Child developed injection site itching and pain with facial swelling the evening after recieving the HPV/Gardasil vaccine, dose 2.  No wheezing, shortness of breath or tongue swelling. No history of food, drug or environmental allergies.  Mother administered Tylenol and Benadryl and was seen in the office 5/31/12.
almost fell on the floor; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone. This case involves a child of unknown gender patient who almost fell on the floor (presyncope) when received vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious almost fell on the floor (presyncope) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (presyncope).  There will be no information available on the batch number for this case.
Red ring on arm; Arm soreness; Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching). At the time of the report, ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not  provided. Laboratory details were not provided.  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.   Reporter did not allow further contact; 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.
Mom reports that 10-20 minutes after imms given that the baby developed rash on cheeks. Over the course of 3 hrs the "rash" changed from red spots, to red bumps & then finally the bumps "scabbed over like tiny chicken pox. Imms given at 1200 pm rash had scabbed over by 4pm. No anaphylaxis.
approx 28-36hrs p/DTP pt became hypotonic/unresponsive x 1-2 hrs; parent gave a bath; pt improved but was still acting strange; was fine next day;
sick; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site. with unknown formulation, strength, batch number & expiry date for prophylactic vaccination. Batch number was requested.  On an unknown date the patient developed sick (malaise) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Client received CanSino COVID vaccine, no reaction. CanSino vaccine not approved by World Health Organization, Pfizer dose number 1 given as an alternative on 09/23/21.
Significant increase to existing shoulder arthritis in shoulder of vaccinated arm causing inability to sleep, work. Combination of several OTC medications (Naprosyn, otc lidocaine topical, another tooical) and hot and cold compresses lessened pain. Pain subsided after 4-5 days of other treatments
Patient began with tingling in her foot on 2/23, her hands then progressing to have a funny feeling. Mother called in on 2/25 to report a facial palsy.  By 2/28 she was more fatigued, and moving slower. She was then seen at Hospital and diagnosed with Guillain Barre syndrome. Symptoms began 14 days after HPV Vaccine.
Developed chicken-pox rash after 1 dose of varicella vax on 10/21. Rash extended to trunk, back, legs & arms. Employee did not require hospitalization.
Knee pain; Fingers swelling/pain; Fingers swelling/pain; Cramps in left leg; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 11:45 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, metabolic myopathy and depression. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); fluticasone propionate (FLONASE); duloxetine; paracetamol (TYLENOL); and CBD (unspecified). No other vaccine in four weeks. No Covid prior vaccination nor tested Covid post vaccination. On 02Mar2021 15:00, the patient experienced knee pain, fingers swelling/pain, and cramps in left leg after 30 min of walking. The patient received no treatment for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 14 month old female with failure to thrive and possible immunodeficiency who on approx. 1/16/01, was vaccinated with MMR II. On approx. 1/23/01, the pt experienced encephalitis, seizures and immune deficiency (that could have possibly been present prior to vaccination). The encephalitis, seizures and immune deficiency required hospitalization. At the time of the report (2/6/01), a spinal tap was pending. The pt's hospitalization continued and the pt was noted to be in poor condition. Additional information has been requested. Follow-up states the pt has died.
Pericarditis; Pain in their chest; shallow breathing; Fever; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Molluscum contagiosum ('triamcinolone acetonide'  as treatment) since 02-Apr-2021. Concomitant products included EZETIMIBE, PANTOPRAZOLE, IBUPROFEN and COLCHICINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 11-May-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Pain in their chest). 11-May-2021, the patient experienced HYPOPNOEA (shallow breathing). The patient was hospitalized on 11-May-2021 due to PERICARDITIS. The patient was treated with MORPHINE for Pain prophylaxis, at an unspecified dose and frequency and OXYCODONE for Shallow breathing, at an unspecified dose and frequency. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PERICARDITIS (Pericarditis), CHEST PAIN (Pain in their chest), HYPOPNOEA (shallow breathing), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Treatment medications included morphine and oxycodone.  Company comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot # 037b21a) with AEs of Pericarditis, Chest pain, Hypopnoea, Pyrexia and Chills 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.   This case was linked to MOD-2021-177226 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot # 037b21a) with AEs of Pericarditis, Chest pain, Hypopnoea, Pyrexia and Chills 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.
Round red patch below injection site.   Slight chills first 8 hours.    Sensitive to touch and  Warm .  3 days later,  site began to itch.
Pt passed out, pt was cool, clammy, dizzy, had jerking type movement. Pt was seen by dr before discharge. Juice given to pt, cool compress placed on pt.
Mom started with pain in her left ankle less than 24 hours after receiving the vaccine. The pain made its way up her leg and after 3 phone calls to 911over the course of 6 days she finally agreed to go to the hospital. These severe leg spasms would last for 3 hours and she had them about 4 times a day. She would state her pain level was a 20. She was admitted to the hospital and the Drs said due to the severe pain her BP was highly elevated and she was in congestive heart failure. She spent 2 weeks in the hospital. Went into A-fib. The spasms stopped exactly 2 weeks after they started but at that point she was so weak from being in bed that they wanted to discharge her to a rehab facility but she would have needed her second vaccine and it wasnt time yet( plus she refused because all her issues seemed to stem from the first vaccine). Or she would have to be in complete quarantine for 14 days and she was hard od hearing and that would not have been good either. So we brought her home for myseld and my sister to care for her. She was independent before this vaccine and needed complete care when she got home. She was home for 6 days and progressivly got worse each day and we had to put her on hospice on the 6 day and she passed that night.
Woke up very early on Sunday with a headache, fever, nausea, and muscle soreness. Got out of bed around 12PM on Sunday, ate, drank a lot of water, and took ibuprofen.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   It was reported that within an hour of vaccination, the patient got COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain, which was not the usual joint achiness. It was reported patient was a very typical case. It was reported the disease had lasted 2 years and the patient was in horrible shape, and his state was worse at the time of reporting . The patient was being treated with a specialist.  No treatment medications were provided. Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced unexpected serious (medically significant) event of Polymyalgia rheumatica which occurred in context of receiving a dose of mRNA-1273 vaccine, which was the patient's unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact vaccination date unknown and exact event onset date unknown, however based on provided information it has started within an hour of vaccination and lasted for 2 years. Event has started with excruciating pain, which was not the usual arthralgia. It was provided that during these 2 years the patient was in horrible shape, and his state was worse at the time of reporting. Further details regarding clinical course and symptoms, concomitant medications and concurrent diseases, accompanying circumstances with potential alternative causalities, etiologic and diagnostic work up with treatment details are not available in the report. Event's outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Just the pain in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just the pain in the arm). At the time of the report, PAIN IN EXTREMITY (Just the pain in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided. No treatment medication was provided. In any of the shots patient had just pain in the arm.