chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid; tested positive for covid; fever; headache; runny nose; nasal congestion; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date: Mar2021), intramuscular (injected in left upper arm ) on 20Dec2020 12:30 to 20Dec2020 12:30 at 0.3 mL for immunisation. The vaccine was administered in a hospital and not in a military facility. Medical history included birth control. The patient had no other history. NO ER or physician's office required Prior Vaccinations (within 4 weeks). Patient had no relevant family history. Concomitant medication include unspecified birth control.There was no previous immunization. Patient, who was a Respiratory therapist, got the covid vaccine on 20Dec2020 (Sunday). She first stated she doesn't have any side effects and just had a question.  Patient had COVID Symptoms on 26Dec2020 21:00 which was minimal like a runny nose. She further reports that on 26Dec2020 she started to have nasal congestion. On 27Dec2020 the nasal congestion worsened, and she started having a headache. She then experienced a 102.6 fever on 28Dec2020 (Monday). She has since tested positive for Covid on 28Dec2020 11:30. Patient asked if it was ok that she received the 2nd dose after testing positive for covid. Investigation assessment was not performed. There was no prescriber. She received at work because she was a front line healthcare worker. The patient does not have SARS-CoV2 antibodies at diagnosis but never tested for antibodies. The patient was not in the hospital, nor was admitted in ICU. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID-19.  The patient did not require the initiation of new medication or other treatment or procedure. PCR on 28Dec2020 (Saturday) Results: just detected. No units available. No reference ranges provided. Standard range was not detected. It was just detected or not detected ranges. No other test or diagnostic imaging performed. The patient had not been treated with immune modulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient was recovering from event positive for covid and runny nose; nasal congestion was not recovered and outcome of the other events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.
Received vaccines 1/23/14. 1/24 - called office arm (left upper) warm swollen itchy. 1/25 seen in office redness Left arm getting worse Diag - cellulitis - given ROCEPHIN and oral antibiotic.
diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Body aches/these symptoms worsened including vision problems; late cramps; Body aches/these symptoms worsened including vision problems; she was off work for a month; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (she was off work for a month), VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product PEGINTERFERON BETA-1A (PLEGRIDY) for an unknown indication.    Previously administered products included for Multiple sclerosis: Aubagio (Nails were thin and she was experiencing hair loss. Teriflunomide was stopped and there was improvement noted.) from 12-Aug-2016 to 01-Mar-2020. Past adverse reactions to the above products included Adverse event with Aubagio. Concurrent medical conditions included Multiple sclerosis, Restless leg syndrome (onset 2016 or 2017), Urinary urgency, Nail thinning, Ache (body aches) and Hair loss. Concomitant products included TOLTERODINE for Urinary urgency.   In March 2020, the patient started PEGINTERFERON BETA-1A (PLEGRIDY) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (she was off work for a month), VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems). The patient was treated with TERIFLUNOMIDE (AUBAGIO) (oral) ongoing from 01-May-2021 for Multiple sclerosis, Pain worsened and Vision abnormal aggravated, at a dose of 14 mg once a day and MAGNESIUM in January 2021 for Cramp, at a dose of 1 dosage form. At the time of the report, IMPAIRED WORK ABILITY (she was off work for a month) had resolved and VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems) was resolving.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Initial unsolicited report received from a non-healthcare professional on 10 November 2015. This case was linked to 2015SA182407 (same vaccine, different patient). This case involves a patient (age and gender not reported) who was vaccinated with a dose of MENACTRA and with a dose of TRUMENBA (batch number, dose, dose in series and route administration were not reported) on arm on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed migraine, swelling in the arm where the vaccination occurred, chills, pain and itchiness. Laboratory data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Patient presented to the pharmacy on 09/08/17 after receiving two vaccines in her left deltoid on 09/06/17. Patient reported experiencing some erythema, pruritis, and edema to left lower bicep, away from injection site beginning approximately 2 hours post injection. Patient did not report these signs or symptoms to her physician, pharmacy, or any healthcare provider. Patient also did not do anything to help symptoms subside. On 09/08/17 the patients symptoms included erythema, pruritis, irritation, and edema to lower bicep which patient reports has not worsened in the last day and a half. I informed the patient that the symptoms appear to be consistent with a potential allergic reaction and I recommend that the patient notify her physician and/or take some benadryl for the possible allergic reaction and ibuprofen/tylenol for any pain or discomfort. Also told the patient to apply intermittent ice packs as needed. On 09/11/17 patient reports that most of the symptoms have subsided and only mild irritation remains. Patient used benadryl, ibuprofen, and intermittent ice-packs. Patient did not consult with physician.
Uveitis; Inflammatory eye condition flared up; Flu like symptoms; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UVEITIS (Uveitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Apr-2021, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant) and EYE INFLAMMATION (Inflammatory eye condition flared up). At the time of the report, UVEITIS (Uveitis), INFLUENZA LIKE ILLNESS (Flu like symptoms) and EYE INFLAMMATION (Inflammatory eye condition flared up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient went to Ophthalmologist and confirmed her condition as Uveitis.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - 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.
On June 22, 2021 I began having pain in my lower right back underneath my armpit. Over the course of the next 24 hours, the pain worsened and I was unable to lay down, had trouble breathing and was sweating profusely. Throughout the day on June 23, I completed a telehealth and urgent care visit where I was (incorrectly) diagnosed with bronchitis. My symptoms worsened that evening and I went to the ER. After a series of tests, I was diagnosed with a pulmonary embolism (PE). I was hospitalized overnight and discharged the next evening. I had no known risk factors for PE. In August I was referred to a hematologist and went through a series of blood tests, which I will outline in the next question, over the course of three months. On November 29, I received a diagnosis of antiphospholipid syndrome (APS). I have had no history of autoimmune disorder, ongoing health issues or clotting. I wanted to report this due to the proximity to my COVID-19 vaccine.
small fiber neuropathy; severe nerve pain; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 10:00 (Lot number: EL9264) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: diagnosed about 15 years ago; "Nerve pain" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "extreme pain" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for neuralgia, start date: Oct2020; TRAMADOL taken for analgesic therapy; ATORVASTATIN taken for blood cholesterol; LOSARTAN taken for blood pressure measurement. Vaccination history included: Bnt162b2 (First dose: 11Jan2021, around 10 am, Lot: EL3249, Expiry: unknown, Anatomical location : injection in left arm), administration date: 11Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: NEURALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "severe nerve pain"; MYALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "Muscle pain"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy". No follow-up attempts are possible. No further information is expected Addition information : It was reported that patient had a reaction to the second Pfizer covid shot. Patient had such severe nerve pain and muscle pain since Feb2021. Patient would like to be able to take the booster and was afraid. Shortly thereafter Patient was diagnosed with small fiber neuropathy and does not know if it was a result of the vaccine. Nerve and muscle pain was severely exacerbated the night after the second dose and thereafter and progressively getting worse. The report was not related to a study or programme. No Investigation Assessment was done. Patient was having Other Products. Patient was taking Tramadol for a year, Atorvastatin for many years, or 15 years. Patient was not been on the same dose the whole time, Losartan for about 2 years, taking 100mg less than 2 years and Gabapentin 100mg capsule to dose, clarifies that patient was taking 300mg three times a day and now takes 400mg three times a day (300mg + 100mg three times a day). Patient was trying to figure out what is going to help pain but so far nothing is. It was not the medication that is causing. Patient had medications, and had a flu vaccine last week. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Emergency Room, Physician Office (maybe spoke to hcp). Prior Vaccinations (within 4 weeks) was none and adverse events following prior vaccinations was None. There was product complaint. No Family Medical History Relevant to adverse events. None Relevant Tests were performed.
Provider hospital summary "Patient with Tongue cancer  Metastatic cancer to cervical lymph nodes who is Gastrostomy tube dependent for nutrition developed confusion and hypoxia.     Active Problems: It was felt this might be Sepsis with metabolic encephalopathy.  The hypoxia appeared to be due to Pneumonia due to COVID-19 virus as she was COVID positive.  Other possible sources of sepsis considered,  E. coli UTI (urinary tract infection) and had positive blood cultures.  One culture with staph epi. which was considered likely contaminant but the another culture grew actintignum schaalii which can be a uropathogen, usually responsive to beta lactams.  There was also some concern for a superimposed bacterial pneumonia. She has completed a course of PIPERACILLIN-TAZOBACTAM which was then discontinued.  She was noted to have a an increasing leukocytosis even after discontinuing the DECADRON that was started for the COVID infection.  She also completed a course of REMDESIVIR.   She remained afebrile but had tachycardia at rest. Patient had no respiratory symptoms such as cough or pleuritic chest pain. She did not require supplemental oxygen. She did not appear acutely ill.  Considered ultrasound for deep venous thrombosis of lower extremities but had no edema or calve tenderness.She had some loose stools but testing for C. Difficile was negative.  Ordered computed tomography angiogram of chest which was negative for pulmonary embolism, noting, "Patchy density throughout the right lung compatible with infiltrates." The patient was anxious to leave the hospital and did not appear acutely ill so she prescribed AMOXICILLIN-CLAVULANATE for seven days and she was requested to have a follow up blood count in 3-5 days through her primary care provider"
in bed for almost 2 weeks with the flu; Initial information received on 04-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-Health Care Professional.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer (with dose, strength, expiry date, lot number not reported) via subcutaneous route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious flu and was in bed for almost 2 weeks (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown.
Patient was given a PNEUMOVAX shot (presumably in her R deltoid by pharmacy staff) on 6/27/2017 and presented to the care clinic in the same pharmacy on 6/29/2017 for swelling, redness and itching in R arm. The patient's VS were stable though the dependent tissue below her R tricep was erythematous, edematous and appears to have some nonblanching areas of capillary pooling. Area was marked with a pen. She did not have pain or fever. No treatment was given. Advised her to monitor and return to clinic or PCP the following day to check for progression of area.
Chronic Parasthesia (burning skin, numbness, pins and needles, feeling like bugs crawling on skin
right hand swelled and both feet and ankles; right hand swelled and both feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunisation. Medical history included COVID through the end of Oct and Nov020. The patient's concomitant medications were not reported. The patient stated that her hospital would like for her to receive the Pfizer vaccine and she was told that it would boost her antibodies. She received the COVID vaccine on Friday, 18Dec2020. Afterwards, on an unspecified day in Dec2020, her right hand swelled and both feet and ankles. She called the nurse and was instructed to take Benadryl. She took the Benadryl for two days and then called her family practice physician who prescribed her a prednisone pack which helped with the swelling. The patient would like to know if she should receive the second shot, how effective the first dose would be if she doesn't receive the second shot, and what the interval is for the second dose of the Covid vaccine. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Systemic inflammation.  Deep in my hip, the iliacus muscle is completely inflamed and spasmed after the second shot. This also affects my psoas to a lesser degree and 2 adductor muscles to a greater degree - the brevis and pectineus.  I have not been able to sit down for more than 10 minutes since the shot, if I do my leg and hip go into spasm, lock up, I can't move and literally will fall out of a chair.
A few minutes after vaccination, patient said she needed to sit down. She sat on the floor and her mom grabbed her. She went unconscious for a few minutes. She was uninjured. We gave her water and chocolate and she was okay in 10 minutes.
I woke up in the middle of the night to an ache in upper left arm with itching. On examination  I saw a slightly raised red welt about 3 inches in diameter. i went back to sleep and in the morning woke with slight body aches and lethargy, welt on arm still there. My temperature has been low grade (99.2) . Still feeling lousy and arm is still inflamed.
Extreme fatigue, achy joints on injection arm, swollen lymph node in neck and arm pit on same side as injection site, nausea, red swollen rash at injection site that is itchy, hot to touch, and painful.
US Venous Doppler LLE 4/19/21 showed occlusive thrombus within the left popliteal vein, thrombus seen within a branch of the posterior tibial vein proximally.  Started on Xarelto (anticoagulation)
Within 24 hours of administration of vaccines child had a febrile seizure with a temperature of 103 F.
Child's mother reports 3 to 4 hours after reciving immunizations yesterday, child started running fever ranging from 99 to 101, Child very fussy and cranky.  Mother states child is crying like she is in pain.  This morning child is still running fever ranging from 99 to 101 and mother reports fever is not relieved by infant Tylenol.  States fever does go down after Tylenol dose but rebounds to 101 again.  Child started having diarrhea stools last evening and mother reports child has had seven diarrhea stools this morning.  Time is now 09:30 A.M.  At 10:30 A.M. childs mother again calls health department reporting child's inner thighs are red and swollen and diaper area is bright red.  Child remains very fussy.  Mother is instructed to take child to her physician or to an emergency room for evaluation.
HE CAME TO ONE OF OUR OFF SITE CLINICS. OUR STAFF REACHED OUT FOR US TO VERIFY THAT SHE NEEDED ANOTHER VACCINE.  TURNS OUT, HE RECIEVED 2 DIFFERENT MANUFACTURES, TOO SOON.  HE IS AWARE HIS SERIES IS COMPLETE MODERNA WAS GIVEIN ON 6/22/21