chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tonic-clonic seizure-like activity which occurred once an hour period (6 or 7 times), lasting only 5-10 seconds. Occurred during a fever of at least 102F (R).
Patient apparently was at health this morning at her nursing home.  Suddenly  in the morning she was noted to have difficulty speaking along with weakness hand her left extremity.  EMS was called patient reached the ER.  Was not found to be eligible for tPA. She recently tested positive for covid and was recovering in her nursing home. Per reporting she was supposed to come out of isolation today. Nursing home has been contacted to fax the reports. Patient is able to comprehend speech having slurring while answering questions. She reports frustration, reports mouth is dry and would like to drink. She reports she had difficulty hearing and now seeing and can not speak and it is frustrating. She is not able to answer much as voice is not clear. CT of the head showing penumbra suspected  inferomedially in the left temporal region and subthalamic region.  No core  infraction demonstrated.  CT angio in neck showing 50% to 60% stenosis in the  left carotid bulb and 60% to 70% stenosis in the right carotid bulb.  No  aneurysms.  Further imaging also showing a small focus of hyperdensity in the  left subinsular region, small vessel ischemic and lacunar change.  Patient  admitted for cerebrovascular accident, not a candidate for tPA because patient  is anticoagulated and there is concern of questionable bleeding on CT.  MRI  suggestive of left cerebellar stroke, left middle cerebral peduncle.  Patient  has symptoms.  Patient was started on aspirin 325 mg per Neurology consulted.   Neurology reviewed images, questionable punctate left cerebral late subacute  ischemic stroke.  Per Neurology, not able to clearly identify ischemic stroke  on the MRI, can be an artifact or late subacute tiny stroke. Patient improved  in terms of motor strength.  Did have an elevated INR and warfarin was held  during admission.  Per pharmacy protocol plan to restart warfarin now 1.5 mg  tomorrow.  Will check INR.  No concerns for swallow problems.  Patient  tolerating pureed nectar thick liquid diet.  PT/OT evaluated the patient.   Plan to discharge for acute rehab at nursing home.  Patient will be discharged  on atorvastatin and continued with warfarin on a lower dosage due to elevated  INR. Discharged on 9/24/21
Cellulitis from immunization- most likely DTaP. Treated with Keflex for 10 days. Follow up appt scheduled 2/20/04.
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine.  The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
1/29/22 pt to ED with c/o Chest pain that started today; has had SOB, non-productive cough, intermittent fever and chills for up to 1 wk; found to be positive for COVID in ED; started on BiPAP due to acute respiratory failure; EKG showed changes, STEMI; TNK given, dexamethasone and remdesivir given; sent to cardiac catherization lab; stent placed; transferred to ICU; later pt had asystole; code blue and ACLS protocol followed with good results; pt expired in the hospital
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatments were reported.
MEDI-003745 is not a serious spontaneous case from a consumer or other non health professional involving elevated blood glucose (unlabelled). The reporter causality is not provided to FluMist. A medical assistant from a physician's office reported that a 7 year old male, with history of new onset juvenile diabetes, experienced elevated blood glucose levels ranging from 300-500 mg/dl, 2 days after receiving FluMist vaccine on 05Oct05. Per the reporter, the patient's mother has since brought the patient to his pediatric endocrinologist for management of the elevated blood glucose. The patient is also receiving insulin (dosage and frequency not specified). He has not recovered. The reporter causality is not provided.
MOTHER STATES THAT SYMPTOMS BEGAN THAT NIGHT.  MOTHER REPORTS THAT CHILD HAD A FEVER OF 101 AND WAS VERY SWEATY.  MOTHER REPORTS GIVING CHILD TYLENOL, AND THAT IT IS HELPING WITH THE FEVER.  MOTHER REPORTS THAT THE CHILD HAS BEEN SAYING HIS LEGS HURT, HASN'T BEEN RUNNING AROUND AS MUCH, AND THAT THE CHILDS FEET/ANKLELS SEEM SWOLLEN.  NURSE INFORMED MOTHER THAT SYMPTOMS, ASIDE FROM SWELLING OF FEET/ANKELS, WERE NORMAL.  NURSE INFORMS MOTHER THAT A VAERS REPORT WILL BE FILED. NURSE INSTRUCTS MOTHER TO CALL DOCTOR. NURSE INSTRUCTS MOTHER TO BRING CHILD TO URGENT CARE/HOSPITAL IF SYMPTOMS WORSEN/CONTINUE.
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was  unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
Headache Body and muscle aches  Joint pain Fatigue Chills Nausea
Information has been received from a physician concerning a 12-year-old male with no medical history or allergies who on 01-FEB-1996 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant therapy. The physician reported that on 10-MAY-2006, the patient developed breakthrough characterized by over 200 lesions above his chest. Unspecified medical attention was sought and the patient was treated with acyclovir. No laboratory/diagnostic tests were performed. At the time of this report, the patient's breakthrough persisted. The reporting physician considered breakthrough to be an other important medical event. Additional information has been requested.
Two episodes of left leg shaking lasting less than five seconds. One episode of right leg shaking < 5 seconds. Fever 100.5. All events occurring on 4/13/2017.
I had the vaccine on 01/20/2021 and in 03/12/2021 I went to the doctor for my 12 week check up and they said I probably miscarried 2 weeks before.  I had a D&C.  The delivery date would have been on September 20, other than that I have had a normal pregnancy.
Could not open eyes; Got up had problems eating; Nausea; Headache; Very very cold; Sick; Woozy; Very weak; Could not stand up or do anything/could not get up; First dose of COVID-19 vaccine Moderna on 22Apr2021. Second dose was administered on 25Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy), ASTHENIA (Very weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not stand up or do anything/could not get up), NASOPHARYNGITIS (Very very cold) and ILLNESS (Sick) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Cholesterol, Anxiety and Depression.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced DIZZINESS (Woozy) and ASTHENIA (Very weak). 22-Aug-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not stand up or do anything/could not get up) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of COVID-19 vaccine Moderna on 22Apr2021. Second dose was administered on 25Aug2021). On 26-Aug-2021, the patient experienced NASOPHARYNGITIS (Very very cold). 26-Aug-2021, the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced SOMNOLENCE (Could not open eyes), FEEDING DISORDER (Got up had problems eating), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of COVID-19 vaccine Moderna on 22Apr2021. Second dose was administered on 25Aug2021) had resolved. At the time of the report, DIZZINESS (Woozy), ASTHENIA (Very weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not stand up or do anything/could not get up), NASOPHARYNGITIS (Very very cold), ILLNESS (Sick), SOMNOLENCE (Could not open eyes), FEEDING DISORDER (Got up had problems eating), NAUSEA (Nausea) and HEADACHE (Headache) was resolving.            Concomitant products included Cholesterol medication, Blood pressure medication, Anxiety medication and Depression medication for an unknown indication.    This case was linked to MOD-2021-299725 (Patient Link).
Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose; Angioedema; This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", Open Forum Infectious Diseases., 2021; Vol:8 (12), DOI:10.1093/ofid/ofab507.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose. A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose"; ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 16.85, notes: log2 dilution; skin test: none. Therapeutic measures were not taken as a result of type i hypersensitivity, angioedema.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug and different patient/event.
SEVERE CHILLS. NAUSEA AND FATIGUE LASTING TWO WEEKS.  BLOOD TEST ADVISED BY PHYSICIAN SHOWED ABNORMAL WHITE BLOOD COUNT.   BLOOD TEST TAKEN IN MARCH 2021.  PREVIOUS BLOOD TEST TAKEN 12/2020 WAS NORMAL.  SEBACEOUS CYST ON BACK PRIOR TO SECOND VACCINE DISAPPEARED.  CT SCAN TAKEN IN APRIL 2021 SHOWED ENLARGED LYMPH NODES.  SCAN ADVISED BY PHYSICIAN BECAUSE OF ELEVATED WHITE BLOOD COUNT.
On 25AUG92 20 min p/DTP devel hypotonic/hyporesponsive episode assoc w/paleness & nausea; last 20 mins self-limited;
Patient received 2 doses of Pfizer at Medical Center on 3-27-2021 and 4-17-2021 and then received Janssen at Pharmacy. On the consent form patient answered no to "Have you ever received a dose of a COIVD-19 vaccine?" system was not checked prior to administration.
Vomiting; Temperature of 104; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and PYREXIA (Temperature of 104) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No medical history was reported.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 29-May-2021, the patient experienced VOMITING (Vomiting) and PYREXIA (Temperature of 104). At the time of the report, VOMITING (Vomiting) and PYREXIA (Temperature of 104) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.   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 event, a causal relationship cannot be excluded.
Increased vertigo symptoms for a little over a week, sore/swollen arm for 3 days
Patient had body aches, right shoulder pain that radiated to the middle of her back, had swelling at the injection site that was red, warm to the touch, and tender.  She also had chill and headache.  Mostly  complained of the discomfort in the back and neck, but also stated she has osteoarthritis.
HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever. This report was non-serious.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild, Additional Details: anxiety related episode, low bp high pulse, complained of symptoms of nausea, lightheadedness at 6:10pm, 1st bp: 100/61 pulse 103 at 6:14pm, 2nd bp:120/75 pulse 97 at 6:21pm, 3rd bp:116/82 pulse 102at 6:35pm, monitored pt for 30 minutes, left at 6:36pm with boyfriend advised not to drive
Patient noted a enlarged lymph node located left side of neck on 9/12/2023. States slight tenderness noted
Aching and pain in every bone in my body for several hours. Started at 10 p.m and lasted until 4 a.m. Today I am fine.
No Adverse Reactions: Employee received her primary series along with her first and second booster. She received her Second Booster on 04/29/2022 and again received her another  booster on 5/24/2022.  This resulted in the administration of an extra booster within 25 days.  This was a Nurse error based on reading the immunization card incorrectly and some understanding  /  language barrier.  Follow-up was completed with this patient yesterday and today. She reports no adverse reactions. no signs or symptoms from the vaccine except muscle stiffness in her arm.  Number provided with instructions to report any adverse events.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN620s), in left arm, on 30Mar2022 as dose 3 (booster), single (Lot number: EP7533), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 55 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 2, single (Lot number: 027c21a), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: known allergies no, other medical history no. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive; (04Jun2022) Negative, notes: tested negative with a home kit on 04Jun2022; (13Jun2022) Positive, notes: PCR and home test; (08Jun2022) Negative, notes: tested negative with a home kit on 04Jun2022 and on PCR test on 08Jun2022; (13Jun2022) Positive, notes: PCR and home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are needed. No further information is expected.
Two days after receiving the vaccination (9-11-2023), I began having signs and symptoms of having a TIA i.e. slurred speech, confusion, blurred vision and imbalance. Taken to Hospital and admitted (9-13-2023) for evaluation, monitoring and treatment. Symptoms resolved with 2 hours and discharged home  the following afternoon 9/14/2023.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021, 00:40 to left deltoid for covid-19 prevention. No concomitant medications were reported.  On 12-APR-2021, the patient took first test of SARS-COV 2 AB (IGG spike, semi QN) and the result were more than 1 which was listed as being negative (confirmed immunological vaccine failure). On 09-JUL-2021, the patient second time took 3 tests at once a rapid test, Polymerase chain reaction (PCR) and antibody Immunoglobulin M (IGM), Immunoglobulin G (IGG) and all three tests came back as negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). ; Sender's Comments: V0:20210733690 -COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.