chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Diarrhea, Tachycardia, Skin Flushing, Diaphoretic Narrative: Employee reported tachycardia. He had Vital Signs taken and an EKG was performed by clinic staff. BP WNL but slightly low for employee. HR was 136. EKG unremarkable. Employee's physician who is also an employee checked in on the event and listed to employee's lungs which were clear to auscultation. Employee advised to take 50 mg Benadryl now and then again before bedtime. Also advised by his physician to go to ER if his symptoms got any worse
pt seen by MD 26JUL96-indicated to mom that rash had nothing to do w/vax;pt recovered completely by 29JUL96 w/rash of unk cause only on lower limbs;
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Headache, described as severe. Photosensitivity, sore throat, fever vomiting- Used Tylenol, Motrin, Lortab 5mg.
Pt had itchy hard blotchy area 3 inch around injection site about 6 days after administering vaccine but was gone the next day after taking BENADRYL.
Extreme dizziness, unable to raise head.  Felt like was going to pass out and was nauseated. Unable to walk.  This lasted approximately 3 hours.
Extreme widespread joint pain resulting in lab tests, xrays and a referral to a rheumatologist
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M035486, with expiry date: 05-JUN-2019 and lot#M041990 with expiry date: 28-JUN-2019 (dosing details were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion for GARDASIL 9 with lot # M035486. Previous temperature excursion included 9C to 25C for a duration of 16 hours for GARDASIL 9 with lot#M041990. No data logger was involved for lot # M035486 but for lot# M041990 data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006518.
Acute Pulmonary Embolism with Acute Cor Pulmonale acute respiratory failure, vascular congestion, right heart strain, elevated BNP, troponins, and  Treated with BIPAP, ICU , oxygen, heparin drip, Coumadin and lovenox
Patient received the first dose of Pfizer at a community event hosted by the health department.  Today when the EMR team was entering data it was discovered that he had received a dose of Janssen on 5/11/21.  I called the patient to inquire why he came for a Pfizer dose.  Patient states he forgot he was vaccinated in May.  Reports no adverse effects from the dose on 9/18.  Instructed patient to let us know if any adverse effects begin and to NOT come in for the 2nd dose of Pfizer.
syringe froze and got stuck so he had to pull it out before the full dose could be administered; received  0.2ml of the dose; fever; chills; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (syringe froze and got stuck so he had to pull it out before the full dose could be administered), UNDERDOSE (received  0.2ml of the dose), PYREXIA (fever) and CHILLS (chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe froze and got stuck so he had to pull it out before the full dose could be administered), UNDERDOSE (received  0.2ml of the dose), PYREXIA (fever) and CHILLS (chills). At the time of the report, DEVICE CONNECTION ISSUE (syringe froze and got stuck so he had to pull it out before the full dose could be administered), UNDERDOSE (received  0.2ml of the dose), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      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.   No concomitant medication was reported. No treatment medication was reported.
Ten days after the shot my arm got swollen red and hot around the injection site. It was about an inch and a half. It was a little painful but mostly hot to touch and itchy. I advised not to scratch, and it slowly went away. It stayed for four days total. I got the second dose in the other arm and I had no reaction.
Severe headache,  vomiting,  diarrhea,  chills,  fever,  cold sweats  No treatment for health professional  Symptoms subsided after 10 hours
4 days after the vaccine, heart palpitations began. I had no prior history of these palpitations. They were so frequent to the point where I had to go to my doctor. He heard them with his stethoscope and believed they were Premature ventricular contractions. (PVCs). After almost 3 weeks, they slowly diminished. I just got my 2nd shot today, and I am hoping it does not continue.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in an 82-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Date of the vials was initially stored in the refrigerator: 24Sept2021
My arm was really sore for weeks. I got really sick on 10/15/22 and stayed sick and on 10/27/22 I went an urgent care because I could not breath. They had to put me on oxygen. My arm muscle was still extremely tight, I had excessive sinus drainage, sore throat, cough. chest congestion. I was prescribed benzonatate, MUCINEX DM, SUDAFED decongestant and an emergency inhaler. The muscles in my arm finally relaxed on 10/31/22.
when we went to mixthe powder with the liquid part of the vaccine we used sterile diluent rather than the liquid part of the vaccine; patient received a dose of HIB vaccine which contained sterile diluent patient received a dose of HIB vaccine which contained sterile diluent; No other AE; This spontaneous report was received from a medical assistant, referring to a 2-month-old patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# UJ589AAA, but upon internal validation established as non-valid, dose, strength, route and expiration date were not provided) for prophylaxis, which contained sterile diluent rather than the liquid part of the vaccine (product preparation error and wrong product administered). Other suspect therapies included sterile diluent. When the medicalt assistant went to mix the powder with the liquid part of the vaccine we used sterile diluent rather than the liquid part of the vaccine. No further information provided. No other adverse event.
On May 9th I began to experience severe pain in my back extending down my left side. The pain was severe enough to prevent sleeping that night. The pain continued throughout May 10th becoming worse with deep breaths or any type of internal strain (cough, sneeze, etc). That evening, I took two Tylenol and later two Ibuprofen and was able to sleep. The pain persisted for the next week, slowly improving but not fully going away. On May 15th I conducted a telemedicine appointment and was advised to go to either Urgent Care or the ER. I chose the ER at  Hospital. A D-Dimer test showed elevated results and a CT scan was ordered. The CT revealed blood clots in my right lung, specifically "Subpleural conslidation in the posterior basilar segment the right lower lobe is present, compatible with pulmonary infarct. Question additional pulmonary infarct in the lateral basilar segment the lower right lobe. Probable atelectasis in the left lung base." MD prescribed Eliquis @ 10mg 2x daily and I was discharged with a referral to    .
This is a spontaneous report received from a contactable pharmacist. A 7-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL0007, expiration date: Mar 7, 2022), at the age of 7, in left arm, on Jan 5, 2022, single dose, for COVID-19 immunisation. Medical history included egg allergy (not ongoing), notes: patient allergic to eggs a long time ago. Patient eats eggs now with no problems. Concomitant medications not reported. The patient developed urticaria (got hives one day later), onset Jan 6, 2022, with outcome of recovered (Jan 2022). Therapeutic measures were taken as a result of urticaria. Additional information: The patient's mom contacted the doctor who had her to use Benadryl and topical hydrocortisone. The hives resolved with these and no other treatments. The mother of the patient mentioned the doctor said if the hives did not resolve within 72 hours to seek further medical attention. In less than 72 hours, patient fully recovered. The mother denied knowledge of any other medications, medical conditions, labs, testing or treatments relevant to these events. NDC number of COVID-19  vaccine for ages 5 to 11: 59267105501. No follow-up attempts possible. No further information expected.
COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; HEART PALPITATIONS; This spontaneous report received from a patient via other manufacturer (Agency) through a company representative concerned an adult female of an unspecified age, race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. It was reported that the patient started to have heart palpitations after she received Janssen Covid-19 vaccine and was under physician care. On an unspecified date, the patient had Covid and was off Humira for four weeks (suspected clinical vaccination failure). The patient also experienced fatigue and covid-19 pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, suspected clinical vaccination failure and covid-19 pneumonia was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number has been requested.; Sender's Comments: V0: 20220553579-Covid-19 vaccine ad26.cov2.s-Covid-19 pneumonia . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220553579-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (2 days after the vaccine, he got shingles), PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ENZALUTAMIDE for Malignant neoplasm of prostate. Concurrent medical conditions included Malignant neoplasm of prostate. In May 2021, the patient started ENZALUTAMIDE (Oral) 160 milligram once a day. 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, the patient experienced HERPES ZOSTER (2 days after the vaccine, he got shingles). an unknown date, the patient experienced PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue). At the time of the report, HERPES ZOSTER (2 days after the vaccine, he got shingles), PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue) outcome was unknown. The patient was enrolled in a sponsored patient support program: Enzalutamide PSP (Enzalutamide Patient Support Program). No concomitant medication information was provided. It was unknown if the physician was aware of the events. No lab test information was provided. Action taken with enzalutamide treatment in response to the events was no change. No treatment information was provided by the reporter. The patient assessed the following events with respect to enzalutamide: Allergic reaction to the 3rd dose for Moderna COVID vaccine (seriousness: Not Reported; causality: Not Assessed). Shingles (seriousness: Not Reported; causality: Not Assessed). Pain (seriousness: Not Reported; causality: Not Assessed). Fatigue (seriousness: Not Reported; causality: Not Assessed). Sender Comment: Product: Enzalutamide: Allergic reaction, Shingles, Pain and Fatigue were assessed as Non-Serious. Non-Serious as the event does not meet any of the RA seriousness criteria. Regulatory Authority assessed Allergic reaction, Shingles, Pain and Fatigue as Not Related, as it could be attributed to the 3rd dose of COVID vaccination. Elderly age could be confounder. Reporter did not allow further contact
Developed bruising (generalized) and dx with ITP on 11/28/09, admitted to hospital and received WINRHO and platelets coming up.  12/4/09 Hospital records received for date 11/28/09 to 11/30/09. DX: Idiopathic thrombocytopenic purpura, right acute otits media, eczema. Presenting SX: bruising, petechiae all over body with no h/o injury or trauma. Pt parent states did previously have a 4 day h/o low grade fever w/ intermittent vomiting. Two wks prior had otitis media and was treated. Received H1N1 vax on 11/14. Pt. blood type is A+ wand was given WinRho 250IU/kg. Assessment: palpable purpura bilat shins, chest, back. Scattered petechiae over entire body. Pt admitted and treated. Stable w/ improved lads at dc.
Red rash around injection site; Injection site warm to touch; Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading) and VACCINATION SITE RASH (Red rash around injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppressant drug therapy (The patient has been on Immunosuppressant medication therapy for 2 years.).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash around injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading) and VACCINATION SITE RASH (Red rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Felt heating sensation in both ears, followed by high pitch noise within my eardrums. The ringing has persisted and gets worse at night. Considered Tinnitus by my main doctor. Will visit ENT soon.
At sight had 2 inch dry, very itchy, scaly red circle. Looked like ringworm. Used hydrocortisone cream. About 1 month later had exact same circle on back of my left thigh. Used hydrocortisone cream, turned to white circle and dissappeared. In Jan 2013 developed a itchy rash on my big toe used hydorcortisone cream did not go away. Turned BRIGHT red and rashy looking. It would subside and come back again. Went to a dermatologist in April and started on.
Abdominal cramps, feverish, night sweats, thirst, insomnia due to fever/sweats
Pfizer on 1/6 and 1/27. Positive on 12/9
muscle aches...all over,  the more he moves the more it hurts he has  mental illness that makes him pace. he stated he feels a lot better after taking his anxiety med, a warm bath and some aspirin all his symptoms subsided.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.27. No concomitant medications were reported. Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature range of 34-35 degrees Fahrenheit from 09:00 AM to 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Initial report was received from a consumer, who was also the patient, on 12 October 2012. The reporter reported another adverse event which was captured in case number 2012-09535. A 77-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE on 06 July 2012 (lot number not reported). On 07 July 2012, the patient began having severe muscular pain at the left deltoid, can't lift her arm, had weakness in her hand when holding things and certain movements caused severe pain. The patient was seen by a physician and an orthopedic physician and was scheduled for an MRI. Treatment included a cortisone shot which did not help the symptoms at all. An x-ray was negative. The patient had no illness at the time of vaccination and no known drug allergies (NKDA). The patient's outcome was not recovered. Documents held by sender: None.
Had itching and clear shingles area on Lt upper arm, back of neck whelps and front neck itching. Went to ER - given IV drugs. Large bump on upper (Lt) arm and Lt thigh back - itching profusely.