chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myositis...excruciating arm pain in left upper arm (where injection was given)...feels nerve related. Radiates up to the shoulder...it was just tender like usual on following day but proceeded to get worse (internally) throughout the week. It has now been two weeks and the my arm radiates with pain. There has been no sign of lessening pain.
Weeping rashes primarily on legs began appearing about 3 weeks after first dose.  Self treated as bug bites until after second dose, when the rashes intensified and spread to lower back and upper right arm. Intense itching.
extreme fatigue, fever of 99.7 to 101.9l lasted asting three and a half days. took 1000 mg. of acetamenaphen every 6-8 hrs.
Shortness of breath, asthma like exacerbation.  Fever 102.1.
a 61 y.o. male with COPD on home oxygen, who presented with shortness of breath.  He started to have increasing dyspnea 3 days ago.  Has had cough, non-productive.  Had fever at home.  No sick contacts.  Denies chest pain.  Found to be COVID-19 positive.  Wears 2-3 L O2 at home."   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.      * COPD with acute exacerbation Acute COPD Exacerbation - with associated COVID-19 viral infection.  Continue nebs, inhalers, IV steroids and antibiotics. Patient improved gradually and was feeling back to his baseline.   COVID-19 infection - CXR no infiltrates and is on his home O2 requirement of 2-3L with no increased need for oxygen supplementation.  Not fully vaccinated, had one dose Moderna 2/6/22.  Discussed with patient and given comborbid conditions will order remdesivir for at least 3 day course.  Continued at baseline oxygen requirement. Patient was feeling back to his baseline and was offered 2 more days of treatment. He declined and felt that he is ready to go home. Was discharged accordingly on a tapering course of prednisone. Follow up outpatient with primary care provider.    Chronic hypoxic respiratory failure - on home O2 2.5L.  Monitor closely.    Paroxysmal A fib - rate controlled.  Order betapace.  Not on OAC at home.
Slight fever; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 10:00, the patient experienced slight fever and soreness at injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events slight fever and soreness at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt received Pfizer COVID-19 vaccine on 3/5/21, and on 3/9/2021 she started experiencing flushed, hot hands, forearms and also chest. She also had a very slight pinkish tone to the affected skin. It disappeared within 2 hrs but then returned in the AM. 3/11 the symptom extended to chest area. The patient also started Sertraline 50mg 3/5/21, same day as vaccine administration. They contacted PCP and she did not believe the rxn was due to the Sertraline. As of 3/15/21 the symptoms have subsided.
72-year-old female who was transferred from a Medical Center ER. to a different medical center with  c/o  sore throat, cough, with loss of appetite, feeling dizzy, and having yellow sputum as well as a watery diarrhea. Rapid    Rapid COVID-19 test was positive and chest x-ray, which showed scattered opacities throughout both lungs, which may represent multifocal pneumonia. She denies any fever, chills, chest pain, or shortness of breath.  First vaccine 4/5/2021   Patient has history of : Hypertension, Diabetes Mellitus   pulmonary fibrosis, NASH, aortic sclerosis, cataracts, GERD, s/p stent
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 22°F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 22°F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:08 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 22°F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 22°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 72.54.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vial was moved to fridge on 11-Feb-2021 and moved to clinic on 17-Feb-2021. Vial was punctured right before administration. Vial best before use date was 13-Mar-2021. Vial was undergone temperature excursion on 09:00 AM with 22 degree Fahrenheit. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Flu vaccine (65 plus) given Sept. 27. Never felt shot. 3 days later terrible pain. Pain continued - went to clinic - 11 days later - told to ice and take MOTRIN. Went to own physician Oct. 17th. Cellulitis - infection antibiotics - (Diag) flu shot introduced infection - in tissue.
BURN LOOKING SKIN WITH BLISTER RIGHT BELOW INJECTION SITE. RPH CONTACTED PT'S PCP DR. DR SCHEDULED PT TO SEE HIM SAME DAY BUT PT WASN'T AVAILABLE THAT DAY SO PT DECIDED TO CANCEL OFFICE VISIT AND WAIT AND SEE. RPH SUGGESTED PT TO SEE DR RIGHT AWAY IF THE INJECTION SITE REACTION GOT WORSE AND TOLD RPH WOULD DO FOLLOW UP IN 3-5 DAYS.
reporter gave 13,703 inject & reported 8 events;4 inject site rxn, 2 rashes & 3 pt w/dizziness; 8 of these rxn occurred w/in 2hr of inj;onset of 1 rxn was unk;there were no sequelae noted;
1st dose / January / 2021 / went / 6 of July 2021 to get the second dose / not administered at time of report; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first dose on 18 january 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient went to the facility on 6th July 2021 to get the second dose. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The health care professional did not provide lot number neither expiration date of the first dose of Engerix B. The reporter consented to follow up.
Severe headache within minutes that lasted 24/7.  Severe gastrointestinal upset with abdominal pain, gas, and diarrhea.  Hypertensive crisis a week later with BP 163/108 prompting an ER visit.  Benign PVCs became problematic occurring throughout the day, with decreased energy, shortness of breath and activity tolerance.
Pt has experienced heavier menstrual cycles since covid vaccination with infrequent half-dollar sized blood clots.
pt woke up @ approx 7AM 29FEB noted raised hive like spots on face;states they were also warm to touch;states noted spots for a few hrs; MD notified 24FEB96 3PM;
diagnosed her with Migraines; Vomiting; sensation of extreme nausea; Severe headache, pain in the back of head; sweating all my body; like my eyes were going to pop out of my head with pain; pain in the back of neck; Diagnosed her with vertigo; Dizziness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo) and DIZZINESS (Dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Bipolar disorder and Vitamin D deficiency. Concomitant products included CLONAZEPAM (KLONOPIN), PROPRANOLOL HYDROCHLORIDE (INDERAL) and FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, CARBAMAZEPINE (TEGRETOL) for Bipolar disorder, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness) and NAUSEA (sensation of extreme nausea). 03-Apr-2021, the patient experienced HEADACHE (Severe headache, pain in the back of head). On 18-May-2021, the patient experienced MIGRAINE (diagnosed her with Migraines) and VOMITING (Vomiting). The patient was treated with ONDANSETRON for Nausea, at a dose of 4 mg as required; MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg as required; BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 18-May-2021, VOMITING (Vomiting) had resolved. At the time of the report, HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness), MIGRAINE (diagnosed her with Migraines), NAUSEA (sensation of extreme nausea) and HEADACHE (Severe headache, pain in the back of head) outcome was unknown.            The patient had three episodes of severe head ache and a sensation of extreme nausea, sweating all my body, pain in back of neck and head, like my eyes were going to pop out of my head with pain. The last episode happened on 18-May-2021. The patient could not remember the other two dates of these episodes. The patient went to emergency room on 18-May-2021 and vomited before entering the emergency room. The patient felt that episodes were becoming more frequent.    This case was linked to MOD-2021-142747 (Patient Link).
Red bumps covered body 1 week after 2nd shot; Covered in hives 1 week after 2nd shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 939676) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) at an unspecified dose and frequency. On 19-Aug-2021, RASH PAPULAR (Red bumps covered body 1 week after 2nd shot) and URTICARIA (Covered in hives 1 week after 2nd shot) had resolved.            No concomitant medication reported.  It had been stated that patient did not had a history of allergic reactions and also did not visit the doctor and the reaction went away by itself.  It was reported that they would like to perform allergy tests now, and they need to know the ingredients of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow up received. Event added
Case completed primary Covid vaccine series in March 2021, then was hospitalized for Covid in September 2021 and died of Covid in October 2021.  Hospitalized: Hospital. Discharging physician:  Dr. MD.  Onset Covid symptoms 9/8/21 (fever, chills, shortness of breath, fatigue), tested positive 9/15/212, hospitalized 9/15 to 9/17/21 (for Covid pneumonia and acute respiratory failure), then again hospitalized 9/24 to 10/8/21, then hospitalized again 10/11 to 10/12/21 when he died.   * Acute respiratory failure  Assessment & Plan Presents with acute worsening shortness of breath day of admission. Was previously only requiring 1L oxygen, feeling improved, now with worsening shortness of breath, needing 4L on admission, requiring HFNC 9/25. CTA negative for PE but shows extensive bilateral patchy infiltrates and mucous plugging consistent with complications of recent covid 19 pneumonia. Suspect may have contribution of poor rate control afib and possible diastolic hear failure as well. Was taken off lasix at last hospitalization, worsening edema, but now dry for days by oct/4. IV lasix administered initially 9/25, oral lasix bid started 9/26 and later stopped around 2/oct due to bp. Increased metoprolol, dig loaded 9/25 and increased diltiazem 9/26 all with improved rate control. Baricitinib added for Covid as noted elsewhere and continued on dexamethasone for now (started 9/15)-complted. Also started on ceftriaxone 9/25 for possible superimposed bacterial pneumonia given elevated wbc and procalcitonin for an 8 day course of therapy. Goals of care d/w spouse 9/25 - he remains dnr with no further escalation of care. Wife, updated daily - continued with decadron completed 3/oct, baricitinib for covid for 12 doses - continue Xarelto (home med) - continued with ceftriaxone - stopped 2/oct after 8 days. -Doing well on 2 L NC at rest on discharge 10/8, but still very dyspneic with exertion.  Pneumonia due to COVID-19 virus Assessment & Plan Symptom onset 9/8 with positive test 9/15. Was due to finish 10 days of decadron 9/25 but given worsening respiratory symptoms continued decadron for several more days. Only on 4L on admission however O2 needs rose quickly over first night, requiring HFNC. Increased up to 100% FiO2, now improving. Received some remdesivir previously, now out of window. Completed moderna vaccination series. CRP up to 29.9, now improved. - added baricitinib 9/25; hold baricitinib if absolute lymphocytes <200cells/mm3 - completed 10 days decadron 3/oct   o2 needs decreasing for days through 4/oct
A male member attended COVID-19 vaccination. After RN education patient sat at a vaccination station and received 1 dose of COVID-19 Moderna vaccine.  He was advised to go sit down in the patient waiting area. Member instead sat down at another vaccination station.  Staff at this station administered second dose of COIVD-19 Moderna vaccine.  When staff went to document on the screening questionnaire the error became apparent that the patient already received the vaccine. Patient monitored for 1 hour post two vaccines.  No adverse reaction at that time.
Muscle aches, joint aches, chills, fever, sweats, nausea,  headache, lightheaded - 40 Hours
Extreme migraine; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration as a single dose on 23Mar2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to sulfa and onions. The concomitant medications included buspirone hydrochloride (BUSPAR) and quetiapine (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested for COVID-19 since vaccination. On 23Mar2021 at 15:30, the patient experienced extreme migraine since injection. The patient did not receive any treatment for reported event. The clinical outcome of migraine was not resolved at the time of this report.   No follow-up attempts are needed. No further information expected.
Diffuse redness with lip and tongue numbness within a few hours of receiving vaccine.  Was given Benadryl, and started on prednisone 60 mg daily and cetirizine 10 mg daily/
12 hours after recieving 2nd dose of COVID-19 vaccine, symptoms began to appear. I began to feel feverish and lethargic. By 30 hours after, I had a very high fever and began hallucinating. I felt as though I was leaving my body. I had taken Ibuprofen earlier and then took Tylenol along with meclizine to alleviate the vertigo and dizziness. I awoke this morning at 9am 11/6/21 feeling much better with no further side effects.
No adverse effects reported; a patient was administered an improperly stored dose of VARlVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.    On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  (rHA (recombinant Human albumin)) (lot # S019581, expiration date 25-JUN-2021; strength, dose and route of administration were not reported) for prophylaxis (product storage error). Temperature excursion was -0.2 Celsius degrees for 2 hours 40 minutes. Previous temperature excursion was 4.25 Celsius degrees for 2 hours 40 minutes. No adverse effects were reported. Data logger was involved.
Patient had receive a flu shot on 10/7/14 from his doctor. A 2nd shot was administered on 11/4/14.
About 3 weeks post 2nd vaccine I started experiencing tinnitus on an intermittent basis.  I can have 2 days of tinnitus and then be fine. Then have 3 days of tinnitus and then be fine.
Symptoms : Rash on forehead and neck. Muscle weakness. Headaches.  Dizziness.   Treatment: Zyrtec, Tylenol, & Motrin
This spontaneous report was received from a medical technologist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 10-OCT-2018, the patient was vaccinated with PROQUAD (rHA)  lot number R015742, expiration date on 02-DEC-2019 (strength, dose, dose number and administration route were not reported), for prophylaxis. Concomitant therapies included a properly stored MERCK STERILE DILUENT (lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposure to a temperature excursion between 6 Fahrenheit (F) and 14 F for 14 hours, which was registered  by the data logger. There was not previous temperature excursion. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1810USA008504: US-009507513-1810USA008505.
By the 3rd day after I staryed feeling chronic fatigue and had a fever. By day four, I couldn't get out of bed. I literally slept for 40 of the next 48 hours waking up with fever and chills, but so week I didn't want to get out of bed.  After 2 days in bed I started to feel better and by the end of the 6 th of May I had fully recovered. I hope.
Was informed today that patient is actually 11 years old. In the appointment scheduler and on form parent/guardian listed date of birth differently.
Started with chills, headache followed by fever, nausea and trouble breathing. Ending about 5 hours later when I feel asleep.
On the day stated the patient received a KINRIX shot who did not meet age requirement. Staff did not initially notice the error. Patient was monitored and no adverse reaction noted by Parents.
Narrative:  COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 11/23, Pfizer, dose #2 12/07 COVID swab, result: not detected 12/23/21 COVID swab, result: detected 12/23 SARS-COV-2 Variant Sequencing: pending 1/4/22 COVID swab, result: detected 12/23 pt cc: cough, fatigue, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown 12/26/21 clinically resolved
Pain and swelling to right upper arm, axilla and chest wall. Pain and decreased range of motion to right arm and shoulder. Difficulty lifting arm or fully extending elbow. Swelling and tenderness to right breast and sternum, pain and swelling also radiates to back under the right shoulder blade.
Vaccine expired on 4-17-22, reported to Moderna, results from internal testing: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Within 15 mins, chills, body and joint pain, fatigue, low grade fever, diaharea
A few minutes after vaccine was administered, patient said she felt dizzy and sat back down in chair. A few moments later she lost consciousness. She regained consciousness a few moments later. Her blood pressure and pulse returned to normal about 5 minutes later. 911 was called and paramedics also took patients vitals.