chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: ep7534) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA, start date: 01Dec2018, stop date: 01Aug2022; OTEZLA, start date: 01May2020, stop date: 01Aug2022; MAGNESIUM, start date: 01Nov2021, stop date: 01Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Negative, notes: Tested negative on Thursday 28Jul2022; (29Jul2022) Positive, notes: woke up Saturday the 29Jul2022 with Covid symptoms and a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Paxlovid for the treatment of COVID-19 from 23Jul2022 to 27Jul2022. The patient has experienced the adverse event on 30Jul2022 at 01:00 AM and the outcome was recovering, treatment received was unknown.
Intense chills started about 7:15 pm (about 10 hours after vaccine).  Fever started about 12 hours post vaccine and measured as high as 102.3. Fever lasted about 18 hours; however fever reducer was used. Intense headache throughout the time of the fever and lasted until 24 hours after the vaccine. Tender lymph node noted about 48 hours after the vaccine in my left axilla and remains tender.
1. DROWSY  2. HEADACHE  3. BODYACHES  4. MEMORY LOSS  5. GAIT DISTURBANCE "WALKING LIKE HE'S DRUNK" 6. WEAKNESS  7. INCREASED URINARY INCONTINENCE  8. INCREASE BLOOD PRESSURE  9. ELEVATED CREATININE   The patient's wife reported on June 6, 2022 that on the afternoon after receiving the Shingrix, the patient started feeling drowsy, weakness, bodyaches, headache, and started to experience memory loss.  As the days passed his urinary incontinence worsened and his gait became "like he was drunk".  His blood pressure increased as well as his creatinine levels.  Patient went to the ER on June 2, 2022 and had a brain, but nothing was detected according to the patient's wife. He was released with ibuprofen.  He had a follow-up appt with his PCP and was given tamsulosin for his blood pressure and urinary incontinence along with ibuprofen for his headache.
Considerable Injection Site Pain; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A 57-year-old male patient received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Considerable Injection Site Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a 72 year old male patient with spinal issues, allergy to VERSED and BENADRYL. The patient's medical history included heart stent in approximately 1997 at age 62 and chicken pox. In approximately March 2008 (about five years ago), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported). Concomitant therapies included atenolol and aspirin. About one week after receiving the vaccine, the patient experienced an allergic type, whole body severe rash. The patient was prescribed 85 mg of prednisone for about three years and still took prednisone at the time of report. He was also treated with acyclovir. The patient experienced pain in his arm and shoulder. The patient went to the physician office for medical attention. No lab diagnostics studies were performed. The event did not improve. The outcome of allergic type, whole body severe rash, pain in his shoulder and arm was reported as not recovered. Additional information has been requested.
After about five minutes of receiving Tdap and MCV patient began to have violent movements of arms and legs for a few seconds.  The patient was placed on a bed with her legs upright for fifteen minutes. When the fifteen minutes had past the patient was doing well and answering all questions.
COVID 19 Treatment; COVID 19 Treatment; 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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: morphine", notes: Known allergies: morphine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jan2023) Positive, notes: COVID 19 Treatment; (29Jan2023) Unknown results, notes: After 5 days had faint and indeterminate rapid test results; (02Feb2023) Positive, notes: Got a clear positive line on rapid test; (03Feb2023) Positive, notes: had very dark red positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
I had congestion, a cough and was achy everywhere. My son came home from school and tested positive so that's kind of why I got tested as well. The symptoms weren't severe I had the doctor call in a prescription for me after 2 weeks so they probably lasted 2-3 weeks before they were gone.
Information has been received from medical assistant concerning an unspecified number of patients who on unknown dates, might be vaccinated with GARDASIL (doses, routes, lot numbers not reported). Medical assistant reported that their office did not record temperature readings of their refrigerator from 24-MAY-2012 through 21-JUN-2012 so the office did not know if their vaccines were stored properly. Medical assistant was not sure if any patients were vaccinated with this product which possibly might have been stored improperly. This is one of several reports from the same source. No further information is available.
Patient's eyes rolled back, head fell back and patient passed out.  911 was called.  Patient came to approximately 1 min later and felt disoriented.  Medics arrived and took her to hospital for evaluation.
Fever, chills, body aches, upset stomach,headaches, dizziness, tired, week
Pt was given original formulation product rather than the bivalent product.   Look-alike vials cited as contributing factor.   Pt did not report adverse events.
A little over 1 month after vaccination on 5-16-2022, I started having a cough, sore throat, headache and fever of 100.5. On 5-17, I took a home Covid test and it was slightly positive so I then called the doctors office and spoke with the nurse practitioner. She ordered Molnupiravir and to go to a lab on 5-18 for a PCR test. It came back positive. I am still having a headache but feeling better. I am reporting my breakthrough case of Covid.
Very strong Headache (worse than what occurred with dose 1 or 2), Fever 101F (also had fever with dose 2, but not this high, afebrile after dose 1), Visually swollen lymph nodes/glands (similar to what happened after dose 1 and 2), swollen gums (new symptom with dose 3 that was not previously present). Swollen gums are very uncomfortable.
43 y/o female received her influenza vaccine injection on 10/8/2010. 3 hours post vaccination patient developed an allergic reaction, facial swelling, difficult breathing, and wheezing. Patient sought care in the emergency room where she was diagnosed with a mild allergic reaction and was discharged home same day. Patient reported that symptoms resolved within 1 day.
Patient had a runny nose and body aches. Her arm was hot to the touch at the injection site and visibly swollen and red. She also stated that it was itchy and her arm was painful.
pt. c/o of pain in the chest.  heavy chest like someone is standing on my chest- pt. said.  lt. hand cold and numbness dizziness, blur vision.  His leg numbness.
Information has been received from pharmacy intern (Pharm. D.) referring to a 67 year old male patient. The patient's current condition included hypertension, diabetes, hyperlipidemia and non-ischemic cardiac myopathy. The patient had no known drug reactions/allergies. On 20-FEB-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown) at another unspecified facility. Concomitant therapies included aspirin, SYNTHROID, losartan potassium, metformin and STARLIX. On 23-FEB-2015, the patient ingested an unspecified amount of dietary whey protein by mouth and an unspecified amount of time after that, the patient experienced an anaphylactic episode on same day. The patient was transported by ambulance to a hospital on 23-FEB-2015, and he became non-verbal while in transport to the hospital. He was wheezing upon arrival to the hospital emergency department, with hives "from head to toe." The patient received 0.5 mL of epinephrine subcutaneously in the ambulance. He received 125 mg of SOLU-MEDROL intravenously, 25 mg of BENADRYL intravenously, and he was started on an epinephrine infusion and a fentanyl infusion. Calcium, Magnesium, Phosphate (CMP), Electrocardiogram (EKG) and Arterial Blood Gas (ABG) were performed while result not provided. The patient was hospitalized, intubated, and he was on a mechanical ventilator at the time of this report. The reporter considered the event anaphylactic episode to be medically significant and life threatening. Additional information has been requested.
This spontaneous report as received from a physician refers to a 21 years old female patient with no pertinent medical history and no drug reactions/allergy. The patient was intramuscularly vaccinated with first dose 0.5 ml GARDASIL in August 2012. Lot # was unspecified. In August 2012, after the patient received her first dose of GARDASIL, she had hives and itchy on an unspecified area of her body. The outcome of itchy and hives was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information has been requested.
migraines for 3 days; still not up to speed; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines for 3 days) and FEELING ABNORMAL (still not up to speed) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (migraines for 3 days) and FEELING ABNORMAL (still not up to speed). On 04-Apr-2021, MIGRAINE (migraines for 3 days) outcome was unknown. At the time of the report, FEELING ABNORMAL (still not up to speed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient exhibited symptoms of a TIA or possible stroke about 4 days after receiving the SpikeVAX 12+ Covid injection. He felt as though he couldn't catch his breath. About 20 minutes later, he began speaking out of context of the questions asked of him. Then his speech became unintelligible for several minutes. He was confused and could not follow verbal instructions. His walk was slightly off balance. Upon the arrival of EMTs, he could not verbalize the name of the watch the EMT pointed to on his own wrist. He could not verbalize the year. He received an IV in the ambulance in transit to the Emergency Department of the nearest trauma center. The EMT stated the iv fluids seem to be helping as Patient began to better answer questions. He exhibited slight drifting of his right arm per the EMT. Days later, he still has some brain fog.
Case number PHEH2014US019176 is a initial spontaneous report received fr om a nurse on 19 SEP 2014. This report refers to a 53 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly on 18 SEP 2014. It was reported that he was vaccinated with 1.0 ml of vaccine instead on 0.5 ml. No adverse events reported after the maladministration (vaccine overdose).
did not feel like getting up and doing thing; tired; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired). At the time of the report, IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-531858, MOD-2022-531857, MOD-2022-531856 (Patient Link).
pneumonia; joint swelling; cardiac inflammation; This is a spontaneous report from a contactable consumer or other non HCP.   An adult male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unspecified date, the patient experienced pneumonia, joint swelling and cardiac inflammation. The events resulted in hospitalization. Therapeutic measures were taken as a result of pneumonia (pneumonia), joint swelling (joint swelling), cardiac inflammation (myocarditis). The outcome of the events was recovering.  The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 28-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
really flaky skin; ill all day; This case was reported by a consumer via interactive digital media and described the occurrence of flaking skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 2nd dose of Shingrix. On 7th May 2022, 1 days after receiving Shingrix, the patient experienced unwell. On 8th May 2022, the patient experienced flaking skin. On an unknown date, the outcome of the flaking skin was not recovered/not resolved and the outcome of the unwell was unknown.   It was unknown if the reporter considered the flaking skin and unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient. The patient had Shingrix on Friday.  The patient was ill all day Saturday and today (at the time of reporting), noticed that he/she had really flaky skin all over. The reporter wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Pt is 36 weeks pregnant. She had tested negative for COVID 10 March (surveillance testing for teachers) and then tested positive for COVID on 25 March (surveillance testing, pt was asymptomatic). Pt also received her fist dose of the COVID Vaccine on 12 March. Not yet delivered.
This spontaneous report as received from nurse refers to a 6 month old infant. Approximately on 18-APR-2014 (also reported as today), the patient was vaccinated with expired ROTATEQ (lot # H017671, expiry date: 25-MAR-2014). No concomitant medication was reported. No adverse effects reported. There was no product quality complaint. Outcome of the reported event was unknown. Additional information has been requested.
Immediately after receiving vaccines, while sitting on chair, became faint, leaned forward at mother's instruction, I supported him as he collapsed, I slowly lowered him to floor. He regained conscious, responded to mother's voice & moved over to put his head in her lap on floor. Very pale. After resting 10 minutes, drank 6 oz fruit punch, felt better, after 20 minutes got up & walked out with mother. Pulse WNL.
Immunization given 08/19/2003: Hives noted 08/28/2003.  No treatment needed.
15aug90 pt vax hepta b. pt devel joint and muscle pain in shoulders. following 2nd vax joint pain reoccured. nurse felt sx were problem from arhtritis rather than from vax.
Narrative:  73yo male pt died at nursing home "SIGNATUR OF  NUSING HOME" on 12/25/2021.  Problem list: PMH: Code Description L20.9 Atopic dermatitis  J30.9 Allergic rhinitis I25.10 Coronary atherosclerosis N40.1 Benign prostatic hyperplasia M54.5 Low back pain Z79.01 Long-term current use of anticoagulant R60.0 Localized edma H81.13 Vertigo E87.6 Hypokalemia I10. Benign essential Chronic obstructive lung disease K21.9 Gastroesophageal reflux disease I48.91 Atrial fibrillation 564.00 Constipation, unspecified 786.59 Atypical Chest Pain (ICD- 9-CM 786.59) 473.9 Sinusitis (ICD-9-CM 473.9) 309.28 Adj Reac W/Mixed Emotion (ICD-9-CM 309.28) 311. Depression (ICD-9-CM 311.) Pt had received covid vaccines on 4/1/21 & 5/1/21. This death is likely not related to the  vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
No adverse events.  HPV #3 given to early.  No event/misadministration.
Case number PHEH2014US024329, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to an 11 years old female patient. Her medical history an concomitant medications were not reported. Her vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. She was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the right deltoid on 05 Nov 2014. It was reported that the patient received FLUVIRIN pre-filled syringe (PFS) that was stored at 49 degree F for 1 hour 15 minutes. The reported confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received form the nurse on 19 Jan 2015: Updated site of vaccination and reporter's comment.
Woke up the following day with rash/red bumps covering arms and legs. They're not itchy, nor appear to be filled with anything, but there are hundreds of them.
FELT LIKE A COMBINATION OF DRUNK AND ON SLEEPING  MEDS; DRY MOUTH; SHIVERING; SORE ARM; 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 (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like a combination of drunk and on sleeping meds, dry mouth, shivering, sore arm, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the felt like a combination of drunk and on sleeping meds, shivering, dry mouth, fever and sore arm was not reported. This report was non-serious.
Teen C/O black spots in (L) eye and trouble seeing from eye. Seen at optometrist 8/21 and was Dx'd w/swollen optic nerve (L) eye. Seen again 8/25 no change in swelling.
Per patient, "tired and thirsty" the next day; experienced "pain under left armpit that radiates to left breast and up to jaw when walking or going up steps" the following day and continues to persist at this time; patient is currently followed by a cardiologist for pre-existing health condition ("cardiac stents") >> seen by cardiologist and "nuclear cardiac stress test" was performed one week ago; "cardiac scans" also completed and results were no different than results from routine scans in March 2021; states cardiologist "cleared" him for work and has no intentions to follow up but patient states pain persists. Patient plans to seek second opinion and referral to different provider.