chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 76 y.o. female patient of DO with history of CAD, SSS, pAfib, CHF presented to Medical Center with worsening cough, sob recent covid since at least 9/19, CT imaging with concern for RLL PNA.   Right Lower Lobe Pneumonia Recent COVID (resolved) Leukocytosis (resolved) Diagnosed with covid 9/19 or earlier; given Decadron 6mg x6 days per PCP and recommended for mucinex, zinc and vit D CT abd/pelvis noted sign of RLL infiltrate, suspect 2/2 bacterial pna  Urine Ag negative, Resp PCR negative Cefuroxime antibiotic course was completed   Abnormal CT abd Hematochezia-resolved CT abd/pelvis-consistent with proctitis GI consulted- colonoscopy on Monday 10/2 Colonoscopy 10/2 - 7 mm polyp in sigmoid resected and retrieved. Diverticulosis of sigmoid and descending colon and ascending colon.  Internal hemorrhoids.   Recommended for high fiber diet   Hemoglobin remained stable    Resistant hypertension-resolved Renal artery stenosis-severely diseased Vascular surgery was consulted-Follow up with Dr. (vasc sx) and continuing ASA, plavix, statin Nephrology was consulted-recommended below BP meds Discharge meds: BP meds-Hydralazine 25mg tid, spironolactone, losartan, metoprolol Renal artery stenosis- ASA, plavix and statin    COPD Seasonal allergies Meds: antihistamine, prn inhaler   Hyperglycemia-resolved Likely from steroids A1c 5.8 SSI was later dc'd   Coronary artery disease CHFpEF LHC 4/2023 - PCI to RCA and hx of CABG Echo 5/23 -EF 60-65%, mild-mod AR, no pulm HTN Meds- DAPT, Lipitor, metoprolol, losartan, aldactone   Paroxysmal Afib Follows with: heart and vascular, s/p MAZE and LAA clip Monitored on telemetry Meds-lopressor, Cardizem   PAD CTA C/A/P 9/9 - significant atherosclerotic disease in multiple areas Meds: DAPT   SSS S/p PPM   Left Carotid Artery stenosis S/p L CEA Meds: dapt and statin   Hypothyroidism Meds: Cont home synthroid   GERD On omeprazole, would dc on pantoprazole with plavix use   Tobacco use disorder Counseled cessation   Addendum was made to below discharge med list- prednisone 5mg x 3 more doses to complete taper (not 10mg as reflected below).
pain that lasted over a year; joint swelling; inflammation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious) with onset May2021, outcome "recovering"; JOINT SWELLING (non-serious) with onset May2021, outcome "recovering"; PAIN (non-serious) with onset May2021, outcome "recovering", described as "pain that lasted over a year". The events "pain that lasted over a year", "joint swelling" and "inflammation" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, joint swelling, inflammation with medications, and physical therapy. Patient had covid prior vaccination was no, and covid tested post vaccination was yes. And other vaccine in four weeks was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received FLUVIRIN vaccination Friday, AM, 10/8/10/ Pt. reported generalized rash on entire body 10/9/10. MD ordered Medrol Dose pak on Sunday, 10/10/10. (Pt ate Lobster dinner on Friday, 10/8/10).
Muscle spasms have been occurring in the tricep of the arm that the vaccine was administered.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Oct2021 14:45 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Muscle spasms have been occurring in the tricep of the arm that the vaccine was administered.". Therapeutic measures were not taken as a result of muscle spasms.  Additional information: Patient did not received any vaccine in four weeks. No medications in two weeks. Patient did not covid prior to vaccination. Patient was not tested for covid post vaccination. No known allergies reported. No medical history reported.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
she contracted Covid last Mar2022; she contracted Covid last Mar2022; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 87-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lung disease" (unspecified if ongoing), notes: She mentioned that her mother is 87 years old and has history of lung disease so she is in the high risk category. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "she contracted Covid last Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) she contracted Covid, notes: she contracted Covid last Mar2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chills; fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 11:45 (Lot number: FK5618) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for influenza, administration date 14Nov2021, administration date 20Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM/ 11:45, Route of Administration: Intramuscular, Dose: 1st, Date/ time: , Date: 13Nov2021, Time: 11:45 , Site and route of injection:, Anatomical Site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FK5127), administration date: 13Nov2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "chills"; PYREXIA (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "fever"; HEADACHE (non-serious) with onset 05Dec2021 03:00, outcome "recovered" (05Dec2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, headache.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was reported as available. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Relevant tests was reported as no. Specific relevant test was reported as no. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  No follow-up attempts are possible. No further information is expected.
Very swollen lymph glands in armpit, neck, and under jaw on same side as shot received.
Case reference 1999026856 is a spontaneous report from a 44 year old nurse referring to herself. In February 1993 the patient received her first injection with Hep A vaccine. Two days later, she experienced flu- like symptoms for one week which kept her out of work. Approximately 1994, the pt had blood work done which revealed elevated liver enzymes. Lab values performed 3 weeks ago in 09/99 revealed elevated liver enzymes (nos) of 212. The most recent information received on 10/07/99 reports the elevated liver enzymes are ongoing.
had vaccine and has shingles right now/suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a patient's wife via interactive digital media. The patient had vaccine and had shingles right now.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
Initial report was received on 06 October 2011 from a consumer who is also the patient. A 46 year-old female patient with a history of seasonal allergies had received on 03 October 2011 an intramuscular left deltoid injection of FLUZONE No Preservative 2011-2012, lot number UH505AA and a left forearm injection of TUBERCULIN PPD (manufacturer, lot number and route of administration not reported) and an unspecified amount of time later vaccination date, developed chills, felt feverish, cough and a sore throat. She woke up later that night with severe neck pain. She developed swollen lymph nodes in her neck the approximate size of golf balls. She was evaluated by a physician. Treatments included ROCEPHIN, KENALOG and DECADRON. Illness at the time of vaccination, adverse events following prior vaccinations, other medications and any other vaccines within four weeks of the suspect vaccines were all denied. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
I developed an itchy  rash initially on my abdomen and then it spread to my arms. It looked like papular hives to me but also had fine smaller rough areas.. I did not go to my doctor's office as I am a retired nurse practitioner and this was not severe. It was minimally responsive to benedryl,  clariton and  topical steroid cream and  it was self limiting to about 10 days then started to fade.  I am reporting this because it occurred within 2 months of my second vaccine, 3/16/2021, and I was on no new medicines, had eaten no new foods and was not in contact with anything different.
I have been in peri-menopause since September 2021 with no period since Augusts 2021.    After my first 2 shots in December 2020  and January 2021 I did have irregularly heavy periods.  After I received the booster shot on 4/13 I got my period after no period for 7months.  I have had very heavy bleeding with clots and abdominal pain.
No additional AEs reported; improperly stored dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant referring to unknown age and gender patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-AUG-2022, the patient was vaccinated with 1 dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, (0.5 ml, lot number U022985 which was determined to be valid with expiration date: 22-JUL-2023) subcutaneously for prophylaxis (product storage error). The vaccine was exposed to a temperature of -12.3 Celsius degree for a time frame of 1 hour. No previous temperature excursion was provided. No additional adverse event (AE) information was provided.
She is on Hospice for her COPD.  After she received the shot her leg and shoulder pain/ache increased to an 8/10 (usually a 2-4/10) and was constant when it usually is intermittent.  Her breathing is worse and she is maxing out her inhalers and needing many more doses of her rescue morphine than usual (usually 2.4 ml of 20mg/ml Roxanol used in a week and last week was 7.5ml).  She has not been taking it for the pain for fear of med interactions.  She has increased her Tylenol use from 500mg qd to 3000mg qd.  Her tremors are worse and she is taking her propranolol for tremors 20mg BID instead of her usual 10mg BID.  Her body sweats have gone from 1 time a week to 1-2 times a day.  No fevers noted.
This spontaneous report as received from a medical assistant refers to 2 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chest or Pain around the lungs (6 days) Pain (6 days) Fatigue (8 days)
Tuesday afternoon began with a headache. Chills followed in the late evening. Body aches by Wednesday morning with continued headache. Neck stiffness and soreness began Thursday evening.  Severe chest pains early Saturday morning (3am).  Taken to urgent care - EKG showed irregularity and high level of troponin. Transported from there to the hospital.  They did angiogram, and diagnosed me with pericarditis. The on call physician believes this was most likely caused by the second dose of the vaccine.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).  ID number was reported as 80777027399.  Patient age was reported as 61 Year 11 Months.  Concomitant product use was not provided by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.   Completion date provided as 28-Apr-2022.  Treatment information was not provided.
Rec'd Tdap I.M and MMR S.Q. in left arm on 08/10/2006.  Area was immediately sore, but on 08/13/2006 became extremely sore, red, swollen and hot to the touch, from shoulder area, extending to elbow. Aleve did not relieve symptoms.  Client has not seen PMD.  Client has insurance and planned to be seen today for evaluation.
This spontaneous report as received from a female consumer of unknown age reporting on herself. On 09-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, lot#, expiration date and route were not reported). On an unknown date in 2014 the patient experienced the inability to move her arm, chest cold and swelling arm after receiving PNEUMOVAX 23. The patient was treated with prednisone (unspecified dose, frequency and manufacturer). It was unknown if the patient sought medical attention. The outcome of the events was not recovered. Additional information is not expected because there is not reporter contact information.
Decrease of Heart rate to 40s, Oxygen levels dropped to 50s, shortness of breath, loss of energy, lips turned blue
Following vaccine patient went to break room. This NP asked patient to return to observation area and patient stated, ' I am just getting my water bottle". A staff member notified this NP that patient "not feeling well". Patient reported that she "just needed to drink water". This NP asked the patient to return to the observation area.  1744- Patient ambulated to gurney and seated. Does not want to lay down and is saying, "I am sorry... I am fine... I am ok... This happened before...I am fine" Initial HR 102, O2 sat 98-100, RR-18, no stridor, BS CTA. Patient requesting Benadryl and reports she took Benadryl after 1st dose of Pfizer vaccine. 1746- Benadryl 50mg PO  1747- HR-86; RR-18; BP- 136/90; O2 sat 98-100% . BS CTA, no stridor. Patient itching at skin. Patient stating " I am fine... this happened before and I am fine".  1749- Patient reports 'feels like something is stuck in my throat.. my tongue feels numb'. Patient clearing throat and taking sips of water. Advised patient that we would give a shot in her leg to help stop reaction and that we would be calling 911. Patient agrees to IM epinephrine. Attempted to have patient lie down, but patient reports difficulty breathing while laying down.  EMS activated 1751- Epipen 0.3mg/0.3ml administered in Left thigh. HR-100; RR-18; BP 150/96; O2 sat 98%. Patient awake alert, speaking in full sentences. BS with faint exp wheezes in LLL, no stridor, RR even and unlabored.  1756- HR-89; RR- 18; BP 118/ 80; O2- 98%. No rash visible, patient no longer scratching at skin or clearing throat. BS CTA, no stridor, no facial or mouth edema. Patient alert. Patient reports past reaction to kiwi where her "tongue went numb and swelled up". She reports she 'just doesn't eat it" and "did not go to doctors". Patient denies any current health issues, significant PMH, or current medications. Reports she took Benadryl last week for rash from unknown substance. She suspects reaction last week from new shampoo.  1800- EMS arrived. Patient clearing throat. Advised EMS we could give additional epinephrine. EMS asked to 'wait while we assess'. RR even and unlabored, no stridor or other sign of respiratory distress. HR-110; RR- conversing; BP- 153-103; O2- 99%. 1803- Patient ambulated to gurney. EMS informed by this NP that patient has downplayed some symptoms and that she continues to have throat clearing. EMS states they have 'epinephrine in ambulance and can administer.' EMS given administered Epipen in plastic carrying case. Patient to awaiting ambulance by gurney with EMS.
This spontaneous report as received from a consumer refers to a 2 patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (concentration, dose, route and anatomical place of vaccination were not reported), for prophylaxis. On an unknown date, the patients experienced shingles (herpes zoster). At the time of reporting, the outcome of herpes zoster was unknown. The reporter did not provide a causality assessment between ZOSTAVAX  and herpes zoster. This is one of several reports from same reporter.; Sender's Comments:  US-009507513-1709USA003161: US-009507513-1709USA004176:
Patient complains of chest pain sharp enough to take prescribed Nitroglycerin tablets 2 days after receiving third dose of Pfizer COVID-19 Vaccine. Patient states continues to have 2-3 episodes every day of chest pain that needs the use of Nitroglycerin tablets to relieve.
Sore arm, started immediately, lasted one week Pain in armpit, started next morning, lasted one week Fever, started that evening, lasted 4 days Tightness in chest, started that evening, feel periodically
?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute COVID-19 infection Acute bronchitis due to COVID Acute hyponatremia, resolved   HOSPITAL COURSE: Pt is a 84 yr old F with PMHx of Chronic diastolic CHF, CAD, HTN, Obesity, OSA, Hypothyroidism, Hx of Renal Cell Ca, CKD III, Hx of paroxysmal atrial fibrillation presented to ED on 11/16 with shortness of breath, cough, congestion, weakness and home COVID test that was positive on 11/15.   In the ED - vitals w/elevated blood pressures but otherwise breathing on room air. Labs showed sodium of 122. CTA thorax ruled out PE.    Patient admitted for hyponatremia and COVID infection. Her Hyponatremia was gradually corrected and for her COVID infection - she was provided supportive care. She had significant wheezing on exam - started on Albuterol PRN, 3% nebulized saline to help with congested cough and oral Prednisone.    Hospital course was also complicated by hyponatremia that improved with supportive treatment.  Patient's sodium was back to normal at the time of discharge.   She also has poorly controlled hypertension which prompted change in her blood pressure medications by stopping her Toprol XL as switching to Coreg 25 mg 2 times a day.  Hydralazine was increased to 100 mg 3 times a day.  She will continue home losartan and Lasix.  Blood pressure was well controlled with above measures.   PT/OT recommend Home with Home PT.   Her symptoms improved - she is discharged home on 11/22 in stable condition.
Enlargement lymph nodes on 2013-12-20. Clinician comment: Infra clavicular and epitrochlear lymph nodes. No fevers. Benign CBC.
ActHIB given with expired diluent, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received first 0.5 mL expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI904AAA, expiry date: 19-SEP-2019 and Frequency = once) via intramuscular route in the left thigh) on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE).  It was a case of actual medication error due to Expired vaccine used. It was reported that ActHIB given with expired diluent.  At the time of reporting the patient had no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.