chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient is an 85 yo who presents to the ED due to NOV 21, 2021 Subjective/Chief Complaint: Cough x 1 week. Objective: Significant bilateral dependent edema, which pt states is worsened. States home-use hospital bed is broken and cannot elevate feet as he normally does. Reports compliance with diuretic medication regimen, but greatly decreased urine production x 1 week. He has been covid vaccinated x 2 (no booster). Patient with history of asthma on chronic prednisone, presents with 1 week of dry cough he denies any fever or chills no chest pain. States that he gets a little short of breath when he is a coughing fit however otherwise does not have any shortness of breath. Has been using his inhaler more often than usual. Did have some ill family members in the home before all this started. HOSPITAL COURSE: slow but good progress have been encouraging greater in room activity, movement, States has been trying to use bedside incentive spirometry, but coughing at times has made it difficult. Flutter valve added. Typically somnolent in a.m. CPAP use in place. Patient has improved to point where he is off oxygen and appears closer to baseline. Discharged home.
Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Administration of vaccine resulted in frozen shoulder.
I was so weak; couldn't move in the morning; temperature 100.8; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was so weak), BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills), MYALGIA (body ache) and FATIGUE (couldn't move in the morning) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Reported.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills) and MYALGIA (body ache). On 25-Jan-2021, the patient experienced ASTHENIA (I was so weak) and FATIGUE (couldn't move in the morning). On 25-Jan-2021, FATIGUE (couldn't move in the morning) had resolved. On 26-Jan-2021, ASTHENIA (I was so weak) had resolved. On 28-Jan-2021, BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomintant Medications were not provided.  Treatment medication were not provided.
6/6/03- anthrax #1 6/20/03- noticed a "lump" developing behind right ear 6/18/03- I&D was performed on the lesion (measuring 4cm according to the medical documentation) and the patient was given a dx of folliculitis 7/2/03- anthrax #2- noticed multiple small lesions developing on his head.  No systemic complaints.  8/22/03- anthrax #3 ? date- anthrax #4 ? date- anthrax #5 Above small lesions worsened ("bigger and more painful")  6/17/04- seen by healthcare practitioners- dx of having "pilar cysts"- given derm referral  7/28/04- seen by derm- given dx of "dissecting scalp cellulites" and was given Doxycycline.  8/16/04- seen by his Case Manager- states has about "ten to eleven lumps" on his head- he has been "popping" the lesions to "try to make them go away."-   Ten subcutaneous nodules present on scalp- pink colored- each measuring from 5mm to 2cm- no bleeding or discharge noted from lesions- lesions firm, tender, round, symmetrical and non mobile- no deviation of temperature noted- estimated depth 2mm to 5mm- lesions disseminated- localized only on scalp- multiple patches of alopecia noted  Has f/u with dermatology
Soreness in arm and muscle aches lasting several days.  Hot flashes lasted 3-4 days.  Headache and fatigue still lasting one week later.  Swollen lymph nodes in neck and mild sore throat noticed approximately 5 days after and still lasting one week after shot.
Lateral R thigh developed red swollen area 2/13 back evening. Thigh painful. On 2/14 child brought back to clinic. Nurse identifies two injection site of Hib and pneumococcal conjugate. Child has a 2x3cm palpable swelling close to the skin surface. Skin very reddened lump is lateral and about 2cm from injection site. 2/17/03 TC, R thigh lump may be smaller. Still tender and reddened. Didn't eat for two days, rejected formula nd Pedialyte. Last night took formula. Will continue warm pack. 2/18/03 TC no answer. 2/19/03 TC no answer. 2/20/03 HV with family-R thigh has hard ridged area 2cm x 0.5cm under skin, lateral to posterior area. Slight yellowish, redden color. Denies any fever. No longer tender.
ED to Hosp-Admission  Discharged 8/27/2021 - 9/15/2021 (19 days) Last attending ? Treatment team Acute on chronic diastolic (congestive) heart failure Final Summary for Deceased Patient   BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: MD    Admission Date: 8/27/2021     Discharge Date: 9/15/2021   Final Diagnosis Principal Problem:   Acute on chronic diastolic (congestive) heart failure  Active Problems:   Paroxysmal A-fib   Pulmonary hypertension, moderate to severe   Chronic obstructive pulmonary disease with acute exacerbation   Pleural effusion on right   End stage COPD   Congestive heart failure, unspecified HF chronicity, unspecified heart failure type   Endocarditis   Lactic acidosis     DETAILS OF HOSPITAL STAY   Date and time of death: September 15, 2021, 12:11 PM   Cause of death: Septic shock from COVID-19 pneumonia Acute respiratory failure from COVID-19 and systolic heart failure   Secondary diagnoses: Severe aortic insufficiency Superimposed bacterial pneumonia Acute renal failure Lactic acidosis Possible endocarditis Atrial fibrillation with rapid ventricular response End-stage COPD Elevated LFTs Coagulopathy from malnutrition and acute illness   Hospital Course Patient is a 72-year-old female with history of COPD, atrial fibrillation on Coumadin, systolic heart failure, recent TMVR presented to the hospital with systolic heart failure.  She is admitted to medical service and seen by the heart failure team.  Echocardiogram showed severe aortic insufficiency and was being considered for valve intervention.  She was treated with IV diuretics however her respiratory status did not improve.  Hospital course was prolonged and she was hospitalized for 18 days.  There is consideration of endocarditis given possible vegetations noted on aortic valve.  CT surgery recommended aggressive antibiotic regimen and stated she was high risk for surgery.  Initially was plan for IV antibiotics through October 4.  She was treated with Lasix infusion, however urine output became marginal.  Patient's x-ray developed progressive infiltrates and on September 14 she was found to have COVID-19 infection.  She was started on steroids and received plasma as well.  Antibiotics were also broadened to cover potential superimposed bacterial pneumonia.  Despite this, her clinical condition deteriorated.  She developed progressive renal failure as well as elevated LFTs and coagulopathy.  She became more somnolent and oxygen requirement escalated.  She became progressively critically ill and was requiring vasopressors, and was maxed on norepinephrine.  Unfortunately, she continued to deteriorate and passed away on September 15.  I passed along my condolences to the patient's son.
stomach problems like hard bowel movements; stomach cramps; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements), ABDOMINAL PAIN UPPER (stomach cramps) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements), ABDOMINAL PAIN UPPER (stomach cramps) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements) and HEADACHE (headache) outcome was unknown and ABDOMINAL PAIN UPPER (stomach cramps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that headache was better, but stomach still hurts. Treatment details included Imitrex.
The pharmacist drew up a vaccination for the Moderna Pediatric instead of the Moderna Bivalent. No adverse reactions.
Localized Reaction lasting longer than 48 hours.  Red, hot, painful, hard.
Tiredness; Headache; Nausea; Swelling; Feeling unwell; Nose bleed; Coughed up a blood clot; Congestion; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced tiredness, headache, nausea, swelling, feeling unwell, nose bleed, coughed up a blood clot and congestion on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results   on   COVID test close to that time too where they swabbed my nose. Details were as follows: patient got the vaccine on 19th (month and year unspecified), and the COVID test with unknown results close to that  time, where they swabbed her nose. She has had  had tiredness, headache, nausea, swelling, feeling unwell, and the last night she had a nose bleed and coughed up a blood clot out of her throat. She also  had a lot of congestion since taking the injection, and did not know if it was from the injection or the COVID Test. The outcome of tiredness, headache, nausea, swelling, feeling unwell, nose bleed, coughed up a blood clot and congestion was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Tinnitus - loud ringing in ears began after vaccine.  Never had it previously.  It  has gotten progressively worse over time.
A non-serious spontaneous report of administration of expired product was received from a physician concerning a 40-month-old male. Neither relevant medical history nor concomitant medication have been reported for this patient. The product expired on 15-Jan-2012. On 17-Jan-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 10-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
I received the second dose and my throat started to swell and the back of my tongue.  I started coughing and had difficulty breathing.  It continued to escalate.  I started to get a headache.  I did wait 30 minutes after the shot and these reactions started.  She said wait another 15 minutes.  They called for the emergency assist to help me. They had to come get me in wheelchair.  They took me to the urgent care part of the hospital.  The PA looked down my throat and my tonsils and nose were closing and very red.  She gave me a shot of steroids.  I asked her for an asthma treatment, and they did not do that, but they did give me Allegra.  The steroid helps a little but did not get rid of it.  The days followed I got worse and nausea and vomiting.  I also had weakness.  That Thursday I went to my PCP, and he called 911.  EMS came and got me and took me to Hospital.  They treated me and told me that I was still having an allergic reaction.  They gave me an epi shot, and Pepcid.  I was stable and I was still not breathing well.  On July 3rd I started to gasp for air.  I went to   the ER.  They admitted me I started to have chest pains.  I was having difficulty breathing and headaches.  I was there from July 3rd to July 7th.  When I was in the hospital, they gave me prednisone, but it was not making me better, but it made me vomit and there bedding in the hospital was giving an allergic reaction.  I also started to have allergic reaction to medication hey gave me. I was having sensitivity to everything.  My IGE was over 1400.  I was having a reaction to something in the vaccine.  I became hypersensitive.  I was discharged and the next week I was admitted for severe dehydration and my veins collapse. I was admitted to Westside Hospital.  I was having allergic reaction to foods and was having convulsions.  I stopped eating due to this.  They were trying to discharge me, and I started to have the reactions again to everything environmental, perfumes, foods, etc.  I have never had reactions to any of this.  I was admitted again to the hospital on August 3rd.  I started to have seizures and I can not speak clearly.  The headaches and severe weakness.  They did an MRI, and I did not have a stroke. They diagnosed me with allergy induced seizures. All together I had 6 ER visits and 3 hospital admissions. I am still waiting to receive treatment because they do not know what it is.  They treat my symptoms and make me stable but then send me home.  I went to the Dr. which he is an immunologist.  He did a blood test and diagnosed me hypersensitive reaction to the vaccine.  My white blood cells are low.   I see an allergist next week.  I sleep in a mask, and I cannot be without it.   I am also unable to work.  The only thing that has helped me a little is Benadryl to help with the convulsions.  My allergist is Dr.  I have lost 17 pounds from July 1st.
My arm, where the injection was, it just started hurting; Body ache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 15Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome "recovered" (15Mar2021), described as "My arm, where the injection was, it just started hurting"; PAIN (non-serious) with onset 15Mar2021, outcome "unknown", described as "Body ache"; CHILLS (non-serious) with onset 15Mar2021, outcome "unknown", described as "Chills".  Additional Information: The patient was asking if it was okay for her/him to feed her/his grandchildren.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277831 (same reporter). This case involves a 32 months old male patient who experienced received 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot UI975AA) once via unknown route in the left deltoid instead of indicated 0.25 ml dose on 03-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to overdose. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patients mother called this am due to a small bump on baby's leg. She stated she read the VIS sheets given, but she wanted to make sure. She also said the baby had a temp of 100.4 brachial. I told mom to continue with Tylenol and bring baby in so I could assess. Leg had a small pink local reaction and bump could be felt. Reassured mom that unfortunately these bumps do happen, reviewed VIS sheet for immunization that was placed on that leg, and mom felt better. Also instructed mom to cont. with tylenol and that I would call her on Friday to check on the baby.
Vaccine expired on 9/21/2021. Administered expired dose on 9/23/2021. No symptoms noted or complained of.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # M036459 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to VAQTA.; Sender's Comments: US-009507513-1707USA000533: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1707USA000536:
Patient arm with severe swelling and pain, plus fever, within 24 hours that worsened for next 2 days, then started subsiding.
Patient passed out after receiving her 1st Pfizer vaccination. Patient mother was present with the patient and the fall was witnessed by  nurse. The patient did not impact her head and patient fell onto her bottom after standing up. Patient was taken via wheelchair for observation. Patient had no obvious signs of injury, patient had full movement of her extremities, with no weakness in her arms or legs. Patient passed a walk test after her observation and her mother was advised to call 911 if she experienced weakness, chest pain, shortness of breath, dizziness, or fast heart rate.
This is a serious literature case, initially received on 16-Nov-2018, concerning a patient of unspecified age and gender. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). Within 24 hours of vaccination, the patient developed unspecified symptoms which required intubation and mechanical ventilation. Within 36 hours of symptom onset, the patient had loss of all brain stem reflexes mimicking brain death. On an unspecified date, electroencephalogram was performed, which consistently showed the presence of cortical brain activity and excluded brain death. Nerve conduction study and electromyogram confirmed the diagnosis of acute motor-sensory axonal neuropathy (AMSAN). The Cerebrospinal fluid showed atypical presentation with polymorphonuclear pleocytosis initially, however, repeating lumbar puncture after two weeks was consistent with cytoalbumin dissociation. On an unspecified date (one week after vaccination), the patient was developing the fulminant Guillain-Barre Syndrome (GBS). The patient was treated with two courses of intravenous immunoglobulin treatment. The patient showed unique process of recovery in terms of gaining back the head and neck movement. At the time of this report the patient had not recovered from the event loss of brain stem reflex and the outcome of the events fulminant AMSAN and fulminant GBS was not reported. The reporter stated that, there was a questionable correlation between the recent influenza vaccination (one week prior to onset) and developed the fulminant GBS.
like having a heart attack; my throat was numb.; It was extreme like after the reflex like pain in my chest; I was having Heart pressure and my heart and my jaw and my throat was numb.; anxiety; I was having Heart pressure and my heart and my jaw and my throat was numb.; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left arm (left upper arm) on 01Mar2021 (age at vaccination was 71 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included cancer (have cancer two years ago) and high blood pressure; both from an unknown date and unknown if ongoing. Concomitant medications included letrozole taken for cancer (A chemo pill, To prevent the cancer from coming back), start and stop date were not reported; lisinopril taken for high blood pressure, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left upper arm on 08Feb2021 (age at vaccination was 70 years) as DOSE 1, SINGLE for covid-19 immunization. On an unknown date, the patient experienced like having a heart attack, my throat was numb, It was extreme like after the reflex like pain in my chest, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety. The patient was having heart pressure and her heart and jaw and throat was numb. She stated that it was extreme like after the reflex like pain in her chest and numbing in her throat and in her jaw like having a heart attack. When asked about the corrective therapy, the patient reported that she just gave three medication that she was on, because of her cancer. She take Cannabis Mint and anti anxiety at night, a pill, So when she had those adverse effect because at that she was having Heart pressure and her heart and her jaw and her throat was numb so she took a CBD to relax her body to the anxiety after almost a hour it come down. She took Xanax and CBD Mint 2.5 milligram. Petra Kiera Concession Cannabis infused Mint and she have one more pill the anti anxiety pill was Xanax and its 0.5 milligram and alprazolam. Therapeutic measures were taken as a result of the events. Investigation assessment was reported. The outcome of the events like having a heart attack, and It was extreme like after the reflex like pain in my chest was unknown. The outcome of the events my throat was numb, I was having Heart pressure and my heart and my jaw and my throat was numb, my jaw was numb, anxiety were recovering.  Follow-up attempts are completed. No further information is expected.
Patient reported onset of headache same day vaccine (Gardasil) #1 was given. Pain lasted for one week, was relieved by taking OTC acetaminophen.
Case number PHEH2016US023523, is an initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1618701, expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 10 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. Upon follow up the pharmacist reported, 5 doses were administered following first temperature excursion. FLUVIRIN vaccine underwent second maximum temperature excursion of 46.58 (units unspecified) for 10 mins. No vaccine was administered after second excursion. No adverse event was reported following this medication error (incorrect product storage). Follow up report received from a pharmacist on 12 Sep 2016: Updated suspect drug information (expiry date) and pharmacist comments.