chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admission Date: 10/12/2022 Date of Decease: 10/19/2022 Discharge Provider:  Primary Care Provider: None Physician, DO  PRESENTING PROBLEM: STEMI (ST elevation myocardial infarction) (HCC)  Severe aortic insufficiency    HOSPITAL COURSE: Patient is a 77 y.o. male. Who presented with the following complaint. 77YOM with PMH significant for GERD and AS s/p 23mm freestyle subcoronary AVR at a facility in 2021 arrived to outside emergency department 10/12/22 with crushing chest pain. He was transferred to a HCF and cardiology evaluation. TTE with EF 65%, severe AI and severe MR. He was also found to incidentally have COVID-19. Patient with mild hypotension and low diastolics. CTS was consulted for redo SAVR.  also consulted for TAVR evaluation. In 2021 he did have a TEE and LHC performed with showed mechanical occlusion of RCA (good collaterals) and mild to moderate "perivalvular leak." He was discharged for outpatient TAVR evaluation.   Unfortunately his sinus diameters were too small for valve-in-valve TAVR and due to his instability he was agreeable to full aggressive measures and underwent emergent redo AVR with root enlargement. Following his surgery he was taken to the ICU for postoperative management.     10/13: High dose pressors, very critical state in ICU. CVVH started. 10/14 remains on high dose pressors, intubated/sedated. Paced at 100 with temp/perm. CVVH running even. IABP 1:1. Corpak being placed today. Platelets trending down. Plan for neuro assessment today 10/15 IABP weaned to 1:2, remains on Epi, adding Nipride. CVVH even. 10/16 IABP removal today. Remains on Epi and NTG, A paced at 100. CVVH -25 10/17 right pigtail chest tube for PTX. CVVH -50. Remains on Epi, NTG, amio and veletri 10/18: Remains on epinephrine and levophed with CRRT. Had been following commands per nursing staff. Workup for thrombocytopenia in process. Patient appearing septic and abdominal xray was completed showing concern for perforated bowel or pneumatosis or obstruction. He was taken to CT and general surgery was notified immediately. CT scan showed intramural air in the dilated cecum, ascending colon and hepatic flexure of the colon consistent with bowel ischemia. General surgery discussed with patient's family and had concern for patient's ability to thrive following the operation they would perform. Dr. with cardiothoracic surgery discussed the case with family and general surgery.  10/19: After lengthy discussion with medical team the family felt that pt. would not want to undergo another surgery and opted for comfort care.    He was pronounced deceased on 10/19/2022 at 0222.
FEVER (TEMP 102, tm), LIP & TONGUE SWELLING (~12 HRS AFTER VACCINE), FUSSINESS AND LEG SORENESS.  NO SOB, WHEEZING.  SXS IMPROVED WITH BENADRYL AND TYLENOL.  FUSSINESS AND SORENESS IN BOTH LEGS (AND ALL OVER) PERSISTS.
Patient received 2 doses of Moderna Covid vaccine, on March 1, 2021 and March 29, 2021. He did not feel ill after receiving either dose.  In April 2021, he began seeing blood in his stool. His cardiologist took him off Eliquis and referred him to a gastroenterologist. On April 30, 2021, an endoscopy found ulcers but they were not bleeding.  On June 29, 2021, blood was drawn in preparation for a visit to his primary care doctor and revealed a hemoglobin level at 8.8 and a platelet count of 80. On July 3, 2021, still thinking that his problems were heart related, his cardiologist inserted a Watchman device into his heart.  Through the next few weeks, his heart failure accelerated with water retention and severe fatigue. On August 19, 2021, he was admitted from the emergency room at Hospital. After numerous tests, doctors diagnosed myelodysplastic syndrome and ?TP 53? gene mutation. He was released on August 30, 2021.  He was under the care of initially one Dr and then another Dr.  Between August 30, 2021 and October 18, 2021, he had frequent blood transfusions at Cancer center to treat the anemia and thrombocytopenia.  On October 18, 2021, he was admitted to Hospital for a clinical drug trial. His anemia and thrombocytopenia accelerated, requiring transfusions that were too much for his cardiovascular system. He died October 30, 2021.  Note: Patient had absolutely no family history of blood cancers. Both Doctor's stated that they did not believe his condition was related to the Moderna vaccine. However, they didn?t explain how they came to this conclusion. With the politicization of health care in this pandemic, it?s hard to know whether doctors are giving an honest opinion or just trying to preserve their reputations and research funding.  As there have been other incidents of the vaccine leading to thrombocytopenia, if this is really a matter of ?science? it would be worth it to explore what factors might contraindicate the vaccine for those individuals.
Seizures with onset within 72 hours of administration of DTAP. 60 Day follow up states: it is unknown if pt has recovered. Delay in gross motor skills, unclear if this is related to the vaccinations. Annual follow up on 02/12/04: "It is unknown if pt recovered from adverse events. Pt still with occasional seizures.  She also has slight developmental delay.
Admitted 08/30/2022 Deceased 10/08/2022     PRESENTING PROBLEM: Shortness of breath       HOSPITAL COURSE:     57 yo M with hx of depression, HTN, hyperlipidemia, tobacco and ETOH abuse who presented to the ED on 8/30 with shortness of breath. Had previously tested positive for COVID 19 on 8/22 and completed a course of steroids. Found to be hypoxic in the ED and thus admitted to the hospitalist team for further care. Started on high dose IV steroids and empiric Abx. Despite this, patient continued to clinically decline from a respiratory standpoint and was ultimately transferred to the ICU and intubated/paralyzed/proned on 9/15. IP placed percutaneuous tracheostomy 9/22.    Hospital course was unfortunately complicated by encephalopathy, septic shock with Strep bacteremia, and VAP. Serial imaging of his thorax continued to demonstrate progressing alveolar damage and fibrosis. Ventilator mechanics also continued to worsen with patient requiring high amounts of sedation for compliance with concurrent shock. Following extensive conversations with family regarding poor prognosis, patient was transitioned to comfort care on 10/8. ETT was removed and vasopressors suspended. He passed away peacefully with family at bedside.
PATIENT WAS GIVEN FLU 3+YRS PATIENT WAS ONLY 2YRS 10M AT TIME OF VACCINATION. THERE WAS NO ADVERSE REACTION TO THE DOSE.
Painless injection. Slight sore arm than night. Woke with discomfort in left armpit radiating down inside of left arm down to middle of wrist. Painful to touch. limited range of motion due to pain. slightly improved by day 4.
Left side of my face was red and swollen, my left eye was swollen, and I woke up in the middle of the night and my face felt like fire. I looked in the mirror ad saw the swollen eye, and it was itchy. The side of my face went from a half a quarter to half of a dollar bill. I also had a patch from underneath my left breast.  Rashes on my thigh, a rash on my left palm, and around the fingers of my left hand. Two spots on the right side of my body(forearm and shoulder).The left side of my body was covered with rashes in different spots.
Pt felt dizzy after vaccine was brought to med bay. Vitals stable (BP 103/60; HR 70; RR 17). Pt states she feels better. Observed for 25 min, no signs of distress & pt released
After administering the above vaccinations, client began itching his back and neck and stated he was itchy. Nurse administered .5 ml of Benadryl and monitored client for 15-20 minutes following. Client verbalized relief of itching and denied any other symptoms.
A few hours following vaccination, arm began to swell. Pt developed fever chills, arm pain, lethargy, cellulitis client reported incident the next day to us by phone.
Patient received the dose at 5:15pm. I was alerted by father at 5:25 that she was not feeling well. I went to check on her and she had lost consciousness in her father's arms. I told the technician to call 911 at retrieved and epipen. I opened the epipen and checked the patient for response. She woke up and appeared very weak and confused. She responded that she could breathe. The epipen was not administered. EMS arrived and checked for vitals. Vitals were within normal range. The father decline transportation for further care. She remained sitting until 5:50 pm and she left on her own power with her family.
Known reactions occurring within 48 hours: arm pain, severe joint pain, chills, fever (short term 101°), headache, fatigue. ***Uncommon reaction: 8 days after vaccine, a lump developed; I assumed this was nothing more than a pimple as I was able to get a thick, white substance out when squeezed. The substance was similar to that of a common pimple. Within 24 hours, the same lump had become much larger (about the size of a golfball) with a ring of what could be described as infection around it. A small black hole in the center had become visible. Within another 24 hours, the lump appeared more severe and the black hole slightly larger. Severe pain, similar to what it feels like after injection. At this point, I visited my PCP who believed this to be a reaction to either the vaccine itself or the manner in which it was administered. My PCP prescribed Doxycycline. 48 hours into antibiotics, the appearance of infection has reduced. However, the painful red lump and black hole remains. This is not an itchy rash.
No additional AE reported; Product expired 1/8/2023 and was administered to 2 patients today 3/28/2023. Product had not experienced any temperature excursions through the date of administration; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On 28-MAR-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (lot number U018309 has been verified to be valid; expiration date reported an established as 08-JAN-2023) (expired product administered) (strength, dose, route of administration, and anatomical location were not provided). No additional adverse events were reported.   This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA010031:
pain in the Right side of neck extending to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the Right side of neck extending to the shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced NECK PAIN (pain in the Right side of neck extending to the shoulder). At the time of the report, NECK PAIN (pain in the Right side of neck extending to the shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Patient states that starting 40 minutes after her vaccine, she vomited. She has vomited 3 times over the course of 24 hours after receiving the vaccine and has been unable to keep foods or liquids down. She also reports "the worse chills and sweats" she has experienced.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient said she had no reaction to doses 1 & 2. Dose 3 administration went well & patient did not notice any reaction until the day after the vaccine in the PM.  Arm became red, hot and swollen.  Finally going down by day 3 after vaccination, but still visible skin response.  Patient wondered if premix formulation had additives that might have caused reaction not had with original vaccine diluted on site? Patient was advised to seek medical attention if resolution stalled or reaction worsened.
pt rcvd vax; pt devel paralysis on right side of face; right eye drooped & unable to close it; right ear ached; pain in back of head; right side of mouth drooling; pt dx w/ bell's palsy;exp clear right nostril drainage;
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Authorization (EUA): Patient received 2 doses on 8/26/2021 and 9/16/2021. Patient presented with covid-19 pneumonia on 1/17/22 which signifies therapy failure. 79 years old with past medical history significant for hypertension hyperlipidemia  and gout who was recently By his primary care physician was started on Lasix and lisnopril due to concern of possible CHF. He is being admitted for acute kidney injury, hyperkalemia, COVID infection. He has DVT, non-STEMI, cannot exclude PE. He is not hypoxic and denies any chest pain or shortness of breath No Known Allergies
Received call on 3/28/05 at 1pm. Patient's left leg red and swollen. No fever present. Mother states vomiting and diarrhea. Took to ER Dx-dehydration. ER told mom to use cool compresses and Tylenol, I encouraged the same.
Wrong vaccine administered. Patient should have been given Tdap. Provider notified and immunization.org stated "DTaP given to a person age 11 years or older: count this dose as a routine Tdap dose." Mother was notified.
vaccine was expired with no adverse event; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00647078).  It was reported that an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Suspension For Injection) was administered to a patient (age and gender not reported), on an unknown date for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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.  There will be no information available on batch number for this case.
gradual worsening of lt shoulder pain w/abduction over 5 wks; finding likely bursitis;
Fever of 103 for hours. Started at 7 pm with chills and advanced to the fever that stuck around for hours. Overnight fever that would break but come right back. Headache tiredness and soreness in arm
2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after 24 of receiving 2nd dose began with hives and itching to face hands and arms.
Myalgia, Arthralgia, headache, low grade temp 99.5 Narrative:
Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid benedryl for the minor allergic reaction.
they have given a healthy 59-year-old female patient a dose of FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a healthy 59 years old female patient received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, a healthy 59-year-old female patient received a dose of fluzone high dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  It was reported that "Pharmacist wanted to check if there are any reported cases that has adverse events for patients that are under 65 years old. As per pharmacist, patient did not report any adverse events after receiving the FLUZONE HIGH DOSE QUADRIVALENT. No further information provided by the reporter."   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 the 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.
Redness, rash, bruising and a knot in her arm where she received the vaccine that lasted a week.
Red rash with bumps, itching, red, size: 9cm x 5cm
Psychosis and mania. Lack of sleep. Started at 9pm. Started having strange thoughts and started hearing noises. Felt like someone was in my house. Went to bed, continues hearing noises and having untrue thoughts. Continued all through the night. Eventually fell asleep at 4:30am. Woke up at 8:20am. Felt very depressed and continues to have psychosis and untrue thoughts. All day had a lack of energy, not hungry. After researching through website I saw psychosis and mania was a side effect of the vaccine. I have never felt these feelings before. I have never had psychosis before. After finding out this was a side effect. I talked to my wife about my untrue thoughts. I convince to feel a lack of energy and depressed, but realizing it?s a side effect helped with the psychosis. It?s still there, but I understand where it?s coming from.
I got the vaccine, then was asked (due to having previous allergic reaction to Levaquin in the past, I was asked to wait 30 minutes) I got up and walked a total of 30 feet to sit in a chair. I felt completely normal, up until this point. I sat down and began to text my Mother that I had just got the vaccine & I was told to wait 30 minutes, at this point (2 mins in) I felt normal. I sat my phone down on my lap and was just looking about. I began at that point (2 1/2-3 mins mark) seeing the tile floor morph; the blue tiles and the green tiles kept merging together and forming one color. Then my heart raced, immediately and I started having hot flashes that shot out my ears. My heart raced even more and at that point I had realized something wasn?t right. A National Guards member came up to me and had asked if I were okay, I explained I was not and something was not right. They took me to a medical area and made me take deep breaths, and made me drink some water. My BP was high, and my Pulse Ox had dropped slightly, and then went straight back to normal once they had asked me to stick my head between my knees and keep breathing deeply. Also, both of my ears had turned deep red/purple and they were VERY warm to the touch. They felt as if heat were tunneling out of them. The only way I can explain truly how I felt, and I have NEVER done it fully, I felt as if I was fainting. Out of nowhere I felt as if I was going to pass out ? but it didn?t happen. The entire ?spell? lasted about 20 mins? I was monitored for an additional 40 minutes and was allowed to leave.
Some bleeding at the site with slight redness-no temp. Bandaid applied. Mother called and advised-no swelling noted by mother.
Canker sores in mouth, swollen gums, malaise, swollen gums, fever, flushed face/cheeks
Information has been received through a pregnancy registry from a female with no pertinent medical history and no drug reactions/allergies who on 2/21/05 was vaccinated with a dose of varicella virus vaccine live, subsequently and learned that she was pregnant 2 weeks later. There were no concomitant medication. The patient indicated that she was not pregnant at the time of vaccination, because she had her period after vaccination. She indicated that she had since terminated the pregnancy. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no product quality complaint. No additional information is expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAR-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # reported as L042264, expiration date: 26-OCT-2017, 0.5 ml, subcutaneously. The vaccine was exposed to temperature of 46.8 Fahrenheit degrees for 6.5 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Very painful injection, limited arm motion without pain especially in shoulder. Still in daily pain 3 months later, can not lift arm over head or put any strain on tricep muscle
1. *** EMERGENCY Has ADDENDA ***  ER Triage Note   Patient, a 66 year old MALE presents to Emergency   Department on 02/24/22 16:50.       Tetanus status: Last Tdap: Dec 23, 2020      LMP:    Chief Complaint: Visit CC: lightheaded, dizzy.   2.  LOCAL TITLE: MED RECONCILIATION                              STANDARD TITLE: MEDICATION MGT NOTE                              DATE OF NOTE: FEB 24, 2022@23:24     ENTRY DATE: FEB 24, 2022@23:24:52             AUTHOR:          EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                          *** MED RECONCILIATION Has ADDENDA ***  Hospital Medication Reconciliation    Patient is being admitted to HOSPITAL Family Care Unit    3. LOCAL TITLE: RX DISCHARGE REVIEW                             STANDARD TITLE: PHARMACY DISCHARGE NOTE                          DATE OF NOTE: FEB 26, 2022@13:20     ENTRY DATE: FEB 26, 2022@13:20:50             AUTHOR:            EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                       Patient is being discharged from HOSPITAL Family  Care Unit today FEB 26, 2022.  Reason for hospitalization: Hypoxia  4. LOCAL TITLE: OUTREACH HOME VISIT NOTE                            STANDARD TITLE: OUTREACH NOTE                                    DATE OF NOTE: MAR 01, 2022@10:48     ENTRY DATE: MAR 01, 2022@10:49:33             AUTHOR:       EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                       Patient, a 66 year old MALE seen for an Home Visit on  03/01/22 08:30.
Resident started having chills, temp of 101.3, nausea, vomitting at approx 7:00pm. Stat labs and UA were done and orders for IV anti biotics.  While the nurse was waiting for the IV team, the resident temp increased to 103.0 at which time the MD gave orders to send to the ER.
This is a spontaneous report received from a contactable nurse. A female patient of an unspecified age received PREVNAR, via an unspecified route of administration in the morning of 12Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 12Jun2018 the patient went to the urgent care due to local reaction. It was further described as about 6 or 7 cm kind of firm area. It was also reported that the patient was warm and red however was not having any problems breathing and she doesn't have a fever. The outcome of the events was unknown.
diaphoretic "feels hot down both arms and back and feels weak.  BP140/90 Pulse 102 seen by employee health physician
pt recv vax 23AUG96 & pt seen on 7SEP96 c/o congestion for 1wk;rt ear blocked & h/a & dizziness for 1 day;exam showed red, bulging rt tympanic membrane & tx w/medst;13SEP96 hearing test was markedly down on rt side;