chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (10.28.21 - still admitted); COVID-19 positive (10.28.21);  fully vaccinated PLUS booster CHIEF COMPLAINT:  Pneumonia due to COVID-19 virus HISTORY OF PRESENT ILLNESS: Patient is a 70 y.o. female who presents today with past medical history of obesity, AF on eliquis, OSA, HTN, venous stasis who presents with shortness of breath. She had developed a cough that started approximately 6 days ago after receiving her booster Pfizer COVID vaccine. She developed diarrhea 2 days later. She has not had any fevers or chils. She lives with her husband and states that she started feeling more short of breath today. She began having difficulty with ambulating around her home to just use the restroom. She has no history of CHF, COPD but does have a history of atrial fibrillation.  In the ED, she received 1 dose of Rocephin for presumed UTI. She also received 125 mg Solumedrol and 500 ml of normal saline. EKG showed atrial fibrillation with RVR at 112 beats per minute. She also received Lasix 20 mg IV. Acute hypoxic respiratory failure Sepsis COVID-19 pneumonia Obesity, BMI 52 Patient presented with tachycardia, leukocytosis tachypnea, hypoxia.  Upon arrival, she was placed on high-flow nasal cannula 50 L. Patient is significant respiratory distress, she is short of breath with short sentences.  Notably, she is fully vaccinated and received her booster shot 6 days ago. Tested Positive: 10/28 Day of Illness #6 Oxygen Requirements: HFNC 50 L, 65% FiO2 - Decadron: s/p Solumedrol x 1,  - Remdesivir: start loading dose - Daily CBC, CMP, D-dimer. - DVT Prophylaxis: Eliquis - Oxygen PRN - Immodium for diarrhea - monitor I/o with goal of net negative              - consider Foley Daily renal and liver function monitoring for kidney and liver toxicity due to Remdesvir is required. Progress Note from 11/8/21:  Plan of the day:  -Continue lung protective ventilation, we will attempt decreasing the PEEP to 12 -Repeat CXR if she develop any decompensation to assess for development of PTX -Keep paralyzed for now given worsening hypoxia and pneumomediastinum  This patient is critically ill and is requiring active support and intensive surveillance to prevent life threatening clinical deterioration. -Worsening hypoxia overnight, CT chest showed pneumomediastinum and small apical PTX. ETT was pulled up,  -CXR this morning with satisfactory position of ETT tube, I could not visualize PTX on left side.  dexamethasone changed to solumedrol and Started on Zosyn and vancomycin overnight,
Immediately following vaccination patient passed out in the chair. Woke up approximately 10-15 seconds later, skin very pale white, clammy. Patient stated she "did not feel right". When asked to describe her symptoms, the patient said she felt "tingly and dizzy". Pharmacist gave patient water bottle and a breakfast bar. Patient ate most of the breakfast bar and then said she felt like she was "going to throw up". Patient then vomited 3 times in the trash can. Immediately after vomiting, patient's color skin color returned to normal and she stated she "felt much better". BP checked and within normal range. Patient stayed at the pharmacy for 45 min for observation and drank a second water bottle. Refused medical care and refused to have someone pick her up from the pharmacy. Pharmacist followed up with patient via a phone call at 6:20pm. Patient said she was feeling much better and had no other adverse reactions.
Patient received the vaccines and walked through hallway to grab water. On his way back to the room, he fell in the hallway. Patient was helped up to nearby bench by staff and mother, and eventually helped ambulate back to room and laid down on exam table where he was examined by his provider. Provider gave clearance to leave after that  Patient did not lose consciousness, just says he felt a little dizzy
Pt states she had extreme dizziness and nausea upon awakening. She has not lost consciousness.
pt recv vax 26JUN96 & pt exp lightheadedness & dizziness;no further details were provided;
Swelling, pain, erythema, swelling near and below injection site.  Fatigue, general body aches, low-grade fever beginning about 6 hours following injection and lasting for approximately 24 hrs.  Took 2 Tylenol ES capsules which provided significant relief.  Three total doses of Tylenol for constitutional symptoms but injection site and surrounding area remain red, swollen and tender at time of report submission.
Pt described pain in arm 2 hours after the dose, then 5 hours after he stated he took a hot bath, began to feel chills while in bath, proceeded to get out and go to bed. He said he awoke abruptly at 9pm to urinate and after finishing urination, felt lightheaded and faint (said he never passed out in his life) and woke in the doorway to his bedroom. He says the proceeding two days he slept more than he was awake and the arm was swollen, red, and painful. By the third day post vaccine, he was not himself, but feeling better overall.
Sat. 06/26 started running a fever of 102 degrees (oral). Sun. 06/27 fever increased to 104 degrees - taken to Hosp. ER bld. test run, none for infection; "due to shot" alternate TYLENOL & MOTRIN/fussy, decreased appetite, loss of sleep. 06/28 blisters in mouth. 06/29 seen PCP put on antibiotics.
pt hosp recv vax the HIBTITER was inadvertently administered intradermally;w/in several hr the pt devel redness & swelling @ the HIBTITER inj site;tx w/warm compresses;
felt like increased HR Narrative:  Patient felt okay to go home. BP 142/93, HR 99
pain on her arm; bruises on the site; This is a spontaneous report from contactable consumers (patient and patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient took the vaccine 13 days ago and she did have pain on her arm and she could not move it and it had bruises on the site where she took the vaccine. The event outcome for events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
27 year old male received his second shot today and immediately after the shot felt nausea lightheaded and dizzy. He says it feels like the room is spinning around him. He does not have any PMH nor does he state that he takes any medication. He denies any street or illegal drug use. Pt states that he had a couple drinks last night and did not eat anything today. After providing water and laying him down for 30 min he was still symptomatic so it was decided that the patient should be seen in the ED for further workup. Patient is in agreement and he will be sent.   148/101, P 92, O2% 99% 150/101, P 90  ED Note: Physical exam reveals an alert, normocephalic male he has a normal heart rate with normal heart sounds, normal pulmonary effort, lung sounds are clear abdomen is soft he does have some tenderness in the epigastric area no rigidity or distention is noted.  Patient is neurologically intact he is alert and oriented x3, able to ambulate unassisted with a normal gait, sensation is intact, strength is 5 out of 5 in both upper and lower extremities bilaterally, no pronator drift, cerebellar function intact with finger-to-nose and heel-to-shin test.  Posterior oropharyngeal area shows uvula is midline there is no swelling airway is patent.   This is an atypical presentation if the patient is actually having an reaction to the vaccination however I am also concerned for possible abdominal issue we will work him up for ACS as well.  We will give patient a dose of Benadryl to see if that helps with some of his symptoms Bentyl for the stomach cramping and spasming and some fluids.   Lab work was unremarkable patient had a negative troponin's EKG was negative for STEMI, ischemic changes T wave abnormalities, lactate was normal, lipase was normal.  Patient still complaining of abdominal spasms but states he is feeling better than when he first arrived and would like to go home.  Patient states that his abdominal spasms have happened intermittently over the last few years he has had multiple imaging of his stomach and that he feels comfortable being discharged with the intention that if anything worsens he would return here to the emergency department.
Pfizer and then the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043D21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine (She receive the Pfizer vaccine on 26APR2021 (lot number EX0438)) on 26-Apr-2021.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna). On 30-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer and then the Moderna) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient received the Pfizer vaccine on 26APR2021 (lot number EX0438) and then the Moderna vaccine on 23JUN2021 (lot number 043D21A). They received these vaccines from a health authority, but recently moved. They wanted to travel, and do not want to be "grounded" due to their vaccination status. She has not experienced any symptoms or received any treatments since receiving the vaccine.
Pain, redness, itchiness all over upper right arm near injection site. Started 6 days after vaccination and has lasted 6 days so far. Most severe on days 6-10 after injection.
Information has been received from a certified medical assistant concerning a 6 year old female with no allergies or medical history who on 04-SEP-2001 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus live (Wister RA 27/3) (Oka/Merck) (MSD). Over five years later, on 20-FEB-2007 the patient developed shingles on the left arm. She initially presented with one lesion and the lesions have progressed to multiple macular clustered vesicles from her shoulder to the hand. Unspecified medical attention was sought. The patient was being treated with acyclovir (Zovirax). No diagnostic laboratory tests were performed. The patient's shingles persisted. A product quality complaint was not involved.  Additional information has been requested. This is an follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a certified medical assistant concerning a 6 year old female with no allergies or medical history who on 04-SEP-2001 was vaccinated SC with a 0.5 mL dose of VARIVAX (Merck) (lot #639128/0567L). Concomitant vaccination included a dose of MMR II (lot # 639570/0698L). Over five years later on 20-FEB-2007 the patient developed shingles on the left arm. She initially presented with one lesion and the lesions have progressed to multiple macular clustered vesicles from her shoulder to the hand. Unspecified medical attention was sought. The patient was being treated with ZOVIRAX. No diagnostic laboratory tests were performed. Subsequently the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Patient started getting severe stomach pains approx. 24 hours after Gardasil vaccine.  She threw-up violently at least 13 times. For the next 3 weeks she suffered from fatigue, joint pain, numbness and tingling in her fingertips, fevers, nausea, sore throat, skin peeling off of her hands, muscle weakness in her legs.    11/30/09:  Infectious disease consultation received for date of service 8/05/09. Dx: Viral syndrome.  Presents with c/o sore throat, fever, emesis, joint pain and tingling and stiffness of fingers following vaccination.  MD states sx. unlikely related to vaccine, rec. continue HPV series.    12/23/09 clinic records and laboratory reports received for DOS 07/28/09-07/29/09. DX: Acute Viral Pharyngitis. Patient presented with c/o sore throat, dysphagia and vomiting.  12/23/09 clinic records received for DOS 08/04/09-10/05/09. DX: Viral infection and acute pharyngitis.  Presents with c/o headaches, fever, vomiting, joint pain, body aches, sore throat, cough and decreased appetite. Plan: Ibuprofen, fluids and rest.
THE NEXT DAY I HAD A FEVER OF 102 WHICH WENT AWAY THE SAME DAY  MY RIGHT ARM AT INJECTION SITE STAYED VERY RED AND SWOLLEN FOR OVER 5 DAYS -  RIGHT ARM PAINFUL IN MUSCLE AND JOINT FOR A MONTH AND A HALF - (COULDNT LIFT ARM WITHOUT PAIN) MUSCLE/JOINT IS BETTER BUT STILL CAN FEEL ITS NOT BACK TO NORMAL  TWO MONTHS LATER - CAN THIS BE PERMANENT?
Information has been received from a physician concerning a 15 year old female patient with no drug reactions/allergies and a history of learning disability and cognitive impairment who on 23-JAN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 660557/0072X). There was no concomitant medication. On 20-MAR-2009 the patient received the second dose of GARDASIL (lot # 660557/0072X) and on 18-SEP-2009 the patient received the third dose of GARDASIL (lot # 663452/0671Y). On 07-NOV-2009 the patient developed a seizure and was hospitalized for 2 to 3 days. The physician saw the patient on 13-NOV-2009 "today" and the patient's mother said the patient was "fine". The patient was on an unspecified antiseizure medication. A neurology consult was pending. MRI results were pending, cat scan and blood tests were normal. Seizure was considered to be immediately life-threatening and disabling. Additional information has been requested.  11/23/2009 Out-patient progress notes and laboratory test reports received for DOS 09/18/2009-11/13/2009. Assessment: Seizure Disorder  Patient had generalized seizure (2 episodes). Hospitalized 11/07/2009 through 11/09/2009. Progress note of 11/13/2009 notes patient alert and oriented X3 and neuro intact.  12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Assessment: Generalized Tonic/Clonic Seizure. Mother heard strange noise, found patient stiff, head turned to left. Tonic/Clonic movements of limbs followed by postictal state. Urinary incontinence. Presents unresponsive. Seizure in ER. Cold sensation. Headache. Hand grasp weak. Slow to answer questions.
This case was reported in a literature article and described the occurrence of cough in a child subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, less than a month after receiving Meningococcal ACWY-CRM vaccine, the subject developed cough. Serious criteria included other: serious per author. The outcome of cough was unknown. It was unknown if the investigator considered the cough to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of cough in a child aged between 2 and 10 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the retrospective observational cohort study that summarized the occurrence of 26 pre-specified events of interest (EOI)  and serious medically attended events (SMAEs) occurring up to 1 year after vaccination with MenACWY-CRM in children aged 2 through 10 years (inclusive-i.e., did not reach their 11th birthday) in routine clinical care. The study was conducted as part of a postmarketing commitment required by the regulatory authority at three medical centers within a particular healthcare system. In this study, most of the children had not received any prior MCV4 vaccinations. The patient was enrolled at  healthcare  system  for 6 or more months prior to the first dose of MenACWY-CRM in order to have 6 or more months of observation time to identify preexisting diagnoses. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 September 2014, the patient received MENVEO (administration site and route unspecified; dosages unknown; batch number not provided). (It was reported, in January 2011, MENVEO, (GSK) was approved by the Food and Drug Administration for children aged 2-10 years in this  country). [In this study, most children had not received another dose of MCV4 during their observation period (out of 327, 318 received 1 dose and 9 received 2 doses). The majority of children (n=236) received their index vaccination between 7 and 10 years of age]. The age of vaccination was not provided. On an unspecified date, within 30 days of vaccination, the patient was diagnosed with cough. (In this study, cough was considered as an SMAE). This case has been considered serious per author "SMAE". Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of cough and MENVEO. The authors concluded, "Data from this descriptive study do not suggest safety concerns associated with MenACWY-CRM vaccination when used as part of routine clinical care of children aged 2 through 10. However, the generalizability of the study results to the high risk child population with complement component deficiencies or functional or anatomic asplenia is more limited due to the small sample size of children with these medical conditions in our population". This is 1 of the 5 valid cases reported in the same literature article.
She experienced swelling, soreness, redness, and burning sensation the night when she had a shot. She couldn't lift her left arm. Her symptoms have been getting better.
36 weeks pregnant patient got first dose of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (36 weeks pregnant patient got first dose of Moderna COVID-19 vaccine) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Jun-2020 and the estimated date of delivery was 06-Apr-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (36 weeks pregnant patient got first dose of Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Mar-2021, EXPOSURE DURING PREGNANCY (36 weeks pregnant patient got first dose of Moderna COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was 36 weeks pregnant and in third semester at the time of the report.  The patient had established prenatal care and had one fetus. There was no complications or acute illness during this pregnancy till date. The patient give live birth to full term baby on 28-Aug-2015.  No treatment details were provided by the reporter.
Patient returned to us on 6/11/21 to get her second dose of Moderna and reported that her arm was still a little sore from the first dose.  The patient stated that the day after getting her first dose (5/15/21), she experience arm soreness. Over the next few days she stated that the pain got better, but she was still feeling a little sore as of 6/11/21.  She reported no loss of movement, nor was the area red or swollen.  The patient was informed to reach out to her pcp.
Patient tested positive before the second dose; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female who was vaccinated with the first dose of GARDASIL on 02-MAR-2009 and vaccinated with the second dose on 07-MAY-2009. There was no medical history. The reporter stated that the patient was now pregnant, and pregnancy was normal to date. The patient's last menstrual period was on 12-APR-2009 and estimated date of delivery was 17-JAN-2010. Her estimated date of conception was 20-APR-2009. A urine pregnancy test was performed. The patient had sought medical attention at the office. Follow up information has been received from the registered nurse concerning the patient with 2 previous pregnancies (1 full term delivery at 40 weeks and 1 elective termination), no birth defects in previous pregnancies, no infant complications in previous pregnancies and prenatal care (vitamins 1 tablet daily started on 06-MAY-2009) during pregnancy who delivered a male infant on 15-JAN-2010 (at 39 weeks). The infant was reported as normal with weight of 8 pounds 1 ounce and there were no complications or abnormalities. There were no infections or illnesses during pregnancy. On an unspecified date the patient had a positive sonogram of bilateral choroid plexus cyst and echogenic focus on the bowel. Follow up for genetic counseling "ie: Amino ml 46xx-AFP>ml." The mothers experience has been reported in 0906USA02107. Additional information is not expected.
ACUTE RESPIRATORY FAILURE 4/23/2023 PNEUMONIA IDIOPATHIC CENTRAL SLEEP APNEA 4/24/2023 PNEUMONIA
This spontaneous report as received from an office manager refers to an unknown number of patients of unknown age and gender. On an unknown dates in 2016, reported as since August 2016, the patients were inadvertently vaccinated with doses of PEDVAXHIB lot # M010439, expiration date 08-DEC-2018 that had been improperly stored. No adverse event was reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 30 minutes. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent to contact a healthcare professional.