chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Physician:  MD Primary Care Physician: MD   Date of Admission: 8/23/2023 Discharge Date: 8/29/2023 Room Number: 2022/2022-1  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Acute renal failure, unspecified acute renal failure type [N17.9] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 86 y.o. male past medical history diabetes, HLD, HTN, CAD, RA, BPH who presents with weakness and a fall.    In the Emergency Department, he had labs showing AKI with Cr of 1.49. His procal was negative, lactic acid elevated at 3.8. He had no leukocytosis. He was found to be febrile on presentation and tested positive for COVID. He was given IVF and tylenol with improvement of his symptoms. He became hypoxic requiring supplemental oxygen and was treated with decadron. CXR was negative. The hospitalist team was contacted for admission and further management. Hypoxia rapidly resolved and covid 19 therapy was not continued. PT/OT evaluated recommended SAR. MSW/CM consulted for discharge planning. Local wound care for bilateral knee scrapes was performed. Discussed Afib on EKG and therapeutic anticoagulation. After consideration family and patient agreed to start eliquis. Initially recommended by PT for pt to discharge to SAR. Pt improved during admit, so was eventually discharged home with HHC under the care of his daughters.    Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge
drops of the vaccine had leaked onto the table at the time of vaccination due to dose less than 0.5ml also administered Flumist/NO AE; drops of the vaccine had leaked onto the table at the time of vaccination/NO AE; drops of the vaccine had leaked due to needle/ hub connection/NO AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received vaccines FLUMIST and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received less than 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency once) lot UT6681NA, expiry date-30-06-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient received a dose of suspect FLUMIST not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Incorrect dose administered and vaccine underdose.  It was also the case of syringe issue.  At the time of report no adverse event was 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.
Information has been received from a nurse concerning a 15 year old female who was vaccinated with her first dose of Gardasil. Subsequently the patient fainted within minutes. Unspecified medical attention was sought and no treatment was required. Subsequently, the patient recovered. Additional information has been requested.
Diarrhea starting 1 hour after injection and lasting 3 hours.   Feeling of having a hot flash about 4 hours after injection which subsided after 10 minutes.  Abdominal bloating and distension the following day (1/09/21) which resovled after 24hours.
Migraines/insane migraines; felt fainting; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 24Sep2021 16:00 (Lot number was not reported) as single dose (at age of 40-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Sep2021 patient experienced fainting and on 24Sep2021 she experienced migraines/insane migraines. Patient stated that she received second dose of Pfizer covid vaccine on 24Sep2021 and began having Migraines, they come in waves and are getting worse. Patient asked if this side effect had been reported and how long to expect it to last. Patient reported she was normally healthy no issues. Patient stated that she had called her family doctor and where she got the second shot, she got this past Friday around 4pm, 24Sep2021. Since getting the second shot she has been getting insane migraines, and she had never even had a headache before. They are debilitation and she felt like they were progressively getting worse. The day of the report was the 4th or 5th day she had been dealing with this. The day of the report she felt fainting and almost fell. She wanted to know if this going end and how long will it last. Patient had not recovered from migraine, while outcome of the other mentioned event was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 12-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R018589, expiration date: 09-AUG-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
4/9 Aches, fatigue, redness and hurt at site of injection - apply soaks, fever 101; 4/10 - red, warm, swollen area 3x5cm right upper arm; Diagnosed cellulitis - Treatment Ceftin 250mgs BID x 10days, compresses
After injection, approximately 6 hours, left deltoid began hurting, then turned red and swollen at site, raised 1/4", not hard, centered, it stayed about 18 hours. Client did not apply ice or any treatment, thereafter it went away without difficulty.
Administered 8/9/15. Pt noticed redness and itchiness a few hours later. Called on 8/11/15 to report site was better on 8/10/15 but has since gotten somewhat worse on 8/11/15. Suggested 50mg diphenhydramine and consult with Primary Care in morning of worsens.
Injection site pain and slight headache  Took Tylenol and Ibuprofen
Morning after the second dose (Wednesday) I awoke up with a headache, sore arm, and fatigue. Within 2 hours of waking I developed a fever (101) and muscle body aches in addition to the headache, sore arm, and fatigue. Tylenol (1300 milligrams) was taken, fluids and rest. Symptoms continued throughout the day into the night.  Awoke Thursday all major symptoms subsided. Fatigue and sore arm continued.
Patient had the Moderna COVID vaccine on 12/30/20. She reports she was diagnosed with Bell Palsy on 1/14/21 in the ER. She does report a history of Bell Palsy at age 20, however denies any complications and reports full resolution of symptoms at that time.
Employee called from doctor office (pcp) to report to us that the patient had a cellulitis infection in the arm that the immunizations were administered in.
On 8/10/2011 the patient's mother called reporting that the child was c/o a red sore RA. Also, had fever.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/4/2021 UNSPECIFIED ANXIETY DISORDER  ACUTE RESPIRATORY FAILURE 10/25/2021 UNSPECIFIED ANXIETY DISORDER  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 UNSPECIFIED ANXIETY DISORDER  HYPOXIA 1/18/2022 UNSPECIFIED ANXIETY DISORDER  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/4/2021 UNSPECIFIED ANXIETY DISORDER  ACUTE RESPIRATORY FAILURE 10/25/2021 UNSPECIFIED ANXIETY DISORDER  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 UNSPECIFIED ANXIETY DISORDER  HYPOXIA 1/18/2022 UNSPECIFIED ANXIETY DISORDER  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/4/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE RESPIRATORY FAILURE 10/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOXIA 1/18/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/4/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE RESPIRATORY FAILURE 10/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/19/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOXIA 1/18/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Rash  down both arms. and then went to both legs, Rash was very itchy and started to bleed.I thought it would go away but it did not.I went to my dotor on 7/27/2021 he prescribed Hyroxyzine 10mg and Triamcinolone .01%. the Rash started to go away. The rash came back on 9/20/2021 I reapplied the cream took my Hydroxyzine.which helps.Please tell this will not be permanent?
Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms.  By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to  ER by paramedics, and admitted  for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths.  Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.
Received the shot 10/11 2:00pm - started achy & tired around 7pm - got worse - pain in (L) with movement and achy all the time. Difficult to raise above head. All that week it hurt called office on Monday 10/18 seemed better - then Tuesday pain became worse again. Taking 800mgm x2 - no redness or swelling in arm.
red rash around injection site; red rash around injection injection site of the size of half a dollar, not raised, big red circle; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (red rash around injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (red rash around injection site). At the time of the report, VACCINATION SITE RASH (red rash around injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
15 Nov 2021: -11:50 AM:  Patient complained of oral itching in top lip.  Patient was given Benadryl 50 mg PO .  Patient was breathing comfortably on Room Air, with no evidence of respiratory distress.  No oral/throat swelling concerning for Anaphylaxis.  -11:59 AM: Vitals - SpoO2 100%, HR 74 -12:16 PM:  Symptoms on lip resolved.  Patient states pharyngeal tingling reduced and much improved.   All throughout clinical encounter, patient remained breathing comfortably on Room air with no evidence of compromised airway or respiratory distress. Patient was monitored by healthcare staff for a total of 1 hour
1- Fever 2- Chills 3- Blood pressure when up to 170/140 4- Pain in chest and intestinal/colon pain that have not gone away 5- Liver damage.
Extreme cold, chills, teeth chatter, contraction in upper chest area( more than a shiver), feeling of blood leaving hands and feet, mild headache  Started 12:30 am aug 1 Added wool afghan, small airline style microfiber blanket, large king size dpuble layer microfiber blanket, polyester filled quilt Ended 4:30 AM. TOTAL 4 hours
The individual was debilitated to the point that she could not get out of bed; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The individual was debilitated to the point that she could not get out of bed) and PYREXIA (fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (The individual was debilitated to the point that she could not get out of bed) and PYREXIA (fever). At the time of the report, ASTHENIA (The individual was debilitated to the point that she could not get out of bed) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 for 10 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported the patient was sick for a month. The patient  approximated worst fever to be 101 for 10 days, and the fever lasted for 30 days total. The individual's immunologist recommended no further Moderna shots. The patient was told by an immunologist that  due to an overactive immune system, which may have caused the reaction. No treatment medications were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-APR-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX lot reported as J003712, expiration date 27-MAR-2015. Secondary suspects and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
:1039: Responded to notification of potential adverse reaction after receiving COVID-19 vaccination.  Pt had been escorted from observation area to emergency area with PA with c/o tightness in throat.  On my arrival, pt was eupneic, p/w/d, ambulatory, NAD.     Vitals @ 1039: P72, 100% pulse ox on RA Vitals @ 1056: P72, 98% pulse ox on RA, 112/78 seated.   Administered 25mg diphenhydramine po per PA @ 1050, pt swallowed with water.   Called 911 for EMS response @ 1103 per instruction from provider.   Vitals @ 1103: 98% pulse ox on RA, P74, denies shortness of breath or pain.   Off phone with EMS @ 1108, en route.   EMS on site @ 1115, report given to medic.    Pt left with EMS en route to ED @ 1116.   Report called to ED Charge Nurse @ 1121.      Patient presented to   vaccination clinic.  Patient received her vaccination at approximately 1021.  Patient reports symptoms onset at approximately 1038 with tightness of the throat and difficulty swolowing.  She described it as a swelling of the throat sensation.  She states she had a sensation moving from her head to her toes as in a "wave ".     Patient denied shortness of breath, chest pain denies nausea.  Patient denies hives or rashes or pruitis.     Patient was assessed and  moved to the emergency area.   Her symptoms continued with some improvement.  At this point time 25 mg of Benadryl was administered orally. Approximately 10 to 15 minutes after administration the patient developed numbness tingling around the upper lip, the right upper extremity.  She denied shortness of breath or chest pain.  She denied increasing severity of the throat sensations.   Pertinent past medical history: Reactions bee stings currently carries EpiPen.    She is not had any previous reactions to vaccinations.      Allergic reaction.   The patient symptoms seem to continue with the numbness tingling around the lips after administration of the Benadryl.  Hand tingling of the right upper extremity also continued although it was decreasing.   Her symptoms of the tightness of the throat remain the same. She did not develop shortness or breath or chest tightness or pain.    At this time I feel be prudent to evacuate the patient to higher level care.   Patient was evacuated at 11:16 by ambulance service.
Arm where shot was administered was extremely sore to the extent that I could not sleep/put any pressure on that side of my upper body; had pounding headache; nausea; and chills. Took an NSAID. Symptoms disappeared within 24 hours.
Vaginal herpetic outbreak (first ever) Occurred ~36 hours after vaccination.  Full recovery.
Patient given Novavax (COVID19) as a booster dose when he had previously received a booster dose (3rd dose) of Moderna (COVID19). No adverse events observed or reported by patient as a result of this dose administration.
Headaches, stomach aches, loss of appetite, red skin  around the area with mild swelling and soreness. Today is day 2 of symptoms, which are milder.
Moderna COVID-19 Vaccine EUA  The day after receiving her shot she exhibited significantly worse dementia symptoms (Very forgetful, repeating questions over and over, confusing close family members, etc.)
Information unavailable.  Death certficate reports respiratory failure, leukocytosis, covid-19
Patient (employee) reports pain in upper right arm and right shoulder to base of right side of neck.  Pain started to two (2) days after injection and continues to present time.  No loss of sensation or function reported.  Fever denied.  Rash, infection, inflammation, bleeding, drainage - all denied.
Fatigue at 24 hours. Sore, painful arm that lasted up to 9 days (still having symptoms as of 4/7/21) - Ibuprofen helped alleviate symptoms.
Events occurred approximately 17 hours from shot. Low fever (between 99.4 and 100.6F) for about 18 hours. Headache/migraine lasting 20 hours. No treatment sought and no medication taken.
Developed fever to 103F, within 24 hours, post vax, and resolved by 48 hours. Had residual swelling about 1cm diameter on 11/1/00.
While this provider was assessing this patients brother, this patient complained of shortness of breath. She was seated in the high fowlers position on the provided bed. She stated her symptom had just started, and described it as a "chest tightening feeling". The patient is alert and oriented, answers all questions appropriately. Vitals were assessed, and lung sounds auscultated. Lung sounds were clear in all lobes, no wheezing noted. Patient was speaking in full sentences with no color change. Airway examined, no swelling or color change in the lips, tongue or gums. She denies difficulty swallowing, no chest pain, or other symptoms. She was assisted in one dose of her prescribed albuterol inhaler which was provided by the mother who accompanied the child. Per the patient, 2 puffs of inhaler provided immediate relief.  Follow up recommended by this provider; continue to watch for signs of worsening trouble breathing, and continued need of inhaler, follow up with primary care physician for notification of symptoms after first vaccine. If at home nebulizer is required, be seen at local emergency department immediately. Patients parent was in agreeance of outcomes and decision. The refusal form was explained by this provider and signed by the mother. The patient stood without assistance and exited the vaccination clinic.
Extremely shaky left arm.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 16Aug2021 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Aug2021, the patient experienced extremely shaky left arm and this effect was not present in right arm. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) and the result was unknown. Since the vaccination the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extremely shaky left arm was not recovered at the time of report.
C/o itching (R) arm at site of varicella injection. Then began c/o tightening feeling in throat & itching of neck. Diphenhydramine 50 mg given IM (R) deltoid. Called EMD. EMS came to evaluate. She reported feeling better & declined transfer for further evaluation.
Due date is in a few months First pregnancy  Adverse effects include fatigue, soreness in arm, body ache and mild nausea.
Looking better this morning but started with redness, swelling, and warmth that spread over the course of 3+ days since Tuesday am, 12 days after vaccination.
C/o an itchy rash on trunk and both upper arms 10 days after the #2 Moderna vaccine on 4/13. No rash with first vaccine. Taking Benadryl 25mg and Benadryl cream- not helpful.  Denied any new med, food, body products including detergent. 11days after that- today, rash improved. Xyzal OTC was helpful.
1 1/2" needle, 22 gauge, used to administer the flu vaccine. Caregiver describes the following: "I  received my flu shot yesterday. The shot itself was awesome and did not hurt at all. By the time I had walked back to my office I had pain down my arm and into my fingers and it was neuropathic like in nature. Sort of tingly but also hurt. I was just thinking it was due to something with the shot but that it would go away. It still feels that same way today". In follow-up she reported that by Sunday, her fingers were no longer numb and her arm felt pretty good.
A nurse stated that this child presented in there office on 06/29/00, with severe large red welts on her upper right arm. Had also gone to the hospital ER on 06/28/00.
Received adult Td booster 2-13-06 subsequently developed L arm (deltoid) redness (circumferential) distal to injection site to level of elbow.  No wheeze no fever no hypotension. Question itch.  Treated with local ice, Benadryl, Keflex.
Numbness extending from pinky and ring finger to elbow. Pt states that this started with his elbow and spread to his hand. He states that a couple days after the vaccine, he felt sick with joint pain and cold symptoms for three days. Pt states that after feeling sick his elbow on left side was still hurting and the pain never resolved. The numbness spread to his hand over the next couple days.  Pre-dose therapies:none
ACHES in all muscles & joints/fatigue/swelling in different areas of the body/disrupted bowel & sleep functions/dizzy/vomitting  After 8 months, I still suffer with aches, stiffness, sleep & bowel problems & swelling