chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed.   2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest.  Patient is resident of local nursing home.  According to nursing home staff, a tech was in his room talking with him as patient was laying in bed.  Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive.  Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately.  911 was called.  This occurred around 5:30 a.m..   Upon EMS arrival on scene, they found a male unresponsive with CPR being performed.  There was no spontaneous respirations or circulation.  Thus, ET tube was placed and life support guidelines initiated.  Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb.  Patient was worked on at the scene for approximately 40 min before being transferred to ER.   Upon arrival to ER trauma room 1 patient is still in full arrest.  ET tube in place with good ventilation.  Patient remains in PEA.  Chest compressions and life support guidelines initiated.   In reviewing patient's chart and nursing home notes, patient is a full code.  Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG.  Patient also has history of 3rd degree heart block and pacemaker placement.  Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.
Fever; chills; body aches; headache; fatigue; loss of appetite; This is a spontaneous report from a non-contactable consumer (patient).   A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 10Mar2021 at 14:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 19Fewb2021 at 12:30 pm  (lot number EL3248) on left arm. Relevant medical history included Asthma, seasonal allergies, hypertension and Shellfish allergy. Concomitant medications included lisinopril and lansoprazole. On 11Mar2021 at 09:00 am the patient experienced fever, chills, body aches, headache, fatigue and loss of appetite. No treatment was received for the events. The patient recovered from the events on 12Mar2021.    No follow-up attempts are possible. No further information is expected.
Started with fever 8-17-10-took to ED T 38.7 treated with TYLENOL, MOTRIN. Seen in our office 8-18-10 T 103.1 rectal. Urged to continue advice given at ED. P.C. on 8-24-10 spoke mom said child recovered two days later. Mother said baby had fever after last vaccines on 5-5-10? (PREVNAR 13 and H1N1 Flu -did not seek care).
The vaccine was given to high. Very close to my shoulder joint.  Shot hurt when given and still hurting! Pain in joint!
This literature marketed information has been received from a published literature article and refers to a 5-year-old boy with known preexisting alpha-gal allergy. Eight months before this episode he had been diagnosed with alpha-gal allergy (alpha-gal sIgE of 8.19 kU/L, total IgE of 149 kU/L) after several episodes of urticaria and facial angioedema 4 to 6 hours after ingestion of mammalian meat, following a tick bite, and was avoiding mammalian meat at the time of his vaccine reaction. He had no history of egg, latex, dairy, or gelatin allergy, and had uneventfully received all prior childhood vaccinations. Concomitant therapies included KINRIX. On an unknown date, the patient was vaccinated  with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis, VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis and five minutes after receiving the vaccines, he developed shortness of breath, wheezing, disseminated urticaria, and angioedema of the face and oropharynx, prompting an emergency room visit where he received epinephrine, diphenhydramine, prednisone, and famotidine with relief of symptoms within 10 minutes. Diagnosed as anaphylaxis by treating physician. The patient was taken to emergency department, received intramuscular epinephrine with resolution of symptoms within 30-40 min. (recovered). The authors repeated his sIgE titers, demonstrating an increase in the galactose-a-1,3-galactose sIgE concentration to 26.9 kU/L, a beef sIgE of 14 kU/L, a lamb/mutton sIgE of 5.64 kU/L, a pork sIgE of 11.2 kU/L, porcine gelatin sIgE of 0.78 kU/L, and a bovine gelatin sIgE of 0.22 kU/L (reference for all <0.35 kU/L). The patient was skin tested to undiluted vaccines and gelatin. Skin prick tests were placed and read at 15 minutes, with appropriate controls. MMR was positive with a 5-mm wheal and 14-mm erythema, and varicella was positive with a 4-mm wheal and 12-mm erythema. Porcine gelatin was positive with a 6-mm wheal and 18-mm erythema. The histamine control had a 7-mm wheal and 20-mm erythema. DTaP/IPV and DTaP only vaccines were deemed negative on skin prick testing and at 1:100 intradermal testing. The authors concluded that based on agreement between skin and ex vivo testing, M-M-R II and/or VARIVAX appear to have been the cause of our alpha-gal allergic patient's vaccine-associated anaphylaxis. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156: Original Case : 1809USA011156.
Felt a flushing sensation, nausea, and reported feelings of anxiety. Laid supine for 30 minutes. After which she reported a resolution of the symptoms.
Patient received .3 un diluted Pfizer dose. No immediate reaction was observed all 15 minutes
Brief Summary of Hospital Stay:  Patient is under treatment for Large cell lymphoma, extranodal and solid organ sites with Malignant neoplasm of overlapping sites of stomach leading to chronic Epigastric pain, Early satiety, Weight loss.  On routine lab testing he was found to have Pancytopenia due to antineoplastic chemotherapy, including Chemotherapy induced neutropenia.  He had a very low grade fever so was instructed to come to the hospital.  He was found have both COVID-19 and Rhinovirus infections.  He is not dyspneic or hypoxic. No acute findings on chest film. In addition to neutropenia, he has further immunosuppression as he is On prednisone therapy so completred three day course of REMDESIVIR. He was also empirically started on VANCOMYCIN and CEFEPIME but blood cultures were negative at 72 hours so antibiotics discontinued.   Oncology recommended starting FILGRASTIM and his ANC rose to 1500 prior to discharge.
Pt. called on call phone Tuesday p.m. Hard, warm to touch, did spread out to thigh/circle drawn. Told to do ice & MOTRIN - if worse appt. or urgent care.  Given Abx. 8/3/11.
Janssen vaccine was administered outside of facility- reported by patient  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 FATIGUE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ANEMIA OF CHRONIC DISEASE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ANEMIA OF CHRONIC DISEASE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 PNEUMONIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ATHEROSCLEROSIS OF AORTA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE MYELOID LEUKEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ANEMIA OF CHRONIC DISEASE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 FATIGUE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 PANCYTOPENIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 FEVER CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE MYELOID LEUKEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE MYELOID LEUKEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/29/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Large tender bruise at site of injection, raised and pink, then very dark coloring.  Tender to the touch, soreness when using the arm.
Client vaccinated with Moderna vaccines for Covid in July and August, 2021.  Symptoms developed 12/16/2021 - nasal congestion, fever, headache, myalgia.
Chronic epistaxis approximately 6 days after receiving vaccine. She is currently on Coumadin therapy and her INR is normal.
Decreased level of consciousness,,Fevers up to 39.7  and erythematous macular rash involving the arms chest and upper back within 20 hours of the vaccine. the fevers and rash resolved within 6 hours of onset
Symptoms were not fun but I didn't need to be hospitalized, coughing, congestion, sneezing, running nose, mild fever for 2 days, shortness of breath. I was away from home when the illness initially hit me. When we landed we were negative. My girlfriend wasn't feeling great when she tested but was negative. Within 2 days she was full on sick. I tested then with an at home test and was negative. But 3 days later I started feeling sick. And tested positive. We were up in attitude so I'm not sure if shortness of breath was due to that. I have a lingering cough occasionally but have felt fine for 3 weeks now.
Narrative: Employee reports feeling better but has lingering lethargy headache, sedation, body aches
Buzzing or fizzing feeling, primarily in left chest, under skin, above my heart. Also I have arm soreness in my left arm where I got the injection, malaise/fatigue, joint pain, and mild nausea. But I'm making this report due to the strange development of buzzing/fizzing in my chest.  It seems unrelated to breathing. I have a Kardia 6-lead EKG and it is reading normal. My blood pressure is about where it usually is (143/93, elevated due to as-yet untreated Cushing's Syndrome. I do take metoprolol succinate to bring it down somewhat, but diastolic has been chronically 90 and above for several months despite medication.) I don't feel this is a cardiac event, but of course I would like to be sure. It has been constant on and off fizzing/buzzing since 7:30 this morning (may also have been occurring while I was asleep), and it's now 11:08 a.m. My question is whether I need to go to urgent care/ER. Plan is to call Moderna and talk to them about this, and then make a decision about what to do next. I'm reading online that this could be an immune response, that some people with COVID get the fizzing and buzzing. But I never stop with Dr. Google. I'm going to speak with the manufacturer and then either my primary care doc or an urgent care/ER doc. So I clicked "none of the above" below, but I will likely be seeing a doctor today.
Light headed/Dizziness for short duration, about 5 minutes around 3:30 pm on 4/8/2021.
Woke up approximately 3:30 AM Monday morning with abdominal cramping and a fever.  Unable to get back to sleep.  My wife woke up hours later and got a hot pad which helped relieve the cramping, managed to sleep until afternoon.  Temperature was about 100 degrees.  Very fatigued, stayed in bed most of the day.  Woke Tuesday feeling better but still a temperature around 100 and fatigued, slept a lot.  By Wednesday morning all symptoms gone.
Headache,fever,chills,nausea,muscle aches,weakness,dizziness, jaw pain,redness,swelling and pain at injection site
pain in right wrist, especially when lifting anything heavy or bending the hand backwards. This began sometime in April 2022, I don't remember exactly. I listed this on the V-Safe check-in to be thorough.
congestion, fatigue, SOB, tested positive for COVID on 3/30/22 ( several days )
Redness at infection site started that evening grew larger over the next few days. Disappeared on Sunday and then on Tuesday it returned large, red and hot. Went to the doctor to  be treated and they said I have cellulitis. As the cellulitis my body became itchy. Continued itching all over body while taking the antibiotic, unsure why I am very itchy. The redness is gone from the infection site and now I am experiencing itching on legs, arms, back.
3 hours after vaccination, she developed a sore throat, chills and a swollen lymph node in her neck.  She was treated with an antibiotic when symptoms persisted more than 10 days after vaccination.  When her symptoms did not resolve with antibiotics, she was referred to ENT.  They did a lymph node biopsy which showed abscess and then ultimately had to have the lymph node removed surgically due to significant symptoms.  She lost 10 lbs due to difficulty eating because of her symptoms.
pt devel sx consistent w/GBS w/in 1 2k of vax;as a result pt sought ER care;pt later adm to rehab on 26DEC96 for 37 days of in-patient care;pt resulting dx is GBS;
Intermittent swelling across various parts of the body, hives, running a  temperature higher than normal, throughout the day which continued to get worse and hives spread all over body for following 4 days.
Moderna COVID-19 Vaccine EUA  At about 9pm on 1/11/21 (i.e. approximately 5 hours after I received the vaccine), my left shoulder started to hurt.  When I woke up the next morning it was even more sore.  It wasn't bad when my arm was at my side, but it increasingly hurt as I rotated my arm upwards.   I would describe it as about twice as sore as I've experienced in the past after a flu vaccine.   This continued that entire day (1/12/21).  By the next morning (1/13/21), the pain was starting to subside and by 9pm that night, it was gone.  As the pain level was relatively minor (approx. 3/10), I didn't treat it with anything.
Sick/Illness comes and goes; High fever; Chills; Headache; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick/Illness comes and goes), PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 22-Dec-2021, the patient experienced ILLNESS (Sick/Illness comes and goes). At the time of the report, ILLNESS (Sick/Illness comes and goes), PYREXIA (High fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The patient received booster dose and was sick by 05.00 pm Treatment information was not provided.   This case was linked to MOD-2021-426928 (Patient Link).
Extremely sore arm, massive swelling of entire upper arm (not just at injection site), redness  of skin around injection site, skin is hot to the touch of entire upper arm.  I used telehealth treatment via Doctor?s on Demand. The doctor was able to see the redness and swelling over the video chat. The doctor stated that it was either a reaction from the vaccination or an infection, but that he did not want to wait and see which one it was. So I was prescribed antibiotics for a week plus diflucan for the yeast infection that antibiotics always cause. The doctor?s name was Aravindan Amuth. He is not my normal PCP. I did alert my PCP via portal. I have not yet picked up my prescriptions as they are not ready yet.
Hives on arm.  Large skin welts on different parts of the body (back and arm). Sometimes on my rear neck.  This also occurred since the second dose of Moderna approximately one month after the second dose. I do not have a history of hives or allergies. I have diabetes but have been on diabetes medication for about two years consistently with no side effects related to skin. My diabetes has been maintained under control. Since the second dose, I have intermittent hives. Since the booster, I have had daily hives after about one week.
I got the vaccine at 9:30 am, by 5 pm I started to have a sore arm. By 10:30 pm I had horrible chills and started to feel achy. The next morning I was still feeling the same chills and ached and had cold symptoms as well.  Around noon I started to have a temp that went to 102.5. The aches in my body were horrible, my legs being the worst. I slept on and off from 6 pm on, my O2 levels were 89-90 and my pulse was high.  I woke up this morning at 6 am in a pool of sweat, my fever broke and I am feeling better. My aches are going away as well. I am tired, still feel a little weak and my chest feels a little heavy.
UNABLE TO DRIVE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced unable to drive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to drive. This report was non-serious.
Initial misuse report received from a healthcare professional on 03 December 2013. A 37 months old patient had received 0.25 ml FLUZONE QIV instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
Patient had a dose of Pfizer COVID-19 Vaccine on 05/28/2021 and another Pfizer COVID-19 vaccine on 06/08/2021
This is a spontaneous report by a contactable nurse. This is third of the three reports. This nurse reported that a patient received PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were unknown. Vaccines taken within the last four weeks were not provided. On an unknown date after vaccination, the patient experienced swelling and redness at the site of injection. Relevant lab data was unknown. Treatment given was not provided. At the time of the report the clinical outcome of the above event was unknown. Follow-up (14JUL2011): Follow-up attempts completed. No further information expected.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient received vaccine and fell in store after becoming dizzy. hit head on fixture. EMS called.
Twice out of the last five I have gotten the flu; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient of an unknown demographics who experienced twice out of the last five had gotten the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) patient stated that got the vaccine every year. He/she in the group, not just age, but health, that should got every year. Twice out of the last five had gotten the flu (influenza).   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
lightheadedness Narrative:  Developed sudden onset of lightheadedness about 13 minutes post-vaccination. Was able to walk on her own from the observation area to the examination room (~100 feet). Denied confusion, dizziness, weakness, disorientation, tachycardia, nausea, abdominal cramps, pruritus, flushing, wheezing, palpitations. No loss of consciousness, angioedema, stridor. Vitals WNL, exam was WNL. She was provided a bottle of water and drank it without any difficulty. After another 10 minutes, she noted that the lightheadedness was subsiding and requested to be excused. She notes that she had been very anxious prior to receiving the vaccination.
Febrile seizures 8 days after MMR/Varivax.  CBC and chem 8 drawn.  Temperature of 101 (Rectal).
Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
Initial report received from a consumer on 10 OCTOBER 2014. A 69-year-old female patient, whose concomitant medication was not reported and had no medical history, had received a dose of FLUZONE HD (batch number, dose, dose in series was not reported intramuscularly in left arm on 21 SEPTEMBER 2014. On 21 SEPTEMBER 2014, after vaccination, the patient presented pain at injection site immediately and has gotten worse since vaccination, left arm was very painful, can't lift her arm more than 6 inches. The patient experienced difficulty in sleeping due to the painful arm. Laboratory investigation was not reported.  Patient was treated with TYLENOL and CELEBREX with no relief. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a non-health professional (Medical assistant) on 26 FEBRUARY 2015: It was reported that the patient did not receive flu vaccine at their office and they did not have any additional information. Documents held by sender: none.