chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 90 y.o. female patient of MD with history of coronary artery disease status post CABG in 1996, type 2 diabetes, essential hypertension, hyperlipidemia, PAD status post left femoral-tibial bypass 5/2019 and recent hospitalization with discharge on 11/29/2022 following intubation secondary to acute metabolic encephalopathy of unclear etiology.  She was initially thought to have had a stroke, but MRI was negative.  She was diagnosed with VZV infection/Ramsay Hunt syndrome and treated with a course of steroids and antivirals.  She was discharged for rehab.  Reportedly she was diagnosed with COVID-pneumonia during that time.  She then had a steady decline over the next week with difficulty with p.o. intake.  She was found unresponsive the morning of 12/3 and was brought into the emergency department. On arrival to the emergency department blood pressure 50s systolic but following IV fluid bolus is 85/33 with subsequent reading of 74/34.  Respiratory rate is 27. Temperature is 99.1. She was 96% on room air. WBC 20,000. Creatinine 5.51. Sodium 151.  Chloride 119. Potassium 3.0. Troponin 111.  proBNP 2,068.  Lactic acid 2.5. Family requested no further radiologic or invasive testing. Condition was discussed by ED attending with the family who opted to proceed with DNR CC and be admitted for inpatient hospice. She had a slow decline over the course of her hospitalization and passed the away the morning of 12/7/22 with a time of death 0750.      Discharge diagnosis ? Viral sepsis due to COVID-19 pneumonia, POA COVID-19 pneumonia Acute metabolic encephalopathy Severe dehydration Hypernatremia/hyperchloremia NSTEMI Leukocytosis AKI on CKD  VZV infection/Ramsay Hunt syndrome Chronic left heel wound, unstageable Dysphagia Chronic HFpEF Essential hypertension Coronary artery disease Type 2 diabetes Peripheral arterial disease
On 4/6/14 vomiting and diarrhea noted blood in stool and very fussy. Sent to ED. Diag. Intussusception.
Pt previously received Orange top Pfizer. Provider ordered the second vaccine without realizing that the patient had a birthday.  Mother of child confirmed age of 11 several times to both provider and MA prior to vaccine administration. Provider realized error as the vaccine was being given. Again, confirmed age with mother of child who contiued to say 11 years old, not twelve. Upon review of her age again and confirmation of birthday, realized that pt was 12, not 11 and that birthdate was correct. Pt received Orange top pfizer instead of grey top pfizer.
PATIENT RECEIVED JANSSEN VACCINE ON 5/19/21.  PATIENT COMPLAINED NEXT DAY, THAT SHE DEVELOPED A BRUISE ABOUT THE 1/4 INCH X  1/4 INCH ON THE INSIDE OF ARM WHERE YOU GET BLOOD DRAWN ON VEIN.  The upper arm was , was clear and no problem. Patient says that bruise went away, but her arm gets nump and falls asleep.  On May 26, 2021 patient called and complained got outer left leg thigh bruise blue in color, the spot is 2 inch x 2 inch in diameter and is hard and hurts. The pain radiates out about the size of palm of her hand and is warm to touch.  Patient says she did not bump herself , and attributes to her Janssen vaccine. Patient feels the pressure, in the area of the bruise when she stands at work. Patient has put call in to doctor. Patient was counseled to go to hospital.
Possible kidney infection; Possible bladder infection; A spontaneous report received from a Consumer concerning, 66-year-old female patient who received first dose of the Moderna COVID-19 vaccine and experienced possible kidney infection and possible bladder infection (Cystitis)   The patient's medical history was not included. Patient's concomitant medication was not included.   On 27JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated she received her first dose of the Moderna COVID-19 vaccine on 27Jan2021. Patient stated on 30Jan2021, she started to smell an odor and believes that she has a bladder or kidney infection. Patient stated that her doctor cannot see her for several days. Patient would like to have the doctor call in a ZPack or other antibiotic but wants to know if this will interfere with the Moderna COVID-19 vaccine. Patient stated that she does not have a fever.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the events was unknown/not reported.; Reporter's Comments: This report concerns a 66--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced possible bladder and kidney infection. Very limited information regarding this event has been provided at this time.  Further information has been requested
HAD FEVER TO 101.5F ON THE SECOND DAY, TOOK 1 PILL OF TYLENOL EACH 6 HOURS (TOTAL 2 PILLS), AND RECOVERED ON THE THIRD DATE.
Shortness of breath, sinus drainage, coughing, tight chest, teary eyes.
Elevated temperatures; Tiredness; Trouble sleeping; Achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, tiredness, difficulty sleeping and general body pain. On an unknown date, the outcome of the fever, tiredness, difficulty sleeping and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, tiredness, difficulty sleeping and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had elevated temperatures, tiredness, trouble sleeping and achiness. The patient did not had any specific details or further information. The reporter did not had lot number or expiration date information to provide for either dose of Shingrix. For tolerances of 2nd dose, refer case US2020AMR125326, reported by same reporter for the same patient. This case linked with US2020124819 and US2020AMR125323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020124819:Wife's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125323:Wife's case 1st dose US-GLAXOSMITHKLINE-US2020AMR125326:same reporter
Rash near injection site; rash then down her back; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2019, less than a day after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. After vaccination, the patient experienced rash near the injection site then down her back. The patient did not consent to follow up.
Information has been received from a licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a non-serous localized injection site reaction. It was unspecified if medical attention was sought. The injection site reaction resolved on an unspecified day by 06-APR-2007. No further information was provided. Additional information is not expected. This is on of several reports from the same source.
Booster 3 08/28/2021 and Booster 4/16/2022-I started experiencing adverse even on 08/29/2021 around 10:00AM- 11:00AM I was nausea, and chills. I checked my blood sugar I was fine. My blood pressure was way down. I usually get blood pressure high so I knew something was wrong. I had fever of 101. I took Tylenol. I called and let my doctor know. I had body aches. I am in a bad health already but this made it worse. It lasted for 3-4 days. Booster 4-I had the same symptoms but I had diarrhea all night 6-7 times very liquidly. It was terrible. This lasted for 3 days and I started to feel better then the 3rd booster.
Onset of strong nausea, chills with fingertips turning blue and fever.  Brain fog and exhaustion made it difficult to get up throughout the evening into the next day.  Nausea, headache and low-grade fever continue to linger and it has now been 3 full days.  Developed an "angry" looking rash in lower left groin area - large red splotches with some itching and discomfort.  Noted rash on the day following the injection and it hasn't diminished as of today.
Patient then started with joint and muscle pain; Patient then started with joint and muscle pain; She had injection site pain which she expected; However she started getting dizziness with headache; However she started getting dizziness with headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jun2021 (Batch/Lot number and Expiry date was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer COVID19 Vaccine 15Jun2021 and she had injection site pain which she expected, however she started getting dizziness with headache that started last week on an unspecified date in Jun2021 and continued until now. Patient then started with joint and muscle pain this past Saturday/Sunday (19Jun2021/20Jun2021). She went to the Emergency Room yesterday and was still waiting on her HCP to call her back as well. The outcome of events headache and dizziness was not recovered whereas other events were unknown.  Lot /batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Report 200102882-1 describes an injection site reaction in an 8 or 9 month old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of Infanrix; it was not known if he had received previous injections of Infanrix. Subsequently, he experienced a "much greater reaction" at the injection site characterized by a 10cm area of redness and swelling. Induration was present in the center of this area. The reporter stated that "it looks like cellulitis." As of 12/03/2001, the outcomes of the events were unknown.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 08-JAN-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # J008802, expiration date: 19-OCT-2014), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient complains of low back pain that radiates to right and left lower extremities within 12 hours of the vaccine being administered, patient states at first she has some numbness in her legs as well. Parent took patient to local ER before midnight on 4-3-19. Patient received CT of lumbar spine w/o contrast that came back with no abnormalities. Patient was treated in the ER with anti-inflammatories. Patient was released home from ER on 4-4-19 at 1:00AM with only mild pain in the lower back and legs but ambulatory at the time of discharge.
This spontaneous report was received from a registered nurse (R.N.) concerning multiple patients of unknown age and gender. No concurrent conditions or medical history were reported. On 21-SEP-2015, multiple unspecified patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot # K018180 Expiration date: 17-SEP-2016) (dose, route and anatomical location of adminstration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
No Adverse event; Received expired 2nd primary dose, 1.5 months after manufacturer expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date) and NO ADVERSE EVENT (No Adverse event) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, 1.5 months after manufacturer expiration date).    No concomitant medications were provided. Caller did not had information on first dose of patient. No treatment medication was provided.   Reporter did not allow further contact
Injection site pain day 1.. resolved. Day 4 intense muscle aches, fatigue, headache, low grade temp,  anorexia. Symptoms continue day 5,6,7... worse in early evening. Limited food intake. Temp to 100.5. No cough or dyspnea. No change in taste or smell   Too ill to work. I am a physician managing symptoms with Tylenol and NSAIDs and rest and fluids
Hospital Course and Significant Findings: 72 year old man with duodenal cancer on chemotherapy, chronic respiratory failure on 2L home O2, COPD, HTN, admitted 1/30/23 with hematemesis. Also with leukocytosis and COVID. EGD 1/30 no active bleeding seen but unable to advance scope into bulb due to compression of the lumen. Suspect that duodenal tumor is the source of bleeding. No active bleeding seen on CT angio. Case discussed w/ IR for possible tumor embolization but was contraindicated due to risk of developing adjacent small bowel ischemia. Has received 3u PRBC this admission.  The pt's diet was slowly advanced to a full diet and his H&H remained stable. Patient seen by palliative care, discussed hospice but patient not interested in pursuing hospice at this time.  Found to be COVID positive on admission, had no worsening of chronic respiratory symptoms, was kept on isolation to continue through 2/5. Had leukocytosis on admission and started empirically on rocephin.  Cultures came back negative and leukocytosis resolved, abx were stopped.
After the 2nd dose, I had the general common side effects of sore arm and feeling tired. About 3-4 days later, I had a consistent dull pain on diaphragm on my chest. I called the doctor and was told not to worry since the pain comes and goes and at that time it had resolved. Around July 2021, the chest pains returned, and it lasted for 3-4 hours and went away. On 8/8/2021, I had another episode of chest pains, and I called the on-call doctor and was instructed to go to the ER if the chest pains did not resolve. I did go to the ER, and they did a blood work, EKG, CAT scan and ultrasound. The ultrasound did show gallstones in my gall bladder. I was admitted overnight to be monitored and to do a stress test the next day.
Sore arm the next morning , not bad Almost exactly 24 hrs later, fever, chills and achiness.
Right eye, redness and swelling of eyelid. Discomfort when blinking.
0859 child stated to father she "did not feel good." 0900 pt. eyes rolled back, and child started to fall forward from exam table. She was caught by M.A. and she was laid down on exam table. Pt. was pallor, and M.D. was called. 0901 SaO2 was requested and saturation was 100%, pulse 98 BPM. 0902 Pt. was given apple juice and crackers and was instructed to stay laying. Blood pressure was checked at 0910am 99/69, and 67 pulse.
Viral Exanthem  8 days after MMR & Varivax Vaccine.
Day of shot-5pm arm started hurting, 11pm couldn't raise arm- extreme pain, could barely sleep due to throbbing, searing pain. This lasted through next day. Gradually subsided until start of 4th day I could raise arm with moderate pain. Day 5 still causing mild discomfort to sleeping and  raising arm.
Lymphadenopathy in the axillary are of my left arm. I have not seen a physician regarding the lymphadenopathy as I have no other signs or symptoms. I?ve read this was considered an adverse reaction and wanted to report it
After having an expected reaction of flu-like symptoms the day of the booster, the following week the skin on my face turned red, began burning and itching, then "erupted" into a complex rash of various types of bumps, red marks, and scaly peeling skin that moves all over my face.  This persisted  for 8+ weeks.
Pt had a panic attack due to fear of needles.  Hyperventilated and appeared to be near fainting, but did not lose consciousness.  EMS reported to care for patient, and she was removed by stretcher.
I started feeling anxious, jittery, and felt like it was effecting my nervous system internally. Started waking in the middle of the night with tingling pulses but there was no outer shaking or accelerated heart rate. I felt to be in a constant panic. It came and went and gradually got better. But I still have tingling and anxiety that surfaces to this day.  I spoke to my doctor 4 days after. I asked them if it could have been the vaccine. They told me to call back if it got any worse but since it was slightly improving everyday, I didnt call back.
pt recv vax & devel erythema multiforme-like rash over whole body; MD noted that the rash was somewhat more diffuse on 20JUN94; pt's mom noted in f/u that the pt ate pasta prior to the time the rash developed;
Patient presents to Urgent Care site on 1-13-22 for arm pain reporting this has been ongoing since receiving vaccine on 11-8-21
Covid 02Aug2022 and then again on 30Aug2022; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTIN, stop date: 02Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Covid 02Aug2022 and then again on 30Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive; (30Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Patient had no known allergies. Anti-viral details included PAXLOVID, treatment start date on 02Aug2022 and treatment stop date on 07Aug2022 for COVID-19 treatment. The patient had Covid on 02Aug2022 and then again on 30Aug2022. The patient enquired did the use of Paxlovid reduce the level of antibodies she created the first Covid round. She believed she had two different strains as the symptoms were not alike.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pain in the left shoulder, which radiated to my back and then my rib cage.  The pain was excruciating, it hurt to cough, to breathe, to even move or turn my body.  I was in tears. I treated it with Tylenol 650 mg and a cold pad for pain relief. The pain was constant and unrelenting until 5/3/21 but I can still feel some tenderness from the areas of pain if I take a deep breath. The pain reminded me of costochondritis but the pain was horrible. I took the Tylenol every 8 hours as directed. I'm taking the Tylenol on an as-needed basis now. Afraid to get the second shot, scheduled for May 16.
Patient received HEXYON and PREVENAR 13 shots. After an afternoon with few naps, but successful feedings, at night patient couldn't sleep, had gas and would vomit after feedings. Symptoms continued until 6:30 AM 03/11/2017 at which point baby paracetamol was provided. Patient then slept 4 hours and resumed normal feeding. But had stuffy green/yellow mucus in his nose all weekend.
p/vax pt exp a 4cm by 6cm warm, red rxn @ the rt side inj site that was raised approx 2mm;pt also c/o discomfort in the area;pt recovered;
Lump under the injection site, 5 or 6 black and blue bruises which are non painful
hypesthenia lt inner arm 2x4cm area paresthesias; nl reflexes, muscle strength
pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid; radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth; Initial information received on 02-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 47 year old female patient who experienced pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth (pain) and (inflammation), while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6855AA and expiry date: 25-Nov-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On 02-JUN-2021, the patient developed a non-serious pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth (pain) and (inflammation), five days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported that the caller is calling on behalf of the patient who received the ADACEL vaccine on Sunday. The caller stated that the patient had pain not at the injection site, but an inch away from it. The pain travels from tricep to bicep and wanted to know if this was normal. That is the only description that was received. Reporter relationship: health care professional (HCP) Product used: used still using product: no  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was reported as unknown.