chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 70 year old MALE with a PMH significant for CLL and prior pulmonary embolism on chronic anticoagulation who now presents with complaints of a one week h/o increased SOB and generalized muscle weakness and numbness. In the ED he was noted to be in atrial fibrillation with a HR of 130-150. He was placed on a diltiazem gtt and is now admitted to the MICU for critical care monitoring and management. He presently denies chest pain, back or pleuritic pain, palpitations. and cough. He had a fever in the ED but denies chills presently. ASSESSMENT/PLAN: 1. Severe sepsis: Not in shock; Most likely due to pneumonia - Start ceftriaxone and azithromycin - Volume replete with crystalloid and colloid solutions 2. Pneumonia: CAP vs. Aspiration - As per #1 3. Pulmonary embolus: No sihns of pulmonary HTN or RV compromise presently - Continue anticoqagulation 4. Acute kidney injury: Most likely due to hypovolemia and sepsis - Volume replete - Start loop diuretics prn 6. Hyperkalemia - start calcium, HCO3, D50, IV regtular insulin, and Kayexylate - Start volume repletion as per #4 - Start loop diuretics prn 70 yo male with multiorgan failure including AKI. He presented to ER and was admitted with Afib/RVR and sepsis. He suffered a PEA arrest and required 3 pressors initially. He was was found to have Streptococcus on biofire. This morning he remains on epinephrine drip and levophed drip and has had no urine output and remains hyperkalemic. Temp ~103 Intubated, unresponsive, not on sedation Skin mottled, cool large ecchymoses on dependent areas of trunk No significant peripheral edema Patient is in multiorgan failure, has AKI undoubtedly in part secondary to ischemic ATN from sepsis and PEA arrest. He is now anuric. He is hyperkalemic with some peaking of T waves on EKG Discussed with ICU team, dialysis would be very high risk given hemodynamic instability, multiple pressor requirement. However, as discussed with team, will offer a trial given he is now anuric and hyperkalemic with EKG changes. However, would do so reluctantly given that dialysis may result in terminal event given current tenuous status and is very unlikely to change the outcome. Patient is not stable enough to transfer to another facility for CRRT as per ICU team.
twelve hours after my first Moderna injection I developed  tightness in my throat ,swollen tongue and lips  which was relieved with benadryl.  Also had burning  down dermatone left face, no facial drooping noted.
The needle was not on tight enough and more than half the dose seemed to dribble down his arm; The needle was not on tight enough and more than half the dose seemed to dribble down his arm; Dribble down his left arm.; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient, who while receiving Moderna's covid-19 vaccine (mRNA -1273), more than half the dose seemed to dribble down his left arm as the needle was not on tight enough/device connection issue, underdose, exposure via skin contact.  The patient's medical history was not provided. Concomitant medications were not reported.  On 07 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, while vaccinating the patient, the needle was not on tight enough and more than half the dose seemed to dribble down his left arm. The pharmacist plans to administer another dose. Treatment details were not mentioned.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event more than half the dose seemed to dribble down his left arm as the needle was not on tight enough was resolved on 07 Mar 2021.; Reporter's Comments: This report refers to a case of underdose, device connection issue and exposure via skin contact for mRNA-1273 (lot # 011A21A) with no associated
15 days after injection, very very large red patch appeared (in the evening). It was itchy. Next morning, it was elevated, hot, with peeling eczema flaking skin.  It was still itchy. Now, 24 hours later, it is still red, itchy, elevated, hot to the touch, with peeling eczema flaking skin.   It is not clear if Benadryl would be helpful and/or safe to take for this so no medication is being used at the present time. More information about this would be helpful.
Pt in to have a port placed for chemotherapy, spiked a fever to 39.8 C
reports severe local rxn lt arm swelling of arm & fingers, red & very painful;seen @ local ER & was told to take APAP;later returned to ER & recv cortisone shot;
COUGH STARTING 2 HOURS AFTER INJECTION TROUBLE BREATHING STARTING THE FOLLOWING NIGHT WITH LUNG PAIN WITH EVERY COUGH WHICH BECAME WORSE
Developed severe pain in abdomen and back, 2-3 days later rash appeared on right abdomen and right back...seen by M.D. , diagnosed with shingles and treated with Valtrex 1000 mg 3 time a day x 7 days.
tinnitus approximately two weeks after second dose and has continued to date numbness/ tingling in feet and face has resolved except minor occasional numbness in feet
Caller stated that she had the first dose of the pfizer covid 19 on 13Feb2021 and then on Tuesday tested positive for covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of age 38 (units unknown) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient had the first dose of the pfizer covid 19 on 13Feb2021 and then on Tuesday (Feb2021) tested positive for covid. Caller wanted to know she should get the second dose on schedule. The event was assessed as non-serious. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Tingling in hand arm going toward injection site. EMS evaluated.. Tigling abated after EMzs raised arm. Stayed until 10:55am and went home.
pt had a low grade fever starting approx. 24 hours after receiving the vaccine, and developed hives on her forearms
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Day 1: Tested negative 1 and 3 days  after stopping Paxlovid; (Nov2022) Negative, notes: Day 3: Tested negative 1 and 3 days after stopping Paxlovid; (Nov2022) Positive, notes: tested positive again on day 4 after stopping Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid taken as treatment from 03Nov2022 to 08Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got first vaccine and did not get menses on time after that, was two weeks later. Has previously had very regular menses.  Also with new bakers cyst left knee developed after vaccine as well. Diarrhea for 2 weeks after each vaccine, developed hemorrhoids as a result.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:00 (Lot number: EW0179) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: AZOR [ALPRAZOLAM].The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered" (2021), described as "Moderate Stomach cramps"; NAUSEA (non-serious), outcome "recovered" (2021), described as "nausea"; DIARRHOEA (non-serious), outcome "recovered" (2021), described as "diarrhea"; IRRITABLE BOWEL SYNDROME (non-serious), outcome "recovered" (2021), described as "IBS symptoms"; FATIGUE (non-serious), outcome "unknown", described as "severe fatigue". The events "moderate stomach cramps", "nausea", "diarrhea", "ibs symptoms" and "severe fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea.Additional information: Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with Zofran for nausea. Follow-up attempts were completed. No further information was expected.
Pt recvd 3 doses of Engerix-B 30OCT90, 30NOV90 & 1MAY91 & 11SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
First night: site pain, redness, fever, chills, swelling, generalized  joint pain. Current: upper arm redness, swelling, itching, pain, afebrile. Benadryl 50mg and tylenol taken last noc without relief.
Pt had injection on 6/10/15, pt said upper arm to elbow swelled, was red, had a rash, and felt a lump. Pt's arm now on 6/13/15 has decreased in swelling and has a 3 inch diameter circular rash. Pt says it itches.
Headache & Fever Narrative:  Emp reports he had COVID vaccine Sat 12/26/20 and started running fever of 101.8 12/27/20. Emp states he checked his temp again today and now is 101.6. Emp reports he had COVID in June 2020. Emp states he called out of work today due to fever and is seeking further instructions on what to do next. Feels better, now, but still has headache.
Vomiting for 2-3 days after vaccines received. Started at 1:30 AM on day vaccine given. Fever 100 degrees F. TYLENOL given.
Fever (102), vomiting, body aches, inappetence, lethargy
She had her 2nd dose of Pfizer COVID-19 vaccination on 08/06 . On 08/07 fell while skating landing on her right knees hitting her head and chest with bruising on her chest. On 08/08, she started with nausea and vomiting. In the evening she had burning right chest pain with palpitations and difficulty breathing.  She presented to the emergency department where she had a WBC 10.56, hemoglobin 10.6, hematocrit 33.6, platelet count 220, neutrophils 73.7%, lymphocytes 15.7%, and monocytes 8.6%.  Sodium 136, potassium 4.1, chloride 105, carbon dioxide 22, BUN 10, creatinine 0.71, AST 55, and ALT 20. CK-MB of 36.26 and a troponin I of 11.801 and a BNP of 62.9. She had a chest x-ray with no radiographic evidence of traumatic injury to the chest.  Cervical spine x-ray normal.  EKG normal sinus rhythm with ST elevation consider early repolarization, pericarditis or injury. Her SARS-CoV-2 PCR was negative.  She was admitted to medical floor on the cardiology service. She was treated with colchicine then ibuprofen and observed without other intervention.
extremely sore arm / body aches; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extremely sore arm / body aches), FATIGUE (fatigue) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concurrent medical conditions included Fibromyalgia (Fatigue and body aches significantly worse) since 1990, GERD since 1980, Paroxysmal atrial tachycardia (P.A.T.) since 1963 and Erosive osteoarthritis since 2000. Concomitant products included FAMOTIDINE (PEPCID AC) for GERD, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS.    On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (extremely sore arm / body aches), FATIGUE (fatigue) and CHILLS (chills). On 07-Feb-2021, MYALGIA (extremely sore arm / body aches), FATIGUE (fatigue) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYALGIA (extremely sore arm / body aches), FATIGUE (fatigue) and CHILLS (chills) to be probably related.    Treatment information was not provided.   This case was linked to MOD-2021-067749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up appended on 15-JUL-2021. Patient medical history was added.
Irregular heartbeat, TIA symptoms and long term bronchial cough (approx 10 weeks before resolution)
Sore Shoulder the day after injection. 35 days later shoulder is still sore.
Experienced head to toes hives (urticaria) the nights of the 12th and 13th of January 2021 that lasted for about 3 hours. Hives were severely itchy, however resolved on their own without treatment following both instances. No other symptoms associated.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for himself of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient ended up in the hospital because he caught pneumonia after vaccination, on an unspecified date. The reporter added that the vaccine did not work. Events outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained.
HPV vaccine administered without incident.  Immediately after Hepatitis B vaccine administration, pt requested to lay back.  Reclined and attempted to elevated legs, at which point patient stiffened.  Called for help, NP and MA responded immediately.  Pt began having  seizure like activity for approximately 30 seconds.  Sat up suddenly, confused and pale.  Ice packs applied to forehead and neck.  Pt reported feeling disoriented and nauseous. Remained in reclined position for approximately 20 minutes, reported feeling better.  Observed for additional 15 minutes.  Recommend she go home and rest, follow up with neurologist.  Left clinic in NAD.
FIRST DOSE ADMINISTERED 3/22/21. SECOND DOSE ADMINISTERED 4/9/21. DIAGNOSED WITH APPENDICITIS 5/6/21 WITH ONSET OF SYMPTOMS 5/2/21. LAPAROSCOPIC APPENDECTOMY PERFORMED 5/6/21.
sore arm; flu like symptoms; loss of appetite; she slept a lot for a few days; She has this fog going on; Her fatigue is much more than it normally is; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days) and BRAIN FOG (She has this fog going on) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (loss of appetite), HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is). At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (loss of appetite) had not resolved and HYPERSOMNIA (she slept a lot for a few days), BRAIN FOG (She has this fog going on) and FATIGUE (Her fatigue is much more than it normally is) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.  Patient received SPIKEVAX on 21-OCT-2023. She previously received Pfizer COVID-19 vaccinations. She states she had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Her fatigue is much more than it normally is.  Company comment: This spontaneous case concerns a female patient of unknown gender, with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia along with other non serious events. The event occurred after a dose of SPIKEVAX 2023-2024. As reported, patient had the general side effect such as sore arm, flu like symptoms and she slept a lot for a few days. She has this fog going on, she is experiencing loss of appetite, she eats because she knows she has to, she is hopeful that eating would help her fatigue. Patient's fatigue was much more than it normally is, as reported. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine). At the time of the report, HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my last dose of vaccine) outcome was unknown.            Patient did not have any problems since March.  Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Reporter did not allow further contact
symptoms of dizziness; feels off balance; feels very hot but doesn't have a fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Apr-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 DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever). At the time of the report, DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Swelling size in same area and also in back and under arm; Felt like ball in neck; Tired; Headache; Nausea; Body aches; Pain in neck lymph node area; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 19Apr2021 at 15:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included cervical cancer on an unknown date in 2012, fatty liver and high cholesterol. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) and vitamins  (unspecified) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 19:30, the patient experienced regular symptoms of tired, headache, nausea, and body aches until wednesday night where she felt pain in neck lymph node area, felt like ball in her neck. The patient fell asleep after taking diphenhydramine hydrochloride/paracetamol (TYLENOL PM). On 22Apr2021, the patient woke up with very apparent swelling size in the same area and also in back and under arm. The patient felt that it was enough to go to doctor for her concerns. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events body aches and pain in lymph node area which included treatment with diphenhydramine hydrochloride/paracetamol (TYLENOL PM). The clinical outcome of the events tired, headache, nausea, body aches, pain in neck lymph node area, felt like ball in neck and swelling size in same area and also in back and under arm were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.