chrisvoncsefalvay/vaers-outcomes huggingface dataset:
55y.o. female with metastatic breast CA to liver (undergoing IV chem last session 9/09), right exudative pleural effusion s/p thoracocentesis (presumed malignant, cytology negative though), who presents with complaints of cough, rhinorrhea, and exertional shortness of breath with covid-19 test positive at urgent care and increased right pleural effusion. Found to be COVID+ on 9/30, s/p 3 doses IV Remdesivir. Thoracentesis performed 10/3 by pulmonology with extraction of 1.1L of fluid and visible improvement on CXR without complication.  Repeat chest x-ray following the procedure showed improvement of the pleural effusion negative for pneumothorax.  Pleural fluid analysis suggest exudative etiology, further studies
Patient had a rapid covid test on 01Sep2021, results were positive; Patient had a rapid covid test on 01Sep2021, results were positive; worst headache; 101 degree fever; heavy chest; lethargic; achy; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer reported that:  A 47-years-old patient of an unspecified gender received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) dose 2 via an unspecified route of administration on 20Apr2021 at the age of 47 years old as dose 2, single, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced worst headache, 101 degree fever, heavy chest, lethargic, achy and extreme fatigue. The patient underwent lab tests and procedures which included body temperature: 101 degree on 27Aug2021 and had a rapid covid-19 test results as positive on 01Sep2021. The outcome of the all events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Info and follow-up info has been received from an RN through a mfr pregnancy registry concerning a 19 year old pregnant Hispanic female with irregular periods who was given 2 doses of varicella virus vaccine live, a 1st vaccination was administered on 06/23/04 and the 2nd vaccination was administered on 8/5/04. Concomitant therapy included rifampin, start date 6/28/04 and stop date 8/5/04, 500mg daily "except for 2 days". Follow-up info reported that the indication for rifampin was "preventive therapy for positive PPD" (the date of (+) results was not provided). It was also noted that the pt used "en vits" (dates not specified). It was noted that the pt had never had varicella disease. The pt estimates that she is 1 1/2-2 months pregnant at this point. The RN reported the pt's estimated delivery date as 3/19/05. It was noted that the pt had no previous pregnancies. The pt was not tested for varicella antibodies before vaccination with varicella virus vaccine live. The had 2 ultrasounds the first one in August, 2004 for "dates" and the second ultrasound was routine, both studies were negative. It was noted that the pt will be going for genetic counseling as her sister has factor v disorder and cannot carry to term. Follow-up info confirmed the pt had factor 5 testing, which was negative. There was no maternal adverse event. It was noted that there was no local reaction at the vaccination site, and no symptoms of varicella or herpes zoster, post/vax. There was no product quality complaint reported. Follow-up info was received from an RN which reported that on 3/24/05, 41 weeks from lmp, the pt delivered a 7 60 8 gram, live born, normal male infant. It was noted the the pt had no illnesses or infections during her pregnancy and no concurrent medical conditions. It was also reported that there was no complication during the pregnancy or delivery: her labor was noted to last 24 hours and she delivered 18 hours after her water broke. There was no infection and no reconium on the infant. It was noted that the male infant did not show any feature of congenital varicella zoster syndrome. Info received on 3/28/05, mentioned the pt experienced the following adverse event: "positive PPD". No further info is available.
Swelling of hands and feet which occurred the same day the pt received Prevnar vaccine; resolved without treatment in 24-48 hours.
A few hours after the injection, the arm became swollen, red and very warm about 6" from shoulder to 4" above elbow.  All this gradually moved down the upper arm to nearly the elbow on the next day after the injection.  I felt shaky, faster heart beat, and slightly out of breath, and a small headache.  This was not a severe reaction, but very noticeable because I had never had a reaction before.  I didn't know what to expect or if it would get worse, but it seemed to begin feeling better the 2nd day after the injection. I took some ibuprofen, and on the 2nd day after injection I took 1 small dose of Benadryl.  So far I feel the same.
INTERFERENCE WITH LIMB MOVEMENT LEFT LOWER EXTREMITY.          REFERRAL: NEUROLOGY
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-NOV-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, dose number, frequency, and anatomical location were unknown) with lot # L043702 and expiration date 03-NOV-2017, subcutaneous route for prophylaxis, and was reconstitute with a sterile diluent (MERCK) (lot # was not known). No adverse effects reported.
w/in 5 mins of vax pt exp red rash devel over upper rt arm; inject site was hot, no itching, no resp discomfort; ice pact immed applied @ clinic;
Injection site pain, redness, general aching, weakness, second day-insatiable thirst and sweating, general tiredness, by 5th day, symptoms have subsided, 7th day, no residual effects or soreness.
About 1 p.m. I get fatigued really bad and also some muscle and joint pain. Took two naps went to bed about 10 could not lay on my side arm hurt. When I get up in the morning about 7 a.m. I could hardly get out of bed I was so achy all over. After breakfast I took a Tylenol and then like 4 hours later another Tylenol and took another Tylenol before I went to bed. Got up Saturday morning and I was fine.
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 2/12/2021 and 3/5/2021.  Patient presented to ED on 7/25/21 and diagnosed with COVID-19 pneumonia.  Associated symptoms included fever and abdominal pain.  X-ray showed development of patchy bilateral alveolar airspace.  While in the hospital, patient was treated with remdesivir, ceftriaxone, and azithromycin.  On 7/27/21, patient received 1 unit of convalescent plasma transfusion.  He was discharged on 7/28/2021.  Patient expired on 8/5/21.
weakness in legs, chills, fever, thirst, headache, congestion, muscle aches, joint pain, fatigue, weakness in general, brain working fine, but weak. Severe high fever went on for 11 hours, from 6 pm until 4:30 am next morning. Chills, headache continued, muscle pain in odd places, fever felt all over, weakness, I could hardly get up, lacked interest to even sip form the drink next to me, even though I was so thirsty....Next day, after fever broke, I still had headache for about 2 more days, and then by Sunday I awoke feeling better. Very tried for three days, weak, exhausted.
Patient was seizure free for almost 2 years. 3 days after first Pfizer dose, patient began having nocturnal seizures  every night for the next 7 days and ongoing. Nights without seizures were due to added dosage of Clonazepam.
Information has been received from a physician concerning a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were unknown. On an unspecified date, "a few years ago", the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported) (lot # and expiration date were not reported). Then, on 31-AUG-2012, the patient received the second dose of GARDASIL (dose, route and frequency were not reported) (lot # and expiration date were not reported). There were no adverse effects reported. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Flu Vaccine was administered on the left upper arm on 10/02/2019.  On 10/03/2019 the redness, swelling and fever occurred at the site of the Shingrix (first in the series of 2) which was given on 06/02/2019 in the same left arm, approximately four (4) inches lower then the location of the Flu Vaccine.  After the Shingrix Vaccine on 06/02/2019, this same redness, swelling and fever occurred.  There was no reaction at the site of the Flu Vaccine.
it is now noticeably thinner; Hair has been thinning since I received the 2nd dose/it is now noticeably thinner; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner) and ALOPECIA (it is now noticeably thinner) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner). In June 2021, the patient experienced ALOPECIA (it is now noticeably thinner). At the time of the report, ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner) and ALOPECIA (it is now noticeably thinner) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.
Felt lousy like when you feel a cold or the flu coming on, started about 12 hours after receiving the vaccine.  Right arm is sore.  I'm now running a fever, about 2 degrees higher than normal.
Site soreness from administration until noon on 11/15/00. Onset of redness and swelling, beginning approx. 1" to 1 1/2" below the deltoid injection site, appearing like a "whelp" and spans 5" horizontally to the medial and lateral aspects of the arms then extends distally approx. 3 1/2" to 4" but is above the elbow. Continues to get progressively increased in size. Referred to her physician.
I had problems in my right eye and it was diagnosed as posterior vitreous detachment. I was having a lot flashing in my eye, sever vision change, and a lot of floaters. I am still dealing with this at this time.
After receiving my third dose I developed a pain in my left should, left arm and neck. I had x-rays but have not received results yet. I'm in physical therapy which I have to take before they can perform an MRI.
Marked pain involving entire upper arm where injection was given, swelling and warmth.  Patient unable to lift her arm due to pain.  Subjective fevers.  All occurred within 1-2 hours after vaccines and worsened over 36 hours.  Managed with acetaminophen and Ibuprofen.
Client reported feeling dizzy, most likely d/t her diabetes. Last time she ate was around 1000am client provided powerade and granola bar snack. Vital signs taken. Dizziness decreased and vital signs re-taken. Client dismissed after no longer complaining of dizziness.
12/25 evening, involuntary movement of legs, arms and torso.  Has happened daily since onset.  The appearance still has involuntary movements, seizure like activity, drooling, loss of speech, paralysis, convulsions, repetitive babble, rapid blinking of eyes, screaming, crying, holding of breathe, biting of tongue, hitting things/people, throwing things, blank stares.   Again, these episodes happen daily, multiple times  a day in most cases.  Afterwards, can't talk or slurred speech, often cannot walk or support self on legs.
COVID vaccine Breakthrough Case  Pfizer Dose 1 3/27/21 (lot not listed in system) Pfizer Dose 2 4/17/21 (lot not listed in system) COVID Positive 10/14/21  10/14/21: Patient is 56-year-old female with no significant past medical history except tobacco abuse.  She presented to the emergency room with complaint of worsening shortness of breath cough and wheezing.  Patient reported that she has been having progressively worsening exertional dyspnea and chest tightness for which she was being worked up by her PCP.  Multiple workups including chest x-ray and echocardiogram were unremarkable.  She came to the emergency room today for worsening of shortness of breath, cough and wheezing for the past 2 days.  Patient reported that since 2 months ago, she has been having exertional dyspnea and chest tightness.  She reported heaviness in retrosternal area mainly precipitated by exertion.  She reported cough productive of scanty sputum which she says has been there for long time as she is a chronic smoker. She denied worsening of cough.  No fever chills or rigors. Since 2 days ago, she has been having worsening of dyspnea and chest tightness.  No fever chills or rigors.  No wheezing.  No nausea vomiting or abdominal pain.  Patient denied family or personal history of cardiac illness.  She has been smoking up to 1 and half pack of cigarettes for the past 4 years.  She denied use of alcohol.  Patient is fully vaccinated for COVID-19.  At the emergency room, she was noted to be hypoxic saturating 87% on room air and requiring up to 2 L of oxygen to maintain saturation.  She was hypertensive with blood pressure of 145/98.  She was afebrile with no tachycardia.  ABG revealed CO2 retention with pCO2 at 58 with normal pH.  Other significant lab findings were hyperkalemia at 5.3 which resolved, and leukopenia with WBC count at 4000. Rapid COVID-19 antigen test was positive. Chest x-ray did not show any infiltrates.  D-dimer was negative.  EKG was unremarkable.  10/18/21: Nebulizer treatments  P.o. prednisone course  P.o. Levaquin course  Hemodynamically stable for discharge  Will discharge home  Follow-up with PCP in 3-5 days  Patient will need pulmonary function testing as outpatient  COVID-19 precautions per CDC guidelines  Patient qualified for home oxygen, 1 L via nasal cannula with activity  Patient agrees with plan of care
3/24/21 eval of dizziness . States sx started this morning  . Was in hospital and transferred  approx. 1 week ago for dehydration and a-fib.  Denies nausea or vomiting.
thrown up a couple of times; intermittent nausea/severely nauseous for a few minutes then it goes away; extreme joint pain/joints cracking; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (extreme joint pain/joints cracking), NAUSEA (intermittent nausea/severely nauseous for a few minutes then it goes away) and VOMITING (thrown up a couple of times) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal (removal of gallbladder due to nausea issues.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ARTHRALGIA (extreme joint pain/joints cracking). On 28-Mar-2021, the patient experienced NAUSEA (intermittent nausea/severely nauseous for a few minutes then it goes away). On an unknown date, the patient experienced VOMITING (thrown up a couple of times). On 24-Mar-2021, ARTHRALGIA (extreme joint pain/joints cracking) had resolved. At the time of the report, NAUSEA (intermittent nausea/severely nauseous for a few minutes then it goes away) and VOMITING (thrown up a couple of times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
dizziness. Patient felt normal after drinking water.  Sx resilved monitored for about 15-20 minutes after symptoms resolved. PSOB, palpitations, chills, ED Precautions discuseed. BP 160/90 Hx High Blood Pressure  T98.0  New BP 151/81 HR 78  #21 allowed to go home advised to contact pcp if symptoms recur or
On 5/3/01 the pt was covered with chicken pox, treated symptoms with Tylenol for fever and Benadryl for itch.
Pt is a 31 y.o. female who noticed left facial weakness and had a feeling of heaviness as well as paresthesias in left face and arm that started 30 minutes after administration of first dose of Pfizer COVID-19 vaccination on 3/29. Two days later, noticed improvement, but still with paresthesias in the left face and arm. Neurologic exam is unremarkable except for a difference in sensation on the left face compared to the right (in all distributions). No clear evidence of Bell's palsy and also this would not explain the left arm symptoms. Plan to obtain MRI of the brain with and without contrast to ensure no demyelinating lesions or other explanations for these ongoing symptoms. Pt has been cleared to receive second dose of Pfizer vaccine pending MRI results.
Received his first Pfizer vaccine (LOT#: EW0179 EXP: 8/2021) at 0940 on 4/28/21. Patient alerted EMT. Patient stated that he felt some eye irritation at 0958. EMT took patients vital sign at 1000. BP: 140/60, pulse: 75, O2: 99%. EMT offered patient water and recommended that patient stay an extra 15 minutes for further observation. EMT reassessed patient and retook vital signs. BP: 130/75, pulse: 76, O2: 98%. Patient stated that his eye irritation was gone and that he was feeling a lot better. Patient completed observation time. Patient left vaccination site at 1015 unassisted and with a steady gait.
Breakthrough case admission after 3 vaccines Moderna 12/29/20 Lot# 025J20A;  Moderna 1/26/21 Lot# 004M20A;  Pfizer 10/6/22 Lot# GJ2524
Around 1:45 -2:00 pm 9/10 - My lips felt tingly and then my cheeks felt tingly and then both started feeling numb. My throat felt thick or swollen, but I could still swallow and breathe. I felt slightly dizzy. My heart felt fluttery on and off. My chest started having a heavy feeling. I was driving and pulled over and called my doctor. I was told to call an ambulance. I decided to go to the local urgent care.  They checked vitals and after speaking to the nurse and doctor I was given prednisone. They monitored me often for a couple of hours. My symptoms subsided with the help of the prednisone. They gave me a prescription. 9/11 - My chest has continued to feel heavy and I have continued to feel dizzy but I don?t feel as though the doctors at urgent care or hospital would do anything different at this time as I am okay and not having a serious reaction that would be considered life threatening.
It started with my left palm exp warm to touch(felt like slight fever around some areas) and itching all over skin.The symptoms will come and go after touching items causes whelps to appear. Around a week ago it was hard to make a fist(both hands) from the continuous itching on my hands. I have went to the doctor was prescribed Cetirizine and prescribed hydroxyzine by the ER.  I have appt on 7/12 to see a Dermatologist.
COVID-19; 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 53-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The patient took Paxlovid (02-Jul-2022 to 06Jul-2022) for COVID 19 Treatment. The patient experienced extreme diarrhea and metallic taste while taking Paxlovid, both symptoms went away when he stopped taking it. On 12Jul he began experiencing worse Covid symptoms than he did before taking Paxlovid, primarily a really runny nose and bad cough. It was now 14Jul and he feel no better. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was vaccinated at approximately 0906 am, was walking out of the gym when a nurse noticed that she appeared to be unstable. The nurse got behind immediately before the began to fall to the ground, and she eased the patient to the ground so that she did not hit her head. After falling she was observed to lose consciousness and have rapid eye movement which appeared to be seizure like activity. After about two minutes she began to have more pronounced arm/leg movement that resembled seizure like activity. Staff attempted to arouse patient but she was not awake until 5 minutes after the seizure like activity. EMS was called at the 3 minute mark, about 0910am. Upon awakening, patient was lethargic, but able to identify herself and that she had a history of a seizure disorder, and took Keppra this morning. After regaining consciousness she again began to have seizure like activity and appeared to go in and out of consciousness. Medics arrived at 920 am and patient was transported to hospital. Husband was contacted via the patients cell phone and informed of the event.
This spontaneous report received from a patient via a company representative concerned an elderly female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: senile osteoporosis. The patient previously received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced rash and bone pain (Dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not recovered and recovered from bone pain. On an unspecified date non-company suspect drugs abaloparatide (injection, subcutaneous, batch number was not reported, expiry: unknown) 80 ug, 1 times every 1 day, therapy dates were not reported for senile osteoporosis. The action taken with Tymlos treatment was not reported. The patient additionally received non-company vaccine Spikevax (Moderna) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, start therapy date were not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with Spikevax (Moderna) (Dose number in series 2). This report was non-serious.