chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in to the pharmacy on 8/25/18 and asked pharmacist to look at her arm from her flu shot. The area directly around the injection site looked fine except for a tiny bruise, however the area was very red and warm down the arm from the mid upper shoulder to the wrist. Pharmacist told the patient to go to the urgent care to rule out cellulitis. Patient was seen in urgent care and prescribed a MEDROL DOSEPAK. She was told that she had an allergic reaction and that she should no longer get a flu vaccine.
One day post vax, the pt developed soreness all over his body and in his joints. States he couldn't drive the car for long because of pain trying to hold onto the wheel and keep pressure on the gas foot pedal. Diagnosed with PMR. The pt was treated with medication. nine months later the pt has no relief other than with Prednisone. Pt stated he would go for a second opinion of his condition. From follow-up info received on 07/28/2000, clarification of the pt's diagnosis was provided. Pt was diagnosed with polymyalgia pheumatica. Additional pt and responsible physician information was also provided.
By the end of the day, the Bursa popped out of left posterior knee with swelling, joint clicking and severe pain. Conditions persists. The following evening I began to have excruciating pain in my upper back, shoulders, down my arms into my wrists and down to my fingertips. The pain was icy-hot and burning as well as throbbing. I take (Aleve) to help with the pain and purchased wrist braces which did not help. The pain is severe in my arms and my hands remain constantly numb. It has, also moved into my face, mouth, sinuses, eyes, and into my chest causing heavy breathing and chest pain similar to the arm pain.  I cannot properly perform my work duties, as my fingers are numb, preventing me from using the keyboard in my normal manner.  I tire easily and have great difficulty trying to find a position that I can sleep in comfortably. I wake approximately every two hours with my hands and  shoulders numb and painful. I also have difficulty with simple dexterity. Events such as holding a glass of water require concentration, because I cannot gauge how it feels.  I have had many cuts, bruises, scrapes, pinches and broken fingernails to my hands and arms because I cannot feel them. The numbness in my eyes causes vision problems. I drive one hour each way to and from work. The other problems are with heat and cold on my tongue and mouth, because they are numb and I cannot feel them either. When the hot/cold is exceptionally extreme in my hands and arms, my whole body gets the chills even when the temperatures are 80-100 degrees ( I live where the temperatures are typically in this range most of the day). This problem consumes my thoughts throughout the day due to it's annoying persistence. I cannot do any of the craft projects that would typically fill my off-time with because the senses I use to enjoy them are numbed. My greatest concern is that this will not go away. When I checked on the Clinic and hospital websites, it stated that the adverse reactions can last 1 to 2 years, or may be permanent.
Information has been received from a registered nurse concerning an adult male patient who on 02-FEB-2010 was vaccinated with the first 0.5ml dose of MMR II (lot# not reported). Concomitant therapy included "tetanus shot". On approximately 02-FEB-2010, 12 hours after the vaccination, the patient developed a vesicle like rash, high fever and difficulty breathing. It was reported that the patient was an immigrant. He called the office to seek medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
HA, body aches, sore throat, coughing ED to Hosp-Admission Discharged 8/25/2021 - 8/27/2021 (2 days) Hospital Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath  COVID-19  Hospital Course         Patient is an 55 y.o. female with PMH of CAD, HLD, gastric bypass, COPD, emphysema who presents with nausea and vomiting and shortness of breath. Patient was well until 8/24 when she noticed that her nausea and vomiting worsen. She also noticed associated shortness of breath which has progressively worsened in the last 2 days.  Patient has associated headaches, cough which she describes as dry. Patient is vaccinated with the Pfizer vaccine x2. Patient has obstructive sleep apnea and is not compliant on her CPAP machine because she feels like she has been smothered. She uses 2L O2 at night when he goes to sleep.   Patient admitted to family medicine service. Her COVID test was positive. She was started on remdesevir and decadron. CT chest revealed COVID pneumonia without PE. Her nausea and vomiting improved overnight. Patient had a rest and exercise oximetry test which revealed that she did not have an oxygen requirement at rest or with exercise. Patient was discharged home on remote patient monitoring and VNA home health aide. Her remdesevir was discontinued and she was sent home on 8 more days of decadron for her COVID pneumonia. Patient discharged home in stable condition.
This is not an adverse event but a vaccination error; I found out  about 3-4 days later that the injection was likely not placed in my deltoid as the area of  needle mark, redness  and pain and were   at the  anterior part of my upper arm at a fatty tissue.  There was no pain , redness,  swelling or needle mark in the deltoid area but in the anterior  upper arm. I took pictures when I realized  this and called /emailed Moderna. There was no pain in the  biceps muscle either.
Shingles left shoulder and posterior neck; the Pfizer booster (#3); the Pfizer booster (#3); This is a spontaneous report from a contactable physician. A 56-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: AF7485) (age at the time of vaccination was 56 years and non-pregnant at the time of vaccination) via an intramuscular route of administration on 30Aug2021 at 10:30 in right arm as dose 3, single for COVID-19 immunisation. The patient medical history included psoriatic arthropathy and psoriatic arthritis. Concomitant medications included Celebrex and Humira. The patient had known allergies with Climdamycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were Steriod and Humira. No COVID prior vaccination. COVID tested positive post vaccination. The patient previosuly received 1st and 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unknown route of administration on an unknown date as dose 1, single and dose 2, single for COVID-19 immunisation. On 01Sep2021 22:00, the patient experienced shingles left shoulder and on posterior neck and on 30Aug2021 10:30 the pfizer booster (3) was taken. The event shingles left shoulder and posterior neck resulted in Doctor or other healthcare professional office/clinic visitx. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab on Jul2021, Covid test post vaccination: Covid test type post vaccination: Nasal Swab, Covid test date: Jul2021 Covid test result: Negative. Treatment was received for the event shingles left shoulder and posterior neck (Valtrex 1gm every 8 hours for 7 days). The outcome of event shingles left shoulder and on posterior neck was not recovered.  Follow-up attempts are completed. No further information was expected.
Pt. had a sore throat was seen by local Dr. in the office diagnosis viral pharyngitis. Dr. visit was on 2-11-2003.
1 of 2 pts vaxed from the same vial who exp inj site rxn;pt recvd vax 17MAY95 in AM & by afternoon of same day,pt's arm was swollen,red,painful & warm extending from deltoid to forearm;no fever reported;
Pt states she had flu shot 2yrs ago with no adverse rxns, temp WNL, immunization given to Left Deltoid IM. Pt states 5 min later feeling throat is swelling and feeling flushed. Kenalog 40mg IM given at 7: 52pm and pt took Benadryl 25mg po at 1958. VSS. Pt monitored x 28min, pt states feeling better, NAD, pt assessed and exam WNL, VSS.
Continuous intermittent  sharp pains in my head on the left side above left ear causing intense pain and blurred vision.
The patient states for the 2 weeks prior to ER visit he has had progressive weakness, cough and diarrhea.  He was seen in the emergency department and found to be positive for COVID-19.  He is vaccinated.  Patient reports he was extremely ill approximately 2 months ago was hospitalized.  Patient was acutely ill upon arrival to the ED workup initiated.  He was hypotensive and sepsis workup was initiated.  He was hypotensive which responded initially to IV fluid bolus, lactic 3.3 which has improved. cbc shows neutropenia of 1.7. bnp 355. cxr worsening pneumonia.  The patient received Zosyn and ceftriaxone. Patient reports subjective fever and chills, he does have a cough which is nonproductive.  He denies any abdominal pain, chest pain but does have some mild shortness of breath.  Severe sepsis with septic shock-possibly due to COVID-19- Treated wth Zosyn, vanc, then cefepime patient recovered and DC home with home care. 12 day hospital stay
Confusion, urinary incontinence, rigors, profound weakness.  Having suffered these symptoms overnight, they continued into the next morning and I was taken to the hospital by ambulance.  Differential included but not limited to infectious (pneumonia, UTI, sepsis, bacteremia, meningitis), neoplastic +/- cauda equina syndrome, stroke/bleed, normal pressure hydrocephalus, vitamin deficiency, arrhythmia (worsening weakness), among others.  Multiple studies done.  Hospitalized overnight with gradual clearing of symptoms.  Discharged the next day.  PRINCIPAL DIAGNOSIS: Rigors   ALL DIAGNOSES:  Active Hospital Problems   Diagnosis POA o Rigors Unknown o Vitamin B12 deficiency Unknown o Acute encephalopathy Unknown o Multip PRINCIPAL DIAGNOSIS: Rigors   ALL DIAGNOSES:  Active Hospital Problems   Diagnosis POA o Rigors Unknown o Vitamin B12 deficiency Unknown o Acute encephalopathy Unknown o Multiple myeloma (*) Yes o Stage 3b chronic kidney disease (*) Yes o Essential hypertension (*) Yes
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 59 years, in right arm 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 Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Oct2023 to 17Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351197 same patient, different drug and AE;
Patient developed an urticarial/hives the afternoon of the COVID-vaccine administration.  She had had the vaccine around 9 to 10:00 in the morning and then later that afternoon developed the symptoms.  No history of urticaria or allergies.
Painful sore on the back side of the tongue; This case was reported by a pharmacist via call center representative and described the occurrence of tongue pain in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 3rd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th April 2019, 1 days after receiving Shingrix, the patient experienced tongue pain. On an unknown date, the outcome of the tongue pain was not recovered/not resolved.   It was unknown if the reporter considered the tongue pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left deltoid. The pharmacist stated that the patient received Shingrix vaccine and on next day patient experienced a painful sore on the back side of her tongue, and she was still experiencing the painful sore. No further details were provided.
Information has been received from a nurse practitioner referring to a 23 years old unpregnant female patient. There were no pertinent medical history or drug reaction/allergies of the patient. On 20-AUG-2015 the patient was vaccinated with a dose of GARDASIL 9 (lot # L014198, expiration date 05-SEP-2017, dose was not reported) intramuscularly. Concomitant therapy included GILDESS FE. On 28-AUG-2015, the patient developed a swollen area at the site of the GARDASIL 9 injection. The patient went to the nurse practitioner's and started BENADRYL and naproxen for the swelling on an unknown date in 2015. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. The causality was not reported. Additional information has been requested.
5 days post vaccination, large soft tissue swelling in vaccination site, size of baseball, warm and red Advised to use warm compress/cold compress, seek PCP if it gets worse
Began having palpitations and heart flutters with chest discomfort about a week after vaccine. Comes and goes and has a been up until now.
Information has been received from a health care professional concerning a patient who on 05/21/1997 was vaccinated with one does of varicella virus vaccine live. On 05/14/2000 the patient developed one lesion on her face and cold-like symptoms. The patient was afebrile. Additionally it was noted that there was no exposure to wild type virus. The patient sought unspecified medical treatment. The patient was seen by a physician on 05/14/2000 with questionable chickenpox lesions on her face. One macular vesicular lesion was noted and the patient was diagnosed with mild chickenpox. Additional information has been requested.
rash over 75% of body (onset 10/14/99);c/o itching;seeing MD on 10/19/99;
Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
pt was very nervous before the vaccine, he was okay right after he received shot and commented it was not bad. After vaccine he was sitting in post vaccine area he got up and said feels very light head. I came out of the pharmacy to direct him back to chair while holding him , he started fainting we sat him down. Eye was rolling and unconscious his mom kept calling out to him . His color was pale. We called 911. he was conscious mom gave him gatorade he vomited right away but said he is feeling better. I  kept rubbing his back. He said he was nervous all day and had not eaten .
Developed a croupy cough, shortness of breath, and pain with every breath, swelling of legs and feet.
I have severe dizziness/Lightheadedness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I have severe dizziness/Lightheadedness) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I have severe dizziness/Lightheadedness). At the time of the report, DIZZINESS (I have severe dizziness/Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Patient received a 4th dose when she already had completed the series with 3 doses when she was under 18....no adverse effects to report
Info has been received from a medical assistant concerning a 52-year-old female with a history of polycystic kidney disease, hypothyroidism and hypokalemia who on 07/23/2002 was vaccinated IM with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L), administered in the deltoid. The pt was "well" at the time of vaccination. Subsequently, that same evening (also reported as 07/24/2002), the pt developed a fever of 103.4 degrees F and nausea. In addition, on the evening of 07/23/2002, the pt developed swelling of the arm. She was seen in the ER and diagnosed with Serum Sickness. Laboratory findings revealed that her WBC was elevated (subsequently reported as increased WBC beginning on 07/24/2002). She was not admitted to the hospital. On 07/24/2002 she developed chills and soreness in her arm. On 07/30/2002, the pt recovered. It was noted that the pt had never been vaccinated with pneumococcal vaccine 23 polyvalent previously. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt developed adverse experiences following vaccination with pneumococcal vaccine 23 polyvalent (lot #640744/0994L) (WAES #0208USA03398). No further info is available.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with VARIVAX lot # L050560, expiration date:14-DEC-2017 (dose, frequency, route and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. There was no adverse effect reported in any patients. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 15.3 degrees Fahrenheit for 1 hour 15 minutes  and 13 degrees Fahrenheit for 8 hour/ 45minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA000696:
Patient developed new onset of psoriasis 10 days post injection of ZOSTAVAX (given by PCP), no personal or family history of psoriasis. Treatments included: Prednisone 20 mg QD x 1mo, reduced to 10 mg QO x 1 month-LIDEX .50% cream QD-BID to affected areas. CLOBEX spray; Selsum Blue.
Hospitalized (9.24.21 - present);  COVID-19 positive (9.18.21);  fully vaccinated  Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   Acute respiratory failure with hypoxia  History of Present Illness Patient is a 46 y.o. male who presents to ER today with c/o severe worsening cough, fever, increasing SOB.  Patient has a 14 yo son that was recently sick with Covid.  He is in school and unmasked and has completed his isolation.  Patient's spouse is also sick with Covid 19.  Patient has not been able to sleep the last two nights due to severe cough.  His cough is productive at times with greenish/yellow secretions. Patient denies wheezing, chest pain, edema, orthopnea.  He does snore sometimes.  He denies OSA.  Patient has been alternating taking acetaminophen and ibuprofen at home for his fevers and myalgias.  Patient reports that he is having watery diarrhea about 2 to 3 in last 24 hours.    Patient has a PMhx of psoriatic arthritis, hyperthyroid, h/o light tobacco use.  Patient follows with endocrinology and rheumatology. Covid vaccination Janssen on 3/13/21.  Patient was ill last October and thought this may have been due to Covid.  Covid 19 IGG antibody in Dec was negative.   ER evaluation today  Fever 38.4, 87% sats on RA, HR 105, RR up to 22. 2L oxygen w/sats up to 93%. CXY bilateral lung opacities consistent w/covid pneumonia +Covid 9/18/21.  Patient was prescribed albuterol inhaler and tessalon perles 2 days ago.   Na 131, AST 86, ALT 77, WBC 3.5, lymphopenia In the ER patient was given dexamethasone 6 mg IV, tessalon perles, albuterol MDI and acetaminophhen. Patient is being admitted for acute hypoxia due to Covid pneumonia w/sepsis.  Notes from 10.1.21: SUBJECTIVE: Significant events in the last 24 hours: intubated 9/27; tolerated prone positioning; slight negative fluid balance; tol heparin gtt no evidence of bleeding. CHIEF COMPLAINT: Pneumonia due to COVID-19 virus Length of Stay: 7 days Assessment/Plan  ASSESSMENT / PLAN: * Pneumonia due to COVID-19 virus Assessment & Plan S/p remdesivir S/p Dexamethasone 6mg -> 20 9/27 Worsening hypoxia Acute Respiratory Failure with hypoxia - secondary to ARDS from COVID-19 pna; worsening COVID-19 pneumonia - dx 9/18; admitted 9/24 -Intubated 9/27 -sedation for vent synchrony - RASS -5 -NMRB - trial holding today --lung protective ventilation - goal pplat < 30 driving pressure < 15 -daily prone positioning for p/f < 150 - 16 hours minimum per 24 hrs. -empiric abx -remdesivir -dexamethasone - 20mg daily x5 days then 10mg daily x 5 days -corpak - I/o goal even to - 500 DVT -  LE/ U/s w/ peroneal dvt 9/28 -heparin gtt Psoriatic arthritis - h/o immunosuppression Hyperthyroidism - methimazole; free T4 nml Proph GI- H2B VTE- heparin gtt VAP- Chlorhexadine Full Code
ABOUT MIDNIGHT 02/08/08 STARTED GETTING A SCRATCHY THROAT THEN BY MORNING HAD A DRAINING IN THE BACK OF MY THROAT BY SUNDAY 02/10/2008 THE DRAINAGE WAS ALOT TO WHERE IT DRAINED INTO MY LUNGS (SEVERAL TIMES) DEVELOPED PNEUMONIA ALSO HAD SEVERE HEADACHES AND BACK OF THE NECK PAIN
nauseated; This is a spontaneous report from contactable consumer(patient).An unspecified age of male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported.On an unspecified date, the patient experienced nauseated.It was reported that the one where you take a shot for every 3 weeks and then go four weeks. He just has a question.When a person gets the shot do they get nauseated for 24 hours and then it might go away. The outcome of the event was unknown.  Communication: Attempted to clarify several times with caller the name of the shot. Caller unable to clarify the name. Caller repeatedly kept stating he only has a question. No further details provided. Caller declined to proceed with the report and requested transfer. Full report details not obtained. The caller was provided with  phone number of (Withheld) option 3 and hours of operation prior to attempted warm transfer.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Systemic: Fainting / Unresponsive-Severe, Additional Details: While resting after injection, patient fainted and fell out of chair and hit head on the ground.  Paramedics responded and patient did not want to go with the as she felt better.  WE gave ice and water and monitored until patient left under her own power.