chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2011, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 29-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 SECONDARY DM W AMYOTROPHY
Syncope while waiting in the waiting period for the 15 minutes. I felt weird and nauseous and started having tunnel vision.
o ED Clinical Course Patient was seen immediately on arrival and plan of care discussed with patient and significant other at bedside.  IV will be established blood work including blood cultures and lactic acid will be obtained.  She will be hydrated in the emergency department.  We will plan for chest x-ray as well as CT head and urinalysis.  Chest x-ray is reviewed with no focal infiltrates.  Her CT of the brain does not show any acute findings.  Laboratory studies are reviewed.  Patient's creatinine today is 3.2 with a baseline of 0.7.  Sodium is 127.  Patient's lactate 1.6.  No elevation white blood cell count.  We will continue aggressive fluid hydration in the emergency department awaiting urinalysis.  Patient's troponin is 0.22 this is likely secondary to decreased renal clearance  Urinalysis is reviewed.  Findings are consistent with a UTI.  Patient will be started on Rocephin.  According to the family the patient usually requires Solu-Cortef due to her removal of her pituitary gland whenever she gets sick.  She normally gets 100 mg this will be given IV as there oral solution expired in August 2020.  Patient's presenting to the emergency department with positive criteria for systemic inflammatory response syndrome with an active infection meeting the diagnosis of sepsis.  Patient with end organ dysfunction in combination with sepsis meeting the diagnosis of severe sepsis.  Patient had blood cultures drawn, serial lactic acids ordered and received a saline bolus of 30 mg/kg based on ideal body weight.   Reexamination reveals vital signs as detailed below, heart regular rate and rhythm without any murmur, lungs diminished at bases with no wheezing, rales, or rhonchi, skin warm and dry with no mottling or rashes, pulses 2+ and equal bilaterally with capillary refill under 2 seconds, no cyanosis, no pallor, neurologic status intact.  Further sepsis care to be completed on inpatient admission.  2/20/2022 1429 Temperature:     99.3 °F Blood pressure:    123/72 Heart rate: 78 Respiratory rate: 18  I, Dr. provided critical care.  The failure to initiate these interventions on an urgent basis would likely (high probability) result in sudden, clinically significant or life-threatening deterioration in the patient's condition is acute septic state.  All critical care time is in addition to any procedures, teaching, or physician assistant work performed.  Critical care time was spent at the bedside, patient reevaluation, reviewing tests, care plan determination, and discussing care with staff, consultants, and admitting care providers in the acutely ill septic patient.  Critical care time spent was 44 minutes.  The organ systems/conditions impaired:  Infectious disease, immunology, pulmonary, cardiology, nephrology.  Contacted that Covid is positive. patient satturating well.   I discussed the case with the facility who graciously excepts this admission for further care and treatment  Admitting diagnosis Acute kidney injury UTI with severe sepsis NSTEMI secondary to decreased renal clearance COVID-19
Day 3 after the vaccine was given pt experienced flu-like symptoms and arm pain. 9/29 pt went to the ER with profuse sweating, nausea/vomiting, oxygen levels were low at 84-88%; pt was admitted due to not being able to stabilize oxygen levels. 10/7 pt discharged on home oxygen. Hospital physicians and patient believe her symptoms were all related to the SHINGRIX vaccine.
12-9-16 Approx. 4 hs. after receiving PNEUMOVAX 23 - limitation of left arm movement. Excruciating joint and muscle pain from just above elbow to shoulder. It took 5 days for the pain to be completely gone. It took 4 days for me to lift my arm. I took plain TYLENOL for pain which eased pain after the first several days.
weakness, SOB, nausea. Acute resp failure with hypoxia, Pneumonia secondary to COVID, AKI.  O2 at 2L. Not a candidate for remdisivir due to AKI/CKD. Solu-medrol, Doxycyline. failed walk study.  DC home with O2
7-8- months post vax the pt experienced blisters on his body and a fever. No further information is available.
pt recvd vax & devel erythema, swelling & macular rash @ the inject site; No further details were provided;
Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH 9899), via an unspecified route of administration on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included achondroplasia. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, and feeling unwell. Outcome of the events was recovered. The events were considered non-serious.
Primary Care Physician at Discharge: MD  Admission Date: 11/2/2023 Discharge Date: 11/4/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Severe persistent asthma with acute exacerbation [J45.51] Acute hypercapnic respiratory failure (HCC) [J96.02] Acute asthma exacerbation [J45.901]   HOSPITAL COURSE: 9 year old with known severe persistent asthma, severe obstructive sleep apnea, and obesity, who was admitted to the PICU severely ill with concern for impending death due to acute hypoxic respiratory failure secondary to status asthmaticus. Presented in extremis to the ED with a pH of 7.16, pCO2 76 and SpO2 of 66%, and was immediately placed on non-breather mask and continuous albuterol. She quickly needed escalation to BiPAP. She also received Atrovent, decadron, fluid bolus and magnesium sulfate. She was on the brink of intubation.    Upon arrival to the PICU, Atrovent and continuous albuterol were continued, as well as additional magnesium, IV and methylprednisolone and eventual aminophylline. Her film array revealed she was also COVID-19 positive, so ID was consulted and Remdesivir was given x3 daily doses. She experienced a rapid and remarkable recovery. She remained on iPAP 20, ePAP 7 until weaned off to HFNC the morning of 11/3/23. High flow weaned to room air by 1700 11/3/23. Continuous albuterol weaned to q2hr then q4hr by morning of discharge. Pulm was consulted 11/4/23 and went over recommended use of nightly BiPAP, and updated her asthma action plan to ensure green zone use of BID Symbicort. They suggested 7 day course of steroids, and to follow-up with them outpatient within a month with BiPAP download. Prednisone prescribed, and patient discharged 11/4/23.    BiPAP and Symbicort compliance are integral to her well-being, this was emphasized.
testing positive for Covid-19; testing positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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), outcome "recovered" and all described as "testing positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She ended up testing positive for Covid-19. The patient received both primary series and booster of Pfizer BioNTech Covid-19 vaccine. She ended up testing positive for Covid-19. She recovered but didn't know anything else. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2 .
By 16:00, on the day of vaccine shots, right arm, which received the pneumonia shot, swelled "twice it's size", was beet red, hot to touch and painful to move. Saw my doctor on 11/13/00 and he gave me Cipro antibiotic and Tylenol for pain and hot compresses. Saw me again on 11/17/00 to see that swelling went down. (Bacterial infection). Totally gone by 11/22/00.
5 weeks after 2nd dose of Moderna vaccine, I developed a persistent moderate headache that felt identical to the headache I experienced 24 hours after my 2nd dose. The head ache persisted non-stop for a week at which time I had a video visit with a doctor and was given a 1 week course of prednisone 40mg/daily. After 3 days on the prednisone, the headache started to abate. Headache has not returned to date,
pt fainted about 5 minutes after the injection was given.  Technician was with him and helped lay him flat on floor.  911 was called but patient was awake when they arrived to assess him.
Pruritus, hives, edema, shortness of breath, difficulty breathing Treatment: Benadryl, albuterol inhaler, singulair
Elevated BP & HR, monitored at work for 1 hr. by healthcare colleagues; sought ED care for onset  of possible anaphylaxis (itching mouth, lips, throat). Treated in ED for ~1 hr. with IV diphenhydramine and steroids.
Patient started to feel dizzy after approximately 10 minutes. She was taken into counseling room and laid flat on the floor with her feet up as syncope treatment. She stated her tongue was swelling and her throat was scratchy and EMS 911 was called. She stated she was having trouble breathing and was administered 1 epinephrine 0.3mg auto-injector. After approximately 5 minutes symptoms continued to progress and she stated her entire body was tingling. She stated she was still having trouble breathing and a second epinephrine 0.3mg auto-injector was administered.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter stated that she had some patients with very large welts at the injection site after the administration of SHINGRIX. The reporter did not agree to provide follow up information.
Red rash appearing at the injection site. Started the day after receiving  second dose of vaccine. Increased in size to cover full area of upper arm by the  same evening. Increased in redness on the morning of the second day and began to itch. Began to fade without treatment on day three.
Pt had syncopal episode after vaccination (BP 132/68; RR 20).  Pt had not eaten all day (vaccination @15000. Self resolved w/observation, given juie/crackers. Pt stable & released from vaccination site.
1800 - very lethargic but fussy, fever 101, refusing food and drink. Hard to sleep. Lasted about 2 1/2 days. Controlled with TYLENOL.
diagnosed with COVID-19 on August 31, 2021 Symptoms started on August 29, 2021 - headache, mild sore throat, mild congestion, complete loss of taste and smell
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-FEB-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 21-DEC-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
01/03/23 presents to ED for "chest pain, corona virus concern". PMHx of "HTN, SVT, HLD"
One week after receiving the first vaccination  of Moderna in the upper right arm, a rash appeared around the injection site, the area is swollen and itchy.  The rash has spread upward toward the shoulder. The condition remains as of this writing.   No other symptoms attributed to vaccinations have occurred.
swelling tongue; Inflamed nodules on the neck; This is a spontaneous report received from a contactable consumer (Patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at left arm on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included diabetes, Hbp (hypertension), casttleman disease. There were no concomitant medications. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at left arm on an unspecified date as dose 1, single for COVID-19 immunisation. Patient do not have any allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient experienced swelling tongue and inflamed nodules on the neck on 31Mar2021. Patient did not receive any treatment for the events. Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 16-MAR-2016, the patient was vaccinated with improperly stored GARDASIL (lot # L037003 exp date 27-MAY-2017) (dose and route not reported). The temperatures and times of excursion were as follows: -0.5 degree C for 128 hours, -0.3 degree C for 24 hours, 0 degree C for 34 hours, 1.11 degree C for 56 hours and 1.5 degree C for 24 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Blood from cut in face is gelatinous. Thick with normal blood around it. Maintains firmness.
Fever, fatigue, chills Narrative: Myalgia, Fever 100.6, fatigue, chills; resolved within 48 hrs.
persistent & fever irritability lt thigh & facial swelling; preferral to ER extreme irritability; fever lt thigh, lt knee, facial swelling;
Information has been received from a medical assistant referring to 32 unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # M019708, expiration date: 25-OCT-2017, oral, dose was unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 month old female presents with fever starting 4 days after vaccination.  Patient continued to fever for 6 days with 102-104.7t with no other symptoms, later developed lethargy and stiff neck and back.  Full septic work up was done including blood, urine and CSF.  CSF was positive for meningitis and she was placed on IV Ceftriaxone while the cultures were pending.  During inpatient stay she remained afebrile and tolerated good PO.  She was discharged afebrile after her blood and CSF cultures were negative for 48 hours.  5/4/09 Received hospital medical records of 3/16-3/18/2009. FINAL DX: no d/c summary available.  Admitted w/probable viral meningitis; left otitis media. Records reveal patient experienced fever x 4 days, decreased appetite,  Exam WNL in ER x 2 & d/c to home w/dx viral syndrome.   Had persistent fever, sleepiness, decreased activity.  Seen by PCP who sent to another ER where dx w/viral syndrome & d/c to home.  Symptoms persisted & admitted.  LP done.  Tx w/steroids, antibiotics & antivirals.  ID consult done.
lt hand felt asleep beginning about 10-12 hrs p/vax & lasting 12-14 hrs gradually dec-using lt hand & arm felt awkward;
Pt called shortly after leaving office and c/o chest pains, rapid heart rate - Advised to call 911 - Seen in ER - Dx with SVT and converted - Discharged to home from ER
Tongue itchy, needing to clear throat. Gave benadryl in clinic without improvement. Was sent to ER. No tryptase done, discharged stable.
pt recv vax & 3 days post vax exp rash from chin to chest, aches, malaise, temporomandibular joint pain, n, tongue numbness, dyspnea, & anxiety;reporter stated dyspnea was related to pt anxiety;pt seen in ER & tx w/DPH;dx viral infect
Dizziness, BPs 103/49 (pulse 61), 100/57 (pulse 77). O2 sats 97%-98%. Given crackers and water.
Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, increased heart rate, decreased kidney functions, blood clots in both arms and jugular vein, slurred speech, severe pain in right side, fluid in right lung and around heart. Admitted to MICU from emergency room. Intubated for 12 days. Chest tubes both sides, central line, Hickman Catheter. Discharged and admitted to hospital. Currently home receiving outpatient therapy.
pt recvd vax; 24 hrs after vax, pt exp'd severe lethargy, muscle pain, joint pain, nausea & diarrhea w/ 1st dose; pt exp'd same rx when 2nd & 3rd dose admin; lab test revealed that anti-HBs titer was less than 10 MIU/ml
Urinary tract infection that would go away...treated with 4 medications... so severe required procedure intervention...now I'm struggling with continued uutis and excessive urination
Janssen COVID-19 Vaccine EAU Headache, dizziness, and nausea starting around 2 and a half hours after vaccination. Left work early due to not feeling well enough to continue.
This spontaneous case, initially received on 06-Jul-2016, was reported by a health professional and concerns a patient of unknown age and gender. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: Tetanus Vaccine. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced arm swelled, "blew up" (outcome: not reported).
urticarial type rash on the left side of anterior torso and left arm. mildly itchy. mild irritability.
Extremely sore arm; chills; night sweats; headaches; tiredness; This spontaneous case was reported by an other and describes the occurrence of   in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Reported data: 5 Months ago. Calculated date: ??-Aug-2020.) and Pneumonia (Reported data: Double pneumonia,5 months ago. Calculated date: ??-Aug-2020.).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
Patient came into the pharmacy on 10/3/18 to inform us she was treated with a medrol dose pack for shoulder pain after receiving her pneumonia vaccine too high in her arm. Patients states she had pain and had to seek treatment on 9/25/18. We called the doctor who treated her to inquire, his nurse  relayed to us that doctor said he could not say if the pain was from the vaccination, they could only say her shoulder was red, painful, and swollen. The patient states the medrol helped relieve much of the discomfort.
Patient developed stomach cramping, abdominal pressure and chest discomfort and pressure within 24 hours of vaccine dose.  Patient went to the ER and was admitted for abdominal blockage and a hiatal hernia.
Fever lasted for 24 hours, experienced chills and hot flashes, trouble sleeping, pain in joints (specifically ankles)