chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported.     In or around October 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles.         In or around June 2018 the patient presented to his dermatologist with a painful rash located near his left flank. The patient was diagnosed with shingles and prescribed medication to treat the condition. The patient's shingles outbreak lasted for several weeks causing severe pain and suffering. The patient continued to have nerve pain in the area of the rash and was required to take medication to treat the pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, the patient have incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of herpes zoster was not resolved. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).     The event herpes zoster was considered to be serious due to disability.  Additional information has been requested.
Patient received vaccine on 12/6/06. Prior to vaccine patient was free from symptoms. No complaints. Patient called H/U to complain of pain at injection site and down arm to wrist. Deep pain/ache. Denies redness/swelling.
Received dose 1 of vaccine on 4/23/21 at outside mass vax site. Called health system call center to report  leg swelling  since 5/1/21 and some itchiness around the injection site. Pt was seen on 5/3/21 by urgent care provider during which pt reports that her swelling symptoms and itchiness have improved.
Pressure in chest, rapid heart beat, skipping heart beat. shortness of breath, headache.  Took Tylenol after 3 days which helped with headache, felt better after 1 week.  heart skipping still although not nearly as often
24OCT approx 12noon pt c/o painful rt arm w/sl redness, feet tired, droopy, had runny nose;exp cough, yellow sputum, c/o arm tender to touch;inc pain w/moving;local irritation from shot, pain & sore to touch;
Patient received the Moderna vaccine for her first dose. On 15April2021, she received the Pfizer vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna vaccine for her first dose. On 15April2021, she received the Pfizer vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna vaccine for her first dose. On 15April2021, she received the Pfizer vaccine). On 15-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna vaccine for her first dose. On 15April2021, she received the Pfizer vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a healthcare provider for shingles at a medical center. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine. 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Child awoke the day after receiving vaccines with an area of erythema and warmth about 5cm in diameter surrounding injection site.
Patient presented to the ED on 10/19/23 complaining of cough and congestion x 3 days.
No additional AE information provided; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and drug reactions or allergies were not reported.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S035100, which was verified to be a valid one, expiration date reported and validated as 03-MAY-2021 (strength, dose, vaccination scheme, route of administration and anatomical location were not provided), as prophylaxis (product storage error); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was exposed to a temperature between 6 degrees Farenheit (F) to 14  degrees F for 20 minutes and 15 degrees F to 46 degrees F - 38.8 degrees F for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event information provided.
Patient presented 5/22 with acute onset right sided weakness and aphasia, found to have left MCA stroke. He was last normal at 0200 and was found at 0600 when he was found by hi wife. He was not a candidate for tPA as he was outside of the time window once he arrived to ER. He underwent IR thrombectomy with TICI 2B, residual clot in the left A1 and left M3 vessels.  He suffered a large territory stroke with malignant cerebral edema requiring emergent decompressive hemicraniectomy.  He has been unable to be extubated thus far, as he is unable to protect his airway. He has severe aphasia and right hemiplegia.
Patient reported on 07/10 at 16:00: Wanted to know if spot on right deltoid was related to Hepatitis B vaccine she received 06/19/2003.  She reported that the spot started out as a tiny point 4+ days prior.  15mm circular (smooth) blanched spot surrounded by some circularing of raised pink skin observed.
Systemic chicken pox-like itch ~2 wks post-Dose #1, then shingles-like rash itchiness post-Dose #2.  Rash continues to flare on my right arm.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (yeast) (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. It was reported that the patient regained consciousness after a "couple of minutes". Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Conflicting follow-up from the physician's office manager stated that the office had no knowledge of a patient with a reaction to GARDASIL. No further information is expected.
This triggered the diagnosis of severe combined immunodeficiency; two cases of infants who were vaccinated with RotaTeq and subsequently developed strain rotavirus (identified by CDC lab); This spontaneous report has been received from a physician referring to two pediatric patients (infants) of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies, drug allergies or reactions were not reported.  On unspecified dates, the two patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot number and expiration date were not reported) orally for prophylaxis.   Subsequently, the two patients developed vaccine strain rotavirus (identified by centers for disease control and prevention (CDC) lab). This triggered the diagnosis of severe combined immunodeficiency, and these two patients were subsequently treated with stem cell transplants. Post-transplant, the children continued to have rotavirus (detected by routine lab, presumed to be persistent vaccine strain) and received additional experimental treatment in attempt to clear rotavirus. The outcome of the events was unknown. The causality between severe combined immunodeficiency and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported. The reporter considered that rotavirus infection to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  Upon internal review, severe combined immunodeficiency syndrome was determined to be medically significant.
IT STARTED WITH NUMBNESS AND THROBBING PAIN WHERE THE SHOT WAS GIVEN AND BY 2:00 A.M. MY WHOLE BODY WAS BURNING.  I COULDN'T WALK AND HAD TO CRAWL TO THE PHONE TO CALL FOR HELP.  MY RIGHT ARM WENT NUMB AND MY RIGHT HAND FELT LIKE WASPS STINGING ME.  I DON'T KNOW IF I SHOULD GET THE SECOND SHOT.
approx 12 hrs p/vax had fever to 104.5 w/febrile generalized sz x about 1 min;
Dizziness, heart palpitations, different taste in throat, lump feeling in throat, face was red and flushed and I was seeing spots.
Feeling fatigued/unwell; Feeling fatigued/unwell; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3248; dose 1) via an unspecified route of administration on 20Jan2021 at 15:00 (at the age of 79-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had an allergy to morphine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced feeling fatigued and unwell on 21Jan2021. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive treatment for the event. The outcome of feeling fatigued and unwell was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
resp distress w/inspiratory stridor p/30-45 mins of receiving 3rd Hep vax;
Patient came in to get the TDAP vaccine and accidently got the Moderna vaccine (3rd dose). Patient did not have any symptoms and only reported a sore arm and tiredness the next day.
Pt vax; fever 101F, sore arm (lt) becoming red hot; Seen by MD tx w/ meds.
Child was staggering, falling and drooling. Could not walk straight or stand.  Was seen at the ED at 10:30 AM-exam, labs-blod and urine, CAT scan performed.  Concluded possible flu shot reaction.  Followed up with Neurology Dept on 10/22/13.  Diagnosis Code 781.0 Involutary Movements; advise MRI.  Also advised to report to VAERS.
scratchy throat, legs ached, lower back hurt, itchy puffy under lt eye;rx ATB sx of conjunctivitis poss herpes simplex;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of ROTATEQ, oral, lot # k016263 and expiration date 26-JUN-2016. There were no concomitant medications reported. No adverse experiences reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
On 9/12/11 pt. received shots around 3 o'clock, no reaction in office. Mom came in for TB results & showed us the reaction on both arms. Per mom patient had fever, gave TYLENOL. Dr saw pt on 9/14 & gave BENADRYL & TYLENOL. (L) arm 5 inch circle, (R) arm 3 inch circle.
Patient noticed some redness, some tingling in his heel and in 4th and 5th digits.  This resolved by 1/17/2017.
Trouble breahting; Lightheaded; Rash; A spontaneous report  was received from a 49-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced rash, trouble breathing and felt quite lightheaded.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient experienced rash and treated the rash with Benadryl 50mg every 6 hours.  On 03 Jan 2021, she had trouble breathing and felt quite lightheaded. Treatment for the events was Benadryl.  On 04 Jan 2021, she started having trouble breathing again.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.   The outcome for the event, rash is recovered/resolved. The outcome for trouble breathing and lightheadedness is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Cold feet; Tingling in legs and thighs; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the right arm on 30Aug2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 01Sep2021, the patient experienced cold feet, tingling in legs and thighs and weakness. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cold feet, tingling in legs and thighs and weakness were resolving at the time of report.
Pt called c/o of 'Raised - red - I got swelling at injection site - " - Says it was 6"X4" - Called ER - They advised BENADRYL - Pt took - area now gone -Did also c/o q joint pain - Denies fever/vomit
About 7- hours after injected, woke up in the middle of the night hyperventilating and unable to move. Sweating and sensitive skin all on the body.  Headaches that have been constant for the past week and a half and chest pain
Moderna COVID-19 Vaccine EUA Face swelling  fever 100.3-102.5 headache body aches joint pain
Symptoms-burning sensation, acute muscle spasms, numbness of hands, paresthesias, headache, severe localized back pain.  Treatment-IV SOLUMEDROL, cyclobenzaprine, DILAUDID, DECADRON, ibuprofen.  8/29/08 Reviewed PCP medical records & vax records of 8/7/08. FINAL DX: allergic reaction to menactra, acute muscle spasm & back pain. Records reveal patient experienced back pain w/redness, burning all over, spasms of back, tingling of arms, radiating all over.  Symptoms began 5 min after received vaccine in left deltoid.  Exam revealed tender paraspinous muscles, flushed skin, diaphoresis.  O2 sats WNL.  Tx w/epi, steroids, pain med & IVF.  Sent to ER for eval.  9/5/08 Reviewed hospital medical records of 8/7-8/8/2008. FINAL DX: allergic reaction to vaccine Records reveal patient experienced severe low back pain almost immediately after vaccination w/paresthesias, muscle spasm & swelling of injection site.  Also had migraine headaches x 4-5 days.  Seen in PCP office & received steroids & antiinflammatory meds. Neuro consult done & dx w/muscle spasm reaction to injection w/no further neuro deficits.  Tx w/IV steroids x 3 doses.  D/C to home.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On, or about 02-NOV-2017, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On, or about 25-OCT-2017, the patient was treated by a physician for a persistent and severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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 would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality between the events and the ZOSTAVAX was related.
Patient has had chronic deltoid pain since 1/10/08.  There is pain to palpation, and weakness in the arm.  MRI normal. 6/3/08- records received-C/O arm pain 4/14/08-arm swollen, arm weakness, discomfort with moving. Injection site tender, pain is aching. C/O getting sick constantly since 3/08, aches and chills, fevers up to 101, nasal congestion, cough. PE: pain on palpation of arm. Assessment:neuritis.
Hospitalized (9.13.21 - present);  Symptoms started week prior;  COVID-19 positive (9.13.21);  Fully Vaccinated Pt is a 69 y.o. male  who presents to hospital with difficulty breathing. The patient is known to have history of multiple comorbidities including chronic obstructive pulmonary disease, obstructive sleep apnea on CPAP, hypertension, pneumonia in the past, tobacco use, hypertension, and diabetes mellitus type 2. On September 9, 2021, the patient was presented to his primary care physician office because of increasing productive cough with poly phlegm, and increase of difficulty breathing.  At that time he did not have any fever.  Also the patient had some diarrhea at that time.  He was given a course of Zithromax.  However since then, the patient did not improve.  Instead he has been feeling feverish with productive cough, and more difficulty breathing.  He came back to the emergency department for evaluation.  The patient COVID-19 PCR rapid test came back positive.  The chest x-ray showed mild bibasilar hazy and streaky opacities right greater than left compatible with pneumonia.  The patient was hypoxic in the emergency department with oxygen saturation 84% on room air.  He has been requiring high-flow nasal cannula initially with FiO2 90% and later it went down to 35%.  The patient is being admitted to the hospital for further evaluation treatment. Assessment and Plan Medical Decision Making This is a 69 years old gentleman who was presented to the emergency department because of 5 days complaining of productive cough with yellow phlegm, difficulty breathing, and diarrhea.  On presentation he was hypoxic with oxygen saturation 85% on room air.  The patient is requiring oxygen supplement via high-flow nasal cannula.  The chest x-rays showed bibasilar infiltrations compatible with pneumonia.  The PCR rapid test for COVID came back positive. 1. Acute hypoxic respiratory failure.  Present on admission.  Associated with COVID-19 pneumonia and chronic obstructive pulmonary disease exacerbation.  The patient is requiring right now high-flow nasal cannula with FiO2 35%.  We will keep monitoring.  The patient is full code. 2. COVID-19 pneumonia.  Present on admission.  The patient is on dexamethasone and remdesivir.  Will re-evaluate in the morning.  We will do daily COVID-19 lab care set. 3. Chronic obstructive pulmonary disease exacerbation.  Present on admission.  The patient has already failed outpatient Zithromax orally.  We will continue breathing treatment.  Notes from 9.20.21: ASSESSMENT / PLAN:   Acute on chronic hypoxic respiratory failure Severe COVID-19 pneumonia s/p vaccination COPD exacerbation - Continue HFNC and titrate to maintain saturations of 90-94% - Continue Decadron; s/p Remdesivir - Maintain euvolemia and diurese prn -Antitussives prn, encourage IS use and prone  - Continue duonebs q 6h prn - Mucinex  - Dulera and spiriva and Singulair  **DDimer was increasing; no PE noted, small acute thrombus in the cephalic vein that does not require full dose anticoagulation. CTA does show PA dilation; likely c/w PAH.