chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is an 80 year old female with a past medical history of chronic respiratory failure with hypoxia, restrictive lung disease due to paralyzed right hemidiaphragm (baseline 2 L oxygen), previous CVA with left-sided weakness, chronic MSSA infection of right THA on suppressive antibiotics, hypertension, and recent admission for possible aspiration pneumonia as well as new soft tissue/lytic bone lesion concerning for metastatic disease (biopsy inconclusive) who presented from her subacute rehab facility with increasing oxygen requirements as well as a cough with concern for pneumonia. On arrival to the ER, patient was saturating normally on her baseline O2 requirement, but did briefly become hypoxic requiring non-rebreather. CTA thorax was completed and showed no evidence of pulmonary embolus, but did note interval near complete volume loss of the right lung with complete opacification of the right mainstem bronchus, bronchus intermedius, and right upper and lower airways. Remaining aerated portions of the lungs showed findings consistent with infection or pulmonary edema and trace/small effusions present bilaterally. Patient was started on broad-spectrum antibiotics to cover for hospital-acquired, aspiration, and post-obstructive pneumonia. This included doxycycline, flagyl, and cefepime. Infectious disease and pulmonology consulted. Aggressive airway clearance regimen was initiated due to suspected mucus plugging. Bronchoscopy was performed on 9/10 which was notable for thick secretions and mucus obstructing the right mainstem bronchus. Secretions were suctioned and continued bronchopulmonary hygiene recommended. Chest X-ray performed on 9/12 to re-evaluate which demonstrated at least partial resolution of prior mucous plugging. Residual atelectasis/consolidation throughout the right middle and basilar lung fields was also noted. SLP also saw patient due to concern for aspiration risk and performed a videofluoroscopy swallow study. It was recommended she have supervision to ensure she eats and drinks at a slow rate to minimize aspiration risk. PT/OT saw patient with recommendations to return to sub-acute rehab facility. Patient's shortness of breath and cough significantly improved to the point she was felt stable for discharge back to her facility to complete her course of antibiotics for pneumonia.
shingles; very sick; pimp bumps; big rash on above my chest; pain; chills; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that she took a first dose of Pfizer COVID-19 vaccine on Saturday (unspecified date). That night, she was very sick. The next day, she got pimp bumps, then the next day afternoon, she got a big rash on above her chest, all from unspecifiefd dates. Then, she talked to her dermatologist and told her that she got shingles. She did not know what to do with that.  At the time of report, she was sick, took terrible pain, and felt some chills. The outcome of the events was unknown.   Information about lot/batch number has been requested.
At 4 month well child check, Mom reported baby had wheezing soon after receiving the vaccine from her 2month visit, that lasted 2 days, and frothy green diarrhea that lasted 3 weeks, with general fussiness during that time. Mom said she was very concerned about these symptoms at the time, but did not call or f/u in any office.
hearing loss from right ear; muffled hearing on right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (hearing loss from right ear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Renal impairment NOS.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DEAFNESS UNILATERAL (hearing loss from right ear) (seriousness criterion medically significant) and PRESBYACUSIS (muffled hearing on right ear). At the time of the report, DEAFNESS UNILATERAL (hearing loss from right ear) and PRESBYACUSIS (muffled hearing on right ear) outcome was unknown.        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 medications were not reported.   The patient was evaluated at the urgent care and found a wax plug in her ear. The patient was told it was a coincidence that it started at the same time after getting a shot and is not related to vaccine.   Treatment for the events was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash on arm where vaccine was injected. Including swelling, pain, redness, and hot to touch
1) severe constant cough causing shortness of breath-onset 3 days post 2nd shot and lasted about a month or so.  2) chest pain/pressure-onset 1 week post second shot symptoms still ongoing but not as severe. 3) heart palpations/unprovoked tachycardia-onset 1 week post 2nd shot and symptoms still on going. 4) shortness of breath-onset 1 week post second shot symptoms ongoing. 5) pitting edema in extremities-onset 1 week post 2nd shot symptoms still on going 6) numbness in extremities-onset 2 months post 2nd shot symptoms ongoing 7) joint/muscle pain-onset 2 months post 2nd shot symptoms ongoing. 8) dizziness/lightheaded-onset 1 month post 2nd shot symptoms ongoing
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 9:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:55 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Feb-2021 at 9:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.94 for 031L20A and 40.03 for 003B21A.  No concomitant medications were reported.  Batch number 031L20A administered on 14-Feb-2021 had  temperature 32 at 09:00 AM, 10:00 AM and 11.00 AM and 35 at 02.00 PM and 03.00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 003B21A administered on 21-Mar-2021 had  temperature 34 at 09:00 AM and 11.00 AM and 32 at 10.00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Golf ball size swelling and warm to touch. Hard knot at injection site that is very itchy and hasn't gone away. The knot is about the size of a quarter.
One month after 2nd dose I started having pain in arm where shot was given along with pain in shoulder blade.  It?s not severe just uncomfortable.
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 an unknown date in 2014, the patient was inoculated with the 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 an unknown date in 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.
Hospital Course:  on 8/26/21 Patient was admitted to the ICU. Her pulmonary status worsened and she eventually required BiPAP. Started on IV antibiotics and steroids. She required Levophed for hypotension.  Started on remdesivir and baracitinib.  8/28: Ivermectin started. Started budesonide and zinc.  On 8/30: Worsened respiratory distress, despite initiation of dialysis, thus was intubated. Proned.   On 8/31: Started CRRT per nephrology, tocilizumab per ID, and given 1 unit of PRBC to improve perfusion due to low hemoglobin. Patient was not proned due to labile BPs.   On 9/1: Bilevel to conventional vent.  9/3: Extubated.
Pt recv vax on 3/3/97; on 3/29/99 pt exp varicella rash
Pt received Flumist on 11/04/08. On 11/7/08 pt presented to urgent care with cough and wheezing.
Assessment and Plan: Patient is a 66 year old female with a history of DM, HTN, HLD, CAD s/p stent, GERD who presented with abdominal pain with lipase 300 and CT with mild pancreatic inflammation.  Admitted for pancreatitis.   CV:  BP and HR acceptable. Losartan 25mg daily for HTN.  ASA for CAD.  Atorvastatin 40mg daily daily for HLD.  Monitor vitals.     Pul:  Good O2 sat on room air.  No hypoxia..   GI:  IVF, PRN pain meds, and NPO for pancreatitis.  Pancreatic cystic structure to be followed up outpatient.  Pain resolved so will start full liquid diet with plans to advance to low fat diet for lunch.  Likely stop IVF at lunch.     Renal:  NS 75cc/hr currently.     Endo:  Regular SSI QACHS.  Monitor BG.     Heme:  Lovenox proph.     ID:  COVID positive but no symptoms.  Isolation in place but no current treatment.     Dispo:  Likely home later today.           Note Details  Author (M.D.) File Time 8/17/2023  7:35 AM Author Type Physician Status Signed Last Editor  (M.D.) Specialty Hospital Medicine Hospital Acct # Admit Date 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023  ED to Hosp-Admission (Discharged) on 8/16/2023   Detailed Report  Note viewed by patient Care Timeline  08/16   Admitted from ED (Observation) 1835 08/17   Discharged 2118
Rigors, Fever, nausea, body aches, headache, dizziness @ onset of symptoms.  Rigors resolved without intervention in 90 minutes.  Fever resolved with ibuprofen several hours later.  approximately 8 hours later, only dizziness, fatigue and body aches remained.  All side effects resolved within full 24 hours of administration.  Was unable to work the next day after vaccine due to aforementioned side effects as they did not resolve until the next afternoon.
I awoke with very sore joints I was sore for over 3 weeks when I went to Dr. I was diagnosed with Guillain Barre Syndrome by Dr. I am now under the treatment of Neurologist. I am being treat for nerve pain with Vicodin and Savella pills. I still have a pain level of 6 at all times and it goes to level 10 at night resulting in no sleep.
pt vaxed @ hlth fair; w/in 5 days, pt exp supraclavicular & cervical adenopathy; event occured 2 mo ago & sx still present to date 10JUN92; referred to an internist for eval;
Got little involuntary movements; Tremors and which was mild; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Tremors and which was mild) and DYSKINESIA (Got little involuntary movements) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (Tremors and which was mild). On 29-Jan-2021, the patient experienced DYSKINESIA (Got little involuntary movements). At the time of the report, TREMOR (Tremors and which was mild) and DYSKINESIA (Got little involuntary movements) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment; Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "sinus allergies" (unspecified if ongoing), notes: sinus allergies. No known allergies. Concomitant medication(s) included: OZEMPIC; BREO ELLIPTA; FLONASE [FLUTICASONE PROPIONATE].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure/severe myalgias and severe headache/COVID 19 Treatment". Clinical course: Rebound symptoms (start date 03Jul2022, 09:00) started with same symptoms but milder- sore throat, headache, brain fog, nasal congestion, and sinus pressure. Tested PCR plus again (had previously tested negative 5 days after initial positive symptoms). The patient did not have severe myalgias and severe headache like the 1st time. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive; (Jun2022) Negative. Therapeutic measures were taken as a result of covid-19. Treatment of COVID-19 included antiviral PAXLOVID (treatment start date=20Jun2022, treatment stop date=25Jun2022) and treatment for symptoms included over the counter guaifenesin and pseudoephedrine.  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 the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Day 8 after injection:  Pea sized tender lump left side of arm, itchy  red rash on upper arm, minor swelling upper arm  Day 9 after injection:  Same as above except red rash slightly less red Day 10 after injection: Same as above except rash dull red & less itchy; upper arm swelling gone Day 11 after injection : Lump smaller, rash gone, still slightly itchy swelling gone Day 12 - Day 13: Only symptom - tiny lump left side of arm
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) lot # N001348 and expiration date: 31-OCT-2019. No adverse effects were reported. On 08-NOV-2017, the PEDVAXHIB was stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006084: US-009507513-1711USA006682: US-009507513-1711USA006684: US-009507513-1711USA006685.
Narrative: COVID infection following COVID vaccine series 07/27, Pfizer, does #1 08/24, Pfizer, dose #2 12/28 COVID swab, result: detected 12/25 pt cc: cough, fatigue, fever, myalgias, rhinorrhea, sore throat exposure: unknow 12/28 pt admitted ED cc: "I have fever, cough, body aches and a sore throat" dx: Covid 19, Dehydration, Hypokalemia LOS: 1 DAY 12/28 CXR impression: No acute pulmonary finding. 12/31 clinically resolved
Got the vaccine on Friday and 14 hours later , early Saturday morning,  I started feeling sick. It started with severe chills, and graduated into fever, lethargy, nausea, hyperventilating, headache, and chills interchanging with sweating.   I had a fever the entire weekend and it wouldn't go away, even with taking Advil and Tylenol.  My oxygen level was fine, but my pulse was elevated.  I felt the same as when I had Covid-19 in June, to the point where I thought I had it again, so I quarantined myself, and was going to get tested on Monday. On Sunday afternoon, I started to feel better and thought it was the end of it, but then Sunday night I started shivering again, and it all started again.     I took an Ambien to get some good sleep and I woke up at 6am Monday morning feeling better.
Pt recvd vax & 3 days later exp mild chest, heart flutter, insomnia, fatigue & flu-like sx;
Patient was given Pfizer 0.3ml undiluted from a pediatric Pfizer vial - not the adult. The dose was correct however the medication was pulled from the pediatric (orange cap) vial undiluted.
Patient has a red rash on her left arm.  She is using hydrocortisone cream which is helping her
3 day history of stridor, cough, progressively worsening. Mom states started within few hours of FLUMIST given. Received dexamethasone, racemic epinephrine.
Started with swelling in hand on 9/01 and developed into inflammed tendons in elbow, shoulder and hand.  Also joint achiness in all areas(feet, knee, hips). In April 2004, developed swelling in hands and feet with discoloration on top of hands and feet (especially on right side). Have taken over the counter anti-inflammatory's continuously for the past 3-4 years but most recently started to take Celebrex.
blood sugar levels went out of range; injection site tenderness; difficulty with glucose control; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site tenderness), BLOOD GLUCOSE ABNORMAL (difficulty with glucose control) and BLOOD GLUCOSE INCREASED (blood sugar levels went out of range) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (LISPRO INSULIN), INSULIN DEGLUDEC (TRESIBA), LEVOTHYROXINE SODIUM (LEVOXYL), AMLODIPINE, OLMESARTAN MEDOXOMIL (BENICAR), SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site tenderness) and BLOOD GLUCOSE ABNORMAL (difficulty with glucose control). On 28-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar levels went out of range). On 01-Jan-2021, VACCINATION SITE PAIN (injection site tenderness) had resolved. On 02-Feb-2021, BLOOD GLUCOSE INCREASED (blood sugar levels went out of range) had resolved. At the time of the report, BLOOD GLUCOSE ABNORMAL (difficulty with glucose control) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
C/o pain L deltoid, c/o tingling to her elbow. Arrived today using crutches. Mild red areas noted, no streaking, lying on her left arm/side for a long time after exam without discomfort.
Initial reprot received from a healthcare professional on 11 October 2012. A 32-year-old female patient received FLUZONE intradermal (batch number: UT4473AA) in the left deltoid on 10 October 2012. Medical history reported as none. Concomitant medications not reported. On 10 October 2012, after receiving vaccine at 10 AM, by 12 noon the patient had really achy body. At 3 PM, she was having hot flashes and hot and cold hands and feet, racing heart, dizziness and was just able to crawl into bed. At 3 AM, she reported neck and spine pain and stiffness. She was advised to see doctor. The lab investigations and treatment medications were not reported. Documents held by sender: none.
Gradually noticed breathlessness in normal activities, worsening over a period of weeks until very serious in early when I sought help by going to ER on July 7. I was immediately given blood test, chest x-ray, chest CT and diagnosed with multiple pulmonary emboli in both lungs.  I was admitted to the hospital where a sonogram showed deep vein thrombosis in right leg.