chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Admission Date: 10/24/2022 Discharge Date: Nov 4, 2022  PRESENTING PROBLEM: Febrile illness [R50.9] Cough, unspecified type [R05.9] COVID-19 [U07.1] COVID [U07.1]   HOSPITAL COURSE: Patient is an 81 year-old male with PMH T2DM on insulin, CKD3b, COPD on 2L, Diastolic Heart Failure (EF 61%), Alzheimer's, Squamous cell carcinoma of RLL of lung s/p resection, chemotherapy, and radiation, and recent ICU admission for bacterial pneumonia who presented with fever and cough.   On arrival to ED, he was found to be febrile, tachycardic, hypotensive. Pressures did not improve with fluids and vasopressors were started. COVID testing returned positive. Thoracic imaging showed bilateral infiltrates as well as subsegmental PE (no RH strain on echo). He was started on heparin, IV vancomycin and Zosyn, decadron, and remdesivir and admitted to the ICU. MRSA nares was negative so vancomycin was discontinued. He was quickly weaned off pressors and oxygenation improved, transferred to gen med floor 10/25.    Able to wean oxygen to room air however patient refuses pulse oximetry as well and is noncompliant with his nasal cannula so unclear if maintaining oxygen saturation.   Developed Afib/flutter 10/30 with rates up to 150-160. Improved with IV metoprolol 5 x2 however BP dropped to 80s/60s. Improved with 1L LR.  Cardiology recommended Toprol, patient currently on 12.5 2 times a day   Septic Shock Present on admission now resolved Suspected superimposed bacterial pneumonia: Multifocal pneumonia greatest involving in right lower lobe noted on CT: CXR concerning for pneumonia with initial shock req pressors Completed 5 day course of Zosyn   COVID Pneumonia Acute on chronic respiratory failure COVID+ on 10/24. Recent ICU admission for bacterial pneumonia. CXR shows small bilateral effusions and multifocal infiltrates.  - Continue Decadron 6mg once daily for total of 10 days - Completed remdesivir course - CURRENTLY ON ROOM AIR
Fever 11/12/99 - 11/14/99 ranging from 102 - 103 degrees.  Fussy, whiney during that time.  Rash on 11/16/99.
Patient broke out in rash all over body after booster however she did not have this reaction with first two doses
Scratchy throat, watery and itchy eyes, SOB. Flushed and body aches.
Rash and itching at site of injection beginning one week after and continued to today, 4 days later
Area of induration at site of QUADRACEL injection at left deltoid, erythema of arm ranging from injection site to just above elbow, mild associated discomfort in this area.
It began with a headache around 2 am, March 26, 2021.  Around 8:30 am I began to experience nausea and fatigue.  At 3:30 pm I vomited one time.  Since 8:30 am I have slept about six hours.  I also felt hot on and off during this time, but I have checked my temperature 3 times and it was normal all three times.
Patient developed a "goose egg type knot" that turned into a rash and then scabbed over.
fever x 24 hrs; vomiting x 6 hrs; consulted w/MD who said due to vax because of pt's age;
headache; fatigue; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported.
Bad headache; Drowsiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 22B21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) ongoing since an unknown date at a dose of unk dosage form. At the time of the report, HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 may 2021 Non significant follow up has no new information
Weakness in legs; Pain beneath my toes on both feets; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs), PAIN IN EXTREMITY (Pain beneath my toes on both feets) and MYALGIA (Muscle pain) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-293640 (Patient Link).
Breakthrough COVID positive on 22Jul2021; Breakthrough COVID positive on 22Jul2021; This is a spontaneous report from a contactable Nurse(patient).   A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on Jan2021(age at time of vaccination 49-year-old) as dose 2, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via intramuscular, administered in Arm Left on 24Dec2020 (age at time of vaccination 49-year-old) as dose 1, single for covid-19 immunisation. The patient previously took Levaquin and experienced drug hypersensitivity and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested COVID-19 post vaccination. On 19Jul2021 the patient experienced breakthrough covid positive on 22Jul2021. The adverse event was not resulted in a visit to Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was positive on 22Jul2021. The outcome of the events was recovering.  Information on lot/ batch number has been requested.; Sender's Comments: Based on the current limited available information a possible contributory role of the suspect product BNT162B2 to the development of events of Vaccination failure and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Child awoke the day following his vaccinations, with swollen, purple lips, swollen gums, pale face and a purple rash under the pale skin. Mom reports he felt fine, no fever, no trouble breathing. Rash didn't itch. Symptoms cleared up in 3 days.
patient came back in the afternoon complaining that his arm hurt more than normal (compared to previous years).  He cannot raise his arm as high as normal. Thinks I hit his shoulder.  I rechecked the area of injection and it was within the "3 finger" guideline from shoulder. I told him I would file a report but let us know if it doesn't start to get better by tomorrow.
Within hours, my arm began to ache to the point that lifting it to shoulder height was uncomfortable.  By evening, the entire upper arm was swollen (measured about 1.25 inches greater in diameter than it does today), hard to the touch, red and very warm;  the arm ached unbearably unless it was supported on a pillow, and I couldn't lift it without significant pain.  The same remained true on Friday (the next day) and to a lesser degree on Saturday.  By Sunday, I had good range of motion back, but the arm remained warm and redder than usual.  By Monday, I only noticed it when I bumped it.  I was taking 800 mg of ibuprofen (my usual dose for headache pain) three times a day Friday through Sunday.
1:44PM. Patient noted to be diaphoretic, and sliding out of his chair (slowly). EMS and nursing staff assisted him to stretcher. Eval by NP and EMS.  1:50 pm BP 114/78; P 61; BS 163; Sat 97%.  R. 16 and easy.  Patient oriented x 3. No loss of consciousness.  Offered water, cereal bar.  Patient returned to normal facial color. Diaphoresis decreased. Asked to go home. He arrived and will depart, he discussed his prior history of fainting, etc after injections. DIscharged at 2:39 pm
A 3-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; A 3-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to case 2020SA262410 (same reporter).  This case involves a 3-years-old female patient who inadvertently received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: QFA2029 and expiry date was reported as 30-Jun-2021, but reporter was not sure about the expiration date] rather than INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] via an intramuscular route at the deltoid, on 18-Sep-2020 (Friday) for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that patient received no other concomitant medication.   It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: at the time of vaccination).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme shivering and shakes.  Blanket 4 hours. Heavy sweating.  Tylenol 10 hours
Patient had dry mouth, dizziness, lightheadedness, and nausea. Patient took 2 capsules of 25mg diphenhydramine.
Sore arm, chills, fever, nausea, vomiting, hallucinations. The hallucinations and all started about 10 pm the first day. It felt like the front door to the house was, but I was in my bedroom  and it wasn't. Then it seemed like curtains were falling around me.  Next, I thought I saw stars in my bedroom ceiling and my wife circling around, but she wasn't. This lasted about two nights.  The remainder of the symptoms I think lasted about 4 days or 5 days.
3/14/06 received phone call from pt father. states pt c/o left leg thigh swollen, red, warm to touch and limping when walking. 3/15/06 treated with Motrin and applied ice packs at site. Also gave Benadryl by mouth 3/15/06. Pt in office today. Lt thigh is red moderate swelling down to knee, warm to touch. Pt seen by private physician.
Pt recv vax on 1/19/99; 3 hr post vax pt exp red/raised rash on trunk w/ blister-like/raised spots
Had fever 11/17 and then developed numerous chicken pox 11/20/02.
Initial pregnancy report received from literature on 07 July 2014. Objective: A recent increase in pertussis cases prompted the Committee to recommend administering the Tdap vaccine during each pregnancy. We sought to describe uptake of Tdap and identify predictors of vaccination in pregnancy. Study Design: We conducted a retrospective study of all women delivering at a hospital between February and June 2013. Demographic, pregnancy, and vaccination data were abstracted from the medical record. The relationship between maternal age, parity, gestational age, race/ethnicity, marital status, prenatal provider/site, insurance, influenza vaccination status, and Tdap vaccine was described by univariate analysis. Independent predictors were identified by multivariable logistic regression. Results: In our cohort of 1467 women, 1194 (81.6%) received a Tdap vaccine. After adjusting for potential confounders, 3 factors were found to be independent predictors of receiving the vaccine. Patients were more likely to receive Tdap if they had been vaccinated against influenza during this pregnancy (adjusted odds ratio [aOR], 1.7; 95% confidence interval [CI], 1.4-2.3). Women of a specific ethnicity were less likely to receive Tdap when compared with other women (aOR, 0.42; 95% CI, 0.27-0.67). Also, women who delivered preterm were less likely to receive the Tdap vaccine (aOR, 0.33; 95% CI, 0.22-0.48). Conclusion: A high overall Tdap vaccination rate was observed following implementation of the Committee guidelines. Women of a specific ethnicity, however, had significantly lower vaccine uptake than other women. Further research is needed to understand and minimize this disparity. Women who delivered prematurely also had a decreased rate of Tdap vaccination; vaccinating earlier should be considered to better capture this population. Documents held by sender: none.
71 year old female with a past medical history of colon cancer status post colectomy and chemotherapy completed 01/07/2021, hypertension, no previous history of allergic or anaphylactic reactions who presents to the ED to be evaluated for pruritic rash x 8 weeks, upper lip swelling and throat tightness since last night, possible reaction to Covid vaccine. She received her first COVID vaccine on 01/19/21 about 10 days later she developed a pruritic rash to her trunk and legs. Spoke with her Heme-Onc team who advised her to take Claritin and benadryl with partial relief of rash.  On 01/30/2021 patient had a virtual visit with the doctor who prescribed a 5-day course of prednisone, as soon as she completed the course pruritic rash returned.  Patient was advised to go ahead with the second dose of the vaccine which she received on 02/16.  She presents to the emergency room today because last night began to feel as though her throat was closing and began to have swelling in her upper lip.  Patient presents today with upper lip angioedema, no troubles breathing. Denies fever, chills, headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, dysuria, change in urine or bowels. Patient cannot think of any provoking factors.  Denies new soaps, lotions, home gardening, outdoor hobbies.  States she has been quarantining at home with her husband who does not have any symptoms.
swelling, redness, and itching of entire right arm, radiating across the upper back and shoulders
Event 1: Poor circulation in hands and feet (they turned white and cold after washing hands in mildly cold water).   Treatment and Outcome 1: This is abnormal for me, and I simply manage it by not using cold water.  Monitoring if this becomes more severe and will seek treatment if necessary.  Event 2: after 36-37 hours I developed a rash all over my body (30-40%) similar to Poison Ivy/Oak in terms of itchiness,  and focused in areas where there is higher warmth   or rubbing (e.g. elbows, arms, backs of knees, fronts of thighs, chest).  lesser degree on my back and backs of legs) Treatment and Outcome 2: Tried Calamine lotion and provided some relief, but only marginally successful.  Monitoring and will try lotion and re-application of Calamine to provide relief.  Will seek treatment if it becomes more severe.
Patient was found unresponsive at home in his recliner. He was covered in vomit. Patient was in respiratory distress and required intubation. Upon arrival to hospital, patient was in DKA, HTN and tachycardiac. His pupils were fixed and nonreactive, with R greater than L. HCT 3/25 showed IPH with IVH, mass effect, effacement of 3rd ventricle, R to L midline shift and obstructive hydro. Cerebral Angiogram showed no large vessel source for bleed. Family chose to terminally extubate on 4/3/2022.
Fever, chills, redness at injection site and red feverish patch about three inches below injection site. Swollen tender lymph nodes under both armpits. Red rash on opposite side armpit.  General sore and achy all over.   Very sore arm on side of injection.
Vaccinee has history of chronic urticaria and sciatica post-trauma (1984), both quiescent prior to vaccination.  On day 2 post-smallpox vaccination, vaccinee developed paresthesias of dorsal left hand + minor swelling of hand. Left hand paresthesias have remitted and relapsed subsequently, and continue intermittently through day 18. No report of muscle weakness. Flare of sciatica on days 5-8 (resolved). Otherwise, no similar symptoms at other sites. Symptoms imnproved by NSAIDs (trilisate).  No history of similar symptoms. Migraine-like HA on day 10 post-vaccination; Pruritis. Also fatigue + malaise. Otherwise no systemic symptoms. No fever. No nuchal rigidity. No LE weakness except with sciatica.
Administered vaccines to patients >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 21Jul2022. the vial  was stored post puncture in Fridge. The vial  doesn't undergo any temperature excursions. Unknown whether the vial exposed to room temperature for how long but not greater than 24 hours No treatment medication was reported.   This case was linked to MOD-2022-615199 (Patient Link).
CLIENT HERE TODAY FOR MEN-B VACCINE CLIENT HAD 1 DOSE OF TRUMENBA PRIOR AND BEXSERO WAS GIVEN AND REPORTED ON EMR AS INVALID. NO ADVERSE REACTION . CLIENT INFORMED OF VACCINATION ERROR , CLIENT WAS MONITORED AND MADE AWARE OF POTENTIAL SIDE EFFECT THAT CAN OCCUR AFTER VACCINATION . NEXT DOSE OF TRUMENBA IS DUE ON 02/29/2024 CLIENT MADE AWARE THAT SHE MUST RECEIVE TRUMENBA AND NOT BEXSERO0
Reported body aches which progressed to moderate joint pain, moderately severe headache soreness at site.  She also reported bilateral gross tremors in hands.  Feet swelling overnight.  Symptoms resolved by 4/26/2011 without medical intervention.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program Pfizer Connect.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient works for a hospital. Said had 1st dose of vaccine. Had tested positive for covid on an unspecified date and is under quarantine. The patient would like to know when she should get 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/Batch number has been requested.
Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo.  Had also used 2 IND drugs on this patient (ribavirin & VeriZIG)  PMH: preexisting pulmonary fibrosis & intermittent thrush since birth.  Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks.  Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration.  PMH: protracted history of colds & ear infections.  Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg.  Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06.  Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage.  8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.