chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 87-year-old female with history of lung cancer status post radiation 5 years ago, chronic obstructive pulmonary disease on oxygen 2 L during the day, Waldenstrom's macrglobulinemia, who present to the hospital with difficulty breathing and cough that started on Saturday.  She was found to be COVID positive, with acute on chronic hypoxic respiratory failure and chronic obstructive pulmonary disease exacerbation.  She was started on breathing treatment, Decadron, remdesivir and azithromycin.     11/15/2022 She removed her own IV and does not want it replaced. Discussed that she only received one dose of remdesivir, but she is not interested in having another IV placed. She has been on room air again since 11/14/2022 at 1500. She "required" oxygen less than 24 hours. She is willing to take prednisone for a few days for COPD. Her only complaint is a cough and inability to bring up the sputum. She has a history of MAI? Also a history of Waldenstrom's macroglobulinemia with anemia and thrombocytopenia. She follows with Hematology. The leukopenia is newer, but likely related to Covid infection. She is eager to go home, without further intervention. I explained that if she goes home and worsens, she may be out of the window for remdesivir, but is still not interested in another IV and treatment. Her greatest concern is getting home soon enough to avoid the worsening weather.
Information has been received from a consumer concerning her daughter with no pertinent medical history and no known drug allergies or reactions who on 04-May-2009, was vaccinated with a 0.5 ml dose of MUMPS virus vaccine live (Jeryl Lynn). There was no concomitant medications. On 11-May-2009 the patient experienced rash all over her face and body. No lab diagnostics studies were performed. At the time of reporting, the adverse events persisted. The patient contacted the physician. No further information is available.
Slightly red and swollen, left deltoid started today.(03/10/2005) 03/11/2005 checked and patient is doing "ok".
? Cough     st, fever and bodyaches with congestion x3days     Patient is a 68 y.o. male with HX of HTN Presents with viral symptoms for 4 days without known exposure to COVID 19. Covid 19 vaccinated. Used lozenges with minimal improvement.
No effects until 8 hours later. Then swelling of shoulder muscle,  and pain, that has lasted 3 days.  Does not appear to be an injury, feels more like an adverse reaction or infection.
Headache.  Muscle aches.   Restless legs.  Nausea.   Exhaustion.   Incapacitated for 24 hours.   Headache still persists now.
Maculopapular erythematous rash (legs anterior ??), itchy - no up tongue chest involvement. No wheels. No change
This is a spontaneous report from a contactable nurse practitioner via a company representative and from a healthcare professional on behalf of physician. A 17-year-old male patient received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) at 0.5 ml single, intramuscular, in left arm, on 09Dec2015 at 02:42 P.M. No other vaccine given along with the vaccine. Medical history included seasonal allergies. Concomitant medication included FLONASE daily (25 days), for 2 years. On 09Dec2015, the patient experienced achiness and extreme fatigue, raised area of redness around the injection site, 4x5 cm red/hot/tender area at vaccination site, that persisted for 48 hours with hot to touch and general lethargy. All these events recovered on 11Dec2015, Additionally it was reported that the patient did not feel on 09Dec2015 after noon but had to go back to school and then presented back at the office the next day. He could not concentrate to stay in school. On 10Dec2015 4x5 cm red/hot/tender area at vaccination site, extreme fatigue, body aches and weakness were noted. Outcome of feeling unwell, impaired concentration and vaccination site tenderness was unknown. On 10Dec2015 the patient had a flu test that resulted negative. The reporter felt that there was a causal relationship between the immunization and the reported side effects. Therapeutic measures included TYLENOL. The patient was not admitted to hospital. Follow-up (10Feb2016): New information from a contactable healthcare professional and nurse on behalf of physician includes: vaccination details, medical history, concomitant drug, additional events with relative details.
fast heart rate; eye redness; eye redness with a burning sensation/they were going to fall out; coughing; felt like throat was "constricting"; remarkably unusual tiredness; Initial information received on 04-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a female patient of unknown age who experienced fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history included Drug hypersensitivity and Hypersensitivity.  Past medical treatment(s), vaccination(s) and family history were not provided.  On 28-Feb-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fast heart rate (heart rate increased), eye redness (ocular hyperaemia), coughing (cough), felt like throat was "constricting" (throat tightness) and remarkably unusual tiredness (fatigue) as diagnosis and eye redness with a burning sensation/they were going to fall out (eye irritation) as symptoms of eye redness (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Laboratory data was not reported.  Final diagnosis was heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness and tiredness.  Corrective treatment: allergy pill.  The patient had not recovered from tiredness and recovered from heart rate increased, redness of eyes, burning sensation in eye, coughing, throat tightness on an unknown date.  Information on the batch number was requested.
Reduced concentration and academic performance noted by teachers in school for "gifted" children several weeks after receiving Menactra meningococcal vaccine and DPT vaccine on 7/27/07; reported by teachers to be falling asleep and spacing out in class with occasional eye fluttering noted; for several months c/o difficulty falling asleep and also awakening frequently during nights; had noticeably reduced concentration and increased difficulty understanding instructions and doing school work; CAT Scan and blood work within normal limits but three petit mal seizures were documented in 1/2 hr EEG done in approx. April 2008, but none subsequently noted in followup 72 hr EEG done in August 2008; IQ previously measured above 140 was subsequently measured in testing done in Spring 2008 to be approx. 100.  Performance on ERB tests was significantly below scores on previous ERB tests taken and especially showing deficiencies on writing portion. Was prescribed Depakote ER 250 mg tabs iii qd. for approx. two months and then weaned off.  Recently, no spacing out, falling asleep in class or fluttering eye movements currently reported by teachers of new middle school and academic performance seems to be improving. 1/27/09 Received Neuro consult medical records of 4/18-7/23/2008. FINAL DX: none provided Records reveal patient experienced significant decline in school performance, staring, inattention, argumentativeness, opposition, intermittent tinnitus, & intermittent dilated pupils since 2007 & recent enuresis.  Prior IQ test at age 5=145, current IQ test=106.  Psych testing revealed Aspergers.  EEG revealed probable seizures & tx w/meds. Referred to university neuro dept.    2/2/09 Received Neuropsychology evaluation of 3/12-3/18/2008. FINAL DX: Asperger's disorder; moderate major depression Extensive test results revealed above diagnosis.  Referred to peds neuro, psychiatrist, ST/OT for additioanl evaluaiton.  2/13/09 Received Neuro consult of 7/25-7/28/2008. Records consisted of a 72 hour digitrace EEG which was WNL.
Pt receives TD, Hepatitis A,  & Pneumococcal vaccine in preparation for upcoming trip to China Experienced onset of rash, itching, redness and swelling of both arms radiating to both elbows within 24 hours Proceeded to local hospital after 3 days when no improvement with self medication of Benadryl. Dx: "Infected" arms. Rx Received I.V. antibiotics in ER, told to continue with oral Benadryl 3/19/02 seen by private physician. Dx. allergic response to vaccines. Rx Steroids and antihistamines.
11Dec90 T 100(R) day /p DPT/OPV vax, #1 were given. Cough by hx but none in clinic. 16Dec90 went to ER & was treated for asthma & URI according to mom.
Initial and follow up information has been received from a nurse practitioner (NP) concerning an 17 year old white female student with no known drug allergies who was vaccinated with a first and a second dose of GARDASIL vaccine (yeast). Subsequently, the patient experienced nausea and vomiting respectively. There was no illness at the time of vaccination. Twenty four to forty eight hours after vaccine, the patient recovered from nausea and vomiting. No product quality complaint was involved. Additional information is not expected.
She reports that her arm has become "magnetic" at the site of the two doses of the pfizer vaccine were injected.; This is a spontaneous report from a contactable consumer. A 28-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on an unspecified date single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had any known allergy. It was unknown, if patient received other vaccine in four weeks or any other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 since vaccination. On 14Jun2021, the patient reported that her arm has become "magnetic" at the site of the two doses of the Pfizer vaccine were injected. Patient MD friend contacted her to let her know that her MA was reporting that she saw on social media that people who received the Pfizer vaccine have become magnetic. The patient subsequently tried to stick various metal objects to her left arm, over the deltoid and noted that they stuck. She reported that her arm has become "magnetic" at the site of the two doses of the Pfizer vaccine were injected. Patient sent three pictures of her arm where a paperclip, small key and a small magnet seem to be balanced over the deltoid muscle/"stuck" to her. Treatment received was unknown. The clinical outcome of event was reported as unknown.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Moderna COVID-19 Vaccine EUA 7PM 3/11/2021 hands and body were very cold 2:30AM 3/12/2021 rose to use the bathroom.  Felt dizzy and weak.  Could not make it back to the bed.  Felt like I was going to faint, so just laid down on the floor for 5 minutes.  Got really hot and sweaty. 3/13/2021 extremely tired (30% capacity) and back ached 3/14/2021 felt fine Since I've had fainting issues in the past, I realized I had to get to the floor, but if I hadn't been aware of that, I would have fainted.  I have to be careful with the Lisinopril because I get dizzy when I get up too quickly.  I did not get up too quickly that evening, though.  I rested on the bed before I tried to walk.  I had hydrated a LOT that day as the nurse advised me to do.  Because I get dizzy with viruses, I it didn't seem unusual for my body to respond this way, but I thought I should report this.
When I caught COVID-19 I started off with a sore throat on 6/10/2022 that Friday night. I started getting a fever and chills. My head felt like a brick, and my eyes hurt to keep them open. I was congested and coughing. I had a very dry cough, but no mucus. It was a deep cough, and after a couple of days I did get mucus. I had confusion and exhaustion that lasted for 6 weeks. I was easily out of breath as well. I was forgetful, had no appetite, and I did lose 5 pounds in the first week. I drunk tons of liquids. I had low stamina, and difficulty sleeping. My body was achy. I had sore joints, nausea, dizziness, and headaches. My feet were cold, and the tips of my fingers were tingling. I had brain fog. The intensity of my symptoms changed hour to hour. I was prescribed PAXLOVID.
positive for COVID again; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and COVID-19 (positive for COVID again) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032f21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN from 01-Jan-2021 to an unknown date for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2022, the patient experienced COVID-19 (COVID-19). On 10-May-2022, the patient experienced COVID-19 (positive for COVID again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2022 to 05-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved. At the time of the report, COVID-19 (positive for COVID again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2022, Body temperature: 99.7 99.7. On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative (By day 7).         It was reported that patient started Paxlovid on day of COVID positive diagnosis and completed 5 day regimen. By day 3 of regimen started feeling better. By day 7, tested negative for COVID. On day 9, had a symptoms bad runny nose, muscle aches, chills, and low grade fever (99.7); tested positive for COVID again. The patient was isolated at the time of reporting.  Company comment: This is a spontaneous case reported by a consumer. A 39-year-old male patient experienced 2 non serious episodes of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Approximately 5 months after vaccination he had a positive diagnosis and completed 5 day regimen of Paxlovid; by day 7 he tested negative. On day 9, patient tested positive for COVID again. Relevant concurrent medical conditions included diabetes mellitus which represents a risk factor for infections, including COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 39-year-old male patient experienced 2 non serious episodes of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Approximately 5 months after vaccination he had a positive diagnosis and completed 5 day regimen of Paxlovid; by day 7 he tested negative. On day 9, patient tested positive for COVID again. Relevant concurrent medical conditions included diabetes mellitus which represents a risk factor for infections, including COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received Rabies Vaccine. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had lower antibodies titer of Rabies, but information on titer levels was not available, which led to decreased therapeutic response. The health care provider inquired if the patient can be given booster dose of RABAVERT due to the low titer. It was unknown which rabies vaccine series the patient received in the past. No further information provided.
Initial unsolicited report received from a physician on 31 October 2016. This case involves 79-years-old male patient who was vaccinated with dose of FLUZONE HD (Batch number, expiry date, dose, dose number and site of administration was not reported) via intramuscularly on 31 October 2016. Patient's Illness at time of vaccination was reporter as none and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Any other vaccinations within 4 weeks of vaccination and concomitant medications were not reported. On 31 October 2016, two hours following vaccination patient experienced low grade temperature also had difficulty in swallowing and felt like a hand was pressing the throat. Patient requires ER/doctor visit and emergency room in case of allergic reaction. Lab data and corrective treatment were not reported. The Outcome of events was reported as unknown. List of documents held by sender: none.
headache; low fever (100 degrees); sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 26Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 26Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 27Oct2023, outcome "unknown"; PYREXIA (non-serious) with onset 27Oct2023, outcome "unknown", described as "low fever (100 degrees)"; PAIN IN EXTREMITY (non-serious) with onset 27Oct2023, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to her pediatrician yesterday and received flu and covid vaccine. She woke up today with headache, low fever (100 degrees) and sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Post vaccine side effects. Flu like symptoms. Headache, fever, chills, fatigue
From nursing notes in chart per K. Ellis-benign. FWP-C 10/25/2001 had yellow fever vaccine 24 hours ago; has 1 ? at sit of immunization. 3 cm x 2 cm solid red lesion in right upper SQ area. Area is warm to touch . Pt denies any egg, latex, gelatin and sorbital allergy. Tx with ice and antihistamine.
On 5/10/01 at 09:20, telephone call from mom reporting that on 4/30/01 got shots. Gave Tylenol for fever of 102F during the night. On 5/8/01, had rash of 10 red, flat, macular "spots" over both shoulders. On 5/9/01, rash covered all of body (flat). She was fussy, probably itching, and did not sleep during the night. On 5/10/01 AM, trunk now as red as extremities. No one else ill, no rash contacts. Mom baby sits 1-3 other children. No new foods or soaps. No treatment to date. On 5/10/01, still had rash. Advised mom to call PMD. On 5/19/01, telephone call to mom and she said that MD saw pt and said it was measles reaction . No treatment. On 5/14/01, rash gone.
Left side Chest pain and light headed with low back pain x4 weeks now; Left side Chest pain and light headed with low back pain x4 weeks now; Left side Chest pain and light headed with low back pain x4 weeks now; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 13:15 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 39-year-old) for covid-19 immunisation. Medical history included none from an unknown date. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No other medication in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced left side chest pain and lightheaded with low back pain x4 weeks now on 07Apr2021. Therapeutic measures were taken as a result of events included Prednisone and muscle relaxer. The outcome for all events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse event but they gave her the wrong dose. They gave her .5 when she is only 6 months old. She should of received .2 of the moderna. She took twice as much for the first dose. I don't know if they reported this or where to report this.
Patient was given the high dose instead of the regular flu vaccine.  No adverse effects per parent report.
Per family had progressive decline post vaccination with agitation.  Significantly worse than prior baseline.  He was hospitalized and transitioned to inpatient hospice.  Time/Date of death   7/22/21 at 23:03pm
even after my first shot had then two more times until the newe; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them 3 times) and pain (hurt like the devil all 3 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: even after my first shot had then two more times until the newe). The outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that even after his or her first shot had, then two more times until the new. The follow-up could not be possible as no contact details were available.
Box of DTaP placed with Tdap. Pt given DTaP instead of Tdap No adverse reactions.
Itching in throat, lips swelled, face redness and itchiness. Got very agitated. Redness and itching all over body. Took 40 mg of prednisone and 50mg of Benadryl.