chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a 66 years old female consumer, reporting on herself. The patient's pertinent medical history included, as current medical conditions, hypertension (reported as "high pressure"); asthma; and a nervous system disorder (reported as "unspecified neurological condition"). The concomitant medication the patient was taking included amlodipine; losartan potassium (manufacturer unknown) (reported as "losartan"); estradiol; gabapentin; calcium (unspecified) (reported as "calcium supplements"); and, omega-3 marine triglycerides (reported as "fish oil supplements"). The patient's drug reactions and allergies history included tramadol drug hypersensitivity and sulfonamide (reported as "sulfa drugs") allergy. In addition, the patient reported that on an unspecified date approximately in 2017 (reported as "about a year ago"), she "got a shot" of PREVNAR 13 and "it gave her like a 3 inch wide welt at the injection site". On 21-MAY-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 as prevention of pneumonia (prophylaxis) (concentration, dose, dose number were not provided; route and anatomical location of administration, lot number, expiration date were unknown by the patient; product circular number uspi-v110-i-1505r041). The patient stated that she was vaccinated at an unspecified "Pharmacy". The same day, about 4 or 5 hours later, the patient experienced a severe injection site reaction after being vaccinated. The patient stated that she had aching and stiffness in an unspecified arm (pain in extremity and musculoskeletal stiffness). Therefore, the patient mentioned she took TYLENOL and ADVIL as treatment. The patient stated that later, that night, "she could not feel comfortable while sleeping as it was very painful. The next day, on 22-MAY-2018, the patient reported that "it started swelling (peripheral swelling), and continued to do so over the next few days, along with the arm and up to her neck" (swelling). The patient mentioned that "it had started to slowly get better". When reporting, on 29-MAY-2018, the patient stated that day was "the first day she felt like it was back to normal", and that pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness had resolved. Further information was not provided and no product quality complains were reported. The patient did not provide any causality assessment for pain in extremity, injection site reaction, peripheral swelling, swelling and musculoskeletal stiffness in regards with PNEUMOVAX 23 vaccination.
pain in injected arm. swelling edema in arm. swelling in upper lip some facial edema(resolving)
Vomiting; feeling sick; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 09:00 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 27Nov2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 28Nov2021 06:30, outcome "unknown", described as "Vomiting"; MALAISE (non-serious) with onset 27Nov2021 20:00, outcome "unknown", described as "feeling sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting.  Additional information: A 7 year-old female patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (Lot number: FK5127) at the age of 7 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 27Nov2021, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 27Nov2021, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Drug Lot number and expiration date: FK5127. Patient details: Patient age at time of vaccination: 7years. Prior vaccinations, concomitant drugs, patient's medical history, relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia were none, Test: Antibody test to platelet factor IV, Date: 17Oct2019, Result: Positive 1 copy, Comments: 1 copy of he factor IV variant. Comment included: possibly caused by stomach bug as there was no reaction to 2nd dose, Timeline: 1st Dose-Friday 9:00 am, Feeling sick -Saturday 8:00 pm, Throwing up-Sunday 6:30 am, Throwing up- Monday 6:00am. Run down and off school for 4 days. Returned to school on Friday.  Follow-up attempts are completed. No further information is expected.
Red rash that starts below where the vaccination was given and goes towards my elbow. It's on the same line as the vaccine and towards the inside of my arm.  Looks familiar to the covid rash.  Arm is slightly swallon and warm to touch.
Red skin, hot to the touch, itches   Started the day after, and continues to today five days.  Slowly getting better.
Shortness of breath developing within 3 weeks of getting vaccine, found to have submassive/intermediate risk PE
Acute on chronic hypoxic respiratory failure due to pulmonary edema secondary to exacerbation of chronic diastolic HF. Patient was treated for acute volume overload with probable acute diastolic heart failure with preserved EF.  She was tried treated with IV Lasix with gentle diuresis every 12 hours.  There was concern for probable UTI and so patient was started on IV Rocephin.  The following day, IV diuresis was discontinued secondary to development of hypernatremia.  It was reported that she clinically appears euvolemic.  Potassium normalized after getting Lasix and calcium gluconate in the ED.  Kidney function did improve. Plan to discharge to SNF with hospice services versus in-house comfort cares. Patient passed away on 12/31/2021. ED visit, hospital admission and death within 6 weeks of receiving the COVID vaccine.
Okay well, so within 24 hours was the typical, just sore arm and fever within the first 24 hours. My fever got up to like 101 degrees and I just took Tylenol to mitigate that. Then the next thing that happened was that I gave birth to my baby that didn't have a heartbeat anymore, that was on July 22, 2021. Her original due date was October 4, 2021. I did have a history of fibroid removal surgery and had ultrasounds every two weeks up until that point, and they were negative for genetic issues, preeclampsia and diabetes. So I was scheduled for a C-section for the week around September 20th. But yea I had to deliver July 22, 2021, I noticed a lack of movement and they did an ultrasound and noticed no heartbeat. I did not have any other symptoms, I just noticed that there was no movement.
Nasal congestion and rash. Total body urticarial rash. Spread to legs and arms.
Pt with history of allergy to PCN, while sitting observation reported a weird taste in her mouth and a warming sensation which traveled from her arm to her throat, then to her chest, and stomach. Pt was evaluated by EMS, she signed a refusal for transport to the hospital. Pt was given ED precautions and advised to contact her PCP to discuss symptoms.
fever of 101 for one day, beginning the day after the vaccine;  fatigue and sluggishness for one day, after the fever.
slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain in center of chest, neck, head no trouble breathing, greast weakness, difficulty rising and standing -- best lying in bed under warm covers- Like the worst cases of flu or virus I've ever had.. Very thirsty
Left thigh induration with erythema of large area of thigh with increase temp of erythematous area. NT to palpations.
Patient's prostate cancer had been stable on previous treatment up until his moderna covid vaccine. He states about a month after the shot his PSA levels went to positive 1 and he had to change medications for his cancer. His wife also had cancer (bladder) and was stable for a couple years; after her vaccine she passed away a few months later and he blames the vaccine.
3/30/23  I had a sore throat and it was fairly severe.  I also had fatigue and did not feel well.  4/3/23 I took an at home COVID test and it was negative. I continued to have the sore throat off and on. About a week later, I had a little bit of a cough and had fatigue. I took another at home COVID test 4/8/23 and it was negative.  On 4/9/23, I felt pretty good. The next day, I felt terrible and started coughing more.  I bought cough medicine, and it did not help. I tested with an at home COVID test on 4/14/23 and it was negative.  I took my temperature several times during this time and never had a fever.  On 4/17/23 I went to the doctor.  They did not do any tests. I was told I probably had COVID because of the fatigue.  The nurse practitioner told me it was probably a bacterial virus because my sinuses were so bad for so long. She diagnosed me with Acute maxillary sinusitis.   I was prescribed Augmentin. I am now taking Augmentin and feel better than I did. I still have coughing fits and am exhausted.
Something is getting in the way in his throat .; stage 1 varices/some type of clot or thrombosis; Thrombocytopenia; Cirrhosis of the liver; stage 1 varices/some type of clot or thrombosis; Recently started having acid reflux and pain in his chest; Recently started having acid reflux and pain in his chest; This is a spontaneous report from a contactable consumer (patient brother). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 as single dose, dose 2 via an unspecified route of administration on an unspecified date in Mar2021 as single dose for Covid-19 immunization. Medical history included ongoing thrombocytopenia. The patient and his twin brother both have thrombocytopenia. The patients concomitant medications were not reported. On an unspecified date in Mar2021 the patient experienced thrombocytopenia, cirrhosis of the liver. On an unspecified date in 2021 recently started having acid reflux and pain in his chest, in Mar2021 patient had stage 1 varices/ some type of clot or thrombosis, in Jun2021, something was getting in the way in his throat. The patient underwent lab tests and procedures which included blood work: excellent on an unspecified date in 2021. It can't be cirrhosis because he has excellent blood work, electrocardiogram (ECG): abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis and cirrhosis of the liver where he had had neither, previously, oesophagogastroduodenoscopy (EGD): had nothing like this when they did the last one in 2018, abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis. The outcome of events was unknown.  Information about lot/batch number is requested.
Client's Mother called and stated client woke up in the middle of the night(8/7) having developed a rash from the lower abdominal area to top of knees.  Also had a few spots on neck and arms. The rash was not a pinpoint rash but was diffuse, flat, circular areas.  Denies fever.  Per Mom, she planned on giving daughter Benadryl but had not done so yet.
Extreme nausea, diarrhea, muscle pain and weakness, tiredness, total inability to function in any way normally, lasting in this way for three weeks, then several more weeks of general tiredness, weakness and emotionally drained.  My pcp said there was no treatment and I had to just wait it out. I think I am still having symptoms relating to the Moderna shot, as I am very emotional with weakness still.
Information has been received from a nurse practitioner concerning a 13 year old female who in January 2007, was vaccinated with Gardasil. In January 2007, the patient developed arthritic symptoms. The patient had developed achy knees and wrists. There was no redness on the knees and the wrists but were sore. It was reported that ibuprofen was little help in relieving the pain. The nurse practitioner reported that she would ask for lab work to be done for rheumatoid arthritis and a sedimentation rate. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow up information has been received from a nurse practitioner concerning a 13 year old, female with a sore throat at the time of vaccination, hypothyroidism and growth hormone deficiency, who on either "02-JAN-2007" was vaccinated IM, with a dose of GARDASIL (Lot #655619/1427F).  On 15-FEB-2007, the patient developed arthritic symptoms, including achy knees and wrists.  There was no redness on the knees and the wrists but were sore.  It was reported that IBUPROFEN was little help in relieving the pain.  The nurse practitioner reported that she would ask for lab work for rheumatoid arthritis and a sedimentation rate (results and tests not confirmed).  Follow up information indicated that "according to rheumatology" the patient probably did not have a reaction to (GARDASIL)."  At the time of this report, it was unknown if the patient had recovered.  Additional information has been requested.
Fatigue, all over body aches, headache, fever, chills, 101-102 temp, blood pressure raised above normal, rapid heartbeat.
I am a physician.  Rec?d both vaccines at same time.  Developed 103.5 fever about 14 hrs after combined administration.  Chills and muscle aches predominated.  Muscle soreness at both deltoids.  Reduced  with Tylenol /ibuprofen.  Now 24 hrs after admin fever still 101.6 off meds.  Also tested for Covid, negative.  I am managing from home.  No nausea/vomit. Can take PO fluids with no problem.  I did have both initial Pfizer vaccines in early 2021.  Booster in Oct 2021.  Positive for Covid in may 2022.
Left arm hurt at the injection site for about 24 hours.  Intestinal discomfort for about 48 hours
sore arm; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who experienced sore arm (pain in extremity) after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and Coronavirus disease (COVID-19) VACCINE  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, 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 received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and COVID-19 VACCINE.  It was reported "I got both the Fluzone high dose: and the Pfizer COVID booster on the same day. The only side effect was sore arm for several hours"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the event  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case
Seriousness criteria other medically significant (OMIC). Initial information received on 11 December 2006 from another manufacturer (no reference number provided). The information was originally provided to the other manufacturer by a health care professional. A patient (gender and birth date not reported) received a dose of influenza vaccine 20 years ago. The trade number, manufacturer and lot number were not reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. Per the reporter, no other information was available at the time of this report. It was not reported whether the patient recovered from the event.
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving  30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID  in December.  as I write this I am fine and it is 1/22/21
Strong Nausea. Went to my doctor, started on Nexium. Had an upper endoscopy that showed gastric mucosa inflamed . No significant findings on the biopsy
Information has been received from a physician concerning a 14 year old male who on 25-MAY-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varivax is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Pt, reported having blurry vision and dizziness denies SOB, dyspnea or itchiness and was instructed to put  head dawn and encouraged to drink water and pt has no other co-morbidities but stated he was nervous to first dose, after a few minutes pt felt better and symptoms subsided. instructed to finish 15 min observation time and to notify team if symptoms return or worsen.
Patient felt funny in her throat, she was  not sure because of anxiety from hearing the side effects.  I observed her closely.  I told her to focus on her breath, She said it was still coming and going.  We gave her  a dose of benadryl and she felt better after 5 minutes.
CHIEF COMPLAINT:   Pt states he hit his head on the dryer, had a painful headache, wife brought him to ED   HISTORY OF PRESENT ILLNESS:     hit head on open clothing dryer door. Wife reports that he went down on his knees due to pain did not lose consciousness but has been unable to speak clearly since that time. Denies any vomiting. Denies take any blood thinners. Has a history of intracranial hypertension as per wife with a CSF pressure of 24 at  Medical Center. History of present illness, ROS, and physical exam are all limited by patient's condition. No chest pain, sob, fever, chills, diaphoresis, or swelling/pain of lower extremity.
Feeling faint/weakness, upset stomach (burning), vomiting, mild diarrhea.
PATIENT EXPERIENCED SYNCOPE, LOSING CONSCIOUSNESS BRIEFLY. FELL OUT OF CHAIR AND REGAINED CONSCIOUSNESS ROUGHLY 15 SECONDS LATER.
Noticed 12/15/08, notes soreness, states no below waist eccythmosis, scattered lesion anterior and posterior trunk and neck, reddened raised macules with 2 pertulis to back, 1 to right lateral trunk.  Denies any on legs or below waist.
Child recently moved from another country, no immunizations available.  Child was on catch up schedule.  First dose of DtaP given 2/5/08.  Second dose DtaP ordered on 5/16/08.  Tdap was given to patient.  CDC was called to report vaccine incident.  CDC informed that this dose of Tdap will not count towards DtaP series.  Child will need next dose of Dtap in 4 weeks.  No adverse reaction noted at time of immunization or since 5/16/08.
KINRIX was administered on RA on 06/05/13. Next day patient developed swelling and tenderness on that area, no fever. Patient came back to clinic 2 days later with moderate swelling and tenderness on right arm, but improving from day before as per mother. Treated with warm compress locally.
Pt complained of Laryngeal edema and trouble swallowing approximately 5 minutes after administration. Benadryl 25mg IVP and Epinephrine 0.3mg IM administered. Followed by 125mg IVP over 5 minutes of Solu-Medrol.
within a month of receiving the booster I started having very serious dizzy spells and both ears ringing loudly.
rapid atrial fibrillation; pericarditis; plueral effusions; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient in her 60's received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "recovered", described as "rapid atrial fibrillation"; PERICARDITIS (medically significant), outcome "recovered"; PLEURAL EFFUSION (non-serious), outcome "recovered", described as "plueral effusions". Therapeutic measures were taken as a result of pericarditis. Clinical course: patient suffered rapid atrial fibrillation, pericarditis and plueral effusions after receiving vaccination with Comirnaty. She was placed on colchicine which she could not tolerate and switched to steroids to treat the pericarditis. The situation resolved after several months and the woman is currently doing well. Patient has not prior of adverse vaccine reactions or known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Atrial fibrillation, Pericarditis and Pleural effusion and the suspect drug BNT162b2 (COMIRNATY) cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.