chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to the ER on 4/21/21 with c/o syncope and abdominal pain and nausea and vomiting.  pt wasn't feeling good earlier in the day and became unresponsive falling back onto her bed and son called 911. she arrived in hemorrhagic shock, abd imaging showed a large splenic subcapsular hematoma of unclear etiology (no hx of trauma) with hemoperitoneum and was transferred to a higher level of care for IR .intervention for embolization. She ultimately required splenectomy and mx units of blood. (did get embolization but progressed to further bleeding) and ultimately needed splenectomy  4/24. She is sp 7 units prbc total, 2ffp, 1 plt, 1 cryo.She remains hospitalized as of 4/24 on critical condition
5 days later, suddenly developed large red, very itchy, burning spot on arm around injection spot
12 days after vaccine, patient developed Acute immune thrombocytopenia; platelets dropped from 224000 just prior to vaccine to 11,000 10days later.  Patient had 25 bruises on body from lowered platelets. Started patient on 60 mg of prednisone on 7/27/22 and on 8/2/22 platelet back in normal range.  Continuing to decrease prednisone over next few weeks to make sure platelet level stable.
I experienced moderate to severe weakness,  joint and muscle pain. My right arm swelled up. I started to feel very nauseous last night. I also experienced a moderate headache.
Itching, redness, swelling, soreness on vaccination site (upper right arm) starting today. Much like if I had an insect bite. Using Benadryl Cream.
Left deltoid pain, swelling, redness, itching. Tx with Keflex 125/5ml. 5ml tid x 7 days. Benadryl 6.25mg/5ml. 3tsp q 6-8 hrs.
Patient walks in to get Covid Vaccine for work.  Pfizer Covid vaccine was given after screening and consent form filled out.  Patient was told to sit on chair  for observation.  After about 5 minutes complaining about chest pain.  Skin was moist and diaphoretic from head to toe,  96.8 F, 88 heart rate, alert and able to communicate without any obstable.   Ambulance was called and check out with emergency crew .
Developed a red knot and pain near the injection site 9 days after receiving my first dose.  By later on in the evening a rash started to appear with severe pain throughout my left arm and my shoulder area started to swell.  The rash and swelling has continued on to the following day with the rash spreading.
Patient presented to ED ~2months after 2nd Moderna vaccine with multiple subsegmental PEs as well as small popliteal and calf vein thrombosis. Admitted for 2 days for anticoagulation then sent home on oral anticoagulation in stable condition. No history of thrombosis.
No adverse symptoms reported. Patient was given an additional dose of Ped. Hep B, instead of HIB.
Moderna COVID-19 Vaccine EUA Swollen arm Large red welt Sore Hot
Two months or less from the time of the shingles shot given my chin felt like worms crawling all over. Progressed throughout my face and the top of my head. It now, when it hits me, feels like ants crawling all over my face and head, when the feeling of ants strike me, thus to take my hands
Within hours of administering flu .25 and Dtap pt had a 105 degree temp. And a seizure. Called 911-ambulance to medical center. Observed - Motrin (Tylenol given) Discharged on same day - 02-26-08.
Pt received COVID vaccine on 2/26 and 3/26. Became COVID positive on 4/17/21. Admitted to the hospital on 4/16/21.
Tenderness, redness, swelling 4 x 4 1/2 cm erythema
felt very dizzy, out of it, couldn't think straight and couldn't focus  for 15 minutes.  Then developed dry mouth and tachycardia  about 20 minutes after shot.  Took water.  Had BP check 140/85 ish.  She felt like she couldn't breath.  Patient was wheelchaired to the ER.
left arm remains hot and painful with heat from shower or upon exasperation. there is visible rash with exertio (small red dots) which stops above the elbow.
Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits; Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN6203), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 49 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Breakthrough infections. Tested positive on 25Apr2022 for Covid using at-home test kits". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: using at-home test kits. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: No covid prior vaccination, no covid tested post vaccination and patient did not have known allergies. No treatment was taken for AE. No follow-up attempts are possible. No further information is expected.
Presents to clinic 2/3/07 - bright red rash covering entire body.  Some hair loss.  No VZV type of rash noted.
Patient started feeling "dizzy", "woozy", "seeing spots" approximately 1 hour after she received her vaccine. She stated that she was very tired. She appeared to be very sweaty and said that she "felt hot" when she took a deep breath. EMS was called and patient went to ambulance with EMTs.
possible gastritis; Abdominal Pain worsened immediately after second dose/Pain was always constant and would get extremely painful at times.More pain in the morning and night.; Lots of gas is associated with the pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Sep2021 09:13 (Lot number: FD0809) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Lot No: FD0809), administration date: 25Aug2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Abdominal pain".  The following information was reported: GASTRITIS (non-serious), outcome "unknown", described as "possible gastritis"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Abdominal Pain worsened immediately after second dose/Pain was always constant and would get extremely painful at times.More pain in the morning and night."; FLATULENCE (non-serious), outcome "not recovered", described as "Lots of gas is associated with the pain". The events "possible gastritis", "abdominal pain worsened immediately after second dose/pain was always constant and would get extremely painful at times. more pain in the morning and night." and "lots of gas is associated with the pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastritis, abdominal pain, flatulence.  Additional information: The patient provided information regarding the reported adverse events with the use of the product and reporter consider the Pfizer product had a casual effect to the adverse event and was willing to be contacted again by Pfizer on the reported adverse event. The patient took PRILOSEC [OMEPRAZOLE] tablet orally from 13Oct2021 to 30Oct2021 for abdominal pain and possible gastritis. The patient went to see physician on 29Oct2021, and started possibly gastritis. The patient was given Rx for gastritis and did an H.pylori test which was negative. Took Rx for two weeks which did not seem to help too much. Pain was still there with no current definition of cause or diagnosis. Will be following of with treating MD on Monday 13Dec2021.  Follow-up attempts are completed. No further information is expected.
BlurredVision States she awoke w/cloudy vision, which has now cleared; feeling hot/cold; denies fever but had chills;  Narrative:  States she had COVID in July/2020 and felt these same symptoms; states her worse issue is that she feels exhausted; no appetite, not eaten last 24 hours; advised to go to nearest ER if condition gets worst; states she is taking tylenol alternating with ibuprofen as needed;
Rash on chest and arms. Difficulty swallowing for 2 days. Denies difficulty breathing.
Patient reported nervousness and itching (arms; nose; scalp; neck; ears). Patient given PO Benadryl 25mg at 11:01. Symptoms improved by 11:16. Patient stable and released from the vaccination site at 11:20 with symptoms continuing to improve. Recommended she follow-up with PCP.
vaccine by mistake- she is 34 weeks pregnant; This non-serious prospective pregnancy case was reported by a consumer via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: vaccine by mistake- she is 34 weeks pregnant). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 07-NOV-2023 The case was reported by patient's husband. The patient received Arexvy. The patient received vaccine by mistake and she was 34 weeks pregnant. She received from the pharmaceutical information which showed there was a clinical study done on pregnant woman.  The reporter needed the results of that study to know what other side effects and they need to look out for.  The reporter had called multiple times. The reporter wanted information for his wife's sake and his unborn daughters sake and asked to get that information.  The reporter just want to know what to look out for concerning the wrong vaccine and what side effects to consider, how this would impact birth, lactation and the child's health. The reporter wanted this information to be passed that his wife had doctor appointment the day after reporting and he was hoping some answers to get then.
Immediate erythema at injection site, and bronchospasm with dyspnea - Rx with epinephrine subq and nebulizer with albuterol, IV site, and IV steroid.
I had the Covid-19  virus in late November until late December 2020.  I was very sick with all the symptoms and finally tested negative about 6 weeks after getting the virus and testing positive 3 times in that period.  I took my first shot in early March and had the typical side effects, but they lasted for 3 days:  After my second shot I had uncontrollable shivering, chills, headache, vomiting, nausea, weakness and fatigue for 2 days.  I was so sick from it that I was pretty scared at the time. It was the intitial reaction from it that was horrible and occurred 5 hours after the shot and lasted all night long.
Lack of efficacy; COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: -This is an spontaneous case concerning an unknown-years-old male patient with no medical history reported who experienced the unexpected events of covid-19 (AESI) and drug ineffective unknown days after a  dose of  mRNA-1273 vaccine.  On an unknown date, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement.; Sender's Comments: COMPANY COMMENT: -This is an spontaneous case concerning an unknown-years-old male patient with no medical history reported who experienced the unexpected events of covid-19 (AESI) and drug ineffective unknown days after a  dose of  mRNA-1273 vaccine.  On an unknown date, SARS-CoV-2 test was Positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement.
Sore and red spot day after. Then about a week and a half later red spot is back and slightly larger. Itchy and a little warm to the touch.
Patient complained of dizziness during the 15 min observation period post-vaccination. Patient requested water which was provided. Patient complained she had difficulty swallowing and shortness of breath. Patient was sent to the onsite Emergency Department. Patient was place in bed in supine position. Symptoms resolved. No further treatment was provided.
Initial report received from a health care professional on 12 December 2007. Four or five patients (identifiers not provided) had received an intramuscular deltoid (site not reported) injection of IMOVAX RABIES Vaccine for pre-exposure prophylaxis and a few hours after vaccination (date not reported), experienced numbness, tingling, and difficulty bending their fingers. Their fingers felt swollen, but did not appear swollen. Symptoms were felt from the injection site, down the arm, to the fingers and resolved within 24 hours. The patients have not been ill at the time of vaccination. All of the patients had recovered from the event. No further information was provided at the time of the report. 28 January 2008: A corrective version was created with the same latest received date as the last version (12 December 2007) for the sole purpose of adding the term "cluster" to the top of the narrative as per internal guidelines. Follow-up information received on 01 February 2008 from a health care professional. Information was provided for one patient. The patient had been a 27-year-old female with a history of allergic dermatitis and nausea and pre-existing allergies to pollen, cats, rabbits and grass. Concomitant medications at the time of vaccination included birth control pills. The patient had been immunized on 04 December 2007 at 10:00 and had not received any prior doses of IMOVAX RABIES Vaccine in the past. No further information was provided at the time of the report.
Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours
Occurred 5 weeks after vaccine and I don't think its related - But you sent me this form anyway. I experienced a possible migraine aura.  A colorful kaleidoscope for about 10 minutes.  In both eyes.  Following I had a mild migraine headache for a day and a half (usual duration of my migraines). I experienced the aura about an hour after eating very ripe pineapple. I think it was a tyramine headache and unrelated to the vaccine.
Patient reported joint site swelling. The swelling was moderate, to the size of a small ball. Some numbness and pain. Some skin discoloration roughly 1 to 1.5 cm
High blood pressure; felt dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt dizzy, nausea on 2021, high blood pressure on an unspecified date. Reported as, She has felt dizzy, nausea and not the same since her 1st dose. She saw her primary and cardiologist for her High blood pressure since and the primary doctor said that if she was not comfortable that she should not get it and wait 6 months before starting over. Her cardiologist however gave an opposite opinion. since her 1st dose of the vaccine, she still has some side effects, she does not feel the same. Outcome of the events were not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Starting on 07/15/2022, I had a mild cough and the test that I took that day was negative. That evening, I went straight to bed due to fatigue, cough, aching, low grade fever, runny nose, mucus and muscle cramps. I tested positive for COVID-19 on 07/16/2022 with an At-Home COVID-19 test. On Saturday evening into Sunday, my temp went up to 101.6. Sunday evening was a little worse than Saturday evening fever wise. On Monday, 07/18/2022, I called my doctor's office and they put in the order for monoclonal antibodies, which I got that very afternoon. I started feeling better, no more fever or aching, just persistent cough and fatigue. I went to work 2 weeks later (08/02/2022). The cough got worse 2 weeks after first testing positive and I have not been able to shake it. I contacted my doctor this past Friday and I got a chest x-ray and some steroid shots. I was prescribed more cough medicine and continued using my inhaler (which I haven't had to use in a very long time but started using with the COVID-19 case).  To this day, I am still pretty fatigued and suffering from the cough mainly when I am talking.
The immunization was given at 10:30 am.  The frist hive was seen by his left eye around 11:30 am, which progressed to left ear and below mouth. He was seen at 4pm in clinic, there were multiple hives on his back, torso and extremities.  Dr sent in a prescription for oral children's Benadryl.
Initial and follow up information has been received from a Nurse concerning a 25 year old female who on 27-JUL-2007 was vaccinated with a 1st dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 20-MAR-2008 the patient was vaccinated with a 2nd dose of GARDASIL (lot# not reported).  The patient sought unspecified medical attention in the office.  The patient did not have any symptoms.  No further information is expected.
SHIVERING; FEVER; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering, and fever. This report was non-serious.
some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event; Initial information received on 29-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient and pharmacist reported that Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Oct-2023, the patient received a 0.7 ml of dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: high dose, frequency: once, expiry date: unknown and lot U8135AE) via unknown route in unknown administration site as immunization and some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event (incorrect dose administered) (same day latency).   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 the 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.
I had not had an Herpes II outbreak in at least 6 months and am not experiencing any stress, which has been a trigger.   Herpes II lesion on left buttock. Began treatment of Aciclovir Not sure if this is a side effect, but thought I would check.
exposed to temperatures below 35 degrees F for 17 minutes on 03 Jan 2019 and then an additional 24 minutes on 04 Jan 2019; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse.  In this case a cold chain deviation occurred with the dose of IPV (VERO) [IPOL] (] lot N1G411M via unknown route in unknown administration site) which was exposed to temperatures below 35 degrees F for 17 minutes on 03-Jan-2019 and then an additional 24 minutes on 04-Jan-2019.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunization; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunization; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunization.  It was actual medication error due to incorrect product storage. It was reported that the patient was then administered this IPOL vaccine on 21-Jan-2019  It was not reported that the patient had any adverse event  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.  List of documents held by sender: none.
Left arm red, swollen, painful size of a silver dollar, denies SOB, or itching-per nurse at home
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: pt came in to tell us about rx- 2nd vaccine-hit nerve jumped(admitted didn't tell vaccinator) 1 hr later throbbing in are "like a heart beat"  very painful took tramdol not help,took oxycodone 1:30am still painfull went to er - nothing could be done, advised him to see neurologist-  neurologist stated very vey rare -nothing can be done- give it time & aleve - is feeling better at the time he reported
Cough, chills, shortness of breath, elevated heart rate, chest pains - started approx. 48 hours after vaccine, lasted five days,