chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 19-year-old male patient. The patient had no pertinent medical history, drug reactions or allergies and there was no concomitant medications. On 18-JUL-2018, the patient was vaccinated with a dose of VARIVAX (lot # R002507, expiration date: 25-JAN-2020, dose, site and route of administration were not provided) for prevention of chickenpox. On 27-JUL-2018, the patient experienced an outbreak of vesicles over his torso. The patient was isolated and treated with calamine lotion. No lab diagnostics/studies were performed. The outcome of an outbreak of vesicles over the patient's torso was reported as not recovered. The relatedness between an outbreak of vesicles over the patient's torso and VARIVAX was not reported.
I work in a hospital. I was informed about the meningitis vaccine which is a series of 3 shots. It was suggested that I have the vaccines. After the first shot I had several swollen joints. I did not know of any possible reactions that I could have. After 2nd shot I developed swollen joints again but this time much worse. I had a temp. of approx. 103-104 degrees. The glands in the back of my head were the size of golf balls. This caused severe headache. I had conjunctivitis in my eyes. When I open my mouth I saw a bright red rash on the roof of my mouth. Light bothered my eyes and I could not get out of bed for about 2.5 weeks. All I did was sleep, ate very little. When I did get up to shower and finished I noticed a bright pink/ red rash from my neck and down. I needed help coming down the stairs. Really though I was going to die during this time. I have never been so sick before. When I was in the ER they did not know what to do and said to go home and that this could be contagious. They ? lymes. I cont. to have episodes of joint pain with no obvious injury, headaches, pain in the back on my head and severe fatigue. After years of nor knowing what was going on and lasting I was told I had RA. I have been suffering ever since. I did not get the 3rd shot as I was convinced this was from the vaccines. I recently read on the internet that there have been other reports of this in other people. I felt the need to inform you of my story as that there should be side effects told to the public on these vaccines. 7/15/09 Spoke with vax provider MD.  Pt recd Hep B  series in 1989. Did not receive meningitis vax in 1998 or at any other time. Did c/o arthralgias after Recombivax #2 on 4-10-89 #2 and did not continue the series. She will fax pertinent data. 7/17/09 Records rec'd from vax provider. Pt reported fever and arthralgias 2 days s/p Hep B#2.  R wrist boggy and synovium tender at 4th and 5th MCP. No further f/u from this provider.
Sunburn like rash on chest after sun exposure on warm winter day on day 10 post vaccine dose 2. Itchy and red, vesicles appeared on day 2 of rash. Aloe applied topically to no effect. Benadryl gel applied topically on day 3 of rash to good effect to alleviate itching. Currently day 9 of rash and area (the size of my palm on my chest right at my breast bone) continues to be very red and mildly itchy.
6x7.5cmhyperedemas and mild induration right deltoid x 3 days.
pt recvd vax & 3wks later was found to have elevated liver enzymes;
COVID infection. Specimen collected on 8/11/21. Patient died on 8/13/21.
Patient was admitted for Routine postoperative care. During her hospitalization she remained afebrile and hemodynamically stable. Hospital admission within 6 weeks of receiving the COVID vaccine.
On 1/28/2021 at 0545 hours as I was on my way into work when I started to have severe right side chest pain, so much so that I had to pull over. Shortly thereafter ambulance arrived on scene at which time it was determined that I would be transported to the hospital. Once there, a series of tests were conducted, one of which was a D-Dimer blood test to rule out blood clots. That resulted in an elevated count to which a CT scan was ordered.   The result of the CT scan revealed that I had 2 Pulmonary Embolisms, one in the upper lobe of my right lung and one in the middle lobe of my right lung.   Due to me being what the doctors said was a healthy 45 year old with no underlying conditions or signs of DVT (deep vein thrombosis) they deemed me low risk at that time and advised I was at low risk of dying in the next 30days. However, they advised that at any time, the clot could possibly become dislodged and cause worse problems, possibly death if time is not given to the body to dissolve the clots. Ultimately it was determined that I be discharged and prescribed blood thinning medications to help thin the blood to prevent further clotting should I have a clotting issue (undetermined at this time).
Hospitalized 11/2/16 with 1-2 WK HX progressive paresthesias and weakness. Diagnosed with AIDP following neuro consultation. Treated with IVIG.
Patient received an extra dose of Varicella at 1130, no adverse reaction at time of injection
Temperature of 100°F, bodyaches, chills, lethargic, some back pain, not feeling well overall, sore throat
PT REC  JANSSEN VACCINE @0800 WALKING TO OBSERVATION AND STARTED TO FEEL WEAK . SYNCOPE EPISODE.
Severe nausea; headaches; weakness; Bivalent vaccine was administered for Dose 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 22Nov2022 at 13:00, outcome "unknown", described as "Bivalent vaccine was administered for Dose 1"; NAUSEA (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "Severe nausea"; HEADACHE (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "headaches"; ASTHENIA (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "weakness". Therapeutic measures were not taken as a result of nausea, headache, asthenia.  Additional information: It was also reported that there was no other vaccine in four weeks. There were no allergies and patient did not had covid prior vaccination and was not covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Increased dizziness for about two weeks and then dropped to the floor with room spinning. Dizzyiness caused vomiting. Ambulance was called and I was taken to the Hospital. My left pupil was rapidly moving side to side for days as they kept me in a dark room with an eye mask on.
Pain, redness, swelling at injection site, muscle pain, tiredness, shivering, fever, queasy stomach. Have been taking Extra Strength TYLENOL as soon as symptoms started and will continue until symptoms subside.
Patient reports persistent severe leg pain radiating down front and back of both legs from hip area down to knee starting the morning of 8/19/2021. No reported pain in lower legs below knee.
Severe headache, emesis the same day once, then fever 102 for 2 days.  Headache lasted for 5 days, less severe after the 1st day.
This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.
6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Approximately 20 minutes following vaccines x 3 guest felt nauseated, eyes dilated, rolled back, arched neck / back X 15-20 seconds, no response; then alert oriented X 3. No further symptoms.
I received the second dose of Pfizer vaccine on Nov 1st. The second day I was pretty ill. That last several days. One thing that remained was the swelling and tenderness in my neck, axilla, the side of my breasts and groin. I sought out treatment at an Urgent Care and pharmacy Clinic on 11/13. On 11/14, I continue to to have the lymphadenopathy and quite uncomfortable. I had no issues with this prior to it he vaccine. The provider I saw thought it was vaccine related and encouraged me to fill out this Adverse affect report.
pt recvd vax & approx 5-6 hrs later vomited & had 2-3 more episodes of vomiting;
11/25/2022 Felt allergy symptoms in the morning.  Tested 11/26 Positive with an At Home COVID-19 Test.  Developed a fever peaking at 100.6 with allergy symptoms continued.  11/27 Visited Doctor who prescribed Lagevrio, Zinc, Vitamin C, Vitamin D3.  Tested positive again on a rapid COVID-19 test.  Advised to treat symptomatically. Fever fell to 99 on 11/28 and gone completely by 11/29.  Allergy symptoms persisted.
Redness in entire upper arm.  Patient also states weakness/difficulty lifting arm where injection was administered.
Accidental implantation of vaccine on the chin after smallpox vaccine. Treated with analysis, antihistamines and antibiotics. Patient is recovering.
4 days after Booster Pfizer, left hip pain started. No injury prior. Then knee pain and ankle pain. Diagnosed as reactive arthritis to vaccine.
11MAR97 c/o fever, h/a & pain in lt arm radiating to hand;took OTC analgesic for discomfort w/applied heat to area;saw MD 24MAR97 w/dx abscess;placed on keflex;radial nerve in lt arm was affected & degree of disability unk;
Injection given outside of the deltoid muscle. Patient experienced prolonged pain and shooting pains down her arm.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with MMR II (lot#, expiration date, dose, were unknown), subcutaneous in the thigh, rather than the outer aspect of the upper arm. No adverse effects reported. Additional information is not expected.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 4/1/21 (EN6198) Pfizer Dose 2 4/23/21 (EW0153) Pfizer Dose 3 12/18/21 (lot NA) COVID Positive 12/22/21  12/22/21: The patient is a 54-year-old female with past medical history of hypertension, hyperlipidemia, anxiety, tobacco use was sent in from urgent care for hypoxia.  Patient reports about 6 days ago she had her COVID-19 booster shot.  After that she started having generalized body ache, nausea, vomiting, diarrhea, abdomen pain, shortness of breath, fevers/chills and headache.  Today patient seen at the urgent care and was found to be hypoxic so she was sent to the ED.  at this time patient reports shortness of breath has improved and denies headache, chest pain, dizziness or dysuria.   In the ED temperature 102.2, heart rate 92, RR 16, the patient did desaturate to 89% room air was placed on 2 L nasal cannula, blood pressure 138/81.  Chest x-ray negative.  CT angio negative for PE but did show scattered viral pneumonitis.  Sodium 133, potassium 2.7, chloride 88, troponin negative, WBC 10, D-dimer 0.85, COVID antigen positive and negative influenza.  Patient received Tylenol, Rocephin, Decadron and potassium in the ED.  12/24/21: The patient is a 54-year-old female with past medical history of hypertension, hyperlipidemia, anxiety, tobacco use was sent in from urgent care for mild hypoxia secondary to COVID-19 infection and severe hypokalemia with a potassium 2.7. Patient was admitted and commenced on oxygen supplementation, potassium chloride, remdesivir, antibiotics in addition to other supportive treatment.  On re-evaluation this morning she is feeling much better. Electrolytes abnormality has resolved.  She had oxygen walk for home determination and does not require home O2. Patient may benefit from COVID 19 program.  She is discharged on pre-admission home medications.
5/10 SUBSTERNAL CHEST PAIN FOR APPROX 10 MIN. BP 146/86 HR 73
COVID PCR + 12/29/21 and admitted to hospital 12/29/21
Had staring and jerking seizures. Had encephalitis from DTaP immunization. Doctors had a hard time controlling seizure. Had to undergo developmental therapy. The 60 day follow up states pt still has some residual inflammation of the brain (encephalitis). She is still on four anti-convulsants and ahs re-started taking steroids to help with the inflammation. The doctors were unable to identify and bacteria or viral DNA that would have caused the encephaltiis aside from the fact she had her shots five days prior to the onset. The discharge summary received on 3/23/04 states viral infection. My daughter is still on anti convalsats and experienced some developmental delays. She is not talking as much at her age appropriate level. I feel that the medical facility should have to report even suspected cases of adverse reactions and that they should face a stiff penalty for not doing so.
My daughter received her 2nd Pfizer covid vaccine on 1/5/2022 at 4:10pm at Hospital.  At 10:00 PM that same night, she began clearing her throat due to mucus.  She also developed a headache and began coughing persistently.   Her temperature reached 100.1 degrees F.  At 4:30AM  01/06/2022 the following were administered at home: Children's mucinex (10ml), Children's motrin (12.5ml), and her albuterol inhaler (2 puffs).  I contacted my daughter's pediatrician's office  and she was seen at an 8:30AM appointment.  The pediatrician ruled out an allergic reaction to the vaccine, but believed that my daughter was likely experiencing side effects from the vaccine.  A covid test was conducted as the omicron variant is circulating widely in our community.  The covid test results were received on 01/7/2022 stating that my daughter was positive for covid.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA at single dose, and the 2nd dose of MENACTRA, both at arm on an unspecified date at around noon for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives and facial swelling (non-serious) in Jul2018, early the following morning after vaccination. Patient went to urgent care and was given steroid shot. The outcome of the events was unknown
Patient has history of anaphylaxis. Preventatively had patient frontline their own benadryl 50mg po 20 minutes prior to vaccine. Observed patient for 30 minutes; no injury to patient.
Fluzone HD was administered to 57 years old female/no AE; Fluzone HD was administered to 57 years old female/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case is linked to case 2019SA274402 (same reporter).  This case involves a 57 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy at the time of vaccination.   On 30-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number UJ268AAA via Intramuscular route in right deltoid.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose). The vaccine was administered by a Physician or a Healthcare professional (not confirmed).  It was unknown whether adverse event was noted or not.  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.
I went into Menopause 4 years ago, I started spotting the next day and am still spotting 2 weeks later
no AE; vaccine that underwent a temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history was not provided.  On 08-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025369, expiration date 01-DEC-2022 (dose, route and site of administration was not reported) which underwent a temperature excursion.  No additional adverse events were reported.
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The local clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer
2 days following vaccine patient had a cardiac arrest at home. Very likely this arrest was due to his underlying medical conditions and not the vaccine, but it is technically possible the vaccine put additional stress on his system.
Patient received expired dose of moderna covid vaccine on 9/8/21. No adverse reaction noted or reported
Allergic to many things; Initial information was received on 15-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had allergic reaction (hypersensitivity) when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.   Allergic to might things including flu shots  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sometime within the few following days after vaccination, I remarked a painless, marble-sized lump under the skin, approximate to the injection site. Feels similar to a fatty deposit. Pharmacist indicated that at least one other patient had reported a similar finding. Nearly two weeks after the injection, the lump remains and seems to be the same size.
3:00 a.m., 02/18/2021: Shaking chills, severe headache, severe overall joint and muscle pain, fever (100.6), extremely fatigued throughout day. These symptoms lasted throughout 02/19/2021 and into the morning of 02/20/2021. By the late afternoon of 02/20/2021, the symptoms abated.
Hot all over body; Everything aches; Ribs are very painful; Spondyloarthritis flare up; Decrease in moving and raising his arms; Tingling sensation; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EVRYSDI; HUMIRA; ATIVAN. The following information was reported: FEELING HOT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Hot all over body"; PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Everything aches"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ribs are very painful"; SPINAL OSTEOARTHRITIS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Spondyloarthritis flare up"; HYPOKINESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Decrease in moving and raising his arms"; PARAESTHESIA (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Tingling sensation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 15-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Patient developed irritability and passed a grossly bloody stool.  Was sent to ER and intussusception was ruled out with ultrasound.  Patient was seen in my office today and is doing better.  Still having mild diarrhea but non bloody and irritability is gone.