chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In Summer of 2014, patient had tingling and numbness of left arm and hand. A CT scan was done and reported as "normal." Two years later, it was discovered that that test was not normal. In June of 2016, patient had unsteady gait, involuntary muscular movements, and slurred speech due to multifocal strokes caused by cerebral central nervous system vasculitis. She was in the hospital for a week, received daily steroid infusions, and after beginning treatment to hopefully protect her reproductive eggs, she began monthly infusions of chemotherapy in the hospital along with daily steroids. After 7 chemo infusions, she began oral chemo. The chemo lasted for about a year and a half and she was on steroids for a year. The steroids caused high blood pressure while taking 3 BP pills at a time, elevated thyroid levels, and elevated pressure in her eyes. Her doctor prescribed calcium to protect her bones from the steroids. Because of all of the calcium intake, she suffered from kidney stones twice. The first one only required an emergency room visit. The second one required surgery and a hospital stay. Even though she was taking the calcium, the steroids caused avascular necrosis of the femoral head (hip bone) and she had to have a surgery called core decompression and bone grafting. She was on crutches for a month. The orthopedic doctor said she'll probably have to have a hip replacement in the future and she has constant hip pain. Last summer, it was discovered that the vasculitis caused moyamoya of her brain. She had 2 surgeries (one of each side of her brain) called pail synangosis (a grafting of blood vessels). She was weaned from the chemo in June, went for a follow up visit with the neurologist last week, and the neurologist said he thinks the vasculitis is back, based on her symptoms of headaches, involuntary muscular movements, and weakness again. She has had 2 steroid infusions in 2 weeks. The doctor recommended chemotherapy again, but my daughter doesn't want to start that all over again. She said she would rather die. She's having mental issues now, such as anxiety, depression, and hopelessness. She has seen a neuropsychologist for these feelings and is trying different meds to hopefully combat these feelings. Her lifelong dream was to become a nurse, but because of her limitations, that is not possible for her now.
28 yo female vaccinated with 0.5ml MMR II vaccine subcutaneously Rt upper arm and 15 minutes later c/o renness and itching at injection site, feeling flushed, diffuse red rash on chest and arms and felt heart was starting to race. Given history of systemic reaction to 2012 trivalent influenza vaccine was taken to ER in same facility for acute allergic reaction treatment. ED treatment consisted of Benadryl, Zantac and Prednisone. Following observation period, patient was discharged home in stable condition. Final impression: Acute allergic reaction to MMR vaccine - Resolved.
Severe headache/ migraine. Took acetaminophen and ibuprofen and rested. 2 hours later my headache was gone.
Broke out in red rash all over body called Dr office to report it -2 days later was told it wasn't caused by vaccine, no treatment recommended. Had pneumonia 3 wks later.  5/15/07 Received medical records from pulmonologist which reveal patient experienced dyspnea, cough, night sweats & dysphagia for approx 6 mos when initially evaluated on 3/15/06. He also complained of occasional HA, daytime hypersomnolence, occasional constipation.  Exam revealed velcro type rales in bases & clubbing of extremities.  Patient referred for open lung biopsy but deferred.  Started on supplemental O2.  Spirometry done 8/06 & 10/06 revealed worsening restrictive disease. FINAL DX of pulmonologist: idiopathic pulmonary fibrosis.  6/12/07 Received hospital medical records which reveal patient experienced acute flare of interstitial fibrosis; acute renal failure; pneumonia; idiopathic pulmonary fibrosis; prostrate cancer; & GERD.  Had increasing SOB, fever/chills, HA & productive cough x 15 days.  Admitted 11/20-12/4/06.  Treated w/high dose steroids, IV antibiotics & high flow O2.  Pulmonary & ID consults done.  Very gradually stabilized & was d/c to home on continued oral antibiotics & steroids w/hospice care for poor prognosis. FINAL DX: Acute flare of interstitial fibrosis; acute renal failure; pneumonia; idiopathic pulmonary fibrosis; prostrate cancer; & GERD. 7/17/07 Received Death Certificate which reveals COD as pulmonary fibrosis.
From initial information received on 26 Apr 2004 from a healthcare professional, regarding an adverse event occurring, it was reported that a four month old female patient received a second dose of DAPTACEL, lot number C1696AA, in the left thigh; a second dose of IPOL, lot number X0707-2, in the right thigh; and a second dose of COMVAX (manufacturer Merck), lot number 0026P, in the right thigh. The routes of administration were not reported. Approximately 12 hours later, the patient developed fever of 104 degrees F and had a seizure which lasted for 45 minutes. No other signs or symptoms were reported. Emergency services were called and the seizure was observed by the paramedics. The patient was transported to the emergency room and assessed by the emergency room physician. A CT scan and spinal tap were performed and were reportedly negative. The patient had been medicated with Tylenol prior to receiving the vaccines. It was not reported whether the patient recovered from this adverse event. The patient's twin sister also received DAPTACEL, IPOL and COMVAX on the same date. Approximately twelve hours later, the patient's twin experienced a fever of 102.7 degrees Fahrenheit. The details of this report are contained in case2004-01711. Follow up on 05/28/04 states: "From additional information received on 05/17/04 from another manufacturer (reference # WAES0405USA00328), it was reported that the pt recovered from these events."
Started feeling dizzy, ears felt plugged, then started with headache, + started having breathing difficulty.  EPIPEN given 0.3 ml @ 1:44 PM vitals P-100, B/D 120/60 R 22,
No appetite, my body completely stopped working, I was immobile. I could barely function. 5 days later I was able to move and I need to go to the pharmacy. I was in the line and I had a stabbing pain in my low back. It was excruciating. I went home and the pain moved up to the right quadrant flank that moved into belly pain. It was almost like kidney stones and then it dropped into the right groin. There was no blood in my urine or stool. I took pain medication baclacin and vultarin, I tried rest and laying down. Nothing worked. It lasted from 9am until 3pm I called a friend to let them know what was happening and I took more baclacin. It got worse. I called my friend again and I was taken to the emergency room and they did urinalysis and blood work and a CT scan for kidney stones but it was not kidney stones. I was given IV fluids. I was having so much pain I was starting to have seizures. I had to stop them or id potentially have a brain bleed. They got it under control. The pain was still not under control. They had to give me fentanyl which I hate with a passion! They got the pain to stop. They discovered that blood/urine/kidney stones were all clear. O2 was 100% and my blood pressure was good. They found minor cyst on the kidneys but it was unlikely to have cause this. I now have severe diarrhea.
Information has been received from a certified medical assistant concerning an adult (age and gender not reported) patient who in approximately Oct 2005 (over the last month), was vaccinated intramuscularly with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently, on an unspecified date, the patient developed an injection site reaction to include soreness, warmth, erythema and swelling. The patient was treated with antibiotics and on an unspecified date recovered fully. The patient experience was considered to be other important medical event by the reporter (OMIC). Additional information has been requested.
Patient described a red rash that appeared accross the front of her torso (stomach and breast areas). She said it lasted a day or two, then went away, and then itchiness followed for one more day in the same area.
Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine) after 12 weeks of age. It was unknown if medical attention was sought. No adverse event was reported. Additional information has been requested.
2 hours after vaccines: dizziness and impaired vision. Went to sleep, woke up with decreased symptoms. 36-48 hours after vaccines: Intense earache and impaired hearing in the left ear. Phenylephrine & acetaminophen, symptoms decreased within an hour
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23, 0.5 ml, which had a lot # of L003188 (also reported as "l003188" and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion was 504 hours and the lowest recorded temperature reported as 27 Fahrenheit (F) (-2.777777778 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Other medication in 2 weeks reported as unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with anti-viral Paxlovid for COVID 19 treatment from 18Jul2022 to 23Jul2022. Paxlovid rebound; recurrence at approximately eight days following final treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032781 Same patient, different product and event;
Sore arm, red, raised bump at injection site, body aches. 103.0 fever for 48 hours
Information has been received from a registered nurse concerning a 60 year old female with penicillin and sulfonamide allergy and no pertinent medical history who in May 2009, was vaccinated with a first dose of PNEUMOVAX 23. The patient was administered PNEUMOVAX 23 at her unspecified primary care physician's office. There was no concomitant medication. The nurse reported that the patient developed hives on her arms and chest after receiving the PNEUMOVAX 23 in May 2009. The date of onset of the hives was reported as unknown. The patient self treated with BENADRYL and the hives resolved. The patient was seen in the office on 29-MAY-2009 and relayed the adverse reaction at that time. There were no lab diagnostic studies performed. No further information is available.
on fifth day post injection; right upper arm injection site 5-6 cm diameter area of redness, swelling, warmth and itching. sixth day post injection; site is 5-6 cm diameter, more red, still warm and slightly swollen and itchy. fatigue and slight headache felt
No adverse event; Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine).    Concomitant medication details was not reported. Treatment details was not reported.  The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day.  This case contains information for the tenth adult patient out of 15 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1, same reporter US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3, same reporter US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5, same reporter US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6, same reporter US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7, same reporter US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8, same reporter US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11, same reporter US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13, same reporter US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14, same reporter US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15, same reporter
Patient experienced loss of consciousness after administration of vaccine.  This happened within 45 seconds of administration.  This happened 3 separate times within a 5-10 minute time frame.  No signs of anaphylaxis were identified during this time.  Patient would "faint" briefly (approximately 10 seconds) and then regain consciousness and confirm that he had no symptoms of anaphylaxis.  Symptoms observed were loss of color of the face and lips and some diaphoresis.  The patient was monitored for any changes and EMS was called.  The patient refused EMS service or hospital service.  He stated that the "fainting" happened to him regularly whenever he received a vaccine.   The total time of the event was approximately 30 minutes and the patient was advised to stay longer for monitoring if he would refuse EMS service, which he did.  The patient has since been called and is currently feeling "normal except for being somewhat tired".  He has been advised to follow up with his primary care.
Information has been received from a consumer via company representative, regarding her daughter of unknown age. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and lot number were not provided). On an unknown date, the patient was diagnosed with the chicken pox, after receiving VARIVAX (Merck). On an unknown date, the patient recovered from chicken pox. Additional information is not expected.
Severe body aches all over; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 15:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, thyroid, COVID-19 and blood pressure high. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 20:00 the patient experienced severe body aches all over. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe body aches all over was recovering.   No follow-up attempts are needed. No further information is expected.
got very Sick; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient's husband) via social media ( in the   This case involves an adult female patient of unknown age who got  very sick (illness), while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received INFLUENZA VACCINE (produced by unknown manufacturer) at an unknown dose administered via unknown route at an unknown site for prophylactic vaccination.  On an unknown date (latency unknown) after being vaccinated with INFLUENZA VACCINE, the patient got very sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
petechial hemorrhage of the upper and lower eyelids [bilateral] [in the absence of trauma]
On 10/30/19 pt. came for her flu shot. Pt felt like may have been given too high on her RDM. has had pain in Rt shoulder area with decreased ROM since injection
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Aug2023 to 21Aug2023.  Clinical course: Covid Rebound 3 days after testing negative now positive. Different symptoms during rebound - more shortness of breath, cough and slight fever vs. prior was fever, headache, muscle aches and fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a sore throat, and I was tired. I thought I had strep so I went to an urgent care. They told me that I didn't have strep, but I had covid. They prescribed me a medication, but I didn't take it. My throat was hurting for 1 or 2 days.
No adverse event; Received Expired Monovalent Booster of Moderna COVID-19 vaccine; Received Monovalent Booster instead of Bivalent; This spontaneous case was reported by a phlebotomist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster of Moderna COVID-19 vaccine) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 2nd of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661313 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661313:1st adult patient case