chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THROMBOCYTOPENIA; COAGULOPATHY; This spontaneous report received from a consumer (wife of the patient) via Johnson and Johnson Corporate Facebook concerned a male of unspecified age, race and ethnicity unknown. Initial information was processed with additional information received on 17-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia. The patient's medical history was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  "In two weeks" after receiving the vaccine, the patient developed thrombocytopenia, coagulopathy, and low platelets with no underlying conditions.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia and coagulopathy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210504574 and 20210503763.; Sender's Comments: V0: 20210532732- Covid-19 vaccine ad26.cov2.s-Thrombocytopenia and Coagulopathy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
LOSS OF TASTE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste. This report was non-serious.
There was a small lump and a little of redness mom state that pt couldn't walk. Called the next day in the morning and mom said pt was doing ok now.
Onset of redness swelling, pain at injection site within 24 hrs with last 3 anthrax vaccines, that is gradually getting worse with each successive AVA shot. Symptoms resolve within a week's time.
Patient came in to get his second pfizer vaccine. He waited his 15 minutes of observation, I told him his time was up and he walked around the pharmacy area a little bit and talked with one of the technicians. He left the store and passed out in the parking lot. An ambulance was called because he was not coherent and the EMS said his blood pressure was over 200 systolic. We informed them he was a diabetic but we weren't told what his blood sugar level was before taking him to the hospital.
This spontaneous report was received from a medical assistant regarding a 59 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 11-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose: 0.5 ml, lot # L038522, expiration date 11-AUG-2017, via intramuscular route in the deltoid on an unspecified arm). In December 2015, the patient experienced excess swelling and redness at injection site and it was very bad. The patient sought medical attention via coming to the office and received treatment with unspecified topical cream. The patient's outcome was recovered (in December 2015). The relatedness between the events and the vaccination with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
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.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "known allergies: tree nuts" (unspecified if ongoing), notes: known allergies: tree nuts; "known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish. The patient took concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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, suspected covid-19. Clinical Information: Patient had paxlovid mouth left a bad taste in mouth that was strongest closing to dosing but remained for hours following dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & had sz; pt seen by MD; achy all noc w/redness & tenderness in lt deltoid; up alot during noc; 740AM devel extensor posture & eyes rolled back; sleepy & postical afterwards
Got a shot on Wednesday the 13th, woke up on the 14th with rash and hearing loss in the left ear. It is now the 18th, I still have slight rash and hearing is restored with ringing in left ear still.
I began experiencing a headache and nausea within 5 hours of the vaccine. By 1 a.m. (the next morning) I began vomiting. I threw up continuously for several hours. I experienced a fever over 101 for 4-5 hours (and a lower grade fever consistently for almost 24 hours). It has been 8 days since the vaccination and I am still experiencing intermittent headaches and dizziness.
w/in 24 hrs of vax pt would break out in hives anytime something touched pt skin; would clear p/20 mins; mom stated broke out back of neck p/last vax; tx w/DPH
I started feeling severe pain in the arm at injection site, all over body aches and fatigue. I had pain in my neck and shoulder that was very difficult to manager my everyday life. My body started to have the inflammation all over my body. I tried to deal with this all on my own for several week. On June 5, I went to an urgent care and they did blood work, urine analysis and x-ray of hand and wrist. I was sent home with naproxen for over a week and it helped. As I would taper off, the pain and inflammation returned. I went to Naturopathic and she that she had some kind of virus that I was fighting but wasn't sure what. I went to another doctor and they decided to go on prednisone for 9 days. That really helped me but when I finished within three days the pain and swelling returned. After a few days, I went back on another round of steroids. I was good while taking the steroid but when I stop I am in pain again and inflamed. I have had constant flare ups since my vaccine in May 2022.
Pt experienced pain in the deltoid & upper arm that recvd the injection from the day after the immunization, continuing x3months. She had her dr prescribe medication for the arm pain (meloxicam)
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ oral, lot # L008053 with expiration date on 30-NOV-2016 (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccine was exposed to temperature excursion of 34F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bad headache; muscle pain; vomiting; chills; fever 100.3 degrees Fahrenheit; nausea; ache all over the body; "throwed away food"; sweating; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), MYALGIA (muscle pain) and VOMITING (vomiting). On an unknown date, the patient experienced HEADACHE (Bad headache). The patient was treated with ONDANSETRON at a dose of 4 mg and BUTALBITAL, PARACETAMOL (BUTALBITAL/APAP) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), HEADACHE (Bad headache), MYALGIA (muscle pain) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
throat was itchy; heart rate increased; lightheaded; Tongue does not feel normal; A spontaneous report was received from a female healthcare professional of an unknown age female patient, who received Moderna's COVID-19 Vaccine and experienced tongue does not feel normal, itchy throat, increased heart rate, and was lightheaded.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On 05 Jan 2021, The patient received his first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly in the for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient reported that she had experienced lightheadedness for four to five minutes, her tongue did not feel normal, had an itchy throat, and an increased heart rate post first dosage of the COVID-19 vaccine. The symptoms of tongue did not feel normal, an itchy throat, and an increased heart rate disappeared after 30-45 minutes that day. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The events of tongue does not feel normal, itchy throat, increased heart rate, and lightheaded had resolved on 05 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Arthralgia, Fever, UrticariaPruritus, Site discomfort Narrative:
Large local allergic reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Sep-2022 Reporter's Comment: This case was reported by a other health professional via  interactive digital media. It was reported that the patient developed a large local allergic reaction to first Shingrix dose. Additional Supportive Information: The follow up would not possible, as no contact details were available.
PAIN IN THE UPPER GASTRO TRACK.  ACROSS THE FRONT OF THE BODY, LEFT TO RIGHT. LASTED 6 DAYS. GOT LESS EACH DAY.
Information has been received from a physician concerning a 36 month old male who was vaccinated with a 0.5mL of varicella virus vaccine live (Oka/Merck). The patient developed a rash of a few lesions while taking varicella virus vaccine live (Oka/Merck). No other information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I have serve fatigue that lasted for 24 hours. I had running nose, fever, chills, headache, body ache and congestive. On Jan 30st, I tested positive for Covid-19.
The patient had symptoms of light-headedness, diaphoresis, and was pale approximately 8 minutes after administration.  No signs or symptoms of anaphylaxis were identified so the patient was observed and monitored.  The patient then became unconscious for approximately 10-15 seconds with small jerking movements identified during this time. 911 was called and the patient was monitored until EMS arrived.  Epinephrine was prepared and ready during this whole time but was not administered because the patient didn't show symptoms of anaphylaxis (trouble breathing or talking, trouble swallowing, hives, flushing etc).  The  time from vaccine administration to EMS arrival was approximately 20-25 minutes.   The patient was able to talk and communicate clearly the entire time except during the brief unconscious period.
Patient admitted for ALTE after receiving flu shot and became minimally responsive. Patient hypovolemic upon admission, IV fluids started and allowed DFA which she tolerated well prior to discharge. Neuro: ALTE event w/in 30 min of receiving flu vaccine. On admission noted to have elevated WBC count, mild acidosis and ketonuria. (+) sick contacts so this may be due to early viral infection. She was afebrile and urinalysis showed no evidence of bacterial infection. EKG done and no arrhythmia or potential noted. Childs neuro exam was normal and she returned to baseline activity prior to discharge. GU: Intermittent genital discomfort by history. Most c/w vulvovaginitis. No evidence currently. GI: Noted to have elevated Alk Phos on admission. Remainder of LFTs and GGT normal. Trended down but remained elevated during hospitalization. No evidence of bony lesions/fractures on PE or CXR. Suspect benign hyperphosphatemia of childhood. Primary MD to follow as outpatient. Derm: Bruise noted at injection site on (R) thigh. No tenderness to palpation.
Chest pains, heavy breathing, speratically through the day, back of neck pain, the injection pain sensation through my whole body. Eyes sensitive to light. Migraines with pressure in the middle of forehead through the day every 45 minutes that last for 30 min longest until Tylenol kicked in for pain.  Today is Sept 5th, Arm still in pain and can still see where the injection was. Still having speratic migraines with pressure in the middle of forehead, eyes sensitive to sun light still. On CDC site it say J&J effects should take up to 2 days tomorrow will be a full week. I've naturally had covid beginning of December in 2020 and was tested positive at a facility. The shot definitely different feeling than naturally having covid. And I am not gona be taking boosters.
Patient received Varicella vaccine by mistake system report showed vaccine being needed but she had gotten varicella at her 1-year checkup and was not in system report Varicella was administered called Mother of child let her know of what happened and that child would not need her second dose of varicella at 4 years of age since she got it 01/03/2023 and it was spaced out enough mother of child understood no questions no concerns
18 month old patient received a dose of Kinrix; received a dose of Kinrix instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix in left thigh. The practice administrator reported that, an 18 month old patient received a dose of Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was linked with case US2022006655, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006655:same reporter
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 22-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Abortion (Induced abortion in 2015). Concomitant products included DIFENIDOL HYDROCHLORIDE (DIPHENIDOL [DIFENIDOL HYDROCHLORIDE]), DOXYLAMINE SUCCINATE;PYRIDOXINE and OMEPRAZOLE for Nausea, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Feb-2021 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Aug-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 08-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided
Child's father called to report on 5-1-08 (two days after immunization given)that child's left leg was swollen from the knee to the hip. Stated they are giving him Tylenol and using ice on the leg. On 5-2-08, this nurse called and spoke with child's mother. She stated that left leg wasn't as swollen today as it was yesterday. Her husband had called their doctor's office yesterday and were advised to give him Benadryl as well as using the Tylenol and ice. She says that ice is "helping a lot." States "he is going to be ok."
Patient received the 1st dose on 12/23/2020. On Monday, 12/28/2020, the patient experienced back pain. On Tuesday, the patient had a stiff neck and last night the patient had swelling in her shoulder and neck pain. Swollen lymph nodes were also reported by the patient.
This patient presented to  our immunization clinic yesterday 01/19/2023. He will be starting college and was advised that he would need a Meningitis B vaccine. The adult immunization schedule was reviewed beforehand and it appeared that adults 26+ were able to receive the vaccine based on shared clinical decision making. The vaccine was administered. Upon further investigation, our department realized that the manufacturer insert only approves the vaccine for individuals between the ages of 10-25 years old. This man did not have any immunosuppression, and will be commuting to college every day. Therefore, he was ineligible to receive this vaccine based on his age. Patient denies any complications or side effects related to vaccine.
Received call from parent this morning stating child had complained of arm soreness last night which then radiated into the right arm. She also complained of nausea and headache and feeling dizzy and was unable to go to school. Parent will take child to doctor for eval.
Sharp tingly sensation on finger tips (very itchy), palm of hand, back of hand, and forearms lasts for about 20 -30 minutes at a time - currently occurs about once to twice a day. ....After initial Vaccination in Iraq July 28, 2003 I experienced the same symptoms with additional redness and rash like appearance immediately after touching anything cold. I was also on Malaria pills at the time but quit and still had those symptoms. Doctors did not know why and did not think it was related to Anthrax vacc. But I am having same symptoms with out the rash.
Started with slight headache and sore arm, felt tired and diarrhea about 5 hours past vaccination - 3 bowel movements within 1 hour. That night around 1:30AM (next morning) I felt a little itchy all over with a throat irritation and I took some Benadryl. Just itchiness and sore throat, no fever. Had pretty bad fatigue on the 17th and had nasal congestion, cough, chills, sneezing. I worked on the 17th but felt terrible throughout the day. Got home and I could not eat anything , could not hold anything on my stomach. On the 18th at night woke up with sweats, no fever, dry cough, nausea. Chest discomfort (minor chest pain - was sure was not cardiac, could be acid reflux). Woke up with nausea and irritation and intermittently felt fatigued and would feel better, throughout the day. Also felt back pains on the 18. That same evening I felt a little better and then on the 19th I had some shortness of breath. I then decided to go to the UC on Saturday the 19th and got a COVID test. Sore throat was gone but still feel back pain and nausea. Around 11PM on the 19th I got itchy again in my arms and chest. Also got chest pains and took a Pepcid and Benadryl. On the 20th I am feeling a little better, still have a cough and some stomach upset and headache (in the AM). About 1:30PM diarrhea came back again. Had it 2X and low back pain and abdominal pain and also chills. There was a time I could not take care of my kids I just had to stay in bed (19 and 20th - I spent in bed most of the day). My heart rate has been good.  The evening of the 20th I felt a little bit better and able to eat a little bit easier. This morning felling a little better. Had diarrhea this morning and a headache that I can't get rid of. Took Tylenol but it has not helped. Also low back pain.
isolated inflammatory response; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.    This patient of unspecified age and gender received (yesterday)pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose in the left arm in Oct2020 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced isolated inflammatory response in Oct2020 with outcome of unknown. It resulted in an emergency room visit, day off of work and taking meds to control the symptoms experienced.  No follow-up attempts are needed. Information about lot/batch number could not be requested. No further information is expected.
10/7/19-Vomiting, nausea, chills, shiver, 104F temperature 10/8/19- marginally better, arm very red and sensitive to touch 10/9/19-nausea, lower gut pain,  arm still swollen with redness
Extreme fever, chills, fatigue, sore muscles lasting.(day after). Extreme neck soreness, cough, migraine, poor ability for clot blood from cuts(two days after)