chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given the vaccine at 712 pm on 12/20/20.  At approximately 715 pm, she began to clear her throat and then became unable to speak, followed by audible wheezes and short, shallow breaths.  At 1923, Epinephrine was administered. At 1928, she was able to speak again and was transported to the ED.   The patient reports after arrival to the ER, the symptoms returned. She was given PO Benadryl, followed by IV Benadryl, and then a 2nd dose of Epinephrine. She was admitted to the ICU for observation.
thinking it's clotting in my legs, in my thighs; having things happening with me, in my body that are painful, within my heart area.; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (thinking it's clotting in my legs, in my thighs) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (thinking it's clotting in my legs, in my thighs) (seriousness criterion medically significant) and CHEST PAIN (having things happening with me, in my body that are painful, within my heart area.). At the time of the report, THROMBOSIS (thinking it's clotting in my legs, in my thighs) and CHEST PAIN (having things happening with me, in my body that are painful, within my heart area.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient called and said that he had received the vaccine in January and February of 2020 and that he has had "several changes in his body". He reported that he had a ton of issues. Patient having things happening with him. The patient was seeking advice on what to do. No treatment drug was reported.  Company comment.  This spontaneous case concerns an adult male patient (unknown age), with no medical history reported, who received two doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) AESI thrombosis. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient thought "it's clotting in my legs, in my thighs". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   Reporter did not allow further contact
HEART RATE INCREASED (Heart rate increased, Heart rate increased) FEVER (Fever, pyrexia) This spontaneous report received from a patient concerned a 26 year old female. The Patient's weight was 59.8 kilograms, and height was 154.94 centimeters. The patient's past medical history included COVID-19 virus test positive on JUN-2020. The patient's concurrent conditions included anxiety (she was unsure if her elevated Heart rate was due to Vaccine or Anxiety). The patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) does not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-20212, the patient experienced fever. On 05-MAR-2021, the patient experienced heart rate increased. The patient was concerned after heart rate was 120 to 135 beats per minute and went to the hospital for evaluation. In hospital she had received blood work evaluations and an EKG. The Patient's reports all test were normal. On MAR-2021, Laboratory data included: Blood test within normal limits, Body temperature : 99.8-100.0 F, Electrocardiogram within normal limits, Heart rate 115 beats per minute (units unspecified) , 120-135 beats per minute. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and fever and heart rate increased was possible. The company cauality between covid-19 vaccine ad26.cov2.s and fever and heart rate increased was possible. This report was serious (Hospitalization Caused / Prolonged). Add7itional information was received from patient on 10-MAR-2021. The following in2formatio was updated and incorporated in to the case narrative: Patient demographic details (DOB, age group, height, weight and Age at the time of vaccination), Concurrent condition added (Anxiety), Past medical history added (Covid-19 infection), No. Of Days Hospitalized added (No information), Other AE characteristics added, Hospital address added, Lab data added (Body temperature, Heart rate, Blood test, EKG, COVID-19 PCR test), seriousness criteria added for events fever and heart rate increased (Hospitalization Caused / Prolonged and other identification numbers was added. Upon review following information was amended: Route of the of the suspect product changed from unknown to intramuscular, therapy end date changed from 05/Mar/2021 to 05/Mar/2021;12:00, unit dose added (0.5 ml), Dosage text added (vaccinated at 12:00 in an unknown site), Batch number added (unknown), Form of admin and route of admin of treatment drug added (unknown), Lab test date of HEART RATE 115 beats per minute changed from unknown to /MAR/2021. On 24-MAR-2021 received Non significant follow up with email delivery failure notification.
Patient developed 1 cm cyst of left thigh at PEDIARIX injection site 1 mo after injection, lesion gradually became more superficial and started discharged milky white fluid on 7/5/08. Now lesion is smaller but dimpling of skin remaining
This spontaneous report as received from a pharmacist refers to a currently 33 year old female patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. Unspecified blood work performed on 16-MAR-2018 revealed that the patient was not immune to M-M-R II. On 19-MAR-2018, the patient was vaccinated with M-M-R II (dosing details, lot # and expiry date unknown) intramuscularly for routine vaccination (incorrect route of drug administration). On 19-MAR-2018, the patient experienced soreness at the administration site on her right upper arm. The outcome of the event was unknown. No treatment was provided for the event. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for 2 patients. This is 2nd of 2 reports. A 14-year-old male patient of an unspecified ethnicity received TRUMENDA (lot J29203, exp. date Jun2016, NDC number: 300050100102) intramuscular in left deltoid 15:03 at 0.5 ml single dose, and GARDASIL (lot L001312, exp. date 24Feb2017, NDC number: 0006412102) intramuscular on right deltoid at 0.5 ml single dose, both on 10Jun2015 3:30 pm (flu like symptoms). The patient medical history was not reported. Concomitant medication were not reported. The patient experienced fatigue on 11Jun2015 and flu like symptom on an unspecified date. The AEs did not require an emergency room or physician visit. The patient did not recover from the event fatigue but the outcome of the event flu like symptom was unknown. The final action taken with the products was to continue to monitor the child. This patient had a sister that received the same vaccine on 10Jun2015 and experienced the same adverse events. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered the Pfizer product had a causal effect to the adverse event. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (23Jul2015): New information received from a contactable other-HCP on behalf of physician includes: HPV-9 set as suspect; TRUMENDA and HPV-9 indication and vaccination date; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Menactra given. Patient waited 10 minutes after immunization.  Patient was observed walking to chair and sat for another minute. Patient stated she felt fine. Patient walked to exit with mother and was waiting at checkout. Patient stated she suddenly felt nauseous and then told mother she felt like she was going to pass out. Mother supported patient and lowered her to floor. Mother stated patient lost consciousness for 2-3 seconds. Patient checked by Dr. BP 100/58. Patient taken back to room via Wheelchair  and rested on table for 10 minutes. Patient then sat up and rested for 10 more minutes. Patient stated she felt like this several times in past with kidney stones but did not lose consciousness. Patient drank water, stated she may have been dehydrated. After standing and walking a few minutes, patient felt fine and walked to car with mother.
Rash all over body, itchy. CLARITIN 1 tsp Q AM, BENADRYL 1 1/2 tsp q 6 hours PRN.
Extreme toe, arch, top of foot and calf cramps both legs, but predominantly in the left leg same side as the immunization that lasted for approx 3 - 5 minutes and continues.
has diverticulitis prior to receiving the COVID-19 vaccine. After the first vaccine, the patient had a bout of diverticulitis; patient got sick; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included ongoing diverticulitis. The patient's concomitant medications were not reported. The patient mentioned that he received his first dose of COVID-19 vaccine in Jan2021. After that, the patient got sick (in 2021). The patient wanted to know if he could get his second dose. The patient confirmed that he has diverticulitis prior to receiving the COVID-19 vaccine. After the first vaccine, the patient had a bout of diverticulitis (in 2021). The patient was advised to follow up with primary care physician or local health care provider for treatment recommendations and medical advice. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Patient said she experienced a rash on the first shot. This was her second shot but the rash has spread up her neck and chest and she felt chest tightening.
Sudden death two weeks after first dose of vaccine was administered. No previous symptoms or signs. Family opted not to do an autopsy so cause of death (stroke or heart attack) not known.
rt thigh area swollen & red, warm to touch;father stated no other rxn noticed;pt referred to MD on 23AUG96 @ 10AM for second opinion;
Approx 39 hrs. after vaccination woke to swelling on bottom left lip.  Thought is was the beginning of a cold sore.  Approx 2 hrs. later woke  again to right side of face swollen.  Felt like when you get novacine at dentist office.  About 2 hrs after that got up and felt top lip swollen, bottom right side had gone down.  At about 3PM face then begain to swell on left.  All swelling stayed except where it began on bottom right lip rest of day.  Throughout the day on Sunday, swelling started to go down.  Still swollen on Monday going down as the day went on.  at this time 6:47PM is it about 90% gone.  Just on bottom of cheeks and the right one is noticeably less swollen than the left.
3.5 hrs p/vax became pale & hypotonic; poorly responsive for several minutes;
Pt contracted cellulitis 2 days after receiving ZOSTAVAX immunization. Received a course of cephalexin from MD to treat cellulitis infection.
5-10 mins after vaccines were administered both cheeks were red and on top of the injections site there was redness on both legs.
No additional AE reported; one dose of VARlVAX was administered; This spontaneous report has been received from a physician (also reported as customer), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 13-DEC-2021, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T035400 with expiration date: 16-OCT-2022, 0.5 milliliter, strength and route were unknown) for prophylaxis following a temperature excursion (product storage error). No additional AE reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 25.9 Fahrenheit degrees (F) for 4 hours and 30 minutes. There was no previous temperature excursions reported.
Started to feel very light-headed, like standing too fast. After bedtime, starting hurting all over, every joint. No fever, a brief episode of chills the next day. The total body pain continued for 2 days. Fatigue started on Day of injection, but continued all week.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications was provided. No treatment medications was provided.
Had stroke; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (12:00) as SINGLE DOSE for covid-19 immunisation, at 70 years old. Medical history included Cad atrial fibrillation (atrial fibrillation), Cad atrial fibrillation (Coronary Artery Disease), CHF kidney disease (congestive heart failure), CHF kidney disease (kidney disorder) from unspecified dates. No other vaccines in four weeks. No COVID prior vaccination. Concomitant medications included verapamil; alprazolam (XANAX); allopurinol (ZYLOPRIM); furosemide (LASIX); potassium; and mirtazapine (REMERON), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines and experienced allergies (Known allergies: Antihistamine). The patient experienced had stroke on 19Feb2021. The patient required emergency room visit and was hospitalized for had stroke for 4 days from 2021 to 2021. Treatment reported as unknown. The patient underwent lab tests and procedures which included investigation: SARS-CoV-2 test (Nasal Swab): negative on 19Feb2021. Event outcome was recovering.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: FD6955), on 14Apr2021 as dose 2, single (Lot number: EW0153), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) and on 05Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history Sjogrens Syndrome" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis; "Other medical history Asthma" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis; "Other medical history Hashimotos Thyroiditis" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis. Concomitant medication(s) included: WIXELA INHUB nasal, start date: 01Jul2020, stop date: 27Sep2022; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 25Nov2016, stop date: 10Oct2022; CEVIMELINE, start date: 25Nov2016, stop date: 10Oct2022; LEVOTHYROXINE, start date: 03Apr2006, stop date: 10Oct2022; PRILOSEC [OMEPRAZOLE], start date: 06Nov2017, stop date: 10Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: after testing negative; (Sep2022) Positive, notes: Treatment of COVID-19; (Oct2022) Positive, notes: rebound 6 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter stated that COVID 19 Treatment (Paxlovid) was done and treatment start date was 27Sep2022 and stop date was 02Oct2022 for Indication COVID-19.  Follow-up attempts are completed. No further information is expected.
headache, pain in neck & jaw; does not feel like control over muscles; floating feeling when laying down; dizziness, uncoordinated, does not feel in control; chronic neck pain going down back
red & swollen @ site of inj lt arm noticed 24hr p/inj;pain in elbow noticed w/in 12hr of inj;muscles spasms in hand 48hr p/vax;pt seen by MD sore arm, localized swelling & muscle spasms in lt hand;
Patient received vaccine on 1/23/18 and started having adverse effects on 1/24/18. Patient presented to pharmacy on 1/26/18 after seeing provider with an antibiotic prescription for KEFLEX thinking it was cellulitis. Later on 1/30/18 patient presented again stating it was not cellulitis, but was diagnosed as a delayed onset allergy reaction. She received treatment and was seeing improvement in symptoms. She experienced a rash on both arms and part of her trunk.
Patient reports at 17:30 the evening of 9/12/18 she noticed small raised red bumps on both upper arms that itched a lot. Patient noticed the same small red raised bumps that itched on her legs also. Patient reports she applied a large amount of BENADRYL cream to where the red raised bumps were. The BENADRYL cream did relieve the itching a small amount then she went to bed. Patient states when she got up this am 9/13/18 the red raised bumps were all gone and the itching has resolved.
Pt experienced numbness and tingling post vaccine to bilateral upper extremities, and swallowing felt "weird". Able to swallow and speak in full sentences. VS stable. Seen by MD, po Zyrtec given. Symptoms improved and discharged home. Education re: worsening symptoms given and instructed to go to ED.
Mom of client states within 15 minutes after getting immunizations her daughter began complaining of a stomach ache and headache, states she was very hot, lightheaded, pale, clammy and cold, states she took daughter out to car and gave her some orange juice, symptoms gone within 15-20 mins. Mom states no other problems, states daughter is in school today.
left side of cheek close to left bottom lip swollen; lips swelled; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 53-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included allergies: Benzoyl peroxide. The patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 at 04:00 PM (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced lips swelled at 4:00 am on 09May2021, she went to urgent care, took a corticosteroid shot, was put on steroids for a week; finished on 15May2021. On 17May2021, the patient woke up with her left side of her cheek close to her left bottom lip swollen. She was at the hospital now. This case was provided as non-serious by reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The adverse event resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment (steroid shot and medication) received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in May2021.
redness around the injection site began as quarter size yesterday and today the area is size of grapefruit, slightly itchy and warm to touch, some swelling and splotchy--treated with anti-itch cream and worked. All other symptoms persist.
First dose was not effective; This is a spontaneous report from a contactable Health Care Professional.   A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. It was reported that the first dose was not effective.  The information on the lot number has been requested.; Sender's Comments: Based on the information provided, the drug ineffective cannot be excluded for vaccine BNT162B2 administration.
24 hrs. after being administered ADACEL pt. began to have nausea, chills, fever, dyspnea. Called office 6/4/08 Am feeling some better but was leaving work to go home to rest.
Severe rash began on throat and face on 10/23/09. Spread down trunk in spots not every where. Did not react to BENADRYL, CLARITIN, or ZYNTEC.
I have had 5 nose bleeds in the past 2 weeks, the first occurring 8 days after dose 1 of the Pfizer COVID vaccine. I hadn?t had a nose bleed prior to that for at least 10 years and I?ve been on the same low dose aspirin dose once daily for several years.  No petechiae, bruising or other bleeding.