chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spouse of a employee, she herself is not an employee., which is why we have no medical records for this patient and do not know her past medical history or current medications.    This individual was initially brought to our attention as she had stated she had severe prior adverse reaction remotely to a vaccine but could not provide particular specifics as to the reaction.  Approximately 5 minutes after receiving her first Pfizer vaccination in her left arm she complained of a tingling  sensation on the left side of her face as well as her left neck.  I had this individual wait  for an additional 20 minutes after the usual 15 minute observation period.  After this amount of time she noted the sensation of tingling on the left side of her face had decreased by approximately 60% and was continuing to improve.  At no time did this individual complaining of shortness of breath, palpitations,  or swelling. A physician called patient at approximately 3:30 PM, 1 hr after vaccination and she stated she had absolutely no symptoms, facial/neck tingling had completely gone away. The Medical Center is not aware of any additional intervention needed after the intial monitoring as described above.
Patient skin around the injection site began to itch about 48 hours after her vaccination.  She says it is a mild itch, but seems to have increased over time.  The skin appears a bit red in that area, but seems to be relatively smooth.
Pt recvd vax on 15MAY92 & 1/2 hr later exp h/a, lips felt funny, devel bilateral hand tremors; BP 150/80; inc to 100; devel diaphoresis & shaking; staring spell, pulse was 140 & respiration was 28; had sz; generalized rash;
golf ball sized knot at the injection site; This spontaneous report was received from a physician via a field employee and refers to a 13-year-old female patient and the physician's daughter. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On an unknown date in September 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) as a prevention of human papillomavirus (HPV). On 15-SEP-2019, the patient experienced a golf ball size knot at the injection site.      The outcome of injection site nodule was unknown. The causality assessment was not provided.
Aches and pains on ours hands and our legs and sometime we cannot even close our fist; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the 1st case of 2 split cases.  A elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date, patient stated,I had the Pfizer, my 2nd shot I had it at the end of March this year and my wife had it at the same time and we have had aches and pains on ours hands and our legs and sometime we cannot even close our fist and I was just wondering if anybody else called and have this complaint at all. Consumer stated, I am going in for surgery, back surgery and that is why I wanted this information. (Further clarification unknown) No treatment was received. The outcome for event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021874165 as same reporter/drug/event, different patient.
Patient tested positive for Covid on 3/12/21 per hospital admission notes. Patient was admitted to the hospital on 3/16/2021 with Covid pneumonia. She passed away on 3/22/21.
Narrative: 84 yo male patient in pallative care at hospital on 12/4/2021. Pt with multiple comorbidities. See problem list below: PROBLEM LAST MO PROVIDER Erectile dysfunction (ICD-10- 03/09/2021 F52.21) Adjustment disorder with mixed anxiety and 11/10/2020 depressed mood (ICD-10 F43.23) Sleep apnea (ICD-10 G47.33) 10/19/2020 Vitamin B6 deficiency (ICD-10 R69.), Onset 1/00/2020 Kidney disease (ICD-10 N18.9) 11/28/2016 Olecranon bursitis (ICD-10 05/25/2016) Closed fracture of clavicle 05/25/2016 (ICD-10 S42.001A) Type 2 diabetes mellitus 01/26/2016 (ICD-10 E11.8) Hypertensive disorder) (ICD-10 01/10/2016 I10.) Abnormal renal function (ICD-9 08/13/2015 794.4) History of male erectile disorder (ICD-9 V11.8) (ICD-9 607.1); Balanitis* (ICD-9 607.1) 03/25/2013 (ICD-9 782.9); Symptoms involving involving skin and 03/25/2013 other integumentary tissue (ICD-9 782.9) (ICD-10 M25.511); Shoulder pain (SNOMED CT 05/16/2017) (ICD-9 719.06); Effusion 11/13/2012 (ICD-9 719.46; Knee: arthralgia* (ICD-9 03/01/2012 719.46 (ICD-9 I10.1); Tinea Unguium* (ICD-9 110.1) (ICD-9 605.) (ICD-9 229.8); Hand 10/14/2009 (ICD-9 078.10); Diseases due to Viruses and 07/28/2009 Chlamydiae, Viral Warts, or unspecified causes (ICD- Wart on face (ICD-9 205.02); Diabetes Mellitus without 07/20/2009 mention of Complication, type II or unspecified type, (ICD-9 054.10; Herpes Genitalis* (ICD-9 07/07/2009 054.10) (ICD-10 E11.40); Diabetic neuropathy (11/28/2016) (ICD-9 459.81); Chronic Venous Insufficiency 07/23/2008 (ICD-9 459.81) (ICD-9 454.0); Varicose Ulcer* (ICD-9 07/23/2008 454.0) (ICD-9 919.0); Abrasion NEC (ICD-9 919.0) 09/20/2006 (ICD-9 782.3); Edema* (ICD-9 782.3) 09/20/2006 Diabetic Retinopathy (ICD-10 01/26/2016 E11.329), Onset 07/14/2004 (ICD-9 365.01); Open angle Glaucoma Suspect 07/14/2004 (ICD-9 465.9); Upper Respiratory Infections 06/25/2004 (ICD-9 465.9) Asthma, unspecified type, without mention of 05/17/2004 status asthmaticus or acute exacerbation or unspecified (ICD-9 493.90) (ICD-9 250.00); DIABETES MELLI W/O COMP TYP 08/11/2003 (ICD-10 E78.5); Hyperlipidemia (CT 11/28/2016) (ICD-10 E66.9); Obesity (CT) (ICD-9 401.9); HYPERTENSION NOS 08/11/2003 Pt had received covid vaccines on 4/12/21 & 5/10/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Received H1N1 vaccine @ school - after about 15 minutes went back to class. C/O feeling funny assisted to hallway and began hyper ventilating and developed hives. BP 138/112 given Epi by school nurse. EMS arrived given BENADRYL, SOLUMEDROL, and IV fluids-Hives over arms and torso. O2 sat 98%. Improved D/C home.
15 mo imm. given in office 8/06/13. Dev. fever 102-104 degrees F (usually runs 101-102 degrees with shots) vomited x 1 on 8/06/13 after O.V. Increased fussiness, restless. Did not walk after vaccines till 08/07/13 after noon. No erythema or edema RT-or-LT thighs on 8/8/13 exam. Tx: continue TYLENOL/MOTRIN alt.
Patient is a 47 y.o. pleasant man with history of diabetes, presented to hospital with intractable vomiting. He was lethargic and unresponsive. He was  found to have bilateral transverse and straight sinus thrombosis, multifocal ischemia consistent with venous infarction.   He was treated with heparin drip from diagnosis 5/11 and transitioned to apixaban 5/22. His mentation improved. As of today, he is conversant, disoriented, ambulatory, no longer requiring a feeding tube.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Other medication in 2 weeks was reported as no. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 25May2022, Treatment stop date: 30May2022, via oral route for the indication of Treatment of COVID-19. Device timestamp was on 04Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
pt recv vax & devel approx 10 skin lesions & no fever was reported;
area around lt deltoid became edematous & itchy;hives appeared on deltoid area 7 lt shoulder area;
Hard, red lump approximately 4 inches by 2 inches, injection site extremely hot to the touch,  sore and itchy 8 days after injection.
tingling in throat, moving into chest.  Duration was approximately 15-20 minutes.  When presented for second dose described symptoms and dose #2 was not given due to potential allergic reaction.
Pt. developed cellulitis of right lateral thigh 3 days after injection.  Redness 17 cm, knot, positive firm.
FEVER CHILLS, BODY ACHES. KNOT TO LEFT DELTOID AT INJECTION SITE. PERSISTENT MIGRAINE HA THAT LASTED FOR 5 DAYS.
Initially I just felt the standard side effects. However, a few days after I broke out in a bad rash all over my body, including my wrists, elbow pits, armpits, chest, both sides of my torso, and thighs.
Passed out; Puked; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 10-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced passed out (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the passed out and vomiting were recovered/resolved.   It was unknown if the reporter considered the passed out and vomiting to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. 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 age at vaccination was unknown. The case was reported by patient's mother. The patient received Fluarix Quadrivalent 2021-2022 season vaccine and passed out 3 to 4 times and also puked. Call disconnected before obtaining patient's demographics. The reporter did not consent to follow up. No additional details were provided.
Patient came to ED with complaints of hypoglycemia.  Admitted to hospital for unexplained hypoglycemia and Covid pneumonia with hypoxia.
fever 99.6  in morning.   fever now 100.4 in afternoon migraine headache for 10 hours -6pm felt sick after dinner- gel ice pack on head at 8pm and when I went to bed
PATIENT HAD ITCHING ALL OVER HER BODY.  PATIENT WAS GIVEN PREDNISONE 10MG, CLARITIN 10MG,
Mother states child began running fever of 102 by 5:30 on 9/29, took child to see PCP the next day; says child has "felt bad" all week, but today had to take child to ER due to her "blacked out" at school; tests were run, all returned back good. Rxn thought to be related to child getting a 4th dose of HPV4 vaccine.
pain in his bones; pain in the palm of his hands and feet; pain in his whole body; pain not only in his joints, but also in his bones; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (pain in his bones), PAIN IN EXTREMITY (pain in the palm of his hands and feet), MYALGIA (pain in his whole body) and ARTHRALGIA (pain not only in his joints, but also in his bones) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced BONE PAIN (pain in his bones), PAIN IN EXTREMITY (pain in the palm of his hands and feet), MYALGIA (pain in his whole body) and ARTHRALGIA (pain not only in his joints, but also in his bones). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, BONE PAIN (pain in his bones), PAIN IN EXTREMITY (pain in the palm of his hands and feet), MYALGIA (pain in his whole body) and ARTHRALGIA (pain not only in his joints, but also in his bones) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.
I received my second Pizer vaccine Tuesday, April 27 in the morning. My partner woke me up about 12:30 am Wednesday morning because I was thrashing about in bed. Shortly after waking up, I felt sick to my stomach and got out out bed to go to the bathroom thinking I needed to throw up. I stumbled to the bathroom and then collapsed on the floor. My arms and hands had gone numb. My legs were going numb. I couldn't stand. I couldn't move my fingers at all. They seemed locked in place. My partner could manipulate my fingers and I could feel his touch on my body, but my brain and body seemed unable to communicate correctly for me to move under my own control.  I thought I needed to go to the emergency room. My partner reminded me that it was the covid shot and convinced me to take Tylenol. I was concerned I couldn't swallow and I was unable to hold a cup, but my partner assisted me and I was able to take medication.  After a time (maybe 30 minutes), the numbness gave way to tingling and I was able to feel and move my body again. I was nauseous and oscillating between cold and hot. My partner helped me to stand and walk back to bed. While these initial symptoms left,  I remained feverish, nauseous, and fatigued from Wednesday until Sunday. Monday, May 3 was my first full day without any symptoms.
High fever, sweats, chills, whole body soreness, both muscles and bones, headache, all symptoms x 2 days.
had a reaction to vaccine; Initial information regarding an unsolicited valid non-serious case received from a consumer (non-health care professional) via Social Media and transmitted to Sanofi on 12-Nov-2020.  This case involves patient with an unknown age who had a reaction to vaccine (Adverse reaction), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the reporter received influenza vaccine and did not had any reaction but reporters daughter refused to take the vaccine as her friend (patient) received influenza vaccine (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination and had reaction due to the influenza vaccine (Adverse reaction).  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Adverse reaction.  There will be no information regarding batch number for the case.
Initial report received from a healthcare professional on 05 November 2013. A 27 year old female received a dose of FLUZONE ID at left deltoid intradermal on 31-Oct-2013. After four days (04 November 2013), patient experienced symptoms of low grade temp, nausea, cold sweats, and a red, raised rash has developed on her arms, axillary area, inside of the thighs, and at the knees. Patient mentioned that rash was itchy. Event was not resolved at the time of report. List of documents held by sender: none.
This spontaneous report was received from a medical assistant who was also the office manager and refers to an unknown number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II lot number reported as M040412, expiration date 30-JUN-2019 (strength, dose, frequency, route of administration, and anatomical location were not reported), were administered to an unknown number of patients on an unknown date for prophylaxis. The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 300 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved.
Within 48 hours experienced severe cold/flu symptoms.  Had Covid negative Covid test with hospital on  November 8th.  Put on antibiotic and steroids.  Experienced shortness of breath, respiratory tract and sinus infection.  No fever but experienced chills/body aches, wheezing.    No significant improvement so provider continued with an additional dose of steroids/antibiotics.  Second  Covid test performed around November 26th also negative.  Was off work on Disability PFL through December 3, 2021. Since 2nd Pfizer dose on 12/14/2021 experiencing the following:  Vertigo - loss of hearing (muffled)- ringing in the ears, dizziness, extreme headache (migraine), nausea, blurred vision, body aches, forgetfulness/memory loss, weight gain, light sensitivity, decreased strength/increased weakness.  Loss of stamina for physical activity. bloating.
I experienced itchiness, nausea, fatigue, muscle pain, skin sensitivity, shortness of breath and chest pressure.
patient is experiencing swollen upper arm with throbbing pain more towards local area, painful lump under the arm
Indication for paxlovid: Treatment of COVID-19; Indication for paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 4, single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: I cannot take nsaids." (unspecified if ongoing), notes: known allergies: I cannot take nsaids.; "Gastroparesis with acid reflux" (unspecified if ongoing), notes: other medical history: Gastroparesis with acid reflux; "acid reflux" (unspecified if ongoing), notes: other medical history: Gastroparesis with acid reflux; "asthma" (unspecified if ongoing), notes: other medical history: asthma and allergies.; "allergies" (unspecified if ongoing), notes: other medical history: asthma and allergies; "Heart murmur" (unspecified if ongoing), notes: other medical history: Heart murmur. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
325PM on 25MAR98 pt devel 3mmx 5mm red, raised & hot area @ site of DTAP inj;also c/o itchy red hive like areas that extended down lt arm upper lt chest & lt back to waist;ice pack cont;
arm swelled up down to elbow crease; arm hot to touch; arm itching; arm very red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up down to elbow crease), FEELING HOT (arm hot to touch), PRURITUS (arm itching) and ERYTHEMA (arm very red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), EZETIMIBE (ZETIA), SERTRALINE and PANTOPRAZOLE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up down to elbow crease), FEELING HOT (arm hot to touch), PRURITUS (arm itching) and ERYTHEMA (arm very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled up down to elbow crease), FEELING HOT (arm hot to touch), PRURITUS (arm itching) and ERYTHEMA (arm very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Vaccine administered Friday 4/9/21 morning.  By afternoon and next morning, pt reports having many COVID 19 symptoms: cough, headache, congestion, fever, shortness of breath, nausea, diarrhea, fatigue, runny nose, loss of taste and loss smell, chills, body aches and sore throat.  Pt tested for COVID 19 4/12/21; was negative.
hives, rash, gums swelling and bleeding, oral ulcers, joint swelling hands and wrist swelling, nausea, fever chills,  lymph  node swelling
got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported.  It was reported that, reporter knows someone who did got the Moderna and got sick because patient was exposed to unvaccinated people, and both got sick.
My arm has a swollen, hard lump above the injection site. The surface of my skin has broken out in small white itchy bumps. Also, my injection site is not healing. It keeps scabbing over and if I scratch the scab it bleeds.
Patient experienced intense pain in the left arm 3 hours after administration of the vaccine. Patient took 1500 mg of acetaminophen and applied ice pack on injection site. Advised patient to take Aleve and go to the urgent care if the pain does not decrease. Will follow up with the patient tonight and over the weekend. Instructed the patient to not take 1500 mg next time as 1000 mg is the max per dose for acetaminophen.
Day of shot 4/13/21 no symptoms a little sore arm, woke up  4 am 4/14 with headache, chills, sweats, nausea, throwing up,  diarrhea, couldn't move arm. This lasted until Friday 4/16 then I was better. Tuesday 4/20 work up with sore arm continued thru Wednesday  4/21 and then woke up on Thursday 4/22 even worse couldn't move arm ,nausea, diarrhea and headache.  Called Dr. they said its "covid arm" take Ibuprophen or Tylenol and warm compress to the area. If isnt better in a few days call back and come in.