chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; 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 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 16Oct2023 to 21Oct2023. Clinical Course: Patient had recovered from covid was testing negative. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350751 same patient, different drug/event;
2in diameter, firm, tender, knot on rt anterior thigh; no fever; mild discomfort & dec walking on it; but tolerated well
pain at the injection site; swelling at the injection site; tired; headache; nausea; Chills; Muscle pain; Shortness of breath; Fever; This is a spontaneous report from a contactable consumer (patient's husband) received via medical information team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613; Expiration Date: Jul2021), via an unspecified route of administration in left arm on 25Mar2021 12:45 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization.  Medical history included allergy to penicillin, ongoing diabetes from 2018, ongoing HIV and ongoing neuropathy. Concomitant medications included atorvastatin taken orally as 10 mg, 1x/day and ongoing; emtricitabine, tenofovir alafenamide fumarate (DESCOVY) taken orally for HIV as 25 mg, 1x/day, taking for four years and ongoing; gabapentin taken orally for neuropathy as 100 mg, 2x/day, taking for several years and ongoing; dolutegravir sodium (TIVICAY) taken orally for HIV as 50 mg; taken once daily by mouth; taking for four years and ongoing; insulin aspart (NOVOLOG) taken 100 Units; taken by injection as needed with meals; taking for four years and ongoing; insulin glargine (BASAGLAR) taken 100 units; taken by injection daily; taking over four years and ongoing. The patient seemed alright for the first 15 minutes after vaccination. No additional vaccines administered on same date of BNT162B2. Prior to vaccination, the patient did not receive any vaccines within four weeks. The patient experienced pain at the injection site, swelling at the injection site, tired, headache, nausea, chills, muscle pain, shortness of breath and fever on 26Mar2021. It was reported that patient is having a severe headache and nausea. Reporter wanted to know how long the side effects will last and if his wife could take her regular medications. It was stated that they thought she could not take aspirin and wanted to know what she could take for her headache. Events pain at the injection site, swelling at the injection site, headache, and nausea were reported as worsened. Patient has been scheduled for the second dose on 15Apr2021. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
I started with a really bad sore throat that lasted 7 days. I had to live off ice chips for those 7 days. I also had were my lip had tiny white bumps on it. I had no other symptoms. I went to the urgent care clinic. They did a rapid a cultured strep test they were negative. They also did a COVID test that were negative. I had a shingles vaccine about 6 weeks after the second dose of the COVID vaccine. I did also travel right before my symptoms started. My lip is still a little numb.
Mild headache, extreme sleepiness (slept from Saturday night thru Monday morning with brief times of being awake but not alert), no desire for food or drink,  temperature 100 Drank some ginger ale Awoke Monday morning feeling hungry and thirsty
Severe chest pain. Peracarditis confirmed. Testing for myocarditis or other issues.
Fever/ got up to 102 degrees Fahrenheit; Body aches; Sore throat; Feels like she has got just a regular cold; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date unknown), intramuscular on 21Dec2020 19:00 to an unspecified date at single dose in the right arm for vaccination. Medical history included menopause from an unknown date. Concomitant medication included levothyroxine sodium (SYNTHROID), fenofibric acid, metformin, escitalopram and unspecified hormones for menopause. The nurse practitioner called to report on herself as the patient. She received her first dose of COVID-19 Vaccine on 21Dec2020 around 7:00pm. Starting about 10:00 am today, 22Dec2020, she had onset of fever, body aches and sore throat. She is hoping that this is all a normal part of the COVID-19 Vaccine; but she called to verify if that is all normal because she has to work tomorrow. Stated that her fever got up to 102 degrees Fahrenheit. She mentioned regarding seriousness criteria of all events that they are not serious, that she feels like she has just got a regular cold. She is scheduled to get the second dose of this vaccine 21 days after first dose. Causality of all events reported as yes, she really believes it is related to product. The outcome of the events was not recovered.  The following information on the batch number has been requested.
Immediate pain shooting through the arm and emmense throbbing it was also given to high up in the arm.. After 4 days the pain was so bad went to the walk in clinic was given ibuprophen 800mg. After 2 weeks in dire pain went to the ER and was give steroid shots. 1 shot start immediately the other to last 2 weeks..felt better then after the pain is back it hurts to lift arm tingling in fingers and the pain wakes me up at night it is so intense.
NO ADVERSE EVENT WAS NOTED.  ADMINISTRATION ERROR.  VACCINE WAS GIVEN AFTER EXPIRATION DATE.  EXPIRATION DATE WAS 4/1/2022 AND VACCINE WAS ADMINISTERED ON 4/19/2022.
Three days after my second Pfizer vaccine, I developed a severe cold including headache, cough, sore throat, body aches, fatigue. Around this time I began hearing a high-pitched  sound in my ears/head, which I never experienced before.  The sound is similar to 7,000 hz and resembles the sound of overhead fluorescent lights.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Between 22-MAR-2016 and 23-MAR-2016, the patients might be vaccinated (nurse stated: "I don't know which ones were administered" but might GARDASIL 9) with improperly stored doses of GARDASIL 9 injection,  lot# L040164 with expiration date 20-FEB-2018 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 F for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt given PEDIARIX instead of DTAP. Father of pt notified on 03/18/2016. Father of pt reports no adverse reactions. "He is doing fine." Father voiced understanding of calling 911 or coming into Urgent Care if there are any reactions to the vaccination.
He was diagnosed for the COVID-19 Virus and he got Vaccinated; He was diagnosed for the COVID-19 Virus and he got Vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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 "unknown" and all described as "He was diagnosed for the COVID-19 Virus and he got Vaccinated". Therapeutic measures were taken as a result of drug ineffective, covid-19. Product included Paxlovid. Clinical course: Reporter mentioned that she's been sick since 13Mar, and her son was sick. Her son was 57-year-old. Reporter husband got sick earlier than 13Mar and her son wanted to go to the emergency room he was diagnosed for the COVID-19 Virus, and he got vaccinated. She mentioned that she never had any vaccines as well. She is worried that she might test positive for the Virus. Reporter stated that she wanted to take the medication since she was having a hard time breathing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
LOW TEMPERATURE; SLEPT OFF AN ON FOR ABOUT 24 HRS; CHILLS; LITTLE SICK ON STOMACH TUM HANDLE; CHEAPNESS ABOUT 4 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced low temperature, slept off an on for about 24 hrs, chills, little sick on stomach tum handle, and cheapness about 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low temperature, slept off an on for about 24 hrs, chills, little sick on stomach tum handle, and cheapness about 4 hours. This report was non-serious.
Uterine bleeding; This is a spontaneous report from a contactable consumer (Patient)   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 07Aug2021 (at the age of 37-year-ol)  (Batch/Lot Number: FA7485) as single dose, dose 2 via an unspecified route of administration, administered in arm left on 28Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. The concomitant medications in two weeks included Levothyroxine 0.75 mcg. The patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced uterine bleeding (medically significant) on 09Aug2021 with outcome of not recovered. The course of events was as follows: Uterine bleeding started after receiving the 1st dose of the vaccine on 07Aug2021. Bleeding started on 09Aug2021 and lasted until 24Aug2021. Uterine bleeding started few hours after receiving second dose on 28Aug2021. No treatment received. COVID was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Patient intended to receive 1 dose of flu shot and booster pfizer dose. The pharmacist administered 2 doses of pfizer by mistake. A shot was given in each deltoid on 1/29/2022. Patient was immediately made aware. Pt followed up with on call PCP and was told to monitor symptoms. Pharmacy followed up with patient's PCP on 1/31/2022 (office was closed during weekend). Pharmacist followed up with Drug Info specialist hotline 1/31/2022 (office closed during weekend). Patient had not experienced any adverse reaction on 1/29/2022 and not reported any reaction to Pharmacy as of 1/31/2022. Patient was advised to monitor symptoms and seek emergency help if any symptoms arise.
I have no full range of motion of my left arm, now there is numbing & tingling down my arm.
She got the vaccine and had no pain at all.   She was in her recliner on 3/29/21 and noticed red dots (petechia) on both legs that were red, itchy.   She took Benadryl and within 3 days the reaction was gone.
02/04/21-groin pain/burning, buttocks and thighs muscle tightness, unable to sit for extended period of time due to groin discomfort 02/05/21-continued groin pain, new bilateral arm/bicept muscle pain with right side worse than left 02/06/21- headache, loss of appetite, chills, shoulder/neck/jaw/hips joint pain 02/07/21-back and ribs pain with sitting or lying- unable to sleep due to extreme pain, unable to transition from lying to sitting to standing due to pain, fever 101.8, worsening of all symptoms. Employee Health contacted, instructed to obtain Covid test, results negative. 02/08/21-First day missed work. Continued worsening of pain, groin and hip pain radiating down the back of both legs to back of both knees 02/09/21- Excruciating pain, difficulty with ambulating. Seen at Emergency Department, labs and imaging obtained, informed of bilateral Pulmonary Embolisms, admitted for treatment.
Patient is a 2 m.o. female who presents with chief complaint of Allergic reaction.  Patient was seen with the PCP today and had 2 month vaccinations.  Went home and took a nap, when she woke up from the nap had a large amount of swelling on the left thigh where she would received 1 of her immunizations, then developed a Norco rash on the trunk, EMS was called. Patient was given epi by EMS which improved the rash and swelling.  Mother denies any complications with pregnancy or the vaginal delivery.  No time in the NICU.  Has been breast-feeding well and making wet diapers.   No past medical history on file.   No past surgical history on file.   No family history on file.
a child received injection of two MMR II vaccines in the office today; no adverse event; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 23-NOV-2020, the patient was vaccinated with 2 doses of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (lot, expiration date, route of administration, strength and frequency were not reported) for prophylaxis (overdose).   Additionally, it was reported that patient was not currently experiencing signs/symptoms of a reaction to her knowledge (no adverse event). No additional details were provided.
Information has been received from a physician concerning a 28 year old Haitian male who on 10/9/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/11/01, the pt was hospitalized for the following other unrelated pre-existing conditions: aplastic anemia, prostatic abscess, hematuria, sepsis, colitis and a tuberculosis pleural effusions. On 10/12/01, the pt developed a severe injection site reaction described as severe swelling and induration from the right deltoid to his mid-forearm. On that same date, the pt suffered from hemorrhagic cystitis secondary to Klebsiella infection, bibasal pneumonia and developed an intracranial hemorrhage. As of 10/19/01, the pt was on a ventilator and was doing very poorly.  A chest X-ray on that same date showed a suspicion of infilitration in both lung bases and a  clinical correlation was suggested. The pt was being treated with piperacillin sodium (+) tazobactam (Zosyn), gentamicin and metronidazole (Flagyl). On 10/21/01, the pt died. The cause of death. The cause of death was intracranial hemorrhage. The reporting physician did not feel that the pt's hemorrhagic cystitis and intracranial bleed were related to his pneumococcal vaccine. Additional information is not expected.
tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-116565 (Patient Link).
the patient was inadvertently administered one dose of PROQUAD on 17-JUL-2019; The titers for varicella were less than 0.9, which the nurse reported as being negative titers to those diseases; The titers for rubeola were less than 0.6, which the nurse reported as being negative titers to those diseases; Information has been received from a registered nurse referring to a 19 years old male patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 01-SEP-2000, the patient received one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On 10-NOV-2000, he received one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On 12-JUL-2004, he received another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (batch/lot #, expiration date, strength, dose and route were unknown). On 24-MAY-2010, he received another of varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot #, expiration date, strength, dose and route were unknown).  On 12-JUN-2019, the patient had titers drawn because he was going to school to be a certified medical assistant, and titers were required. The titers for rubeola were less than 0.6 (unit not provided), and for varicella were less than 0.9 (unit not provided), which the nurse reported as being negative titers to those diseases (measles antibody negative, antibody test negative). Because of that, on 17-JUL-2019, the patient was inadvertently administered one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (1 dose, batch/lot # S003173, expiration date: 30-JUL-2020, strength and route were unknown) for prophylaxis (inappropriate age at vaccine administration). Medical attention was sought to the physician. The outcome of the events was unknown.  The causality between the vaccines and the events was not provided.
still get second dose 6 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Treatment medication not reported. patient had not taken second dose 6 months after the first dose .
Pt experienced the following: Muscle Aches, Joint pain, nausea, dizziness, chest tightness. BP 137/84 HR 100-138
Rash on my buttocks/ it was itchy and it had gotten a little bigger; My face was swollen; Very tired; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8732 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 23Mar2021 at 12:45 (at the age of 54-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included sinusitis from Oct2020. 6 months ago, when patient had a sinus infection, doctor gave a steroid shot back. In 02Mar2021, the patient had to go back to the doctor's, and they gave her amoxicillin and steroid pills that patient had to take for the sinus infection as well. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 24Mar2021, the patient face was swollen, and patient was very tired. On 30Mar2021, patient noticed a rash on her buttocks and stated that it was around that steroid shot, rash started there, and it seems to be getting bigger and itchy. Further reported that patient was sleeping a lot on Mar2021. The patient would like to know If the rash is part of the symptoms and if they could get shingles with the vaccine as side effect. No treatment was received for the event Rash pruritic.  The outcome of the event Swelling face recovered in 25Mar2021, Tiredness was recovering, Rash pruritic was not recovered, and Sleeping a lot was unknown at time of report  No follow-up attempts are needed. No further information is expected.
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
Patient noticed numbness of the arm and shoulder starting 20 minutes after receiving vaccine- returned to pharmacy to monitor. Symptoms have neither worsened or gotten better.