chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having 6-month mammograms to keep an eye on a spot I found in 2021. When I went for my mammogram on January 6, 2023, the doctor found a new spot within the last 6 months. The spot was biopsied January 18th, 2023, and the next day it was confirmed that it was Invasive Ductal Carcinoma. I had genetic testing done and all the tests were negative so it's not because of a genetic mutation. I had a Lumpectomy surgery on February 23, 2023, and I will be having radiation and chemotherapy starting this month. Surgery confirmed that I am stage 1A.
Patient was vaccinated with J&J on 3/30/21. Patient was admitted with COVID 19 after a 3 day history of cough/fatigue. Patient has been admitted since 12/27/21
feeling very very ill; bed ridden for entire day; couldn't even stand up; Diarrhea; Fever; unbelievable headache / severe headache; throwing up; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. A47A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was never tested positive with COVID-19.  Concurrent medical conditions included Allergic to cats, Pollen allergy, Migraine, Anxiety, Depression, Asthma and Sleep problem (melatonin for sleep problems.). Concomitant products included MELATONIN and ALPRAZOLAM (XANAX) for Sleep disorder.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Head pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Patient was on medications for Migraines, anxiety, depression, asthma and allergy shots.   This case was linked to MOD-2022-561640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Live Follow-up document received includes no new information.
Patient developed fever and irritability on Saturday November 16th around 3pm. Full dose of 1.875 mL of infant's motrin given approximately 3:15pm. Patient was put to sleep around 7pm and awoke several times due to fever. Second full dose of motrin given around 9:45pm. Rectal temperature taken around 11pm upon waking. Temperature was 103.9. Patient was crying and upset throughout the night. Around 2am patient was jerking quickly and repeatedly while crying, which lasted for about 2 minutes. Jerking occured again around 5am and lasted for 2-3 minutes, about one jerk every 5-10 seconds. 3rd dose of motrin given around 5am.  Rectal temperature taken around 5am; result was 103.4. Patient was extremely upset and irritable and appeared to be in pain. Around 5:30am decided he should be seen at the ER.  Patient's fever lasted for 4 days, subsiding on Tuesday November 19th. Patient was lethargic and unable to stay awake for more than  2 hours at a time throughout the day from Sunday November 17th-Friday November 22nd. Patient was lethargic and unresponsive; he was not able to stay awake for more than 2 hours at a time and slept 5-7 hours a day and 12-13 hours at night. His behavior was dramatically different as he is usually very active and aware. Patient began returning to normal behavior on Friday November 22nd; total adverse event lasted for 6 days.
6 inch x 8 inch area of erythema and edema to right upper arm post vaccination. Mother reports erythema today is improved since yesterday. Area warm to touch, mildly tender and pruritic. Erythema suggests moderate to severe allergic response/possible cellulitis. No systemic symptoms of allergic reaction, patient stable at time of assessment on 8/18/2014 at 4:56 PM. Referred to urgent care for evaluation.
This case was reported by a healthcare professional and described the occurrence of thigh erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with combined KINRIX. Concurrent vaccination included unspecified vaccines given in an unknown deltoid in December 2008 or January 2009. Concurrent vaccines were given on the same date as KINRIX. On an unspecified date (either in December 2008 or January 2009) the subject received unspecified dose of KINRIX in an unknown thigh. In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site. The events worsened the next day and resolved over the next couple of days. The healthcare professional considered the events were possibly related to vaccination with KINRIX. These events occurred in three different subjects under the age of 6 years. The children's parents called to report the events and were told over the phone to treat the redness and swelling with compresses and Tylenol. Linked cases include A0762587A and A0762590A. Follow-up information received on 27 January 2009 indicated that the subject was a 4 year old male. KINRIX, 0.5 ml, was administered to the subject on 12 January 2009 along with concurrent Hepatitis A vaccine (intramuscular at 0.5 ml). The events occurred one day following KINRIX administration on 13 January 2009. At the time of reporting, the events were unresolved and considered by the reporter, related to treatment with KINRIX.
Patient came to outpatient clinic to receive her second dose of Pfizer vaccine to complete dose 2 of 2 dose series.  RN administering the dose obtained a new vial of Pfizer-BionNtech COVID 19 vaccine and drew up 0.3 ml's of undiluted vaccine.  The 0.3 ml's of undiluted vaccine was administered to patient prior to discovery that the vial had not been reconstituted.  Patient reported feeling a little light headed for about 15-20 minutes.   No other adverse effects reported by the patient.
I had body aches, sore throat, chills, congestive, coughing, and fever. These symptoms lasted for about 4 days but the sore throat is still ongoing. On April 18th, I tested positive for COVID-19.
Patient was emaciated, with muscular weakness. Mother mentioned that patient was not warm, had a seizure and was taken by her to the doctor. Patient taken to doctor on 08/09/07,indicated that patient had seizure due to fever.
Cried unconsolable for 7-8 hours. Seen in the ER, follow up with clinic. Fussy, sleepy, and altered behavior for 72 hours.
Pt in for required vaccine and PPD. Gave all vaccines. Brought pt and family out front to give copy of record. Noted PPD site was bleeding a little. Had pt come back to exam room to clean off site. Pt stated that he felt "dizzy" then pt collapsed. RN caught pt and lowered to floor. Pt then had "seizure-like" movements. Pt. regained consciousness and was placed on exam table were he passed out again and had seizure like movements. Pt was very pale called EMS squad to have patient evaluated.
A report was received from a health care professional on 10/24/2003 concerning an octogenarian female who experienced rash and hives on her upper body and chest tightness 2 days after receiving Fluvirin on 10/22/03. On 1/24/2003 the vaccinee experienced rash and hives on her upper body and also chest tightness after she used her inhaler (type of medication unknown). She was prescribed loratadine, diphenhydramine hydrochloride, and prednisone (if condition worsened). The vaccinee had no known drug allergies and received the influenza vaccine in the past without any problems. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 11/27/2003: Follow up information received from a health care professional indicated that the 71 year old female vaccinee with generalized hives recovered on 11/27/2003.
Passed out, fell to floor bumping back of head, skinning left knee, only out for few seconds, felt better, able to walk to sit in chair, became dizzy, vomited large amount, ambulance came, bp 114/56 p 60.
Arm with large area of redness, warmth and induration.  Started 2-3 days after injection and lasted until day 7
got up in the night and stated that she couldn't breath, ambulance was called, pt expired in route to hospital.  *relayed to me by Facility staff RN.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EL9261), in right arm, on 04Mar2021 at 10:00 as dose 2, single (Lot number: EL9267), in right arm and on 25Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Oct2017; ROSUVASTATIN, start date: Jun2018; HYDROCHLOROTHIAZIDE, start date: Jun2001. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Covid-19 treatment. Paxlovid. Treatment start date: 29Jun2022. Treatment stop date: 03Jul2022 Lot number: GC9431. Indication: Treatment of Covid-19  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of uveitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown. The reporter considered the uveitis to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was recently diagnosed with uveitis and was concerned the uveitis might have been caused by having the 1st dose of SHINGRIX. At the time of reporting, the patient was due for her 2nd dose of SHINGRIX. The patient disconnected before providing additional information.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drug details were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Pfizer-BioNTech COVID-19 Vaccine EUA: Developed headache (about 3 hours after injection), diarrhea (about 20 hours after injection) and sneezing/runny nose (about 4 days and 3 hours after injection)
9APR97 fever present;seen for routine check up n 10APR-red papular lesion son trunk & lower extremities, very itchy;
(L) arm swelling/cellulitis. On BENADRYL and ABx: Cephalexin 250mg every 8 hours.
Woke up at 3 AM with an anxious feeling and couldn't fall back asleep.  A few days later anxiety came on again with right calf muscle twitching. A several days passed and the twitching moved to other parts of my body.  Here it is June 9th and the twitching still continues. I saw a Neurologist, Dr. and he ran additional tests to check for any muscular issues - everything came back normal.
Pt contacted office 11/12/19 with reports that her Right arm was painful and unable to move extremity, pt came into office for evaluation, was prescribed Tramadol to help with pain and to be monitored. Pt was contacted 11/13/19 for follow up on how she was doing with report that her arm was 100 % better with no pain and range of motion was per her norm.
Developed rash (L) arm around vaccination site spread down arm to wrist. 2 days later involved (R) lower arm.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Pt was seated during 15 minute mandatory observation period. Within 10 minutes, Patient fell out of chair and was found on the floor conscious within seconds of her fall. Pt reports feeling queasy, lightheaded, flush, hot and having chills prior to fainting. Pt was assessed by nurse practicioner, bp, breathing, pulse reported to be normal. EMS was called and pt assessed by paramedics. Pt reports feeling better.
After vaccine waited in auditorium to make sure no reaction. All of sudden shooting pain back of head and heat flash went from head to chest causes my heart to start racing. I had to go to ER hook to a heart monitor vitals BP 150/90;HR 160 this all happen in the first 15 mins. It went away then came back in a 1 hour 1/2 timeframe. I discharged sent home still felt weird. The next day legs was sore, pain in headache and twinge in my chest. On the third day pain back in head and pain in leg has went away.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 173 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information
First dose given at facility on September 24 2021 at approx 5:00 pm, by midnight Sept 25th have entire body pain, by breakfast was feeling ill with body pain, fever of 101.9 and severe headache. This lasted the duration of 4 days. Began losing hair shortly after.  Received Second dose on  October 8, 2021 at approx 4:30/5:00 pm at a different facility due to vaccine being out of stock at first facility. In the exact sequence and time frame i experienced the same reaction. Within days I began profusely losing my hair. As of now i have lost over half of my hair and continue to.  Have been following the Dr recommendations with no success. In addition there has been three toes that swell with pain that comes and goes.
Parent wrote the wrong date of birth on the consent form. Year was modified to make the child 12 years old. Age was not verified and child received the vaccine at age 11. Parents were notified and told they cannot get child their second dose until they are 12 years old.
Sore gums, just a few days after 2 dose, most recent within a few weeks excessive gum bleeding to the point of seeing my doctor who encouraged me to report this.
Hacking cough; Loss of taste; and smell; not like herself; felt tired; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste) and ANOSMIA (and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced FATIGUE (felt tired), NAUSEA (Nausea) and MALAISE (not like herself). On 16-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (and smell). On an unknown date, the patient experienced COUGH (Hacking cough). At the time of the report, FATIGUE (felt tired), NAUSEA (Nausea), COUGH (Hacking cough), AGEUSIA (Loss of taste), ANOSMIA (and smell) and MALAISE (not like herself) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any medications.   Reporter did not allow further contact   Reporter did not allow further contact
11/21/2020 1:00 PM - pain in right arm - treated with ice and tylenol - pain is reduced but is ongoing, treating with tylenol 11/22/2020 7:00 AM - nausea and headache upon waking. - continued until 9:00 PM 11/22/2020 11:00 AM - chills. - continued until 3:00 PM 11/22/2020 1:00 PM - shivering and fever of 100.6, treated with tylenol - continued until 3:00 PM 11/22/2020 - 3:00 PM - fever of 99.4, treated with tylenol - continued until 11/23/2020 10:00 AM 11/22/2020 - 7:00 PM - rash starting on upper chest and right side of neck.  rash continued to spread throughout the day on 11/23.  By 6:00 PM on 11/23 rash had spread to below breasts, upper chest, both sides of neck, sides of face, back of neck and around hairline.  Rash has subsided with antihistamine treatment but continues as of 11/24 8:00 PM.
This spontaneous report as received from a registered medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-AUG-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020002 and expiration date on 08-AUG-2015 dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The licensed practical nurse reported that the they inadvertently administered an expired dose of Havrix yesterday. The reporter asked what to look for and asked should we revaccinate. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix, which was already expired on 30th January 2023, which led to expired vaccine used.
15 hours after vaccine - Tingling/swelling of lips and tongue, headache, back of neck stiff.  Next day not as bad. Third day - intense tingling pinpricks on hands, feet, ankles, scalp. Large bumps on back of tongue and throat.  Called COVID hotline.  Take Benadryl- go to ER if breathing becomes an issue.  Fourth day better with Benadryl. Fifth day - exhausted, back of throat swollen, hard to swallow, now itchy on hands, feet. Went to urgent care. ?Don?t know what to tell you?.  Continue Benadryl.  By 7th day, most symptoms gone. Tongue and lips sore. Occasional itching.