chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60y.o. female patient, presented to the EC yesterday with altered mental status, the patient sustained a fall at home.  On evaluation the hospital she was found to have traumatic frontal and parietal occipital subarachnoid hemorrhage and left acute subdural hematoma.  She is currently in the ICU setting, she is intubated.  She has a past medical history for metastatic breast cancer with involvement in the brain, suboccipital craniotomy tumor resection in 2003.  History of hyperlipidemia, type 2 diabetes.
Patient has been diagnosed with Early Onset BiPolar Disorder.  Within 24 hours of receiving his MMR2 vaccination, we noted a marked change in hyperactive, impulsive and aggressive behaviors.  In the following 3 months, his medication (Risperdal) needed to be increased 3 times, to the point where we no longer felt it was effective.  Within 6 months, we found it necessary to change his medications altogether (Abilify, Trileptal).  We feel that the 9 week long (Aug 1 - late September, 2003) manic cycle that he experience is directly correlated to the immunization, considering there were not other external factors that could have influenced such a drastic change.  During this same time, intervention had to be sought in an effort to prevent him from being dismissed (expelled) from pre-school for excessive aggressive incidents.
24 hours after the first injection symptoms started.  In dose 1, I experienced pain and swelling in the arm of the injection site, fatigue, headache, chills, fever of around 100, nausea, all over body aches.  24 hours after the second injection, I experienced all of the same symptoms only to an extreme degree with fever of 101.3.  My entire body hurt and I felt like I was going to die.  In both cases, symptoms subsided after 48 hours but fatigue lingered for several days afterward.
Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, and "intense chest tightening". She took a children's tylenol tab and put heat on her back and then rested and fell asleep for a period of time. SHe woke up to "pins and needles" feeling in her head and face that felt "intense" to her maybe 4-5 hours after vaccination. She continued to feel "discomfort, tightness in chest/back" for 2-3 days. SHe then stated around day 10 she had abdominal tightening, overwhelming nausea, and pressure in her stomach, but no diarrhea for about 6-7 days. She also states she had "bad reflux". Around Feb 14th-16th she started feeling a rash on both arms/neck/chest  and then hives that were red/blotchy a few were raised and hard on thighs/hip/arms. She went to physician and was given Benadryl and Steroid cream. She then reports that on Feb 20th she had swollen lymph nodes under arm.
Patient passed away suddenly and unexpectedly on 5/7/21.  Cause of death on death certificate states ventricular fibrillation
Same day as injection with fever, chills, headaches. Now with pressure like substernal chest pressure that is non-exertional, constant, worse with laying down. Associated symptoms includes right sided neck swelling with pain on breathing (opposite of injection site).
This spontaneous report as received from a pharmacist (both e-mail and phone call) via company representative refers to a 23 year old patient, gender not reported. On 15-MAY-2013 the patient was vaccinated with the third dose of GARDASIL lot # 668261/1397AA, expiry date 09-APR-2013, route of administration and dose were not reported. Pharmacist reported that the GARDASIL was administered 36 days past the expiration date. No adverse effects were reported. Additional information has been requested.
I experienced severe pain in the arm vaccinated, eyes were nearly swollen shut with mucous discharge, stuffy nose, post nasal drip, dry mouth, muscle pain and chills.
Pregnant; Fatigue; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not take any treatment. No concomitant medication were reported
Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasting less than 12 hours.
now vomiting; very sick throughout the night; Fourth day fever/Fifth day fever of 106 throughout the night; weak; chills; Headache; tired; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Sep2021 10:00 (at the age of 17-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19. Patient did not have known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced headache, tired on 17Sep2021, fourth day fever/fifth day fever of 106 throughout the night, weak, chills on 20Sep2021, very sick throughout the night on 22Sep2021, now vomiting on 23Sep2021. The patient underwent lab tests and procedures which included body temperature: fever on 20Sep2021 Fourth day fever, body temperature: 106 on 21Sep2021 Fifth day fever of 106 throughout the night, sars-cov-2 test: negative on 22Sep2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient has covid prior vaccination and covid was tested post vaccination. The patient did not receive any treatment for adverse events. The outcome of all events was not recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Arm soreness for 24 hours. Muscles aches and chills in the evening after the vaccine.; Arm soreness for 24 hours. Muscles aches and chills in the evening after the vaccine.; Arm soreness for 24 hours. Muscles aches and chills in the evening after the vaccine.; This is a spontaneous report from a non-contactable physician reported for self. This 26-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EH 9899) at single dose on 18Dec2020 at 07:00 on arm left for COVID-19 immunization. Medical history and concomitant medication were not reported. There was no allergies to medications, food, or other products. Concomitant medication was not reported. There was no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced arm soreness for 24 hours, muscles aches and chills in the evening after the vaccine. Onset was 18Dec2020. There was no treatment for the events. The outcome of events was resolved in Dec2020.  No follow-up attempts are possible. No further information is expected.
Small red welt, hard to the touch, itchy, painful to touch, and looked like a bruise. This increased in size by 12/17 to about a 2 in diameter with the same symptoms. Lost to follow-up, tried multiple time over 72 hours.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer (patient) or other non HCP.  An adult non-pregnant female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 26Mar2021 as dose 2, single for COVID-19 immunisation was in doctor's office/urgent care. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), administered on an unknown date as  dose 1 single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. On 06Jul2021, the patient tested positive for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: positive on 06Jul2021.Therapeutic measures were taken as a result of tested positive for COVID-19. Outcome of the events was resolving.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
4x5 cm red area surrounding DTap injection site.  Tenderness  no induration started 24 hours post injection.
02NOV2022 I began feeling ill first thing in the morning, it started with extreme tiredness and chills. I had sore throat respiratory I lost sense of smell, appetite, very strange muscle soreness, in the lower body area that I have not experienced before, my cough somedays was unrelenting my sore throat changing in intensity. One of the scariest times was waking up early in the morning feeling unable to breath for maybe five hours, my doctor prescribed an inhaler and week three or four antibiotics for an upper respiratory type infection and week four I started doing small things again during this period of time my watch was alarming me as to a low heart rate. Week five I was allowed to go to a schedule doctors appointment and my low blood pressure was 188/55. I took my blood pressure at home it went down only slightly the following Friday my blood pressure was high although not as high. It was recommended I see a cardiologist. The taste returned mostly but I have had depression now as a result and heart issues are now present. I am taking amlodipine and was told to drink a lot of water. It now seems to be what I call the green zone on my blood pressure app.
After I finished a light jog, I felt a pulse type feeling near my heart. It dropped my too my knees, but I did it lose consciousness. Early on that same day I felt light headed,?but nothing serious.
Headache, body aches, extreme tirdness,neck pain, arm pain from injection site to elbow. These smptoms have continued since vaccination date.
Rash at the site of injection developed this morning. The rash gradually became more itchy and spread a lot on my arm through out the day
patient started shivering almost instantly. Followed up via phone later - reported chills and nausea. Later again spoke to husband - stated patient has fever and was feeling "tight chest"
Resident received 2nd COVID Vaccine and developed Flu-like Symptoms on 2/3/21. Vaccine administered on 2/2/21 Resident was sent to hospital on 2/4/2021and diagnosed with SOB. Readmitted to the facility on 2/5/2021
I had breakthrough case of Covid I had headache, sore throat, fever, fatigue, congestion.
Information has been received from a pharmacist concerning a 19 year old female with no pertinent medical history who was vaccinated with the second dose of GARDASIL (lot#, dose, route and site of administration not reported). There was no concomitant medication. The patient experienced seizures after receiving the second dose, and she went to an emergency room for treatment. The patient recovered from seizure. Seizure was considered to be life threatening by the pharmacist who stated that this case might have been already reported by the patient's physician. Additional information has been requested.
Large local reaction in left thigh (7x7cm) with induration and erythema within 24 hrs of injection. Mom also states child had fever.
Muscular and joint inflammation, unusual muscle mass/weight loss without dietary changes, accelerated loss of scalp hair, reduced sex drive/semen production.
50 yo female received flu shot for the 1st time. After 2 seconds pt experienced itchy eyes & chest area, achy body, HA, cough, and fatigue (no energy). She did not take anything, just relaxed. Pt felt better the next day and today she feels normal. Pt called the pharmacy to let me know.
Patient received vaccine at 5:30pm and started to feel dizzy. Patient was given water, juice and snack. Patient after 5 minutes felt tingling in the arms and lips. EMS was called to take patient to the hospital.
PT C/O TINGLING IN HER MOUTH, METALIC TASTE 25 MINS AFTER 2ND DOSE. ELEVATED BP, TARNSFERED FOR FURTHER OBSERVATION.
This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L023587, expiration date- 26-JUN-2017, for (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient called with upper body muscle aches in his arms, neck and fingers and muscle stiffness. No treatment
I felt a lot of very much weakness. I had Bronchitis, and Pneumonia.
This is a spontaneous report received from a non-contactable consumer (patient). A 55-year-old male patient received at clinic BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in left arm on unspecified date in Feb2021 09:30 AM as 2nd dose, single for COVID-19 immunisation. The patient's medical history was reported as none. No known allergies reported. The patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in left arm on unspecified date in Jan2021 09:30 AM (at the age of 54-year-old) as 1st dose, single for COVID-19 immunisation. The patient did not receive any other vaccine in 4 weeks. On 18Feb2021 05:00 AM the patient experienced fever, chills, and pain at injection site. No treatment was received due to event. The patient was not tested for COVID post vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Pt presented for a COVID booster at that time we were aware she had one dose of J&J.  After giving a moderna booster it was discovered that the pt had 2 doses of moderna as well.
Cellulitis started same day of injection.  Arm became extremely sore on day two; started running fever of 104.0 degrees.  Redness became visible on day three (11/24); pain became worse and redness increased/spread throughout the day.  On 11/25/11 patient rushed to ER with heart attack/myocarditis/cardiomyopathy.  No obstructions of heart as determined by catheterization.  Decreased ejection fraction 45%.
Approx 8-10 hours after injection - severe muscle cramping all over body, neck pain, headache, frequent urination, chills, excessive sweating, heartburn, nausea (lasting approx 12 hours), followed by approx 8 hours of no symptoms. Muscle cramping and headache  then returned for a  duration of approximately 6 hours. 48 hours after vaccination,  the injection site has become increasingly red, swollen and painful/itchy. Redness has grown substantially in the past 24 hours.
Client received FLULAVAL Quadrivalent vaccine 9-19-2016 in (L) deltoid. After playing baseball game noted a raised red lump approx. 10 mm in (L) axilla. Continues to remain reddened with increased tenderness since Monday pm - 9/19/2016.
This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, 21 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the office manager. The patient (worker in this office) took FLUARIX QIV and 2 to 3 weeks later got the flu. This case was considered as a suspected vaccination failure case as the lab test confirmation for influenza were unknown. The reporter agreed to follow up from GlaxoSmithKline. This is 1 of the 3 linked cases reported by the same reporter.
Full facial locking. Tightening like lock jaw but from the forehead all the way down to full jaw line
The same day at 8:00pm after receiving the first dose, the chills began, on the second day pain in the arm could be lifted, chills and fever
Just want to share. This was my booster vaccine with Phizer. Seems this third shot effected me a bit more. Normal sore arm and swollen lymph node in the arm pit. However the inflammation and hot feeling was a bit more intense. If you have inflammation issues this could cause increase reaction. My face is bright red and a bit swollen. I do carry epi pen for bee stings and wasps. .... it feels a bit like that. Last night shortness of breathe. Again this is is a mild reaction to the vaccine that my immune system tends to overreact to anything foreign.
flu-like symptoms; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 26Mar2021, outcome "unknown", described as "flu-like symptoms". Additional information: Reporter was asking if wife (patient) can take Advil or Aleve for that. Both drugs are pain relievers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling tired; Oxygen saturation decreased; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation decreased), CONDITION AGGRAVATED (Condition aggravated) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL, AMLODIPINE, SELEXIPAG (UPTRAVI) and OXYGEN for an unknown indication.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg. In March 2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criteria medically significant and intervention required), DYSPNOEA (Shortness of breath) (seriousness criteria medically significant and intervention required), NASOPHARYNGITIS (Cold symptoms), MUSCLE TIGHTNESS (neck tighing), ARTHRALGIA (pain in her knee) and FATIGUE (Feeling tired). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen saturation decreased) was resolving, CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Shortness of breath), MUSCLE TIGHTNESS (neck tighing) and FATIGUE (Feeling tired) outcome was unknown and NASOPHARYNGITIS (Cold symptoms) and ARTHRALGIA (pain in her knee) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 71 % (Low) 71%. On an unknown date, Oxygen saturation: 96 % (Inconclusive) improved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that the night after the vaccination the oxygen saturation decreased to 71% on oxygen 10 liters per minute. Treatment for the event included a non-invasive ventilator device (trilogy machine) with improvement of oxygen saturation to 96%.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.