chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (very mild, symptoms: runny nose and dry cough. COVID-19 test was positive, date: unknown) in December 2021. Concurrent medical conditions included High cholesterol and Overactive bladder. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR OD) for High cholesterol.    On 09-Oct-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine). At the time of the report, PAIN IN EXTREMITY (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine), HEADACHE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) and FATIGUE (She had the usual sore arm, headache and feeling tired which she usually felt every dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: not below 96. On an unknown date, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as Crestor on Z tab. Other Moderna covid-19 vaccination details were as follows: patient received first dose on 01Jan2021 (lot number: 014F21A), second dose on 28Jan2021, third dose on 09Apr2022 (lot number: 001M21A) and fifth dose on 19-Sep-2023 (lot number: 3030342). Treatment information was not provided.   This case was linked to MOD-2023-741466, MOD-2023-742199 (Patient Link).
MMR vaccine given 2/21/07; reported malaise 12 days later 3/5/07, then starting on day 16 joint swelling and arthralgia particularly in knees & wrists.  Treated with OTC anti-inflammatory meds.  Subsiding by 3/12, and much improved by 3/14.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        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.   No concomitant medications were provided.   No treatment details were provided.    This case was linked to MOD-2021-016959 (Patient Link).
Had normal (but very strong) vaccine side effects - 102 fever, bed ridden due to body aches, headache, and nausea. But starting around noon, I began to notice a sore throat. I never came out of lockdown, so I have no exposure to the outside world (work from home, rarely go out, mom does grocery shopping and hadn?t gone shopping in over a week at the time of my vaccine).  It doesn?t seem feasible I would?ve caught a cold/flu from someone. The following day (9/18), my throat became extremely swollen and white patches developed on tonsils. My vaccine side effects (fever, headache, nausea, and body ache) diminished significantly, while the sore throat got exponentially worse. By that night, I had excruciating pain and difficulty swallowing. My fever was mostly gone (from 102 to 99-100), but the grogginess returned. The next day ( 9/19) I went to Urgent Care and was prescribed antibiotics. Overnight, I began having difficulty breathing. This morning, the pain worsened and I noticed both of my ears aching. Eventually, the pain became less consistent, except when I try to eat or drink anything other than warm tea with honey. I have been unable to force down soups and other easy to eat foods because even those hurt too bad, and make me not feel hungry anymore from the pain. OTC pain relievers aren?t doing much of anything aside from making my stomach extremely upset as they ravage my body, which is not receiving any nutrients other than chamomile tea and honey. I?m not ruling out the possibility that I got sick before I got my vaccine, but it seems unlikely considering my extremely low exposure to germs, my strong immune system (haven?t really gotten a severe sickness since middle school, my body usually fights things incredibly well), and  the fact that I felt 100% healthy and peak performance before the vaccine, but began getting a swollen, infected throat a day after.  My COVID-19 and Strep-A tests both came back negative today.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON  09/03/2021. PATIENT FULLY VACCINATED ON 03/09/2021.
I am very off balance; Dizziness; It's gotten worst to the point I can hardly get out of bed in the morning; I am having vertigo. It was mild at first but now it's gotten worst to the point I can hardly get out of bed in the morning; This is a spontaneous report from a contactable nurse (patient)  A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced vertigo on 31Dec2020. The patient reported that it was mild at first but now it's gotten worst to the point she can hardly get out of bed in the morning on unknown date. After sleep of about 2 hours it was better but she had been up for over all 2 hour that morning and it was still, the patient was very off balance on unknown date. The patient experience also dizziness on an unspecified date. The outcome of vertigo was not recovered, for the other events was unknown.  No treatment as performed for the event vertigo.
shortness of breath, chest pain, abnormal EKG, elevated troponin, epigastric pain, left lower quadrant abdominal pain, nausea
Approximately 7 hours (8:00 pm) after receiving the shot, I was hit with violent shivering, so violent that I was afraid to take my temperature until the next day, afraid of breaking teeth.  It hit me all of a sudden.  I started feeling a little bad and within 5 minutes I was shivering uncontrolably.  This violent shivering continued for approximately 1 1/2 hours and then settled into normal shivering, like you would have with the flu.  This shivering lasted all night.  Took my temperature the next morning.  It was 100.5.  I slept almost straight through for 31 hours.  Got up one time to eat some soup and went right back to bed.  Was freezing.  Had 4 heavy blankets.  Then woke up the next morning and felt basically fine except my body was sore from the clenching that occurred while I was shivering.
8 year old male patient received a dose of FLUBLOK QIV, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse and transmitted to Sanofi on 09-Oct-2020.  This case involves a 8 year old male patient who received a INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   No other concomitant vaccines administered to the patient.  On 02-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ446AA and expiry date: 18-Mar-2021) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
SHINGRIX VIAL (10-PKT) Kit Bruising around shot area and the next day a large rash below it.  Pain in upper arm for 4 days.
Slight sore throat, extreme fatigue, headache, body aches, loss of appetite, mild dizziness and nausea lasting through the weekend into Wed-10/15.
Over the course of the evening, my arm wasswollen, red and painful. I developed a fever of , 102?, and had chills-my teeth chattered. At about 2 AM I still had a fever but was very hot. The fever was down by morning but was still hovering around 99-100  for another day.
DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory disease due to COVID-19 virus [U07.1, J06.9]   HOSPITAL COURSE: Patient is a 15 year old male with a history of Duchenne muscular dystrophy who was admitted after being diagnosed with COVID as well as influenza.  He required close monitoring due to his chronic conditions that carry increased risk of morbidity including acute respiratory failure.  Patient was started on both remdesivir as well as Tamiflu.  He did not require supplemental O2 or pressure support while admitted.  Of note, he is supposed to be on CPAP with sleep but does not tolerate it and so never wears it, and it was decided to not put him on while here.  Because patient also has adrenal insufficiency, he was placed on stress dose steroids on admission until day prior to discharge.     Nurse care manager worked with mom to help set up home nursing, physical therapy, and occupational therapy.  His mom is also going to set up virtual learning because she is nervous having him exposed to germs at school.     CONSULTS/RECOMMENDATIONS: None   Physical Examination:  GENERAL ASSESSMENT: active, alert, no acute distress, well hydrated, well nourished MOUTH: mucous membranes moist LUNGS: Respiratory effort normal, clear to auscultation, normal breath sounds bilaterally HEART: Regular rate and rhythm, normal S1/S2, no murmurs, normal pulses and capillary fill ABDOMEN: Normal bowel sounds, soft, nondistended, no mass, no organomegaly. NEURO: hypotonia   35 minutes were spent coordinating patient's discharge.  More than 50% of this time was counseling family on the need for close follow-up with patient's primary care physician, review of medication risks and benefits as indicated, signs of worsening illness, and reasons to return to the primary care physician or Emergency Department for reevaluation.   Patient's primary care physician's office was updated of discharge via message.
Severe leg pain and joint; lower back is absolutely hurting bad; Headache; joint pain; spasm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), HEADACHE (Headache), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), HEADACHE (Headache), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm). At the time of the report, PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm) was resolving and HEADACHE (Headache) outcome was unknown.            Relevant concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Additional information included new events.
Vaccinee rec'd "Booster shots" w/Engerix-B vax series on 16MAY90, 15JUN90 & 5SEP90 & produced inadequate titers that decreased w/progressing boosters.
Patient called 7 days later saying he began suffering over weekend with swollen eyes and now face is swelling - advised to consult MD. He insisted was caused by his flu shot, I informed him we would report it.
Myalgia, Fever, Tender/swollen lymph nodes, fatigue Narrative:  Other Relevant History:
mom states pt had temp of 105.3 & stayed  @ hosp overnoc;seen in clinic 21FEB97 for reading of TB skin test;pt alert walking about, responds appropriately to stimuli
Cellulitis at site entire upper 1/2 of upper arm. Event may be related to patients own aftercare. (OMIC).
Pt recvd 1 dose of Engerix & felt bad & arm hurt the day of inject; joint pain;
Patient is under the age of 12 and was administered comirnaty vaccine approved only for the ages of 12 and older. There are currently no adverse reactions at this time.
Woke up at 3 am, felt a little off and walked to the restroom. While sitting on toilet, with no warning completely passed out and apparently fell on my face. Woke up in a pool of blood from a nose bleed and cut on my nose. I don't know how long I was out. Was disoriented and lay down on the hallway floor and was shaking for quite some time. My partner cleaned the wounds and helped me to bed. Was in pretty bad pain from the fall - knee, nose and neck. Tried to sleep and finally did about an hour later then woke to profuse sweating and nausea. Didn't throw up, but then finally went back to sleep. Have had a 100.1 degree temperature most of today.
receiving an expired dose of Fluzone Quadrivalent; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that receiving an expired dose of Fluzone Quadrivalent (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UI996AB and expiry date: 30-Jun-2019 via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none
PT C/O DIZZINESS. PT APPEARS PALE WITH CYANOTIC LIPS. VS BP 141/40 HR 69 SpO2 98%  REPEAT  BP (R ARM) 107/72 HR 63  AFTER CLOSE MONITORING AND REHYDRATION, PTS' COLOR RETURNED TO NORMAL. SYMPTOMS RESOLVED AND PT WAS SENT HOME.
It was reported post vaccine's pt developed erythema and swelling of the R upper tricep area that was warm to touch. Follow up 5/14/02: during internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added vasodilatation).
Immediate systemic effects: dizziness, fatigue,,headache, nasal congestion, flushing. I took two Benadryl and waited 30 minutes before going home and slept . I woke up to pain in my arm at shot location symptoms continued the next day and included a sore throat. I felt ill and weak.still symptomatic on 3/26 and 3/27; sleeping as much as possible. Arm no longer painful except when touched.
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications.  The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
I almost fainted and was sweaty and felt an intense buzzing / vibration in my hands and I had a pain in the back of my throat (this throat pain was different than I?ve ever felt before from a sore throat) that lasted a few minutes
shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 63-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-SEP-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis by unspecified provider at the pharmacy. On 07-JUL-2016, the patient suffered shingles , including any and all of its sequelae as a result of her receipt of zoster vaccine live (ZOSTAVAX). As a result of the patient's receipt of the zoster vaccine live (ZOSTAVAX) vaccine, she had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result, the patient  was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and/or would require more health care and services and did incur medical, health, she would in the future be required to obtain further medical and/or hospital care, attention, and services. The patient had incurred and would continue to incur medical and related expenses. The patient suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event of shingles was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling.
I began noticing mild itching and a pink rash 3 cm or so around the injection site on my upper left arm. Hadn't noticed it in the days immediately after the injection until the itching started. As of today, there is no more itching and the rash, while still visible, is fading. I did not ask for or use anything to treat this.
For 1 day - Fever, chills For 2 days - Hives on legs, torso, and buttocks. Itching on arms, legs, torso, buttocks.
Swollen lips, Itching spread from face to neck then to entire body, Hives, coughing, sore throat about 1/2 hour after receiving vaccine.. Started with numb lips and spread from there.  Went to the pharmacy and pharmacist gave me benadryl an d told my husband to take me to ER.   Sat in ER a long time and Benadryl started working so I left.  Took Benadryl every 4 hours.  Tried to lower dose to one pill this morning and became itchy and have hives again (19 hours after vaccine).
Fever of 101.3; chills; This is a spontaneous report from a contactable consumer or other non hcp.  A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 21Feb2021 15:30 (age at the time of vaccination 68-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient took other medications in two weeks. The patient had Covid prior vaccination. The patient did not Covid tested post vaccination. There were no known allergies. On 22Feb2021 16:45, the patient experienced fever of 101.3, chills. Therapeutic measure was taken as no. The patient underwent lab tests and procedures which included body temperature was 101.3. The outcome of event was recovering.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Systemic: wife called today in the moring,,, she said he husband woke up  today with bruzing on the other arm ,,, on the inside part by the elbow ( looks like he had blood work ) put she confirmed he didnot,,, we adviced her to monitor it and seek medical attenison-Mild, Additional Details: wife called today in the moring,,, she said he husband woke up  today with bruzing on the other arm ,,, on the inside part by the elbow ( looks like he had blood work ) put she confirmed he didnot,,, we adviced her to monitor it and seek medical attenison if it didnot go away or got worse, will follow up with the patient