chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a company representative referring to a currently 68 years old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency were not reported). On an unknown date the patient developed a severe reaction and needed to be hospitalized. The patient was expected to go in and see the Doctor for a follow up in 2 weeks. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Information has been received from a consumer concerning her 12 month old daughter with otitis media since December 2004 and no known drug allergies who on 2/25/05 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included influenza virus vaccine and gantrisin. On 3/1/05 the patient experienced a seizure and was unresponsive for 20 minutes. Unspecified medical attention was sought and the patient was admitted to the hospital. An RSV test was done and the patient was also diagnosed with RSV. The patient had a CT scan, x-rays, ECG, EEG, blood work and heart monitor for 24 hours (results not reported). At the time of the report, the patient was recovering. There was no product quality complaint involved. Seizure and RSV were considered to be immediately life threatening by the patient's mother. Additional information has been requested.
Patient noted to have injection site that was hot to touch and hard. Right thigh, which patient received vaccine in, was swollen to about 3 times the size of her left thigh. Patient constantly picked at site and reported pain. Mother treated patient with Tylenol and cool compresses.
Fever of 103, development of rash on head and torso 2 days after fever.
Patient presented for routine followup.  Provider ordered shingrix vaccination.  Patient was only given the diluent portion of vaccination instead of mixing with powder prior to administration.  No adverse reactions noted.
SM received AVA x3 during first trimester of pregnancy. LMP: 28 Jan 2004. PREGNANCY OUTCOME: Infant born on 19 Oct 2004 (37 weeks gestation) by urgent C-section with multiple medical problems. Initial Apgar 3; 5 minute apgar - 6. Hospitalized in NICU as hospital for 60 days. With several readmissions during first year. Eventually diagnosed with Gaucher's disease (neuropathic form with infantile onset).
Information has been received from a medical assistant concerning a 12 month old female with no pertinent medical history or drug allergies, who on 28-JUN-2007 was vaccinated at 09:00 with her first SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 656526/0284U) in the left arm. On 28-JUN-2007 at 09:15, the patient experienced injection site raised welt and injection site redness. No medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Right arm has been hurting since day 1 of vaccination. Symptoms increased of time , I lost rang of motion, aches and pain down entire arm. I was seen by my doctor on 3/25/2021 and she give me a pack of Methylprednisoline-one 4 mg dosepk. My doctor referred me to a Clinic .
Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up.  I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist.  The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping
Grandmother brought patient into clinic 5/3/12 stating patient was itching and had fine, raised rash on face and torso after receiving vaccines 4/23/12. Grandmother states has given patient Benadryl since vaccination date and rash has not gotten better.
10/21/08 22:30 chills and mouth chattering.  White colored hands couldn't get warmed-up for 3 hours.  Frequent vomiting.  Slight wheezing noted.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAR-2016, the patient was vaccinated with an expired dose of PROAUD (Merck) (lot # K012919, expiration date: 28-FEB-2016; dose and route were not provided). No known adverse effects were reported. Additional information has been requested.
Information has been received from an attorney concerning a pt who on 6/2/98 was vaccinated with a dose of hep B virus vaccine. Other reported vaccinations included a dose of MMR II (620003/0238E). Subsequently the pt experienced death. The cause of death was death unexplained. Additional info will be provided as it becomes available.
In 8/99, the pt developed four lesions with no fever. Four days post onset the pt recovered. The pt's sister was reported to have had a similar experience following vaccination.
Night injections in both arms had heat at injection site, fever, aches and pains.  Has lasted for two weeks with arms itching and overall weakness, dizzyness and night sweats.
Patient was given 0.5 ml dose, instead of 0.25 ml booster dose.
I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm.  Immediately at the time of the administration, I noticed numbness in my left pinky & ring finger that extended to my elbow.  I figured they may have ?hit a nerve? so I called my PCP afterward.  My PCP advised me to take Ibuprofen 600mg and to call the next day with any new or worsening symptoms.  When I woke up the next day, I noticed numbness in both of my feet (with continued numbness in my left forearm).  I had a visit with my PCP where I had a normal neurological exam except for the paresthesias.  I did not sleep well the night before, so I was sent home with a medication to assist in sleeping and to observe over the holidays to see if my condition improved.  Otherwise, my PCP would order more testing.   Monday after the holidays (12/28/2020), my symptoms didn?t improve.  I noticed that I have constant numbness in bilateral hands and feet with periodic episodes where my entire left leg and then my entire right arm had tingling/numbness/crawling sensation.  I had some fasting labs done on 12/29/2020: CBC, CMP, CRP, Sed Rate, TSH, Magnesium, eGFR were all within normal limits.  My B12 was slightly low at 210 (normal levels are listed as 211-911).  I received a B12 injection that same day and started OTC B12 supplements.  I am currently waiting on the referral to go through an EMG.    Since receiving my B12 injection, I noticed a few more episodes over the New Year holiday break. From 12/31/20-01/02/21, I had this tingling/unpleasant sensation episode on my whole right side. My entire arm and leg were being affected; the episode was constant throughout most of the day with a few moments of relief with hot showers/heating blanket. No weakness noted.  I currently have a message out to my PCP to update.
Redness, induration 2 x 2.5 inches. No fever, pain, itching or limitation in range of motion of left arm.
Several months after my 4th vaccine I experienced Cardiomyopathy. Increased calcium score. I went from basically with no problems at all with problems. The dramatic Aorta increased to 16 per tile. It was very low score now is off the chart. The diameter of my aorta increased. I went to the Cardiologist who did CT scan which revealed this information. I took several statin to help me with this issue.
Left deltoid soreness began within a couple of hours  of injection.  By 6:00 pm fever, chills,  body aches, and headache began and persisted through the night.  Temperature elevated to 102° for approximately 12 hours.  Resting heartrate during the night elevated to 99 - 103 bpm (typically 57 -61 bpm).  Treatment was acetaminophen and fluids.  Symptoms began subsiding 24 hours post-injection.  Fatigue and light headedness persisted for  36 hours.
7:30PM flu like symptoms with severe shaking and fever ranging from 102 to 104  the first night. At approximately the same time for the next two nights fever ranging from 101 to 103 and flu like symptoms . These symptoms lasted 3 days during the evening hours only.
This spontaneous case was initially received on 06-Oct-2015. The case report was received from a Non Health Professional and concerns a 31 years old female patient. Weight: not provided, Height: not provided. At the time of the event the patient concomitantly suffered from Some degree of cold-like symptoms and Sore throat. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA via Pharma Jet injector on 05-Oct-2015, Batch no: not provided, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, after starting treatment with AFLURIA the patient experienced Symptoms began to worsen (some degree of cold-like symptoms), Symptoms began to worsen (sore throat). Action taken: Discontinued. For relevant test results see appropriate report section.
Severe, debilitating chills with teeth chattering and overall body shaking, fever, body aches, headache and loss of appetite.
18 months old patient was administered adacel instead of Daptacel, no AE; patient was administered ADACEL instead of Daptacel, no AE; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 months old female patient who was administered with 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: Lot: U6511AA expiration date: 22-Oct-2021) instead of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via intramuscular route in the right thigh as prophylactic vaccination on 03-Sep-2020 (wrong product administered and product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination and Avacta.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event symptoms reported at the time of reporting.  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.
Gave dose of Pfizer after patient had already received Johnson & Johnson COVID-19 vaccine on 3/31/2021. No adverse events during 15 minute monitoring, no treatment necessary.
localized hives and swelling of bilateral lower extremities occurring 5 minutes after vaccination.  Benadryl given at 5 minutes.  However rash resolved completely after 15 minutes. No systemic anaphylactic symptoms.
I woke up at 11:30 at night and had fever, chills, dry mouth, and a sore throat with headache. I was only sick for about 8 hours, I called the Dr in the morning and she ordered Paxlovid for 5 days and I took another test on Sunday and was negative.
headache for 16 hours Chills for 3 hours neck and back pain for 3 hours nausea for 8 hours
Body aches, fever, headache, abdominal cramping, nausea. Around 10am I started not feeling well. At about 1:50pm bought a thermometer temperature 100.3, pain was escalating to a 10. Got home around 2:30pm. Took 1 tb 800mg ibuprofen because in severe pain. By 4pm. Tempeture went to 101.8 then took 2 tbs acetaminophen 500mg. Pain subsided an hour after the last dose. Within 2 hrs pain again. All cramping. Muscle and joint pain, headache, jaw, ear pain. Lower back. Pretty much everything. Loss of appetite. In the am on Wednesday 2/10/2016 reported to facility and nurse line stated she didnt think it was the vaccinne but if pain is severe to go to urgent care. I told her I can't lack of transportation. I ride a bicycle or bus and my body ached too much I need to call someone for transportation. I've been laying in bed since 2:30pm the day before.
Systemic: tight throat was given 50 mg of benadryl and water and recovered with an hr; symptoms lasted 1 day
Monovalent Covid-19 (Pfizer and Moderna) boosters were administered to 24 patients after FDA removed their authorization; these errors occured from 9/1/22 to 9/7/2022. No more monovalent booster vaccines administeredafter we received the Bivalent Boosters on 9/8/2022. No adverse event noted. RN.
Fever 102.1, nauseas and vomiting. High hood pressure, strong headache, shaking chills,  breathing difficulties. Weakness at least 2 whole days.
pt recvd vax 16AUG93 & 19AUG93 urine HCG test was neg; 8SEP93 home pregnancy test was pos & MD reported that LMP 28JUL93; pt had 5 prior pregnancies, 2 of which carried full term & 3 aborted;
pink like circular area,not on the site of the vaccination but a little bit on the right side of the site of vaccination . Looks like a circular rash. She was using cold pad.After consulting she start taking benadryl and put on hydrocortisone 1%. She felt better the next day .She said she will continue with the same treatment because she is improving. she doesnot want to go to doctor office or hospital because she is afraid of covid. She hopes feel better because she is getting better with the treatmento of benadryl 2mg every 6 hours and hydrocortisone 1% cream 4 times a day.
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and receiving hospice care for end life care in the months leading up to his passing on 3/9/21. In addition to his advanced age, the patient had chronic afib on anticoagulation, hypothyroidism, HTN, HLD, COPD, depression, and increasing cognitive and memory issues towards the end of his life.
Injection site pain; Headache; Joint pain (primarily knees and ankles); Fever; Nausea; Unusual itchiness on head; Swollen lymph nodes in armpits; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN) and LO LOESTRIN FE, all for unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021, the patient experienced injection site pain, headache, joint pain (primarily knees and ankles), fever, nausea, unusual itchiness on head and swollen lymph nodes in armpits. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and result was unknown. The outcome of vaccination site pain, headache, joint pain, fever, nausea, itchy and axillary lymphadenopathy was recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Approximately 13 hours after shot, got chills, fever above 100 deg F, body aches. Symptoms didn't respond to Tylenol taken at the time. Symptoms started to abate about 12 hours later and then responded to ibuprofen. Within 48 hours symptoms mostly gone.  When measuring temperature with non-content temporal scanner, temples measured 2-3 deg F higher than forehead.
This is a 76y.o. male significant past medical history of HTN, MI, dyslipidemia, and ESRD on hemodialysis that presented to the hospital with chief complaint of fall. He states he fell out of his recliner chair yesterday and landed on his left side. He admits to striking his head but denies any LOC. He reports he did miss hemodialysis on Monday secondary to episodic diarrhea. He is seen today resting in no acute distress. Endorsing overall he is feeling well. Denies any fever, chills, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, or changes in motor strength.    In the ED, patient hypertensive, afebrile, stable SPO2 on room air. CT head, C Spine and radiographs negative for acute process. CXR concerning for pneumonia. He was started on antibiotic therapy and admitted to observation for further evaluation and management with nephrology consultation.     ROS:   Constitutional:  Deniesfatigue, fever or chills.  Eyes:  Denies change in visual acuity, diplopia or pain. HENT:  Denies nasal congestion, sore throat or tinnitus. Respiratory:  Denies cough,difficulty in breathing or shortness of breath.  Cardiovascular:  Denies chest pain, palpitations or edema.  GI:  Denies abdominal pain, nausea, vomiting, constipation or diarrhea.  GU:  Denies dysuria, urinary frequency or hematuria. Musculoskeletal:  Denies back pain, atrophy, spasticity or joint pain.  Hematologic:  Denies anemia, bleeding or bruising. Integument:  Denies rash, lesions, or history of cancer. Neurologic:  Denies headache, focal weakness, seizure or stroke. Endocrine:  Denies temperature intolerance,polyuria or polydipsia.   Lymphatic:  Denies tender, abnormal, swollen glands  Psychiatric:  Denies irritability, depression or anxiety.
Itchy; Pain; Red blotch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotch at injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Red blotch at injection site) was resolving.            No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received TCR document  Patient declined further follow up and state that she is fine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Noticed right leg was red and warm. On 11/26/00, had some diarrhea and emesis. Leg continues to be red with a scab. To ER on 12/2/00 in PM. "The doctors weren't sure what it was", possible infection or allergic reaction.
I lost all feeling on my right side. I lost feeling in my neck, arm, leg, and foot. I also lost feeling in my tongue. The hospital treated me for stroke symptoms. I was given a cat scan. I was given an ultrasound of my heart.  They checked my thyroid levels.   I also had issues with my heart racing. My nurses kept running into my hospital room to check on me. They said my heart was racing like I was running around the room. But I was just laying there or slowly walking to the bathroom. These symptoms lasted for 3 days.
COVID-19 symptoms started 07/08/2022; tested positive on 07/15/22. It started with a sore throat for 4 days and at that time I did a rapid test and it was negative and I also did PCR and that was negative. Then, the sore throat stopped and became sinusitis, like burning in my nose and some congestion and cough, and I did another rapid test and it was negative. After about5-6 days I ran fever and had aches and felt fluish and did another test and it was positive and I was sick in bed 23-3 days. I called Doctor and she prescribed 5 day course of Paxlovid and I was feeling better after a couple of days of taking that and now I am completely recovered. The week before I got COVID-19 I had an outbreak of herpes and took Valtrex for 5 days. Unsure if this could be of any significance.
Chest cramping and pain; Chest cramping and pain/cramping between shoulder blades; pain in left arm and left clavicle; pain in left arm and left clavicle; shortness of breath; burning and aching under skin; burning and aching under skin; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 39-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. The patient previously received the first dose of BNT162B2 (lot number EW6207) on 13Mar2021 at 15:15 (at the age of 39-years-old) for COVID-19 immunisation. The patient experienced chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin on 16Apr2021. The events required an emergency room visit and physician office visit. No treatment was received for the events. The clinical outcomes of chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.