chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd MMR vax 24JUL90; On 01AUG90 pt devel maculopapular rash, temp greater than or equal to 102, lymphadenopathy, & myalgia; pt recovered; On 01OCT90 lab eval revealed pt had acquired immunity for rubella;
Started having bottom gums bleed about a week after the shot. Also developed mouth sores. As of now the mouth sores are gone, but my gums are still bleeding. Mostly bleed when I brush, but sometimes they bleed with out really doing anything to agitate them.
The patient is a 85 y.o. male patient of doctor with history of hypertension, hyperlipidemia, colon cancer with subtotal colectomy with ileorectal anastomosis in 4/2000, skin cancer, diffuse large B-cell lymphoma stage IV,  DJD, right subclavian thrombosis, follicular lymphoma involving the T10 vertebral body and abdominal lymph nodes s/p T10 kyphoplasty, chemotherapy, and radiotherapy, and recent admission for SBO s/p exploratory laparotomy with partial small bowel resection and release of internal hernia on 9/18/2022 who presents to the ED with a chief complaint of SOB and weakness.  He also reported productive cough, chills, and low-grade fever.  Work-up in the ED was significant for bilateral lower lobe atelectasis versus infiltrate.    Acute hypoxemic respiratory failure Hospital-acquired pneumonia Covid-19 Virus Infection/pneumonia Date of onset of symptoms: 10/3/2022 Symptoms present on admission: SOB, fatigue Date of covid positive test: 10/4/2022 Vaccination status: vaccinated Imaging: CTPA bilateral basilar infiltrates Oxygen requirements on admission: none done 2 L Current oxygen requirements: Room air Medical therapy: remdesivir and steroids and IV antibiotics Consultants following: ID Anticipated special isolation end date: 10/12/2022 Incentive spirometry Follow inflammatory markers Daily CBC CMP magnesium. Sputum and blood culture unremarkable, reviewed daily Strep pneumonia urine Legionella unremarkable   Recent history of small bowel obstruction status postsurgical intervention 9/18/22. Currently tolerating diet   Acute UTI Microscopic hematuria Broad-spectrum IV antibiotics then p.o. antibiotics and discharge Urine culture unremarkable Follow-up UA as an outpatient   Normocytic anemia Likely anemia of chronic disease. No evidence of blood loss at this time.   Outpatient evaluation and management.   Continue to monitor while inpatient.
Moderna COVID-19 Vaccine EUA fatigue, headache, muscle pain, joint pain, chills, fever, difficulty breathing, fast heartbeat, weakness
SHE HAS A WOLLEN LEFT FOOT FOR 3 DAYS WITH VERY PAIN. SHE CALLED THIS MORNING AND AFTERNOON. SAYING SHE CAN NOT WALK ON LEFT FOOT. SHE MISSED WORKING, SELFOWNED BUSINESS. I SUGGEST HER TO GO TO NEAREST URGENT CARE OR EMERGENCY ROOM.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose expired applied) 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 medications were reported. Caller was a Pharmacist who stated that they administered the booster dose of the Moderna COVID19 vaccine from a vial that was less than 24 hours expired.
EMS called due to severe dyspnea; O2 sats 68% on RA; O2 sats 78% on NRB; diagnosed with COVID pneumonia; eventually used BiPAP; pt's condition worsened and he was placed in hospice; pt passed away the same day he was admitted to hospice
No adverse effect from dose 1.   Dose 2 adverse affects:  - Monday - By 11PM - Fever - 101.2, Headache - Wed - Severe abdominal pain.  Put on antibiotics and pain meds
massive heart attack; Death; rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (massive heart attack), DEATH (Death) and RHEUMATOID ARTHRITIS (rheumatoid arthritis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (massive heart attack) (seriousness criteria death and medically significant), DEATH (Death) (seriousness criteria death and medically significant) and RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criteria death and medically significant). The reported cause of death was massive heart attack. It is unknown if an autopsy was performed.            No laboratory was not given. No treatment information was provided by reporter. According to, "The caller stated that she does not know if her brother´s friend received a Moderna, Pfizer or J&J vaccine."  This a report of dead one day after the second dose of the product in a 55-year-old patient with concomitant Rheumatoid arthritis. Very limited information regarding the event has been provided for inferring causality. Further information has been request.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow Up information was received 08-JUL-2021 and added concomitant product and event verbatim; Sender's Comments: This a report of dead one day after the second dose of the product in a 55-year-old patient with concomitant Rheumatoid arthritis. Very limited information regarding the event has been provided for inferring causality. Further information has been request.; Reported Cause(s) of Death: massive heart attack
Narrative: Patient reported lightheadedness following second dose of pfizer covid vaccine. Patient's vitals were taken and were within normal limits. Patient was able to be released with no additional intervention.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Immediately after administration of vaccine as we were discussing scheduling an appointment for his second dose in 28 days, patient's fainted. He was sitting in a chair and slumped over. I caught him and was able to get him to floor in lying position while having my technician call emergency number. Patient came to in a couple of minutes and seemed a little disoriented. We got him a bottle of water and a cold rag for his face. He was clammy and sweating. When EMT arrived, they checked him out and cleared him to leave on his own.
10/06/2020 Patient called office and reported fever and chills.  10/26/2020 Patient called with complaints of Shoulder Pain. 10/30/2020 Patient saw Dr. with Orthopedic Institute. He stated her arm pain is an adverse reaction to influenza vaccine. MRI ordered. 11/12/2020 Dr. with Orthopedic Institute called and spoke with primary Dr. MRI is within normal findings.
Severe muscle pain, spasms in my muscles. Chills, weakness. Extreme fatigue not able to do my daily functions.
pt recvd vax 14JAN93 & p/getting home 1 1/2 hrs p/vax t101; treated w/APAP; pt irritable & feverish for days 101-103 until 19JAN93 temp 104; took to Er; MD stated ears mildly infected;
Moderna Covid 19 Vaccine EUA Fever 101.1   with chills Body Aches Headache Nausea
Myalgia, c/o flank pain,chills,sweats,injection site sore and swollen. Told to visit primary care physician if promblems persist.  Narrative:
This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 83-year-old female patient who received SHINGRIX for prophylaxis.  On 10th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 7 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant), systemic sclerosis sine scleroderma (serious criteria GSK medically significant), sjogren's syndrome (serious criteria GSK medically significant), pain in hand, swelling, stiffness, tingling and movement disorder. On 23rd December 2018, the patient experienced inflammatory marker increased and c-reactive protein increased. In January 2019, the patient experienced antinuclear antibody positive. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, swelling, stiffness, tingling, inflammatory marker increased and c-reactive protein increased were unknown and the outcome of the pain in hand was not recovered/not resolved and the outcome of the movement disorder was recovering/resolving. It was unknown if the reporter considered the autoimmune disorder, systemic sclerosis sine scleroderma, sjogren's syndrome, antinuclear antibody positive, pain in hand, swelling, stiffness, tingling, movement disorder, inflammatory marker increased and c-reactive protein increased to be related to SHINGRIX. Additional details were provided as follows: A week later after receiving SHINGRIX, the patient woke up with swollen, painful hands, difficult to make a fist and her fingers tingling and stiff. The patient had seen her physician at the office and was also seen at an urgent care on 23rd December 2018 for these issues. At the first visit, blood tests were drawn that showed antinuclear antibody (ANA) negative, elevated inflammatory markers at 56 with a normal at 40 and C-reactive protein of 14.9 and normal at 4.9. Two weeks later, the patient had blood test which showed antinuclear antibody (ANA) positive. The patient had paperwork which showed autoimmune disorder, systemic sclerosis sine scleroderma and Sjogren's syndrome. The patient received Prednisone as a treatment for the pain. The patient was taking physical therapy for her hands. The patient had been referred to a Rheumatologist and that appointment was on 13th March 2019. The blood test for rheumatoid arthritis came back negative. The reporter consented for follow up. Lab Comments: On an unknown date, the patient performed blood test for rheumatoid arthritis.
Syringe needle retracted seemingly faster than usual (Vanishpoint syringe) and significant amount of the vaccine leaked from either hub or needle (estimated at more than half the volume leaked by RN).  Pt was counseled on CDC recommendations and was given a full redose of vaccine since more than half of the initial dose leaked.
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe
3hr p/vax pt devel an inj site rxn characterized by redness, warmth, & swelling which extended below the elbow;pt was treated w/DPH & ice & was recovered @ the date of this report;
Severe pain throughout the entire body, especially in the brain the first night. Both thighs also became very hot. Extreme nausea and weakness the second day, limited range of motion in left arm the second day. Again, THC gummies were taken preemtively, yet measured stress level was as high as 94% on Welltory and measured heart rate was as high as 108 bpm due to the extreme pain.
Patient said he developed a deep chest cough, throat seemed a lttle tight, glands seemed puffy and tight and his eyes became very reddened and mattery.  Everything was fine the next morning.  Wondered if it could have beena recation to flu shot.  This was his first flu shot.  No other allergies.
Post vax, the pt developed nonfebrile seizure for 2-3 minutes. Evaluated at ER and released.
Patient brought into Covid Observation area after becoming light-headed immediately after receiving 2nd dose Pfizer vaccine. Patient was assisted to floor by her dad and staff, with legs elevated on chair. Per staff, patient did not hit her head or loose consciousness. Remained alert and oriented x 3, speaking in complete sentences. Denied any difficulty breathing or throat tightness. No swelling noted to face lips or tongue. No rash or hives noted. Patient assisted up to wheelchair and to then to gurney. Placed in trendelenburg position.  Reports feeling better lying down. Per dad, patient did not experience any of the above symptoms with 1st dose Pfizer. Patient states she had an egg sandwich and iced coffee this morning and bag of veggie chips this afternoon. States she has not had any water to drink today.  3:33 pm- VS: BP 134/64, HR 65, RR 18, 02 SATs 100% RA  3:41 pm- VS-BP 112/50, HR 63, RR 18, 02 SATs 100% RA- Patient reports feeling better. Provided bottle of water to drink. Will continue to monitor  3:48 pm- Call placed to on call ED physician, informed of patient symptoms above. Per Dr, continue to monitor patient for additional 30 minutes and if vital signs remain stable, ok to be discharged home and no need to be evaluated in Emergency Department.  3:54 pm- VS:BP 123/74, HR 68, RR 18, 02 SATs 100% RA. States she still feels a little shaky, but not as much as initially.   4:09 pm-VS: BP 123/76, HR 73, RR 20, 02 SATs 100% RA. Reports feeling better and less shaky.   4:27 pm-VS: BP 125/74, HR 64, RR 20, 02 SATs 100% RA.  Assisted patient to sitting position and standing. Denies dizziness with position changes. States shakiness resolved and she feels back to normal.   4:31pm- Discharged home in stable condition, accompanied by dad. Informed dad to seek emergent care for any returning or worsening symptoms. Also advised ok to give OTC Tylenol or Ibuprofen as directed for sore arm or body aches. Dad verbalized understanding.
left leg I have like almost tingling; left leg I have like almost tingling and (numbness) things; This is a spontaneous report from a contactable consumer (Patient). An unspecified age and gender patient received bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 29Jul2021 into left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date Jul2021, the patient experienced left leg have like almost tingling and (numbness) things.The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Bruising and firm nodule noticed at previous injection site. No redness, not warm to touch, pt complained of soreness.
This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-IPV/HepB; GlaxoSmithKline; unknown; unknown given on 14 January 2014; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014. On 14 January 2014 at 09:36 the subject received 1st dose of ROTARIX (1 ml, oral). On 19 January 2014, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The vaccination course with ROTARIX was discontinued. The physician considered the event was probably related to vaccination with ROTARIX.
Patient was administered vaccine and stated she was nervous but no other concerns regarding the vaccine. Patient's timer was set and patient was instructed to sit out in the chairs in front of the pharmacy to be monitored. At approximately 11:10 AM, patient approached the counter. I (pharmacist) asked the patient if she was having any problems. She nodded her head yes. I then took her into the office and asked her what was going on. She stated she felt like her chest was tightening and she couldn't breathe. She also stated that she felt like she couldn't swallow. Patient's mother who was with her administered the patient's self-prescribed epipen. Patient sat in chair while one of my technicians contacted 911 to have the ambulance sent to the store. Patient remained in chair and was itching her right arm as well as stating she felt like she couldn't swallow. Ambulance arrived and took the patient to the emergency room for further evaluation.
Patient administered age appropriate vaccine and after receiving vaccines had felt weak, dizzy and clammy. Client's head brought down to knees. Client fanned and cold compress applied to neck and facial areas. Client offered crackers and juice. Verbalized feeling better after treatment.
Muscle and back pain. Blood pressure substantially increased. Sinus cold infection. Severe and unbearable left arm pain - the pain does not go away. The left arm pain goes down from my shoulder to my elbow. Treatment: I've been on blood pressure medication, and I've been seeing a chiropractor.
Woke up with chills, headache, weak, felt like fainting, arm pain. Called off work. Fever of 100.4.
Came down with cold and fever and heightened congestion.  Am having trouble breathing.  Spent all day in bed 4/22/2015.  Was better 4/23/2015 and 4/24/2015 in the AM but developed fever in the afternoon again.  Saturday morning woke up at 3:00am drenched in cold sweat.  Had to get out of bed as it is all wet.  Am now trying to see if illness is due to pneumonia shot.
Patient with sensation of generalized body warmth within 15 minutes after receiving first dose of Moderna COVID-19 vaccine No rash noted on exam No associated symptoms including but not limited to itching, chest pain, shortness of breath, difficulty swallowing, or any focal neurologic deficits   We will monitor patient for 1 hour  Patient states that his symptoms continue to improve and that he is feeling well Vital signs have remained stable throughout patient's ED course including oxygen saturation of 100% on room air Patient remains afebrile and nontoxic in appearance   At the time of discharge the patient remained in stable condition.  The patient was counseled to return the emergency department immediately with worsening symptoms.  The patient voiced understanding and agreement with treatment plan.  He is also aware that he may return to the emergency department at anytime for any reason for reevaluation, and should return with worsening or persistent symptoms.
vomiting; fever; chills; pain at injection site; nausea; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (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: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization.  The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I tested positive for COVID-19 on 11/22/2021. I was working and I start feeling really bad, I had flu like symptoms, nausea, fever, fatigue and chills. It lasted about 48hrs. I symptoms to me was severe. The kicker was that when I started feeling better, I lost me full since of smell, I kept my taste. It lasted about two and a half weeks.  My wife tested positive and we was instructed to stay in house for about two weeks. I didn't go to the doctor but I did do a telehealth visit with the pharmacy.
This spontaneous report as received from a 26 year old female pharmacist refers to herself. The patient had none pertinent medical history. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot # not reported) at the age of 26 years. Concomitant therapies included contraceptives and vitamins. Soon after vaccination, on 12-FEB-2013, the injection site became red, itchy, warm and raised. The patient reported that she developed a slight injection reaction to all vaccines including unspecified flu vaccine (manufacturer unknown) (related ID: 1302USA011802). The patient did not seek medical attention. No treatment was given. The outcome of injection site became red, itchy, warm and raised was reported as not recovered/not resolved. Additional information has been requested.
pt recv vax 8DEC97 & 2FEB98 pt lab results revealed a negative antibody titer;
PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT  KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.