chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This registered nurse reports that this 17 year old female patient received Live Attenuated Influenza Vaccine (LAIV), 0.2mL, via inhalation, on 30Oct2009 for the influenza. The patient's relevant concomitant medication includes human papillomavirus vaccine (HPV) on 30Oct2009.  On 30Oct2009, this nurse reports that an automated vaccine tracking application recommended the Trivalent Influenza Vaccine (TIV) but due to the patient's age she was eligible for LAIV. The registered nurse asked the patient the screening questions for both, LAIV and TIV, from memory, not looking at the "encounter". After administering the HPV and LAIV, the patient stayed in the room for about 10 minutes since she had received the HPV vaccine and this can sometimes cause the patients to feel dizzy or sick. When she was getting up to leave, the registered nursed asked the patient if she felt dizzy and she said, "I get seizures." The nurse did not ask this screening question prior to administering the LAIC vaccine. The outcome of the event is unknown.
Janssen/J&J COVID-19 Vaccine  Admission Date: 4/15/2021                 Primary Discharge Diagnosis/Active Problems:  Pulmonary emboli  Cardiac Procedures Performed: echocardiogram 4/15/2021 Echocardiogram o Ejection fraction is 60-65%. o Abnormal left ventricular diastolic function. o There is a transcatheter aortic valve present. Trivial paravalvular regurgitation and mean gradient 14 mmHg. o Moderate pulmonary hypertension present. o Normal right venticular size and systolic function. o The ascending aorta is mildly dilated. Reason for admission: Present on Admission: o Pulmonary emboli  .Hospital Course: 84-year-old male past medical history of CAD status post CABG, hypertension, obesity, COPD and hyperlipidemia.  TTE back in fall 2020 had noted severe aortic stenosis with a normal ejection fraction.  Heart catheterization and 9/10/2020 showed severe native vessel CAD.  Occluded saphenous vein graft to the circumflex, occluded saphenous vein graft to the RPDA.  Distal RCA fills retrograde collaterals from the distal circumflex.  LAD 100% occluded in the midportion and 90% stenosis proximal to a small diagonal.  Patent LIMA to LAD.  He underwent a TAVR procedure on 9/22/2020 with a 26 mm sapien valve.  He was most recently seen in 10/2020 for a follow-up visit.  At that time he was doing well.  TTE from 10/20/2020 with an EF of 60%, abnormal LV diastolicDysfunction, mildly dilated ascending aorta and mild MR.  There is mild perivalvular regurgitation with a mean gradient of 15 mmHg. He presented to his local emergency department on 4/15/2021 with a complaint of shortness of breath, worse with exertion.  His symptoms were present for 1 week.  He had the Johnson & Johnson COVID-19 vaccination on 3/17/2021.  Rapid Covid test was negative.  High-sensitivity troponin was elevated at 276.  CT of the chest showed bilateral pulmonary emboli most pronounced on the right.  EKG showed sinus rhythm with right bundle branch block and ST depression was noted.  He was transferred to Hospital for further evaluation.  Echo on 4/15/2021 showed EF of 60 to 65% with abnormal LV diastolic function and moderate pulmonary hypertension.  He was transition to warfarin, he is unable to take NOAC due to Dilantin history.  INR was slowly increased to 3 mg.  He was discharged with Lovenox bridge with plans to have INR checked on Wednesday or Thursday at the Hospital and he will follow-up with his PCP for management.  He was discharged on warfarin and Plavix, aspirin was held to avoid triple therapy.  Resume aspirin once therapy completed for PE/DVT protocol. Patient discharge goals: Patient Transition Goal: Return home/prior residence to highest level of function by anticipated discharge date
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, strength, dose, lot#, expiration date and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms consistent with Giullian Barre. As of Today 09/05/2021 symptoms persist.
On 9/15/99, the pt's lab evaluation revealed antibody titer of 1.07.  Re-testing at a later time was recommended. On 12/3/99, the pt was re-tested and the level of IgG antibody was negative. On 12/10/99, she was vaccinated with the 3rd dose of the vaccine. At the time of reporting the pt had not seroconverted. No further information is available.
I am a healthcare provider, received first dose of Vaccine, had slight tachycardia about 5 minutes after receiving. Tachycardia resolved after about 5 minutes, chills lasted about 5 minutes. Most concerning when driving home about 20 minutes after vaccination right side of my face began tingling and numbness. This numbness and tingling lasted throughout the night until sleeping. There was no facial paralysis. When I woke up  symptoms had resolved. Throughout the next 48 hours would have intermittent tingling on right side of face only for a period of a couple minutes. After 48 hours no symptoms.
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
77 y.o. male with past medical history of lymphoma, atrial fibrillation, chronic anticoagulation, hypertension, who presents to the Emergency Department with chief complaint of as mentioned above.   Patient was exposed to his friend who was tested positive for Covid.  He has been sick for the last 4 days with cough, sore throat and shortness of breath.  The patient presented to ER yesterday and had a negative chest x-ray.  He was not hypoxic.  The viral panel was positive for COVID-19.  The patient was given Regeneron monoclonal antibody and was discharged home.   The patient symptom is getting worse with more shortness of breath, productive cough with white color sputum; therefore, he came back to ER.  He has no chest pain, vomiting, diarrhea, leg edema, calf tenderness.  Onset of his condition was gradual with moderate symptoms.  There is no aggravating factors.  Oxygen helps   In the ER today, patient was hypoxic with O2 sat of 88%.  He requires a couple liters of oxygen.  The patient this point is being admitted for COVID-19 infection, hypoxic respiratory failure, failure of outpatient treatment
At 10 p.m. on 3/20/21, I began feeling arm pain and the following day had flu symptoms - nausea, headache, dizzy, body aches, chills, slight fever of 100, joint pain. Then, when I woke up on Monday morning I had a slightly swollen upper lip on the left side. The nurse suggested that I report it. Thank you
Fever; Feel Sick; Arm hurts a lot; This case was reported by a consumer and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever, feeling unwell and pain in arm. On an unknown date, the outcome of the fever, feeling unwell and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, feeling unwell and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and had fever, feel sick and her arm hurts a lot. The patient asked when would I feel better and would I be allowed to get the 2nd dose.
Left arm became reddened, swollen at site and warm. noticed lump under left clavicle. Later diagnosed by PMD as a swollen lymph node. Area under clavicle remains very sore.
Pt has Wagner's disease and after receiving FLUZONE Quad flu shot had joint pain throughout body especially in left arm that received injection.
Patient returned to pharmacy and and had a swollen, warm to touch, tender large bruise from shoulder down to elbow. Patient took an aspirin to help with pain. Offered to call primary doctor for treatment (steroid tabs) patient declined and would rather wait. No respiratory/ systemic symptoms reported
Daily intense vivid dreams; This is a spontaneous report from a contactable consumer, the patient. An male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on unspecified date in 2021 as a single dose for COVID-19 immunisation. Medical history included allergies to some artificial sweeteners. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date in 2021, pretty much after the first shot, the patient experienced daily intense vivid dreams. Usually 2 plus a night, for every night. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event daily intense vivid dreams was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Notified by hospital of admission due to ITP - possibly related to flu vaccine.  12/22/2008 MR received for DOS 11/6-16/2008 with D/C DX:  ITP-platelet count now 54K.  Anemia, probable acute blood loss anemia-hematocrit stable at 31.  Admitted with heavy menstual bleeding and mucosal/skin bleeding and petechiae-rsolved (2' to #1).  HTN-probably 2' to steroids-stable on Norvasc.  Mild hyperglycemia 2' to steroids. Anxiety d/o. Pt presented  with heavy menstual bleeding, bleeding spots on shins and thighs and oral mucosal bleeding.  Platelet ct on admission = 7K. Admitted for thrombocytopenia and started on steroids. Required several platelet transfusions. Platelets took 9-10 days to increase to 54K. D/C for outpt f/u.
a great inflammation under her right armpit were she got her vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (a great inflammation under her right armpit were she got her vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced VACCINATION SITE INFLAMMATION (a great inflammation under her right armpit were she got her vaccination). At the time of the report, VACCINATION SITE INFLAMMATION (a great inflammation under her right armpit were she got her vaccination) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided
5 days post vaccine developed malaise and swelling of parotid and sub mandibular salivary glands. Sx's decreasing now 10 days post vaccine.
Two weeks after my second dose of Pfizer covid vaccine, I got a horrible case of Shingles.
SORE ARM; LITTLE TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number were not reported) for prophylactic vaccination on an unspecified date and had no adverse events.   The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number were not reported) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination as a booster dose. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On 21-NOV-2021, the patient experienced sore arm and little tired. (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the little tired and sore arm was not reported.  This report was non-serious.
Initial report received from the health care professional on 30 Jul 2010: On 29 Jul 2010, this patient inadvertently received a intramuscular dose of the MenA lyophilized component of MENVEO (box lot No. 100005) that was diluted with sterile diluent instead of Men CWY 135 liquid conjugate component. No adverse reaction had occurred following this administration.
Information has been received from a certified medical assistant concerning a 9 year old female patient who on 16-Jun-2001 was vaccinated with the first dose of VARIVAX (Merck). Today on 29-JUN-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) subcutaneous back of left thigh (lot # 664020/0503Y). There were no concomitant medications. While at the front desk the patient fainted, but she did "not have a seizure". The patient had sought medical attention in office and had recovered. Fainted was considered to be an other important medical event by the certified medical assistant. This is one of several reports received from the same source. Additional information has been requested.
Headache, then chills violent tremors, vomiting & fever. After sleeping at night, fever went down, chills too. However, very week for the next 2 days. First time ever took the Sr. Vaccine flu shot. Very terrible reaction!
Shot was given very high near shoulder, have had pain in muscle from shot site down to elbow, and have noticed a twitch in my left index finger that began approx. 1 week after shot to current.  Called my physician and was told to take ibuprofen for pain.
Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; Severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm right on 27Mar2021 08:00 as dose 1, single for COVID-19 immunization (at the age of 58-year-old). Medical history included ongoing asthma, ongoing blood pressure increased and codeine-based medications from and unknown date to unknown date. The patient was not pregnant at the time of vaccination and was healthy before vaccination. The patient did not take any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. Patient took other medications in two weeks which includes medication for asthma. On 27Mar2021 16:00, the patient experienced severe and persistent dry cough, fever, chills, body aches, arm pain at site of injection, lasting over 3 days resulting in an ability to function at workplace. Seriousness of the events was reported as non serious. The patient did not received any treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; having a lot IO symptoms; fever; has been feeling "sick"; This is a spontaneous report from a contactable consumer.  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 at single dose for COVID-19 immunisation.  The patient's husband and daughter tested positive (COVID-19).  There were no concomitant medications.  The patient stated, "had the first vaccine shot, later clarified as Pfizer COVID vaccine, on 22Dec2020, and didn't have any symptoms before that, her husband and daughter tested positive, but she was staying away from that, had no symptoms, but after taking the shot, on 24Dec2020, she was feeling sick and had a fever, and has had a fever ever since, and she is taking Tylenol and Motrin every six hours, and even then she still gets the fever, it hasn't stopped, she is having a lot IO symptoms, and is wondering if the vaccine can give the reaction, or maybe she has the virus. On 24Dec2020 is when the fever started and she was feeling sick. States she filled out a report online, on (Website)". The outcome of the events was not recovered.
A nurse who was drawing varicella virus vaccine live into a syringe inadvertently splashed herself in the eye.
Headache; fatigue; body aches; cold-like symptoms; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 12Feb2021 15:00 as single dose and was previously administered the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 19Jan2021 07:30 for covid-19 immunization. Patient was 34-years-old at the time of vaccination. Vaccination facility type was workplace clinic. Patient medical history was not reported. Concomitant medication included fish oil, alprazolam and vitamins nos (DAILY MULTIVITAMIN). On 14Feb2021 at 09:00, the patient experienced headache, fatigue, body aches and cold-like symptoms. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. No treatment was given for the event. The outcome of the events was recovering.
I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 4/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Sharp and persistent pain at the point of injection that began exactly 12 days after the injection. I had the usual 2 days of tender soreness usually associated with the injection, and experienced no symptoms of any form until 12 days later. It has been 4 weeks since the pain started, and it has not abated or changed. The pain is sharp, my arm is very stiff and weak. The pain is centered where the flu shot was administered. The range of motion of my arm is  limited, making dressing quite difficult.  The pain has resulted in the inability to get more than a few hours of sleep a night,  and that lack of sleep is impacting performance in the workplace. The pain has made me  unable to participate in the exercise I used to rely on to help maintain mental and physical health.
Swollen, edema, intense pruritus,  App 24 hours post immunization, Dev vesicles, Resolving when seen on 12/08/02, (vaccine given 12/05/02)
Reaction was a few inches below injection site and mother said initially it was the size of a 1/2 dollar but now it's about double that size. It's raised, itchy and hot to the touch. Will treat with 5ml's of ZYRTEC BID for a few days and cool compresses.
Right arm aches when he tries to bend it backwards; It was very severe at first, is getting better, but still is bothersome
After receiving three vaccines, Tdap, Varicella, and Meningococcal, the patient stood up but not immediately and started to pass out.  His father caught him and the father and I laid him flat on the floor.  After about 5 seconds he opened his eyes and said what happened. His bp was 124/72. He said his left jaw area hurt but neither the father nor I saw his face come into contact with anything. He had had no food this morning before the vaccines.  He drank a jucice box and felt better. He was initially pale but the color returned to his face.  He was released to the care of his father.
vaccines exposed to reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees C for 1-hour and 30-minutes due to a reason unknown with no reported adverse event; consumer received a dose of Tenivac after it was exposed to unsuitable temperatures with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 56 years old female patient who received a dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] after it was exposed to unsuitable temperature reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees c for 1-hour and 30-minutes due to a reason unknown with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jun-2023, the patient received 0.5 ml dose (strength: standard; frequency: once) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection of lot U7679AA and expiry: 25-Mar-2024 via intramuscular route in the right deltoid for immunization.  On an unknown date, it was reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult vaccine was exposed to reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees C for 1-hour and 30-minutes due to a reason unknown with no reported adverse event (product storage error) (unknown latency).  On 15-Jun-2023, the patient received a dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult vaccine after it was exposed to unsuitable temperatures with no reported adverse event (poor quality product administered) (latency: 1 day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.  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 the 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.