chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exactly 2 weeks after having the second moderna COVID vaccine, the patient developed acute chest pain and shortness of breath. She was evaluated in the ER. Negative troponins, normal EKG, negative CT angio PE. She followed up with a cardiologist. Echocardiogram was normal. She was treated for presumed pericarditis with colchicine and NSAIDS with no improvement in symptoms. She had very severe chest pain and shortness of breath at times to the point that it was difficult to breathe and do light exertion. There was a second ER visit a month later for the same symptoms negative for acute MI/ heart failure. Cardiac event monitor showed many PVCs and there is slight symptom improvement with metoprolol but she is still symptomatic to some degree 2.5 months later. She is following up with general cardiology and electophysiology. There was also a TSH elevation at the time that symptoms started. This resolved upon recheck about 6 weeks later with no change in levothyroxine dose and a thyroid ultrasound was normal.
Had started on the evening vaccine was given then a large , red welt formed at the site of injection on Sunday after vaccine. Reports site is also itchy.
patient was dizzy shortly after vaccine, then symptoms subsided after deep breathing and relaxation. Ten minutes later patient became tachycardic to 160 bpm and was brought to ED
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 19-year-old male patient of an unspecified race and ethnicity received two single doses of TRUMENBA on unspecified dates for immunisation. The patient medical history and concomitant medications were not reported. One month after each dose patient had a seizure. The patient had no prior history of seizures. Outcome was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Immediately following PNEUMOVAX 23 shot pt stated she felt dizzy. Her eyes then rolled back but remained open and she started having a seizure in the chair. I got behind her so she wouldn't fall and hit her head. I had the tech call 911 and another tech helped me move her to the ground. She seized about 1 min the became responsive and declined the ambulance.
No symptoms for 10 hours. After 10 hours I started to feel tired and some fever. I was pale. After 12 hours high fever (104F) and chills. I started shivering intermittently. With fever my muscles, joints and all areas where I had surgeries (dental implant and appendices) started to hurt  (6-7 on a scale from 1-10). Pain was not constant and lasted for about 4 hours. After 14 hours I had difficulty breathing. Eventually I went to bed but could not sleep. I hydrated with water but the taste of it was like cooking oil (strange feeling which I never experienced before). After 16 hours severe headache started to the point where it was hurting turning my head. By morning (24 hours after vaccination) the muscle and general body pain was almost gone but headaches continued for another 12 hours. Fever went down after an afternoon nap. After another night sleep I returned to a functional normal (48 hours after injection). Pain to the injection site lasted for another 5 days but was mild. It is the first injection in my life when I had side effects of this nature. I did not seek medical attention because my heart did not show any abnormal behavior during this time and that was truly my primary concern.
Approximately 5 minutes after receiving the vaccine I experienced an extreme elevated heart rate for approximately 90 seconds. Heart rate gradually returned to normal over the next 30 seconds. I was fine afterwards and drove home.  Over the next 3 days my arm was very sore, even to a light touch and I experienced fatigue.
Severe burning and sensitivity on left lower back, genitals and left leg. After 5 days got blisters and rash with pain.
Body aches, fever, chills for at least 2 days, taking alternating Ibuprofen and TYLENOL - immediate felt hot after injection.
Hospice patient received Janssen vaccine on Friday and passed away peacefully on Monday.  We don't think the death is related to the vaccine but reporting it since it happened less than a week after receiving vaccine
Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
TWO TWO DOSES IN A ROW; This spontaneous case report was received from a nurse (PVX2019-593) on 06-Mar-2019. It describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer accidentally took two doses of Vivotif in a row.  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
On April 15, exactly 3 weeks after vaccination, patient developed abdominal pain, eventually prompting an ER admission  4/20 and was subsequently found to have a portal and superior mesenteric vein thrombosis prompting admission and initiation of anticoagulation. He tolerated the anticoagulation well and was discharged on  4/23.
No additional adverse effects; an expired dose of properly stored VARIVAX which was inadvertently administered to a patient; This spontaneous report was received from a nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 27-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R009410, expiration date 29-MAR-2020 for prophylaxis (exact dose, route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported.
I did not know at the time of the 2nd shot, but I was pregnant. I miscarried on 3/12. I was approximately 11 weeks pregnant.
Severe generalized  pruritic maculopapular rash, fever (101.6) and  mucosal swelling
Lateral left breast asymmetries; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 14Jan2021 (Batch/Lot Number: EK 9231) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included valaciclovir taken for an un-specified indication, start and stop date were not reported. The patient previously took nickel and experienced Nickel topical allergy. The patient experienced lateral left breast asymmetries (anisomastia) on 19Jan2021. The patient underwent lab tests and procedures which included mammogram: lateral left breast asymmetries-cc view only. On 19Jan2021 BI-RADS Assessment Category 0 (Incomplete, Need additional imaging evaluation), mammogram: lateral left breast simple cyst & simple cyst cluster on 02Feb2021 benign-accounting for the mammographic appearance. BI-RADS Assessment Category. Patient did not received treatment for the adverse event. Patient was not pregnant at the time of vaccination. patient did not diagnose with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovered on unspecified date of 2021.
Vomiting, fever, dizziness started at 2am following vaccination at approximately 10:45am.    In the morning of 3/12/21 reported vomiting black.  Sent to ER.
This spontaneous report was received from a licensed practical nurse and refers to unspecified multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot number L038132, expiry date 01-OCT-2017 and L023589, expiry date 26-JUNE-2017, (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient walked into clinic stating he has a reddened area to the site where he had a pneumonia shot a week ago and it keeps getting bigger.  126/68 66 97.0, no pain but itchy, 18 95% on 2L. This writer noted a very large red area non raised no defined edges, 160cm across but when to measure vertical noted the rash was patchy and up into the  neck region.
I had a SHINGRIX shingles inoculation on the above date, the first in the two part series. About five days after the injection, about the time that the usual 'kick' in arm the feeling at an injection site had passed, I started to have all over aching muscles, stiffness and generally feeling unwell. I also developed a burning sensation over the surface of the right side of my stomach and an area down from the groin spreading into the inside of my right thigh. Ten days after the injection, feeling pretty generally miserable, I saw a primary care physician who investigated my response to physician physical prodding of organs located in the area of discomfort, sent me for a stomach x-ray x-ray, and an array of blood and urine tests. The results were all negative: in the office I had no fever, regular low blood pressure, no pain from physical investigation; the lab results were all within the normal range including a negative result for inflammation. But brushing across the surface of my stomach rather than prodding was uncomfortable and I began feeling rather sharp jabs in my right side and a whole central body 'jolt' - a sensation I'm afraid I can't properly describe. The following morning, the 24th 24th, I woke up to find two red blisters center and right, low on my stomach and over the following four days my lower right stomach area and a band just below my waist waist, around my right side to mid back has broken out with a blistery red rash. It's truly painful rather than simply uncomfortable, deeply felt pain as well as a shocking surface jolt whenever just carelessly grazed. Confirmed by my doctor yesterday, this is indeed shingles and I think that it would be too great a coincidence not to conclude that it's my body's reaction to the SHINGRIX injection.
A report has been received from a Health Professional concerning children of unknown age and gender. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. It was reported that nurse had removed the clip from the FLUMIST QUADRIVALENT (Intranasal) and gave some children the entire syringe of in one nostril on an unknown date. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of some children have received a full dose of FLUMIST QUADRIVALENT on one nostril was unknown. The report was considered to be non-serious by reporter.
I did not have an adverse event after receiving the vaccine. In 12/2022, I was having trouble hearing and a feeling of congestion in my right ear. I went to my primary care doctor and her referred me to an ENT. I had an initial visit in 01/2023 and started a steroid. I have had three appointments since for injections in my ear. I am waiting for a follow-up appointment. As of today, my hearing has not improved.
Red, swollen upper arm, with scab where band aid was pulled off. Tx: Benadryl, Tylenol after seen by MD.
Patient received vaccine at 8:34am. At 8:36am, patient began to experience difficulty breathing, dizziness, redness in face, and stated "felt funny". Blood pressure was obtained and patient was treated with Albuterol inhalation and Diphenhydramine 25mg IM.
Administration of Kinrix instead of Infanrix; Administration of Kinrix to a 24 month old patient; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 24-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  The Healthcare professional called to report the administration of Kinrix to a child but had intended to give Infanrix. AE filed. Provided Medical information phone number for reporter's reference and a warm transfer to Medical information. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received Kinrix vaccine instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
felt tired; weak; This is a spontaneous report from a contactable consumer or other non hcp. A contactable consumer (Patient's husband) reported for 77-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, (Batch/Lot Number: unknown, expiry date: unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:00 as DOSE 1 SINGLE for covid-19 immunization (age at vaccination:77Yearold). Medical history included coronavirus infection from Jan2021 to an unknown date. She stayed in quarantine for 14 days. There were no concomitant medications reported. On 24Jul2021 SATURDAY, the patient experienced felt tired (fatigue) and weak (asthenia). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021.The outcome of all the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Pt recvd MMR vax & exp fever up to 104-105; also exp lethargy & loss of appetite; pt described as very sick @ that time; poss measles from info parents suggested;
PFIZER COVID 19 VACCINE EUA:  ADMINISTRATOR ERROR INDIVIDUAL RECEIVED 2ND DOSE ONLY 13 DAYS FOLLOWING 1ST DOSE INSTEAD OF RECOMMENDED INTERVAL OF 21 DAYS.  NO ADVERSE EFFECTS REPORTED.  FACILITY WILL NOTIFY INDIVIDUAL THAT CDC RECOMMENDS REVACCINATE.
Child had inconsolable screaming, crying for over 9 hours. Child had rash, redness, swelling, and warmth on legs bilaterally for over 24 hours. Child had fever of 100 F for the duration of inconsolable crying/screaming. Tylenol and ice pack for legs given upon arrival home. No seizures or loss of consciousness noted. Child did have lethargy and drowsiness.
I have been developing rash throughout my body. It comes and go it has almost a month. I was prescribed twice prednisone but no luck. Biopsy sample has been taken by dermatologist.
HIVES/ WELTS ALL OVER BODY/ LIMBS; FATIGUE/ TIRED; FACIAL DROOPING/ SWELLING FROM EAR TO MOUTH; This spontaneous report received from a parent via a company representative concerned a 26 year old female. The patient's weight was 125 pounds, and height was 70 inches. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: Patient had no known allergies and no medical history otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced facial drooping/ swelling from ear to mouth. On an unspecified date, the patient experienced hives/ welts all over body/ limbs, and fatigue/ tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial drooping/ swelling from ear to mouth on 17-NOV-2021, and had not recovered from hives/ welts all over body/ limbs, and fatigue/ tired. This report was non-serious.
Information has been received from a licensed practical nurse concerning a 17 year old female with anxiety and no reported allergies who on 10-DEC-2007 was vaccinated with 0.5 ml Gardasil intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified).  On 11-DEC-2007 the patient developed swelling of the throat.  Patient said that it felt like her throat was swelling shut.  The patient's mother was instructed to administer BENADRYL to her.  The patient recovered and went to work on 11-DEC-2007.  Additional information has been requested. 04/07/2008 Information has been received from a licensed practical nurse concerning a 17 year old female with anxiety and no reported allergies who on 10-DEC-2007 was vaccinated with 0.5 ml GARDASIL intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 11-DEC-2007 the patient developed swelling of the throat and slight nausea. Patient said that it felt like her throat was swelling shut. The patient's mother was instructed to administer BENADRYL to her. It was noted that the patient also took CELEXA for the first time on 11-DEC-2007. The patient recovered and went to work on 11-DEC-2007. Additional information has been requested.
bloody stool; Severe stomach pains; fever(103 degrees); diarrhea; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 (Batch/Lot Number: EN6208) at the age of 35-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications, no other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Severe stomach pains, diarrhea, fever (103 degrees), bloody stool on 24Mar2021 06:00. Adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment included Antibiotics, pain meds and colonoscopy for adverse events of Severe stomach pains, fever and bloody stool. Covid test post vaccination (Nasal Swab) on 02Apr2021: Negative. The outcome of the events was recovering. The patient received second dose of bnt162b2 (lot number: ER8737) on 02Apr2021 at Left arm for covid-19 immunisation.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event haematochezia, abdominal pain and pyrexia and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Burning pain in chest and head, blurry vision, pressure in head left side incl ear and eye, problems to breathe, muscle pain, pain in colon and stomach, extremely tired, strong headache since I got the booster.
High dose flu given inadvertently to 3 year old.  No s/s at time of call to mother.