chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lightheadedness/feeling lightheaded/felt herself going backwards and caught herself; disappointed and upset; This is a spontaneous report from a contactable consumer (patient) who reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was allergic to aspirin, if she takes it her eyes will come out of her head and quite a few other things will happen to her. Patient reported that she got the COVID-19 Vaccine on 17Dec2020 and it was like 1 hour after (also reported within 1 hour) she got the vaccine that she started feeling lightheaded which she had never experienced before, even today. Patient is an environmental service worker, she had so many discharges and so many COVID rooms to wipe down that she just kept pushing herself because they are just short staffed; but at one point she felt herself going backwards and caught herself, she decided to sit down and drink a water and continued to feel lightheaded. No one was available to relieve her yesterday (17Dec2020), she had to stay at the hospital until midnight and continue her activities with lightheadedness (pending clarification). Patient said, almost a day later, lightheadedness persists, she was still feeling the lightheadedness today (18Dec2020). Her concern is it's like 3-4 days afterwards that you will feel some effects. She wanted to know if this is what they are talking about, if this is expected. Patient initially reported being a healthcare professional (HCP), but clarified her profession is Environmental Service, working at (Institution name). Patient is allergic to aspirin, she wondered if the COVID-19 vaccine contains aspirin. Patient was suggested contacting her doctor to find out if she is allergic to any of the components in the vaccine. Patient was reminded it is possible to consult the ingredients as part of the Vaccine Fact Sheet on (Website name). Patient was disappointed and upset for experiencing lightheadedness after receiving the vaccine (Dec2020). She wishes she hadn't received it. As indicated in previous requests, was referred to an HCP for guidance after experiencing lightheadedness. Outcome of lightheadedness was not recovered, outcome of disappointed and upset was unknown.   Information on the Lot/Batch number has been requested.
Extensive bilateral numerous large central pulmonary emboli including a saddle-type embolism.  Right heart strain with the reflux of contrast into the inferior vena cava (per CT angio Chest PE protocol) Started on Eliquis, has follow up ECHO today
Headache for 4 weeks, used Tylenol to alleviate pain, still have mild headaches sometimes
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of PNEUMOVAX 23 lot number: K023328, expiration date: 23-JUN-2016 (dates, doses and routes not reported), that was improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two hours and 5 minutes and of 1.7 C for 2 hours and 15 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
AFTER RECIEVING VACCINE FIRST DOES PT HAD A SEIZURE AND VOMMITED. DOES HAVE HISTORY OF SEIZURES.
Patient received first dose of Moderna COVID-19 Vaccine EUA on Jan 7, 2021.  She experienced some injection site pain the following day.  Seven days post-vaccine (1/14/21), patient noticed injection site swelling, area was very hot and mildly painful to the touch.  Patient took a Benadryl 25 mg and iced the area.  The following day the swelling resolved and only noticed a red mark that was left.  The following day, symptoms were mostly resolved.
Patient had her HPV shot on 1/14/08 at 3pm. Patient had started back on Adderall 10mg in January after taking a 6 month break. She got very light headed 1 hour after her shot and almost fell in the bathroom at home. A couple of days later, she had a temp of 104 degrees for 2 day. Tylenol was given every 4 hours with no real aid in dropping the fever.  The 2nd night of the high temp, she had a vision of a boy standing by her bed in the middle of the night. The boy was not real. The temp broke that night. In March, patient saw the vision of the boy by her bed in the middle of the night again. This continued to happen on an inconsistant bases, but by April she was seeing different visions of people during the day and night all of the time. She saw pediatrician on April 15, 2008. She was told to stopped taking the Adderall. Patient was set up with an appointment with psychiatry on April 23. Patient began Seroquel for her visions and numerous psychiatry appointments. After trying different doses, she continued on 1/2 pill per day until the end of May 2008.  The visions went away after the second day of Seroquel.  Patient also has a major fear of having any thing injected into her or taken out of her (example, immunizations and blood draws). She said the HPV shot hurt and you could feel the medicine go into your body.  She had sessions to desensitize her to have a blood draw done. The blood draw did show that her Auto-immune numbers were at 40.  We have not followed up on this yet.
Myocarditis Troponin = 12 Required hospital admission Sxs = severe, worsening chest pain beginning approximately 24hrs following booster dose
MENACTRA given from Lot #U2867AA Exp 3-5-10. Doctor notified no new orders. Local Health Dept staff notified. Follow up call made to parent at 1930 PM same night. Denied any signs or symptoms of adverse reaction
After injection pt c/o pain at injection site. She had syncope spell along with "jerking" that couldn't be controlled. Injection site became very red and pt became very upset. She stated she "didn't know what happened" when questioned. VS were stable.
Patient developed fever and redness of left upper arm. Treated with BACTRIM and KEFLEX.
Patient discharged after (3) days inpatient admission. Patient is a 73-year-old man with a past medical history significant for coronary artery disease status post PCI, paroxysmal atrial relation Eliquis, parkinsonism along with cognitive impairment who presented with weakness and mechanical fall.  He was found to be hypoxic requiring 2 L. patient tested positive for COVID-19 pneumonia.  He was started oral dexamethasone.  Given the unclear etiology of fall, echocardiogram performed which showed LVEF 38% and moderate global hypokinesis.  Cardiology is consulted recommended starting Entresto.  Patient was initially on IV Lasix and was transition to oral Lasix 20 mg at discharge.  Cardiology recommending patient following with mitral cardiologist to evaluate for possible stress testing given that etiology for cardiomyopathy was unclear.  Patient was evaluated by PT and OT recommended home with home health.  Patient was evaluated by pulmonary rehab who recommended patient be discharged on 2 L by nasal cannula supplemental oxygen at all times.  Patient is discharged home in medically stable condition.
Starting approximately 18 hours after first dose on 3.01.21: Severe migraine-like headache for 24 hours (I have experienced severe chronic migraines for the past 35 years, so I know what I'm talking about) Flu-like body aches for 48 hours Vomiting and nausea for 48 hours Sweats and chills for 36 hours, but no fever All I wanted to do for two/three days was sleep  After second dose on 3.29.21: Some body aches and general malaise, but nothing dramatic like after the first dose
Patient was an 81-year-old gentleman past medical history A. fib on Eliquis, hypertension, prostate cancer diagnosed in 2017 enrolled in clinical trial, admitted to the medical ICU at Hospital for acute hypoxic respiratory failure secondary to Covid pneumonia, transferred from Hedrick Medical Center for acute worsening of his hypoxia. Intubated on 12/2/21.  After multiple failed attempts, the patient passed his ZEEP on 12/15 and patient was extubated to NIPPV. s/p Dexamethasone 12/02-12/05, remdesivir 12/02-12/06, baricitinib 12/02-12/09 AND Tocilizumab 12/09 Hospital course complicated by bradycardia and concern for possible AV block vs junctional rhythm. Cardiology felt that the patient did not have a complete heart block.   Discussion had with patient on 12/16 with wife at bedside about respiratory status and if need for reintubation occurred what his choice would be.  Patient was wearing BiPAP and shaking his head to answer questions.  Was following commands appropriately.  Patient asked directly if his respiratory status would worsen and he was about to die would he want a tube down his throat again and placed on the ventilator, patient shook his head no multiple times.  Wife was present during this encounter and was in agreement to honor patient's wishes.  Patient's CODE STATUS is DNR/DNI.  since extubation  12/15 patient failed multiple attempts to wean O2 requirement to HFNC and required to be put back on BiPAP due to worsening resp status.s/p lasix with adequate urine output.  Chest x-ray noted worsening bilateral opacities consistent with COVID-19 on 12/18.   Family discussion 12/19: Goals of care discussion had at bedside with patient's wife, daughter, and daughter (via phone).  Discussed worsening respiratory status, increased work of breathing, and patient comfort.  Patient expressed his wishes the other day to be DNR/DNI; Family expressed understanding that patient is worsening and they would want to transition to comfort. All family questions were answered.   Family was able to gather at bedside on 12/20/2021 and patient was transitioned to comfort care and taken off respiratory support. The patient passed away at 17:45 with family at bedside. Pronounced by MD.
Patient admitted to hospital on 6/9/22 for increased fatigue, nausea, epigastric pain and increased liver function test.  Symptoms developed after fourth dose of Covid 19 vaccination..  Patient was also taking tylenol 650mg three times daily and has been advised to discontinue use along with other hepatic toxic agents.
Sore arm; nausea; diarrhea; slight fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included Auto immune disease from an unknown date and unknown if ongoing. Concomitant medications included (in two weeks) Zoloft, geodon, ambien, allerclear from an unknown date for unknown indication and unknown if ongoing. Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 12:00 as dose 1, single for covid-19 immunisation. It was reported that on 12Mar2021 07:00 patient experienced Sore arm, nausea and diarrhoea 2 days after receiving the 2nd vaccination, slight fever, and chills. Patient did not receive any treatment for the events. Outcome of the event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained
Pt. had Hives with itching   Pt.took Benadryl.  Hives started 4/23/22 until 6/27/22 so far.
Symptoms of an elevated heart rate began a month or so after the vaccine.  In. April 2022 high blood pressure warranted a 911 call.  The next day another 911 call was needed for spiking elevated blood pressure.  Blood tests revealed extremely hyperthyroidism.  A cardiologist ruled my heart as healthy and thyroid is causing the elevated HR and BP.  I have never had any issues nor is there any family history of thyroid disease.
BRUISING OVER ARMS AND LEGS; This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bruising over arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising over arms and legs. This report was non-serious. This case, from the same reporter is linked to 20210632493.
Fever to 103.2 in 12 hr. time period of vaccine administration fever broke 8-10 hrs. later, treated with TYLENOL.
Case number PHEH2013US018029, is an initial spontaneous report received from a nurse on 22 Aug 2013, with a follow-up received on 17 Sep 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12126), intramuscularly at a dose of 0.5 ml into deltoid, without being reconstituted with Men A lyophilized conjugate vaccine component on 20 Aug 2013. No adverse event was reported following this administration error. Follow-up was received on 17 Sep 2013: Vaccination site and dose were updated.
I felt really fatigue and I was very ill for the first 24hrs. I wasn't feeling like myself. I got bronchitis and now its as mastic bronchitis. I had chest pains and wheezing and the first few weeks of April.
1hr p/vax pt cried constantly for approx 4hr;APAP was adm prior to immun q 4hr throughout PM-no significant temp elevation;lt leg bruised & had hard knot-warm compress applied;finally went to sleep p/4hr & was much improved next day;
Multiple joint aches knee/ankles. Breast pain on side of (arm vaccine site). No arm pain - joint stiffness continues.
At 17 hours after the 2nd dose. I started with a fever, back pain, hips to the bones, followed by chills and a bit of a headache. The acetaminophen was taken every 4 hours but as the day passed before 4 hours the fever and all the symptoms began. I felt as if I had fire inside my body. In the mouth and eyes. Then that fire continued and after 79 hours I noticed large welts on my legs, very intense itching and burning all over my body, I consulted a Dr on the phone and he told me to take Benadryl 50 every 8 hours, low a little the hives with the first dose but continued the same. I feel the allergy the same as when they administer Iodine and I feel acid or fire through my veins. I have not been to the hospital since I do not have the facility (the means or capability) to leave my children and be able to go with someone to the hospital. At this moment I write 4/20/2021 9:20 pm I am with these symptoms.
Rash on left side of the body.; Hot burning sensation; Muscle is tender to touch; Itching in torso, back area; Itching started couple days after near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in torso, back area), VACCINATION SITE PRURITUS (Itching started couple days after near injection site), RASH (Rash on left side of the body.), VACCINATION SITE PAIN (Hot burning sensation) and MYALGIA (Muscle is tender to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREGABALIN (LYRICA) and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itching in torso, back area), VACCINATION SITE PRURITUS (Itching started couple days after near injection site), VACCINATION SITE PAIN (Hot burning sensation) and MYALGIA (Muscle is tender to touch). On an unknown date, the patient experienced RASH (Rash on left side of the body.). The patient was treated with PREDNISONE for Itching and Rash, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itching in torso, back area) had not resolved and VACCINATION SITE PRURITUS (Itching started couple days after near injection site), RASH (Rash on left side of the body.), VACCINATION SITE PAIN (Hot burning sensation) and MYALGIA (Muscle is tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection site itching; Injection site papule; Injection site redness; Injection site irritation; Flu like symptoms; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritation), INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE PAPULE (Injection site papule) and INJECTION SITE ERYTHEMA (Injection site redness) was resolving.            Concomitant medication was not reported.  On unknown dates, the patient experienced injection site irritated, palm size red at injection site/dime size red area, itchy at injection site and raised area at injection site. In 2021, the patient experienced fatigue, flu like symptoms and nausea. In 2021, the fatigue, flu like symptoms and nausea resolved. MODERNA COVID-19 VACCINE (elasomeran) was also considered suspect.  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Muscle pain at injection site; 2 days later developed swollen lymph nodes near collarbone, neck pain, intermittent facial numbness.
Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
This spontaneous report as received from a nurse refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with M-M-R II injection (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The nurse informed that on an unknown date the patient had titers drawn because she was starting a new job and M-M-R II titers resulted showed that patient did not have immunity to measles. The patient did not seek medical attention. Additional information has been requested.
Shortly after my shot I was unable to breathe,  my hubby drove me home but i could not walk or get out car he carried me., heart and chest was tight.
Patient started having symptoms on 08/02/2021. Patients symptoms were Fever, Chillis, Muscle aches, Runny Nose, Sore Throat, Headache, Fatigue, Cough, Wheezing, Shortness of Breath, Chest Pain, Nausea and Diarrhea
This is a spontaneous report from a contactable consumer via a sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced chills and headache on an unspecified date (the day after the vaccination) with outcome of unknown.
A non serious labeled spontaneous report of fever and cold symptoms has been received from a registered nurse concerning a four-year-old male, three days after receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. According to the reporter the patient has no past medical history; no concomitant medications were provided. The patient received FLUMIST on 01-Oct-2008. On 04-Oct-2008 the patient experienced a fever of 103 degrees Fahrenheit and cold symptoms. No treatment information was provided. The fever resolved on 05-Oct-2008 and the cold symptoms resolved one week later on 11-Oct-2008. The patient's physician indicated they did not believe the event was related to FLUMIST.
This spontaneous report as received from a nurse refers to a 3 patients of unknown age and gender. On 16-FEB-2016, the patients were vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency, therapy type, route of administration and indication were not reported, lot # reported as L040143 with expiration date 13-MAR-2017). No adverse effects reported. Additional information is not expected, because the reporter did not wish to be contacted.
sore arm, low grade fever, body aches, headache still having symptoms into day 3
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 05-APR-2016, the patient was treated by a physician's group for severe herpes zoster and post herpetic neuralgia. The patient was prescribed dexamethasone, valacyclovir, hydrocodone and ibuprofen and silver sulfadiazine for the management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Patient vaccinated with Anthrax, JEV, smallpox, and Hep B on 14March 2017. On 19March, patient found out she was pregnant with home pregnancy test. On 20March, pregnancy verified by HCG qual. Pt indicated she was not / could not be pregnant on pre-vaccine questionnaires.