chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MEDI-0005846 is a serious spontaneous case from a physician involving cardiomegaly concerning a twelve-year-old female patient. No concomitant medications have been reported for this patient. The patient received FluMist in Oct/Nov 2006. Over past seven months, the patient developed dysphagia, acute fatigue, and cough which progressively worsened. The patient was diagnosed in the past week with cardiomegaly by x-ray with a ten percent ejection fraction. No outcome for the events was provided by the reporter. The reporter provided no causality assessment for the events. Per 60 day follow up: Three follow-up attempts made. No response from the reporter received. No additional information expected from the reporter. 07-MAR-08
Within a few hours of the shot patient was inconsolible crying with a fever topping 105'. I called the after hours exchange and was told it was just a virus and it WAS NOT because of the vaccine. I called the Dr the next day and he said that same thing. The fever lasted a few days. Directly after that his mental stability started to break down.
He developed a red, bruise-like reaction on his arm below his injection site. It was about the size of a softball and was warm to the touch. It developed the same day as the vaccination and has improved in size over the next two days.
Narrative: Pt received first dose of COVID vaccine (Janssen) at approx 1600. After approximately 15 minutes, pt reported feeling dizzy, lightheaded , and fatigued. Also reported BLE weakness. He attempted to stand and was unable to support himself. Pt provided with juice, VS monitored with BP 142/90, HR 92-99, SPO2 100^ on RA. He continued to feel week and dizzy. After another 15 minutes, pt was agreeable to be transferred to the ED for additional monitoring. In the ED, pt received IL NS. Labs and EKG were done. Full note from ED not available at time of this report. Pt discharged home in stable condition at 19:33
Patient developed stroke-like symptoms (right flashing light/temporary vision loss, word-finding difficulty) 24 hours after completion of Moderna COVID vaccination requiring hospitalization for stroke workup.
This spontaneous report as received from nurse refers to a 23 year old male patient. The patient's medical history included chicken pox and had no drug reactions/allergies. On 11-SEP-2014 the patient was vaccinated with VARIVAX (Merck) 1350U (lot # K002922, expiry date: 26-FEB-2016) (dose, route, frequency not provided). Concomitant therapy included TORADOL and doxycycline. Nurse reported patient experienced paralysis and was diagnosed with Bell's Palsy (medically significant) on 13-SEP-2014. As treatment, patient was given 1000mg VALTREX one tablet by mouth for 3 times a day for 7 days and 10mg prednisone taper (manufacturer unknown) for 6 tablets daily for 5 days, 5 tablets daily for 5 days, 4 tablets daily for 5 days, 3 tablets daily for 5 days, 2 tablets daily for 5 days and 1 tablet daily for 5 days. Lab diagnostics studies were not performed. Patient did not recover from the reported event. Patient sought medical attention and went to see a doctor. Causality of the event was unknown. There was no product quality complaint. Upon internal review the event of Bell's palsy was considered to be medically significant. Additional information has been requested.
both lower arms, neck broke out w/flat red area; went to pharmacy & MD prescribed a DPH; also red, hot area @ vax site;
Pt described mild numbness on and around her lips and face that started within 15 minutes of vaccination and lasted several minutes.
Suspected vaccination failure; had the 2 vaccinations & got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had two Shingles shots then developed shingles again. The patient stated that it was not as bad as previous. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient has no pertinent medical history. The patient has egg allergy. On 04-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number reported as H021712, expiry date 06-MAR-2014 and route was not reported). On an unknown date, the patient developed injection site reaction following vaccination of ZOSTAVAX. The time frame development of the injection site reaction following vaccination of ZOSTAVAX was unspecified. The patient described the injection site reaction as a raised, red, warm, itchy area at the injection site of ZOSTAVAX vaccination. Laboratory diagnostics was not performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Vertigo, fullness in ears, hearing loss, tinnitus  Vertigo -- has been "strong" to slight --  have had 17 different episodes now Fullness in ears -- I have not been able to clear my ears since 4-29-21...
Radiculopathy; tender to touch; disrupted sleep; left arm  pain; damaged nerves in her neck, going all the way up the side of her neck; red bumps; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 71 year old female patient who experienced radiculopathy, tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder), left arm pain (Pain in extremity), damaged nerves in her neck going all the way up the side of her neck (Nerve injury) and red bumps (Injection site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past vaccinations included Tetanus 5 years ago.  Medical history, medical treatments, concomitant medications and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number U6628AA) via unknown route in unknown administration site for immunisation.  On an unknown date, The patient had a reaction of a whole left arm pain (Pain in extremity), damaged nerves in her neck, going all the way up the side of her neck (Nerve injury) and having been diagnosed as Radiculopathy, red bumps (Injection site swelling), tender to touch (Tenderness), disrupted sleep (Non-24-hour sleep-wake disorder) and continues to be red (latency unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No relevant laboratory tests were unknown.  She received steroids for all the events.  Event outcome was reported as not resolved Pain in extremity and Injection site swelling, as resolving for Tenderness and Non-24-hour sleep-wake disorder and as Unknown for Nerve injury and Radiculopathy.
Muscle/joint pain, chills, fever (100.7), weak, tired, rash.
Slept almost all day, all night; Had symptoms like the flu for like a week after she took the first shot; Was just real fatigued; Low grade fever like a 99.5/Had fever; Coughing; Coughing a blood; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HAEMOPTYSIS (Coughing a blood), SOMNOLENCE (Slept almost all day, all night), INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) and PYREXIA (Low grade fever like a 99.5/Had fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COUGH (Coughing), HAEMOPTYSIS (Coughing a blood) and PYREXIA (Low grade fever like a 99.5/Had fever). On an unknown date, the patient experienced SOMNOLENCE (Slept almost all day, all night), INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) and FATIGUE (Was just real fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing), HAEMOPTYSIS (Coughing a blood) and PYREXIA (Low grade fever like a 99.5/Had fever) had not resolved, SOMNOLENCE (Slept almost all day, all night) and FATIGUE (Was just real fatigued) outcome was unknown and INFLUENZA LIKE ILLNESS (Had symptoms like the flu for like a week after she took the first shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 99.5 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient stated that she was exposed to it probably about 8 days ago. However, she was not coughing a lot, it was not tremendous and it was not constant. Patient was scheduled for her second dose tomorrow but she was not sure about taking it and wanted to find out if she should take it or postpone until she got better.   Reporter did not allow further contact
Approximately 9 hours after vaccine - patient reported having diarrhea x 1. Approximately 15 hours after vaccine - patient reported having vomiting x 1. Approximately 20 hours after vaccine - patient reported having headache lasting approximately 2 hours then patient able to resume normal activities.
Information has been received from a physician assistant concerning a female patient "between the age of 17 and 21" years, who on an unspecified date was vaccinated with the third dose of GARDASIL. The physician assistant reported that on an unspecified date, the patient tested positive for HPV after receiving the three doses of GARDASIL. The patient sought unspecified medical attention. It was noted that the patient had unprotected sex. At the time of the report, the patient's outcome was unknown. No further information is available.
Patient received vaccine around 3p on 12/22/2016 and reported swelling, redness, and erythema to pharmacy and following morning. Swelling was approximately 4 inches in diameter. Both vaccines given into right deltoid. Advised patient to do compress and take TYLENOL.
Itchy; Arm is red and swollen; Arm is red and swollen; felt like fainting; hard time breathing; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE SWELLING (Arm is red and swollen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O17C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Drug allergy (allergy to unspecified medication).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing) and HEART RATE INCREASED (heart rate increased). On 12-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen). At the time of the report, PRESYNCOPE (felt like fainting), DYSPNEA (hard time breathing), HEART RATE INCREASED (heart rate increased), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Arm is red and swollen) and VACCINATION SITE ERYTHEMA (Arm is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has medications for high blood pressure, diabetes and potassium pill but not specified.  Patient has allergies to some medications but caller is unsure about it.  Treatment included  Ibuprofen and Loratidine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started feeling  tired so I laid down. While laying down  and as time progressed, my head started aching very bad, my arm that received the shot started hurting,  I had chills, joint pain, it hurt to touch my skin, off balance when trying to walk,  some nausea but I could eat some, I felt  pen sensation poking areas in legs but mostly my abdominal area. Overall a feeling of ratchetness,  pain, and misery.  Next morning I woke with the headache  and sore arm but I felt MUCH better. By Monday, all I had was sore arm and slight headache. Now, today, Tuesday, I have small headache, some coughing, sore forearm and thigh (really weird because this just started). Overall I feel good and I am glad that Saturday is over!
Approximately one hour after injection, patient developed red, blotchy raised areas which were itchy.  Patient advised to take Benadryl 50mg PO.  Symptoms resolved completely several hours later.
The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Pt reports decrease hearing to bilateral ears after vaccine administration Observed for 45 mins  reported slight improvement in difficulty hearing Pt was educated to follow up PCP or visit ER if symptom doesnt improve or gets worse Pt verbalized understanding
The pt experienced erythema, urticaria mainly to the upper chest, groin, abdomen and upper back.
Pain in shoulders immediately after injections where pain made shoulders nonfunctionable so orthopedic surgeon initially diagnosed as 'frozen shoulder'.  Upon further testing, found inflammation throughout body.  Had xRay, MRI, cortizone shot, orthopedic surgeon, physical therapy, and now being treated by a rheumatologist for auto immune and inflammation.
Heart started skipping beats in mid April through current date. Went to doctor who ordered a heart monitor for 2 weeks. Results show PVC's Also  doctor order 2nd blood pressure pill on 6/2/21 due to extremely high blood pressure readings taken at home.
Nurse gave first dose of Rotateq after 15 weeks of age on 3/20/09. Infant has had no untoward affects when nurse checked with the parent the next day and none by 3/25/09.
Flu symptoms: extreme headache, body soreness, temperature, upset stomach, cold chills, fatigue.
Due to reported adverse COIV vaccine, had pt. sit on site 15: pt vistied with staff member additional 15 min, left, returned~ 10 min later c/o"numb lips and tongue" Pt had Bendadryl & took 50 mg po. Vitals stable o2 98% pulse 70, 150/80. Provided gatorade, no problem swallowing noted.Pt remained stable; sx resolved. Returned to work on site at her request.
Systemic: Tachycardia-Mild, Additional Details: patient reported having rapid heart beat as she was checking out.  Had her sit, checked pulse, it was 73 but could feel full pressure of beat.  She said she was feeling pouding. Had her sit another 15 min, she was feeling a little 'out of it', rechecked pulse and rhythem felt irregular. NO other symptoms. Mom was going to call PCP right away or go to Urgent Care.  Did not want us to call an ambulance
Patient was very excited to receive injections. Patient first received Hep A with no reaction. Then she received HPV and she did not feel good. Had her lay down on bed and applied wet paper towel to her head. Patient right side leg and arm was shaking. Patient calmed down later. Patient able to leave at 9:21am after receiving injection at 9am.
Associate had hand numbness and tingling in her left hand, left arm extermity was cold. Blood pressure was elevated to 149/96, which is not normal for the associate. She was monitior for a hour. After being monitor for a hour,  the associate stated that there is no more numbness or coolness in her left extermity, and no resiratory issue so she was sent home @ 19:50.
Shortness of breath, racing heart, dry mouth, dizziness, body felt hot, migraine
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 31-JAN-2023 Reporter's Comments: A nurse reported that a female patient received an expired dose of havrix Additional Supportive Information: The patient received Havrix, which was already expired.
Patient presented to pharmacy 3 days after vaccination with warm red bump at injection site. There was a large area (6 in x 3 in) erythematous bump surrounding injection site. At 4 days the swelling reduced to the injection site and was improving. The patient required no further treatment.
Left sided facial paralysis consistent with a peripheral Bell's palsy. Treated with Prednisone and acyclovir starting 11/29/09. Lyme test-negative. Still symptomatic as of 12/10/09 but has improved slightly.
Fever, body aches, nausea, fatigued, increased heart rate, chills, sweating
Developed tinnitus suddenly, several weeks after vaccine, fairly continuous (always there). Originally thought to be a viral infection in ear, took 10 day course of antiviral, helped with ear pain and fullness, but the ear continues to have the ringing. Planning to see doctor again on August 30th, will request CT Scan.
No appetite; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), CHILLS (Chills) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine (migraine with seeing spots), Vitamin D deficiency and Constipation. Concurrent medical conditions included Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DECREASED APPETITE (No appetite), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. On 20-Feb-2021, it was reported that patient experienced Undetected antibodies.
4hr p/vax pt had shaking chills & fever to 102;the next day pt felt lousy;the following day pt was better;
Client complained of feeling dizzy with chest discomfort following vaccine.  She also complained of a lump in her throat with swelling. and a headache. Client was able to talk without gasping. She was monitored by EMS and Dr.who administered an Epi pen 0.3ml at 17.20 pm  At 17.33 pm blood pressure was 136/77 with heart rate of 93.  Client was transported to EMS observation van and monitored by DR. .  Dr  administered several medication intravenously following IV insertion by EMS. Solumedrol 125mg, Benadryl 50mg  and pepcid 20mg.   Client was transported to Hospital.  Her husband was advised that client needed to receive further vaccines in the office of an Allergist for observation
This spontaneous report as received from a pharmacist and the patient herself refer to a 73 years old patient with high blood pressure, cholesterol issues and allergies of LIPITOL, ZOCOR(MARR# 1208USA009102), morphine and phenobarbital. The patient's medical history included shingles rash in" the same area" of her face. The patient was vaccinated with 0.65ml of ZOSTAVAX (Lot#671786/0254AE, Exp date 08-MAR-2013, route and duration were unspecified) on 14-AUG-2012. No other co-suspects were reported. Concomitant medications included NORVASC(reported as Norvafc), NIASPAN and articaine (reported as attican). On 19-AUG-2012, the patient reported that she started feeling a "tingling felling in her face and her eye" when she inspected her face she noticed a breakout on her face, the discomfort was followed by a two day headache. It was reported that the patient had sought unspecified medical attention. Patient was put on VALTREX(results not provided). On 20-AUG-2012, Pharmacist reported that, the patient developed a tingling around her face and nose on 19-AUG-2012. The patient spoke with the pharmacist about the case and she would be going to see her doctor. At the time of reporting there was no rash. No treatment was given for the adverse event. The outcome was unknown. Additional information has been requested.
began to have shortness of breath and a chest tightness, occasional chest palpitations. this has lasted for over 2 weeks. had a MD appt and now having a cardiac stress echo in 1 week. EKG was normal.
Moderna vaccine #1. High heart rate and atrial fibrillation reported by Watch over three day period beginning about 3 hours + after injection. . Resting heart rate was  up to 167 at one time  and sleeping rate was up and down in the low 100?s   Did several ECGs and atrial fibrillation reported several times. Heart rate began to subside after a full two days with spikes. Monitored through weekend to be sure no further spikes. Have copies of reports. Called and reported to physician on 2/16. Called VARES and Moderna to report and no return calls as yet as no choice but to leave voice mail.