chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient currently in the office received two doses ofGARDASIL (quadrivalent) on unknown dates, and is currently in the office now to complete the series with GARDASIL-9.; No additional symptoms were reported; This spontaneous report has been received from an office manager who is also a nurse, referring to a patient of unknown age and gender. The patient's history condition, current condition and concomitant therapy were not provided.  On unknown dates, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route, strength, lot# with expiration date not reported) for prophylaxis.   On 10-JAN-2020, the patient was currently in the office to complete the series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, strength, lot# with expiration date not reported) for prophylaxis (interchange of vaccine products). No additional symptoms were reported in the patient.
itching one arm in one spot with brief throat itching. Pt felt much better with parents driving  her. Called family on phone daughter doing better went to  store
left arm is swollen; it's hot to touch; a slight or very light sore throat; 2nd dose on 4Mar2021; left arm is pretty sore; a little fatigue; low grade fever at 99.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and MYALGIA (left arm is pretty sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05RE21A, 029A20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021), MYALGIA (left arm is pretty sore), FATIGUE (a little fatigue) and PYREXIA (low grade fever at 99.5). At the time of the report, PERIPHERAL SWELLING (left arm is swollen), FEELING HOT (it's hot to touch), OROPHARYNGEAL PAIN (a slight or very light sore throat), MYALGIA (left arm is pretty sore) and FATIGUE (a little fatigue) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on 4Mar2021) and PYREXIA (low grade fever at 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) Patient had low grade fever this morning at 99.5..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient not sure if he's immunocompromised Concomitant medications was not provided by the reporter Treatment Patient put ice on it and didn't take any other treatments 2-3 hours after, his temperature became normal.
Developed acute onset of urticarial/hives on trunk and extremities a couple of hours after receiving the shot.
Patient presented to the ER with c/o fatigue, flank pain and odorous urine x 5 days. Patient had a syncopal episode witnessed and documented in the ER. Patient found to have pneumonia. Patient experienced multiple syncopal events during admission. Patient was tested for Covid on 12.28.21 and tested positive. Patient received IV abx. Syncope was likely due to Covid-19 infection per Discharge Summary. No evidence of orthostatic htn, carotid ultrasound was unremarkable. Patient was discharged home.
This spontaneous report was received from a pharmacist via company representative refers to a 63 year old female patient. No medical history, concurrent conditions and concomitant medications were reported. On MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, intramuscular. On MAY-2014, the patient developed injection site reactions a day after receiving ZOSTAVAX. Injection site reactions included itchiness and redness. Treatment was rendered for the event. No lab tests were performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. Additional information has been requested.
Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer) (Manufacturer Report Number: 2018266370). This case concerns a patient (age and gender not reported) who experienced tetanus toxoid allergy, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported. The patient developed a non-serious tetanus toxoid allergy (Unknown latency) following the administration of TETANUS TOXOID. (Other relevant tests included No lab data.) Final diagnosis was tetanus toxoid allergy. It was not reported if the patient received a corrective treatment. The patient outcome was Unknown for tetanus toxoid. List of document held by sender: none.
Initial misuse report received from a healthcare professional  on 26 July 2013. During an inventory, it was found that the patient, who received ACTHIB on 24 July 2013, might have received ACTHIB that was reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Fever 104.6F, insistent crying & twitching in 6wk old; Occurred evening of inject; Hospitalized;
Within a minute of vaccinations patient fainted. He recovered in about 5-10 seconds but was still very dizziness. Dizziness passed within 15-20 minutes. Patient laid in the pharmacy for 40 minutes and was monitored for an hour after dizziness passed. Patient was fine after this time. Followed up with patient 12/20/09 had no adverse effect.
On 3/7/2021...Eight days after my first dose I woke up with my left arm swollen to the diameter of a baseball and welted, burning hot, sore to the touch, a hard lump and itchy.
I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my throat. I didn?t associate this with the vaccine. I left the facility around 3:45pm and started driving home. The right side of my face started to feel funny and felt numb. By the time I got home at 4:20, the whole side of my face felt numb. I could smile and talk. It felt like I had received Novocain from the dentist. I immediately started looking for phone numbers to call and tried to figure out what was happening. I left a message with a nurse hotline and left a message with the answering service at my primary care doctor?s office. Doctor FaceTimed with me for 7 minutes at 5:04 and said to go to the hospital.
Patient was brought in to the clinic approximately 48 hours after receiving his immunizations.  He had a 10cm x 10cm erythamatous, warm to touch raised rash on his left leg that was blanchable, non-tender.  He was prescribed antihistamines and instructed to ice the site.  Return to clinic if problem persists.
This spontaneous report was received from a nurse via company representative and refers to a patients of unknown age and gender. On an unknown dates, the patients was vaccinated with doses of GARDASIL (dose, frequency, route of administration were not reported). On an unknown date the unspecified number of patients experienced unspecified joint pain immediately after receiving the vaccine. It was also reported that there were some cases where it took an unspecified number of months for the joint pain to be under control. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
presented to the ER due to the symptoms. The patient was experiencing chills, feeling hot, fever, shaking, sweating, swollen red arm, and tight throat. per chart note, he was given a ZPak and Keflex in the ER, with unknown dosing. The patient was suspected to have pneumonia in addition to the vaccine reaction. Does not appear that anything was administered in the ER for the vaccine adr. NauseaVomiting & chills, hot, fever, shaking, sweating, swollen red ARM, tight throat
Root canal; This spontaneous case was reported by a consumer and describes the occurrence of ENDODONTIC PROCEDURE (Root canal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ENDODONTIC PROCEDURE (Root canal). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. On 08-Feb-2021, ENDODONTIC PROCEDURE (Root canal) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Pt developed abdominal pain and anorexia beginning two days after receiving vaccine dose. Presented to ED and found to have portal vein, SMV and splenic vein thrombosis. Underwent TIPS c/b recurrent thrombosis x 2 and cecal pneumatosis s/p exploratory laparotomy, open abdomen, delayed closure. He was mechanically ventilated and briefly requiring vasopressor support, now extubated and off pressors. Remains inpatient on anticoagulation and TPN. Hematology work-up while inpatient was negative.
5 minutes post flu shot started to cough, and stated it felt like there was a bubble in her throat. Felt like she had to belch and could not. Hospital unknown that she was transported to.
Little warm,almost like a bee sting, around the injection site/warm around the injection site; itchiness around the injection site; Broke out in a rash, looks like welt, three inches wide/rash around the injection site; peeled like a sunburn; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Penicillin allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site). In March 2021, the patient experienced VACCINATION SITE EXFOLIATION (peeled like a sunburn). At the time of the report, VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (Little warm,almost like a bee sting, around the injection site/warm around the injection site), VACCINATION SITE EXFOLIATION (peeled like a sunburn), VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (Broke out in a rash, looks like welt, three inches wide/rash around the injection site) to be possibly related.    The patient takes concomitant medications for a HGC diet.  No treatment information was provided by the patient.   This case was linked to MOD-2021-246857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received: Medical history updated, action taken and  event outcomes were updated; new additional event of peeled like a sunburn was reported.
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention.  Remained in the observation room symptom-free for additional 30 minutes.   At home, symptoms of shortness of breath and chest tightness returned and worsened.  Throat felt tight, able to move air, however had trouble swallowing.  Voice was raspy and increased coughing.  From past experience with allergy shots, this was my cue to use epi pen.  Within 5 minutes after using epi pen, all symptoms were resolved.
had inj @ 10:30, c/o lower lip swelling & chest tightness # 12:30-1PM;
WOKE NEXT MORNING WITH EXTRMELY LOUD TINNITUS. HAD MILD TINNITUS PREEXISTING. REMAINED VERY LOUD FOR ABOUT 2 HOURS THEN STARTED GOING DOWN BUT HAS NOT RETURNED TO BASE LINE AND IS MUCH WORSE THAN BEFORE
Received Pfizer booster and had only soreness at injection site. No other symptoms noted. About a week later I woke up with tinnitus in my left ear. Has been constant ever since -- 5 months now. In December, had physician check for other causes, had hearing test. No change.
Patient had soft node to R/L anterior thigh region.  Nurse Practitioner recommended to massage the affected area & to apply warm compresses PRN.
Red Rash on the Left Upper Arm (About 5"); Itching Injection Site (About 5"); This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) and VACCINATION SITE PRURITUS (Itching Injection Site (About 5")) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) and VACCINATION SITE PRURITUS (Itching Injection Site (About 5")). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 12-Mar-2021, VACCINATION SITE PRURITUS (Itching Injection Site (About 5")) had resolved. On 15-Mar-2021, RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information was received on 06-May-2021 added contact information and dose 2 received.
Arm was sore; It was difficult to move; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (It was difficult to move) and SWELLING (Swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (It was difficult to move) and SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Arm was sore), MOBILITY DECREASED (It was difficult to move) and SWELLING (Swelling) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided. No lab data was provided by the reporter.
5hr p/vax area surrounding inj site was red, bumpy, & itchy;p/48hr area was solid red & +itch;area measured 4in x 2 2/3in;pvt MD contacted who advised DPH & ice & cortisone cream;MD will provide medical exemption for final 2 inj;
Tightness in back started 03/03/22. Spread to the rest of the back and left chest on 03/04/22. Difficulty breathing and moving morning of 03/05/22.
SITE OF VARICELLA INJECTION SWELLED UP AND HOT TO TOUCH, EXTREME ITCHINESS AT THE SITE. USED ICE AND HYDROCORTISONE CREAM AT SITE OF INJECTION.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 5/1/2021 and 5/29/2021. Presented to ED on 8/11/2021 with complaints of worsening symptoms over the past 10-11 days including generalized fatigue, body aches, weakness, decreased appetite, nausea, vomiting, diarrhea, dyspnea, and cough. Intubated 8/19.  His course was complicated by L pneumothorax requiring Left chest tube placement X 2.  He was given Decadron 10 d through 8/21. Completed course of Remdesevir 5 days. Course complicated by MSSA pneumonia and concern for fungal pneumonia. Was being treated with Ancef and Micafungin. However he rapidly declined on 9/2. The patient was with significant.  hypotension and bradycardia, despite vasopressin and levophed gtts. Atropine x 1 given.  Patient with full cardiac arrest at 1255 and CPR was initiated. Epinephrine 1mg given.  1257 pulse check revealed a pulse that progressed into vtach at 1259, shock x 1 at 200J with PEA and subsequent sinus tachycardia. 1303 patient again went into vtach and another shock x 1 at 200J given and amiodarone bolus of 150mg administered. Return of sinus tachycardia.  ABG revealed acidosis and 3 amps of bicarb were administered. At that time the patient's family was called and the wife and daughter arrived at bedside. The family decided at that time to make the patient comfort care. He was taken off the ventilator and passed at 1350.
w/in 30min p/vax mom noted hives on arms & legs gradually progress to affect trunk; coughing spells & turning blue;pt rushed back to office given 02 & adrenalin, Decadron; to ER for observation 1-2hrs; sent home w/DPH
Information has been received from a registered nurse concerning a 28 week old patient who on approximately 17-OCT-2007 and 06-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ. The patient sought medical attention via physician's office visit. The nurse mentioned that the patient had not experienced any difficulties since the first vaccination. There was no product quality complaint. Additional information has been requested.
Patient felt faint, laid down on the ground. Started sweating perfusely. Said he had tingling in his arms difficulty breathing and chest felt heavy. Ice pack was given. Epipen was not administered. EMS was on site by then very quickly. EMS stated possibly due to anxiety. Patient was hyperventilating  and EMS stated this was not a reaction to the shot and this could be anxiety induced/related. Patient did not seem anxious during the shot but got very anxious when he experienced these symptoms.  Patient stated he had eaten only two strips of bacon the entire day and had some anxiety with getting the shot.
On 05/29/21 while driving i neglected to see a parked car to my right, twice.  My wife being in the car at the same time needed to shout a warning to me to avoid a collision.  Going home, taking a nap, my decide to test my blood pressure.  it was very high, calling my family physician, he stated for me to call an ambulance and go to the hospital.  There  I was  diagnosed with a CVA, cerebrovascular accident.
Axillary pain with swelling of lymph nodes in axillary are of left arm and up into neck.
immun was given on 29APR94; 2MAY94 mom called state pt had elevated temp on 30APR, 1MAy & arm was very swollen & red; erythema 2" elbow & below site of inject; area hard & warm to touch
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA000892:
Patient stated that 35 minutes after the influenza vaccine was administered her lips started tingling. she immediately took 25 mg of Benedryl , but the symptoms worsened and her tongue began to swell. She then drove to an Urgent Care facility and they administered Solumedrol and a 5 day course of prednisone. After approximately 1 hour all symptoms had dissipated.
Numbness on his lips and on the left side of his face; Numbness on his lips and on the left side of his face; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 04Feb2021 (33-years-old at the time of vaccination), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Feb2021 an hour after getting the vaccine, the patient experienced numbness on his lips and on the left side of his face. Patient wanted to know if this is a normal side effect of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
This case was considered medically important. Information regarding DRYVAX was received from a literature source regarding a participant enrolled in a prospective immunogenetics study who developed myocarditis after receiving a dose on an unspecified date. The patient was enrolled in a prospective immunogenetics study with measurement of cardiac muscle, specific troponin-1, prior to and 5-21 days after immunization. On an unspecified date following vaccination with DRYVAX, the patient developed myocarditis. Treatment and patient outcome were not reported. The authors concluded that myocarditis is a hypersensitivity reaction to vaccinia immunization, regardless of product used (calf lymph derived or cell cultured derived) or number of punctures (3 versus 15 for eLDVac), and that it appears to be far more common than predicted by passive and epidemiologic safety surveillance methods. The natural history of myocarditis, clinical or subclinical, remains to be defined. See attached literature abstract. The assessments of the investigator(s) and medical monitor(s) for myocarditis were unknown. No additional information was available at the time of this report.