chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 11 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 09-NOV-2012. Other suspect therapies included a dose of AFLURIA (lot #, dose and route not reported) on 09-NOV-2012. Concomitant medications included: Tdap (manufacturer unspecified). The physician reported that the patient also had blood drawn for unspecified blood work (results not provided) on 09-NOV-2012. After receiving the GARDASIL, the patient felt dizzy and nauseated, and had an episode of "explosive diarrhea" and fainted on toilet. No injuries incurred. Physician reported at that time, patient had no wheezing, no injuries and no hypotension but patient was "clammy and pale". After leaving the office, he had another syncopal episode and diarrhea in the parking lot. No injuries reported from fall. The mother of the patient called the physician the weekend to report that the patient continued to have vomiting, diarrhea and severe headache and that she was taking him to the emergency room. The physician stated the mother would call to follow up on his status. No treatment information was reported. The outcome of syncopal episode and fall was unknown. The relatedness for the reported events was not provided for GARDASIL and AFLURIA. Additional information has been requested.
itches , hives , and redness at the left arm; itches , hives , and redness at the left arm; itches , hives , and redness at the left arm; A spontaneous report was received from a consumer concerning a 72-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itches at the injection arm/pruritis, hives at the injection arm/Urticaria, redness at the injection arm/Erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/pruritis . On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/Urticaria . On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/Erythema. .  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itches at the injection arm was unknown.The outcome of event(s), hives at the injection arm was unknown.The outcome of event(s), redness at the injection arm was unknown..
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient c/o lightheadness after vaccination. Patient states has medical hx of anxiety, panic attacks and asthma. 1st VS BP:120/91 Pulse:81, 2nd VS: BP 124/81, Pulse 86. lung sounds clear upon auscultation, radial pulse strong and regular, patient AOx4. PERRLA. Offered rescue services to patient, she declined, stating she felt better and wanted to go home. Advised patient to call 911 if any change or worsening of condition occurs, patient verbalized understanding.
Headache, Myalgia, NauseaVomiting, chills Narrative:  Reports chills, headache, nausea, vomiting, muscle aches
Suspected vaccination failure; Got the Shingles vaccine / 6 months later I got Shingles on my face and head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving 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.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The patient received Shingles vaccine and got Shingles on his or her face and head and they were horrible. The doctor said patient had a mild case and god help those who have a full blown case. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
purple/blue flat rash (petechiae like) under lower lip;lower lip sl swollen;appears like a goatee;
I started to have a bad cough. I thought I might have a cold or allergies. My cough got worse, and I was unable to talk. I went in to see the doctor and he did a chest x-ray. It showed that I had pneumonia in my left lung. I was prescribed a steroid, crystals for the cough, and antibiotics. A few weeks later I woke up in the middle of the night and I was coughing up phlegm, and blood. I went into the emergency room had a chest x-ray done, and also a COVID-19 test. The x-ray showed my pneumonia was clear but my COVID-19 test came back positive. I was extremely tired and I felt run down for a few weeks. I still have a cough and fatigue.
No blood clot but testing shows signs of blood clot; Unable to eat; Chest pains; Red spots; Muscles feel like needles; She has not taken second dose; Fainted; hand turned red; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (No blood clot but testing shows signs of blood clot) and SYNCOPE (Fainted) in a 26-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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), ERYTHEMA (hand turned red) and PALPITATIONS (Palpitations). On an unknown date, the patient experienced THROMBOSIS (No blood clot but testing shows signs of blood clot) (seriousness criterion medically significant), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose). At the time of the report, THROMBOSIS (No blood clot but testing shows signs of blood clot), SYNCOPE (Fainted), ERYTHEMA (hand turned red), PALPITATIONS (Palpitations), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coagulation test: signs of blood clot (abnormal) signs of blood clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that within 3 minutes of receiving dose, patient's hand turned red and she fainted. Patient was brought to the hospital and was released a couple hours later when palpitations stopped. No medication given to treat symptoms.  The patient was receiving unspecified acid reflux medication.   Company comment Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.
pt recv vax MAY97 & several days later pt devel several pox rash on the ankle & thigh on lt leg;MD was not sure what the bumps were;
Body aches started hours after vaccination. Finally after second shot the joint pain in my hand never resolved  Was told it was RA
STROKE A YEAR LATER; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The latency was one year.  On an unspecified date, the patient experienced stroke a year later after vaccination. The reporter stated that "So sorry for your loss. I have heard that same story many times. People have heart attacks that never had heart problems. My husband took 1 shot. Had a stroke a year later. I will never take a covid shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke a year later was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0-20221260478- Stroke a year later-The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
jun90 pt vax hepta B.  24hrs - pt ex n/v/ h/a. pt stated that she ex such sx after any vax.
16 year old patient who got through the initial screening and got the first Moderna vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient who got through the initial screening and got the first Moderna vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-114321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114321:
Pt received FLUZONE HD and PNEUMOVAX on 10/23/18. His arms were both very sore that evening, lasting for 2.5 days. On Thursday he started to see urine was getting dark yellow. On Friday morning, urine was very pink/red. Then, every urination after that was light red/pink. The color of the urine returned to normal on Friday evening. Friday afternoon, went to see his wife's doctor, no bloodwork done. No abdominal pain. Pt had bloodwork done on 10/29/18, lab tests did not show any abnormalities. Since then, pt has also had a ultrasound and CT scan to check for stones, tests did not find any abnormalities. Pt is scheduled for a cystoscope exam. This is patient's first time receiving FLUZONE HD and PNEUMOVAX. Also his first time receiving 2 shots at the same visit.
pt recvd vax 2NOV94 & w/in 48hrs, pt exp bloody diarrhea; stool culture neg; no treatment initiated; pt recovered;
RECIEVED VACCINE AT 1000 A.M. STARTED FEELING HOT AND DIZZY, AT 1010 AM., LASTED ROUGHLY 5 MINUTES. GOT UP TO INFORM STAFF, STANDING MADE ADVERSE SYMPTOMS VANISH. STAFF MADE ME WAIIT 15 MORE MINUTES BEFOR LEAVING HOSPITAL.  FEELING HOT AND DIZZY REOCCURED AT LEAST 5 TIMES THROUGH-OUT DAY, ONE TIME STANDING MADE WORSE.  ALL EVENTS LASTED ROUGHLY 5 MINUTES.  AROUND 9 PM FELT ICE COLD HEADACHE FRONTAL LOBE AND PAIN IN CHEST.  WENT SLEEP AT 930 PM.  WOKE UP  530 AM SAME HEADACHE BUT CHEST PAIN GONE. HEADACHE CONTINUED TILL AROUND 9 AM.
Caller wanted to know if he got the right medication since the second dose "did not hurt"?/Caller mentioned he "did not have any response; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 72-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of ad-ministration, administered in Arm Right on an unknown date as DOSE 1, SINGLE for covid-19 immunization. Medical history included patient fall on an unknown date, limb injury from an unknown date. The patient's concomitant medications were not reported. On 13Jul2021, the patient wanted to know if he got the right medication since the second dose did not hurt caller mentioned he did not have any response. Patient also expressed concern if the dose was properly administered (feeling abnormal). On an unknown date in 2020, the patient underwent lab tests which included tuberculin test and result were unknown. The outcome of the event was reported as unknown at the time of report.  No follow up attempt was possible. No further information is expected.
No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.   On 16-FEB-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115, expiration date was 07-FEB-2022, dose, strength and route were not provided) for prophylaxis.         Temperature excursion of this vaccine was -10 degrees Celsius to 8 degrees Celsius (-3.7 degrees Celsius) for 22 hours without any previous temperature excursion. The digital data logger was involved. No additional adverse events were reported.
Patient reported difficulty breathing, dizziness/weakness, numbness/tingling and a fast heartbeat - and suicidal ideation - went to ED. CHIEF COMPLAINT: SUICIDAL IDEATION (pt. reports suicidal thoughts) and FEVER (pt. received 2nd Moderna vaccine approx 1100 yesterday approx 3-4 hours ago developed chills/fever/anxiety/visual hallucinations/generalized body aches) HISTORY OF PRESENT ILLNESS: HPI:  Patient is a 41-year-old male who presents to the emergency department from home with his wife for chief complaint of suicidal ideation, anxiety. Nursing noted him to be hyperventilating in triage. Patient states these thoughts started about 4 hours ago after he started feeling unwell.  Patient states that he got his 2nd moderna COVID vaccine at 11:00 a.m. yesterday.  This evening after trying to go to bed he started getting fevers body aches and myalgias.  He took Advil around 8:00 p.m..  After this, he started having increased thoughts of wanting to harm himself.  He states he is having "hallucinations of himself cutting his arms and legs off".  He called telemedicine who told him he needs to go to the emergency department.  Patient originally did not want to wake his wife up and did not want to go in but he eventually woke his wife and she brought him here.  Patient does have a history of PTSD and depression.  He is on Cymbalta which apparently he has been taking.  He has not been able to see a counselor since the beginning of the year because of his insurance.  He does see physicians through the hospital.  he has never had to be inpatient but has had to come to the ER a few years ago for suicidal ideation. He also tells me that he quit his job yesterday because he doesn't like seeing people be mean to other people. ED Course as of May 19 0613 Wed May 19, 2021 0339 Patient is a 41-year-old male who presents to the emergency department with suicidal thoughts.  Patient has PTSD.  Suicidal thoughts started about 4 hours ago.  He did get his 2nd moderna COVID vaccine at 11:00 a.m. yesterday and now has a fever and generalized body aches and fatigue.  I do believe this is a normal immune response to the COVID vaccine.  We will give him Toradol.  Patient is very tearful and anxious.  I will give him some Ativan while we are waiting for lab work to return.  Medical social worker will have to evaluate the patient.   0521 MSW is currently talking to the patient.    0611 Medical social worker and wife felt that patient could be discharged home with the safety plan.  He will follow up with the hospital for mental health counseling services.  Patient feels much better after fever subsided.  He will continue to rotate between Motrin and Tylenol.    ED Course User Index DO
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: 15 minutes after vaccine pt said had numbness and tingling in left arm with no other symptomes, pt waited additional 15 minutes and said felt better and ok then left. Pt advised if gets worse or not gone after 1 day to see Dr.
20 hours after the injection, I started violently vomiting.   21 hours after the injection, I spiked a fever.  (My husband could not locate any of our thermometers.)  I was sweating and trembling until 3/4 am.
Left shoulder pain and weakness - 2 weeks Chest tightness and pain - randomly for 2 weeks
Expired vaccine administered to patient; Vaccines administered after being in stored in fridge past 30 days; Patient received Moderna bivalent vaccine as First dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
I received my first dose of vaccine on January 12th, 2021 and just had a little bit of a sore arm for the first 2 days after.  Then on January 20th, 2021 I woke up in the morning and my arm was very painful, red, inflamed and itchy.  The redness continues to spread on my arm.
Metallic taste in mouth./Food, and water are tasting extremely salty, like tin/metal, and marzipan; This is a spontaneous report from a contactable consumer. A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (age at vaccination 44 years) as dose 1, single for covid-19 immunisation. Medical history included Periodic iron deficiency, Bee stings, penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced metallic taste in mouth /food, and water are tasting extremely salty, like tin/metal, and marzipan on 08Jun2021 12:00. She has brushed my teeth twice. Currently no other symptoms. Drinking plenty of water, (2-3 liters), which is her normal daily routine. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Presented to the ED on 3/1/21 with progressively worsening SOB with cough for past 1.5 weeks. He also reported having bright red blood per rectum for the past 6 months. He denied fever, N/V, abdominal pain, etc. He reports that he stopped smoking ~2 weeks ago and this is when his symptoms started.  Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
After chills low grade fever March 8th first night of vaccine, the second day March 9th severe headache neck stiffness/pain, dark urine on waking in am.  Heart bounding with some skipped beats. At 12:30 wave of nausea, sat on bathroom floor then awakened outside of bathroom on floor. Got to couch and checked my oxygen saturation with husbands pulse oximeter with no reading showing.  My fingers were yellowish and nailbeds pale slightly bluish. I put my husbands oxygen on nasal cannula at 2liters and oxygen saturation came up to 96% and I felt better. Left oxygen on till evening. Drank as much water as I could. March 10th still dehydrated heart rate 100 with some skipped beats and still bounding oxygen saturation 94% room air. Still some nausea. Urine less dark but cloudy. March 11th. Still stiff neck. New left face pain and yellow bruising near left jaw below temple with 2 small blood filled pimple like spots. Better now.
Shingles - rash and severe hip pain on set approx 3.5 weeks after vaccine
Patient developed painful blurry vision in left eye that progressed to painless blurry vision in same eye within 24 hours after onset of symptoms. Patient had edematous and pale retina with swollen optic cup. Patient has had complete vision loss in his left eye since.
SWELLING UNDER THE ARM OF INJECTION SITE. SLOWLY RESOLVED ON ITS OWN WITH NO MEDICAL INTERVENTION. PT STATES THIS HAPPENED ONCE BEFORE A COUPLE YEARS AGO BUT WAS WORSE THE LAST TIME.