chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed away; Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) and MYOCARDIAL INFARCTION (Heart attack) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2018.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient died on 13-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            The patient did not receive a second booster dose. The patient experienced a heart attack around holiday 2021. It was reported that the father's death was not in relation to the vaccine.   No concomitant medication was reported. No treatment medication was reported.  Company comment: This case concerns an 85-year-old male patient, who experienced unexpected, serious (medically significant) AESI of Myocardial infarction and who had a fatal outcome with unexpected serious event of Death. Onset latency cannot be determined as the start date of the events as well as the vaccination dates were not reported. The patient reportedly received 3 doses of mRNA-1273 vaccine Clinical course and treatment details are not available in this report.  Cause of death was not reported in this case. It is unknown if an autopsy was performed.  The event was considered unrelated to the mRNA-1273 vaccine as per the reporter's assessment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up documents contains no new information.; Sender's Comments: This case concerns an 85-year-old male patient, who experienced unexpected, serious (medically significant) AESI of Myocardial infarction and who had a fatal outcome with unexpected serious event of Death. Onset latency cannot be determined as the start date of the events as well as the vaccination dates were not reported. The patient reportedly received 3 doses of mRNA-1273 vaccine Clinical course and treatment details are not available in this report.  Cause of death was not reported in this case. It is unknown if an autopsy was performed.  The event was considered unrelated to the mRNA-1273 vaccine as per the reporter's assessment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Death- after vaccine patient was ill with dizziness and lethargia. Patient went to bed at 8pm that night. Patient was found deceased the next day when housemate went to wake him up. Patient had no prior history of underlying health complications. Cause of death ruled to be sudden unexpected heart attack.
Patient with syncopal episode after shots. He turned grey and tightened up with loss of consciousness and eyes rolling back for a few seconds. He lost control of his bladder. No tonic clonic activity. Episode lasted several seconds and then patient recovered spontaneously. HR 70 and Sat 97% at end of event. Patient rested and ate peanut butter cracker with complete resolution of symptoms after several minutes. Mom has history of procedural syncope. Patient had skipped breakfast prior to shots. MD discussed with the family the need to eat before shots and to rest/lay supine for a while afterward.
Syncope - pt. received vaccine, went to sit in waiting area then approximately 2 minutes later the pt passed (fell out of his chair).  Pt. was rolled over on his side to prevent aspiration incase of a seizure.  EMS was called immediately who responded within 45 sec to 1 minute as they were already in the store.  EMTs then took over care. Pt. declined a hospital visit and was released after responders left the scene.
NICM, Mixed hyperlipidemia, hypokalemia, Elevated Metanephrines, mayocardia.
Came week after shot had low back pain with a little swelling, then neck, shoulders, and elbows, thinks it might be polymyalgia rheumatica. Taking ALEVE and using hot packs but getting worse.
fever; chills; severe body aches; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 13Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history and concomitant medications were none. Historical vaccines included first dose of BNT162B2 on 23Dec2020 for Covid-19 immunization and with a week (30Dec2020 16:15) he developed COVID positive test, had a mild to moderate illness. The patient received second dose and developed fever, chills and severe body aches on unspecified date in Jan2021. The outcome of the events fever, chills and severe body aches was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Fever 102 F within 3 hrs of injections and for 36 hrs following. Irritability, anorexia x 1 wk. Recurrence of fever 1 wk after injection with complex seizure (45 minutes and requiring intubation). The discharge note states, "ehtmoid and maxillary sinusitis." The discharge summary received on 3/23/04 states atypical complex febrile seizure.
Patient stated she had SHINGRIX number 1 injection on 6/29/2018 and c/o fatigue, headache local pain on the left deltoid.
At the time of injection giving, patient was under the age of FDA approval of 18 years old. Pharmacy reached out to patient to notify them and explain what happened and how to proceed.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 29Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. It was unknown if the patient had allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Positive, notes: testing positive for COVID 19 on Saturday 26Aug22. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started paxlovid on 18Aug2022 through 22Aug2022 and rebounded on 25Aug22, testing positive for COVID-19 on 26Aug2022.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 21-year-old female subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and Influenza (manufacturer and lot number not reported). The subject's troponin I result was not available. The subject had a normal ECG on 12 November 2009. The subject was diagnosed with other, chest pain on 13 November 2009. The subject had a medical history of dizziness/fainting spells and notes that were not available on an abnormal ECG and eczema. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sudden memory loss 3 weeks after vaccination. MRI showed the following several days after onset of symptoms:  Restriction abnormality involving the mesial LEFT occipital lobe and LEFT aspect of the splenium  representing acute or subacute infarct perhaps in the distribution of the LEFT posterior  cerebral artery. Other etiologies certainly could be considered for restriction abnormality.  Moderate periventricular white matter ischemic demyelinating disease.  Health care provider immediately informed via "nonverbal call report".  DICTATION TIME: 4/10/2021 12:59 PM
Information has been received from a RN concerning an adult pt who in approx Feb 2006 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). Subsequently the pt developed an injection site reactino to include redness, swelling and pain at the injection site. Unspecified medical attention was sought. At the time of the report, the pt was recovering. Additional information has been requested.
Patient not administered second dose within timely manner. Initial dose administered 3.3.2021, discovered 5.24.2021 that second step had not been administered.
2/28/23 I started coughing continuously. I had a little bit of a temperature around 98.6 which is high for me. I took an at home COVID test which was negative. I began coughing up stuff. As the days progressed, I could not stop coughing. I began coughing up a yellowish, almost green mucous. On 3/2/23 I took an at home COVID test which was negative. I had a telehealth on 3/10/23 and was put on doxycycline and prednisone. I started breathing easier and the coughing stopped. I was able to cough up all the mucous. It took about a week before I started feeling better. I woke up on 3/21/23 with severe intestinal cramping. I have never had these types of issues. The cramping was very severe. I was told my color was gray. I went to the emergency room. I was given IV fluids, pain medicine and had a CT of my abdomen which did not show anything. I started having diarrhea and nausea in the emergency room. I was given medication for the nausea. The pain medicine subsided my pain some. I had bloodwork which was normal.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:10 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.95 for dose administered on 28-Mar-2021 and 65.88 for dose administered on 28-Feb-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit from 09 AM to 01 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome in the mechanical cardiac valve, leukipenia, thrombocytopenia, encephalopaty, acute kidney injury, respiratory failure, tachycardia, new onset afib. Patient is currently still hospitalized and declining in status- on ventalator
Severe Multisystem Inflammatory Syndrome; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (medically significant), outcome "unknown", described as "Severe Multisystem Inflammatory Syndrome".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Severe Multisystem Inflammatory Syndrome. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-202200572949 Same article/drug/event and different patient.
Shoulder pain/impingement starting more than a week after the vaccination. it has lasted to now.
Information has been received from a physician concerning 2 patients who on unknown dates, were vaccinated with a dose of VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) (dose and route not reported). It was reported that the physician had two patients who experienced swelling on the leg, fever, it became red, itchy and warm to the touch (dates unspecified). The patients were given BACTRIM and KEFLEX as treatment for the adverse events. The patients sought unspecified medical attention. At the time of the report, the patient's outcome were recovering. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a health care professional who stated that she was not familiar with the two patients who were vaccinated with the VARIVAX (Merck) (lot number 670992/0822AA, expiration date June 2013) and experienced the above adverse events. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, date of event and recovery status. This is one of the two reports from the same source. Additional information has been requested.
Patient reports symptoms started 4 hours after vaccination- changes in vision, severe abdominable pain, rash to both arms, high temp 100-102 and was sick for 6 days.
Very strong chills resulting in muscle spasms began at about 3am ~11 hours after receiving the vaccine. These spasms lasted until roughly 8am and were strong enough to rattle my 300lb bed frame. The only treatment I could think of at the time was to get as warm as I could so i covered myself in 8 blankets and just waited it out. It is now noon and the chills/spasms seem to be gone.
day 2 (3/2/2021) left arm swelling and red over the inject site; painful to raise arm overhead. day 3 - fatigue/chills - arm better, little pink inject area; swelling down.  day 4 nausea/regurgitation/loose stools.  day 5 called doc Thursday still weak-  Dr said symptoms are among those possible; Advised I  likely have more severe symptoms for 2nd shot; get gatorade; Imodium, BRAT diet foods, etc.  Mon 3/8 had 3 near fainting spells. (3/8 pm -red painful rash on left arm inject site. Lasted till 3/15 Mon COVID ARM?) Checked BP and Pulse/Oxy. Called Doc/video visit; Thought my BP/O2/Pulse  numbers OK/ Ordered  blood work.  3/11/2021 8:40am  did blood/urine tests/ Made follow up appt for 3/16 with GP.
240PM pt c/o nausea, blurred vision, sweating, dizzy, feeling weird, neck pain, h/a noted 2 episodes of weak voice, slow to respond the last episod;posturing of head to rt & shaking head;slow but responsive;no rash noted;
Blisters in my mouth, my tongue; Blisters in my mouth, my tongue; Hadn't have any other symptoms except I had not been feeling right that I had been feeling real bad.; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Big blotch, not at the injection site but below it, it was red, swollen and itchy; All blistered and swollen ; whole mouth is sore and my tongue is blistered; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Tongue is tightening; I think that was a symptom of Covid, called Covid tongue; This is a spontaneous report from a contactable consumer (patient).  An 86-year- old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318 and expiration date not provided), via an unspecified route of administration second dose on 26Jan2021 at single dose for Covid-19 immunization.  The patient's medical history included High Blood Pressure. The patient's concomitant medication included amlodipine, alendronate sodium, hydrochlorothiazide, levothyroxine, losartan for Hypertension, and simvastatin. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) first dose on 05Jan2021. It was reported that patient had the second dose 5 days ago on 26Jan2021 and three days after the patient got the vaccine  on 29Jan2021 the patient experienced got all these blisters in my mouth, my tongue and everything, top of my tongue is tightening. The patient wonder if that was a type of reaction from the vaccine. The patient think that was a symptoms of Covid, called Covid tongue. The patient did not know if she should go to the doctor or thought that it was just a reaction. It was still on, it was 5 days now and it was still all blistered and swollen. The whole mouth was sore and patient tongue was blistered. The patient did not have any other symptoms except the patient had not been feeling right that I had been feeling real bad.  The patient had a real big blotch, not at the injection site but below it, it was red, swollen and itchy but other than that I have nothing and I just know for sure I hadn't heard of anything that there had been a reaction from the vaccine. The patient wanted was wondering if these reaction was from the vaccine or you think I should go, get tested? The events Oral mucosal blistering, Tongue blistering, Oral pain, Swollen tongue, Mouth swelling, and Tongue disorder was treated with mouth wash. The outcome of the events was unknown.
Patient was diagnosed with Myocarditis as a result of the booster. Symptoms of chest pain showed up 3 days after the vaccine. The patient was released after a day in the hospital. He was prescribed anti-inflammatories to help with the inflammation. Ongoing check-ins are needed.
Fatigue, metallic taste in mouth, increased thirst and urination, tinnitus, chills, achy, headache
No adverse event; 1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture) and NO ADVERSE EVENT (No adverse event) in a 62-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 9:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture).    No concomitant information were reported.  The reporter asked for some stability information.  On 29-Sep-2022 at 11 am PT, the vial (size 2.5 mL) was first punctured.  The vial was refrigerated post puncture. The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was reported as refrigerated for 22.5 hours.  No treatment details were reported.
I had already been scheduled for a mammogram three days before my mammogram. I had to do my annual breast check up and noticed a big mass I never felt before. That same day it was confirmed that it was a mass but the doctors didn't know what it was. Then I was scheduled five days later to have a biopsy with an oncologist Dr. from Hospital. Everything started moving fast in my body once they detected what I have. I have o negative blood. When I have anything foreign in my body in causes my body to overreact.
5-6 hrs p/vax felt weak had rapid pulse, felt like had a hard time staying conscious went to ER; was sent home a couple of hrs later-slept all next day, had fever, backache; doesn't feel well, had orthostatic hypotension, syncope went to MD
1 week after vaccine c/o redness and swelling at site. Tender to touch no c/o fever.