chrisvoncsefalvay/vaers-outcomes huggingface dataset:
product=COVID 19 Treatment, brand=pavlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=pavlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), in left arm and on 08Apr2021 as dose 2, single (Lot number: EP7533) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 as dose 3 (booster), single (Lot number: 059H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "DIABETIS" (unspecified if ongoing). There were no concomitant medications. No other medication in 2weeks. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "product:COVID 19 Treatment, brand:paxlovid/vaccine brand:Pfizer / BioNTech". Treatment start date:12May2022..NO known allergies Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Pt felt cold, sweaty, nauseous, dizzy, and had trouble seeing right after receiving the vaccine.
Upon sitting in chair in observation area, pt. states he pulled out his phone to look at it and "it hit me all of the sudden" feeling dizzy, and then he "woke up on the floor." When RN in observation area arrived pt. was unconscious and not responding. Turned pt on to side; pt. was breathing and "stiff." Pt. then came to and was able to answer questions. Pt's eyes dilated and face was pale. EMT on site responded to pt., assisted to wheelchair and taken to observation room. Pt. continued to feel lightheaded with waves of nausea. Pt. drank 3-4 small water bottles, 1 juice box, and ate 2 packs of crackers and 1 protein bar during 45 minute visit. Other than color returning to face, status remained unchanged and unimproved during stay. Pt. encouraged to be seen at hospital for further observation; he agreed. EMT's transferred pt. to hospital.
First two shots, I fell and had hard time getting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 2, single (Lot number: EW0171) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "taken blood pressure medicine" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9264), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Fell". The following information was reported: FALL (non-serious) with onset 2021, outcome "unknown", described as "First two shots, I fell and had hard time getting up". Therapeutic measures were not taken as a result of fall.  Patient had an adverse reaction to the first two Pfizer Covid-19 vaccine shots. First two shots, patient fell and had hard time getting up. Patient had taken blood pressure medicine at that time and found out later on, you should not take it as it can drop your blood pressure. No investigations were conducted. Patient had blood pressure medication that patient stopped taking before he got the shot, booster shot. Because with the blood pressure medication getting the shot, the blood pressure dropped, according to patient's doctor. So, patient didn't take his blood pressure. That was week a later. Patient did not take regular medications, had no lab work, no treatment, and no prior vaccinations. There was a product complaint to report.; Sender's Comments: Linked Report(s) :PFIZER INC-202201375592 Same patient/reporter, different vaccine dose;
couldn't use her arm from the shoulder to her finger tips; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips). At the time of the report, MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient can't guarantee it was the Moderna vaccine she got. No concomitant medication was reported. No treatment medication use was reported.
very mild heart attack; chest started burning; couldn't breath; incomplete course of vaccination; very sick; arm got little sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (very mild heart attack) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SIMVASTATIN for an unknown indication.    The patient's past medical history included Allergic reaction (MMR vaccine allergic reaction as an infant) in 1973. Concomitant products included PANTOPRAZOLE, SERTRALINE and VARENICLINE TARTRATE (CHANTIX) for an unknown indication, ACETYLSALICYLATE LYSINE (ASPARIN).   On 24-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SIMVASTATIN (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm got little sore). On 25-Mar-2021, the patient experienced ILLNESS (very sick), DYSPNOEA (couldn't breath) and INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 25-Mar-2021 at 8:00 AM, the patient experienced MYOCARDIAL INFARCTION (very mild heart attack) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (chest started burning). The patient was hospitalized on 25-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (very mild heart attack), ILLNESS (very sick), CHEST PAIN (chest started burning), DYSPNOEA (couldn't breath), INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) and VACCINATION SITE PAIN (arm got little sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Angiogram: normal (normal) no signs of plaque buildup. On 25-Mar-2021, Blood creatinine: abnormal (abnormal) levels determined patient was having a mild heart attack. On 25-Mar-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was very panicky about getting the second dose for fear that she would have another heart attack. She went to the cardiologist for a follow up and the doctor could not determine why she had a heart attack. The patient reported that it was not a normal heart attack in that her blood pressure and pulse were not raised, but instead, were low. The patient agreed to follow up with her HCP (health care provider).  Treatment for the heart attack included SIMVASTATIN and BABY ASPIRIN to prevent blood clots.  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.
pt recv vax 19JUN96 & that night and next day devel 5x9cm welt approx 2-3cm distal to inj site, local inflammation, erythema, h/a & leg weakness;
fever and rash. Fever resolved over 72 hours with Tylenol and ibuprofen. Rash gradually improving at 96 hours without intervention. Patient's fussiness and irritability gradually getting better at 96 hours with Tylenol and ibuprofen as needed.
Information has been received from a physician concerning a female who on unspecified dates was vaccinated with the three doses of GARDASIL vaccine (yeast). The physician reported that the patient tested negative twice for HPV before receiving GARDASIL vaccine. After her three injections, the patient tested positive for HPV. On an unspecified date the patient had a "Reflex Test" with WCP lab; which revealed she was a patient that had "ASCUS (abnormal undetermined cells)". The patient sought unspecified medical attention. Additional information has been requested.
Throat started to close and mouth got very foamy, hard to swallow-noticed about 5 mins after shot.
red, raised patches that are itchy; bump near injection site; sore around injection site; red, raised patches that are itchy; red, raised patches that are itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy), VACCINATION SITE PRURITUS (red, raised patches that are itchy) and RASH (red, raised patches that are itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and # 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy) and VACCINATION SITE PRURITUS (red, raised patches that are itchy). On an unknown date, the patient experienced RASH (red, raised patches that are itchy). The patient was treated with IBUPROFEN (ADVIL 12HOUR) for Itching, at a dose of 1 dosage form and CORTISONE ongoing since an unknown date for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy), VACCINATION SITE PRURITUS (red, raised patches that are itchy) and RASH (red, raised patches that are itchy) outcome was unknown.            no concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable
BRIEF OVERVIEW: Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 9/13/2022 Discharge Date: 09/22/2022 Presenting Problem: COVID  DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 63 y.o. male with past and current medical history of ICM s/p HM3 implanted at facility 2016, currently listed status 4, CAD, hx CVA with slight residual right-sided deficits, hypertension, hx strep bacteremia, hx VT on amio and mexiletine, and iron deficiency anemia.    He presented to Facility 9/12/22 for evaluation of fatigue and abdominal pain. CT abd/pelvis showed intussusception. He was transferred to Facility 9/13 for evaluation and treatment by team. Incidentally, he tested positive for COVID. On admit, patient was seen by general surgery, no acute concerns and no indication for surgery or intervention. Concern that his symptoms were all from COVID. CXR concerning for pneumonia and he initially required supplemental oxygen. ID was consulted who treated COVID with decadron and remdesivir.    The patient also demonstrated evidence for fluid overload with acute on chronic combined CHF.  He responded well to IV diuresis he became euvolemic.  He was also quite constipated and this resolved with aggressive bowel regimen.  He had notable improvement in his general condition, although some lingering symptoms attributable to COVID-19 (primarily cough).  No issues with vaginal Shin appreciate during the hospitalization.   The patient's condition stabilized and he was started on routine/daily torsemide to continue at home.  He felt comfortable with the plan to  return home and was discharged on 09/22.
Physician Discharge Summary      Admit Date:  7/12/2022 Discharge Date:  7/15/2022      Principal Diagnoses:  Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   HTN (hypertension)   HLD (hyperlipidemia)   Acute diastolic CHF (congestive heart failure)   Chronic respiratory failure with hypoxia   Elevated troponin   COPD with acute exacerbation   GERD (gastroesophageal reflux disease)     Discharge Diagnosis:  Acute on chronic hypoxic respirtory failure, COVID 19, Acute diatolic CHF, elevated troponin. HTN.    Hospital Course:  The patient was admitted with the above. She was treated with remdesevir 3/3 days and steroids. Her oxygen requirement here was 21/2 liters and her home oxygen was 2 liters. She was initally treated with IV Cefepime and vanc but nothing grew on cultuers so she was placed on omnicef to complete 5 days. She had an elevated troponin on admission with no chest pain. She had a preserved EF on 2D echo. She had a low risk stress. She was asked to follow up outpatinet.    Consults to: Pulmonology, Cardiology.    Significant Diagnostic Studies: 2D echo, Stress test.    Procedure(s): none.    Disposition:  home   Discharge Condition:  fair
Severe local reaction 100cm swelling redness, tenderness, fever on 13DEC & 14DEC91 t101;
Right Knee is extremely swollen; Difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking). The patient was treated with DICLOFENAC at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking) outcome was unknown.            Concomitant product details was not provided by the reporter. Action taken in response to mRNA-1273 was not applicable
I take medication for endometriosis that prevents me from having periods. I started cramping and bleeding slightly earlier. So far I still am but am monitoring my symptoms
ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
At 11:00 AM on 12/18/2009 five minutes after receiving H1N1 flu mist client had a bloody nose. Bleeding stopped within a few minutes, but client reported she was becoming very tired. Client struggled to keep eyes open. She became faint, and her speech became slurred. Nurse laid client on the floor and elevated legs. Lethargic condition increased in state. 911 was called. Paramedics arrived at 11:10 AM and took the client to the ER. There it was determined client recently had a sibling die and may have an adjustment disorder. Client was treated for syncope and dehydration and then discharged.
issues getting the product to mix/ After about 4-5 hours some of the particulate dissolved, but not all of it; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Sep2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pf-06928316 (ABRYSVO), as dose number unknown, single (Lot number: HF5014, Expiration Date: Feb2025) and as dose number unknown, single (Lot number: HF5016) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "issues getting the product to mix/ After about 4-5 hours some of the particulate dissolved, but not all of it". Additional information: She ended up going through 3 seperate kits. She went through it 3 times for 2 different patients. Caller reported that they had particulate in the product that would not dissolve. All 3 had particulate matter. After about 4-5 hours some of the particulate dissolved, but not all of it. These Abrysvo that had the issues mixing were not administered to the 2 patients. The 2 patients received different kits of Abrysvo that did mix properly. Caller confirmed no patient involvement with the Abrysvo with the product quality issues. Caller said that the 3 kits of Abrysvo in question all had the same lot numbers for all of the components. The sample of the product is unavailable to be returned, if requested (Y/N). Packaging was sealed and intact.  Causality for "issues getting the product to mix/ after about 4-5 hours some of the particulate dissolved, but not all of it" was determined associated to device constituent of pf-06928316 (malfunction).  The information on the batch/lot number for pf-06928316  has been requested and will be submitted if and when received.
My hands went numb whenever I wasn't using them, especially when sleeping.  I am woken up several times a night with numb hands and tingling fingers.  This got slightly better about 2 weeks after my booster but it has not improved since and is still very substantial.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 11-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # reported as L028277, expiration date 28-JUL-2017). No adverse effect reported. Additional information has been requested.
CHIEF COMPLAINT Progressive shortness of breath with cough and generalized weakness x 1 week
Crying (R) leg was red & swollen had T. max of 102.2 went to ER no tests ran, no meds given.
Last week I experienced a very big blockage pressure in both my ears it was very uncomfortable felt like something was stuck inside.  It did happen couple times following the vaccine but last week was the longer lasting tried cleaning it with those ear scraper but the walls was clean. Then today I seen on the news about this condition tittius Vaccine one 7/12/21 Vaccine two 8/3/21 It was after second dose I would experience this stuffy hear but last week oct 2021 was the worse because it was ringing for short while and the stuffiness lasted about an hour unlike the other days it comes and goes
He developed severe hyponatremia (114 meq/dl) approximately 6 hours after receiving an adult Td. Patient has recovered.  Nurse follow up on 05/25/04 states: "Altered Mental State (Confusion)."
HPI: Patient is a 71 y.o male with a history of postviral herpesvirus reactivation, B12 deficiency, and recent COVID vaccination who presents with tingling sensations bilaterally in the thigh of 2.5 weeks duration. Patient received 2nd dose of COVID (Moderna) vaccine on 3/20, and afterwards reported feeling lower back pain, tingling sensations mostly in the lateral thigh down through the lower leg and dorsum of feet. As of one week ago, these symptoms have receded somewhat, and the patient now reports tingling localized to the thigh only, bilaterally, circumferentially. He describes the tingling/numbness as similar to a sunburn, and that it bothers him when walking due to friction between his skin and pant legs. Of note, the patient denies any diplopia, and notes only very minor numbness in the jaw, both of which he has experienced during episodes of his postviral reaction. Furthermore, patient did report a worsening of his tinnitus, but states that it has improved in the past 3-4 days, almost back to baseline. Patient was taking 3x 200 mg ibuprofen to little effect, and reported similar lack of relief with naproxen. Patient notes inconsistent use of B12 supplements.  Diagnosis: Immune/inflammatory response to COVID vaccine. This is the most likely etiology of the patient's symptoms given the timing of events and his history of postviral herpetic reactions. His symptoms of tingling/numbness began soon after his 2nd dose of the COVID vaccine, and due to this rapid onset and temporal association, it appears likely that his current symptoms may be related. While the symptoms described by the patient and their duration are not typical of COVID vaccine side effects, these neurological symptoms are similar to previous episodes (albeit in a different location) experienced by the patient, which responded to antivirals. As the COVID vaccine is immunogenic, and given these prior episodes of similar symptoms, the patient's current presentation is likely a reaction to the vaccine.
Received 2nd dose of the vaccine while pregnant; arm was sore; nausea; Fatigue; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Jun-2020 and the estimated date of delivery was 02-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant), PAIN IN EXTREMITY (arm was sore), NAUSEA (nausea) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received 2nd dose of the vaccine while pregnant) and PAIN IN EXTREMITY (arm was sore) had resolved. On 15-Feb-2021, NAUSEA (nausea) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included certax. Treatment information was not reported.   This case was linked to MOD-2021-026240 (Patient Link).
Upon administration of pfizer adult dose, the self retracting syringe retracted prior to complete administration of immunization. Some of the dose leaked out onto the arm. Per standing order, if equal to or greater than half the dose was administered, do NOT administer a second dose. I am confident patient received over half the dose.
Slept 6 hours, woke up with tremors and stuttering lasted about 4 hour. Was hard to walk.  Using my cane now for precautions.
2 DAYS POST SHOT PATIENT DEVELOPED TONGUE SWELLING, SWOLLEN LYMPH NODES AND WELTS ON THE BACK OF TONGUE THAT CAUSED PAIN IN THE MOUTH