chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Triple vaccinated with BNT162b2/ he tested positive for COVID-19; Multisystem inflammatory syndrome; Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare, life-threatening complication of coronavirus 2 (COVID-19) infection characterized by severe inflammation and multi-organ injury.  Case: A 20-year-old male with sickle cell trait and obesity who was triple vaccinated with BNT162b2 presented with 1 day of dyspnea. Two weeks before presentation, he tested positive for COVID-19 and was asymptomatic. Ten days later, he developed fevers and diarrhea. The next day, he had dyspnea and presented to the emergency room. Vitals were T 39.3, HR 148bpm, BP 82/57mmHg, RR 20/min, O2 saturation 97% on HFNC FiO2 40%, 40L/M. Lab data were notable for WBC 25k, Cr 2.1 mg/dL, lactate 8.0 mmol/L, ESR 130 mm/hr, CRP > 300 mg/L, high-sensitivity troponin 759 ng/mL, SARS-CoV-2 PCR negative. Transthoracic echocardiography demonstrated severely reduced biventricular function with an LVEF of 15-20%. Pulmonary artery catheterization suggested mixed distributive and cardiogenic shock, with a pulmonary capillary wedge pressure of 31 mmHg, PA Saturation of 47%, Fick cardiac index of 1.7 L/min/m2, and a SVR of 266 dynes/seconds/cm-5. CT scan of his chest, abdomen, and pelvis demonstrated right middle lobe collapse.  Decision-making: The patient had severe mixed cardiogenic and vasodilatory shock, hypoxemic respiratory failure, and oliguric acute kidney injury. On hospital day 2 he required intubation, VA-ECMO cannulation with 29F right femoral venous drainage cannula and 15F right femoral arterial reinfusion cannula, and CRRT. With multi-organ failure and cytokine storm as well as unremarkable infectious and autoimmune workup, he met criteria for MIS-C. He received broad antibiotics, IVIG, steroids, and anakinra. His cardiac function improved, he was decannulated from ECMO after 7 days, and discharged to acute rehab on day 29 with complete cardiopulmonary and renal recovery.  Conclusion: This case demonstrates the feasibility of ECMO support with immunomodulatory therapy for the successful treatment of a patient with MIS-C. ECMO support should be considered early in patients with cardiopulmonary dysfunction refractory to conventional treatment.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events. 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.
I still don't feel like my old self; tired; aching all down her left side; I started feeling not well /I still don't feel like my old self/ tired; arm got very sore; extremely painful; headache; earache; nauseous; chills; A spontaneous report (United States) was received from a reporter like consumer concerning a 81yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like started feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. The patient's medication history was not provided. Concomitant medications included Vitamin C Women's probiotic , Multivitamin. On 3feb2021 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 028L20A ) intramuscularly in the anatomical location in the left arm for prophylaxis  of COVID-19 infection. Following the vaccine administration the patient experienced feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. Laboratory details were not provided.  Treatment information was not provided. The outcome of the event was recovered/resolved. Action taken with mRNA-1273 in response to the events was unknown.  Based on MSA comment all events (MAH causality assessment is missing)
SARS COV-19 Infection. Cough, congestion, runny nose, fever, loss of taste, loss of smell, headache, shortness of breath, sore throat, fatigue, chills, muscle aches.
Pt given Rabavert on 5/8/01 and returned on 5/9/01 with generalized rash.
temperature excursion; This spontaneous report was received from a registered nurse and refers to currently 11-year-old patient of unknown gender.   There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1637641 with expiration date 16-FEB-2022 (dose, route, and anatomical location were not reported) which where stored at temperature excursion. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to temperatures between 0.3 and 11 degrees Celsius during 4 hours 45 minutes and 1 hour, 30 minutes respectively. There was previous temperature excursion of 17 degrees Celsius during 2 hours and 42 minutes. Data digital logger was filled.  This is one of several reports from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient notice swelling underneath left arm radiating to the left breast. Noted soreness, pain at a level of 6/10, and tenderness. No redness noted, skin is not warm. No swelling or redness noted on the injection site.
(1) Maculopapular blanching rash - 1 wk after vaccine mainly unilateral (Right side of body). (2) Fever. (3) Body ache loss of appetite. (4) vomiting/diarrhea.
By nighttime the day of the shot I had developed a fever of 103, strong chills, fatigue and muscle ache. Fever and chills did not respond to fever reducing pills (Tylenol, acetaminophen or ibprophen). It lasted for 4 days straight before the fever broke. No noticable energy or strength for about 2 weeks.
Hospitalization for COVID-19 Repiratory Infection with hypoxemia treated with redmdesivir. .   Symptoms: right side chest pain, cough, body aches for 2 days prior to hospitalization. Hospitalized for 5 days
The night of getting the vaccine I had a horrible headache. My body was stiff and sore with severe muscle aches and pain. That lasted for 2 days. The headache lasted for 3 days. I took some sumatriptan and Amitraz. I could not raise my left arm for 3 days.
pt recv vax 1AUG95 & on 10FEB98 pt broke out w/chicken;had a total of 14 lesions which were not really pruritic;no fever was noted & was acting okay & was not ill @ all;13FEB98 lesions had crusted over & pt recovered;
Fever of 101.8, chills, and body aches starting at 7pm and ending the next morning
This spontaneous case, initially received on 28-Sep-2016, was reported by a health professional and concerns a 52-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 27-SEP-2016 to 27-SEP-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WAT55407. No additional suspect drugs. Adverse reactions/events and outcomes: On 27-Sep-2016 immediately after injection with AFLURIA, the patient was nauseated and experienced a metallic taste in mouth (outcome: unknown). Reporter comments: The healthcare professional considered all events non-serious.
MODERNA VACCINE GIVEN TO PATIENT WHO IS 16 YEARS OLD. CURRENT EUA FOR 18+ ONLY.
Information has been received from a mother concerning her 12 month old son who in May 2003 was vaccinated with a dose of MMRII, SC.  Subsequently, "8-9 days after administration," the pt had blood in his stool, was dehydrated and was inconsolable.  The pt was hospitalized. X-ray and blood test were reportedly performed, however results were not reported. No product quality complaint was performed. The reporter considered blood in stool, dehydrated and inconsolable to be immediately life-threatening. Additional information has been requested.
Onset wrist itching, then trunk. Gradually developed red, raised rash. Feet became painful with walking 10/19 and continued 10/20/09 with swelling. Severe indigestion-symptoms better 10/20 afternoon.
Had pneumonia shot at approx 1400 state around 1600 arm began to swell. In the evening felt chilled, had a low grade fever. Phoned health dept around 10:00 on 10/18 stating that are was red, warm and swollen, bigger than her head.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 09-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Resting heart rate reached 120 bpm. Blood pressure reached 172/111 at 10:44 pm on 2/5/19.  Arrived at emergency room (Medical Center at 11:01 pm on 2/5/19. Had EKG which was fine. Had blood work which was fine. Vitals were checked every few hours: 1:17 am on 2/6/19 -- BP 135/96, heart rate 113, temp 99.5. At 3:00 am 2/6/19 -- BP 159/93, heart rate 104, temp 100.0. At 4:02 on 2/6/19 -- BP 156/97, heart rate 103, temp 99.0. By 5:00 am, BP down to 96. Given 700 mg TYLENOL and discharged home. Heart rate and blood pressure continued to decrease throughout the day on 2/6/19.  Around 8:00 pm on 2/6/19, broke out in sweat and felt much better, BP 125/86, heart rate 86. By 2:00 am on 2/7/19, BP 112/76, heart rate 76. Feel almost 100% well now on 2/7/19 9:00 am.
4:15 pm Presented self after vaccination w/ c/o sl. H/A and lips feeling funny.  Lips observed w/ no swelling.  B/P 97/61, HR 86, O2 sat 99%, T 97 deg.  Stated lots of stress.   4:30 pm Stated feeling much better. 4:40 pm Left observation.
p/vax pt devel redness, swelling, limping & tenderness over rt anterior thigh;8/19/99 swelling & redness extended from anterior thigh to knee+warmth;tx w/keflex-improved;resolved by 8/21/99;
fever; fatigue; general sickness 6 days post vaccine/illness; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 10Mar2021 (at the age of 55 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. On 16Mar2021 at 20:00 patient experienced fever, fatigue, illness, general sickness 6 days post vaccine. Covid test after post vaccination [covid test type post vaccination=Unknown]: Negative. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for events. No hospitalization required. The reporter considered events as non-serious. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Cardiomegaly without typical pulmonary edema; Had shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 13Aug2021 at 15:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included diagnosis (dx) with glioblastoma 62 days after COVID hospitalization in Oct2020 and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. On 01Feb2021, the patient underwent COVID-19 test via nasal swab and the result was negative.  Concomitant medications included losartan (MANUFACTURER UNKNOWN), pregabalin (LYRICA) and levetiracetam (KEPPRA); all from unknown date for unknown indication and unknown if ongoing. The patient previously received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 16Jul2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. On 14Aug2021 at 13:00, the patient experienced cardiomegaly without typical pulmonary edema. The patient had computed tomography (CT) and chest X-rays before first shot and after second shot. The patient's daughter noticed that the patient had shortness of breath and the patient did not had the issue all year. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included CT and chest X- ray. Since the vaccination, the patient had not been tested for COVID-19 (also reported as yes). The clinical outcome of the events cardiomegaly without typical pulmonary edema and had shortness of breath was unknown at the time of the report.
PRODUCT ADMINISTRATION ERROR; VACCINE LEAKAGE AT THE SITE OF INJECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced product administration error. On 01-APR-2021, the subject experienced vaccine leakage at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from product administration error, and vaccine leakage at the site of injection. This report was non-serious.
Immediate Symptoms - Metallic taste in mouth, racing heart, dizziness, full body weakness, upper body shaking, nausea, breakout in sweats, felt pop in right lung and pain in rib cage that persisted for several weeks within the first 24 hours. 1st Month Symptoms - Neuropothy stemming from neck shooting down right arm to right leg. 2nd to 4th Month Symptoms - Return of concussion symptoms, not able to drive, light sensitivity, headaches, nausea, sensitive to sound, loss of sensation from right side of body top of head down to toes, muscle weakness, difficulty walking, problems with coordination and clumsiness, profound fatigue, heat intolerance, hard to empty bladder, blurred vision, cognitive issues, dizziness. 5th Month thru 7th Month Symptoms - Intense neuropothy on right side, right calf pain, pins & needles in right hand and foot, joint pain, intense burning aching pressue thoughout the entire spine, swelling of feet that reopened an incision on right foot (was sent to a rheumatologist), profound loss of appetite, frequent bouts of diarreah, uncontrolled bouts of high blood pressure, intense pain throuout entire body. 8th Month thru 11th Month Symptoms - Remission from pain with continued brain fog, gastrointestinal issues remain. 12th Month thru 14th Month Symptoms - Orthostatic intolerance, heart rate fluctuations, palpatations, chest discomfort, blood pressure variations from high to low, blood pooling, shortness of breath, difficulty breathing, blurred vision, intense brain fog, perfuse sweating on face only, dry eyes, constant thirst, stomach bloating issues upon eating, near fainting experiences, calf pain leading into muscle weakness in the leg, difficulty walking. 15th Month thru Current Symptoms - Caffeine intolerance, sudden food allergies ie berries, preservatives and gluten, pins and needles in hands and feet, headaches, fatigue upon exertion, occasional brain fog.
A 74-year-old male received GARDASIL 9 immunization series in 2019; A 74-year-old male received GARDASIL 9 immunization series in 2019; This spontaneous report was received from a pharmacist via vaccine employee and refers to a 74-year-old male patient. The patient's historical condition included throat cancer. The patient's historical drugs, previous drug reactions, allergies, concurrent conditions and concomitant therapies were not reported.   On an unspecified date in 2019, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on an unspecified date in October 2019, with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)      (formulations, strengths, doses, frequencies, routes of administration, anatomical locations, indications, lot numbers, and expiration dates were not reported for the three doses).  The patient had a prescription from an unidentified specialist for patient to receive vaccine as patient had a history of throat cancer (product prescribing issue; product administered to patient of inappropriate age).
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching). On 20-Feb-2021, ILLNESS (Very Ill), DYSPNOEA (Difficulty Breathing), TACHYCARDIA (Fast Heart Beat), DIZZINESS (Dizziness) and PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
my tinnitus elevated to a high level the next day and now 3 months later has not come down or diminished .
I woke up with chest congestion and a cough, the congestion got worse and did not respond to OTC medication so I made an appointment with my doctor who ordered COVID-19 test plus strep and flu tests all were negative. A chest x-ray was then ordered which also was no result.
Tingling and numbness, pain on left arm from shoulder to fingertips, headache.
Weight gain; Allergic reaction; Limb mass; Swelling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), LIMB MASS (Limb mass), SWELLING (Swelling), PYREXIA (Fever) and HYPERSENSITIVITY (Allergic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 15-Feb-2022, the patient experienced HYPERSENSITIVITY (Allergic reaction). In February 2022, the patient experienced LIMB MASS (Limb mass), SWELLING (Swelling) and PYREXIA (Fever). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, WEIGHT INCREASED (Weight gain), LIMB MASS (Limb mass), SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products reported.  No treatment products reported.  The reporter's causality for the event(s) of WEIGHT GAIN, LUMP ON ARM, SWELLING and FEVER was not provided.  The reporter's causality for the event(s) of ALLERGIC REACTION TO MODERNA BOOSTER VACCINATION with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-624698 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant follow- up received included updated event information, reporter opinion of causality, suspect drug information and narrative description. The events of "LUMP ON ARM", "SWELLING" and "FEVER" were added.