chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic signs in throat; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EP7534) via an unspecified route of administration in right arm on 23Mar2021 01:30PM (at the age of 53-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure, seasonal asthma and allergies, depression, stomach ulcers and allergies to nuts and seafood. Concomitant medications included losartan, omeprazole (OMEPRAZOL), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VIT C), trazodone hydrochloride (TRAZODON) and cetirizine hydrochloride (ZYRTEC). On the evening of 23Mar2021 the patient had wheezing. On 24Mar2021 09:30AM she woke with rash on right side of face, followed by hives, then itchy head and neck, then in throat. When she got to rash stage, symptoms developed quickly, leading up to anaphylactic signs in throat. She called the doctor immediately (after taking Benadryl). The event resulted in doctor or other HCP office/clinic visit. Treatments included prednisone, Benadryl, famotidine, Zyrtec - 8 days. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination.  Information on the lot/batch number has been requested.
positive for COVID; positive for COVID; fluid in lungs; severe shortness of breath; This is a spontaneous report received from contactable reporter (Other HCP) via Pfizer Sales Representative. The reporter is the patient.  A 26-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for COVID"; PULMONARY OEDEMA (medically significant), outcome "unknown", described as "fluid in lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "severe shortness of breath". Clinical course: Patient had direct exposure to relative with COVID and subsequently tested positive for COVID two weeks after their first bnt162b2. Patient had severe COVID symptoms (described as worse than flu) including severe shortness of breath and fluid in lungs. Event took place after use of product. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Covid-19,drug ineffective,pulmonary oedema. The case will be reassessed once new information is available. 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
Patient received two vaccines ( FLUBLOK ) and the Pnuemovax 23(  LOT: TO21485)  on the same arm ( right arm) on September 25th 2021. Patient stated that the evening of the 25th she started to feel soreness and had a low grade fever and chills,  these symptoms worsened the following day. Patient saw her PCP to get the injection sight inspected and was prescribed Bactrim on 09/27/2021. At this doctors appointment, doctor did an outline of the injection site reaction that appeared red and warm to touch. The following day on September 28th, the injection site worsened which spread beyond the outlined mark the day before. Patient at this point went to the emergency room. At the emergency room, per patient, she was admitted from  September 28th and released on October 1st 2021. She was treated for a cellulitis infection that per patient may have been caused by vaccine administration as the area of concern was where the two vaccines had been administered. Patient was released and prescribed Cefdinir 300mg for a 10 day course treatment.
8 DAYS AFTER VACCINATION PATIENT EXPERIENCED A RED RAISED AREA ON ARM WHERE VACCINE WAS GIVEN. COMPLAINT OF MINOR TENDERNESS, WARM TO TOUCH, ITCHINESS, AND SWOLLEN AREA APPROX. 4" IN DIAMETER. DID TAKE TYLENOL WHICH DECRESED TENDERNESS SOMEWHAT.
Tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung cancer", start date: 2007 (ongoing), notes: I have Lung Cancer, I take chemo pill, Erlotinib. I will give you the other name Tarceva . Concomitant medication(s) included: XGEVA; TARCEVA taken for lung neoplasm malignant. Vaccination history included: Bnt162b2 (First dose., Date: 24Feb2021., Lot number: EN6203.), administration date: 24Feb2021, when the patient was 67 years old, for Covid-19 immunization.  The following information was reported: PARAESTHESIA (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Tingling sensation". Therapeutic measures were not taken as a result of paraesthesia.  Additional information: it was reported that patient was Very annoying regarding event and want it to go away.  No follow-up attempts are possible. No further information is expected.
pt had transient fatique and myalgias on 4/8 post vaccination. adm 4/15 with chest tightness and palpitations; found to have suspected polymorphic VT/wide complex tachycardia and pericarditis. otherwise healthy young adult with no med hx. CTA neg for PE.  given amiodarone.  echo normal LVF.  troponins normal arrhythmia resolved to be discharge today
COVID-19 PFIZER GRAY TOP WAS DILUTED WITH 1.8ML OF DILUENT IN ERROR PATIENT RECEIVED DILUTED DOSE
arm soreness; lymph node soreness; itchiness at injection site; Severe headaches; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), LYMPH NODE PAIN (lymph node soreness), VACCINATION SITE PRURITUS (itchiness at injection site), HEADACHE (Severe headaches) and FATIGUE (exhaustion) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Spinal stenosis in 1959, IBD and Uterine cancer (Survived uterine cancer years ago.). Concurrent medical conditions included Type 2 diabetes mellitus since December 2004, Bronchial asthma, Allergy to antibiotic, Seasonal allergy, Penicillin allergy, Latex allergy, Herpes simplex (erythema multiforme), TMJ syndrome (At 17 years) and Bladder cancer (remission) in 2019. Concomitant products included SIMVASTATIN, ATENOLOL, PARACETAMOL (TYLENOL), FAMOTIDINE (PEPCID [FAMOTIDINE]) and CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), LYMPH NODE PAIN (lymph node soreness), VACCINATION SITE PRURITUS (itchiness at injection site), HEADACHE (Severe headaches) and FATIGUE (exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), LYMPH NODE PAIN (lymph node soreness) and HEADACHE (Severe headaches) had resolved and VACCINATION SITE PRURITUS (itchiness at injection site) and FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Heart rate: unknown (High) Increased. On an unknown date, Electrocardiogram: unknown (abnormal) sinus rhythm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28APR2021, updated patient demographics, past medical history, concomitant medications, treatment medication and events outcome as recovered.
CHEST PAIN; HIGH BLOOD PRESSURE; HEART BURN; YELLOW SKIN; DIZZINESS; LOSS OF APPETITE; TIREDNESS; FEELING WEAK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808979, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included losartan potassium for hypertension. On APR-2021, the subject experienced yellow skin. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced feeling weak. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced high blood pressure. On 18-APR-2021, the subject experienced heart burn. Laboratory data included: Blood pressure (NR: not provided) 180 not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart burn, high blood pressure, yellow skin, dizziness, loss of appetite, tiredness, feeling weak and chest pain was not reported. This report was non-serious.
Patient is still sore, has weakness in her arm and it hurts when she lifts it high to shoulder height or above her head.  This is all still happening even though she received the vaccine over 1 week ago.
Arm was hot, red, itchy, bumpy, and swollen.; Arm was hot, red, itchy, bumpy, and swollen.; Arm was hot, red, itchy, bumpy, and swollen.; arm of injection became red and hot; Arm of injection became red and hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was hot, red, itchy, bumpy, and swollen.), PRURITUS (Arm was hot, red, itchy, bumpy, and swollen.), PERIPHERAL SWELLING (Arm was hot, red, itchy, bumpy, and swollen.), SKIN WARM (arm of injection became red and hot) and ERYTHEMA (Arm of injection became red and hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced SKIN WARM (arm of injection became red and hot) and ERYTHEMA (Arm of injection became red and hot). On 26-Apr-2021, the patient experienced ERYTHEMA (Arm was hot, red, itchy, bumpy, and swollen.), PRURITUS (Arm was hot, red, itchy, bumpy, and swollen.) and PERIPHERAL SWELLING (Arm was hot, red, itchy, bumpy, and swollen.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Arm was hot, red, itchy, bumpy, and swollen.), PRURITUS (Arm was hot, red, itchy, bumpy, and swollen.) and PERIPHERAL SWELLING (Arm was hot, red, itchy, bumpy, and swollen.) had not resolved and SKIN WARM (arm of injection became red and hot) and ERYTHEMA (Arm of injection became red and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
parent states soon p/vax child began inconsolable crying-nonstop for 13hr;pt was taken to ER & given infant motrin;child was released from ER & went back home w/parents;
fever; chills; fatigue; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 10-Mar-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved.            Treatment medications were not reported. Concomitant medications were not reported.   This case was linked to MOD-2021-101857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant follow up appended
Approximately one week after the first injection, this patient with known psoriasis developed pustules on hands and lower legs. This was biopsied and shown to be a variation of psoriasis (psoriasiform dermatitis) on 4/23/21.
Persistent, dull chest pain Visited local walk-in clinic for treatment after several days of persistent dull pain/ache.  Had labs and x-ray.  No causes discovered.  Was told to take Tylenol.  Pain persisted for several more days and is slowly diminishing but still present on day 13.
Arm site pain; Headache; chills; muscle aches; tired; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old female patient received second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 22Mar2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and hypothyroidism. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 01Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Concomitant medications received within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and acetaminophen (TYLENOL) for unknown indications from unknown dates. On 22Mar2021 at 16:00, the patient experienced arm site pain, headache, chills, muscle aches and tired. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events arm site pain, headache, chills, muscle aches and tiredness were resolving at the time of this report. No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Sore throat, pain across shoulders and down arms and earaches , all of which came on suddenly while walking outside some 7 hrs after vaccination
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unkonwn age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ routes of administration default to oral (lot numbers, expiration dates and doses were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness on left upper arm expanded towards the inside of the arm. No fever, no reported pain. Complaints of itching.
Information has been received on 10-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 10-FEB-2017 and 23-FEB-2017, the patient was treated by a family nurse practitioner at a medical center for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
These symptoms happened during the time of the injection on 4/24/2021 and lasted from Saturday 4/24/2021 until Tuesday 4/27/2021: intermittent slight tongue spasms, slight tightness in the back of the throat, dry mouth - since 4/27/2021 these symptoms have stopped but now there is less sensation than normal in the tongue and the back of the throat which is still ongoing as of 5/1/2021.  // These symptoms happened during the injection on 4/24/2021 and only lasted until the observation time at the vaccination location was over :  lips felt very lightly swollen, very slight tinge in eye sockets.
Severe chills and muscle spasms that lasted several hours. It was very difficult to sleep when many of the muscles in my back and in various parts of my body were spasming.  Early on the morning of 10/11/2016 (6:30 AM) I proceeded to have severe hot flushes and sweats that lasted several hours (until about 10:00 AM on 10/11/2016.  I took 400 - 600 mg ibuprofen every 6-8 hr to try and alleviate the muscle cramps and pain. There was significant muscle fatigue and pain that lasted until 10/12/2016.
Burning tingling sensation on all extremities accompanied by severe dizziness. Dizziness subsided 3/10 but continues though not as severe. The tingling sensation persists on  lower extremities.
vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event; Initial information received from on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA377287(CLUSTER) and 2022SA379737(CLUSTER).  This case involves a 65 years old male patient who was administered Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] vaccine after temperature excursion reached 28.2 degrees fahrenheit for 2 hours and 29 minutes. and 30 degrees fahrenheit for 6 hours and 11 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 ml, once dose of suspect Influenza quadrival A-B high dose HV vaccine unknown formulation (lot UJ875AD, Exp date: 30-Jun-23) via intramuscular route in the left deltoid for intramuscular.  On 07-Sep-2022 the patient developed a non-serious "vaccine was involved in a temperature excursion reached 28.2 degrees fahrenheit for 2 hours and 29 minutes. and 30 degrees fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Started having seizures 4 days after immunization.  Now has uncontrollable seizure disorder, has lost all milestones.  4/21/2008 MR received for DOS 1/3-8/2008 with D/C DX:  Seizure Disorder.  Infant presented to ER with several episodes of generalized clonic seizures over the previous 24 hrs.  Infant initially seen in local ER after 1st episode and D/Cd after normal CT and labs. Pt had 2 more episodes of eyes rolling back, head deviation to the R, and becoming stiff.  Last episode with cyanosis. Pt then had witness tonic-clonic seizure in the ER with desaturation to the mid 30's which improved with O2. T=100.4'F. Pt had daily seizures while hospitalized, but slowly improved with titration of Tegretol. Follow-up: severe developmental delays, gastrostomy button.
At 4:32 pm patient was found on the floor of the exam room I was able to arouse patient. Pt blood pressure was 95/60 Heart rate 66 02 98% . Pt was moved to a seated position. At 4:48 pm patient stated her symptoms have resolved. Pt blood pressure was 100/60 heart rate 77 and 02 98%. Pt left clinic at that time.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805412 was crossed linked to original cases 201804863 due to same reporter.
Arm swelled up at injection site, formed little red blotchy rash on face that lasted couple of days, formed fever of 99 and cough that was treated with cough medicine.  Saw PCP 6 days later.