chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling "racey" (a lot of energy); trouble sleeping; This is a spontaneous report received from a non-contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: ENERGY INCREASED (non-serious) with onset Apr2021, outcome "unknown", described as "feeling "racey" (a lot of energy)"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "trouble sleeping".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache  in back of head, fever , chills, nausea  ,vertigo loss of appetite,  body pain, upper back pain
After receiving MMR and Varivax in RAT approx 3-4 minutes later immediate redness and swollen.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (route, dose number, and lot number unknown). Concomitant therapies included an unspecified flu vaccine. On an unknown date the patients experienced injection site redness and soreness. The outcome of the events was unknown. Additional information is not expected because there is no permission to contact physician.
Patient had body aches, headache, and developed a rash/hives on his cheek and neck.
Burning in my arm and soreness for one week and a half in the arm of the injection site. Fatigue - what is ongoing still - extra fatigue that I never had before; and I had a headache for two days. Eczema about four weeks after the vaccine were started getting rash and the doctor said it was Eczema and I've never had that before. I went on steroids (topical) and Oral steroid for that. It helped somewhat but it's been recurrent. I get it every month or two months now. I went to the doctor for the fatigue recently. He told me to get more rest which is not improving it. It's abnormal fatigue. I never have felt this fatigued before - even get it doing housework and working out - things I try to do every day. It's becoming more difficult to do those things. I have an appt with him in December and he said if I still have fatigue - he'll do test then. He gave me another prescription for B12 shots which I had been taking regularly before this vaccine but now they're not helping. I also got a sinus infection (started getting it in September) and I haven't gotten a sinus infection since 2019. It was severe this time. This time I had to see an ENT specialist yesterday for this because it wasn't going away. In the past, it has resolved on its own. He told me he didn't want to give me antibiotics at first and suggested doing a nasal rinse and take Flonase to help with the congestion. I am still having the sinus infection; it has not resolved yet.
Patient was given the wrong formulation of the vaccine. She was due for the second monovalent in the series for the pediatric 6m-4years Pfizer Covid vaccine but received a Bivalent dose instead. I contacted Ask the Experts from the CDC and they advised the 3rd dose also be the Bivalent 6m-4years.  Parent reported zero side effects from the vaccine.
was given the vaccine and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient stated that the commercial for the shot said that it stops most cases. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
client stated feeling warmth on right side of neck within 5 minutes of receiving vaccine. per client blurry vision, denied shortness of breath, dizziness, headache. First vitals at 4:42 BP 165/87 pulse 103. Client stated feeling relaxed as if "sleepy". Second vitals at 4:46 BP 155/89 pulse 102. Symptoms the same. By 4:49 client appears lethargic, slower to answer questions, mild shortness of breath. 911 was called. Vitals 142/ 91 pulse 103. Followed instructions by 911 operator, carotid pulse 107 at 4:54 and blood pressure 177/96. Fire department assumed care at 4:58PM.
Around 8 hours after injection developed a raised , puffy red rash on trunk only. Fever 102 from 01/19/05 in the evening with rash thru 01/22/05. Seen at ER. Dx with viral rash. Follow up in office on 01/26/05. Rash on trunk - pink, dry lesions, varying sizes, coalescing.
Covid Arm, on Wed 21st, red to touch, itchy and blotchy. On July 23, it has spread down to crook of elbow, still warm to touch and itchy.
The patient is a 85 y.o. male patient of MD with history of atrial fibrillation, congestive heart failure with reduced ejection fraction, COPD, OSA noncompliant with CPAP, hypertension, hyperlipidemia presented to the ED with 3-day history of abdominal pain.   Sepsis, POA Acute cholecystitis WBC 21, afebrile.  Lactic acid 1.5. Direct bilirubin 0.7, total bilirubin 2.7.  LFTs otherwise normal. CT abdomen pelvis: Findings compatible with acute cholecystitis with distended inflamed gallbladder containing multiple gallstones.  No biliary duct dilatation. Right upper quadrant ultrasound:Thickened gallbladder wall with cholelithiasis but patient was not tender over the gallbladder.  Given the findings of ultrasound and CT examination findings are suspicious for acute cholecystitis Initially on cefazolin and Flagyl Bile cultures from drain grew E faecalis, abx switched to Vancomycin 2/17 (penicillin allergy) Further management of cholecystitis per surgical team - have signed off, f/u in surgery clinic in 1 week Keep perc chole drain in place until general surgery follow-up Continue PO Levaquin x 5 days per ID final recommendations Stable to discharge   Covid-19 Virus Infection Acute hypoxic respiratory failure - resolved Date of onset of symptoms: Unknown. Symptoms present on admission: Hypoxia present on admission. Date of covid positive test: 2/15 Vaccination status: vaccinated Imaging: Chest x-ray the lung volumes are diminished and there is opacity obscuring the left lateral aspect of the left lung base.Atelectasis and/or infiltrate could have this appearance Oxygen requirements on admission: 3 L Current oxygen requirements: room air Medical therapy: decadron and remdesivir Consultants following: ID Anticipated special isolation end date: 02/25    Paroxysmal Atrial fibrillation S/p AV node ablation and CRT-P placement in May 2020. Is chronically on Eliquis. Eliquis held for cholecystostomy procedure. Cholecystostomy tube has bloodstained fluid. Resumed Eliquis per surgery   Chronic HFrEF Echo February 2022: EF 36%.  Mild to moderate mitral valve regurgitation. He is on Coreg, lisinopril, Lasix at home. Holding Lasix in the setting of sepsis. Resumed Coreg at a lower dose 3.125 mg twice daily.  Takes 25 mg twice daily at home. Uptitrated coreg dose 02/20 sec to elevated BP BP stable   CAD  Status post CABG x3 in June 2020  Continue aspirin, statin.   OSA Not on CPAP.   Acute metabolic encephalopathy - resolved Patient apparently very somnolent after the cholecystostomy tube placement. Fully alert and oriented as of 2/16
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000409: US-009507513-1707USA000411: US-009507513-1707USA000412: US-009507513-1707USA000407: US-009507513-1707USA000410: US-009507513-1707USA000408.
I experienced a rash, swelling and itching in the injection site that began 8 days after my injection. I also experienced fatigue during this time.
Shaking and sore bones during routine exercise. Had to sit out Zumba!!! Went home with chills and shaking. No fever. (98.8F)
shake or can call it tremble; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shake or can call it tremble) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (shake or can call it tremble). At the time of the report, TREMOR (shake or can call it tremble) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient states that he had all Moderna vaccines with no reactions.  A night before a day of reporting, patient received the new vaccine and when he was inside, he was shaking or can call it tremble when it was a little cool or the air was on. When patient went outside, the shaking or trembling stopped and never had that before. Patient did not have chills or any other reactions.  No treatment information was provided.   Reporter did not allow further contact
Patient passed out onto floor, eyes rolled back into head, had jerking movements with arms, urinated, and vomited.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Negative, notes: I have taken another at home COVID test which was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 for COVID 19 Treatment with Paxlovid from 07Jan2023 to 11Jan2023.  Clinical course: Patient received vaccine and other medication in 2weeks yes. patient treated with Paxlovid for event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
heart racing; sleeping a lot; histamine intolerance/histamine intolerance got exponentially worse; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), SOMNOLENCE (sleeping a lot), HISTAMINE INTOLERANCE (histamine intolerance/histamine intolerance got exponentially worse) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 045B21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart racing), SOMNOLENCE (sleeping a lot), HISTAMINE INTOLERANCE (histamine intolerance/histamine intolerance got exponentially worse) and FATIGUE (Tired). At the time of the report, PALPITATIONS (heart racing), SOMNOLENCE (sleeping a lot) and FATIGUE (Tired) outcome was unknown and HISTAMINE INTOLERANCE (histamine intolerance/histamine intolerance got exponentially worse) had not resolved.            The treatment information were Detox through doctor's care. Two supplements (DAO digestive enzyme and Aller DHQ)   This case was linked to MOD-2021-421477 (Patient Link).
Beginning 3/3/21 my left arm began to hurt and my fingers became numb (as if my arm was asleep).  I noticed swelling in my arm and began taking Ibuprofen.  Sometimes my arm would begin to "wake up" and my whole are would tingle. On 3/7/2021 I developed a red area around the injection site and my arm swelling was more pronounced.  My arm also feels hot somtimes.    I have continued to take Ibuprofen and place ice on my arm in the evening.  I continue to have the swelling, hot arm, red patch, and pain in my arm as of today.  The "numb" feeling is something that comes and goes.
Palpitations; Lightheaded; SOB; Asthma; Wheezing; Got my period 2 weeks early; My joints have been super painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:00 (Lot number: Ff2590) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ehlers danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: VIT D [VITAMIN D NOS]; IBUPROFEN. The following information was reported: PALPITATIONS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Palpitations"; DIZZINESS (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Lightheaded"; DYSPNOEA (non-serious) with onset 12Oct2021 18:00, outcome "recovered" (Oct2021), described as "SOB"; ASTHMA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Asthma"; WHEEZING (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Wheezing "; MENSTRUATION IRREGULAR (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "Got my period 2 weeks early"; ARTHRALGIA (non-serious) with onset 12Oct2021 18:00, outcome "recovering", described as "My joints have been super painful". Therapeutic measures were not taken as a result of palpitations, dizziness, dyspnoea, asthma, wheezing, menstruation irregular, arthralgia.  Additional Information: Facility type Vaccine: Pharmacy or Drug Store. No other vaccines in four weeks. No covid prior vaccination. No Covid tested post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Case PHEH2016US026700 is an initial spontaneous report received from nurse on 12 Oct 2016. This case refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number and expiry date not reported) at a dose of 0.5 intramuscular on 11 Oct 2016. On 12 Oct 2016, nurse administered the vaccine to a medical doctor with a small arm yesterday. Medical doctor returned to office on 12 Oct 2016 with a small bubble under her arm at the site where she received the vaccine. It was reported that, nurse was not sure if vaccine was given subcutaneous or intramuscular. The outcome of events was unknown. The seriousness of the events was non serious. The causality of the events was not reported.
Moderna COVID - 19 Vaccine EUA three days after injection site pain had gone away I started have sinus discomfort and joint pain, next day was fatigue not severe/ and continued joint pain. Upper respiratory discomfort and minor cough . Today had trouble sleeping minor headache slight cough  Hips and legs pain,  Appetite is good I am drinking plenty of fluids. I am taking acetaminophen and ibuprofen for pain as needed.
C/O nausea, Dizziness, stated that she was about to find. The client was helped to floor, head flat, and leg elevated. The patient was alert and oriented, Vital signs were stable. VS: BP:105:68, 66 Reg, RR:18.  The mucosa was pink. Juice and water given, observed for 45 minutes.  sent home with boyfriend with instruction to F/U with PCP if symptoms persist and call 911 if symptoms worsen
Rash on face & arms & genital area. Felt "sun bound", itchy - hive like. Consult w/MD given Prednisone & Benadryl.
After receiving a pneumococcal vaccine during an outpatient clinic visit, the patient called to report soreness and swelling at the injection site, which she reported to our nurse practitioner, who advised treatment for possible allergic reaction. The following day the patient went to the ER because the injection site seemed no better. She was treated with IV antibiotics for a diagnosis of cellulitis.
Extreme exhaustion and fatigue, nausea and abdominal pain, chills, low grade fever and my arm is red from the injection site down to my elbow.  As of 3/28, all symptoms are improving except the red arm. I was not able to get out of bed for two full days.
DIAREA, FEVER, FELT FLUSH, DRAINED OF ENERGY, EXHAUSTION
Red rash around injection site, roughly 1" x 4" area Itchy Has lasted 2 days so far
Pt presented to receive to routine adult vaccinations, flu and tetanus were indicated.  Gave patient flu vaccine and tetanus-diptheria vaccine after confirming no known allergies to vaccine and/or components.  Pt then remembered allergic to tetanus.
8 days after vaccine the injection site was hot to touch, red, swollen. Mild Chest pain (sternum area) since one day after vaccine.  Day 9 swelling, redness and tingling at site  Day 10 swelling and redness improved but pain in shoulder and neck area started on left side.  Tingling and numbness on left side of face.   Day 11 pain in neck and shoulder cont and face tingling left side.
A couple hours after vaccines L side of patient's face became swollen & lip on L side is real swollen.  Pt states he became a little mucosy & coughed, but that resolved.  Given dose of BENADRYL & sent to Urgent Care.
Upper arm was sore, swollen & red during the day. Fever of 101 - 103 started at approx 7:00pm, continued for several days as injection site grew in size and got blotchy, very hot & red. Went to Urgent care and was treated for a cellulitis with Rocephin & amoxicillin at urgent care.  Fever continued for two more weeks, again treated with Rocephin & zithromycin for bronchitis but fever and body aches continue to return. Patient is still recovering.  It has been a month since vaccine and is still having problems with infections.
Varivax given sq in Emp Health on 5/29/2008 due to low titer. on 6/10/2008 employee noticed pain and itching at injection site.  Presented to Emp Health Dept on 6/12,  40X55cm area of erythema, slightly raised wiht clean margins, hot and itching.  No vesicles seen. Beige spot directly where injection given. Seen in Acute care by MD, prescribed doxicycline and zyrtec.  ?cellulitis.
No adverse symptoms were reported; the patient was administered a dose of improperly stored PEDVAX HIB; This spontaneous report was received from a nurse, referring to a 3-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.   On 03-JUN-2020, the patient was vaccinated with a improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX HIB) (dose, route of administration, vaccination scheme, site of vaccination were not reported). Lot number S007072, and expiration date reported as 24-JAN-2022, were invalid for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), administered as prophylaxis (product storage error).    The vaccine was exposed to a temperature above 47 degrees Fahrenheit (F) for 10 min as recorded by the data logger. There were no previous tempeture excursions. No adverse symptoms were reported.
Pfizer vaccine was administered outside of location - reported by patient  G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 COMMUNITY ACQUIRED PNEUMONIA I95.9 HYPOTENSION 5/28/2021 COMMUNITY ACQUIRED PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 COMMUNITY ACQUIRED PNEUMONIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 COMMUNITY ACQUIRED PNEUMONIA R09.02 HYPOXEMIA 5/25/2021 COMMUNITY ACQUIRED PNEUMONIA G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 ACUTE RESPIRATORY FAILURE I95.9 HYPOTENSION 5/28/2021 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 ACUTE RESPIRATORY FAILURE R09.02 HYPOXEMIA 5/25/2021 ACUTE RESPIRATORY FAILURE G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 5/28/2021 AORTIC VALVE STENOSIS J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 AORTIC VALVE STENOSIS J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 AORTIC VALVE STENOSIS R09.02 HYPOXEMIA 5/25/2021 AORTIC VALVE STENOSIS G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 HYPERCALCEMIA I95.9 HYPOTENSION 5/28/2021 HYPERCALCEMIA J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 HYPERCALCEMIA J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 HYPERCALCEMIA R09.02 HYPOXEMIA 5/25/2021 HYPERCALCEMIA G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 AORTIC VALVE STENOSIS    CANCER METASTATIC TO BRAIN I95.9 HYPOTENSION 5/28/2021 AORTIC VALVE STENOSIS    CANCER METASTATIC TO BRAIN J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 AORTIC VALVE STENOSIS    CANCER METASTATIC TO BRAIN J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 AORTIC VALVE STENOSIS    CANCER METASTATIC TO BRAIN R09.02 HYPOXEMIA 5/25/2021 AORTIC VALVE STENOSIS    CANCER METASTATIC TO BRAIN G47.33 OBSTRUCTIVE SLEEP APNEA 7/3/2021 AORTIC VALVE STENOSIS I95.9 HYPOTENSION 5/28/2021 AORTIC VALVE STENOSIS J96.00 ACUTE RESPIRATORY FAILURE 7/3/2021 AORTIC VALVE STENOSIS J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/13/2021 AORTIC VALVE STENOSIS R09.02 HYPOXEMIA 5/25/2021 AORTIC VALVE STENOSIS