chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mental confusion; Fever; chills; shaking/tremors; diarrhea; indigestion; joint pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in Arm Right on 07Mar2021 (at the age of 71 years old) as dose 2, single for COVID-19 immunisation. Medical history included Coronary artery disease, high blood pressure, diabetes, all from an unknown date and unknown if ongoing. Concomitant medication(s) received within two weeks included irbesartan (IRBESARTAN), rosuvastatin (ROSUVASTATIN), both taken for an unspecified indication, start and stop date were not reported. The patient previously amoxicillin and experienced allergy (Known allergies: Amoxicillin). Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 14Feb2021 19:45 (at the age of 71 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced mental confusion, fever, chills, shaking/tremors, diarrhea, indigestion, joint pain on 10Mar2021 12:00. No treatment were given for the events. Patient did not tested for COVID post vaccination. Outcome of all the event were not recovered.  No follow-up attempts are possible. No further information is expected.
right hand finger tingling; Headache, Right sided.; body muscle aches; overall feeling of being sick; This is a spontaneous report from a contactable other healthcare professional.   A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 25Feb2021 09:00 am (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. Medical history included high cholesterol, heart disease, diabetes from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; carvedilol (COREG) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 04Feb2021 09:00 am (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. On 25Feb2021 16:00, the patient experienced right hand finger tingling, headache, right sided, body muscle aches, overall feeling of being sick. No treatment was taken as a result of events. The outcome of the events were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Intermittently febrile early morning on second day after J&J. Afternoon became suddenly dizzy and lightheaded. Briefly passed out. Was pale, had dusky lips and sudden, perfuse sweating. I drove him immediately to the hospital. On the way there he complained of tingling in both arm and I was unable to palpate a radial pulse. Had weak carotid pulse that skipped beats for a few seconds. Duskiness worsened during this, and improved when normal bets returned. Was weak and dizzy and unable to walk to into the ER. Had elevated BP 143/92. HR 74. O2 sat 96% Resp 17. Orthostatic BP obtained, no hypotension noted. Received 1L bolus of normal saline. Discharged after testing complete and syncope resolved, roughly 2 hours later. Remains intermittently febrile, fatigued, restless and "not feeling right", thought the evening at home.
The first night after my shot on Friday April 2nd 2021. I experienced extreme tiredness and pain at the injection site. On a second day Saturday April 3rd 2021. I experienced severe body aches muscles awareness in the injection site, and insomnia as well as nausea and a horrible headache. On the third day Sunday April 4th 2021. I had severe headaches arm was still sore and I was still experiencing nausea.
washed out; doesn't have any energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 17May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (First Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "washed out"; ASTHENIA (non-serious), outcome "not recovered", described as "doesn't have any energy".  Additional information: Consumer calling about her husband and her getting their second booster shot last Thursday. She doesn't know what shot it was, but then states it was her second shot for Covid 19. She got her first shot, the second shot and both were boosters. The first one was Covid 19, then the second booster shot, then another booster shot. Caller refers to her last vaccine received as her second booster. Aware this is discrepant, but details were confirmed and documented as provided by the caller. Caller feels like she is washed out and doesn't have any energy. States it is the same with her husband, he has the same thing.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced vasovagal syncope.  Treated conservatively with recumbent position and feet elevated. Awake and alert within 15 seconds. Observed for 30 minutes with no sequellae.  Patient has history of syncope with IM injections.
I am a very athletic person. I go to the gym daily. It started with a lot of discomfort with bowel movements and I had a lot of blood in my stool. I am having anxiety and depression. It has been a year and a half since I have had any of those symptoms. It has done a lot to my mood and attitude. The bleeding in my stool has gotten worse. My gut hurt constantly, it doesn't feel the same. I went to see a doctor for and she said that I was having hemorrhoids problems. I am a very healthy person. Never had any problems before taking the Moderma Vaccine. I watch what I put into my body.  I live a very strict life.  I am a college student and I even think it has done something to my memory, It's like I have short term memory lost. I also been having cold feet and hands. The week of the vaccine it felt like I was coming off of some type of drugs and I don't do drugs. I am still having the cold feet and hands symptoms and it is 95 degrees right now. It has never went away.
Missed menustration; Dose Number: 1 (08Apr2021); Dose Number: 2 (22Apr2021); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 44 years 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, SINGLE, route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Missed menustration"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Apr2021, outcome "unknown", described as "Dose Number: 1 (08Apr2021); Dose Number: 2 (22Apr2021)". The event "missed menustration" was evaluated at the physician office visit. Additional information: The patient received dose 3 Pfizer COVID-19 vaccine intramuscularly on 05Nov2021. The events were not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
devel measles rash covering face & trunk & scattered lightly x 4 extremities; fever of 103.4 x 2 days;
Pt reported that her entire body hurt the day after receiving the vaccine. She also reported achiness in the bend of her right hand. No injection site pain was reported.
On 9/18, patient came to pharmacy and reported he got red blotchy first on his red side trunk for 1 day then next day right cheek progressed to left cheek and then right upper lip.
Patient with extensive hospital stay d/t multiple .severe comorbidities. Patient initially admitted due to malaria infection. Patient underwent treatment was also found to have Covid infection. She had significant respiratory distress as well as kidney failure and was placed on hemodialysis. Patient respiratory status had shown some improvement patient developed peripancreatic abscess and warm autoimmune hemolytic anemia. Patient underwent percutaneous drainage and antibiotics were placed to treat ESBL E.coli infection. Patient had significant metabolic encephalopathy which was waxing and waning was evaluated by neurology.  Patient later to have infarct on MRI.  Patient had an upper GI bleed and underwent an EGD and was found to have perforated duodenal ulcer.  Developed severe sepsis requiring vasopressor support.  She had respiratory distress and placed on mechanical ventilation.  Patient was placed on comfort care, terminally extubated and quickly passed.
she couldn't breathe; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PFIZER-BIONTECH COVID-19 VACCINE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to know since the Pfizer shot is an mRNA vaccine but the Johnson and Johnson one is not, what are the chances that it would be safe for a person to switch over after an allergic reaction to the 1st dose of the Pfizer covid vaccine. The patient had an allergic reaction to the first Pfizer covid shot. She was fine until 4 hours later when she could not breathe. Had to use her rescue inhaler for asthma and took 3 puffs. It took 20 minutes for her to be able to breathe. 20 minutes afterwards, again she could not breathe again, she was arching her back trying to breathe. She took 1 Benadryl 25 mg and put Vicks vapor rub under her nose. 20 mins later that started to help. She felt like 'a fish on the sidewalk' gasping for air. She took a 2nd Benadryl. Called her primary care who sent her to an allergist. The 1st allergist refused to see her, and the other said there's nothing they can do more than her primary care could do for her. Primary care sent her back to allergist. No one wants to be responsible for her. She went to the pharmacy today to get 2nd shot, pharmacist said they do not think she could get it, and also confirmed with a 2nd pharmacist. She did not receive the 2nd dose. Outcome of the events was unknown.   Information on lot/batch number has been requested.
No additional adverse events reported; a temperature excursion (1.8 C) with administration of GARDASIL 9 during the excursion; This spontaneous report as received from a medical assistant refers to a 16-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-OCT-2020, 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) 0.5 ml, lot # S022599, expiration date: 25-FEB-2022 for prophylaxis (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 1.8 degrees Celsius for 7 hours and 25 minutes. Digital data logger was not involved. There were no previous excursions reported. No additional adverse events were reported. 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: S022599; expirationdate: 25-FEB-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
Case number PHEH2014US020647 is an initial spontaneous report received from a pharmacist on 10 OCT 2014. This case refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported), intramuscularly on an unknown date, which had been at 33.7 for 30 minutes twice over a 10 hour period on 23 SEP 2014. No adverse event was reported following this administration error.
arm red approx 6" upper arm inj site 3 1/2 post vax, severe chills, slept all noc, next day arm is red;
received first dose on 19Mar2021 and was scheduled to have 2nd dose on 09Apr2021/tested positive for Covid19 on 07Apr2021; received first dose on 19Mar2021 and was scheduled to have 2nd dose on 09Apr2021/tested positive for Covid19 on 07Apr2021; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her first dose on 19Mar2021 and was scheduled to have her second dose on 09Apr2021. Patient tested positive for COVID-19 on 07Apr2021 and missed her second dose. She wanted to know how soon should she be able to receive her second dose of vaccine. The outcome was unknown.   Information on the lot/batch number has been requested.
Information has been received from a physician concerning a male child who was vaccinated with a dose of of varicella virus live. In approximately February 2005,  the pt experienced moderated case of breakthrough chickenpox, low fever and 50 lesions. Unspecified medical attention was sought. No Tx was recommended. Subsequently, the pt recovered on an unknown date. There was no product quality complaint involvded. Additonal information has been requested.  This is in follow-up to report(s) previously submitted on 5/16/2005.  Information has been received from a physician and a medical assistant concerning a 6-year-old male child with no known allergies who on 05-AUG-1999 was vaccinated with a dose of VARIVAX (Oka/Merck) (route and lot # unknown).  There was no illness at the time of vaccination.  The mother of the child had stated that in 2004 the patient had a chickenpox illness.  The child was seen in the physician's office on 12-FEB-2005 at 11:00 with more than 50 papular vesicular lesions in several stages and a low fever.  He was diagnosed with chickenpox.  No treatment was recommended.  Subsequently, the patient's present status was reported as unknown (previously reported as recovered on an unknown date).  There was no product quality complaint involved.  Additional information has been requested.
Started with painless L blurry vision, fixed in size. 16 Oct - VF deficit.  18 Oct - MRI Brain/Orbits showed abnormal signal suspicious for L optic neuritis.  4 Nov - worsening sx, hospitalized, evaluated, treated with IV steroids followed by 10 day taper.  26 Nov, fever x2 days followed by decreased in L eye vision.  30 Nov - hospitalized, IV steroids x3 days then taper.  11 Dec - Neuro/Ophth eval showed no improvement of vision.  VA 20/400.  10 Jan 2010 - acute worsening of L eye vision.  11 Jan - IV steroids x3 days then 1 month taper.  24 Jan - MRI Brain/Orbits, C-Spine - L optic nerve signal enhancement, otherwise nml.  12 Feb - Neuro-Ophth second opinion.  Dx atypical optic neuritis with permanent vision loss.  12 May - Neuro-Ophth 3rd opinion - no change of recovery.  No other evaluation warranted.
Patients mother called on 1/25/2023 at 0900 to report patient has warm red raised area of about 5.5 in across and 0.25 in high on her left deltoid where one of the vaccine shots was given. She has not felt "well", had low grade fever on 100.7 F last night that has resolved. No trouble breathing, no hives, no feeling of swelling in her mouth, mother is unsure if any axillary swelling. They tried both warm and cold packs with no improvement. In review of records would have been Hep A vaccine, this is 2nd in series. Recommended she be seen by a practitioner, they recently moved here and do not have a pediatrician yet so suggested an urgent care to evaluate. She will do that today.
No adverse event reported, however patient received expired lot. Vaccine expired on 9/14/2021. It has been properly stored and handled. Dose was given on 9/22/21.
Patient stated she has been having arm pain/shooting pains at injection site since vaccine. She uses topical creams, but just now mentioning this to the pharmacy. She said the pain hurts most at night when sleeping on arm. Recommended doctor visit and gave recommendations on some OTC products that may work better than current regimen.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") and TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid"), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site.), VACCINATION SITE ERYTHEMA (red circular rash at injection site.) and PYREXIA ("fever under 99 degrees"). In June 2021, FEELING HOT ("both hands were very hot "), DRY SKIN ("both hands were dry"), FEELING ABNORMAL (heat of hands "felt like pepper seed" on skin), TEMPERATURE DIFFERENCE OF EXTREMITIES (right hand read 100.1 degrees F., left hand temperature was 100.3 degrees), VACCINATION SITE PRURITUS (injection site was "a little itchy"), VACCINATION SITE RASH (red circular rash at injection site), VACCINATION SITE ERYTHEMA (red circular rash at injection site) and PYREXIA ("fever under 99 degrees") outcome was unknown and ALLERGY TO VACCINE (injection site of left arm "I had a allergic reaction but could have been from the Band-Aid") had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include magnesium potassium supplement. Treatment includes wet washcloths to cool the temperature of hands down. 2nd dose scheduled for tomorrow 2Jul2021.
Erythema and induration approxiamtely 3 inches surrounding the site of injection. This began to appear with in a few hours of the vaccination. I few hives around the injection site. Severe generalized itching for approximately 3 days. Improved with benedryl and ranitidine.
L side jaw pain - 7 PM, HA nausea 9 PM (9/1), 9/2 continued HA, fatigue, 9/3 loss of sense of taste, 9/4 eyes: dilating (L) pupil; 9/5 eyes: swelling lid/lid droopy, 9/6 left side facial sensitivity, 9/12 lump in throat, 9/14 - Bell's Palsy Dx.
Injection given on Left Arm, deltoid muscle. Injection given on Weds, pt presented on Friday with left upper inner arm with well demarked induration, taut skin, non-fluctuant, increased warmth and redness, small punctate wound 2-3 fingersbredth below mid upper deltoid insertion with faint pink red area inferior to presumed injection site.  But reaction is noted inside upper arm, near axilla area.
got the shot and then got sick; Initial information received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who got the shot and then got sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious event got the shot and then got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: Not applicable.  Corrective treatment: Not reported.  At time of reporting, the outcome was Unknown for the event got the shot and then got sick.
Red, raised spots all over face. Heated up and itchy, felt like sunburnt. Also a fever 100 degrees.
Initial and follow-up information has been received from a physician concerning a female with a history of a clotting disorder who was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL vaccine (yeast). Subsequently, the patient developed a nose bleed one hour after GARDASIL vaccine (yeast) administration. She also later developed swollen glands. The patient called the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to reort previously submitted on 11/14/2007. Initial and follow-up information has been received from a physician concerning a female with von Willebrand type II B who on 28-SEP-2007 at 8:00 pm was vaccinated intramusculary into the deltoid with a 0.5ml third dose of GARDASIL. On 28-SEP-2007 at 8:00pm the patient developed a heavy nose bleed lasting one hour. She also later developed mild swollen neck glands. No other viral type symptoms were noted. The patient called the office. On 30-SEP-2007 the patient recovered. Additional information is not expected.