chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 hours after the shot I experienced headache and a weird skin discomfort feeling, I took Tylenol. 12am I woke up with violent shaking and clenching with no fever. Took Tylenol again. 2am woke up without the shakes but severe body pain.  7am  another headache bad body aches  took more Tylenol. Everyone i feel like I?m getting better I feel worse again. I feel like everything is coming back again.
I had congestion which led to trouble breathing, swollen throat and irritation. That was the worst of it. Occasional mild headache that lasted for 5 days. I took 1 day off and went to urgent care on 10/10, COVID-19 test was negative. Days later when I self tested it was positive. By the 10/22 I was feeling good.
Muscle aches,  body aches, unable to sleep,high fever ,nausea and vomiting, red hot rash at injection site
Hospitalized (11.5.21); COVID-19 vaccine (11.3.21); fully vaccinated  Admission Date: 11/5/2021 Discharge Date: 11/07/2021  DISCHARGE DIAGNOSES 1. Acute hypoxic respiratory failure 2. COVID-19 pneumonia 3. Chronic obstructive pulmonary disease exacerbation 4. Heart failure with reduced ejection fraction 5. Permanent AFib status post AV node ablation and PM placement  6. Status post mechanical AVR and MVR 7. GERD DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 66 y.o. male who presented with 2 days of worsening shortness of breath.  Patient and family had upper respiratory symptoms for several days and he was experiencing fever, headache, loss of appetite, fatigue, productive cough.  He was tested outpatient for COVID-19 and was found to be positive.  While most symptoms resolved, his shortness of breath continued to get worse and so he presented to the emergency department.  He was concerned as he has underlying chronic obstructive pulmonary disease but does not use oxygen at home and his home inhalers were not helping. Upon arrival he was hypoxic and placed on nasal cannula.  Chest x-ray showed findings of chronic obstructive pulmonary disease and interstitial opacities.  He was given steroids and albuterol and admitted for acute hypoxic respiratory failure due to COVID-19 pneumonia.  His breathing improved with steroids and supplemental oxygen and he was quickly requesting to go back home.  Given his clinical improvement in decreased supplemental oxygen needs, he was evaluated by respiratory therapy who recommended 1 L nasal cannula at rest and 2 L nasal cannula with activity.  He was prescribed steroids to complete a 10 day course in the setting of COVID-19 pneumonia and chronic obstructive pulmonary disease exacerbation.   Additionally, shortly after admission initial labs identified supratherapeutic INR greater than 8. Pharmacy was consulted and recommended 1 time dose of vitamin K which was provided and his evening dose of warfarin was held at that time.  His INR was recheck in the morning and had decreased to 4.4.  Given his significant comorbidities and extremely high risk for clot, further discussion with pharmacy was had regarding his next evening's dose of Coumadin.  The decision was made to give 5 mg and the medication was ordered however this dose was not provided.  On day of discharge, his INR was 3.1.  Pharmacy was again consulted for recommendations regarding resumption of Coumadin.  Plan was to have patient take 2.5 mg the night of discharge and then 5 mg the next six nights, with this cycle repeating every 7 days.  He was to follow-up with Coumadin clinic and have INR rechecked morning of 11/08/2021.  He was instructed if his INR was below 2.5 to use his home Lovenox and urgently contact the Coumadin clinic for further instructions.  Patient verbalized understanding of these instructions and these were reviewed by nursing upon his discharge. He was subsequently discharged home in stable and improved condition with supplemental oxygen as well as skilled nursing and OT services
Loss of taste; This is a spontaneous report from a contactable pharmacist (patient). A 47-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 21Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were none. No known allergies. There is no other vaccine in four weeks and no other medications in two weeks.  No covid prior vaccination. The patient previously took the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration into left arm on 31Dec2020 14:30 at a single dose for covid-19 immunization. The patient experienced Loss of taste on 22Jan2021. There is no treatment received for event loss of taste and no covid test post vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asplenia" (unspecified if ongoing); "congenital scoliosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Negative, notes: previous negative results; (06Jun2022) Positive, notes: Tested positive again 6 days post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. On 06Jun2022, Tested positive again 6 days post treatment after previous negative results. Patient received the other medication in 2 weeks. Patient received antiviral Paxlovid from 27May2022 to 31May2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) positive, notes: tested positive with symptom 4 days after finishing plaxovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported that received vaccine. Reported anti viral details regarding product COVID 19 Treatment, brand name was reported as plaxovid, treatment started on 08Jul2022, and treatment stopped on 12Jul2022. The treatment received for the indication COVID-19. The adverse event reported that patient tested positive with symptom 4 days after finishing plaxovid on 16Jul2022. The event was recovering. Therapeutic measures was not taken for the event.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician and her medical assistant via a sales representative refers to a female patient of unknown age. Pertinent medical history, drug reactions and allergies, concomitant medication were not specified by reporter. On an unknown day in March 2014, (within the last 48 hours), the patient was vaccinated with ZOSTAVAX (dose, route of administration and expiration date were not reported). On an unknown day in March 2014, (within the last 48 hours) the patient developed redness, swelling and severe itching at the injection site, exceeding around her upper arm. There were no lesions. The patient self-treated with a topical steroid cream without improvement of symptoms. The patient had an appointment in the office on 12-MAR-2014, for evaluation. No lab diagnostic studies were performed. The outcome of events arm was reported as not recovered. The relatedness between the ZOSTAVAX and events was not reported. Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to a 63 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot#671596/1056AA, expiration date 05-OCT-2012) on 12-JUL-2012 for "shingles prevention". No concomitant medications were reported. In July-2012, "over this past weekend", the patient experienced redness, itching, bruising, welts, hives and blisters around the injection site area. No treatment was given for adverse events. The outcome of patient was reported as not recovered/not resolved. No lab diagnostic study was performed. The patient sought medical attention via contacted pharmacist. Additional information is not expected.
Started getting "water blisters" on his Rt & Left arm and a blood clot formed in his lower Rt. Leg Approx 11/2 weeks after Vaccine
It was reported that a 68 year old female patient received a yellow fever vaccinations on 14-Mar-2001. Reportedly nine days after vaccination (23-Mar-2001), the patient developed a generalized rash over body. The patient had neither respiratory distress nor a fever.
Information has been received from a physician concerning a 59 or 60 year old female who in approximately November 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). "Nine days after vaccination, in November 2007", the physician confirmed that the patient had shingles. Shingles were present around the torso on one side. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Swollen, itchy, hot & red face this morning when awoke. Took a CLARITIN p.o. at 10AM. Symptoms worse & went to clinic at 1230 - IV steroid meds. No redness or swelling at injection site.
Chest fluttering Dizzy/nauseous/fatigued 1st day  Fever/chills/tension headache 2nd day Mild chest tightness 3rd and 4th day  Sweaty/clammy hands and feet every day since vaccine  Waking up sweaty every night Mild left ear Tinnitus 4th day  Forehead Neck/throat/chest/stomach warm no fever 3rd and 4th day  Some loose stool 4th day, vertigo Imbalanced feeling chest quivering elevated heart rate 4th day  constipation 5th day and insomnia along with severe vertigo when lying flat  severe tension headaches mild hearing imbalance and popping both ears 6th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 7th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 8th day pressure on head, stomach burn, heartburn weak legs vertigo 9th day
Migraine was present at time of vaccination, but evolved and worsened after 36 hours. Nausea and anorexia developed after 24 hours. Severe aching back pain developed after 32 hours. Fever 101.5F developed after 36 hours. Symptoms lasted 24 hours and resolved. Diarrhea developed at 48 hours, was intermittent, and lasted  12 hours. Ondansetron 8 mg PO was taken once. Ibuprofen 400 mg PO was taken after 48 hours.
Eight days post vaccine woke up with warmth, erythema, pain, induration to the area suspicious for soft tissue infection/cellulitis. Symptoms starting to improve after doxy x48 hours, I plan to take a full ten day course.
103 degree fever, chills, headache, muscle fatigue, nausea, brain fog, sleeplessness. Symptoms persistent for 4 days.
Pt developed low grade temp of 99-100 clear rhinorrhea x 2 days ago. Started breaking out with vesicular lesions on trunk extremities.
MD noticed erythematous swelling at injection site and asked patient to return to pharmacy MD gave preventative sulfa drug.
This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L004014, expiry date 04-MAR-2017 (strength, dose, route and site of administration were not reported0. No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
BODY ACHES AND CHILLS AND HEADACHE AROUNG 10 A.M. 04/02/2021      101.1 FEVER AROUND 5 P.M. 04/02/21
Major reaction.  Field vaccination by Strike Teams of Department of Public Health.  At ~13:01, patient vaccinated with Pfizer COVID-19 vaccine.  Within a few minutes of vaccination with Pfizer COVID-19 vaccine, patient showed urticaria + generalized chest pain (6/10) + postural weakness + convulsions.  Field RN assessed an immediate, severe clinical deterioration.  Epinephrine 0.3mg given by auto-injector to same left arm.  Field RN summoned EMS.  Field LVN provided postural support and second-eye VS measurement.  EMS arrived at ~13:22.  Taken by EMS to ED.  VS: BP 90/40; HR 70; Pain 6/10 general chest. ? BP 110/60; HR 90. S/S: Physical weakness; ALOC. ? AOx4 upon EMS arrival.  Current disposition unknown at time of this report.  Department to attempt contact with family or admitting facility.
Information has been received from a medical assistant concerning a 65 year old female with a history of lung problem unspecified who on 20-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F). There was no concomitant medication reported. On 21-DEC-2006, the patient presented back to the office with fever, and an injection site reaction which was sore, red, and swollen. On a unspecified date, the patient recovered from fever and the injection site reaction (sore, red, and swollen). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Patient received her Pfizer booster at vaccination site, even though she is 17 years old and is not eliglble. Her aunt was in the car with her at the time and signed consent form for the shot. Aunt stated she was told by medical doctor that patient should receive booster at this time because it had been 6 months since her primary series. However, patient does not have any coexisting conditions and is was not eligible. Troubleshooting: reviewed with scribes and vaccinators that if a patient is under 18 years old they cannot receive a booster shot unless they are immunocompromised.
Case number PHEH2015US022832 is an initial spontaneous report received from a health care professional on 05 Nov 2015 and from the health care professional on the same date (combined report). This report refers to a 64 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with an expired 0.5 ml dose of FLUVIRIN (batch number: 145004) intramuscularly on 04 Nov 2015. The case was reported as non-serious. No adverse events were reported following the maladministration.
Had shortness of breath while doing everyday active over multiple days multiple times a day. Avoided exercise as a result, was usually active but afraid to exercise due to the reaction.  Initially had a terrible reaction to the 2nd dose the night of the second dose had some trouble breathing, fever, shakes, felt as bad as I've ever felt, but slowly disappeared over a about 4 days.... Then had issues of shortness of breath after these episodes. I don't remember exactly when the shortness of breath started but remember it clearly two weeks after may have started earlier.
Rt arm started swelling Wednesday-Thursday the arm had reddened 6" in diameter, t101, itchy; took 5 days for reddness to disappear;
On 10/11/00, pt received vaccines and developed erythema and subsequent desquamation on all extremities. Also had fever, nausea and vomiting for several days.
After my first dose I had the normal symptoms of achiness, fatigue, and cold like symptoms but no fever. 7 days after shot I developed a rash around injection site. 14 days after the shot, I developed what they call COVID Arm around the injection which looked like a ring or spider bite around the injection site. All of these symptoms lasted for weeks. After I spoke with my doctor, he advised that I wait to receive my second shot which is why I waited until September to get my second dose.
The day after the Pfizer vaccination there was a small bruise on my arm away from the injection site.  After conversation with a friend she experienced the same.
After taking the vaccine, I had normal feverish symptoms and a sore arm. After several days, These local symptoms subsided. Then I felt like the insides of my bloodvessels were bruised. Resting my arm on a solid object would make me feel pain in my arm. My chest also has a recurring stinging sensation.  The inner bruising sensation has subsided, about 4 weeks after the vaccine. The stinging of my heart still continues, even as I write this. Its intermittent. It will go away for several hours, then it will return for hours. I try to reposition my body, but the it feels like my chest over my heart has a bruise on the inside.
Resident was noted with generalized rash throughout her lower and upper extremities,  trunk, back area. left harm at injection site was grayish red.
Dizziness , light headed, numbness and tingling sensation face and extremities Had difficulty standing Airway was clear. No difficulty  breathing No rash  Placed in supine position Given oral juice and bottle of water  Vital signs were stable in supine position After > 30 min individual felt steady and was allowed to leave the facility
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-OCT-2015 the patient was vaccinated with improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-2017, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pfizer 4/12/21, 5/12/21. Positive on 2/5/22
vomited APAP evening of shot; woke up w/t106; pvt MD consulted addtl APAP ordered-t104; tc from mom fever broke evening of 20JUL94;
Fever, hives, aching all over, brain fog lymph swelling neck + arm pits, pain large joints, muscle pain, neurologic dysfunction tremor, migrain sever pain right eye blindness, unable to recognize words, brain fog, lost words MRI on 23- white bodies and lesions
Fever of 101 that did not respond to tylenol.  sever headache that did not respond to tylenol.  fasting blood sugars went from 100 to 120.  1.5 hour post meal blood sugars went from 130 to 205.  brain fog returned  I had covid.  Positive test was Nov 28, 2020.  Last under doctor's care March 19, 2021 but that was a diabetes follow up.
Missed second dose; Ill; This spontaneous report was received from a nurse concerning a 74-years-old female patient  who received Moderna's COVID19 vaccine (mRNA-1273) and felt ill and missed second dose.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 18 Jan 2021, prior the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number: 028L20A) Intramuscularly in the left arm for prophylaxis COVID-19 infection.      On 18 Jan 2021, the patient felt ill. On 25 Feb 2021, the patient had a brain surgery due to which missed second dose appointment.    The action taken with mRNA-1273 in response to the events was not reported.  Th e outcome of the event ill was not reported. The outcome of the event missed second dose was considered recovered.
Bruising and swollen knot at injection site with pain still on 2/2/16.
Pt. limited english speaking. Given nasal H1N1 after having inactivated on 11/17/09. Confusion on pt. part.
sore throat; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-239060 (Patient Link).
The patients got COVID 2 weeks later; The patients got COVID 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) 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) all with onset Nov2021, outcome "unknown" and all described as "The patients got COVID 2 weeks later". Clinical course: Caller, a pediatrician, reported that the patient received first dose of Pfizer covid-19 monovalent vaccine on 11Nov2021 and then got covid two weeks later and did not come back in for the 2nd dose. Caller stated she saw the patients on 11Nov2022 and gave them Pfizer covid-19 for ages 5-11 monovalent vaccine. Caller asked is this the 2nd primary dose or should she repeat the dose. NDC number, batch/lot number, expiry date: Not provided. Caller was going to call the patients back but called Pfizer first to try to figure out if they need to restart the series.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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,Linked Report(s) : US-PFIZER INC-202201300797 Same reporter/product/event, different patient;
Pt given booster, Mom was under the understanding that pt could receive it.  Parent did not inform facility until after vaccine was given.
High temperature 104.3 12/31 I am  Trouble breathing Extreme chest pain still continuing 1/5/21