chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick with COVID; sick with COVID; Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4520987-00 (Agency).  A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 69 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 027L0A), on 04Mar2021 as dose 2, single (Lot number: 011M20A) and on 10Dec2021 as dose 3 (booster), single (Lot number: 048F21A), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Dizziness" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Tobacco use", stop date: 1998, notes: Tobacco use (stopped 1998); "Abstains from alcohol" (unspecified if ongoing); "Tuberculosis" (unspecified if ongoing); "Statin allergy" (unspecified if ongoing), notes: Statin allergy. Concomitant medication(s) included: PREDNISONE; DILTIAZEM; MECLIZINE [MECLOZINE HYDROCHLORIDE] taken for dizziness; LEFLUNOMIDE taken for rheumatoid arthritis; MELOXICAM taken for arthritis; FOLIC ACID taken for rheumatoid arthritis; CITALOPRAM; LISINOPRIL; TOPIRAMATE; PREGABALIN; ONDANSETRON; BENZONATATE; MONTELUKAST; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "recovered" (28Aug2022) and all described as "sick with COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 Fahrenheit; SARS-CoV-2 test: (28Aug2022) Negative; (21Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter considered "covid" not related to BNT162b2.  Clinical information: Solicited report from a consumer of a 70 year old female with events of non-serious slept a lot and sick with COVID with Humira 40mg/0.4ml (Adalimumab). On 21Aug2022, the patient experienced slept a lot and sick with COVID. On 28Aug2022, the slept a lot and sick with COVID resolved. Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with Paxlovid.
Starting to suffer from Kidney Failure because of the protein did not breakdown correctly in my kidney, I have kidney failure to the rest of my life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 33023BD) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "Starting to suffer from Kidney Failure because of the protein did not breakdown correctly in my kidney, I have kidney failure to the rest of my life.".  Clinical course: The patient got the Pfizer Vaccine a two months ago unfortunately. The patient was starting to suffer from Kidney Failure because of the protein did not breakdown correctly in patient's kidney. So the Pfizer, the whatever vaccine (Clarified as Pfizer COVID-19 Vaccine) would it be, 'as using the' Vaccine it didn't breakdown correctly in patient's kidney and now the patient was having kidney problems.   No follow-up attempts are possible. No further information is expected.
There was blood in the stool and coming alongside the stool; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 08Apr2021 at 18:15 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not pregnant. The patient has no known allergies. Facility type vaccine was health clinic/facility. No other vaccine in four weeks. Concomitant medications included escitalopram oxalate (LEXAPRO), clarithromycin (CLARITIN) and melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient experienced there was blood in the stool and coming alongside the stool on 09Apr2021 at 23:00 with outcome of not recovered. No treatment was received for the event. No Covid prior to vaccination and not Covid tested post vaccination.
It is a large red area 2 inches wide and 2 and 1/2 inches tall at the injection site that is raised up and  itchy at times.
Significant myalgias, polyarthralgias, fatigue, malaise, chills the day after vaccine Myalgias and fatigue have persisted for weeks
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
Pt received the vaccine sat in our waiting area and then passed out a couple minutes after receiving the vaccine. He came to in a minute or so. We called 911 and the paramedics came and took him to the local hospital. Per his report he had not had anything to eat that day and when he came to he felt nauseated and clammy.
allergic reaction; fast heartbeat; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes; terrible chills; blurred vision; neurological damage; injection site in still sore and its goes down to thumb; injection site in still sore and its goes down to thumb; This is a spontaneous report received from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on an unspecified date in Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes, terrible chills and blurred vision, on an unspecified date in Feb2021 neurological damage and injection site in still sore and its goes down to thumb on an unspecified date in 2021. The reporter stated that the patient received her first dose of the Pfizer covid vaccine in Feb2021. The patient experienced an allergic reaction 30 mins after the shot, fast heartbeat, numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes. She took and treatment included BENADRYL, which helped some, but she still have it. She also had terrible chills, blurred vision. She has seen doctors and was advised to not take the second dose and stated she still has the numbness in tips of her fingers, toes and on the tip of the nose. Her neurologist was going to see her today and do a scan of the head. She thought she might be allergic to PEG in the vaccine, but her doctor thought she might have neurological damage. She said her injection site in still sore and it goes down to thumb. Re-porter wanted to know should she take the second dose or not. Therapeutic measures were taken as a result of allergic reaction and numbness from the injection site to face and in the mouth, up-per lip, tip of the nose and tips of the toes and treatment included BENADRYL. The outcome of the events allergic reaction and numbness from the injection site to face and in the mouth, upper lip, tip of the nose and tips of the toes with outcome of not recovered, fast heartbeat, terrible chills, blurred vision, neurological damage and injection site in still sore with outcome of unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Swelling of the back of the tongue and trouble breathing that caused coughing. I took 2 Benadryl tablets and 15 minutes later I felt the swelling go down and I was able to breathe normally. No other issues.
The tips of my fingers turned purple about an hours after the vaccine. It lasted for about 2 or 3 days, and it went away. On 10/18/22, I went in for a pre-op physical and they did an EKG. They told me I had A-fib. A couple of days after that I felt weak and lightheaded.  I ended up in the Emergency Room and they kept me overnight they did an echocardiogram and an EKG they put me on Morphine and Metoprolol Tartrate.  I went to the Emergency Hospital on 10/21/22 and they release me on 10/22/22. I checked back in my records on my computer, and I found out that my heart rate started increasing back on 6/13/2022.  I am going in for another echocardiogram on 11/2/22. 10/28/22, as of today, I still feel weak and tired. If I do anything strenuous, I get a little light-headed. I feel better than I did, but I have not fully recovered.
Patient was given KINRIX instead of PENTACEL. PCP was notified and safety report done. Mother was notified. Per health dept this will count and should not be harmful to patient.
Experienced chills after second dose; after second dose her arm started to hurt; She could barely sleep because whole arm was so painful; She could barely sleep because whole arm was so painful; she cannot move her right arm at all after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose), CHILLS (Experienced chills after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029520A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Dry macular degeneration. Concomitant products included BUDESONIDE (PULMICORT) for Asthma, OLMESARTAN for Blood pressure abnormal, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Dry macular degeneration, MIRTAZAPINE for Sedative therapy, BUPROPION HYDROCHLORIDE (WELLBUTRIN), MONTELUKAST SODIUM (SINGULAIR), CALCIUM, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful). On 23-Feb-2021, the patient experienced CHILLS (Experienced chills after second dose). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) from 23-Feb-2021 to 24-Feb-2021 for Adverse event, at a dose of 2 dosage form. On 24-Feb-2021, CHILLS (Experienced chills after second dose) had resolved. At the time of the report, VACCINATION SITE PAIN (after second dose her arm started to hurt), INSOMNIA (She could barely sleep because whole arm was so painful), VACCINATION SITE MOVEMENT IMPAIRMENT (she cannot move her right arm at all after second dose) and PAIN IN EXTREMITY (She could barely sleep because whole arm was so painful) outcome was unknown.            Concomitant medication included probiotic supplement. The patient felt that Tylenol was helpful. It was reported that chills went away on 24-Feb-2021. On 24-Feb-2021, the arm was still hurting (in the muscles and top of shoulder).   This case was linked to MOD-2021-024305 (E2B Linked Report).; Sender's Comments:  MOD-2021-024305:
States her head began to hurt about 10 minutes after she received the nasal spray. Student rested. States her headache improved, 12:10. No other complaints.
Swollen and tingling tongue and lips Severe headache 1 day after swelling above left collar bone that looked like a softball sliced I half and placed under skin.
Patient reported instant burning sensation and pain. Arm (right deltoid) became red, warm to touch, knot at injection site at size of quarter.
Pt recvd 1st dose of Engerix-B & immed exp a sore arm-no nodules; nurse prescribed heat; soreness lasted for 1 month & arm still feels sore; recvd 2nd Engerix-B vax & has had no untoward effects yet;
No additional adverse events reported; administered RECOMBIVAX HB that had undergone a temperature excursion; This spontaneous report was received from a nurse, referring to 12 years old female patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 19-AUG-2021, the patients was administered hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route were not reported; lot# S005808 has been verified to be a valid lot number for hepatitis b vaccine (recombinant), expiration date 02-NOV-2021) for prophylaxis that had undergone a temperature excursion. No additional adverse events were reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S005808; expirationdate: 02-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006895: US-009507513-2108USA007014:
103 fever; insane head pain; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 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 fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced fever of 103 degree F and insane head pain. The patient stated that he/she had the worst reaction in his/her life to this vaccine. The patient also stated that but after reading the comments, it sounds like it was worth it. The follow-up would not possible as no contact details were available.
I felt fine going in to get the vaccine, that evening my stomach hurt a little. And I do recall after the first dose I received back on 03-01-21 I had a little stomach issue but it was gone the next day. That evening I went to bed and I began to get the worst stomach cramps I will call them and sick to my stomach feeling I had ever experienced. I did not ever get a fever. I went to the ER the next morning and had my gallbladder and Pancreas as well as the liver scanned and checked. I was told that my blood work was good only  a small elevation in a part of the liver test. but it was nothing to worry about. I came hone where I laid vomiting, very lose stools, and unable to keep anything in for almost 6 days. I followed up with my regular dr and will follow up again at the end of this week. I was literally down for 6 days. My blood sugars were over the chart because I was unable to eat or drink. The cramping or pains were  awful. I am still sore in my stomach  but now beginning to eat and feel better.
Headache; nausea; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:30 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient stated that in Mar2020, his wife was tested positive for covid. The patient's concomitant medications included Vyvanse, Duloxetine, Divalproex, Tamsulosin, Levotab. The patient did not have covid prior to the vaccination nor been tested post vaccination. The patient had no Known allergies. On 04Mar2021 at 18:30, the patient experienced Headache, nausea and tiredness. All symptoms were mild and lasted. The patient did not receive any treatment for the events. On an unknown date in Mar2021, patient had recovered from all events.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & heavy blotchy, red rash occured; pt taken to MD; questionable fifth disease; rash over all body, extremities & face; pt felt tired;
wednesday 2/24/2021 around 1am, pt woke with fever, sweat, nausea, vomiting, exterme weaknes, fatigue, dizziness and a headache, these symptoms continued until friday 2/26/2021 1 pm,  then resolved, pt felt fine that day.pt treated with tylenol, fluids..
Initial misuse report received from a healthcare professional on 06 January 2014. A patient has received a dose of PENTACEL on 3 January 2013 reporter said that they found the ActHib on the counter and don't know how long it was there. The patient was received DTap-IPV was not received ActHib component of PENTACEL. No adverse event was reported. List of documents held by sender: none
Patient stated that after she was vaccinated, her arm got warm and swollen. She went to prompt care and they told her it was cellulitis most likely due to the pneumonia shot. She did also receive a high dose as well in the same arm. Doctor told her it wasn't due to technique. Her arm is better today and she wanted to make us aware.
Began with a sore arm the night of the injection (a few hours after). Then woke up with severe joint and bone pain especially in the hips, legs, knees, lower back. As the leg pain lessened in severity, pain increased in the left elbow and the entire left arm was achy. This began around 8-9 a.m. until around noon or so. (Pain noticed approximately 17 hours after the injection and lasted for 4-5 hours.)  Now, 24 hours after the injection, the main symptom is a sore arm.
pt recv vax 10JAN97 & t102 11JAN97;stiff neck 12JAN97;
Administered vaccine to nervous patient. After the patient was standing for 5 minutes she collaped and hit her head on the wall. Patient was placed in supine postion given water and sugary snacks. Doctor came and evaluated patient. After 5 minutes patients vital were taken. Patient stated that she felt dizzy. After laying in supine postion for 10 minutes patient felt better.
This spontaneous report as received from consumer reporting her sister, a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided). Co-suspect and secondary therapies were not reported. On an unspecified date, the patient received ZOSTAVAX and approximately a week and a half after receiving vaccine experience a "small, itchy rash on her back". No medical attention was sought. At the time of the report the outcome was unknown. At the time of the report the outcome was unknown. Additional information has been requested.
Blue mottled trunk and limbs, temperature > 102, rash similar to measles then petechiae during last 2 days before hospitalization. These symptoms started about 9 days after injection and lasted about 1 month including hospital stay where she received IVIG. PLT count was 28,000 and less.
knot in arm where shot was injected; Red spot on arm; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 20Mar2021 at 08:15 (at the age of 27-year-old), as a single dose, for COVID-19 immunisation. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), ZOLOFT, XANAX, biotin (MANUFACTURER UNKNOWN), buspiron (MANUFACTURER UNKNOWN) and AIMOVIG. The patient had history of drug allergy to Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021 at 21:00, the patient experienced red spot-on arm (vaccination site erythema) and a knot in arm where shot was injected (vaccination site mass). No therapeutic measures were taken as a result of adverse event. 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 events vaccination site mass and vaccination site erythema was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
died at 36 years old.; This is a spontaneous report from a non-contactable consumer.   A 36-years-old male patient received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient died at 36 years old. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died at 36 years old
The day after I got my vaccine and I passed out and I stayed the night in observation and I was running a fever.
Patient received second dose of vaccine on Saturday morning.  Saturday night had chills and started a fever.  Was not able to get out of bed at all Sunday. Had a fever ranging from 103 to 104.  Tylenol brought it down to 102 for short periods.  Sunday had numbness on the right side of face but did not see drooping.  It has mostly resolved except for top lip to my cheek. Fever Monday was between 100-101 and patient was able to stay awake for longer periods.  Tuesday had no fever and just feel tired and dizzy.  Today entirely better.
Tingling and numbness to my left, arm, fingers, toes, leg. Fluttering to my left eye. Electric shock feeling to entire body.
Secondary Transmission Nonvaccinee Limited information obtained. Primary SPV vaccinee had vaccine on 7 Feb. 2003. Approximately 20 days later, his wife developed a pustule-->eschar on her left forearm with erythema. No specific memory of exposure to vaccine site; vaccinee reports wearing a bandage.