chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following the second dose of Pfizer, I became very ill.  That evening, I had a very severe headache, body aches, nausea, the following day I vomited profusely upon waking.  I could barely walk, couldn't work.    In the following days, my urine became very frothy and bubbly.    Approximately one month following vaccination (10/25/2021), I presented with severe pain in my right side (same side as injection).  I went to a walk-in clinic, a CT scan was taken showing severe hydronephrosis of my right kidney.   I have no family history of renal disease or any prior inclination that something could be wrong.    Shortly after, a urologist inserted a stent to drain my kidney.  This required a minor surgery.    Approximately one month later, I had robotic pyeloplasty to remove a section of my right ureter to allow my kidney to drain.  My right kidney was left with approximately 5-10% function, which will not recover.  I had another stent placed during that surgery.    Within a month of surgery, I started having pain in my left side.  A renal function scan revealed 5% function in my right kidney and 70% function in my left kidney.    I am still trying to figure out what's wrong.
Rocephin 250mg Lot U0769 RUOQ, Augmentin ES600 Tsp PO Q12 x 10day, Hydroxyzine 10/5 3/4 tsp RO Q 8 hrs prn. Follow up in AM 8/4/05.
Metal taste in mouth, tingling of tongue and lips then moved to ears and cheeks.  Felt itchy. Waited 30 , symptoms seemed to subside went home and took Benedryl. 3-19-21 4:15pm Next morning felt fine but later in morning felt tingle in face and mouth area and took another Benedryl 3-20-21 10:00 am
Sore throat, fever 103.5 by thermometer. Started 11/16/09 injection given 11/12/09 H1N1.
Patient experienced a syncope event, had the patient lay down and monitored his vitals for 20 minutes before releasing him. Patient started feeling faint and was having tachycardia - and shallow breathing. Patient was alert after 30 seconds of fainting and had patient lay down.
Severe upper arm pain. Unable to raise arm or lift anything with left arm.; Sudden severe & profuse diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 15:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, premature ventricular contractions, partial right bundle branch blockage and osteoarthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 21:00, about 6 hours after shot, the patient experienced severe upper arm pain, unable to raise arm or lift anything with left arm and sudden severe and profuse diarrhea and unlike anything she had ever experienced. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced severe upper arm pain, unable to raise arm or lift anything with left arm and sudden severe and profuse diarrhea was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Approximately 12 hrs after receiving my booster, symptoms started. Nausea, dizziness and severe brain fog. My arm and chest on the side I received shot felt inflamed from the inside. I had prickly chest pains for 5 days which lessened starting day 6 and for another week til they were gone totally (after two weeks). I ran a fever  of 103 for first 5 days (that did not break easily w/ Tylenol. I and was in bed for 7 days feeling mostly delirious. At one point, my husband and mom considered rushing me to emergency. We waited it out, did not contact a doctor. After 14 days, I felt mostly like myself but it took a full 3 weeks - a month for me to feel normal, to feel I could think and communicate clearly (brain fog). The symptoms did not return. I feel no residual effects beyond that. I have not reported, and did not have this response with either my first or second shot of Moderna issued 3/12/21 and 4/9/21
Fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Aches) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Aches). At the time of the report, PYREXIA (Fever) and MYALGIA (Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Treatment Information was not provided by Reporter.
pt recv vax 20FEB96 & 7 days p/vax exp visual disturbance, h/a & dizziness;ER or MD visit was required;pt has not been treated yet;sx have improved but have not resolved as of 1APR96;
C/o throat feeling tickly or itchy, Denied SOB, felt like her lips were tingling as well. Later had itching in her arm. After second co-vid vaccine had a headache for 2 weeks, now has a rash that comes and goes on her antecubital area.
A 46 year old female patient received the first COVID-19 vaccine on August 20,2021. On August 26, 2021, itchiness developed at the injection site. The next day, on August 27, 2021, a rash developed. The rash was approximately 5 inches long and 3-4 inches wide. The patient  used topical Benadryl to treat the itching. The patient did not notify a primary care provider. The pharmacist recommended oral antihistamines and to continue to monitor symptoms and notify primary care physician at patient's discretion.
Information has been received from a Licensed Visiting Nurse concerning a 14 year old female who on 13-AUG-2007 was vaccinated with the first dose of Gardasil (659655/1486U). On 15-FEB-2008 the patient received the second dose of Gardasil and experienced pruritic rash all over her torso and swelling on her hands. She was prescribed Zyrtec for the symptoms. As of 19-FEB-2008, the patient was recovering. Additional information has been requested.
pt recv vax 9JAN97 & 23JAN97 pt devel hives;pt was seen @ local hlth clinic were was treated w/med;
Productive cough; Feeling "bubbling up"; Cough; Arm was very sore; Injection site was itchy; Injection site was swollen; Injection site had red dot line; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Productive cough), ABDOMINAL DISTENSION (Feeling "bubbling up"), COUGH (Cough), PAIN IN EXTREMITY (Arm was very sore) and VACCINATION SITE PRURITUS (Injection site was itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Productive cough), ABDOMINAL DISTENSION (Feeling "bubbling up"), COUGH (Cough), PAIN IN EXTREMITY (Arm was very sore), VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen), VACCINATION SITE ERYTHEMA (Injection site had red dot line) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (Productive cough), ABDOMINAL DISTENSION (Feeling "bubbling up"), COUGH (Cough), PAIN IN EXTREMITY (Arm was very sore), VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen), VACCINATION SITE ERYTHEMA (Injection site had red dot line) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-060530 (Patient Link).
101.6°f fever. Redness, swelling, pain, itchiness at injection site. Inflammed lymph nodes in left underarm. Tylenol, ibuprofen, epsom soak, topical benadryl ointment.
On 08/20/2021, the night of the vaccination, I had 104 fever for 36 hours and that was with Tylenol and Motrin. I slept for almost 36 hrs. straight. When I walked the body pain was so severe that I almost had to crawl. On that Sunday, 3rd day i started getting really bad bloody noses, with huge clots. They are very heavy and vey thick, and a lot, like 2 or 3 times a day. The clots are the size from anywhere from a dime to a quarter.  I would say unknown if I have recovered from the AEs because in the past 2 days the bloody noses have slowed down. Now they are maybe once a day.  Before my vaccine, 2nd  dose of Moderna. I would get bloody noses once a month, depending on the season, but my bloody noses were never heavy like they are now.  I have been sending the doctor messages through the portal on 08/25/2021, She said there was not much she could do and to use a humidifier.
Chills and fever started 2 days after the injection. The chills and fever have continued for a week and have intensified. Chills are so intense patient is shivering and shaking when he tries to sleep. Also suffering from what seems to be a respiratory infection. Patient coughed up sputum on Saturday 7/17 what showed signs of infection.   Treating this like the flu- patient has taken Tylenol, Advil, Advil Cold & Sinus, Elderberry. Drinking  lots of fluids,  resting as much as possible, but having difficulty sleeping due to fever, chills, and breathing difficulty.
pt with a history of eosinophilia treated with xeljanz 5 bid presented 9 days after covid vaccine with symptoms of acute LCMA ischemic stroke and was treated with tPA.
After 2 or 3 days of vaccination, I started feel not good in left low side of up body, the areas are left low back, side, front of left stomach, left leg, symptoms included numbness, muscle weakness, pain, pressure and difficult get up and uncomfortable walking, after sitting, these symptoms got worse, longer sitting time, the worse I felt. I can still felt pressure even when I laid on my bed. In October 4, 2021, I visited facility, Doctor, he prescribed 2 meds, one is Cyclobenzaprine 10mg 20 tablets total, another one is Prednisone, 30 tablets total, 10mg each, he also gave me instruction sheets for Back Exercise, after 8 days of taken meds I felt problem gone.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of metallic taste in mouth in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 4 October 2010 the subject received unspecified dose of HAVRIX (details unknown). On 7 October 2010, 3 days after vaccination with HAVRIX, the subject experienced metallic taste in mouth. At the time of reporting the outcome of the event was unspecified. Follow-up received from the healthcare professional on 11 October 2010: The event was improved. On 11 October 2010 the subject reported that the bitter taste in his mouth had almost gone. Follow-up received from the healthcare professional on 27 October 2010: The subject was 33 years old. Concurrent medical conditions included bee sting allergy, occasional alcohol use and marijuana use several times a week. The dose of HAVRIX was possibly the subject's 1st dose. He was seen in September 2008 and stated that he had already had dose 1 of Hepatitis A vaccine, but when seen on 04 October 2010 he stated he had never had dose 1 and that he did not want it in 2008 and had given the reporter wrong information. HAVRIX was administered intramuscularly in the left arm. The bitter taste occurred when the subject was eating and drinking. The event resolved on 15 October 2010. The reporter did not consider the event to be serious. The reporter considered that the event could not be associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medicinal product or any other reason.
VACCINE BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced administration of expired vaccine. On an unspecified date, the subject experienced vaccine being at room temperature for over 2 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and vaccine being at room temperature for over 2 hours after first puncture was not reported. This report was non-serious.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from Health Authorities of country under reference W824444. This case involves an unknown age female patient who experienced allergies to sulfa, while she received vaccine TETANUS TOXOID and while treated with LYRICA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient started taking LYRICA dosage unknown (with an unknown batch number) for Neuralgia. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious allergies sulfa (drug hypersensitivity) <<Unknown latency>> following the first dose intake and <<Unknown latency>> following the last dose intake of LYRICA. The patient developed a non-serious allergies sulfa (drug hypersensitivity) <<Unknown latency>> following the administration of TETANUS TOXOID. (Other relevant tests included No lab data reported.) Final diagnosis was allergies sulfa. LYRICA was unknown. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergies sulfa.
On Monday December 20.2021 work through the day was fine then fever 104, body aches, migraines, stomach cramping. I called my dad cause I felt super sick. Then next day I got tested December 21, 2021 positive for Covid-19 experienced really bad nausea. I started having issues with no taste, smell on December 24,2021. I applied Vick's vapor rub that night to help with the smell. Upon me waking up on December 25, 2021 my smell had came back. On December 26, 2021 I went to retest Covid (negative) and still having nausea. I had a Ultrasound of abdomen on January 3,2022 and a follow up with Radiologist for Ultrasound of pelvis and uterus .
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with PNEUMOVAX 23 (dose number, route, lot # and expiration date were not provided). In 2014, doses of PNEUMOVAX 23 that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified dates, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
LOST 4 LBS; BAD DIARRHEA; This spontaneous case report (PVX2019-2074) was received from a consumer on 12-Aug-2019. It described a 66-year-old elderly male consumer who had bad diarrhea (PT: Diarrhoea) and lost 4 lbs (PT: Weight decreased), after the administration of Vivotif (lot number: 3003277) for vaccination for trip.  Case report: The consumer took two doses of Vivotif a month ago for a trip. He stated that he had a little bit of diarrhea after the first dose, but it was severe after the second dose. The consumer stopped taking Vivotif because of diarrhea and lost up to 4 Ibs of weight. He stated he did not receive any treatments for it and have not spoken to a physician. However, he had received the typhoid injectable vaccine afterward.  Moreover, he had no relevant past medical history and he never had anything like it. He stated he was not on other medications.  Action taken with Vivotif was vaccine discontinued.  The consumer had been recovering from the reported events.  Company's Comment: In this case, it was reported that the consumer had bad diarrhea and lost 4 lbs after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea is labelled as per CCDS.; Sender's Comments: In this case, it was reported that the consumer had bad diarrhea and lost 4 lbs after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea is labelled as per CCDS.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 06-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
This spontaneous report was received from a pharmacist via a company representative concerning a male patient in his twenties. Medical history and concomitant medications were not reported. On an unspecified date, the pharmacist accidentally administered VARIVAX subcutaneously (lot # not reported) to the patient instead of ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Terrible nausea, dizziness, off balance, sick feeling all over.  Still the same way today (Friday Dec 11). Can't do anything without getting sick.  Lost a work week.  Doctor didn't help me.  So I am hoping this will go away, but I am still very sick.
Inflammatory immune response to vaccine. Left arm went cold immediately, then sore for 1-1/2 days. Dizzy/lightheaded for about 15 minutes. Significant numbness and tingling in Left arm, Left leg, Head/face/neck, right leg and arm, which has persisted for 7+weeks now. The intensity of the numbness and tingling has lessened over time but is still present and significant itching/skin crawling  in face, head, neck arms. Swelling of left arm and leg, which moved to right leg after 6 weeks. difficulty remembering words/names of things for the first few weeks (most significant in the first 2 weeks after shot). Balance issues have persisted 7+ weeks now.
Microembolisms on her right side blocking flow to lungs; Enlarged heart that is most likely caused by the pulmonary embolism; Pulmonary embolism; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another Manufacturer.   A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as dose 2, single for COVID-19 immunisation; treprostinil sodium (Batch/Lot number was not reported), nasal from an unspecified date to an unspecified date, at 18-54 mcg (3-9 breaths), qid, inhalation for secondary pulmonary (pulmonary arterial hypertension). Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included apixaban (ELIQUIS) and amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. The patient experienced pulmonary embolism on May2021, micro embolisms on her right-side blocking flow to lungs and an enlarged heart that is most likely caused by the pulmonary embolism on an unspecified date. The clinical course was as follows: The patient reported that she had a pulmonary embolism in May. She stated that she thought it was a result of the second Pfizer Covid vaccine dose. She also had micro embolisms on her right-side blocking flow to lungs. She also had an enlarged heart that was most likely caused by the pulmonary embolism. The events pulmonary embolism and microembolism were assessed as serious and medically significant. The action taken in response to the events for TREPROSTINIL SODIUM was unknown. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  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
sore throat after the second dose; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat after the second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat after the second dose). At the time of the report, OROPHARYNGEAL PAIN (sore throat after the second dose) outcome was unknown.
Covid 19 arm rash, itching, swelling, on eighth day after vaccine shot.