chrisvoncsefalvay/vaers-outcomes huggingface dataset:
KIDNEY ISSUES; VISION ISSUES; WHITE BLOOD CELLS IN URINE; RED BLOOD CELLS IN URINE; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced vision issues. On APR-2021, the patient experienced white blood cells in urine. On APR-2021, the patient experienced red blood cells in urine. On an unspecified date, the patient experienced kidney issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vision issues, red blood cells in urine, white blood cells in urine and kidney issues was not reported. This report was non-serious.
Pt recvd vax & 2 wks p/2nd dose exp transverse myelitis or spinal cord infarct;
Fever, chills, fatigue, body aches lasted about 2 days. Today, experiencing headaches, fatigue, lack of focus, dizziness, taking a lot of naps throughout the day, brain fog, body aches, bruising at injection, irritability and whole arm soreness. Got shot about 2 weeks ago. Went to Urgent Care for something unrelated but she did mention her symptoms. Had bloodwork done but have not gotten results back yet.
itching at injection site; rash at the injection site - 2-inch square; soreness at injection site; headache; fever - lasted for less than 4 hours; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date, unspecified number of patients were administered improperly stored GARDASIL 9 lot # M044717, expiration 19-JUL-2019 for prophylaxis and unspecified number of patients were administered improperly stored ROTATEQ lot# M045546, expiration 12-JUN-2018. No adverse effects reported. Temperature between 9 degrees Celsius (°C) to 25°C (14.5C). Time frame 1 Hour. No previous temperature excursion. Digital Data logger report was not involved. Additional information has been requested.
Mother presented child for flu vaccination. Mother reports that she takes flu shot annually, with no previous reaction. Vaccine administered. Child began itching skin @ site before leaving clinic. Last eve. injection site became reddened- this A.M. area of redness @ site was 5 cm and circular. Warm and mod. firm. Mother reports she saw vaccine "run out" of injection site @ time of injection into skin. Advised application of ice pack several x today and take TYLENOL po 3 tsp. every 4 hrs prn discomfort.
Bruton-Like hypogammaglobulinemia type illness following 4th OPV @ 18mo of age;Annual follow-up received on 02/15/01 provides no additional data.
Information has been received from a registered nurse (R.N.) concerning a 12-month-old female who on 04-MAY-2006 was vaccinated with a dose of Varivax (lot# 652804/0263F). Concomitant vaccinations included a dose of MMR and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Subsequently, on an unspecified date, the patient developed a minimum of 50 pock marks, sought unspecified medical attention and was diagnosed with chickenpox. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Dizziness, Headache, Myalgia, Fever, c/o chills,fatigue,rash at injection site. Told to see primary care physician if symptoms persist. Narrative:  Other Relevant History:
Severe leg pain (both), overall muscle soreness, diarrhea, nausea, vomiting, coughing, and tiredness.
This spontaneous report was received from a 50 year old female patient referring herself. The patient did not have concurrent conditions, medical history, drug reactions or allergies. She was not taking concomitant therapies was provided. On 07-MAR-2017, the patient received one dose of ZOSTAVAX, subdermal (product use issue) in the left arm to prevent shingles (strength, frequency, lot # and expiration date were not reported). On 08-MAR-2017 (reported as "the morning after"), the patient developed a small dime size circle at the injection site, and on the same date by the afternoon, the circle turned into a swollen, hot, "golf ball" size lump (injection site mass, injection site swelling, injection site warmth). On an unspecified date, the patient talked to a pharmacist and an unspecified treatment for the adverse events was given; laboratory diagnostics studies were not performed. At the time of the report, the patient had not recovered from the events of injection site mass, injection site swelling, and injection site warmth  The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
84 y.o. female with PMH of coronary artery disease with prior RCA stent in 2019, atrial fibrillation s/p pacemaker, type 2 DM with diabetic nephropathy, and CKD 4 who was admitted on 4/23/2021 with chest pressure radiating to the arm.
Fever to 105, generalized febrile seizure within 24 hours of vaccine administration.
Nasal congestion; Burning hyperesthesia over the back; facial pain, seemingly over paranasal sinuses-e.g. pain over cheekbones/maxillary sinuses.; Fatigue; Headache; developed allodynia; This is a spontaneous report from a non-contactable physician, the patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 08Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included silodosin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. On 08Mar2021, approximately 45 minutes post vaccination, the patient developed headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses. As day went on, the patient developed nasal congestion, fatigue, and later that evening developed allodynia manifesting as burning hyperesthesias over the back. The patient was fully recovered by next day. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache that extended to facial pain, seemingly over paranasal sinuses-example, pain over cheekbones or maxillary sinuses, nasal congestion, fatigue, and allodynia manifesting as burning hyperesthesias over the back was resolved on 09Mar2021. No follow-up attempts are possible. No further information is expected.
Left arm red and swollen. No treatment. Per dad noticed her arm at 8:30 P.M.
tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (at the age of 76 years old) (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included blood cholesterol, glaucoma. Concomitant medications included brimonidine tartrate, brinzolamide (SIMBRINZA) taken for glaucoma (been on it for about 6 years), latanoprost for glaucoma (Due to her insurance she was just changed to the generic. She had been taking brand name. She had been on it about the same about of time as Simbrinza), simvastatin taken for blood cholesterol (been on it between 8 to 10 years). It was reported that the patient received her first dose of the vaccine on 10Mar2021 and 12 days later tested positive for Covid on 22Mar2021. She received experimental infusion and they said she cannot receive another covid vaccine for 90 days. The doctor was not sure if she needed to restart the series. She asked if she would need to restart the series if she waits that long. She stated they recommend she get a blood test to see what the antibodies are after 90 days and she stated she will contact her HCP at that point. She had tested negative 5 days before, then tested positive. She got the infusion on 22Mar2021. They were very quick and on top of that. The patient has not received any other vaccines within 4 weeks prior vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: positive on 22Mar2021. The outcome of the event was unknown.
Hospitalized (9.15.21);  COVID-19 positive (9.15.21);  Fully Vaccinated  Discharge Provider:  Primary Care Provider at Discharge:  Admission Date: 9/15/2021 Discharge Date: 9/23/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] AKI (acute kidney injury) (HCC) [N17.9] Acute respiratory failure with hypoxia (HCC) [J96.01] Aspiration pneumonia, unspecified aspiration pneumonia type, unspecified laterality, unspecified part of lung (HCC) [J69.0] COVID-19 [U07.1]   HOSPITAL COURSE: he patient is an 81-year-old gentleman with presented to the hospital with acute respiratory insufficiency.  He was noted to have COVID-19.  Number has a past medical history significant for dementia, diabetes mellitus type 2, hypertension, dyslipidemia, CKD 3 and prior DVT for which he is on Xarelto. Apparently the patient became increasingly weak over the past 2-3 days prior to admission.  He is normally able to ambulate around the home with use of walker but he was so weak on the day admission that a wheelchair was needed.  His also had a cough, diarrhea and reduced oral intake.  The patient has dementia at baseline but his mental status has even worsened.  Denies any fevers chest pain abdominal pain or vomiting.  The patient has a history of having aspiration pneumonia in the past.  The patient does have a history of vaccination for COVID in the past.  Upon evaluation in the emergency department the patient noted to be hypoxic.  He was requiring 2 L of supplemental oxygen.  Also found to have AKI on CKD positive for COVID PCR.  X-ray chest demonstrated mild pulmonary vascular congestion.  Was started on remdesivir and dexamethasone.  He is on vent to the conservative management.  And was subsequently taken off oxygen.  Shortness of breath and cough also resolved. He did have significant hyperglycemia while he was on steroids.  The sister was subsequently discontinued.    Doing fine off oxygen.Plan is for home with OT/PT.
TDAP given LD IM on 5/24/10. Moderate to severe rxn c/o nausea, diarrhea; large, hard area where shot given. Warm to touch. Also c/o myalgia - all with onset after shot given. Call to Immunization Program - ok to report.
This spontaneous case reported by a consumer, describes the occurrence of rash (all over body) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (all over body). At the time of the report, rash (all over body) outcome: unknown. No concomitant medication or treatment information reported. Action taken with mRNA-1273 in response to the event: not applicable.
On or about 4/1/2022 at 7:30pm I started experiencing symptoms of low blood sugar. The lowest reading I got was 51 mg/dl. I attempted to treat myself with food twice before deciding to get seen at Hospitals ER. Once there, I was admitted to the hospital for 3 days and taken off all medications except for the Letrozole so my blood sugar levels would finally normalize. I was discharged at the end of the three days with orders to see my endocrinologist at office. I was seen within a few days and my medication was adjusted so the event doesn't happen again.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). Other case identifier: US-PFIZER INC-202101176813. A 72-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had vertigo (non-serious), dizziness (patient woke up the next day and couldn't get up because he was dizzy as can be) and felt drunk (patient felt drunk-like), with outcome of unknown. Additional information: Pfizer COVID-19 vaccine patient felt drunk-like with vertigo. After the second shot was in bed for 5 days again with vertigo to the point he needed a walker to get to the bathroom. Patient wondered if he got a booster, should he expect to feel the same or worse. Patient suffered from a little bit of dementia (ongoing) prior to him being administered any doses of Pfizer COVID-19 vaccine. The batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Friday I began to not feel well. Sore throat, congestion, my ears hurt, low grade fever body aches, fatigue, loss of appetite. Symptoms continued through the weekend without improvement. Wednesday morning I work up to an itchy arm and large red bump on the injection site. Wednesday night I took Benedryl and began to improve. By Friday I felt great again.
after taking the new covid vaccine, he collapse while he was walking.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, 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: SYNCOPE (medically significant), outcome "unknown", described as "after taking the new covid vaccine, he collapse while he was walking.".  Clinical course: Caller calling in to report that he got a side effect after taking the new covid vaccine, he collapse while he was walking.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling, induration & tenderness in left deltoid at injection site. Complains of pain and swelling in entire arm and neck area.
By the evening felt stomach cramps and a little off. By morning, 4/5, had body aches, chills, stomach cramps, strong headache, vomiting and diarrhea -- patient was sick as could be in less than 24 hours. Took 3 ADVIL and called doctor who advised just wait it out and take ADVIL as needed. Symptoms continued and aggravated over the next days. Patient called doctor again on 4/8 who recommended visit to office or ER. On 4/9 called doctor again since developed fever (approximately 99.5); doctor provided now new recommendations. Patient not satisfied with provider's handling of case so has appointment with new doctor on 5/15. Patient mentions that she had chickenpox as a child--a bad case, a shingles outbreak on left torso at age 44, and at 55 years patient received the Zoster vaccine with no problems. Today patient is doing better--has turned corner; patient has been in bed the entire week. Patient continues to take ADVIL and lots of fluid as needed.
Mom described 1/3/07 awoke in am, Pale, weak pulse, vomited, moist cough, fever to 103.
DIARRHEA; CHILLS; FEVER; SEVERE HEADACHE; FATIGUE; INDIVIDUAL 16 YEARS OF AGE  RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a consumer concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 14-MAR-2021, the subject experienced off label use. Laboratory data included: Body temperature (NR: not provided) 102 F. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, severe headache, diarrhea, chills, and fatigue, and the outcome of individual 16 years of age received vaccine and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of M-M-R II and VARIVAX (Merck). The nurse reported that the labels of M-M-R II (Merck) and PROQUAD (Merck) had similar coloration and M-M-R II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested.
Information has been received from a pharmacist on 10-FEB-2015, concerning a 12 month old male patient with gastric reflux and no known allergies. The patient's medical history included eczema and ear infection. On 04-FEB-2015 the patient was vaccinated with a dose of M-M-R II (lot # K005574, expiration date 17-APR-2016) (dose and route unspecified). Concomitant therapies included omeprazole. On 09-FEB-2015, the patient experienced seizure-like movements and 101F fever and went to an emergency department on 10-FEB-2015 at 12:11. The patient was treated for the seizure-like movements with DILANTIN, phenobarbital, VERSED, and lorazepam, and he was transported to another hospital at 02:24 on 10-FEB-2015, by flight transport to be admitted for further evaluation. The patient underwent blood culture and other unspecified blood tests without results. The pharmacist requested a lot check for the lot of M-M-R II that the patient received. The outcome of events was unknown. The pharmacist considered the event seizure-like movements to be medical significant due to "normally, patients don't get put on a VERSED infusion and then flown to another hospital to be admitted". This is one of several reports from same source. Additional information has been requested.
pt recv vax in later summer to early fall 1994; pt fainted & fully recovered w/o tx;
12 hours after receiving vaccine, c/o joint pain, ankle, knee and hip. C/O soreness at injection site; c/o N/V/headache for 24 hours.
Awoke Monday (4/11/11) with achy flu-like symptoms, came home from MD office - nauseated and vomiting. MD attributed his S/S to the ZOSTAVAX injection given Saturday 4/9/2011 s/s duration 8-12 hrs.
Large area of erythema extending from superior portion of left shoulder down to left elbow with associated warmth, lymphadenopathy, myalgia and malaise. Patient has had this reaction repeatedly with his annual booster for 5 years. Patient had reported to local medical authority every year and it was watched locally, not reported.
My arm was in pain for about 5 or 6 days and it suddenly got itchy. The day before MLK day and my arm was a little red. It looked like hives and it got bigger. I was literally a heart shape right around the injection site. I contacted my doctor b/c it was a week later. I spoke with the NP and they said they had no idea. They prescribed me an EpiPen, but I didn't use it and told me to take Benadryl. A few days later it was fine, the rash was gone and my arm no longer hurt. I was instructed to call an allergist and was told that it was just a delayed reaction. I got my 2nd dose and I was a little achy and feverish, but it went away in about 24 hours.
COVID Booster shot brought back poison oak rash a few weeks ago; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Unknown), for COVID-19 Immunization. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "COVID Booster shot brought back poison oak rash a few weeks ago". Additional information: COVID Booster  Rash. Do not have much information, just what was listed above. He said the booster from Pfizer. Age was reported as 60.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.