chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a 19 months old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N017094 with expiration date 31-FEB-2018, 1 dose, strength unknown) intramuscularly for prophylaxis. No adverse effect was reported. The vaccine was exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1711USA012903: US-009507513-1712USA005651: US-009507513-1712USA005649.
fever the day after shot, headache, chills,  body aches, joint aches, exhaustion,  so far 2 full days. This is now the end of the 2nd day. sight pain and swelling which is nothing compared to the other .
Patient states he experienced tingling in his arm approximately 1 day after vaccination (Sunday 6/12). He began having some tingling in his calf on Monday the 13th which has progressed to his second calf and worsened.
expired dose of quadracel was administered with no adverse event reported; Initial information was received on 18-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient who stated expired dose of quadracel was administered with no adverse event after receiving diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 17-Apr-2023, the patient received 0.5 ml once, Total dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (Suspension for injection) (lot C5851AA, expiry date: 25-Mar-2023), (strength: Standard) via unknown route in the left deltoid for Immunization.  On 17-Apr-2023 the patient developed a non-serious event of expired dose of quadracel was administered with no adverse event reported (expired product administered) same day following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Flu like side effects, sinus pressure, tightness in broncial area of chest, headache, aches, fatique, foggy brain & dry cough started 24 hrs and continued for 48 hours after the 1st Moderna shot. Stayed in bed and slept a lot. 1 dose of Nyquil Cough to sleep for 2 nights. Felt progressively better and all symptoms just lifted away right at 72 hour mark after shot! I did not see the cough and all the flu like symptoms listed as side effects. So our family started a chat and a cousin's husband - big strapping police captain had the exact same side effects as me.
2nd dose it spread to systemic infection.; Dose: 2nd Date: 18Nov2021; severe diarrhea for 5-6 days after that I developed UTI'S; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 2, single (Lot number: 32030BD) at the age of 72 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 1980 (unspecified if ongoing); "heart disease", start date: 1980 (unspecified if ongoing); "allergies: food related since birth" (unspecified if ongoing), notes: food releated since birth. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Date: 12May2021, Site and route of injection, Anatomical Site of injection: arm, Route of administration: Intramuscular [checked], Batch/Lot number: EW0176), administration date: 12May2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "I developed UTI's", "Feels really awful", "She is achy/achy all over", "Her arm hurt/arm hurts", "Nausea", "Diarrhea", "I threw up. Not only that, it was brown", "feel lazy", "I threw up; I threw up it was brown and my stomach hurt too". The following information was reported: DIARRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Diarrhea"; URINARY TRACT INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "severe diarrhea for 5-6 days after that I developed UTI'S"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Dose: 2nd Date: 18Nov2021"; SYSTEMIC INFECTION (medically significant), outcome "unknown", described as "2nd dose it spread to systemic infection.". The events "severe diarrhea for 5-6 days after that i developed uti's" and "diarrhea" required emergency room visit. The patient underwent the following laboratory tests and procedures: ER evaluation: (Nov2021) Diarrhea, notes: 6 days diarrhea followed by UTI put on antibiotics. Therapeutic measures were taken as a result of urinary tract infection. Clinical Courses: Vaccination Facility Type was Hospital.   No follow-up attempts are possible. No further information is expected.
The knee and his neck are still in pain; The knee and his neck are still in pain; sick; his neck had always caused him grief; his energy level increased; Unexpected therapeutic benefit.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old-male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry Date and NDC number: unknown), via intramuscular in left arm on 12Feb2021, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Unknown, NDC number unknown), via an unspecified route of administration in right arm on an unspecified date, as 2ND DOSE, SINGLE DOSE on 05Mar2021 for COVID-19 immunization. The patient underwent a knee surgery in Dec2020. Patient received the Pfizer BioNTech COVID-19 vaccine (30 days after contracting the virus) after testing negative for the virus. Patient mentioned that the virus attacked his joints but did not alter his taste and smell. Concomitant medications were not reported. After receiving the Pfizer BioNTech COVID-19 vaccine, patient stated that some side effects from the virus minimized, improvement was noticed, joints did not hurt as bad and energy level increased. Patient's experience after receiving the Pfizer BioNTech COVID-19 vaccine had been pretty positive. Patient was healing well, but once he caught the virus everything, they did to fix his knee turned bad. Patient had to have a complete knee replacement now because of the COVID-19 Virus. While he was sick, he had just had knee surgery and his neck had always caused him grief, and the virus exacerbated all of that. The knee and his neck were still in pain. After he got the vaccine, some of those effects from the virus had reduced, they were not gone entirely, but there was an improvement. Patient felt an improvement, but he still had residual symptoms from the virus. Pfizer BioNTech COVID-19 vaccine helped alleviate some symptoms from the COVID virus. The outcome of all events was recovering. Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
A health care professional prospectively reported the administration of a dose of hepatitis A inactivated and hepatitis B recombinant vaccine to a 26 year old female patient during the first trimester of pregnancy. The patient's last menstrual period was on an unspecified date in August 2004. On 9/8/04, the patient received the first dose of Twinrix (lot HAB276A6). The reporter stated that, on 9/9/04, "the patient took a pregnancy test and it was positive." Follow up was received on 1/24/05 from the reporting health care professional. The health care professional reported that the patient terminated the pregnancy. The date of the elective abortion was not provided. Comment: Elective abortion was assessed as medically serious (OMIC). No additional information obtained.
Information has been received from a nurse concerning a 22 year old female patient with penicillin, amoxicillin and erythromycin allergies who on 26-JUN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot # 660553/0070X), 0.5 mL, IM. On 30-JUN-2008, the patient developed "red welts" on her abdominal and trunk area. On 10-JUL-2008, the patient had dry, small raised, red bumps on her abdominal area and upper back. The patient was recovering from "red welts" on her abdominal and trunk area and dry, small raised, red bumps on her abdominal area and upper back. The patient sought medical attention at the physician's office. Additional information has been requested. Follow up information was received from a registered nurse concerning a 22-year-old femal with ESS/ampicillin and Penicillin allergies who on 26-Jun-2008 was vaccinated with a first dose of GARDASIL (lot# 660553/0070X), intramuscular into the left deltoid. The patient called ad stated that 4 days after GARDASIL (lot# 660553/0070x), on 10-JUN-2008 (also reported as 09=JUL2008) she felt hot and hada red rash. She saw similar reaction to penicillin. At the time of reporting the patient recovered. There were no laboratory/diagnostic test performed. There was no illness at the time of vaccination. No further information is available.
p/ pt recv vax approx 10 days later pt exp diarrhea, fever & a general rash w/a chickenpox appearance.
DATE OF ADMISSION:  08/26/2022 DATE OF DISCHARGE:  08/31/2022   Attending physician, Dr.  covering for Dr.   DISCHARGE DIAGNOSES 1. COVID-19 infection with COVID pneumonia. 2. Weakness with fall. 3. Relapsed acute myeloid leukemia. 4. Pancytopenia. 5. Paroxysmal atrial fibrillation with bradycardia episode of atrial flutter. 6. Vasogenic edema with history of encephalopathy, resolved last admission. 7. Recent febrile neutropenia with recent acute hypoxemic respiratory failure. 8. Transfusion-related iron overload. 9. History of dysuria, hematuria, urinary frequency. 10. Recent rectal bleeding. 11. Hypertension. 12. Diabetes type 2 with steroid-induced hyperglycemia. 13. Chronic low back pain. 14. History of left lower extremity deep vein thrombosis. 15. History of prostate cancer.   HOSPITAL COURSE The patient is a very pleasant 80-year-old male with past medical history as listed above including relapsed AML, who was recently admitted for relapsed AML and treated with azacitidine and venetoclax, who presented today after discharge for weakness and fall off the toilet.  Initial laboratory studies and imaging can be found per Epic review.  Of note, routine COVID-19 screening was positive and chest x-ray showed right upper lobe pneumonia.  The patient was started on cefepime and Zithromax was added.  Each was treated with a 5-day course of remdesivir and dexamethasone taper.  His MRSA was negative.  He was stable on room air.  Procalcitonin 2.54.  PT, OT were consulted and recommended home PT and OT.  The patient received transfusions as needed.  His other medical conditions stay stable. Endocrinology was consulted to assist with steroid-induced hyperglycemia.  He was felt medically stable for discharge following his last dose of remdesivir on 08/31/2022
tested positive; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who received her first dose of Pfizer-Biontech Covid19 vaccine on 18Feb2021. Two days later, her boyfriend tested positive for Sars-Cov-2 infection, and she tested positive a week later. The patient experienced tested positive on 25Feb2021. The patient underwent lab tests and procedures which included covid-19: positive on 25Feb2021. The event assessed as medically significant. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Adolescent received Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Noticed itching and slight rash on distal portion of extremities the evening of Dec. 30, rash became worse over next few days and became more inflamed/raised even with Benadryl taken as directed on box.   I went to urgent care on Jan 1, 2021 and was started on Steroid taper of 60-40-20 each dose for 3 days.   Improvement noted after 2nd steroid dose.  No respiratory involvement with vaccine or rash episode
61 Y/o female with PMH DM2, HLP, OA, peripheral neuropathy, lumbosacral radiculopathy, PTSD, fatigue, GERD, asthma, allergic rhinitis, migraine, monopoiesis-arm, HTN, hypothyroidism, and hx of multiple nodules of lung called triage to inform the clinic of her ADR to Moderna Vaccine n 3/15/2021. PT received both Moderna on 2/13 and 3/13/ Patient reported that she "Reacted badly" to the COVID vaccine over the weekend and will not any future booster have shot. She reported that her face swelled up, body temp dropped to 94-plus, she could hardly breathe and her 02 sat level dropped into the 80's and RA (her normal range is 91-98% RA). Stated that because of her " Neuropathy and nerve damage" she couldn't not tell that she was having an allergic reaction. Did not realize that her face was swollen until she looked in the mirrow. Per Patient, it took her 2 days to get body temp and 02 Sat's back up to normal and for facial swelling resolve. Patients' shard that she has had the Covid infection (tested positive 11/9/2020 and believes her reaction to the vaccine was worse than the actual infection. She is eating, drinking, breathing and speaking without difficulty today. Denied symptoms all the time of her call to triage line on 3/13. Patient did not have to seek medical care.
tested positive on PCR test for COVID 19 > 2weeks after receiving 2nd Moderna dose.  currently asymptomatic
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant medication was not reported. The pharmacist reported that a patient received a PNEUMOVAX 23 (dose 1, exact dose, route, lot# and expiration unknown) in January 2017 and that the same patient received another PNEUMOVAX 23 (dose 2, exact dose, route, lot# and expiration unknown) for prophylaxis (inappropriate schedule of drug administration) on a recent unspecified date in 2017. No adverse effect reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Muscle twitches all over body. Decreased cognitive abilities. Short term memory loss. Increased impulsiveness. Decreased awareness. No thoughts. Inflammation of brain and heart. Difficulty breathing. No period.
Pt. reports arm swollen, whelps and red lines going around arm. Also reports he was very irritable and short tempered. Pt. called to report and was not seen in office.
Second dose was given approximately 11:30am on 12/22/21 at a hospital run clinic.  Patient was distraught to get a shot, but was in good spirits and health afterwards and completed her day at school. Around 11:30pm, she woke up screaming and calling for Momma/Dada saying she couldn't stop shaking and that her legs felt "funny" and her "tummy felt yucky". When we saw her she was shaking as though she was shivering very violently and couldn't stop.  When we took her temperature it was normal.  Skin felt fine. She looked ok, but very scared. Arm where injection was is tender/sore. (left) No redness or blotches etc on skin. No vomiting/diarrhea. No sore throat. No coughing. No runny/stuffy nose. No sneezing.  She snuggled with her dad in a recliner with a blanket and watched a cartoon as a distraction to help her calm down.  The shivers/shakes stopped completely in about one hour.  Slowly (from top to bottom) as her dad says. (she had chattering teeth) She went back to bed with her mom so she'd have an adult nearby, around 1-1:30am Patient awoke around 4:30am moaning and complaining of a yucky tummy, and felt hot to the touch.  Temperature was about 99-100F.  Gave 2 Jr Advil (chewables) and she felt better and was "normal"  until around 10:00am.  Complained of feeling yucky again. No fever.  2 more Advil.  Felt better.   Returned to normal activities.  Tired because of lack of sleep, but other than that she seems better.
Information has been received from a consumer concerning her 13 year old daughter with menstrual problems who in January 2008, was vaccinated with the first dose of GARDASIL (dose and route not reported). Concomitant therapy included albuterol and Zantac. In February 2008, after getting her first dose of GARDASIL, the patient developed vomiting, nausea and stomach cramps and pain lasting about 2 days after the completion of each menstrual period. The patient took blood tests and sonograms (results not reported). She didn't get her 2nd or 3rd doses. She sought medical attention. Her vomiting, nausea, stomach cramps and pain persisted. Additional information has been requested.  12/18/08 Reviewed PCP office records. FINAL DX: epigastric pain, RAD, possible gastritis Records reveal patient experienced cold s/s, felt hot, nauseated, difficulty breathing on 3/08 visit.  RTC 7/08 w/nipple discomfort.  RTC 9/08 LLQ pain & chest pain s/p vomiting & diarrhea.  Tx w/meds. Referred to ER & cardiology.  To return if no improvement.  No further visits available.
This is a spontaneous report from a contactable consumer who reported for his wife. A 84-year-old female patient received PREVNAR 13, at single dose for pneumonia pneumococcal and a yearly influenza vaccine, both in her left arm (about a half inch away from each other) on 10Oct2016. The patient took influenza vaccine in the last four or five years and normally had just a sore arm for a little while.  The patient, who was in the hospital for four days for pneumonia in her right lung, received both vaccines (first pneumococcal 13-val conj vaccine and after influenza vaccine) when she was in the ICU department and then she was discharged from the hospital. On 10Oct2016 the patient experienced left arm paralyzed and within a half hour of receiving the products (always on 10Oct2016) she started complaining about pain (sharp pain). In Oct2016 (not sure if on 10Oct2016 or 11Oct2016) oxygen deficiency occurred and patient was hospitalized from 11Oct2016 to 21Oct2016. Reporter was not sure if while at the hospital they got the oxygen deficiency back up to normal or got rid of the pneumonia. The patient was on oxygen at Medical Center before she was given the products; prior to her discharge from hospital, her oxygen tubes were removed and the IV's disconnected. Patient has been on oxygen for the last two months, she has the oxygen on hand, it was just as needed. Patient has been doing therapy on arm paralyzed at least once or twice a week. Her left arm has not improved period, the range of motion was zero.  Final outcome of the events was not recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Apr2022 as dose 4 (booster), single (Lot number: 046L21A) 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: "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; HYDROCHLOROTHIAZIDE.  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: (12Jun2022) Negative; (unspecified date) Unknown results; (13Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (14Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (15Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (16Jun2022) Negative, notes: I had four successive days of negative rapid antigen tests and no symptoms; (20Jun2022) Positive, notes: did a rapid antigen test on 20Jun which was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti viral product for COVID 19 Treatment, brand Paxlovid, treatment start date 07Jun2022, treatment stop date 12Jun2022. The patient stopped the Paxlovid on 13Jun and had been testing negative on the antigen test starting on 12Jun. The patient had four successive days of negative rapid antigen tests and no symptoms. She developed symptoms on 19Jun and did a rapid antigen test on 20Jun which was positive. The patient had no known allergies.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.