chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History of Present Illness:  This is a 84y.o. male with a medical history of endocarditis secondary to staph aureus on chronic doxycycline suppression, bioprosthetic valve, coronary artery disease, COPD, atrial fibrillation on Eliquis, dementia, and thrombocytopenia who presented to the hospital secondary to hypotension. The patient resides at a facility and was sent in for low BP. Patient is overall a poor historian.   Presentation, his min blood pressure was 95/61. CT of the abdomen and pelvis showed intrapelvic fluid collection with concerns for possible abscess, long segment of sigmoid colitis, and right lower lobe groundglass attenuation concerning for acute infectious process.   ROS: Constitutional:  Denies fever or chills  Eyes:  Denies change in visual acuity, eye pain  HENT:  Denies nasal congestion or sore throat  Respiratory:  Denies cough or shortness of breath  Cardiovascular:  Denies chest pain or edema  GI:  Denies abdominal pain, nausea, vomiting, bloody stools or diarrhea  GU:  Denies dysuria, hematuria   Musculoskeletal:  Denies back pain or joint pain  Integument:  Denies rash, papules Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies tender or enlarged lymph nodes  Psychiatric:  Denies depression or anxiety  Tested + for Covid 5/4/2021 with admission  CT abd with ground glass RLL
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. P pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 02-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
noises in the head; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st DOSE), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "noises in the head".  Additional information included: The patient received Pfizer vaccine two times and had tinnitus at the time of reporting. The patient enquired what could be done about tinnitus. The patient read on internet many people complaint about it. The patient was not alone. When paraphrased the concern, consumer stated, it was tinnitus, it is noises in the head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large amount of swelling of arm, chills, fever, malaise, herpetiform papules on arm.  I have had repeated herpetiform outbreaks with shingles symptoms ever since the vaccination.
I developed a dizziness disorder labeled PPPD after receiving my second shot which was quite debilitating. I had slow improvement with therapy and medication. After receiving my booster shot I had a marked return of worsened symptoms for 1-2 months.
Information has been received from a pharmacist concerning a 14 year old male who on 04-JUN-2007 was vaccinated with 0.5 mL hepatitis A virus vaccine inactivated SQ in the left arm, down the interior of the arm instead of IM. The patient's mother called the hospital to report her son had an oozing round circle, quarter size swelling at injection site; and the edges are raised and red. The oozing has stopped and the site is scabbing and healing. It was unknown if the patient was hospitalized. It was unknown if the patient sought medical attention. Additional information has been requested.
Bedridden; body aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a 46-year-old female patient 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 BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, BEDRIDDEN (Bedridden), MYALGIA (body aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment medicines includes anti-nausea medication.
Date of Admission:  1/24/2022   Chief Complaint:  Altered mental status   Source of Information:  Available medical record   History of Present Illness:  This is a 62y.o. female with a past medical history significant for ESRD, history of aortic valve replacement, CABG, lupus, seizures.  She presents for evaluation of altered mental status.  Patient is reported to be alert and oriented x1 at baseline and able to speak.  However recently she stopped talking and it is only responding to pain.  Patient is reported to be ESRD getting dialysis Monday Wednesday Friday and missed dialysis today.  On my examination patient is now A and O x3. She states that she was confused earlier in the day but resolved over the course of the stay in the ED. She reports only upper respiratory congestion as her symptoms along with a cough approximately 4-5 days in duration. She states that she has post nasal drip that was evaluated with a laryngoscope and was told that she had the post nasal drip. She states that her husband recently tested postive for COVID on Tuesday of last week and had to be admitted to the hospital for SOB. She states that she started noticing her symptoms on Thursday of last week and tested positive with a home antigen test. She states again that her only symptoms are cough and congestion, denying any SOB, CP, abdominal pain, change in bowel patterns, change in urination patterns. Does admit to orthopnea but states it occurred after she started receiving dialysis. She denies hx of CHF but states that she has had multiple valve replacements aortic and tricuspid. She denies any fever or chills. Denies any change in strength, vision, sensation. States that she is not lightheaded/dizzy.
developed hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 86 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration on 29Jan2021 14:00 (at the age of 85 years) as SINGLE for covid-19 immunization, Followed by patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Pfizer 6198 and expiration date were not reported), second dose on deltoid left via an unspecified route of administration on 19Feb2021 14:00 as single for covid-19 immunization. Medical history included colonoscopy from an unknown date and unknown if ongoing 15 years ago, she was preparing for a colonoscopy and took MiraLax and experienced drug hypersensitivity. The patient concomitant medications were not reported. On 09Feb2021 exactly 11 days later the patient experienced developed hives. The patient underwent lab tests and procedures which included biopsy founded nothing unusual on 2021 biopsy of the hives found nothing unusual. The outcome of the event was not recovered.
Temp (101.7) headache, neck pain, joint pain (severe), muscle aches (severe), swelling, redness, pain at injection site from deltoid to elbow, nausea, fatigue. Treatment: TYLENOL, MOTRIN, BENADRYL, cool showers, fluids, ice and heat to arm.
pt recvd vax & 3 days p/vax exp maculopapular rash; pt was seen by a MD & recvd DPh;
Immediate flushing to face and head, rapid pulse, nausea, dizziness following the administration of FLUZONE HIGH DOSE 2016-17; Vaccine as administered on 11/7/2016 at store.
104 degree fever; aches; rapid heartbeat; hives all over body; wheezing; ER visit; IV, Benadryl injection; 3 weeks of prednisone; ongoing antihistamine regimen.
Maculopapular rash on face, chest and arms, palms, knees.
fever, chills, headache, nausea, joint pain, muscle ache, soreness at injection site
Dizziness immediately after vaccine that improved within a few hours. Pain at injection site lasting 2 days. Joint pain in fingers and hips lasting one week. Body aches starting 3/9 (no fever), still present daily. 5 days late for menstruation, 2 negative pregnancy tests.
slight heaviness in the chest; tired; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), CHEST DISCOMFORT (slight heaviness in the chest) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (tested positive for COVID-19). On 07-Apr-2021, the patient experienced CHEST DISCOMFORT (slight heaviness in the chest) and FATIGUE (tired). At the time of the report, COVID-19 (tested positive for COVID-19), CHEST DISCOMFORT (slight heaviness in the chest) and FATIGUE (tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided.
fever 100-101.3  Tx'ed with infant Tylenol recovered within 24 hour
Thigh swelling & redness R >> L pt seen also 2/16/11 by Dr. given cephalexin 250 mg 3x/d x 10d cool compress & BENADRYL 1 tsp 2x/d x 3 days then PRN.
Acute delirium 12 hours after vaccination resulting in disorientation, fall, minor musculoskeletal injuries.  did not require hospitalization or ED visit.  Resolved after 2-3 hours rest
After my 2nd Moderna vaccine on 3/31/21, , my arm was sore. However, on 4/9/21 (8 days after the vaccine), I experienced all of the post-Covid symptoms:  severe fatigue, headache, muscle ache (my whole body hurt), fever, chills. It lasted through the night, and I was fine the following day.
Patient received the second dose 8 days before; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 8 days before) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 8 days before). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 8 days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 08-Jun-2021, the patient received their second dose. The patient received their first dose on 19-May-2021 and came 8 days early for their second dose. The reporter also mentioned that the patient was taking other medication and was not aware of the patient's symptoms.  Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ?
Patient had both her COVID Moderna booster vaccine and Flu Vaccine administered both to the Left deltoid muscle about 1 inch from each other on 12/7/2021.  Patient noticed redness, warmth and swelling to the left deltoid starting on 12/11/2021.  Erythema measures 6 inches in length and 2.5 inches in width.  It is warm to the touch and tender to palpation.  patient also has some axillary lymph node swelling to the left axilla.  Patient has taken tylenol to help with symptos as well as a zyrtec.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009DZIA) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transdermal) 1 dosage form once. On 29-Jun-2021, the patient experienced PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever) and NAUSEA (Nausea) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-Significant Follow-up Appended
Pt received first dose of Pfizer Covid 19 vaccine at around 12:45 and within 20 seconds, pt reported feeling sensation of tightness in his throat. Pt was observed for 15 minutes and his symptoms persisted but did not progress. Patient was taken to ED for evaluation. At 30 minutes post injection symptoms resolved. Monitored in ED for approx. 3 hours and discharged.
Left arm with mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Left arm with mild symptoms) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Left arm with mild symptoms). At the time of the report, VACCINATION COMPLICATION (Left arm with mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided.   This case was linked to MOD-2021-042753 (Patient Link).
lower back spasms and pain when going from leaning over to going upright; lower back spasms and pain when going from leaning over to going upright; worse the 6th day; sore arm several hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL 8982, Expiration date: Unknown) via an unspecified route of administration, in left arm on 21Jan2021 10:00 AM (at age of 72-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Concomitant medications included irbesartan (IRBESARTAN) 75 mg; allopurinol (ALLOPURINOL) 150mg; cyanocobalamin (VIT B12); ergocalciferol (VIT D). Patient received these medications within 2 weeks of vaccination. Patient was not allergic to medications, food, or other products. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.   On 26Jan2021 at 14:00, the patient experienced sore arm several hours after the shot, patient had lower back spasms and pain when going from leaning over to going upright. It occurred the 5th day after the shot, was worse the 6th day, and is slightly better today, the 7th day. It was more like the 5th day of pain. If today wasn't better, patient was going to see a doctor, but Motrin was helping. The outcome of the events was resolving.
I started to notice my symptoms on 11/24/2022, I typically I get bronchitis one time a year, I developed wheezing, coughing, nasal drainage, laryngitis and chest hurt as well. I went to urgent care on 11/25/2022.  I saw an APN doctor who examined me at an urgnet care center.  I had a COVID-19 test and it was negative on 11/25/2022.  I can say I have recovered from my symptoms.
Information has been received from a pharmacist concerning a female who on 09/18/2001 was vaccinated with a dose of hep b vaccine recombinant. On 09/20/2001, labs were drawn and an elevated liver function test was observed. No other info was available. Unspecified medical attention was sought. Additional info has been requested. Follow up info received from the pharmacist indicated that she was stopped in the hallway by a physician who asked her if she was aware of the hep B vaccine causing an elevation in AST liver function tests. The pharmacist indicated that she did not know which brand of hep B vaccine was administered to the pt. No further info is available.
Diarrhea; Pain in the lower right side of my back; This is a spontaneous report from a contactable consumer (patient, self-reported). A 17-year-old female patient (age at vaccination: 17 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 13May2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included allergy to Biotin (big amounts of Biotin). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID. The patient reported that on 13May2021 at 16:00, she had diarrhea and pain in the lower right side of her back, the first few days after the first dose. There was no prolonged hospitalization. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in May2021.  Follow-up attempts are needed. Further information is expected.
no adverse event; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to male patient.   The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On 14-FEB-2023, the patient was vaccinated with one of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions for total time: 25 minutes (product storage error). There were 3 excursions reported on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 01-JAN-2023 for 12 minutes. Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. No additional adverse event (AE) details were reported (no adverse event).   The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter.
pt in clinic on 21NOV95 for vax around 2:30;mom states gave Motrin as soon as got home, but not sure gave enough;mom states did not check temp, but felt warm; shaking all over lasting 1-2min;
5mins post vaccination pt reported dizziness. 15:40 105-65, 75, 18, 95% -- > 15:50 104/56, 89, 17 -- > 16:00 104/56, 89, 17, 100% Patient stable and released from the vaccination site
Consultation with the Vaccine Healthcare Center (VHC) was initiated on 5/23/2008 following reports of Pt with myopericarditis day 6 post ACAMBIS Smallpox vaccination. Attempts to contact the Pt directly have been unsuccessful. Review of available medical records and HPI from MD identified the following chain events: This 25 year old male complained of 12 hour hx of sharp constant left sided chest pain, mild/upper back pain, trapezius pain, occipital headache, non productive dry cough, SOB, fatigue on day 6 (5/20/2008) after receipt of primary ACAM smallpox vaccine (5/14/2008). Pain onset was at rest to back and chest, worse in supine position and with inspiration. He was treated and diagnosed by providers (May 20, 2008), transferred to another location, then to another country for further cardiac evaluation (May 25, 2008). Laboratory studies included: 5/20/08 WBC 15, CK 1358, CKMB neg, Trop neg; 5/21/08 CK 917 with positive troponin; 5/24/08 WBC 3.2, CK 150, troponin neg (<0.5), negative myoglobulin; 5/25/08 CK 104 with neg/normal CBC, troponin and CKMB, EKG was NSR with HR 79 bpm and 5T elevation V2-6. Records indicate he was later medevaced early June 2008, and ultimately returned to full duty late June/early July 2008. Cardiology note 7/21/2008 documented an 8 week eval (stress test, no labs) for sporadic episodes of chest pain/pressure that continued following his return to duty. This discomfort was "much better than last month" and was dwindling. He denied any other symptom. Medication included colchicine one tab/day for 2 months (June-July 08). His stress test 7/21/2008 was normal and he was again return to full duty. He was evaluated by Doctor (internal med-cardiology) 12/19/2008 for palpitations per recommended DOD myopericarditis recommendations with last echo May 2008 as normal and 12/19/2008 EKG normal. On 1/12/2009 his stress test was normal. On 9/12/2008, Pt had no new issues and chest pains or palpitations.  7/7/09 ER records received DOS 5/22/08 to 1/7/09. Assessment: Myocarditis, acute; Pericarditis, acute NOS. Patient presented with left sided chest pain, back pain, neck pain, pain across shoulders, occipital headache. Chest pain is sharp, constant, worse with inspiration. Non-productive dry cough. Shortness of breath. Palpitations.