chrisvoncsefalvay/vaers-outcomes huggingface dataset:
50 yo F. Came with daughter. Pt with Hx of DM Type II diagnosed 6 yrs prev. Also hx of anxiety, not on anxiety meds. On Metformin 1200 mg daily. C/o syncope and tachycardia. VS x5 checked 11:06 am- 154/106 98%, 97.1 F. Had granola in the am, reported BS at 8:30am was 199 mg/dl. VS, heart rate elevated. VS 11:40 am- 137/97, 96%, 85 bpm, 98.7 F. Paramedics called 11:45 am and arrived 11:48 am. Checked VS 11:50 am, BS 124 mg/dl. Reported stable, able to go home, cleared by EMS. Pt insisted to drive home, and said she felt well and safe to drive self. Escorted to car by PHN. Instructed to call PCP with additional concerns, to seek UC if needed, and to call 911 for resp. distress; verbalized understanding.
Itchy; A little warm at the touch; Rash at the injection site; Swelling; Pain in the arm on the first day; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm on the first day), PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm on the first day). On 20-Jan-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Pain in the arm on the first day), PRURITUS (Itchy), VACCINATION SITE WARMTH (A little warm at the touch), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        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.   No concomitant medications were reported Patient reported taking unknown medication to treat her symptoms
On 11/4/22 it was noted that pt. was only administered saline on 9/8/22.  PCP notified and and ordered another dose of vaccine.
Rash on chest. Swelling in areas where they also have arthritis (neck, fingers, and knees)
This spontaneous report as received from a pharmacist refers to a 10 year old patient. On an unknown date the patient was vaccinated inadvertently with VAQTA, injection, 1 ml, (strength, dose number, lot number and expiry date unknown) intramuscularly. No adverse effects reported. The outcome of 1 ml dose administered and no adverse effects was unknown. No further information provided. Additional information is not expected.
w/in 12hr arm swollen red & sore;72hr later had temp felt like had the flu;nauseated, stomach pain lasted through weekend;
Approximately 18 hours after vaccine received c/o nausea, headache, chills, achy all over. No fever. Resolved in approximately 36 hours.
Tachycardia; I am trying to up breath but I can't do more; Tachycardia; I am trying to up breath but I can't do more; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0177, Expiration date: Unknown), via an unspecified route of administration on 23Jun2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jun2021, after vaccination, the patient felt tachycardia, because before 50 minutes patient was driving to home and felt little bit tachycardia or something like that and then chills; but the first day was normal. Patient still feeling the tachycardia and when patient trying to up breath, patient can't do more. Patient don't know if it's normal or a different reaction. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report by a contactable nurse via a sales representative. This nurse reported similar events for six patients. Thi sis the sixth of six reports. A patient (age, sex and race unknown) received a dose of PREVNAR13 as a scheduled vaccination on an unknown date. Relevant medical history and  concomitant medications were unknown. ON an unknown date after being administered the PREVNAR13, the patient experienced dark red, hard and raised swelling at the site of injection. Relevant lab data was unknown. At the time of the report, the clinical outcome was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.
patient had developed an infection in his lower arm  where it was given and required antibiotics; incorrect vaccination site that was well below the deltoid muscle; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site infection (Verbatim: patient had developed an infection in his lower arm  where it was given and required antibiotics) and vaccine administered at inappropriate site (Verbatim: incorrect vaccination site that was well below the deltoid muscle). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the injection site infection was not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site infection to be related to Shingrix.     It was unknown if the company considered the injection site infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter reported that the patient was concerned that the Shingrix might not be effective due to inappropriate vaccine administration. The reporter consented to follow up. The Shingrix injection was given below the deltoid muscle, which led to vaccine administered at inappropriate site. This case was identified as duplicate of US2023077761. Case US2023077761 was deleted, and all the future correspondence will be added in the present case US2023AMR077452 which stands as a case of record for this subject.
A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events.  There was insufficient information to determine the reporters causality assessment. Update1 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 09 month old female vaccinee was inadvertently administered Fluvirin intramuscularly on 11/19/2002. The vaccinee experienced no adverse reactions. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP00851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200805, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870
Full body chills, body aches, headache, sore arm. No fever. Drowsiness. Symptoms lasted approximately 24 hours, from 7am on Feb 3rd to sometime in the early morning of Feb 4th.  I took a total of 2000mg acetaminophen and 800mg ibuprofen throughout the day to relieve aches.
Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning a pregnant female patient with herpes simplex type II who was vaccinated with GARDASIL.  Concomitant therapies included VALTREX and prenatal vitamins (unspecified).  No complications during the pregnancy.  On 24-NOV-2008 the patient's baby was having non reassuring fetal heart tones, and patient delivered her baby via cesarean section.  Infant was born normal, without congenital anomalies 40 weeks from LMP.  Baby is a 6 pounds male with an Apgar score of 7/8.  Upon internal review, non reassuring fetal heart tones and cesarean section was determined to be an other important medical event.  No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BMI 39.9" (unspecified if ongoing); "3 time cancer survivor" (unspecified if ongoing), notes: Other medical history: 3 time cancer survivor, 70+ yrs old; "Only topical allergy to latex" (unspecified if ongoing), notes: Known allergies: Only topical allergy to latex. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 39.9; SARS-CoV-2 test: (unspecified date) positive; (15May2022) positive, notes: I tested positive 2 days after completing 10 dose course of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took no other medication in 2weeks. COVID 19 Treatment, brand: Paxlovid, Treatment start date: 08May2022, Treatment stop date: 13May2022 lot number: unknown, indication: Treatment of COVID-19.
No hx of head injuries except in remote past, no loss of consciousness.  Developed symptoms after 4th AVA received July 9, then left for moutain hiking expedition in August 2003.  While hiking, noticed that he couldn't ford rivers using toe-heel gait over log.  He then deployed and had his 5th AVA in February 2004. By March 2004 he was experiencing frank vertigo, which prompted an MRI in March or April, which had normal findings, and his vertigo was attributed to stress.  He received his 6th AVA in September 2004.  By November his symptoms had worsened to feeling lightheaded dizziness at all times, walking unsteadily because his balance id off, EMG abnormal.  He was referred to a neurologist, who determined vestibular hypofunction of unknown etiology.  He was seen at WHMC by Dr., MRI of brain stem normal, CT scans of auditory canals normal, MRI of neck showed herniated disc C6-7.  He has been receiving vestibular therapy.  His RF was 51 when seen at WHMC, repeat now is 93. Gait abnormality start: 08/2003, Vertigo start 3/2004, Hearing loss start 3/2004, Tinnitus start 10/2003
Approximately one week after vaccination: red "dot" noted at injection site, itching of arm from elbow to shoulder, occ.  tingling at site.  Self treated with anti-itch cream, but intense itching continues to date.  No fever.  Recommended physician visit.
12/2/08 S&S inc. numbness/tingling in hands/feet. 12/3/08 ER for intense pain in joints = Dilaudid. 12/5/08 medical center = constipation/MAALOX. 12/7/08 numbness/tingling hands/feet & muscle control problems & pt fell x2 & went to clinic & transferred to hospital & currently still in rehab since 12/12/08.  5/22/09 Hospital records received DOS 12/7/08 - 12/12/08. FINAL DIAGNOSIS: Guillain-Barre syndrome, urinary retention, Paroxysmal atrial fibrillation, autonomic instability, partial CN IV palsy. Post Vaccination: abdominal pain, multiple joint pain, progressive extremity weakness resulting in multiple falls. Tingling sensation palms. Hands became weak, cold intolerance, constipation, bloody diarrhea. Course lung sounds, diminished lung sounds. Diminished sensation extremities. Loss of reflexes lower extremities. Withdrew foot on right with upgoing toes. Poor hand finger coordination. Diplopia IVIG administered. Episodes of hypertension and hypotension.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 11:00 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 at 11:00 as dose 2, single (Lot number: EW0150), in left arm and on 01Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing). The patient took concomitant medications (other medication in two weeks). Past drug history included: Known allergies: clindamycin for Known allergies: Clindamycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Apr2022, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Pfizer/ Dose #4: Moderna/ Dose #5: Pfizer"; VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given from 11Feb2023 to 13Feb2023.
Pt received seasonal flu vaccine at pharmacy on a Sunday evening (which preparation is not known so do not know if this was a fluzone product). Monday morning awakening with redness, tenderness, and swelling in area of vaccine on left shoulder and with migraine.  Presented to clinic on Tuesday due to area of swelling, swelling and tenderness on left shoulder increasing and migraine not responding to medication. Neuro exam intact at visit. No limited ROM, weakness or changes in grip strength at visit.  Pain localized to affected area at visit. Pt denies any numbness or tingling at visit.
This spontaneous report as received from a medical assistant with no patient involved. The medical assistant stated the MMR II (lot# not reported) and the sterile water diluent packages look similar which led her to improperly store the MMR II at room temperature with the diluent. "The cartons look so similar that this could lead medication error." The improperly stored MMR II was not administered. Additional information has been requested.
The day after the second dose of vaccine I experienced usual myalgia, arthralgia, fatigue and fever. Resolved with Motrin.  Two days after the vaccine I experienced significant dyspnea on exertion. No associated symptoms. No wheezing. Normal heart rate. Never experienced anything similar in the past. Resolved after two days without intervention.
really bad headache; fever of about 101.1; had chills really really bad in her whole body; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (really bad headache), PYREXIA (fever of about 101.1) and CHILLS (had chills really really bad in her whole body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy.    On 08-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (really bad headache) and PYREXIA (fever of about 101.1). 08-Apr-2021, the patient experienced CHILLS (had chills really really bad in her whole body). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. On 09-Apr-2021, HEADACHE (really bad headache), PYREXIA (fever of about 101.1) and CHILLS (had chills really really bad in her whole body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.1 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included for high blood pressure, for allergies, cholesterol medicine.
VOMITING; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, non alcoholic, non smoker, and diabetes, and other pre-existing medical conditions included patient has no known drug allergies. no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced vomiting. On 08-JUL-2021, the subject experienced chills. On 08-JUL-2021, the subject experienced nausea. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and nausea on 08-JUL-2021. This report was non-serious.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: pain and swelling from hematoma per MD diagnosis-Medium, Additional Details: MD prescribed Keflex for possible infection but request for CT scan if symptoms not improve in a few days.
Pt recv vax on 2/23/99; on same day pt exp fever (102), irritable, not sleeping, bulging fontanelle, not playing, not eating well
Flushed face, Elevated BP, Swelling at injection site and streaking in arm
Patient received vaccine around 5:15 pm on 4/13/21 and later that night he experienced small tremors in both arms, shortness of breath, and a pounding heart. All symptoms lasted about 3 days. He did not notify pharmacy or doctor until he was ready for the second dose which he did not receive. He will follow up with his doctor. Patient mentioned he thinks he was Covid 19 positive in January 2020 but was never tested to confirm.
He only has arm soreness; He got a good reaction / After getting the shot he is not using cane; This spontaneous case was reported by a respiratory therapist (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Osteoarthritis and Cane user. Concomitant products included HYDROCODONE, GABAPENTIN, CLONAZEPAM (KLONOPIN), IBUPROFEN, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane). At the time of the report, PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane) outcome was unknown.        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.   No treatment was reported for the event of arm soreness.   This case was linked to MOD-2021-089572 (Patient Link).
Information has been received concerning a pt who 06/30/00 was vaccinated with varicella vaccine. The pt also had MMRII. Within 24 hours post vaccination the pt developed a full blown rash. Her arm was red and hot and she had a bumpy rash on her stomach, back and between her breast. It was noted that it did not look like a typical chickenpox. On 07/02/00 the area around the injection site became worse, it looked like an orange peel. The pt went to ER and was told by a physician that it was a vaccine reaction. The arm she had the MMRII in was normal. She was given NSAIDS, Vistaril shot and a Medrol dose pak. the pt stated that within 2 hours of the cortisone injection in the ER she noted a marked improvement. The pt recovered on on 07/05/2000
PT WAS SUPPOSED TO RECIEVE THE NEW MODERNA BIVALENT BOOSTER. HOWEVER, INSTEAD NURS ADMINISTERED FLUZONE HD
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/24/21 (ER8732) COVID Positive 12/8/21  12/8/21: 86-year-old male with CKD stage 3, COPD, hypertension, hyperlipidemia and BPH presented with left hip pain after fall.  Patient is very hard of hearing, part of history obtained from patient's daughter at bedside. Patient lives at home alone and apparently woke up at 6:00 a.m. on the day of hospitalization and was in the kitchen when he passed out landing on his left side, patient denied hitting his head or neck pain.  Patient was not able to get up and apparently was down for about half an hour  before he crawled to the phone and called daughter.  Daughter reports patient usually is independent at home, does not have any functional limitation in terms of chest pain or shortness of breath with activity.  Recently involved in a car accident with no injury and had not been driving.  In the emergency room patient is a febrile and hemodynamically stable.  Creatinine 1.7 which is close to his baseline, CK 74 and WBC normal with hemoglobin of 13.2.  Chest x-ray showed emphysema.  Hip x-ray is showing left intertrochanteric fracture.  He EKG showed left and right bundle branch block with sinus pauses.  Orthopedics consulted and evaluating patient.  12/27/21: I spoke to the patient's daughter who is the patient's POA.  After discussing his clinical condition, she decided for the patient to be made comfort care and transferred to the Hospice of if bed was available.  Case manager  was contacted and arrangements were made for the patient to be transferred to the hospice on 12/27/2021. discharged to Hospice
CONSTANT HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced constant headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches. This report was non-serious.