chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a sudden onset of chest tightness; feeling of being light-headed and dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 18:00 as dose 2, single (Lot number: EL9261) at the age of 55 years, in right arm and on 19Nov2021 at 10:00 as dose 3, single (Lot number: FJ1620), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Poultry allergy" (unspecified if ongoing), notes: Poultry allergy. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy". Vaccination history included: coviD-19 pfizer vaccine (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right, Vaccine Administration Time: 06:00 PM), administration date: 27Jan2021, for COVID-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "a sudden onset of chest tightness"; DIZZINESS (non-serious), outcome "unknown", described as "feeling of being light-headed and dizzy". The events "a sudden onset of chest tightness" and "feeling of being light-headed and dizzy" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, dizziness.  Additional Information: Within 3 months of receiving the 2nd/3rd dose of the vaccine I had multiple episodes (4) of a sudden onset of chest tightness and feeling of being light-headed and dizzy. The chest tightness would subside after about 30 minutes and the feeling of being light headed could last 1-6 hours. On 23May2022 patient did qRT-PCR (Nasal Swab) test and result was Positive. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, the patient been tested for COVID-19.On an unspecified date, patient underwent blood work result was unknown. Cardiac tests result was unknown.
Weakness; seeing spots; headache; nausea; dizziness; lightheaded. Started later on in the day evening time.
1PM Sore arm, massage and cold compress 6:30PM Body aches & chills 8:30PM Temp 99.7 12:45AM Temp 101 4:25AM Temp 100.3 7:30AM Temp 99.5 10:00AM Headache persists  9:20AM Temp 99.3
1/13/10 - pt call office c/o redness and swelling @ Rt deltoid, fever, body aches. Vomited x1 - Seen -Dx prob. reaction to immunization. 1/14/10 -Returned to ER with increase pain. Fever, lab worse. Admitted to Hospital given IV ROCEPHIN, SOLUMEDROL IV, monitored lab values. Discharged home the next day.
Was aware of soreness in arm 4/18/09 while performing routine housework.  Noticed red, swollen, warm 3 in X 3 in area 3-4 inches below injection site late pm of 4/18.  Also reports slight headache since pm of 4/17.
Patient reports 1 day after vaccination, blood pressure rose to 210/120 and patient had to be rushed to ER. Patient was treated in ER and followed up with PCP. PCP advised Patient not to have second dose of Covid-19 vaccination.
Patient received DTAP #4, Hib #4 & PCV& #4 on 8/16/05. Patient inadvertently received DTAP,HIB,PCV7 on 10/18/05 also. CDC contacted, should expect no problem. Service request # 1-11930345. No adverse effects seen. Child only received extra set of vaccined - Hib,PCV7, DTAP.
The patient has 1 1/4 by 2 3/4 inch resolving hive in the left deltoid area, it first appeared approximately 48 hours after DTaP, IPV, MMR, and Prevnar vaccines.  The hive occurred over DTap, and IPV site. No other symptoms.
Missing Heart Beat. Often 1/4 beats were missed and at times 1/2 the beats were missing. Heart Rate slowed to 38 beats per min per my  home BP monitor. These events were sudden, lasting hours and repeated daily.
(increase in muscle weakness; decrease ind endurance; feeling worsening after each injection; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ALGLUCOSIDASE ALFA (LUMIZYME) for an unknown indication.    Concurrent medical conditions included Glycogen storage disease type II.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ALGLUCOSIDASE ALFA (LUMIZYME) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection). At the time of the report, MUSCULAR WEAKNESS ((increase in muscle weakness), EXERCISE TOLERANCE DECREASED (decrease ind endurance) and FEELING ABNORMAL (feeling worsening after each injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. For LUMIZYME, it was unknow whether 0.2 micron inline filter was used during drug administration and where was the drug administration performed.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.
Patient experienced scattered lesions on the upper extremities, chest and upper back. Patient had pruritus with a lesion at the corner of her mouth.
This spontaneous report as received from a registered nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
COVID arm; More irritated; More red; More painful; More warm to touch; Swollen arm; Itchy; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful) and VACCINATION SITE WARMTH (More warm to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-022335.
She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure; Feeling like having shingles flare-up; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had two outbreaks prior to receiving Shingrix) and chickenpox (had as a child). Concurrent medical conditions included osteoarthritis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: She describes her symptoms as feeling like she's having shingles flare-up /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Feeling like having shingles flare-up). The patient was treated with hydrocortisone + lidocaine (Hydrocortisone And Lidocaine). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter reported that the patient received Shingrix vaccine and experienced symptoms as feeling like she had shingles flare up. The reporter stated that the symptoms are on and off and sporadic it was uncomfortable and unpredictable. It was came in fingers or upper extremities, legs and feet and it was rotates. The patient received cream include lidocaine 4percentage and Hydrocortisone OTC maximum strength as a treatment. The patient symptoms was last a week to 10 days after putting the cream on that area and patient never tried going without putting the cream on it.  The patient saw rheumatologist and all her tests with him had came back negative for any rheumatology disorders. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter requested to consent the follow up.
pt recvd vax; lt arm is warm;reddened area all the way to elbow;crying;reddened area slightly hard to touch;cold compresses & analgesies;
Patient received covid 19 pfizer vaccine on 4/8/21 and 4/30/21. Patient presented to local ED from a HCF for chest pain, troponin elevation c/f ACS. Troponin 270 -- > 430, covid negative, ECG with diffuse up-sloping ST segments.  Below is the impression from the 10/20 cardiac mri: 1. The left ventricular size is normal. The left ventricular ejection fraction is 50 % by Simpson's method. Global left ventricular function is low normal. There are no regional wall motion abnormalities of the left ventricular wall. The left ventricular mass is normal.   2. There is no resting first pass myocardial perfusion defect. There is patchy mesocardial late gadolinium enhancement in the anterolateral and inferolateral walls at the midventricular level and involving the apical septal and anterior walls. There is evidence of focal myocardial edema by T2 weighted imaging in the anterolateral wall at the midventricular level. Extracellular volumes are normal: 26-31 % (normal values 3T: 27-32%). Native T1 times are normal: 1273-1350 ms (normal value 3T: 1200 +/- 80ms). Myocardial T2* decay time is within normal limits, indicating absence of abnormal myocardial iron overload.   3. The right ventricular size is normal. The right ventricular ejection fraction is 49 % by Simpson's method. Global right ventricular function is normal. There are no regional wall motion abnormalities of the right ventricular wall. There is no late gadolinium enhancement of the right ventricle.   4. Left atrial size is mildly enlarged. Right atrial size is normal.  Patient was appropriately treated and was referred to cardiology upon discharge.
Pt clamins to have fainted in shower morning after vaccination. Went to hospital feeling weak and flu like with chills. Pt was monitored and given fluids. Next day arm was red, painful and swollen. Pt could not lift arm laterally. (Similar to other pt. on same day)
Pt claims to have sustained a shoulder injury/bursitis from injection technique. Pt claims that the injection was given too high and was injected into her shoulder joint.
Bad taste on tongue; Vaccination site rash; pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Bad taste on tongue), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE RASH (Vaccination site rash) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 10-Apr-2021, the patient experienced TASTE DISORDER (Bad taste on tongue) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with FLUCONAZOLE (THRUSH ORAL CAPSULE) (oral) for Taste disturbance, at an unspecified dose and frequency. At the time of the report, TASTE DISORDER (Bad taste on tongue), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were reported as anxiety medicine.
10/18/2021 Cough, Spitting up mucus, Diarrhea  10/19/2021 Pulmonary emphysema, unspecified emphysema type, Atrial flutter, unspecified type, Low oxygen saturation, Non-intractable vomiting with nausea, unspecified vomiting type,  Acute recurrent maxillary sinusitis,  Cough in adult, Exposure to COVID-19 virus ED to Hosp-Admission Discharged  10/24/2021 - 10/30/2021 (6 days)  Hospital  - Hospital Problems          POA    * (Principal) Generalized weakness Yes         Anemia Yes         Cardiac pacemaker in situ Yes         Chronic congestive heart failure Yes         Chronic foot ulcer Yes         COPD (chronic obstructive pulmonary disease)  Yes         Essential hypertension Yes         Type II diabetes mellitus with peripheral circulatory disorder Yes         Subtherapeutic international normalized ratio (INR) Yes          Presenting Problem/History of Present Illness/Reason for Admission Generalized weakness [R53.1] Profound fatigue [R53.83] COVID-19 virus infection [U07.1]   Patient is an 75 y.o. male with past medical history of atrial fibrillation, CHF, cardiac pacemaker, chronic anticoagulation, diabetes mellitus, unhealing wound to left heel, CKD, COPD, hypertension, recent covid-19 infection (10/19), who presented to the ED with complaint of intermittent cough, chest pressure with cough, overwhelming fatigue, poor appetite and nausea. Patient states that his Covid symptoms started 16 days ago, him and his wife both tested positive on the 19th.   Patient is afebrile on arrival with oxygen saturation of 96% on room air, B/P 126/60.  Pertinent ED work up includes laboratory studies that shows WBC 4.5, H&H 11.0/33.3 (which appears to be his baseline labs) platelet 136, BNP 474, lactate 1.0 Respiratory viral panel positive for Covid. EKG A/V paced, no ectopy, no acute ST-T wave elevation or depression, similar to prior. CTA of chest shows mild COVID-19 pneumonia, Moderate to severe cardiomegaly with marked dilation of the right and left atrium, no pulmonary emboli.  Patient referred to hospitalist service for admission.    Hospital Course   Patient admitted for generalized weakness, functional decline due to COVID-19 infection, patient CRP minimally elevated, no oxygen requirement, patient respiratory status did not change during hospitalization, so patient was not a candidate for steroids or remdesivir.  Regarding left heel wound patient was seen and evaluated by wound care, dressing was changed daily, according recommendations.  Patient had slight bump in creatinine, which improved after holding Lasix and starting on Flomax, due to bradycardia his metoprolol was decreased to 25 mg. Patient will discharged to Facility in stable condition.
SHIVERING; FEVER; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180272, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced shivering. On 08-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering, and fever on 10-MAR-2021. This report was non-serious.
off label- extended time between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (off label- extended time between doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.
She was re-infected with SARS-CoV-2; She was re-infected with SARS-CoV-2; This is a literature report for the following literature source(s):   In Mar2020, a 47-year-old physician with a history of asthma developed an acute viral illness characterized by 12 days of sore throat, fatigue, diarrhea, and myalgia while working on an inpatient COVID-19 ward. She was not tested for SARS-CoV-2 infection due to the lack of availability of nucleic acid testing and the absence of fever, cough, or recent travel, which were strict criteria for testing during this time period. While many of her acute symptoms improved and she returned to work, she subsequently experienced progressive symptoms which included worsening myalgia, trouble concentrating ("brain fog"), chest pain, chronic diarrhea, and intermittent debilitating fatigue which persisted over the subsequent 20 months; this was presumed to represent Long COVID. She received 3 doses of the BNT162b2 SARS-CoV-2 vaccine with minimal change in her symptoms, although the third dose resulted in a week of intensified chest pain. Her Long Covid symptoms continued to progress to the point that she decided to take a leave of absence from work in early Winter 2022. Two months later, she was re-infected with SARS-CoV-2 and prescribed nirmatrelvir/ritonavir given her elevated risk for severe disease. She began treatment on Day 2 of her acute re-infection. She reported that within two days of initiating therapy, she began to experience relief from her chronic Long COVID symptoms, with substantial improvement in myalgia, diarrhea, and chest pain.; Sender's Comments: Based on the information available as reported at this point, a possible contributory role of the suspect products cannot be excluded for the reported event of re-infected with SARS-CoV-2 for the lack of efficacy of the vaccine.
TINGLING AROUND LIPS. PT. Took BENADRYL ... FELT BETTER> WANTED TO LEAVE.
MID CHEST COLD VOICE; SCRATCHY THROAT; SINUS ISSUES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 14-MAR-2021, the subject experienced mid chest cold voice. On 14-MAR-2021, the subject experienced scratchy throat. On 14-MAR-2021, the subject experienced sinus issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, sinus issues and mid chest cold voice was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Persistent, strange taste in mouth, especially after eating (chalky/metallic/sour). Concentrated at tip of tongue.
shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number DH3SB, expiry date 20-MAY-2024) for prophylaxis.   On 13-APR-2023, the patient received the 1st dose of Shingrix. In MAY-2023, 1 month after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter stated that a patient received Shingrix and developed shingles a month later.  It was now resolved. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
LARGE RED, SWOLLEN ARM AND FEVER TO TOUCH. IT COVERED MY WHOLE ARM AND DOUBLED IN SIZE EACH DAY. CONTINUE TO GET WORST EACH DAY. ON FIFTH DAY FINALLY STOP GETTING WORST. PAINFUL. TOOK TYLENOL,IBUPROFEN, ICE AND BENADRYL. NOTHING SEEM TO HELP.