chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose 1 of Shingrix sometime in October of 2019, and has yet to receive dose 2; pain at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site erythema and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for the 2nd dose. The patient received 1st dose of Shingrix and experienced redness and pain at injection site, which resolved after about 3 days. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
pt c/o chest tightness 10-15minsp/vax; BP 92/60, P80, R20;
Mom reported 2 days, post vax, pt complained of swelling from above shoulder to elbow with redness and pain. Started at approximately 21:00 on 4/14/00. Instructed to use cool, moist compresses, Tylenol and Benadryl and follow-up with PMD, if not resolved.
swollen with pain at the site of the injection; red patch, swollen with pain at the site of the injection; swollen with pain at the site of the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix).  On 5th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine her left arm. The next day, the patient noticed a red patch, swollen with pain at the site of the injection. The patient took benadryl and used cold patch to relieve the adverse event.  Additional information was not obtained. The reporter did not consent to follow up.
Started having dizziness and nausea since morning, feeling of vomiting, tiredness and unable to walk or sit. By the noon, I was completely down with fever which went up to 101F and lost appetite or anything to eat completely so could not eat anything that day and in the night, unable to sleep at all due to this. Second day started feeling better after morning and had some breakfast and now it feels slightly better not completely ok. Fever is also not there now.
Pt reported difficulty breathing, dizziness, numbness to (L) arm and hands 20 min after receiving H1N1 FLUMIST. BENADRYL 50mg/ml 95 cc IM given to (L) deltoid, O2 administered, is clear bilateral. V/S 122/92, HR 124, Resp. 28. Symptoms did not improve or resolve, EMT called by school nurse. Pt transferred to hospital via EMT.
Assessment and Plan Patient is a 70 y.o. female patient of CNP with history of atrial fibrillation, diabetes mellitus, chronic diastolic heart failure, HOCM, nonsustained V. tach, status post ICD device, OSA on CPAP, who presented to the emergency room with altered mental status, congestion, shortness of breath, cough, phlegm production.   Acute hepatic encephalopathy-resolved CT head-non acute (prior ischemic dx) On BiPAP with improvement Hold home gabapentin TSH-4.66 (mild elevation) Ammonia level 99>68 Patient admits she is not taking her lactulose regularly DC home today, patient informed to take lactulose to prevent recurrence   Acute on chronic hypoxemic hypercarbic respiratory failure-resolved Asthma with exacerbation-resolved OSA Start the patient albuterol MDI, Symbicort, dexamethasone BiPAP as above if needed She is on 3L of nasal cannula at baseline in addition to CPAP nightly   Acute on chronic diastolic heart failure Moderate pulmonary hypertension Hypertrophic cardiomyopathy Ejection fraction 60 to 65% BNP of 2700 Patient on Bumex 4 mg twice daily at home Continue metolazone and spironolactone Stop Bumex per nephrology and monitor for now   Covid-19 Virus Infection Date of onset of symptoms: 12/22/22 Symptoms present on admission: Shortness of breath, cough cold, congestion Date of covid positive test: 12/23/22 Vaccination status: vaccinated Imaging: Chest x-ray personally reviewed, bilateral pulmonary venous congestion, mild left pleural effusion Oxygen requirements on admission: 3L Current oxygen requirements: 3L Medical therapy: steroids Consultants following: ID Anticipated special isolation end date: 1/2/22   AKI on CKD III Creatinine baseline around 2 Presenting creatinine 2.41 Bumex as above Increased to 3.1 on 12/25 Nephrology consulted- recs appreciated   Lower extremity wounds Mainly on left, right appears improved Consult wound care   Atrial fibrillation Nonsustained V. tach s/p ICD Coumadin, dosed by pharmacy   Elevated troponin demand ischemia, trend troponin every 3 hours Troponin of 86 and then 88   Diabetes mellitus Diabetic diet Edo consulted- recs appreciated Increase as needed while on steroids   Hyperthyroidism Continue home Levothyroxine  TSH 4.66   Lower extremity Ulcer Follows with Podiatry outpatient Continue dressings left leg Xeroform, 4x4, kerlix, ace wrap and right leg kerlix with ace wrap    Morbid obesity due to excess calories BMI 44 Encouraged on lifestyle modification   GERD Continue daily PPI   Chronic fatigue PT/OT eval and treat
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccination site pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided by the reporter. Treatment information was not provided
I was around my granddaughter, who had a sinus infection. I thought that was what I was getting as well. When I went to Urgent Care, they decided to do a Flu and Covid-19 test and it came back positive. I only had a bit of nasal congestion and a sinus headache. I was given Paxlovid. I guess it helped because my symptoms were gone within a day or two.
Hypertension; Lightheadedness/ Dizziness; Chest pain; Ear/jaw pain (same side as injection); Ear/jaw pain (same side as injection); Neck pressure (same side as injection); Whole arm numbness and pain (same side as injection); Whole arm numbness and pain (same side as injection); Leg cramping (same side as injection); Fatigue; Chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7458) via an unspecified route of administration in the left arm on 03Aug2021 at 16:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Aug2021, the patient experienced hypertension, dizziness, light headedness, chest pain, ear and jaw pain, neck pressure, whole arm numbness and pain and leg cramping-all on same side of injection, fatigue and chills. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 04Aug2021, 14Aug2021 and 18Aug2021, the patient underwent Biofire/covid test through nasal swab and the results were negative. The clinical outcome of the events hypertension, dizziness, light headedness, chest pain, ear and jaw pain, neck pressure, whole arm numbness and pain and leg cramping-all on same side of injection, fatigue and chills was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt c/o lightheadedness and sweaty. BP 142/82 manual. . Later c/o chest tightness without shortness of breath. Lungs clear w/good air exchange. Denied options for meds or go to ER. Later pt stated she felt well enough to go home.
Within about 4 hours started feeling fatigue, then chills. By 8 PM significant joint pain, chills, and fever near 101. The following day was continued joint pain, headache which lasted approximately 36 hours, with continued chills and fever. By day 2, joint pain and aches were gone as well as the headache, but afternoon fatigue and evening fever continued, over 100 but less than before. By day 3 there was no morning fever or aches, but afternoon fatigue returned. Fever returned approximately 8 PM and went higher than initially after the shot. It reached as high as 102.4 before falling. At that point, I was worried I had something else such as the flu or pneumonia. I made a doctor appointment for day 4. In the morning, fever was gone. I had what felt more like a bad cold with a cough by then. I was swabbed for flu which was negative. I had a chest x-ray which ruled out pneumonia, as well as blood work and urinalysis, all negative. All the symptoms were apparently from the vaccine. The fever has not returned. I missed 3 days of work from a vaccine taken on a Saturday morning.
chills; Fever; muscle aches; chest pressure; shortness of breath; headache; running nose; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "angina" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; METOPROLOL; HUMULINE; GLIPIZIDE; ISOSORBIDA [ISOSORBIDE]. Past drug history included: Celexa, reaction(s): "Allergy"; Tramadol hcl, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 14Jan2021, for covid-19 immunisation; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 04Feb2021, for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "muscle aches"; CHEST DISCOMFORT (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "chest pressure"; DYSPNOEA (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "shortness of breath"; HEADACHE (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "headache"; RHINORRHOEA (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "running nose"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2021 23:00, outcome "recovering", described as "sore arm". Therapeutic measures were not taken as a result of chills, pyrexia, myalgia, chest discomfort, dyspnoea, headache, rhinorrhoea, pain in extremity.  Additional information Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Caller's father Covid 19 positive 3-4 days after first dose of the Covid Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient's son). This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration on an unknown date in Jan 2021 (at age of 71-year-old) as single dose for covid-19 immunisation. Medical history included prostate cancer from 2020 which was ongoing (this was recurrent prostate cancer that came back in the Fall of 2020), cardiac dysfunction (his fathers heart only functions at about 30 percent due to a prior illness), father was allergic to penicillin. The patient's concomitant medications were not reported. Caller does not know the date or Lot Number for his fathers first dose of the Covid Vaccine. The caller stated that his father became covid 19 positive 3-4 days after first dose of the covid vaccine in Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The outcome of event was unknown.  Follow up attempts are completed. No further information is expected.
A pediatrician reported that a Native American female child received her 2nd dose of Prevnar on an unspecified date. Approx. 2 1/2 weeks later, the child was hospitalized with meningitis. No further information was available at the time of this report.
Headache, Myalgia, Arthralgia, HA, fatigue, body aches and pain at inj site Narrative:
Initial report received on 10 November 2006 a health care professional. A 35-year-old female patient had inadvertently received a left deltoid, intramuscularly injection if Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case in the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03046, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
Sore arm; Fever; Nausea; Headache; Very very tired; Chest pounding/Heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Chest pounding/Heart palpitation), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Dystonia, Anemia, Autoimmune disorder (autoimmune disease but its not official diagnosis), Sulfonamide allergy, Allergy to antibiotic, Drug allergy (most oral antifungals) and Drug allergy (muscle relaxant: Baclofen).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Chest pounding/Heart palpitation). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired). At the time of the report, PALPITATIONS (Chest pounding/Heart palpitation) had not resolved and PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Heart rate: 90-125 (High) High. On 25-Aug-2021, Heart rate: normal (normal) normal. On an unknown date, Body temperature: 102 (High) fever of 102.         Patient reported concomitant medication as corticosteroids used for autoimmune disease.  No treatment medication was  reported by patient.  Patient reported that she contacted HCP and she  was told to monitor her symptoms and she is scheduled for EKG test.   This case was linked to MOD-2021-302231 (Patient Link).
SIDE EFFECTS: Beginning 12 hours after the Moderna Booster, I experienced severe side effects, most notably fever peaking at 102 degrees F, along with severe full body rigors. Both symptoms were reduced somewhat by use of extra strength Tylenol, however not eliminated. Symptoms returned full force within 4-5 hours of each Tylenol dose. Symptoms lasted approximately 33 hours, gradually tapering.  These side effects were also experienced subsequent to the first and second Moderna vaccines.
sweating, shaking chills, fatigue & numbness in arm p/3rd dose in series;had cat scratch;
Blisters near injection site. Then blister breakouts six months later and still continue to happen to current day.
Chest pain, headache, facial numbness. No medications taken. Chest pains and facial numbness have resolved. Headache continues.
Vaccine administered on 10/2/12 at 345 p in (L) deltoid. Tolerated well. Pt. called triage 10/2/12 7 p to report (L) arm red & swollen from injection site down. Triage nurse advice was cold compresses and ADVIL. Pt. returned to immun. clinic on 10/10/12 9 am to show nurse arm.
I felt like I only had days to live...bones hurts so bad.  Generally felt ill all over.
Patient developed typical fever, myalgias, body aches in the days after his vaccine.  He would describe them as severe.  This was followed by chest pains.  These chest pains prompted him to seek care in the ER.  Upon workup, I found the patient to have developed myocarditis with a significantly elevated troponin prompting hospitalization.
Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 02-OCT-2012 (reported as on or about 02-OCT-2012), the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the health provider. On unknown date, the patient experienced shingles and on or about 04-DEC-2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.