chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and  erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues.  My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms.  I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday  the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers  and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.
Discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort".   Additional information: She remembers having some discomfort with the second dose, more so than the first. Caller clarified that she received the Pfizer Covid-19 Vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse reporting on a patient of unknown age and gender who on 28-AUG-2012, was vaccinated with an expired dose of ZOSTAVAX (lot # 670820/0660AA, exp 04-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that no symptoms were reported. Additional information has been requested.
Developed a red, itchy round patch about 2 inches in diameter; Delayed skin reaction at injection sitein upper left arm.; Developed a red, itchy round patch about 2 inches in diameter; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:45 (at the age of 49-years-old), as single dose for COVID-19 immunisation. Medical history included hypertension (controlled with medication). The patient did not have any allergies to food, medications, or other products. Concomitant medications included calcium levomefolate; drospirenone; ethinylestradiol betadex clathrate (BEYAZ) and olmesartan (MANUFACTURER UNKNOWN), both for unspecified indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced delayed skin reaction at injection site in upper left arm and developed a red, itchy round patch about 2 inches in diameter. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site reaction, red rash and itchy rash was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Yesterday I got the 2nd Moderna dose at 1:15pm, and today (about 30 hours later the injection) I noticed a broad range of hive/rash area on my upper left arm below the injection site. I am going to take a 25mg Benadryl pill.
Patient presents to the ED with shortness of breath, cough, fever, and generalized weakness.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Patient received the wrong vaccine requested.  Patient received a Pfizer Covid Booster when he wanted the flu shot.
I experienced shortness of breath that is getting progressively worse, fatigue and a breakthrough case of COVID-19.
at approximately 1240-pm after receiving both vaccines patient stood up in room and started to walk to waiting area and said he was nauseous. he immediately sat down in a chair and immunizing tech said he slumped in the chair and began making noises. she called me (pharmacist) to quickly come out.  i told pharmacy to call 911. patient appeared to be having a seizure was swaying in chair with eyes closed still making noises. he started to froth at the mouth but very little and his hands and legs began to stiffen. wife said he has high anxiety.  i continued to ask patient are you ok are you ok and after about 2  minutes of doing this the patient came to. he was sweating profusely but his color was back.  he asked what happened and about that time the rescue arrived.  they worked him over and he had good bp good pulse and o2 levels were good.  he refused to go to er.  patient at this point was doing better but not 100%. he remained in waiting area another 30 minutes then decided with wife to go to er. i put the patient in a wheelchair and helped him out to his car.
heart was beating fast, light-headed, foggy brain, body felt tingly, trouble remembering things
Headache, Myalgia, NauseaVomiting, Hyperglycemia(insulin dependent), fatigue Narrative:
Burning sensation down my arm (where I received my shot) with pain in my wrist, fever and soreness within hours, followed by whole body aching and muscle soreness, numbness in my face, swollen eyes that hurt and face feels swollen, headaches, weakness and tiredness, runny nose, sore throat. I have most of the symptoms even after 4 days. Will be seeing my doctor asap.  12/15/09 PCP medical records received. Service date 11/20/09. Assessment: Low Back Pain, Asthma w/o status asthmaticus, depression. Patient presents with back pain, had tingling sensations for few hours after H1N1 vaccine, now resolved. Morbidly obese. Back ROM decreased. Lower extremity joints arthritic. Benign appearing moles.
Information has been received from a physician concerning a female who was vaccinated, intramuscularly with the first, 0.5 ml dose of Gardasil. The patient concomitantly received Menactra and Dtap. The patient complained that her subsequent menstrual period was "much more painful than usual" with severe menstrual cramping. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Site: Pain at Injection Site-Severe, Additional Details: Came in and explained that his arm was sore and he was in severe pain, He was going to visit his doctor to seek treatment for the pain
Generalized lesions >200, afebrile, first lesion 5/23/2000.
Unable to raise left arm due to pain in left deltoid. Pain began in the evening after vaccine administered earlier the day - treated with analgesics, sling and light-duty at work.
Headache; arm became sore later that day, and the soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   Concomitant products included medication unknown (Unspecified Treatment).   On 16th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, 1 week after receiving Shingrix, the patient experienced headache. On 16th January 2020, the patient experienced pain in arm. The patient was treated with PARACETAMOL (TYLENOL). Shingrix was discontinued. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at a cancer center institute where was being treated as a patient and had her arm sore later that day, and lasted approximately 2 to 3 days.  Approximately 1 week after vaccination, the patient developed a headache that reoccurs in different area of her head. The reporter initially thought headaches were sinus related but determined they were not. The day before reporting on the left side of her forehead she developed a headache and it extended downwards. The patient taken Tylenol to help with headache pain.  The patient did not received her 2nd of Shingrix due to headaches. The follow up consent was granted.
G.M. brought child in 5/9/08 for us to evaluate R arm.  Upper arm is warm to touch; red; & swollen.  Pt. states that it is not painful.  GM states child has not complained.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-AUG-2012, a licensed practical nurse at a VA health care facility/medical center administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-APR-2017 and 19-JUL-2017, the patient was treated by a physician at a medical center for shingles and post-herpetic neuralgia. The patient was diagnosed with shingles, post-herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
pt recv vax 2JUN95 AM;7JUL had pain in shoulder;20JUL suffered weakness, & numbness of lower extremities & in lt hand;
Continued fluid in ears, not responding to treatment as allergies, nor as ear infection. Pain is severe and unrelenting. First 2 days of Prednisone titration (50/40mg) helped however nothing has since. Pseudoephedrine takes edge off pain. No fever. No runny nose. No congestion. Ear pain is the only true symptom.
Redness all around the injected area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness all around the injected area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE ERYTHEMA (Redness all around the injected area). At the time of the report, VACCINATION SITE ERYTHEMA (Redness all around the injected area) outcome was unknown.            No concomitant medication reported. No treatment information reported. patient having redness all round the injected area
Hives 10 minutes after injections. Now vaccines today included Flu, VARIVAX. Pt has had egg beaters in past, never had Gelatin. Plan to refer to allergist for testing. 2nd Flu if no rxn. Monitored pt x 30min. 1 tsp ZYRTEC given. Hives resolving & no facial swelling no lip swelling observing rechecked 3 hours later and pt doing well.
Arm was very painful and she could hardly lift it/her arm pain and soreness was back; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included no adverse event (no medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back). At the time of the report, PAIN IN EXTREMITY (Arm was very painful and she could hardly lift it/her arm pain and soreness was back) 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.   Concomitant product use was not provided by the reporter. Treatment for the event included Ibuprofen 800 milligrams.   Company comment: This case concerns a 71-year-old female who experienced a nonserious unexpected event of severe pain in extremity.  Event onset within a few hours on Day 1 after the first dose of mRNA-1273. Event resolved and then recurred on Day 8. Treatment with ibuprofen. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 71-year-old female who experienced a nonserious unexpected event of severe pain in extremity.  Event onset within a few hours on Day 1 after the first dose of mRNA-1273. Event resolved and then recurred on Day 8. Treatment with ibuprofen. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This injection was the pt's 5th DTaP and 2nd IPV. I contacted nurse line and spoke with employee. Employee states the doses were valid and don't need to be repeated.
Large area of induration and redness with subsequent sloughing of skin, discoloration, swelling.
Information has been received from a 66 year old female with Graves disease and no allergies who on 10 Nov 2006 was vaccinated with a dose of varicella zoster virus vaccine live. Concomitant therapy included SYNTHROID. Concomitant vaccination on approximately 27 Oct 2006 included a dose of influenza virus vaccine (unspecified). On 12 Nov 2006, two days after vaccination, the patient developed blisters on the same arm where the injections was given. The blisters were approximately six inches below the injection site and on her left arm. On 13 Nov 2006, the third day after vaccination, she also developed welts on her left arm. The blisters and welts caused itching. Presently, the blisters and the welts were fading, but she could still see them. No medical attention was sought and no diagnostic laboratory test were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Situation: Moderna COVID-19 Vaccine Dose 2 administered too soon Background/Risk Factors: Patient scheduled for dose 1 of COVID Vaccine on 09/22/21. Unclear how patient had second dose appointment scheduled on 10/13/21. For unknown reason (not documented in chart) patient received dose 7 days after first dose. Assessment: Vaccinator must look at vaccine record card or database to ensure appropriate timeframe between first and second dose. Response/interventions: Patient notified that dose administered too soon. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Information has been received from an office manager via a field representative referring to 75 year old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions were reported as none. On 08-AUG-2018 the patient received her first dose of PNEUMOVAX 23 (lot # R002084, expiration date 26-OCT-2019, route, strength and dose not reported) at left deltoid for prophylaxis. On 09-AUG-2018 the patient experienced fever, chills and body aches. There was redness and inflammation around the injection site, which had moved down her arm slightly. Arm had also stiff and her range of motion was limited due to pain. The outcome of events was reported as recovered. The causality between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA010654.
Significant Urticarial Rash, swelling, cellulitis to bilat thighs.
The day following my Pfizer booster injection I developed extreme paint in my joints, and muscles widespread.  I also felt extreme fatigue.  I have struggled with pain and symptoms from osteoarthritis and fibromyalsia but it was managed with light medications.  The joints with issues were the hardest hit.  At night I am kept awake by shooting pains up my shins and widespread pain.  I tried managing with additional prescribed medicine and extra strength Tylenol.  Nothing seems to give me relief.  This reaction has been life changing.  I have been told by a Pharmacist this could be weeks or longer and even permanent.  I am really disturbed by this and want people to know.
Discharge Provider: PRIVATE MD Primary Care Provider: None Physician, DO Admission Date: 12/1/2022 Discharge Date: Dec 16, 2022 COVID positive date: 12/1/2022 PRESENTING PROBLEM: Weakness [R53.1] COVID-19 virus detected [U07.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Pt. is a 78 y.o. male with past medical history significant for essential hypertension, coronary artery disease, and dementia. Pt. presented from Medical Facility with worsening weakness and ground level fall. He was reportedly declining for the past six months, but in the last 3 to 4 days prior to arrival developed increased confusion and new agitation. Vitals were stable on room air. All imaging negative for acute traumatic injuries including CT head. Labs found to be COVID positive. Patient was admitted with COVID-19 infection, generalized weakness and encephalopathy with agitation in setting of underlying dementia. Chest x-ray showed no acute abnormalities. Patient remained on room air since admission thus did not receive decadron nor remdesivir. He developed urinary retention requiring straight catheterization and  urology was consulted.  He was started on flomax and recommended intermittent straight catheterization if PVR > 400.  Urinary retention did improve but still requiring straight catheterization on occasion. Will follow up with urology outpatient. Psychiatry was consulted due to agitation and changed Geodon to nightly Zyprexa with prn Zyprexa for agitation. Urinalysis and culture obtained due to leukocytosis and resulted with Klebsiella and Enterococcus. He was started on IV Unasyn based on susceptibilities and transitioned to PO Augmentin 875-125 mg BID for total of 7 days that was completed inpatient. Throughout admission, patient's orientation, memory and behavior fluctuated but overall improved. Zyprexa was changed to risperdone due to fatigue throughout the day. Patient improved back to his baseline. PT/OT recommended home PT. He will follow up with his PCP outpatient. Pt. is discharging in improved and stable condition
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/8/2023 Discharge Date: Feb 12, 2023  PRESENTING PROBLEM: Acute renal failure, unspecified acute renal failure type  [N17.9] Acute kidney injury superimposed on chronic kidney disease  [N17.9, N18.9]   HOSPITAL COURSE: Patient is a 66 y.o. male with past medical history significant for chronic combined systolic dysfunction and diastolic dysfunction CHF, severe RV dysfunction, valvular heart disease with repair for mitral valve, ASD repair, tricuspid valve annuloplasty  8/19, atrial fibrillation on Coumadin, CAD s/p CABG, type 2 diabetes, CKD III, malignant melanoma on left eye '19, iron deficiency anemia who was sent to ER by his cardiologist due to elevated creatinine, INR during routine check on the day of admission  Patient recently had right thoracentesis on January 26 and pleural fluid study was suspicious for small B-cell lymphoma or CLL.     In he ED;   Vitals in ER showed blood pressure 97/53, pulse 58, temperature 5, respiration 18, O2 sat 98% on room air. Labs showed BUN 89, creatinine 3.84 which is elevated from his baseline, INR 2.7, potassium 5.2, hemoglobin 10.8, white count 7.3 platelet 172. BMP 1218. He was also positive for COVID-19.  CXR showed pulmonary congestion and small to moderate right pleural effusion. Patient reported recently finishing a course of antibiotics for his abscess on his left buttock and has subsequently developed watery diarrhea after he finished antibiotics.            Patient had a echocardiogram, which showed left ventricular ejection fraction 60% and small pericardial effusion.  Patient stated that he has been taking home diuretics on time and has been making urine without decreased urine output noted.  He also denies weight gain or weight loss or lower extremity edema.   He was admitted to hospitalist service, and was started on fluid, and diuretics were held.  His creatinine improved from 3.84 on admission to 1.68.  The patient was also had hyperkalemia following improved after restricting his potassium intake as well as giving Kayexalate and coma.   Chronic combined CHF was stable, he continued Coreg, but was advised to restart Torsemide in 2-3days as well as his Lisinopril and metolazone.  He was instructed not to continue with spironolactone at this time due to hyperkalemia and was advised to follow-up with his primary care doctor or cardiologist in order to assess reassess restarting the medications.     He was not interested in repeating thoracocentesis. Diarrhea resolved prior we were able to test for C. Diff.  Chronic A. Fib with well controlled rate. He was discharged on warfarin    He has known history of iron deficiency anemia and he received Ferrlecit 125 mg 5 infusion during this hospitalization.  He will follow-up with hematologist as scheduled before for her this study to exclude small B-cell lymphoma CLL.   The patient was discharged home in a stable condition.  He was instructed to for 2 weeks.  He was also given a prescription for repeating his BMP.
1st injection 23 minutes post injection, sudden onset of extreme vertigo with moderate nausea, lasting approximately 8-10 minutes  Chills and night sweats : severe on nights 2-3 post injection, moderate nights 4-6, mild nights 7-8 (tonight will be night 9)