chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced puffiness and redness of her face, mainly her cheeks/ Puffing of the face; Experienced puffiness and redness of her face, mainly her cheeks/ Redness; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0164) via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 or 10:30 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history included acid reflux (diagnosed years ago), high blood pressure (many years ago), atrial fibrillation (diagnosed 2-3 years ago). Concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation; metoprolol (METOPROLOL) taken for hypertension started taking this years ago; losartan (LOSARTAN) taken for hypertension started taking this years ago; hydralazine (HYDRALAZINE) taken for hypertension started taking this years ago; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastro-esophageal reflux disease; nifedipine (NIFEDIPINE) taken for hypertension she states she stated taking this a long time ago. No investigation assessment was performed. No prior vaccinations (within 4 weeks). On 03May2021 21:00, the patient experienced puffiness and redness of her face, mainly her cheeks/ puffing of the face/ redness. She went to the Emergency room. She asked how long this is expected to last. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Narrative:  Pt felt dizzy during 15 min obs period. VS- BP: 180/80, SpO2: 95%, P:73, R:16. Pt stated that he did not take his blood pressure medication that morning. Offered pt crackers and juice, which he accepted. Monitored for a total of 30 minutes. Pt still felt dizzy and said he could not walk all the way to his car. Transported pt via wheelchair to ED for further evaluation. Symptoms:  Dizziness Treatment:
Admission: 3/23/2023 to 3/28/2023. Serious Adverse Events Terms: 1) Acute Kidney Injury and 2) Elevated INR. Patient presented to the ED with concern for persistent nausea, vomiting, diarrhea associated with generalized weakness, fatigue, shortness of breath since 03/17/2023. Was started on Ozempic about 5 weeks ago hoping that losing weight could potentially help with shortness of breath, with the last dose of Ozempic being on 3/13/2023. On 3/17/2023 developed nausea, vomiting, mostly watery diarrhea and inability to tolerate p.o. Reports diffuse abdominal discomfort. Patient had Creatinine level of 6.4, with a baseline of 1.3-1.6, and GFR of 9. Noted on admission also to have INR > 8, for which coumadin held for 3 days without improvement. Patient was given Vitamin K 5 mg in the ED. His abdominal exam was unremarkable. No leukocytosis. CT scan therefore deferred of the abdomen pelvis, although was considered. During admission, was finally given dose of Vit K 10 mg on 3/27/2023, and by 3/28/2023, INR improved to 5.3. This is anticipated to continue to decline, thus d/w pharmacy and recommended to continue reduced dose coumadin 2.5mg daily until he can f/u with his hematologist. Noted felt AKI is due to tacrolimus toxicity, with level >30. Tacrolimus was held during admission. Patient's creatinine was 2.32 at time of discharge.
In the Wheel chair for the rest of her life  after vaccination; Pain all over her body after Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. In 2021, the patient experienced WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) (seriousness criterion disability) and PAIN (Pain all over her body after Moderna COVID-19 vaccine). At the time of the report, WHEELCHAIR USER (In the Wheel chair for the rest of her life  after vaccination) and PAIN (Pain all over her body after Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter states that her friend had pain all over her body after Moderna COVID-19 vaccine and she ended up in the Wheel chair for the rest of her life. Consent received for safety to follow up. Company comment: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of wheelchair user. The event occurred after an unknown time interval after the dose of the mRNA-1273 vaccine. The rechallenge is not applicable since there is no information that states vaccination dose number, the dose date and there is only one dose reported. The event implies disability, although there is not enough information. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected event of wheelchair user. The event occurred after an unknown time interval after the dose of the mRNA-1273 vaccine. The rechallenge is not applicable since there is no information that states vaccination dose number, the dose date and there is only one dose reported. The event implies disability, although there is not enough information. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Lethargy, flushing, fever & arthralgia p/2 doses of vax;
The night after the second shot, patient began vomiting and had diarrhea.  She had flu-like symptoms and a fever of 102.  She presented to immediate care and did a stool culture, which was positive for Cdiff.  She was treated with vancomycin x 10 days.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Swollen lymph nodes with pfzier covid vaccine, resolved in ~12-18 hours
12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21.  Then on 4-7-21, my left leg calf was very sore and hard for me to walk,  Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf.  (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)
Pt was on schedule for HPV vaccine. Confirmed vaccine prior to administration and patient was unsure of which vaccine she was receiving. Pt called on 8/21/23 to inform office that it was the incorrect vaccine because she received a bill from her insurance.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Information about concurrent medical conditions and medical history was not reported. In approximately 2004 (reported as "about ten years ago"), the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration: unknown) (lot #, exp date: not provided). No concomitant medication was reported. In approximately 2011 (reported as "for the last three years"), the patient has had ongoing outbreaks of shingles. The outcome of ongoing outbreaks of shingles was unknown. Relatedness between ongoing outbreaks of shingles and ZOSTAVAX was not provided. Additional information is not expected, as the reporter did not have any patient information available.
Narrative: Admission Date: Nov 30,2021 Discharge Date: Dec 4,2021 Condition of patient at discharge: Stable 75 yo with past medical history of COPD on 2L O2 and recurrent urethral strictures (s/p multiple interventions, self caths), HLD, ocular MG, OSA, GERD, and PTSD who presented to the Emergency Department (ED) for a 4 day history of fever/chills. Patient stated that 4 days prior, he began experiencing fever/chills, with maximum temperature of 102F. States chronic cough from COPD has remained stable without sputum production. Denies urinary symptoms, chest pain, diarrhea, abdominal pain, and rashes. States he has never had fever/chills like this which prompted ED visit today. Patient drove himself without oxygen supplementation. Denies any sick contacts. Vaccinated x2 with Pfizer on 1/22/21 and 2/16/21. In ED patient found hypoxic into 70's on RA and altered but quickly recovered to baseline Aox3 with supplemental oxygen 3L NC. Otherwise HDS and afebrile. Labs significant for COVID-19 positive, pancytopenia (WBC 1.38, Hgb 13.7, Platelets 71), negative troponin, negative BNP, and creatine 1.46 (baseline 1.4). Patient was admitted, he did not come with his home O2 and unable to be sent home without it. He received a total of 6 days of remdesivir and dexamethasone. Patient finished azithromycin course (3 days), and 5 days of the ceftriaxone. He was discharged on 2 more days of cefdinir to finish a 7-day course. Twelve days after discharge, on 12/16/2021, the patient presented to the ED again complaining of chest pain and shortness of breath. He was readmitted to the ICU. Leading diagnosis is organizing Pneumonia post COVID. Received IV antibiotics. CT w/pulmonary fibrosis new since August 2021. Started on Prednisone 80 mg daily(1mg/kg) for organizing Pneumonia and a prolonged taper as below. Discharged to home.
Pneumonia; 104 Fever; A spontaneous report was received from a consumer who was also a 71-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 104 fever and pneumonia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 19 Jan 2021, after receiving the vaccination, the patient reported a 104 degrees Fahrenheit fever. The patient went to his health care provider (HCP). X-ray was taken. Pneumonia was diagnosed. Treatment included prednisone, antibiotic and nebulizer. The patient was also prescribed albuterol but did not use.  On 21 Jan 2021, the fever had resolved.  On 29 Jan 2021, the subject returned to the doctor. On the same day, pneumonia was gone.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event was reported 104 fever was resolved on 21 Jan 2021. The outcome for the event pneumonia was reported resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 71-year-old male subject, who experienced a serious unexpected event of Pneumonia, and non-serious expected event of Pyrexia. The events occurred same day after the first dose of the mRNA-1273 administration. Treatment included prednisone, antibiotic and nebulizer. Pyrexia resolved 2 day after, and Pneumonia resolved 10 days after first dose of vaccination. Since Pneumonia has insidious onset rather than acute onset, the event was possibly caused by underlying condition confounded by elderly age of patient. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event of Pneumonia and Pyrexia, a causal relationship cannot be excluded.
I contracted COVID 3 months after my vaccination. I contacted my doctor and was prescribed paxlovid. Within about 5 days I was feeling much better and no longer testing positive.
Severe pain and stiffness of lower back, lower spine, pelvic and hip muscles and bones 1 week after the Moderna booster.  Plus severe abdominal bowel pain, constipation and vomiting starting 5 days after booster. My previous two vaccines were Pfizer?s, April and May 2021.
1.Patient has rash along right side of neck, and top of back, noticed Wednesday. Patient wondering if its a reaction to the Shingles vaccine he had on Monday. 2.Woke up with stiff neck Tuesday, went to bed Tuesday night used a heating pad for about 15 min, stiff neck now gone. 3. Rash itchy, or painful. Herpes Zoster without complication - 053.9 (Primary).
Vaccine given to patient who is 16 years old, EUA is only for 18 years and older.
Pt recv vax on 10/27/98; on same day pt exp cellulitis of upper LA (5.5 x 7)
I don't know if it was related to the vaccine or not, but V-Safe recommended I report it. Anyway, I had a UTI /Bladder infection. Fever, back ache, and all the usual symptoms of a UTI.
SORENESS UNDERNEATH ARMPIT; SOME BODY ACHES; LETHARGIC FEELING; REDNESS UNDERNEATH ARMPIT; STOMACH UPSET; SORE ARM; HEADACHE; SORENESS AT SITE OF INJECTION; REDNESS AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastro esophageal reflux disease, high cholesterol, penicillin allergy, and sulfa allergy. The patient was previously treated with hydrochlorothiazide, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 01-FEB-2022, the patient experienced soreness at site of injection, and redness at site of injection. On 02-FEB-2022, the patient experienced soreness underneath armpit, some body aches, lethargic feeling, redness underneath armpit, stomach upset, sore arm, and headache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some body aches, lethargic feeling, stomach upset, and headache on FEB-2022, and had not recovered from soreness underneath armpit, soreness at site of injection, sore arm, redness at site of injection, and redness underneath armpit. This report was non-serious.
Fever, body aches, muscle pain and soreness at injection site, fatigue (started day after injection - went away after 1 day) *Right Neck pain immediately after injection *Underarm pain and swelling in right arm pit (started at time of injection and has lingered 3+ days) *Swelling, pain and warmth at mid point of Right Clavicle (started at time of injection and has lingered 3+ days)
On 7/25/07, pt developed swelling, blotchy red appearance on left thigh, warm to touch.  Seen at local E.R., treated for cellulitis with Bactrim Suspension 10 ml bid x 10 days.  Mother reported significant improvement on 7/31/07.
Typical mild symptoms 24-36 hours after injection (arm soreness, redness and minor swelling at injection site, myalgia, arthralgia, fatigue), all resolved within 73 hours. Day 11 post-injection, re-emergence of urticaria at injection site, red, warm, swollen, about 2 inches in diameter. Day 12/13 post-injection, increased diameter.
2 days following flu shot, I began experiencing ongoing internal vibrations throughout body. Dr. has ran blood work and no other sign of illness present to correlate to such symptoms. Therefore, symptoms appear correlated to flu shot, still experiencing same symptoms.  12/01/09 PCP notes for DOS 10/26/09 and 11/19/09 DX: Chest pain, palpitations  12/02/09 and 12/03/09 ER notes for DOS 10/18/09.  DX: Muscle spasms, visual disturbances, lower extremity numbness.   Pt c/o night sweats, chest pain, heart palpitations, spasms in the whole body. Symptoms of palpitations and SOB consistent with sinus tachycardia. ECG normal. tx: Neurontin and Valium. Pt discharged home in stable condition. Pt to follow up with a neurologist.
Client given Zostavax at 59 years of age and it is not recommended to be given until the age of 60 years.
Onset of infantile spasms within 2-3 weeks of vaccines.  11/16/07 Reviewed neuro medical records which reveal patient experienced daily stiffening & spasms of extremities since 2 mo old.  Admitted to hospital at 4 mo old & dx w/infantile spasms.  Had multiple clusters/day prior to med.  Having 1-2 spasms /wk in clusters of 3-4 after med started.  Seen in neuro clinic 10/16/07 & was improved on meds w/only increased tone in UE's & med increased. 11/16/07 Received hospital medical records which reveal patient experienced irritability, crying, jerking of extremities, rhinorrhea x 2 wks, . D/C to home on anticonvulsant med & to peds neuro follow up. Admitted 9/5-9/7/2007. FINAL DX: no d/c summary available, infantile spasms per neuro consult.
Pt described "funny taste in mouth" 2 minutes after receiving the vaccine, felt heat wave. Received 25mg of Benadryl 5 minutes after dose then another 25mg of Benadryl
07/22/2006: Fever for 18-24 hours, no other symptoms.  07/26/2006: Low grade temperature 99 degrees, generalized maculopapular rash, facial swelling noted.  Mom states rash worsening daily, giving MOTRIN as when needed, explained side effects to proquad vaccine.  07/29/2006:  Mother states rash starting to dissipate, fever gone
Rashes to neck and trunk; Nausea; Vomiting; Red eyes; Shortness of breath; This case was reported by a nurse and described the occurrence of rash in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced rash, nausea, vomiting, eye red and shortness of breath. On an unknown date, the outcome of the rash, nausea, vomiting, eye red and shortness of breath were unknown.   It was unknown if the reporter considered the rash, nausea, vomiting, eye red and shortness of breath to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, there was Flu immunization where the patient experienced adverse reaction reaction with rashes to neck and trunk, nausea and vomiting red eyes. The patient also experienced shortness of breath. This is 1 of the 10 cases reported by the same reporter.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Nurse did not have information available on the first two doses. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. It was reported that the vial was moved to refrigerator on 03-Mar-2022. Proposed desired use by date was reported to be on 16-Mar-2022.  Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions.  The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine. The temperature excursions occurred on 4-MAR-2022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 8-MAR-2022, 9-MAR-2022, and 10-MAR-2022.  No treatment information was provided by the reporter.
FACE SWELLING; VOMITING; HEAD RASH; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced face swelling, vomiting, and head rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, face swelling and head rash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Hives, fever, majority of hives on trunk and face. Took BENADRYL until hives subsided.
Pt with increased lethargy  and minimally responding to questions and commands. Temp 101.3. Respirations 24.  Blood pressure: 156/60 and heart rate: 72. Patient returned back to baseline neurologic status at 1640  after Tylenol administration at 1549      CT head and CXR performed, lactic 0.7, temp down to 98.3, STAT CBC/BMP/ABGs done - Dr. reviewed scans and labs, no new orders or antibiotics. Patient now responsive and answering questions
STORAGE IN REFRIGERATOR (2C-8C) UP TO 30 DAYS. (VACCINE USED AFTER 10/16/2021)
Within a few hours of administration of vaccine patient complaining of pain in right leg and cannot walk without pain.
day 2 vaccine I woke up with rash all over my body except for face. No itch it burned with heat. day 4 petechiae on my legs. day 5 nausea with extreme pressure and fullness  in the back of my neck. It felt like pressure on my head. No pain unless touch Only relief when sitting straight up. Took tylenol and ibuprofen and allegra but did have any relief. Telehealth with occupation heath.
Patient received COvid vaccine x2 with last dose administered on 2/5/2021. Patient developed symptoms of Covid 19 Case tested positive for COvid 19 on 7/30/2021 and was admitted to Medical Center on 8/11/2021. Patient expired while still hospitalized  on 8/19/2021.