chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improved state of mind from vaccine; Chills; fever; Body ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine), CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050c21A and 016c21A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine), CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improved state of mind from vaccine) outcome was unknown and CHILLS (Chills), PYREXIA (fever) and MYALGIA (Body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included oswelia and olive leaves extract with MSM.  Treatment medication included Benadryl.  Patient reported improvement of quality of life after second dose.
Information has been received from a literature article concerning a 19-month-old boy presented to the emergency department with asymmetrically distributed skin lesions that developed 2 days after immunization with MMR (manufacturer unknown) through the right thigh and the VARIVAX, DTaP vaccines administered through the left thigh. He developed a fever to 39 degrees C the night of the immunizations but then remained afebrile. He had no preceding respiratory or gastrointestinal symptoms, initially, pink papules were noted at and around the site or the injection on the left thigh, which them coalesced into larger plaques. Pink macules and edematous papules developed later on the pinna, face, trunk, and right leg. A punch biopsy from the left thigh showed interface dermatitis with perivascular lymphocytes and histiocytes and rare neutrophils and eosinophils. These findings were read as consistent with Gianotti-crosti syndrome (GCS). Because the major site of involvement was at the site of the injection of the left thigh, the authors suspected that the DTaP vaccine or the VARIVAX was responsible for precipitating the skin eruption. GCS is most common in children aged 2 to 6, with papules measuring 2 to 5 mm in diameter and distributed symmetrically on the face, buttocks, and extremities. Although GCS was initially described in association with anicteric hepatitis caused by hepatitis B, has been more commonly associated with other viruses. In addition to viral infections, GCS has been reported to occur after immunization with live, killed, and recombant vaccines. Some authors have suggested that combined vaccinations carry a higher risk for precipitating GCS lesions. Other authors have suggested that the risk of developing GCS is greater when an active viral infection is present at the time of vaccination. The patient had a history of fever immediately after the vaccination but no fever or other viral symptoms before or at the time of the vaccination. Additional information has been requested.
Shortly after getting vaccine started getting headaches and dizziness intermittently, but frequently for the following 2 months. I thought it finally resolved, but I keep getting headaches/migraines intermittently. I've never had a problem with headaches or dizziness before (outside of acute illness like a cold or sinus infection) and never so persistently or intensely. Sometimes they make my vision blur and thoughts foggy. The dizziness isn't so bad or frequent anymore, primarily headaches/migraines now.
Immediately after vaccine began to feel dizzy and lightheaded. Head pressure and began to feel coldness in head. Heart palpitations and skipped beats. It began to get worse as time passed. I ended up being so lightheaded I couldn?t walk or move and my heart palpitations and chest pain got worse. I ended up going to the hospital and having an entire battery of tests with some like the EKG that weren?t great and being admitted. I received steroids, Benadryl, fluids, and tylenol
I got a lump in my throat, the scans came back and theres little lumps scattered around my lymph nodes, my throat area looks permanently swollen like there is a lump there
Red swelling, erythema and warm to touch 17 x 21.3cm erythema and swelling.
Hair loss, very thinning hair, breakage.  Looks like little wires sticking up.  Noticed this immediately after the shot..  I keep getting haircuts to get rid of it, not working yet.
Information has been received from a physician concerning a 20 year old female who in "6 years ago", was vaccinated with the second dose of RECOMBIVAX HB, and 2 weeks later the patient experienced hives. The patient received unspecified medical attention. The patient recovered on an unspecified date. No further information is available.
Came down with a real bad headache at work. By the time I got home it was getting worse. Laid down fell asleep, when I woke up the headache wasn't as bad. But I sat up and I was really dizzy, then made it to the bathroom had diarrhea and was nauseous. Then had a low grade fever and chills. I think the worse part of this was the dizziness this has lasted 2 days. I started getting the flu shots in 2005 after learning I have MS. Even though I have MS I have never been sick from any of the shots before this. I don't know if it was the certain strain in this years vaccine or not. Just thought you should know this info it may help you. Thank you.
The patient waited the required 15 minutes. At that time the patient felt lightheaded and requested water. The patient and his mother reported that he did not have anything to eat that morning. The patient was given 1 granola bar and bottled water. Vitals: BP 100/65 P 66 T 97.1. The patient consumed the food and reported feeling better.
No unusual pain at injection site, but increased swelling after 10 hours.  Woke at 2:00 a.m. with severe vomiting and headache.  Headache fatigue all the next day. No hunger at meal times. Constant thirst. Itching at injection site
A 20 year old female pt developed a full body rash following RabAvert admin. She received her first dose of RabAvert on an unk date and the second dose on 17Nov03. Concomitant medication included oral contraceptives. The pt has no past medical or surgical history. No adverse events were reported after the first dose of RabAvert. On 19Nov03, two days after the second RabAvert dose, she developed a full body rash with severe itching. The rash was described as red and papular and present on her back, arms and most dense on the abdomen and upper thighs. Steroids were given for treatment. Follow up received 13Jan04: the first dose of RabAvert was given on 10Oct03 and the second dose on 17Oct03. She developed an intensely itchy rash on her lower abdomen and legs on 19Oct03. Three to four weeks later, the event resolved.
A non-serious spontaneous report of FLUMIST administered 1 day beyond 48 hrs recommended time frame of use was received from a health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 01-Nov-2011, the patient received FLUMIST vaccines exposed to 14 degrees C one day beyond the 48 hour recommended time frame of use. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patient with complaint of nausea, dizziness, fever, vomiting on 2/21/15. Symptoms lasted on and off for 6 hours. Symptoms improved after taking a dose of TYLENOL and Fluids.
RESIDENT PASSED AWAY ON 12/13/2021 ON HOSPICE SERVICES WITH COMFORT MEASURES IN PLACE.
MD states ran high fever 2 days p/vax was freezing cold; lt arm hurt to touch; chest-lt leg burning & painful like paralized; pain relieved by heat; fever still present a wk p/shot;
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything.   I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
SLEEPLESS NIGHTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included cetostearyl alcohol/glycerol for drug used for unknown indication. On an unspecified date, the subject experienced sleepless nights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleepless nights was not reported. This report was non-serious.
Moderna vaccine administered to a patient 10 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age). On 12-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that it was 39 days since the administration of the first Moderna Covid-19 vaccine.   No concomitant medications were reported. No treatment medications were reported.
Patient is a 86 y.o. female patient of, MD with history of CAD, hypertension, hyperlipidemia, former smoker, breast cancer presented to Hospital from nursing facility with hypoxia and confusion.   Acute metabolic encephalopathy resolved Etiology not clear, CT is negative Urine analysis was normal, per family history of frequent UTIs As per daughter mental status back to baseline    Acute respiratory failure with hypoxia Probable COPD 2/2 COVID-19 infection? Has about a 30-pack-year history of smoking but quit about 30 years ago per patient and daughter.   CT PE study negative for acute abnormality Auscultation revealed clear lung sounds, without wheezes.  No indication for Auscultation revealed clear lung sounds, without wheezes.  No indication for albuterol at this time.  Patient denies shortness of breath.  Has slight cough. Required 2 L but able to wean off to room air, encourage incentive spirometer   Covid-19 Virus Infection Date of onset of symptoms: Unsure Symptoms present on admission: Confusion Date of covid positive test: 7/13/2023 Vaccination status: Unknown Imaging: CT without evidence of PE or pneumonia  Oxygen requirements on admission: 2L Current oxygen requirements: On room air Medical therapy: steroids, cont on decadron for 6 more days at dc Consultants following: N/A Anticipated special isolation end date: 7/23/2023 Rectal bleeding with pain History of internal and external hemorrhoids, on rectal exam noted to have multiple external hemorrhoids with pain Frank BRBPR noted, started on sitz bath with Anusol HC Surgery consulted, recd rectal MRI given abnormal finding on rectal exam Daughter was unsure if they want to proceed with rectal MRI.  Continue maximum medical treatment and follow-up with surgery in 2 weeks as an outpatient for possible anoscopy and then discuss with family whether or not to pursue additional testing    Coronary artery disease No history of chest pain EKG nonacute, troponin 19, recheck is pending Continue cardioprotective medications   Abnormal liver imaging H/o breast ca CT showed right hepatic lobe ill-defined low-density heterogeneous lesion With history of breast cancer malignancy is on differential Discussed with son-in-low, family not considering aggressive measures Possible liver mets Outpatient MRI if family will reconsider    Vascular dementia Continue ASA/statin    Essential hypertension Continue home medications As needed hydralazine for limited BPs above 170 systolic   RLE edema Chronic.  Right lower extremity venous Doppler-interval resolution of common femoral vein and right great saphenous vein noted  Daughter notes that patient might not be able to take blood thinners if needed though since she has had bleeding complications in the past.    History of breast cancer Continue on Femara
Hypoxia, Decreased responsiveness,  Narrative: 86yo male with PMHx HTN, Afib not on AC after head trauma, CVA, and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900, and was monitored for 15 minutes following immunization no noted issues. Later that night, had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight, had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note, per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine, which was administered on 1/16/21.
after flu shot was given, developed swelling & pain next day and persisted. Saw ortho who diagnosed as due to flu shot given too close to axillary nerve need a steroid injection for pain and 6-8 weeks of physical therapy
The second shot caused severe arm pain in entire arm starting about 3hr after shot.; Pain increased until unable to use/lift. Started to decrease some after 72hr; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, expiration date: an unknown date in May2021) via an unspecified route of administration in the left arm on 03Feb2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure controlled with medication. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included hydrochlorothiazide (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN) and esomeprazole (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246, expiration date: an unknown date in Apr2021) via an unspecified route of administration in the left arm on 12Jan2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. The second shot caused severe arm pain in entire arm starting about 3 hours after shot on 03Feb2021 at 16:00. Pain increased until unable to use or lift. Started to decrease some after 72 hours. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event second shot caused severe arm pain in entire arm starting about 3 hours after shot; pain increased until unable to use or lift; started to decrease some after 72 hours was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Left arm - shoulder elbow to forearm - unable to lift arm, 0 N & T  Limited ROM not worsening tenniz ball induration at injection site, warm, tender to touch, w/movement 9/10 pain  Ibuprofen - helps a little, & Biofreeze Rec - F/U w/PCP Offered Occ med - declines at this time. Rib pain
Pt 7-months pregnant developed bump under skin at site of injection. Tender not very large but can be felt under skin.  Also itchy, no rash, no elevation of temp in area, no fever, no soreness on movement of arm. Feels fine.
Patient states reactions started with redness and swelling in lower section of her arm (not at injection site) follwed by itching in the same location on her arm. She states that she still has some swelling in the lower portion of her arm and extreme tenderness here also on 3/5/18 and that vaccine was administered on 2/20/2018. Patient was referred to her primary care provider. Patient states that she was on her way to see the doctor for a further evaluation on 3/5/18.
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat.  BP 135/65 SP02100%, HR 66 bpm.  Given apple juice and didn't feel lightheadeness or tnling.  Then expressed waves of episodes reported by the patient.   Monitored for 117 minutes.  PRovider called 1 hour after monitoring symptoms that were not worsening.  Still felt shakey.  Given option to go to ED or be transported by ambulance.  Went via ambulance to ED.  Did not receive any additional treatment in the ED.  ED noted that it did not appear to be anaphylactic reaction.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients received doses of improperly stored VARIVAX lot # M042495, expiration date 19-OCT-2018 (dose and route of administration not reported) on the following dates: 25-MAY-2017, 05-JUN-2017, 06-JUN-2017. Between 18-MAY-2017 and 22-MAY-2017, the vaccines underwent a temperature excursion between 47 and 77 degrees Fahrenheit for 47 hours and 15 to 46 degrees Fahrenheit for 90 hours. There were no previous excursions reported. Digital data logger was used to record the excursion. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004880: US-009507513-1707USA000670: US-009507513-1707USA000668:
Muscle ache; Redness; Soreness Injection site; Fever; Body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Lot number: Fc3183) at the age of 15 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin for allergy, notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Sep2021, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Muscle ache"; ERYTHEMA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Redness"; INJECTION SITE PAIN (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Soreness Injection site"; PYREXIA (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 04Oct2021 12:00, outcome "unknown", described as "Body ache". The events "muscle ache", "redness", "soreness injection site", "fever" and "body ache" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of myalgia.  Additional information: Vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination.  Follow-up (02Nov2021): Follow-up attempts are completed. No further information is expected.