chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was uncomfortable and sore; arm was uncomfortable and sore/the pain was unbearable, it felt like someone punched my arm; Indication: Covid-19; I can barely lift my arm to take off my shirt; By the time I went to bed I could barely sleep; The spot where I received it is swollen and hot to the touch; The spot where I received it is swollen and hot to the touch; This spontaneous report was received from a 47-year-old female patient reporting on herself. The patient's concurrent conditions included allergy induced asthma. Drug reactions or allergies included allergy to tetracycline. Pertinent medical history was not provided.  On 24-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one dose, administered in the right arm (exact dose, frequency, route of administration, lot# and expiration date were not provided) as she had asthma and was nervous about getting Covid-19.   After the vaccination, her arm was uncomfortable and sore. By the time she went to bed she could barely sleep, and the pain was unbearable. It felt like someone punched arm. She could barely lift her arm to take off her shirt. The spot where she received the vaccine was swollen and hot to touch. The patient took acetaminophen (TYLENOL) to treat the events. No laboratory diagnostics or studies were performed. The patient did not seek for medical attention. The outcome of the events was reported as not recovered.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Fever, uncontrollable shaking, extreme fatigue, joint pain, headache, pain and swelling at injection site, muscle pain upper back.
Due for 2nd flu shot today. Call to parent because of "no show" and parent stated child was ill & vomiting after recvg. 1st flu shot, and lasted a week. Parent questioning a reaction to the vax. Did take child to DR. Will not cont. series.
5/11/03 Parents noticed left side of lower facial swelling. Left ear ache. Examined 5/12/03 . On follow up visit 5/16/03 swelling was subsiding.
Swollen, redness and tenderness around injection site. 08/30/06-records received for DOS 07/28-07/31/06 DC DX: Seizure secondary to Xanax withdrawal.             Cellulitis of right great toe              Hypertension HX: 28 year old male transferred from Hospital with fever and chill and 2 episodes of seizures with LOC.  PM HX: hypertension, narcotic drug abuse and drug seeking behavior, treatment for tuberculosis in 2000. Stopped taking Xanax recently before episodes of seizures. Hospital course: admitted with diagnosis of possible meningitis. Treated with fosphenytoin then switched to Dilantin. IV Rocephin and vancomycin. Spike of fever on 7/30/06 to 102.5. DX right great toe cellulitis, continued on Rocephin. Complained of headaches but during hospital stay became less intense. Red arm redness and swelling improved. No seizure since admission. At time of discharge free of headache, erythema of great toe was better.  DC Medications: Augmentin, lisinopril and ibuprofen.
Pt took 2 aspirin tabs then 45 minutes later broke out in rash to left side and left arm. Rash itches and in the course of 2 days has moved from left side to back, then feet and legs, then to stomach. Rash disappears from one spot as it appears in another. No fever. Pt taken to MD 7/7/03 and put on Prednisone.
Seven hours after i got my shot, i had severe stomach ache and right abdominal pain that was deep and also severe.
pt recv vax & devel an inj site rxn characterized by erythema,sl welt,redness & itching;this is one of 6 patients from this site who devel this rxn;
IPOL vaccine was given to a 12 month old instead of the hib vaccine; the patient received 4 doses of the polio vaccine instead of 3 doses; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received vaccine IPV (VERO) [IPOL] instead of HIB (PRP/T) VACCINE [ACT-HIB] and reported that she received 4 doses of the polio vaccine instead of 3 doses.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
ABOVE AVERAGE REDNESS AND SWELLING ON THE RIGHT LEG; FEVER & FUSSY AFTER 24 HOURS; RED AREA WARM TO TOUCH; SUSPECT VACCINE REACTION ON TREATMENT FOR CELLULITIS: CEPHALEXIN 250mg/5ml oral suspension ON 6/25/20 @ 9:50am OFFICE EXAM but area still swollen no longer red warm to touch
Nausea, sneezing, fever 101, sore throat, headache. Head/forehead hurts to turn head. No muscle rigidity.
Patient states when she got home from receiving the vaccine, her arm turned red. The following morning she went to the hospital because it became more red and swollen. Patient states the hospital did blood work and ultrasound. After the tests were done, patient went home and it got worse. Patient then went to the ER and they diagnosed her with a bacterial infection and provided antibiotics.
Narrative: ADMISSION DATE: 08/09/2021 DISCHARGE DATE: 08/14/2021 DISCHARGE TYPE: regular PRINCIPAL DIAGNOSIS (Reason for admission after study): Acute hypoxic respiratory failure. ADDITIONAL DIAGNOSES: Acute SARS-CoV-2 viral pneumonia Sore throat Pleuric chest pain Asthma HLD Obesity HISTORY OF PRESENT ILLNESS: Per HPI: "Patient is a 55 year old with a PMH notable for asthma admitted via ED for Covid positive with hypoxia. Patient who was seen in the ER on August 2 at which time Covid test was negative returned today with complaints of sore throat that started last night and cough, shortness of breath, generalized weakness that started today. Repeat Covid test was positive. Denies any chest pain. Patient reports two family members tested positive for Covid on Friday. Of note, patient was immunized with both doses Covid Pfizer vaccine in May." HOSPITAL COURSE: Patient was admitted for reasons mentioned above. Patient was treated with a 5 day course of remdesivir ,fluids and oxygen and improved with intervention. Upon discharge patient was able to tolerate activity without shortness of breath or becoming hypoxic. Presenting symptoms of sore throat was determined to partially due to oral thrush for which patient was treated with nystatin. Patient is to continue his outpatient maintanence inhalers for underlying asthma and to follow up with his pcp 7-10 days after discharge. Patient will be discharged home today to complete a 10 day self quarantine in his home. PROCEDURES/OPERATIONS: n/a PERTINENT ROS: ROS: Otherwise unremarkable PERTINENT PAST MEDICAL HISTORY: asthma HLD obesity PERTINENT PHYSICAL EXAM FINDINGS: Gen- WDWN MALE in NAD/NTA, A&O x3 HEENT- NC/AT Neck-supple CV- RRR Lungs- CTAB Abd- S/NT/ND Ext- no edema Neuro- Nonfocal
A non-serious spontaneous report of runny nose, congestion, fever, sore throat, and persistent cough was received from the patient's mother concerning an eight-year-old female patient, subsequent to FLUMIST. The patient's past medical history included allergic rhinitis. Concomitant medications included cetirizine and fluticasone nasal spray. The patient received FLUMIST on 21-Sep-2009. On 21-Sep-2009, within 12 hours after receiving FLUMIST, the patient experienced runny nose, congestion, fever, sore throat, and persistent cough. Per patient's mom, "she was well and since she got the FLUMIST, she has been sick for three weeks." On 23-Sep-2009, the fever resolved. The events of persistent cough and congestion were ongoing at time of the report. The outcome for the event of sore throat and runny nose is unknown.
Hive scattered all over body, itching. Started Thursday night 9/22/2022 per patient.
red rash on both the breast went across like a bridge; breasts turned fire engine red; symptom she experienced after receiving 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge), ERYTHEMA (breasts turned fire engine red) and EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0S2E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose). On 21-Aug-2021, the patient experienced RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge) and ERYTHEMA (breasts turned fire engine red). On 20-Aug-2021, EXTRA DOSE ADMINISTERED (symptom she experienced after receiving 3rd dose) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on both the breast went across like a bridge) and ERYTHEMA (breasts turned fire engine red) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient reported that she had an MRI of breasts 3 or 4 months ago.   Reporter did not allow further contact
3/24 3pm to next day - headache, rapid heartbeat, warm body temp, poor sleep. 3/25 All day fatigue, no appetite. 3pm to next day  -aches. 6pm to next day - chills, fever? (No thermometer to verify). Midnight - fever broke? (Woke sweaty, cold) 3/26 All day fatigue, aches, no appetite.  7pm to 9pm vomiting. 3/27 All day fatigue, no appetite.  8pm to 9pm vomiting.  3/28 All day fatigue, no appetite.
Left side face tingling and numbness, with severe pain over entire body. Patient took Tylenol this am and called HD. Patient advised to go immediately to ER for assessment and treatment. Patient instructed to call back to notify us as to treatment plan.
Severe joint pain. Felt like I could feel my bones and that they could shatter. My spine felt like it was on fire. Lasting about 24 hrs.  Still having persistent left elbow pain, and have had it since my first COVID vaccine.
Symptoms started with tingling and numbness in hands and feet. This progressed in intensity and spread to the trunk of the body as well as the face. Approximately a week after initial symptoms I began experiencing weakness in the legs as well as muscle soreness and dull pain associated with certain movements. Had trouble controlling some facial muscles. Symptoms increased in intensity for about 2 weeks, leveled off for about 2 weeks, and since have been slowly diminishing but are still present to this day.
patient fainted during observation, did not recall fainting, felt dizzy upon waking.  Rapid onset, rapid recovery. patient felt better once home after followup
A non-serious spontaneous report of difficulty concentration, pressure in ear, eyes watering, headache, runny nose, sore throat, nose fully congested, cold and chills has been received from a consumer concerning a 53-year-old female, subsequent to FLUMIST. The patient did not receive Flu vaccination in years prior to this one. No concomitant medication was reported for this report. On 10-NOV-2010, the patient received 0.2ml FLUMIST nasally for influenza. Within one hour after the vaccine, the patient experienced headache and pressure in ears, soon after, got a runny nose which became fully congested the next day on 11-NOV-2010. Sore throat also started on 11-NOV-10. On 12-NOV-2010, the patient experienced chills. On 15-Nov-10, this developed into full blown cold symptoms. The patient was fully congested with eyes watering at the time of report. Only the pressure in the ear symptoms resolved on 11-Nov-10 and the chills resolved on 12-Nov-2010. All other events resolved after one week. The outcome of all the evens was resolved. Additional information was received on 02-May-2011 and incorporated into the narrative: Outcome and duration of the events.
Monday 6/17 , Patient was lethargic and slept for a large portion of the day. Tuesday 6/18, Patient woke up with a low fever and felt lethargic all day.  He slept most of the day and ran a temperature between 100 and 101.5. Wednesday 6/19, Patient woke up with no fever (temperature a normal 98.2) and is feeling normal but has a red rash all over his torso.  This is on-going at this time.
Mother concerned when child awoke flushed with red puffy cheeks, Child feverish temp. 102 degrees F, Taken to ER began convulsing in waiting room. ER staff worked with child. Convulsions stopped. Child has never had convulsions before or since event. A follow up report received 9/20/2002 adds: Rx Tylenol. No site reaction.
101 fever, chills, body/bone aches, dizziness when standing for the night and day following the shot.
Woke up at 4am with extreme rapid heartbeat. This subsided after I drank some water. At 6am, I had teeth chattering chills. As the day progressed I had extremely painful body aches and the worst headache of my life! After 4 advils and sleeping all afternoon, I finally felt a little better, but still sluggish. Per CDC, not recommended to have 2nd dose due to bad reaction, and most probably allergic reaction.
April 3 - mild headache (HA) morning and evening treated both times with extra strength Tylenol with relief April 4 -  mild to moderate HA with fatigue and weakness during entire day  took Ibuprofen 600mg, drank plenty of water and rested                     headache relief moderately April 5 - 9am  moderate in morning with some fatigue - Ibuprofen 600mg                    1pm moderate to severe headache, noise and sunlight hurts  - Ibuprofen 600mg                    2pm severe headache resting                    3:30pm continues severe headache, called Nurse referred to physician                    3:45pm  return call by physician after repeating condition, recommended going to ER immediately                    4:15pm Treated in ER, received Tylenol orally, and IV Metoclopramide
Information has been received from a registered nurse concerning a 75 year old female patient, with a history of vaccination (route unknown) by another facility with her first dose of Pneumococcal 23v polysaccharide vaccine (manufacturer unknown) >5 years ago and unknown drug reactions allergies, who on 11/17/05 was vaccinated intramuscularly in the left deltoid with a 0.5ml booster dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant therapy included metoprolol succinate (Toprol XL tablets), simvastatin Zocor, Lansoprazole Prevacid, aspirin, vitamins unspecified, Irbesartan Avapro, levothyroxine NA Synthroid and zolpidem tartrate Ambien. On 11/18/05 the patient developed a fever of 99 degree F, swelling, induration, and erythema at the injection site. The doctor diagnosed the problem as cellulitis and put her on cephalexin Keflex. He also told her to elevate the arm, ice it and take diphenhydramine hydrochloride Benadryl. On 11/21/2005 the patient called the office and indicated that she was nauseous from the cephalexin Keflex, the arm was improved, and therefore Keflex was stopped. The doctor would like an investigation into this lot number. The patients experiences were considered to be other important medical event by the reporting physician (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition a review revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Received H1N1 vaccine at school. C/O dizziness, 120/78, NKA, chest pain. To hospital via ambulance. To ER.
This spontaneous report was received from a registered nurse referring to two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis. The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is valid because patient information were updated. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA006380: US-009507513-1812USA005347.
74 yo M PMH CKD 2/2 chronic glomerulonephritis s/p renal transplant in 2008, COVID-19 pneumonia 7/27, HTN, OSA, paroxysmal afib, possible COPD vs asthma and extensive occupational exposure in cement production plant who presented 8/21 as a transfer for evaluation of persistent fevers. Patient tested positive for COVID pneumonia on 7/27 and afterwards he had shingles on his left arm that was treated with acyclovir for 1 week. After treatment, his fever persisted along with diarrhea and loss of appetite with a 23 pound weight loss. He also has worsening acute on chronic dyspnea with mildly productive cough. Patient was taken for bronchoscopy with BAL and transferred to MICU 8/25 for postprocedure management s/p intubation for bronchoscopy. Treated empirically with Cefepime, doxy, azithromycin, Rocephin and IV steroids decadron 10mg BID for suspected persistent COVID-19 PNA. Respiratory culture +Klebsiella and rare Candida. He was extubated 8/27 to nasal cannula and tolerating well since that time.  Spoke with patient's wife re: home care services. States she is not sure they will be needing at this time. States they will be staying in nearby condo for a few days and then travel back home. Verbalizes unsure if they will go to outpatient therapy vs home care. States she will look into it once home.
Physician thinks it's anxiety issues; Muscles are very achy in neck and upper back; Feel really awful/Feels like he has been run over; Dizziness; Head Pressure; Ear Pressure / left year pops; Feels off balance; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops) and BALANCE DISORDER (Feels off balance) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported. .    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance) and MYALGIA (Muscles are very achy in neck and upper back). On an unknown date, the patient experienced ANXIETY (Physician thinks it's anxiety issues). At the time of the report, FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance), ANXIETY (Physician thinks it's anxiety issues) and MYALGIA (Muscles are very achy in neck and upper back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. No lab data has been provided by the reporter.
Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID). At the time of the report, SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood test: abnormal (abnormal) End Protein - Antibody was 0, Spike protein was 700. On 23-Nov-2021, Blood test: high (High) End Protein - Antibody was 20.1, Spike protein gone up to greater than 2500..     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.  Company Comment  This case concerns a 78-year-old male patient with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 78-year-old male patient with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mom states pt was "sick" x 1 1/2 wks after flu vaccine.