chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia on and off; whole bodyerythema rash; generalized rash; Injection site itching; Big rash on the injection site; red on the site of injection; Swollen at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia on and off), RASH ERYTHEMATOUS (whole bodyerythema rash), RASH (generalized rash), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Big rash on the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025S202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia on and off), RASH ERYTHEMATOUS (whole bodyerythema rash), RASH (generalized rash), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Big rash on the injection site), VACCINATION SITE ERYTHEMA (red on the site of injection) and VACCINATION SITE SWELLING (Swollen at the injection site). The patient was treated with PREDNISONE (oral) for Rash, at a dose of 10 milligram. At the time of the report, TACHYCARDIA (Tachycardia on and off), RASH ERYTHEMATOUS (whole bodyerythema rash), RASH (generalized rash), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Big rash on the injection site), VACCINATION SITE ERYTHEMA (red on the site of injection) and VACCINATION SITE SWELLING (Swollen at the injection site) 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.   Upon in internal review on 19 May 2021, the age was corrected to 75 years. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
a little rash on the shoulder of the arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RASH (a little rash on the shoulder of the arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and CALCIUM for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced RASH (a little rash on the shoulder of the arm). At the time of the report, RASH (a little rash on the shoulder of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-218922 (Patient Link).
Pharmacist received prescription to administer ACT-HIB to patient that is over 5 years of age - with no adverse event; Initial information received on 20-Dec-2021 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age female patient whose pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].     The patient's past medical history included Paroxysmal nocturnal haemoglobinuria. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported, formulation not reported via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event, "pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no adverse event" (product prescribing error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported, "Pharmacist states they received a prescription from a provider to administer the ACT-HIB vaccine to a patient. However the prescription is for an adult, and the pharmacist states they know the vaccine PI states 2 months through 5 years for the age range. The consumer has paroxysmal nocturnal hemoglobin urea and the ActHib was ordered for her but they haven't given it as yet. Consumer came back in today to get it but has left at the moment. Pharmacist has spoken with the doctor and is waiting for the script but will probably administer the injection."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Pharmacist received prescription to administer ACT-HIB to patient that is over 5 years of age - with no adverse event).  At time of reporting, the outcome was Unknown for the event pharmacist received prescription to administer act-hib to patient that is over 5 years of age - with no adverse event.     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 the 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.
RASH ON LEFT SHOULDER, FATIGUE, JOINT  PAIN. Narrative:  Other Relevant History:
The day after the vaccine I was sick for three days with a high fever even with taking Tylenol and Motrin every four hours, nuasia, headache, extreme fatigue, could not raise arm vaccinated and lymph nodes in arm and i armpit of vaccinated am swelled.
1981, when he was 22 years of age, he received an influenza shot. Over the next 24 hours he remembers his feet feeling numb but attributed to new shoes. The next day his hands were numb with arms and legs feeling weak. He was unable to open packages and sought medical care. He was admitted to the ICU for about 10 days with difficulty walking. He did not receive plasmapheresis or IVIG. He denied any respiratory, speech impairment or difficulty swallowing. He advised it took about 6 months for all symptoms to resolve. He received influenza and yellow fever vaccination 11/30/1995. About 1/9/1996 (day 39), his records document complaints of cold like symptoms, such as a stuffy nose and sore throat. On 1/16/1996 (day 47 after vaccination and 9 days after onset viral illness) he experienced tingling and numbness of his feet and hands after standing up for a long period of time. On 1/17/1996 he was unable to grip or swing his golf clubs stating his hands felt clumsy. Medical documented normal neuro exam and released. On 1/18/1996 he was admitted to Hospital for 6 days testing and observation. Neurologist documented extensor weakness of his left foot (4/5), he could not walk on his left heel, and had absent ankle reflexes bilaterally otherwise normal neuro exam. An EMG and nerve conduction velocities were negative. Lab studies included CBC, chemistry, ESR, RA, ANA, TFT, LFT, Lyme, campylobacter stool cultures, 24 hr urine porphyrin screen (see below). Findings were consistent with recurrent Guillain-Barre syndrome. Symptoms slowly improved with physical therapy. He was released in no acute distress to f/u with neuro on no medications.
cellulits of arm; arm inflammed all the way up on scapula; received her first dose a year ago; sore arm; couldn't lift arm; felt horrible, awful; felt like the flu; fever; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna COVID (received dose on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever, inflammation localized and incomplete course of vaccination. On an unknown date, the outcome of the cellulitis, inflammation localized and incomplete course of vaccination were unknown and the outcome of the pain in arm, injected limb mobility decreased, feels awful, influenza like illness and fever were recovered/resolved.   It was unknown if the reporter considered the cellulitis, pain in arm, injected limb mobility decreased, feels awful, influenza like illness, fever and inflammation localized to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself, who was also the nurse. The age at vaccination was not reported. The patient received the first dose of Shingrix exactly about a year ago (unsure of date) on a Thursday and she had a terrifically sore arm, worse than the Moderna COVID shot. Her arm was sore that night (Thursday) after receiving the shot and lasted until that Monday. She couldn't lift her arm for 2 days. She thought she had cellulitis of arm.  The next morning after receiving the Shingrix shot (Friday), she felt horrible.  She felt like she had the flu and had a fever.  These symptoms lasted until that Sunday afternoon. Till the of reporting, the patient did not receive her second dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case was liked with US2021215443 and US2021215524, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215443:same reporter US-GLAXOSMITHKLINE-US2021215524:same reporter
Patient presented to ER with worsening SOB of moderate severity. Patient developed symptoms of COVID on 10/14 and had a formal positive test on 10/17. Previously vaccinated with J&J on 5/11/21 and Pfizer on 12/8/21. Admitted to Hospital 10/29 and discharged 10/31/21.
Information has been received from a 71 year old female patient concerning herself. The patient's concurrent conditions included unspecified heart problems, allergy to penicillin and a lot of medicines (captured in MARRS#1609USA003361). Concomitant therapies included ibuprofen. On 13-AUG-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, via intramuscular route (reported as "in the muscle") (strength, dose, lot number and expiration date were not reported). Other suspect medications were not provided. On 15-AUG-2016, the patient experienced low grade fever (pyrexia) she was no able to move her right arm, she could not brush her teeth, comb her hair and was difficult to drive (movement disorder). she had hives on her right arm (urticarial), her right arm was swollen (peripheral swelling) and numb (hypoesthesia). Also, around the injection area her right arm was hot (injection site warmth) and red (injection site erythema). Her skin near the injection area was blotchy, and the blotchy on her right arm was spreading (rash macular). In addition she had no strength (asthenia) and a lots of pain in her right arm (pain in extremity). The patient did  not seek medical attention and no treatment was given for the adverse events. On an unspecified date in August 2016 unspecified blood tests were performed, however, the results were not reported. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the movement disorder, pain in extremity, asthenia, rash macular, injection site erythema, injection site warmth, peripheral swelling, hypoesthesia, urticarial and pyrexia. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter did not consent for further follow up.
On 10/02/2000 the patient experienced chickenpox. The patient had only a few red lesions on her chest and stomach. The patient had no fever. Unspecified medical attention was sought. Follow up information indicated the patient recovered. No further details were provided.
Approximately 9 hours after vaccination, began to have severe pain at injection site, fever of 101.9F, chills, sweats, abdominal pain, and vomiting. This lasted through the night but alleviated the following day. 2 days after vaccination, all symptoms were gone
A couple of days following patient's vaccination of DTaP, he was complaining of nausea and stomach pain. He rested for a couple of days, but then on Monday the 28th, he began to throw up bright green fluid. We thought he might have a flu, so we waited 24 hours to see if the vomiting would stop. On Tuesday the 29th, he threw up once in the morning. He continued to rest that day, but he refused to drink or eat anything. On Wednesday the 30th, he was very lethargic and would only drink a few sips at a time. I noticed that he was showing signs of dehydration, so we tried to get him to drink more fluids, but he would resist. On Thursday the 31st, I took him into Urgent Care, as his symptoms weren't improving and he was indicating a worsening pain in his stomach. They sent us to the ER, where they took a CT scan, which showed that his appendix was inflamed. From the time we left the CT and up to surgery, his appendix had ruptured. Due to the contamination in his system, he stayed in the hospital for a week.
Serious dizziness; Blurry vision; chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain). On 05-Apr-2021, DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up attached Added newevent chest pain.Updated reporter contact information.
4-21 - 4-22-08 was in hospital for syncopal episode. She had normal EEG recording. Was referred for evaluation of a 2 months Hx of spells. First in 2/2/08 - Felt chills, hands & face turned white with corresponding perioral cyanosis. Tachycardic with sweaty palms. Episode free for 3 mo. 4/14/09-records received for DOS 4/21/08-referred for evaluation of 2 month history of spells beginning 2/08, C/O feeling chilled to face and hands turned white with corresponding perioral cyanosis, tachycardic, sweaty palms. Seen in ED with normal EKG, CBC, chemistires. Out of country travel and upon return increase in spells. Syncope.
Shortness of Breath (Increased work of breathing today. Covid positive 10/2. )
Cellulitis covering area from shoulder to mid upper arm; red, swollen and warm to touch.
Pt had a flu shot at a community clinic 11/7/02. On 12/19/02 pt's wife called that pt developed itching at site on day following flu shot. Has seen family doctor on 2 occasions since, still itching. Will see dermatologist 12/20/02 as itching now involves much of bout.
Patient began to have a fever (spiked at 102.6). Fever continued through yesterday night. Localized swelling noted on the injection site.
SHAKES; COUGHING; ARMPIT PAIN; HAND/PALM PAIN; HIVES; STRONG HEADACHE; TIREDNESS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a female 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 not reported, batch number: UNKNWON) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced shakes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced hand/palm pain. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shakes, strong headache, fever, hives, coughing, nausea, tiredness, armpit pain and hand/palm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425516, 20210425296 and 20210427112.
Admission Date: 10/19/2022 Discharge Date: 10/21/2022  PRESENTING PROBLEM: Hypoxia Pneumonia due to COVID-19 virus COVID-19   HOSPITAL COURSE: The patient is a 89 y.o. male with PMHx of metastatic prostate cancer and HTN who presents today with malaise. Patient is accompanied by his wife and son at bedside. He has been vaccinated and boosted for COVID, last in 4/4/2022. He spent time with family over the weekend and two of them tested positive for COVID on 10/18. He took a home COVID test and was negative. He had a sore throat but otherwise felt fine. On the morning of presentation, he spiked a fever 102.5F and was feeling very weak, lethargic and became nauseated and dizzy with movement. He developed coughing but no shortness of breath. No diarrhea, myalgias, rashes or poor appetite. He took his regularly prescribed medications but nothing else. His wife initially called his PCP office to arrange for Paxlovid but was advised to call an ambulance. She called EMS and patient was brought to ED.   In the ED he was febrile, tachypneic with normal O2sats on room air but he became hypoxemic with activity 88 percent. Labs with normocytic anemia, normal WBC count and platelets, CMP with hypoalbuminemia. UA negative for infection, COVID-19 PCR positive. CXR with moderate left greater than right patchy airspace densities concerning for multifocal PNA and mild bilateral pleural effusions. He was given tylenol, ibuprofen and a liter of normal saline and was admitted for further evaluation.    He was continued on IV remdesivir.  He was started on Decadron due to episodes of hypoxia was sleeping.  CT angiogram thorax was negative for PE.  He felt improved enough to go home.  He was evaluated by pulmonary rehab and did not require supplemental oxygen.  He was range of home care.  He was enrolled in a transition to home program.  He was instructed to hold home prednisone until completion of Decadron then resume taking prednisone.  He should follow up with his PCP as an outpatient.  He was discharged home in stable condition on 10/21/2022.
Patient received second dose of Pfizer vaccine at 5pm on 2/18/21 and experienced expected symptoms of fatigue, injection site pain and minor body aches. Patient began to experience difficulty breathing on the morning 2/20, at that time the patient attributed it to asthma. Patient reports that he has not had an acute asthmatic episode in 25 years and has not experienced any respiratory condion like this before. Shortness of breath, chest pain and dizziness increased in the day to follow. On Monday 2/22 at 8:30am patient was seen at family medical facility by Doctor presenting with a 02 SAT of 93%.  Covid test was preformed and was negative. Dr prescribed a preventative inhaler and some prednisone and sent patient home. Patient continued to decompensate and at 6pm was seen by previously treating physician, presenting with 02 sat of 91% given a nebulizer and sent home. Patients condition worsened overnight and he was seen in the faility Urgent care at 9am on 2/23. Patient was given a repeat covid test, that was negative , flu test that was negative, and chest xrays that were clear.
Myalgia, Fever, fever per pt report, no temperature taken. chills. Pain at injection site Narrative:
PATIENT RECEIVED VACCINE IN LEFT DELTOID, MOVED TO NEIGHBORING CHAIR, FELT HOT SAID SHE FELT LIKE SHE WAS GOING TO PASS OUT.  LESS THAN 30 SECONDS LATER PATIENT TURNED BLUE PASSED OUT AND 10 SECONDS LATER WAS CONSCIOUS AND DISORIENTED.  PATIENT WAS ASKED QUESTIONS AND WAS AND REPLIED CORRECTLY TO ALL.  ICE PACKS WATER AND OIRANGE JUICE PROVIDED.  AMBULANCE RESPONDED AND PATIENT WAS CONSCIOUS AND AWARE BUT VITALS REMAINED TOO LOW
Body aches, nausea, vomiting, and fevers.  Also severe left arm pain with associated weakness and radiating pain down my arm to 4th/5th fingers
no adverse effects; the patient received improperly stored dose of Varivax; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 15-MAY-2019, the patient was vaccinated with with  improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # R027989, expiration date 01-OCT-2020; strength, frequency, route of administration was not reported for prophylaxis. The patient's concomitant therapies included properly stored sterile diluent. The temperature of excursion with varicella virus vaccine live (oka/merck) (VARIVAX) was from 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees ) for 3 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-1905USA011345: US-009507513-1905USA008600:
Fully vaccinated patient with a booster as well was diagnosed with Covid 9 days ago.  States she has had no appetite since then, very nauseous, some dyspnea and profound weakness and fatigue.  SOB and fever. Pneumonia due to COVID-19 virus and acute hypoxic respiratory failure. Not candidate for remdesivir/decadron. Cefepime/vancomycin. Stable and discharged to home.
Pt recvd Recombivax for 2 doses & Engerix-B for 3rd dose given OCT91; JUN92 titers checked; 9 pts were considered non-responders; addtl doses may be given;