chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; hot rash near the injection site; itchy rash near the injection site; rash near the injection site; red rash near the injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site) and VACCINATION SITE ERYTHEMA (red rash near the injection site) in a 44-year-old female patient 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 was provided by the reporter.  Concurrent medical conditions included Vertigo (approximately once every two years). Concomitant products included TELMISARTAN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site). On 29-Apr-2021, the patient experienced VERTIGO (Vertigo). On 11-Apr-2021, INJECTION SITE WARMTH (hot rash near the injection site), VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (rash near the injection site), VACCINATION SITE ERYTHEMA (red rash near the injection site) and VACCINATION SITE SWELLING (swollen injection site) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient applied ice to the rash but did not take any medication for vertigo.
This spontaneous report was received from a registered nurse referring to 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 28-OCT-2015, the patients were vaccinated with doses of MMR II, lot # L015281 with expiration date 30-APR-2017, (dose and route of administration were not provided); which had been exposed to a cumulative of 10.9 C for 7 hours and 28 minutes. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information was received from a nurse concerning a 16 month old patient who on 28 FEB 2005 was vaccinated with 0.5 ml of MMR.  On 28 Feb 2005 immediately after vaccination the patient "broke out in hives at the injection site"   The patient was treated with oral Benadryl.  Subsequently on an unspecified date the patient recovered.  The nurse requested  lot number check.  The records of testing prior to release of this lot has been checked by quality assurance and found to be satisfactory  The lot complies with the standards of the center for biologics evaluation and research and was release.  There was no product quality complaint involved
Pt received Pneumococcal 23 vaccine on 11/30/15. That evening started w/ pain, swelling in arm. Next day ,unable to lift arm, 12/01/15 evening, swelling radiated down to wrist, c/o fever, chills; arm was itchy, hot. By 12/03/15, itchiness/redness reduced. Fully healed by 12/04/15.
I woke up at 3AM nauseous with a fever of 99.0 after taking Tylenol I slept for 15 hours still weak and stomach is upset 3 days later.
pregnant; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 27-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunisation.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Reflux esophagitis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Nov-2020 and the estimated date of delivery was 03-Aug-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Pt got up from bed, moved to sit on a bench. Said felt dizzy. Fell forward and mom caught him. Sat him back up and he was biting his tongue. No abnormal movements of extremities. Mom was able to put her finger in his mouth to open jaw to stop him. I walked in 3-5 seconds after she started doing that and he was responsive, admitted feeling dizzy. Was moved back to the bed (able to stand), laid down, bp was 105/59, was given some juice. After 5 min tried to sit up, felt dizzy and lied back down for 5 more minutes. Then able to sit up with out dizziness and bp was 115/69. HR normal throughout. No emesis. Only reporting due to the tongue biting which was witnessed by mom and MA and lasted 5-6 sec before mom put finger in his mouth and was able to open jaw easily.
Patient complained of excruciating pain in the right arm. She cannot move or raise her right arm.
presented to hlth svcs w/cervical lymphadenopathy x 1wk accompanied by h/a, gen malaise, dec appetite, occasional coughing & sneezing;
Patient woke in middle of night with burning sensation under right arm. Had raised, red, welts down arm to elbow. Took BENADRYL and area improved. Reports similar reaction in past to latex.
Pt was given an expired vaccine, Proquad.  Mother of child was notified and informed that she needed to bring the child at least 30 days after the incident to be revaccinated.  Provider was advised of the error.   MA was counseled.
health center manager gave TENIVAC that expired on 23Sep2023 to a patient with no reported adverse event; Initial information received from on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient to whom health center manager gave Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that expired on 23sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 26-Sep-2023, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot U7183AA) via intramuscular route in the left deltoid as prophylactic vaccination that expired on 23-Sep-2023 with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ulcerative Collitus" (unspecified if ongoing); "anemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "exercise-induced asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX; OMEPRAZOLE; ALPRAZOLAM; FLUOXETINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "slightly sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Heart attack; Hemochromatosis; Enzyme troponin showed up; The initial case was missing the following minimum criteria: specific suspect drug. Upon receipt of follow-up information on 30Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EP6955), as dose 2, single (Lot number: EP7534), as dose 3 (booster), single (Lot number: FF8841) and as dose 4 (booster), single (Lot number: FJ9943) for COVID-19 immunisation; atorvastatin (ATORVASTATIN), (ongoing) (Batch/Lot number: unknown) at 20 mg 1x/day for blood cholesterol abnormal; lisinopril (LISINOPRIL), (ongoing) (Batch/Lot number: unknown) at 20-25 mg, 2x/day for hypertension. The patient's relevant medical history included: "High blood pressure" (ongoing); "Cholesterol" (ongoing); "Heart murmur", start date: 21Dec1956 (ongoing). Concomitant medications included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); NP THYROID (ongoing). The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 04Oct2022, outcome "recovered", described as "Heart attack"; TROPONIN INCREASED (non-serious) with onset 05Oct2022, outcome "recovering", described as "Enzyme troponin showed up"; HAEMOCHROMATOSIS (non-serious), outcome "unknown", described as "Hemochromatosis". The patient was hospitalized for myocardial infarction (start date: 05Oct2022). The events "heart attack" and "enzyme troponin showed up" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: (unspecified date) Unknown results; Blood test: (unspecified date) Unknown results; Cardiac monitoring: (unspecified date) Unknown results; Cardiac stress test: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging heart: (unspecified date) Unknown results; Troponin: (05Oct2022) Showed up. The action taken for atorvastatin and lisinopril was dosage not changed. Therapeutic measures were taken as a result of myocardial infarction, troponin increased. Clinical course: The patient reported that she recently had a heart attack. She was admitted to emergency on 05Oct2022. The enzyme troponin showed up but subsided around 10AM on 05Oct2022. While there, she was put on Metoprolol and Eliquis. Echocardiogram, angiogram, MRI of her heart, and all kinds of blood work (blood was drawn throughout her stay) were performed. She had a stress test since and was currently wearing a heart monitor. She does have a heart murmur but still no cause. The patient also reported that she does have hemochromatosis (unspecified onset date). Additional information: Lisinopril and Hydrochlorothiazide start date: 20 years, Atorvastatin start date: 10 years, NP Thyroid start date: 4 years prior to the time of the report.
rec'd 1st dose on 3/3 and 10 days later I had a pain in left arm and it felt like it had heat in it, it finally went away. and the 2nd dose was taken on 3/31 and now today and the exact pain started and the muscle is a little swollen in the arm
Headache; vivid/anxious dreams; muscle pain in both thighs; injection site pain; vivid/anxious dreams; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6202) via an unspecified route of administration at Left arm on 01Mar2021 17:30 (at the age of 34-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included Insulin resistance, endometriosis and patient previously took Ciprol and experienced Known allergies. Concomitant medication(s) included Colecalciferol VITAMIN D taken 50000 IU 1x week (other medications in two weeks). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 01Mar2021, patient experienced, vivid/anxious dreams, muscle pain in both thighs, injection site pain. There was no treatment for the events. Treatment recommended for AE to take Claritin and antihistamine eye. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
tiredness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Psoriatic arthritis.    The patient's past medical history included Knee replacement in 2011. Concurrent medical conditions included Psoriatic arthritis, Non-smoker, Abstains from alcohol and Neck injury. Concomitant products included PREGABALIN (LYRICA) for Neck injury, METHOTREXATE for Psoriatic arthritis.   In 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced FATIGUE (tiredness). In 2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if she was enrolled in a covid 19 vaccine trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up information received wherein added dosage regimen for RINVOQ, concomitant medication, medical history.
This is in follow-up to report(s) previously submitted on 9/15/2008. Initial and follow-up information has been received from a physician concerning a 21 year old female  with no related medical history who on 18-AUG-2008 was vaccinated into left deltoid with the first dose of GARDASIL. (Dose and site of administration not reported). (Lot # 60616/0570X). There was no illness at the time of vaccination. Concomitant therapy included birth control medication. At 1100 after shot was given patient started feeling dizzy and fainted. It lasted for couple of minutes.  The patient fainted after first dose within 2 minutes of receiving injection. No injury sustained. No hospitalization was required. It was unknown if the patient sought medical attention. No further information is available. Additional information has been requested.
Day p/MMR was given pt had fever inc to 106; APAP given, pt taken to ER to bring fever down;
Achy, fever (100.6), very tired, nausea, very painful injection site (area size abt 4" wide by 6* tall), slightly swollen injection site.
Herpes on mouth; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO0158) via an unspecified route of administration in the left arm on 19Apr2021 at 14:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, the patient experienced herpes on mouth. The event did not result in doctors 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event herpes on mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 12 month old male with cold symptoms and no other medical history or allergies, who on 3/13/05 was vaccinated with an SC dose of MMR (lot # 651815/0950R). There was no concomitant medication. On 3/14/06 the patient developed a temperature of 99.5F-102.5F rectal and he also had cold symptoms. On 3/16/06 the patient was diagnosed with an ear infection and was treated with amoxicillin. It was noted that he was wakeful at night. On 3/23/06 the patient had a fever of 101 F and was pulling at his ears. On 3/24/06 the patient was febrile, but his cheeks were flushed, he was fussy and he had a red spot on his cheek. On 3/25/06 the patient developed a macular erythematous rash on his face spreading to his trunk and extremities, was irritable but afebrile. His left ear was slightly pink and his right ear was normal. The amoxicillin was stopped and he was diagnosed with an amoxicillin reaction. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's adverse events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested. Information has been received from a registered nurse concerning a 12 month old male with no known medical history or allergies who on 13-MAR-2006 at 9:30 am was vaccinated SC in the right tricep with a first dose of MMR II (+) VARIVAX (Merck) process (lot #651815/0950R). Illness at the time of vaccination included cold symptoms for two days, no fever. On 14-MAR-2006 within 24 hours of vaccination the patient developed a fever of 99.5 - 102.5F. The patient was seen on 16-MAR-2006 with mild cold symptoms x4d. He had left otitis media and was treated with amoxicillin. On 23-MAR-2006 the patient had a fever of 101 F and he was pulling on his ears. On 24-MAR-2006 the patient was afebrile had flushed cheeks was slightly fussy and had one red spot on his face. On 25-MAR-2006 the patient had a rash described as confluent macular, erythematous, on his cheeks, trunk, and extremities, and he was irritable. Unspecified medical attention was sought. No laboratory diagnositic tests were performed. The patient recovered on an unspecified date. The patient had no adverse events following prior vaccination. Additional information is not expected.
Pt was given APAP by mom p/immun & 4 hrs later; Next day went to school & a friend's house; @ 530PM appeared to be running temp, measured 102.5 AX; About that time eyes rolled back in head & wouldn't respond for a few minutes; Vomited x 1;
Woke up bleeding (my cycle isn?t supposed to start for another week) Veins on injection arm are bulging + swelling + pain
This spontaneous report as received from a pharmacist refers to a patient of an unknown age. On 29-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M001747, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 29-AUG-2017, the patient experienced expired product administered. No adverse effects were reported. The outcome of expired product administered was unknown.
Fatigue; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A 21-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration on 07Aug2021 12:45 (age at vaccination 21years old) as single dose for covid-19 immunisation. Medical history included heart rate increased from an unknown date and unknown if ongoing He has rapid heart rate and blood pooling from Covid, covid-19 from an unknown date and unknown if ongoing He has had covid for 13 months. He still has antibodies, blood pressure abnormal from an unknown date and unknown if ongoing he is on medication for his blood pressure and heart rate already. The patient experienced fever on unspecified date in Aug2021, fatigue, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine on an unspecified date. Additional information reported as her son had adverse effect also. He was vaccinated on 07Aug, 12:45 in the afternoon. He has had covid for 13 months. He still has antibodies when he got the vaccine. We got it pulled out 1 day before the vaccine. When he got the vaccine, he felt okay for the first 3 days, then he started with a fever on day 4 and it continued for 8 days. We tested him for Covid and influenza. He was negative for everything it was the vaccine. Then he started to feel fatigue. It is almost 3 weeks, and he still feels fatigued, does not feel normal and he has had problems with very rapid heart rate and blood pooling. He has rapid heart rate and blood pooling from Covid, but it got worse after the vaccine. He also has low fever and fatigue from the vaccine and is not going away. Consumer stated, He is 6 feet 1 inches and weighs approximately 150 pounds. Treatment: Reporter stated, He hydrated, he took Tylenol and Advil for the fever, and he is on Medication for his blood pressure and heart rate already. No, he can't take anything for the fatigue. I don't think there's anything to give for fatigue. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date, influenza: negative on unspecified date, sars-cov-2 test negative on unspecified date. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of fever, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine.  Follow-up attempts are completed. No further information is expected.
Unwitnessed loss of consciousness-mom came into pts room he was lying on floor initially responded to verbal stimuls with eyes opening then was limp with increased HR that would suddenly decreased po moc. Breathing was fine. No Tonic-clonic activity but possibly post-ictal.