chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine at 1:48 pm.  Prior to administration patient's mother stated she had previously fainted after vaccine administration.  Advised patient to wait in vaccine area for 30 minutes.  Approx. 10 minutes after receiving the vaccination, the patient's mother called for help from the waiting area I went outside to waiting area.  Had patient sit back and grabbed patient water and returned to waiting area.  Patient began to faint and upon awakening she started to vomit continuously.  Patient's mother and I decided to call EMS.  EMS arrived and assessed patient.  It was determined that her vitals were okay and since she was feeling better she would not go to the hospital and would follow up with her pediatrician about the incident.
I am experiencing   Chronic Spontaneous Urticaria after COVID-19 Vaccine booster. I have broken out in itchy hives all over my body, from my scalp all the way to my calves. They are persistent and will disappear and reappear throughout the day. It started as itchy palms then transferred to hives in my scalp and in my back. Areas of my body will become red hot to the touch and incredibly itchy throughout the day.
Rheumatoid arthritis flare up; Sleep difficult; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INSOMNIA (Sleep difficult) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and VACCINATION SITE PAIN (Vaccination site pain) had resolved and INSOMNIA (Sleep difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  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.  Company comment: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The event resolved. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. Concurrent condition of rheumatoid arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
extremely weak; nausea; severe headache that comes and goes; joint pain; Tiredness; dizzy; very sick, and . Also has and . Onff c and oough; very sick, and . Also has and . Onff c and oough; no appetite; could not taste anything; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ILLNESS (very sick, and . Also has and . Onff c and oough), COUGH (very sick, and . Also has and . Onff c and oough), DECREASED APPETITE (no appetite) and AGEUSIA (could not taste anything) in a 54-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.     Concomitant products included LISINOPRIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizzy), ILLNESS (very sick, and . Also has and . Onff c and oough), COUGH (very sick, and . Also has and . Onff c and oough), DECREASED APPETITE (no appetite), AGEUSIA (could not taste anything), ASTHENIA (extremely weak), NAUSEA (nausea), HEADACHE (severe headache that comes and goes), ARTHRALGIA (joint pain) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Joint pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ILLNESS (very sick, and . Also has and . Onff c and oough), COUGH (very sick, and . Also has and . Onff c and oough), DECREASED APPETITE (no appetite), AGEUSIA (could not taste anything), ASTHENIA (extremely weak), NAUSEA (nausea), HEADACHE (severe headache that comes and goes), ARTHRALGIA (joint pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Tylenol, Aleve and nausea medication
Pt reported feeling retrobulbar pain behind right eye s/p injection. The next evening, noticed sudden visual loss in right eye. Upon arrival in clinic on Wednesday morning, pts best corrected vision 20/200. On fundus exam, large peri-papillary sub-retinal hemorrhage along inferior optic nerve head. Some vitreous hemorrhage noted.    Patient was referred to Hospital for eval. Possible OCT/ IVFA
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination.  Patient said she felt like she couldn't breathe.  Taken to ED for further evaluation.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 23-SEP-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Temperature of 100.4 degrees, shakes,  fatigue, body aches, headache
Lot of people got sick; Experienced anxiety before the vaccine which is panic related due to covid; Lot of people felt tired/Fatigued; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Lot of people got sick), ANXIETY (Experienced anxiety before the vaccine which is panic related due to covid) and FATIGUE (Lot of people felt tired/Fatigued) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Lot of people got sick), ANXIETY (Experienced anxiety before the vaccine which is panic related due to covid) and FATIGUE (Lot of people felt tired/Fatigued). At the time of the report, ILLNESS (Lot of people got sick), ANXIETY (Experienced anxiety before the vaccine which is panic related due to covid) and FATIGUE (Lot of people felt tired/Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Red, warm raised large circle extending 3 inches from injection sites. Itching. Occured on day 11 after the injection.
Necrotizing Crescentic Glomerulonephritis (ANCA); This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0167), via an unspecified route of administration on 16May2021 (46-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included allergy to PCN. There were no concomitant medications (no other vaccine in four weeks; no other medications in two weeks). The patient experienced Necrotizing Crescentic Glomerulonephritis (ANCA) on 30Jul2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (5 days), and Disability or permanent damage. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the event and included Solumedrol 500 IV/ Rituximab IV. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
patient given Pediatric Td instead of the ordered Boostrix. parent notified. no adverse reactions or symptoms at this time.
A 64 year old female reported that she received a dose of pneumococcal vaccine in 1998 at the age of 61. She indicated that, the year following receipt of the vaccine, she developed a pneumococcal infection. She reported a chronic history of pneumonia, bronchiectasis, earaches and various respiratory infections. These illnesses developed after previous pneumococcal immunizations. No further information was available at the date of the report.
Upon awakening the morning of 11/5/2021, I noticed a red rash on my extremities and on my back, possibly my head as it is also itching.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Post herpetic neuralgia; itchiness; neurological pain; residual discomfort; develop herpes zoster which was a severe case; This case was reported by a consumer and described the occurrence of herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th January 2020, less than 6 months after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the patient experienced pruritus, nerve pain and general discomfort. The patient was treated with gabapentin. On an unknown date, the outcome of the herpes zoster, pruritus, nerve pain and general discomfort were not recovered/not resolved.   It was unknown if the reporter considered the herpes zoster, pruritus, nerve pain and general discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The patient received the 1st dose and was due for 2nd dose on about 12th January 2020. On that day, he began to develop herpes zoster which was severe case. Till the day of reporting, he was suffering from neurological pain and itching.  It affected his chest, back and upper arm. The reporter asked for suggestion regarding 2nd dose and what to do about the residual discomfort. The patient was on Gabapentin. This case was linked with US2020AMR039709, reported by same reporter.   Follow up information received from consumer on 16th April 2020: On 13th January 2020, the patient had herpez zoster. Less than 6 months, the patient experienced from post herpetic neuralgia. The reporter stated that, till the time of reporting, the post herpetic neuralgia was not recovered. The reporter gave consent to contact physician (or other licensed medical practitioner) who was most familiar with the reported event.
Hospitalized 8 days post positive covid test, pt with dyspnea, fatigue, weakness, cough, decreased oral intake, weakness. Per chest xray Covid pneumonia Remdesivir, dexamethasone, O2 6L/min via nasal cannula.
Swollen red area circling upper left arm. Pt stated was very painful. Dr. prescribed a Medrol Dosepak and Benadryl.
never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received the first dose of Shingrix on 17-MAR-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported that a patient received the first dose of Shingrix back on 17-MAR-2023 and never came back for the second dose. The pharmacist called to inquire if the patient need to restart the series. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination
Red hard bump extending to about as far across as a baseball...still in existence at 8 days. Extremely painful muscles and joints, body-wide, level 8 on a 1-10 pain scale.  Headache with dizziness and chills from October 9-13.
Patient outside approved age with prescription; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 29-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, the patient had a prescription for Bexsero and was over 25 years of age, which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Information has been received from a registered nurse concerning a female patient (age not reported) who on 30-MAY-2012, was vaccinated with an expired dose of ZOSTAVAX (Merck) (lot# 669189/1389Z; exp. date 19-JAN-2012) (dose and route not reported). No adverse event was reported. Follow up information was received from the registered nurse concerning a 74 year old retired female patient who on 30-MAY-2012 before midday was vaccinated intramuscularly with the first dose of ZOSTAVAX (Merck) (lot# 669189/1389Z), which expired on 19-JAN-2012. The patient had no adverse reaction. No further is available.
Patient complained of fatigue, shivering, myalgia starting about 8 hours after vaccination. Patient treated with TYLENOL and hydration and condition improved over the next 24 hours.
This spontaneous report was received from a healthcare worker (medical assistant) concerning a patient of unknown age and gender. It was reported that on 30-APR-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 29-JUN-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 10-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 15-OCT-2012 and on 03-SEP-2013, the patient was vaccinated with the extra doses (fourth and fifth doses respectively) of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first 0.5 ml dose of VAQTA (lot # not reported) on 23-MAR-2012. The medical assistant reported that the patient was vaccinated intramuscularly with the second 0.5 ml dose of VAQTA (lot # not reported) on 04-SEP-2012, which was a little earlier than the recommended interval of 6 months. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Monitored for 15 minutes after administering vaccination. Patient felt fine with no reports of concerns and exited. Returned back next day 9/19 @ 0645 advising of reactions before bedtime @ 0900. slight fever, headache and slight nausea. took Tylenol. Woke up next day with redness, swelling in left arm where administering occurred and slight nausea. Patient was checked into call and assisted by provider on duty.
Patient developed large, raised red area at site of injection. She consulted her physician who placed her on antibiotics for suspicion of infection.
The patient's left arm (PNEUMOVAX 23) was extremely sore to the point that she described being unable to move her arm. She also noted red blotches on her upper arm. Symptoms lasted about 2 days. Patient had stated that her arm was very sore after the PREVNAR 13 so had chosen to get the PNEUMOVAX 23 in her non-dominant arm in case she had a similar reaction. She described this reaction as much more severe. Patient did not seek treatment or report the adverse reaction until 5 days after it resolved.
Headache; Fever; Fatigue; Doses administered accidentally/ unintentionally > 1 month apart; A spontaneous report was received from a consumer concerning his wife, a 73-years-old female patient, who received Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, headache(headache), fever(pyrexia), fatigue(fatigue) and second dosage vaccine administration past the 28 day mark (inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant medications were not reported.  On 18-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23-FEB-2021 at 1600, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection  On 18-JAN-2021, the patient received the first dose of mRNA-1273. On 23-FEB-2021, the patient received second dose of vaccine past 28 days marker and on 24-FEB-2021, she woke up and experienced headache, fever, and fatique. As per the report, the patient's pain level was of 3 out of 10. Treatment details were not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the events, headache, fever and fatigue were unknown. The event, second dosage vaccine administration past 28 days marker, was considered to be recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events headache, fever and fatigue, a causal relationship cannot be excluded.The causality for the event inappropriate schedule of vaccine administration  is assessed as Not Applicable.
Did not have record of booster information to enter.  77 y.o. male with past medical history of CLL (followed by Dr. in oncology), hypertension, dyslipidemia, CAD with history of CABG, remote tobacco smoking presents to local ED for cough, fever, malaise. Patient also endorses associated loose diarrhea which started approximately 24 hours ago.  He has had poor oral intake, experienced rigors and subjective fevers at home.  In ED, patient is noted to be febrile to 101.5 as well as hypotensive.  94% on room air.  COVID(+) PCR.
Transfer from Hospital on 8/15 for evaluation following biopsy of pelvic mass for possible ovarian cancer with small bowel obstruction with NG tube. Biopsy returned adenocarcinoma. Repeat CT showed mass with omental caking and extensive adhesions contributing to bowel obstruction and possible aspiration pneumonitis lower lobe. NG in place with NPO status and IV fluids. 8/16 COVID +. Developed tachycardia, leukocytosis pretension and worsenng renal function requiring ICU care. Started on vancomycin and cefepime. Continued metoprolol for a fib. Due to worsening staus and complex medical comorbitities, pallative care was consulted. Patinet requested DNR/DNI and comfort care measures provided.
About 12 hours after initial injection I had the chills.  While sleeping that evening, I kept on repeatedly waking up because I had a slight fever (about 1 degree F higher than usual).  After having breakfast the next morning I felt fine.
Excessive swelling of face and eye lids;tingling sensation on face-immediatly the morning aftervacination Discoloration of cheek and texture change to skin at cheek-continuous through next three (3) weeks
26OCT92 @ approx 1AM awaken w/upset stomach, h/a, weak, sick feeling, achy, temp lasted x 24 hrs;
Immediately sore right arm lasting approximately 1 day. Then after initial dose on the second day after first injection, I began with chills, headache, fatigue, body aches. By the second day after initial dose,  I began with mucus cough and same symptoms with chills, headache, fatigue and body aches. I took Tylenol, cold and cough medication. It is the third day after injection, symptoms same, but slightly better, still extreme fatigue and body aches and chills and I took an Proventyl inhaler as needed. Note, I do not take Proventyl inhaler on a regular basis, I just felt the need as I was beginning to have a lot of bronchial mucus. The inhaler seems to help. I am waiting it out and did not contact my family physicians. I am hoping I will feel better soon. Still taking OTC medications and Tylenol, fluids and rest.