chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt sleeps with her face on boyfriend's vaccinated arm. Has sinusitis, cough, nasal congestion: Bloody nose, pupular drainage from first right eye, now both eyes. Opthalmology consult reveals membranous conjunctivitis, no lesions or karatitis. Pt recovering. Inadvertent inoculation (vaccinee or contact)
The day following injection had symptoms consistent with CDC-published information. My normal body temp is about 97. Fever increased as the day went on, reaching 99.7 at about 11:00 pm, reaching 100.4 at about 12:30 am, and it was at this time I could feel a mild burning, almost clutching feeling in my upper chest, and my breathing was much shallower. No medications were used, but I put a damp washcloth on my forehead. Waking up again 12 hours later, my temp had returned to about normal and no adverse effects were felt at that time.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The pharmacist reporting that his niece's husband, received ZOSTAVAX (dose, frequency, route, lot # unknown) a year ago in 2013 (specified date unknown) and following vaccination (a week) the patient had pain in his vaccinated arm and then fell and broke his arm, during examination an area was identified around the area of vaccination - that was diagnosed as Merkel Cell Cancer. The pharmacist stated that the patient now was in Stage 4 of Merkel Cell cancer. The patient had not started treatment yet for his cancer but he would be receiving chemotherapy, radiation and an unspecified treatment which would stimulate his immune system. One of the facilities he would be getting treatment from was a cancer center. The patient would be undergoing just radiation for treatment (no date specified). The pharmacist stated that the patient had "2 factors" (unknown what factors - but pharmacist believed had to do with immune system) missing and the radiation treatment would "generate" what was missing. The patient sought medical attention via unspecified contact. Stage 4 of Merkel Cell cancer, fell and broke a bone was reported as not recovered. Outcome of pain in his vaccinated arm was unknown. Upon internal review, merkel cell cancer was considered to be medically significant. Merkel cell cancer, fell and broke a bone were considered to be life threatening by reporter. Additional information has been requested.
On the 30 th of September experienced RT lower quadrant pain ? went to Urgent care- CAT scan and Blood work done- all negative. On Oct. 1 went to ER was diagnosed with flare up of back stenosis - given Flexeril and Tylenol #3.  Continued to have pain even though taking muscle relaxants and Tylenol #3? couldn?t walk any longer than 5 minutes and couldn?t sit in chair at all.  Big change for me as I am usually very active! Wasn?t back to ER on  October 6 - MRI done- mild progression of Lumbar Stenosis ! Was for pain control . Was put on Robaxin and Tylenol #3 ( 2 tabs) three times a day. Discharged home on October 8 on same regimen
very tired; hurting so bad in my neck; hurting so bad in my back; hurting so bad in my arm; real sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back), PAIN IN EXTREMITY (hurting so bad in my arm), MYALGIA (real sore arm - right arm) and FATIGUE (very tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (real sore arm - right arm). On 10-Apr-2021, the patient experienced NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back) and PAIN IN EXTREMITY (hurting so bad in my arm). On 13-Apr-2021, the patient experienced FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back), PAIN IN EXTREMITY (hurting so bad in my arm), MYALGIA (real sore arm - right arm) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication reported.
muscle ache; Chill; Fever; Arm pain that I can hardly lift my arm up; Joint pain; where they gave me the shot at my muscle was sore; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiration date: Unknown), via an unspecified route of administration in left arm on 03May2021 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease, gout, psoriasis, sinuses and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications included triamcinolone taken for psoriasis; ibuprofen taken for pain in extremity; nifedipine taken for gastroesophageal reflux disease; famotidine taken one every day for an unspecified indication; salbutamol (ALBUTEROL HFA) taken for an unspecified indication; ascorbic acid (VITAMIN C MP) taken 2 daily for an unspecified indication and unspecified inhaler for her sinuses, start and stop date were not reported. The patient experienced muscle sore, muscle ache, chill, fever, arm pain that she could hardly lift her arm up and joint pain on an unspecified date. It was reported that she had side effects from the shot that she got yesterday for COVID-19. She went for to get her COVID-19 shot yesterday and she had side effects on the where they gave her the shot at her muscle was sore. She was having muscle ache, chill, fever and arm pain. It was reported that she felt like it's gone into her arm, in her armpit she was still freeze. It's kind of say in that progressing little bit. The patient did not receive any treatment in response to the events. The outcome of the events was unknown.   No follow up attempts are needed. No further information expected.
77y.o. female presenting with COVID and low hemoglobin. She reported some dark stools prior to admission. Upon presentation, hemoglobin was low at 7.6. However, upon recheck it had increased to 9.6. Consideration to initial value being lab error. Regardless, she was seen by GI and recommended for eventual, outpatient endoscopy due to dark stools. She was also seen by ID and begun on 3-day course of remdesivir. She was then stable for discharge and was sent home with a course of molnupiravir to prevent progression of her COVID infection. She will follow-up with GI clinic for eventual endoscopy.
Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        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.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021 and contains no new information.
pt admitted to hosp with generalized weakness and lower abdominal discomfort; found to be positive for COVID; UTI; sepsis secondary to UTI, acute renal failure, mild acute exacerbation of COPD; developed gross hematuria, acute blood loss anemia; hypovolemic shock; required packed RBCs transfusion; vasopressor, ABX; worsening renal failure; underwent cystoscopy and removed blood clots from the bladder; required hemodialysis; pt's condition worsened overall; went into PEA arrest; CPR done without success; pt expired in the hosp
Approximately 12 hours after vaccine, patient developed small, macular rash on arms, abdomen and legs.
01/27/22 presents to EC ED for "fatigue and AMS". PMHx of "ESRD on HD, CAD, CHF, CVA, depression, DM, and HTN"
This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored VAQTA (dose, route, lot number and expiry date were not reported). No adverse effects were reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
exhausted; weak; couldn't sleep; nausea; body aches; Chills; tenderness at the injection site; swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011520A or 011G20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced NAUSEA (nausea), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 09-Feb-2021, the patient experienced ASTHENIA (weak), INSOMNIA (couldn't sleep) and FATIGUE (exhausted). At the time of the report, ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
Case number PHEH2012US021697, is a combined initial and follow up spontaneous report received from a nurse on 29 Oct 2012. This report refers to a 12 year old male patient. He was vaccinated with the first dose of MENVEO (batch number: A10133, expiry date: Feb 2013) intramuscular on 18 Oct 2012 and inadvertently received a second dose of MENVEO (batch number: A11051, expiry date: Apr 2014) on 26 Oct 2012. No adverse event was reported following administration.
Pt reports swelling/irritation/fluid at site... fever/chills temporary body aches.
Information has been received from a health professional concerning an approximately 73 year old female heart pt who was vaccinated with a booster dose of pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N) 10 years after her last dose. Concomitant medications included Diovan and "unknown others". Within 48 hours of the vaccination, the pt experienced a site reaction from the shoulder to the elbow including "swollen, red, hot and tender to touch". It was reported that the pt was treated with antibiotics for the condition. This was one out of 2 pt's reported. It was reported that "one of the pt's developed a fever". The other pt (WAES # 0405USA00382) had a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N).  Additional information has been requested.
Fever, sweating, large 4-5 inch diameter area of redness at vaccination site. No warmth or heat palpated over redness at the time of evaluation by Employee Health. I referred her to clinic.
Patient received a total of 4 doses of shingrix.  Original 2 shot series done 3/19/19 & 5/20/19. Received second series on 12/2/20 & 4/13/21 .  Patient did not have any reported adverse reaction.
Patient complaint of SOB and numbness of the mouth, Epipen was administered by officer. VS taken VS- B/P140/80 P-113 R-21 patient stable no SOB noted still complaint of  a little mouth numbness. Re-evaluated after 15 mins VS- B/P-122/70 P-101 R-19 Advised patient  to seek further evaluation refused at site ER attention wanted to go to Hospital. EMS called by officer patient transported to Hospital for eval.  Stable to left site.
Froggy throat; Cough; This is a spontaneous report from a contactable consumer, the patient   A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: LV6199)  via an unspecified route of administration, administered in Arm Left on 04Mar2021 (right before 12:00PM)  as SINGLE DOSE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Hospital Medical history included  pulmonary embolism from Aug2020 to an unknown date , Arthritic injured equestrian knees/Has bad knees (gets x-ray guided knee injections) , abdominal pain,  Small hiatal hernia (had a stress test in January and they found a small hiatal hernia) , hearing aid user,  weight decreased (prior to getting the vaccine),  Lost her appetite (walking around with a pulmonary embolism and lost her appetite) , Pulse rate low (hospitalized twice  thought she had heart attack, but it was just the blood pressure medication) and tooth extraction (Root canal and Crown went bad). Concomitant medications  included apixaban (ELIQUIS) taken for pulmonary embolism from Aug2020, losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), omeprazole (OMEPRAZOLE) taken for abdominal pain,  paracetamol (TYLENOL) taken for arthritis. Past drug events include Lisinopril made her feel awful, Amlodipine (put her in the ER), Metoprolol (kept her blood pressure low. No other vaccines were given within 4 weeks.   Historical Vaccine includes bnt162b2 Dose 1, Lot Number: EM9810 in the: left upper arm for Covid-19 Immunization.  Historical vaccine also includes Pneumonia Vaccine, Shingles Vaccine (up to date with vaccines that are appropriate for her age group) and Flu Vaccine (last fall). The consumer (patient) stated she is just reporting what she believes is a side effect. On 09Mar2021,The patient experienced froggy throat and on Mar2021 experienced cough that came on a few days after getting the vaccine.  Patient only called to her physician see if they were tracking it, Not that she needed care. She called her doctors office and they were not concerned unless it did not go away. Froggy Throat  is persisting, but like right now she is talking and drinking it is a little better. The patient underwent lab tests and procedures (all tests were prior to covid-19 vaccine) which included Regular annual physical unknown results on Dec2020; Stress test discovered small hiatal hernia  Every now and then she gets chest twinges in January (year unspecified) and they found a small hiatal hernia) on an unspecified date; CT scan result pulmonary embolism Aug 2020, EKG (After her last annual physical and after the embolism) Unknown Results on an unspecified date, Pulse rate 48 (hospitalized twice and they thought she had heart attack, but it was just the blood pressure medication)  on an unspecified date and X-ray (for guided knee injection) on unspecified date. The clinical outcome of the event foggy throat was recovering while cough was unknown.
Itchy rash with swelling of the left bicep in the vicinity of the injection site approximately 10 days later.
pt recv vax & returned c/o feeling lightheaded, BP 120/62, HR 60, profusely diaphoretic w/loss of radial pulse; extreme weakness; EMS called 02 applied, taken to hosp
Initial unsolicited report received from the literature in the United States on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047,2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout an integrated healthcare system. We queried the VAERS database to determine the healthcare system's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves a patient (age and gender not reported), who was vaccinated with a dose of DTAP-IPV (manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) and a dose of MMRV (manufacturer: other, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient developed rash. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Follow up information received from a physician on 19 October 2015. No new information reported. Documents held by sender: none.
Patient reports a rash - itching - developed 2 days after vaccine given 3/18/2009 - Reports used Neosporin with success - Referred to PMD or clinic for evaluation - walked into health unit 3/26/2009 to report rash.
Injection site soreness, fever, nausea, chills, headache, fatigue.
ITCHING ALL OVER THE BODY/ ITCHY HANDS AND FEET; THROAT FELT WEIRD; CHILLS; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 159.8 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included alcoholic, grass and trees allergy, dust allergy, and non smoker, and other pre-existing medical conditions included patient is allergic to outdoor grass, trees and dust since childhood. drinks alcohol sometimes or once a week. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 14:40 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced itching all over the body/ itchy hands and feet. On 21-MAR-2021, the subject experienced throat felt weird. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching all over the body/ itchy hands and feet, and throat felt weird on 22-MAR-2021, and chills, and tired on 17-MAR-2021. This report was non-serious.
No adverse effects reported; product storage error; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient had no illness at the time of vaccination. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).   On an unknown date in 2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012240: