chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe redness, heat, tenderness at site of injection and extending to (R) clavicle, supraclavicular lymph node swelling and tenderness.
Full-blown symptoms of influenza; sore throat, fever (101 degrees), sinusitis, complete nasal congestion,severe productive cough, weakness and general aching muscles and joints.
pt recv vax 28APR97 11AM 5sec of shaking followed by 1hr of hypotonia (?post-ictal) starting @ 230PM 28APR;
I95.9 HYPOTENSION 5/17/2021 HYPOKALEMIA I95.9 HYPOTENSION 5/17/2021 ABDOMINAL PAIN
Progressively worsening chills, myalgias, headache, fatigue peaking at 24 hours post vaccine. All mild. Did not need medication.
This is a spontaneous report from a non-contactable consumer. A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 17:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced elevated temperature, body aches, fatigue on 09Apr2021 16:00. Outcome of event was recovering. No treatment received.  No follow-up attempts are needed. No further information is expected.
3/5/08 PM "welt" at injection site (right upper lateral thigh).  3/7/08 "welts" spaced over body - taken to urgent care hospital in AM and received steroids.  3/9/08 to hospital in PM and received histamine blocker.  3/10/08 to PCP and then to hospital ER and labs done.  Released to home.  3/11/08 to PCP for new symptom of mouth sono and sent back to hospital ER.  Not admitted.  Seen by PCP daily.
This spontaneous report was received from a registered nurse via company representative refers to a 19 year old male patient. No pertinent medical history was reported. On an unknown date (also reported recently) the patient was vaccinated with PROQUAD (Merck) (dose, route, lot number and expiration date were not reported). They were unaware of the recommended age limit of 12 for PROQUAD (Merck) at the time of administration. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who on 18-OCT-2010 was vaccinated with PNEUMOVAX 23 expired on 10-JUN-2010. No adverse event reported. Follow up information was received from a pharmacy student concerning the patient was scheduled to have a surgery for uterine cancer on 02-NOV-2010. Upon internal review, uterine cancer was determined to be an other important medical event. Additional information has been requested.
Patient got Gardasil on his right deltoid. He was sitting by himself, took injection well - was even talking. After injection putting on bandaid, he walked to the waiting room then complained of having dizzy, looked weak & pale. Father walked him back to the exam room. He was talking, feeling dizzy. I checked his vitals - BP was 90/60 - 100/32; Pulse 69; Then regained his pink glow BP 100/62, PR 69 - BP 94/68 PR 66. By now his BP was 108/67, PR 76, BP 116/74 PR 71 at 12:30pm. Patient left after 12:30pm with his father & mother & 3 siblings. They were going to eat. Patient did not eat breakfast.
booster dose of 0.25 ml was administered 11/12. Pt said he ran a fever that night and the next day he had a  rash. he said his hands swelled to the size of boxing gloves on Nov 20 and on Nov 25, he left dinner to go to ER bec rash and swelling were so bad. Dr gave him steroid shot and Prednisone to take by mouth. Pt said he is still having issues, so I suggested he contact doctor again and let him know that the issues are ongoing
Patient had abnormal liver results come back 1 day after receiving vaccine and wanted to know if this was caused by the SHINGRIX vaccine.
Itchy bumps, 1 on arm, 1 on breast, 1 on back.
pericarditis; pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were not recovered/not resolved.   It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix and developed  pericarditis and pleurisy 3 days after injection. The patient reported that it was now 8 months and he/she still suffering.  The patient also stated that he/she also reported this information after a couple days of symptoms and a diagnosis, and asked for update on the same. The reporter consented to follow-up.
Patient received four months vaccinations on 8/11/03 in clinic. On 8/12/03 morning mom took patient's temperature and it was 101.5 F (Registered). Mom reported that upper thighs (both sides) were red swollen at site of injection and hard. Right thigh was warm. Mom gave patient Tylenol at 7:00 am and brought patient to the clinic at 9:30 am. The doctor diagnosed "cellulitis at vaccination site" and gave Keflex 60 mg, orally, three times daily for seven days and Tylenol for fever.
Fever at least 103, chills, fatigue, loss of appetite, diarrhea, vomiting; vomiting lasted at least 2 days (ongoing but getting better)
On 01/03/01, this patient developed hives approximately 6 PM, tightness in the upper chest, and difficulty breathing. The patient saw the doctor on 01/04/2001, said his lungs "sounded like a 70 year old smoker" in stead of a 42 year old non-smoker. Given breathing treatment on 01/04/01 and 01/05/01. Medications: Prednisone, Combivent inhaler, Atarax, and Zantac.
Patient received her second dose of her COVID vaccination after she received her dose she went into the waiting room and fainted and fell on the floor. We called 911 and EMS checked her out she was fine after 15 minutes.
PATIENT FELT DIZZY, LIGHTHEADED, GOT VERY COLD AND CLAMMY, WAS "OUT OF IT" FOR A FEW MINUTES. TREATED BY LAYING PATIENT DOWN, GIVING COLD WATER, AND MAKING SURE SAFE AND NO AMBULANCE NEEDED. RECOVERED SOON AFTER.
4/7 - First dosage. Following day experienced lack of energy, lethargic - as is typically reported. Initial symptoms resolved after 24 hours or so. 4/16 - started experiencing cold/cough symptoms. Symptoms persisted as minor cough until second dosage on 4/29 4/29 - received second dose 5/3 - started having trouble breathing. Pulse-Ox around 93/94. Went to urgent care. No findings reported from X-ray. Given subscription for coriciden and left.  5/3 - 5/22 - coughing And trouble breathing persist. Manage symptoms at night typically with NyQuil  5/24 - the preceding few days mucus had been getting darker and darker leading me to believe I had an infection. Did a telehealth visit with Dr  where she prescribed z-pack.  5/24 - 5/29 - Course cleared up dark mucus but cough remained. 5/29 - 6/30 - cough throughout. Symptoms worsen at night. Overproduction of mucus in airway. Feels constrained.  6/30 - met with Dr Money. Took blood sample and ordered CT scan.
Localized itching, swelling, hardness, tenderness, redness and heat on day 8 after vaccine was given
Pt received moderna booster on 10/25/21. Called hospital call ceneter on 10/28/21 c/o - itchy eyes, cheek swelling the day after the booster dose. But states during the call, her symptoms jhave improved.  ALso reports dizziness and body aches. Pt takes PRN tylenol..  Pt was advised to go to ED for additional evaluation given pt's report of cheek swelling. PT understood and will go to ED
Systemic: thigh pain and burning on night off vaccine, then 2 lumps appeared on upper thigh left side on 7/5-Severe
Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (mentioned as 20th) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Clinical course reported as when probed if patient wants to report adverse event (rash), patient stated, Yes, not sure of what it was but was curious. The patient experienced rash on an unspecified date. Outcome of the event was unknown at the time of reporting.   Follow-up attempts completed. No further information expected.
Severe pelvic pain, endometriosis, hysterectomy, fibromyalgia, psuedotumor cerebri
PATIENT PRESENTED WITH A WARM, RED 4 INCH DIAMETER RED SPOT. REFERRED PATIENT TO HER PHYSICIAN WHO PRESCRIBED ANTIBIOTICS.
2 minutes after injection - patient passed out. Woke and alert yet clammy.  BP 77/29; HR 53;. 6 minutes after injection BP 81/40, HR 66.  Layed on litter.  At 8 minutes BP 75/5, HR 70.   Repeated BP 104/80.  BP laying down 108/33.  Sitting up 98/48.  Observed for 40 minutes. BP siting 116/35, HR 69.  BP Standing 105/43, HR 88.  Patient felt better and okay to leave with son.
I felt tired and sore in my arm for a day or two. I developed a cough in 01/2023 that got worse. I went to my doctor and was diagnosed with bronchitis and received an antibiotic. As of today, I still have a cough.
About 10 minutes after vaccine, I was going out to give another vaccine and saw pt in distress. Got her in vaccination room and got 2 Benadryl from Emergency Bag down her - pt was able to talk but her wheezing was getting progressively worse so we called her emergency person (because she wanted to take herself to ER) to take her and let them know what was happening then I called 911 because even I could tell it was getting worse (Pt was reluctant to take an EpiPen - wanted to wait til it was worse) Dispatch highly recommended EpiPen and since I felt it was getting worse also I gave an EpiPen from Emergency Bag as well. Within 5 minutes pt was clearly doing better. Kept her in room just to stave off gawkers since we had 5 other shots waiting in waiting room - took ambulance about 15 minutes to arrive ...  but that gave pt mom time to get to the store and accompany pt to ER with ambulance.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old child patient of unknown gender. On 21-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
4 days p/vax pt devel irregular tender erythema/swelling @ shot site, myalgias/arthralgias & low grade fever;
BP  under control for 40 years with meds totally out of control since the second "jab"... Dailly range from 190/105 to 95/50 within q 12  hour period..  PB is starting to be under control  after  5 months since the last Moderna jab. Not there yet. The Devil himself will be organizing snowball fights before I take another Covid shot.
cellulitis; Edema; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and edema. On an unknown date, the outcome of the cellulitis and edema were unknown.   It was unknown if the reporter considered the cellulitis and edema to be related to Shingrix.  Additional details were provided as follows: The age ar vaccination was not reported. The age group of the patient was selected as an adult as per vaccine indication. The reporter stated that, after vaccination with dose of Shingrix, the patient experienced cellulitis and edema. The reporter did not consent to follow up.
Large red area at site of injection (4" by 3"), swelling, soreness, itchiness at injection site (upper left arm). Soreness extending to the left back near the left armpit. No treatment yet.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergies.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included DIMETHYL FUMARATE (TECFIDERA), ROSUVASTATIN CALCIUM (CRESTOR) and ENALAPRIL for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: negative (Negative) negative. On day-06 and positive (Positive) Positive tested positive from day 7 to 11.         Device Date : 31May2022 Paxlovid used for the treatment of Covid-19.  Company comment-This spontaneous case concerns a 45-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid starting on 20th May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had rebound covid, after completion of paxlovid with negative antigen test on day 6, followed by positive antigen test from day 7 to day 11. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid starting on 20th May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had rebound covid, after completion of paxlovid with negative antigen test on day 6, followed by positive antigen test from day 7 to day 11. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
pt coded @ home 4Dec93 (MI) in evening. Expired 14Dec93
Incidental finding on hospitalization 2/17/22-2/24/22 for change in mental status. No COVID treatment indicated. Patient with metastatic lung cancer and discharged to hospice service.
Symptoms that lasted ~12-18 hours; Body Temperature dropped to 90, couldn't warm up for hours, was shivering/shaking for whole time period; Loss of strength trouble walking collapsed multiple times; Strong; Headache; Loss of Control of Bowels; Vomiting; Brain Fog; Numb Face and issues talking; Issues since then Discomfort in chest at all times.
Sore throat developed a few hours after injection, then later developed into a fever of 101 degrees F, body aches, headache, and fatigue.
Had high fever; Muscle weakness; Pain in hands, feet, legs, arms; Fast heart beat. In the E.R. They had me follow up with primary doctor who prescribed steroids.
Unusually heavy period began 1 week after vaccine booster. Did not have period for 3 months prior.  Previously had Nexplanon implant birth control from July 2021. After 3rd dose in December, began having 4-6 day long periods almost weekly until Nexplanon was removed on 4/18/2022.
On 1-21-08 Mon came to office with child stating rash on neck, chest, belly -> crusted lesions.
Headache, Myalgia, sore arm Narrative: Headache, body aches, sore arm
Reaction: tingling in fingers of vaccine arm and small local rash on forearm  Outcomes: Benadryl 25 mg given at 17:10. Rash resolved and tingling subsided.
Severe allergic reactions; Tachychardia; Hypertensive; Blood pressure shut down; Dizzy; Weak; A spontaneous report was received from a consumer concerning a 46 year old, female patient who experienced severe allergic reactions, hypertension, blood pressure shut down, dizzy, weak and tachycardia.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 19-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19-Jan-2021, the patient had tachychardia 130-140, was dizzy and weak, bp shut off.  The patient said she was also hypertensive.  Treatment for the event included IV fluids, nitroglycerin, aspirin and Benadryl.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a 46-year-old female hospitalized with serious unexpected events of severe allergic reaction, tachycardia, hypertension, dizziness, asthenia and blood pressure shut down. The events occurred the same day as the first dose of mRNA-1273. Treatment included IVF, nitroglycerin, aspirin and Benadryl.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
He states that the low grade fevers have been up to 99F & 100F & they come & go; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go) in a male patient of an unknown age 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 PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go). At the time of the report, PYREXIA (He states that the low grade fevers have been up to 99F & 100F & they come & go) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f and 100f (Low) the low grade fevers have been up to 99F & 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Redness and irritation on injection site on right leg, patient prescribed: Sulfamethoxazole-Trimethoprim 200-40mg/5mL take 5 mL po BID x 10 days.
Patient was given incorrect vaccines. He was given MMR/Varicella/KINRIX.
Starting at 10 pm day of vaccine #2: sleepy, muscle soreness,   By 2am I had a fever 102 degrees which lasted until  3pm the next day.  Then tapered to 101 by the next night and continued until 48 hours after the vaccine.  At 3am I was UNABLE to MOVE MY RIGHT KEG IR ARM OFF THE BED ( same side I had polio  when I was infant).  I was unable to walk to bathroom and husband had to help me. All I could do was shuffle my feet forward once he got me standing.   By 4am I COUKD NOT RAISE MY ARMS OR LEGS OFF THE BED, EVEN AN INCH HIGH. and had a VERY hard time breathing. The only relief I had to help me breathe was lying on my stomach.  I was seeing streaks of light across my vision for the next few hours.  By 11 am I still had a fever 102 but I was able to start breathing easier and I could start moving my arms .  It wasn?t until 48 hours after the vaccine that I could move my arms and legs without assistance. I had a slight fever of 100 all day Sunday and slight muscle soreness.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information about the patient's medial history, drug reaction or allergies and concomitant therapies provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L037574, expiration date 01-JUL-2017). There was no adverse effect reported. The administered dose of  vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 75 minutes. A data logger was involved. Thee were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.