chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient noted redness, heat and swelling and pain to injection site; also had nausea, dizziness, low grade fever. Patient took ibuprofen for the pain and fever, ER doctor looked at it and stated that it was "cellulitis". Patient worked the rest of her shift.
We admitted patient to the hospital  DOB 08/30/1938    MR#46977    FIN#98705621120  on 04.30.21 through our ER to Med/Surg for new right middle lobe PE.  Pt received the Johnson and Johnson (Janssen) COVID vaccine on 04.02.21 at the Pharmacy (lot# 042A21A).  The pt was on warfarin prior to admission for diagnosis afib and therapeutic (INR 2.2) at time of admission so he was placed on heparin high intensity infusion.  Pt subsequently developed hemoptysis so heparin infusion was held and pt was transferred to the hospital for hematology/pulmonology/oncology consult.  At accepting facility heparin was held on admission and was restarted on 05.02.21.
Immediately after receiving the shot, my tongue went a little numb.   That only lasted about 45 minutes.  But now, I?ve been in bed all day.  Can barely function at all!  Really awful body aches.  Rising fever, despite taking Tylenol every 4+ Hours.   Currently at 102.  I feel awful!!!  Nearly threw up after trying to drink a little chamomile tea with honey.   Staying hydrated with ginger ale, water, gatorade
Sore arm, 104 degrees fever, body ache, headache, nausea, nosebleed.
injection site be red swollen and itchy; injection site be red swollen and itchy; injection site be red swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen) 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 VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen). At the time of the report, VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.
Pfizer 5/19/21, 6/10/21. Positive on 5/3/22
Developed "blood spots" on legs that progressed.  Went to see MD, no specific treatment, employee  recovered after 10 days
left arm approx  5inches from injection site because very itchy, developed hives, and multiple blisters. The blisters coalesced into a single large bullae and broke open on 11/11/2021 leaving a 5-6 cm area denuded, tennis ball sized injection site is only mildly tender no issue on right arm with where tdap and menactra were given no systemic signs of illness
Sore eyes, body chills, fever, headache after first dose lasting more than two days, sore body, dizzy, nausea
24 hours later, I developed issues with my throat.  I have spasms that feel like my throat is tightening up.  This has been going on for 3 weeks.  I have trouble swallowing and i constandly feel like something is stuck in my throat.
01/30/21 First dose of vaccine received - Pfizer EL9265 02/27/21 Second dose of vaccine received - Pfizer EL9266 06/23/21 Left knee replacement revision surgery by Dr. at Facility.  06/28/21 Discharged from hospital to home for Soliris Infusion on 06/29/21. 06/30/21 Picked up and transported to Facility for care and physical rehabilitation until 07/09/21 07/08/21 Around 9PM I started having breathing problems. I called the nurse and told her of my problem and that I thought it might be due to my Myasthenia Gravis. I asked her to call 911.The nurse replied that she would go check. After some time, another nurse came in and I repeated my concern and my request. I asked the nurse if 911 have been called and she replied that she would go check. At that point I asked her to get the charge nurse and she left. After some time, the charge nurse came in and again I have to repeat everything and I asked if 911 had been called. He said he would check. At this point I stopped him from leaving and he turned and told me that I had my own cell phone in my hand and that I could call 911. I called 911 myself. Ambulance eventually arrived and I was transported to  Emergency. Eventually a CAT scan revealed that I had a substantial blood clot in my left lung that was blocking all the main breathing passage ways. They said I basically saved my own life by me calling 911 myself.  I have never had problems with blood clots and now, 4 months after receiving the Pfizer Covid vaccines I go through this.
I received my second Moderna shot and felt very tired and weaker.  Later that night I developed a welt that then turned into small blisters next to the vaccination site.
Patient said she has an extremely sore and swollen arm. Wasn't aware this could happen.
severe pain at injection site, horrible headache, dizzy, blurry vision, sensitivity to light, congestion, difficulty breathing, cough, heavy chest, abdomen swollen and tender to touch, nausea, bloating, loose stool, moaning, fever, sweats, chills, severe joint pain full body, restless, unable to sleep, unable to eat or get out of bed or work
Pt is a healthy 12 year old boy presenting for numbness, tingling, extremity pain and headaches occurring after receiving his 1st COVID 19 vaccination.  We discussed that he is experiencing likely transient numbness and tingling.  It is reassuring that 1) the symptoms are intermittent and not persistent 2) symptoms are improving 3) the distribution is not overly concerning for a neurological cause.
It's been a month today since I received my second dose of Pfizer-BioNTech (Lot #EW0164) on April 18, 2021. My first dose was at the same location, on March 28th, 2021 with lot #ER8732. I experienced extreme muscle soreness the day after, which I took with Tylenol. The feeling subsided. A month later on Sunday, May 16th, I started feeling pain at the injection site again. Though I've felt no other side effects, it's bizarre that this muscle soreness should come back. I took tylenol, but it's noticeable and very uncomfortable.
Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen; Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 303308A) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing); "High BP" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jul2022, outcome "not recovered" and all described as "Covid rebound, Positive antigen tests, 10 days after completion of Paxlovid regimen". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took anti-viral medication Paxlovid for covid 19, starting on 16Jul2022 and stopped on 20Jul2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025436 Same patient, different product and event;
"seizure" like actions--eyes rapid blinking, clinching of hands, unable to communicate during the event.   Event lasts between 30seconds and 2 minutes.   Events happen between 1 and 2 times per day.
2 days after receiving 1st dose pt developed facial swelling, arthralgias, diffuse rash, pain, not sleeping well. Rash biopsied by dermatology, concern for rheumatologic process.
Red swollen sore right arm warm to touch c/o Headache, no nausea or vomiting. Temperture 102, Mom gave Tylenol and alternated with Ibuprofen, applied cold compresses. Gave oral Benadryl and Benadryl cream this Am applied to site.
Patient c/o nausea and vomiting. at 10 am. Vital signs were taken fluids and snacks was provided to patient. Patient rested 15 minutes vitals improved.  Patient left in a stable condition.
This spontaneous report was received from a physician via daughter of a nurse and field employee referring to a female patient of unknown age. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with VAQTA (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced arm sore after Hepatitis A vaccine was administered. The adverse event was filed since VAQTA could not be ruled out. It was unknown if treatment was given for the event or if lab diagnostics or studies were performed. It was unknown whether the patient sought medical attention for the event. On an unknown date, the outcome of pain in extremity was recovered/resolved. Causality assessment was not provided. There was no product quality complaint (PQC) reported.
It was weird again; Turning into a bruise; Felt crappy; A couple of bad breakthrough bleeding episodes; Menstrual cycle was interrupted; Felt off; In her right leg raised hive; Headache; A spontaneous report was received from a consumer concerning a 21-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a couple of bad breakthrough bleeding episodes, Menstrual cycle was interrupted, Felt crappy, Felt off, In her right leg raised hive, Headache, Turning into a bruise and It was weird again.  The patient's medical history was reported as migraines. Concomitant medications were not reported.  On 27 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection.   On 27 FEB 2021, the patient experienced Raised hive (Urticaria) about the size of a half dollar, after that she "felt off" (fall) had a headache (Headache) and Felt crappy (Malaise), and she had a couple of bad breakthrough bleeding episodes (Hemorrhage) which was assessed as medically significant, and the patient also experienced interrupted Menstrual cycle (Menstrual disorder). On 07 MAR 2021, the patient experienced Turning into a bruise (Contusion) and on 08 MAR 2021 it was weird again (Feeling abnormal).  Laboratory details were not provided.  Treatment medication was provided as Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events Hemorrhage, Menstrual disorder, Contusion, Malaise, Feeling abnormal, Fall, Urticaria and Headache was considered as unknown.; 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, a causal relationship cannot be excluded.
Within 20 minutes after receiving the shot I felt pain in my chest pain over the area of my heart and numbness thru my entire left arm. Then in addition it started to feel like something was squeezing my heart really hard.  I also felt so extremely tired I was falling asleep while I was talking to people, I couldn't stay awake. I went to the ER at this point.
has a huge circle on her arm 3 1/2 inches; itching; worm; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (worm), CONTUSION (has a huge circle on her arm 3 1/2 inches), VACCINATION SITE ERYTHEMA (red) and INJECTION SITE PRURITUS (itching) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (worm) and VACCINATION SITE ERYTHEMA (red). On 31-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching). On an unknown date, the patient experienced CONTUSION (has a huge circle on her arm 3 1/2 inches). On 24-Jan-2021, VACCINATION SITE WARMTH (worm) had resolved. At the time of the report, CONTUSION (has a huge circle on her arm 3 1/2 inches) outcome was unknown and VACCINATION SITE ERYTHEMA (red) and INJECTION SITE PRURITUS (itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported.  No treatment information was provided
Pt recvd vax & w/in 24 hrs of vax pt had either an onset of or an inc in apnea;
The patient has a history of diabetes type II. He was brought to the ED by EMS on 9/25/23 after sustaining multiple falls in the past 24 hours. His O2 sats were found by EMS to be in the mid 80's. In the ED, the patient also reported having a cough for the past few days. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted to the hospital from 9/25/23 - 9/28/23, with discharge diagnoses including COVID infection, among other diagnoses. The patient did not require oxygen or steroids during his admission. Of note, he has received four doses of the Pfizer Monovalent COVID vaccine (given 2/2/2021; 2/23/2021; 10/14/2021; 4/5/2022) and one dose of the Pfizer Bivalent COVID vaccine (given 1/9/2023).
development of tachycardia, dizziness, lightheadedness and recurrent disorientation beginning about 1 day after receiving vaccine with persistent "brain fogginess' and lightheadedness.
DIARRHEA AND VOMITING ON SUNDAY NIGHT AT 8PM UNTIL 4AM NEXT DAY. STARTED RESOLVING THE NEXT DAY AND PATIENT IS OKAY NOW.
Patient stated that he was afraid of needles.  As I administered the shot, patient starting breathing heavily and fast.  He said he felt hot and as I pulled the needle out of his arm.  He started to slump over and his eyes were still open.  I caught him in his chair to keep him from falling over and he starting to clench his hands and make a grumbling sound in his throat.  I called his name a few times and he straightened out his body for a few seconds and then looked at me and snapped out of it.  He then said he felt hot and I got a wet towel to put on his head.  Then he said his hands were tingly.  After about 5 minutes he felt better and we walked around Target to see if he felt better. He also said his last meal was at 10am that morning and he's always been very scared of needles.
Pain started next day, got red. Noticed a lump. Went to Urgent Care got an antibiotic and pain relief Rx's. Swelling started w/in 24 hours. Redness with in 12, fever, chills, hot and cold sweats. Redness almost gone. Lump still.
knee pain; slight back pain; throat tickling; slight fever; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of throat irritation in a 64-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS SHOT) for prophylaxis and epinephrine for an unknown indication.   Concurrent medical conditions included antiphospholipid syndrome, diabetes and animal bite. Concomitant products included warfarin sodium (Warfarin), immunoglobulin human normal (Gamma Globulin), paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On an unknown date, the patient received the 1st dose of RabAvert, TETANUS SHOT and epinephrine at an unknown dose and frequency. On an unknown date, unknown after receiving RabAvert, the patient experienced throat irritation, fever, blurred vision, knee pain and back pain. On an unknown date, the outcome of the throat irritation, fever and blurred vision were recovered/resolved and the outcome of the knee pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the throat irritation, fever, blurred vision, knee pain and back pain to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The Rabavert was given along with tetanus and epinephrine and experiences throat tickling which goes away after a day.  The patient had slight fever and blurry vision both of which resolved after a day and had ongoing knee pain and ongoing slight back pain. The reporter consented to follow up. The patient receieved Rabavert for post exposure prophylaxis. This is 1 of 5 case reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148390:same reporter
She received her 4th DTAP on 8/12/04 at 3:30 pm.  At 10pm that evening, she developed a high fever to 104 and had a 5-10 minute whole body seizure.   At 4pm on 8/14/04- she had another short seizure and had a persistant fever. She was admitted to the hospital where a CT scan, LP, blood and urine culture, lytes were normal. She had 2 additional short episodes of shaking lasting 30-45 seconds in the hospital. She was discharged home on clonopine for 24 hours. Follow up is scheduled with peds neurology.
Pt was 7 wks pregnant at time of H1N1 vaccination. Received vaccine vaccine on 11/3/09. Went to OB/GYN for follow-up @ 8wks and was found to have miscarried and had to have a D&C on 11/13/09.
Coronavirus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Coronavirus) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Coronavirus). On 04-Oct-2022, COVID-19 (Coronavirus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2022, SARS-CoV-2 test: (Negative) Negative.         Patient was not on any concomitant medications before the vaccine.  Patient's COVID-19 symptoms include headache, slight cough and running nose, very mild, no sense of taste and smell. Patient had been negative for 21 days ago. Patient had no other reaction to the shots.  Treatment information was not provided.   Reporter did not allow further contact
Left thigh has redness and swelling at injection site. Noted on 3/13/17.
He lost his taste on the tongue; After receiving vaccine, he was coughing next day; He had shortness of breath that started on next day; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (After receiving vaccine, he was coughing next day), DYSPNOEA (He had shortness of breath that started on next day) and AGEUSIA (He lost his taste on the tongue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes and Arrhythmia (flutter arrhythmia). Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, FOLIC ACID, METFORMIN and VITAMIN B NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced COUGH (After receiving vaccine, he was coughing next day) and DYSPNOEA (He had shortness of breath that started on next day). On an unknown date, the patient experienced AGEUSIA (He lost his taste on the tongue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN DRY COUGH) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COUGH (After receiving vaccine, he was coughing next day) and AGEUSIA (He lost his taste on the tongue) outcome was unknown and DYSPNOEA (He had shortness of breath that started on next day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Angioedema 1/22 Difficulty swallowing, red face facial swelling Narrative:
Day AFTER vaccination:  -Fatigue -Chills -Queasy  Very sore arm for 5 days
No additional AE; incorrectly administered "too low" on the deltoid injection site; This spontaneous report was received from a certified medical assistant concerning a 33-year-old female patient. Information regarding the patient's concurrent conditions, medical history or concomitant medications was not reported.   On 29-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL administered intramuscularly for prophylaxis (lot # U007477, expiration date: 14-APR-2023) (dose number was not reported). It was reported that the vaccine was incorrectly administered "too low" on the deltoid injection site (Product administered at inappropriate site). No additional adverse event was reported.
I experienced swelling in my legs, wheezing, and pain in my ankles and I went to the ER on 11/01/2021. The doctors performed an Ultrasound along with  lab work which showed  a D-Dimer (possible blood clots). I was given medication  Lasix and Potassium to help with the fluid in my legs. My CT Scan came back showing that there were no blood clots.  They asked me to purchase some compression socks to help ease my symptoms. I have to go back for a follow with my PCP on 11/10/2021 (will be seeing the Nurse Practitioner since my PCP will not be available). I'm also awaiting another test result as well..
Employee stated the patient received their 3rd dose approx 12 weeks after their 2nd dose.; No additional AE; This spontaneous report was received from other health professional referring to a female patient of unspecified age.  The patients' concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) only approximately 12 weeks after she received the 2nd dose (unspecified date) (inappropriate schedule of product administration) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Patient did not had any symptoms. No adverse event was reported and there was not PQC reported.
Patient suddenly collapsed while jogging. He was 33 y/o healthy, fit, active male with no cardiac issues, Autopsy diagnosis is Myocarditis.