chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot in left leg; Not feeling like herself since second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in left leg) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FEXOFENADINE, LOSARTAN and SERTRALINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling like herself since second dose). On 16-May-2021, the patient experienced THROMBOSIS (Blood clot in left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in left leg) outcome was unknown and FEELING ABNORMAL (Not feeling like herself since second dose) had not resolved.            It was reported that the patient was not feeling like herself since the second dose but was unsure if it was a result of the vaccination.  Company Comment : Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
pain; redness; tired; swelling; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (pain) and VACCINATION SITE ERYTHEMA (redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (tired), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain). On 19-Feb-2021, FATIGUE (tired), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
patient had pain and swelling in left leg - sent for doppler - positive for thrombiphlebitis
A week later and I have a round hard lump in the vaccination site.; This is a spontaneous report from a contactable other health care professional. A 33-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0185, Expiration date not reported), via an unspecified route of administration in arm left on 18Jun2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunization at Doctors office/urgent care. The patient medical history was reported as none. The patient had no known allergies. Prior vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient was not tested with COVID. The concomitant medications included Levothhroxine (MANUFACTURER UNKNOWN), montekulast (MANUFACTURER UNKNOWN) and birth control; both for an unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. On 25Jun2021 12:00, a week after the vaccination, the patient had a round hard lump in the vaccination site. The patient did not receive any treatment for the event. The outcome of the event was unknown.  Follow-Up (01JUL2021): Follow-up attempts are completed. No further information is expected.
12/20/20 FEVER 102, NO APPETITE, WEAK, VOMIT ONE TIME
Patient stated she  was feeling nauseous ~13 minutes post vaccination. Patient's husband called for assistance. Patient then fainted. She came to but was incoherent. She could not form sentences and proceeded to go in and out of consciousness. Paramedics were called and arrived on the  scene within 5 minutes.  Patient was taken  away on a stretcher.
Extreme weakness & Fatique Dizziness Fainting Death 04/09/2021
PATIENT STATED THAT HE WAS HAVING AN INTENSE, TINGLING SENSATION UP ONE SIDE OF HIS NECK. HE STATED IT GOES AWAY THEN COMES BACK .   HE WAS SEEING SOMEONE, WHO WAS USING COMPRESSION TECHNIQUES. HE STATED HE IS STILL HAVING SOME SYMPTOMS BUT SEVERITY HAS DECREASED. HE SAID HIS PAIN STARTED OUT ABOUT 9 OUT OF 10 BUT IS NOW ABOUT A 1 AND 1/2
The patient had arm pain, swelling, limited range of motion, pt had received pneumonia shot and flu shot at same site, of right arm on 11/14. The patient had acute severe local reaction to immunization,  no abscess identified, just diffuse inflammatory changes.
Diagnosed with COVID-19, Cough, Congestion, Mild Respiratory Illness
Patient reporting having redness at/around site that evening of immunization given.  Redness increased in area over next day.  On third day after immunization patient reported to local ER.  The ER marked the area of redness on her skin and started her on bactrim per PA note.  On fourth day patient reported to Family Practice clinic to be seen by PA.  Patient reported fevers, pain at/around site and the redness.  PA marked current size of redness area, had her continue her course of bactrim, will have patient return tomorrow to see him for f/u per PA note.
Within about 5 minutes, I started experiencing my heart beating really fast. I got hot really fast. The pharmacist had me sit down for - minutes. After that time, it felt like it wouldn't go away so I went and got some water. I went home and told my parents that I felt really weird. My heart was still pounding. This went on for about a week and a half. It felt like there was a burn sensation in my chest. It felt irregular. I couldn't really workout or anything. Any time I tried doing anything laborious, I felt shortness of breath. It was an uncomfortable, burning, irregular feeling that I was experiencing. By the 2 week mark, I started feeling normal again. The day after I got my first vaccine, I went to a gastro appointment and they took my blood pressure. It was sky high. I have been put on some blood pressure medicine.
Vomiting; Chills; body pain; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Redness at site, then a raised area, infection at site, (dead skin), which resulted in a wound, still in treatment, from September 6, 2017. Also after shot very sick, fever, sick to stomach, very sore arm red at site. The shot gave me a blood clot, which became infected. I have suffered from pain at site. Since the wound was so deep it has taken a very long time to heal, once it is healed it will take 6 months or a year to fully heal. Of course I will have a scar, left arm. I have had to buy supplies. Pain from healing. I feel as a older 66 years old, I would not had received this booster shot. I did recover somewhat. The effects rule my life. My arm will never be the same. The company needs to know this fact.
I tested positive for COVID on 01/30/2022. Starting 02/03/2022, I experienced sustained tachycardia at a rate of about 160 bpm. I was light headed, feeling like I could pass out and couldn't stand up. I had a friend take me to Urgent Care, who upon looking at me and my HR, sent me to the Hospital ER. Lab work came back normal and EKG was normal (hours later) so they referred me to see my PCP who referred me to a cardiologist (have an appointment tomorrow 02/25/2022)
From 11/13/85 to present; muscle pain and weakness, chronic fatigue, severe allergies, pruritus (1/93), joint pain. Per doc 199622, patient has joint pain, muscle weakness, chronic fatigue, severe allergies, pruritis, skin sensitivity.
Patient is 16 years old and should have been given the pediatric/adolescent formulation of Havrix, instead he was given the adult formulation of Havrix.   Provider, patient's mother, and immunization branch notified.  Correct formulation will be given in 6 months.
patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; no adverse effect; patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; This spontaneous report was received from a nurse regarding to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 02-NOV-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, frequency, route, lot and expiry date was not reported) for prophylaxis. On 19-JAN-2017, the patient was vaccinated 1 dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, lot and expiry date was not reported),(wrong product administered and interchange of vaccine products). On 04-MAR-2019, the patient was vaccinated 2 dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R020200 and expiry date 05-MAY-2021, (strength, dose, frequency, route were not reported). On 15-MAY-2019, the patient was vaccinated dose 3 with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R004689 and expiry date 29-NOV-2020, (strength, dose, frequency, route was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Pain in upper chest especially near front clavicle and shoulder, and in neck when inhaling. Worse on left side, and worst when lying down on that side. Spread to right side. Gradually decreased over several days. Accompanied by difficulty breathing, plus general malaise, weakness, fatigue, runny nose, muscle aches, chills, and feverish (but no increase in temperature)
Sore arm, tingling in hand and fingers.  severe nausea and head ache. fatigue
A large granuloma and several small granulomas developed under the skin in my right arm and hand following the first vaccine.  I had the second given in the other arm, and within 10 days, it started growing granulomas.  (We are assuming they are granulomas.  Biopsy results are due to be given to me tomorrow, June 4, 2021.)  These nodules/granulomas are also growing in my toes and fingers and it is painful.  Additional symptoms include night sweats, fatigue, body and joint pain, which is sometimes severe.   The granulomas are visible under the skin.  If they begin to affect the use of my arms, etc., they will have to be surgically removed.   It took me a very long time to get anyone to listen to me or help me.
PAIN, REDNESS & SWELLING @ INJECTION SITE,BODY ACHES & CHILLS, JOINTS SORE, HEADACHE
tachycardia; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced tachycardia on an unspecified date. The outcome of event was unknown.  The physician wanted to know the side effect of tachycardia resolves on it's own or if intervention is needed, if side effects would increase at the 2nd dose, should Md pre-medicate for second dose or avoid 2nd dose.   Information on the lot/batch number has been requested.
This child had 1st dose of DPT (Acel-Immune), IPOL, Comvax, and Prevnar vaccine. He developed irritability and crying episode for 4 - 5 hours on the same day, evening after the immunization.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: CELLULITIS OF THE LEFT ARM-Severe, Additional Details: NONE
Fine confluent macular rash upper extremities inner thighs associated with local heat within 24 hours of initial vaccination.
Immunization was given on 4/11/2013 at 2 pm. Client returned to clinic 4/12/2013 at 3:30 pm left upper arm from shoulder to elbow was inflamed, felt hot to touch and swollen. Pt reported pain. Reaction began around 7-9 pm 4/11/13 and continued to worsen until AM 4/12/13. Temp. on 4/12/13 3:30 pm. 98.2 at 7 pm on 4/12/13 101 degrees normal T 97.7 degrees on 4/16/13 10 A.
Patient was administered 0.5mL of vaccine instead of 0.25mL. (They received higher dose than indicated for age.)
Swelling, erythema, warmth at injection site 7x6 cm size.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not provided. On 12-JUL-2016 the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017, dose and route were not reported). No adverse effects were reported. The vaccines had been stored under temperature of 1 degree Celsius for 48 hours. There were no previous temperature excursion and data logger involved. Additional information has been requested.
2 raised red heated circular rashes near injection site. Appeared 11 days after injection. About 6-7 inches in diameter. Slightly painful but not impacting daily activities.
ON 1/19/21 DEVELOPED NAUSEA AND VOMITING. FOLLOWED UP WITH PCP.
He got his vaccines, the followoing day he had a sore arm.  The next day he was driving his car and he knew somethign was wrong.  He came to a rotary and did not go around it and went over it.  He did not hit anything, knew that he was in trouble.  He went to a gas station and got half out of the car, and grabbed the steering wheel and could not move his arm.  Attendend asked him if he was OK and he could not answer, he called 911 and he was taken to the hospital by ambulance.  He went to Hospital.  Once he got to the ER in about 3 hours he could speak and he could move his arm.  They informed him that he had had a stroke.  He was admitted to the hospital, and was there for 4 days.  He did have blood work, MRI's and CAT scans.  He was put on Plavix for 21 days and then they wanted him to wear a heart monitor for 30 days, but he was going to travel in 20 days and he was told to see his cardiologist and he was put on a 14 day heart monitor and still has 6 days to go with the heart monitor.  He is feeling tired at this point, more tired than he usually is.  He did have some chest discomfort that is recorded on the event monitor that he is wearing.
7 days after receiving my shot I developed Covid arm. A painful, itchy raised rash about 2 inches by 3 inches and it was very hot and painful.
This spontaneous report as received from a certified 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 03-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly, lot # L043214 with expiration date: 03-OCT-2017 (dose was not reported). Immediately after vaccination, the patient began experiencing tingling from injection site radiating up the neck. The medical assistant requested a lot check for GARDASIL 9 (lot # L043214, expiration date: 03-OCT-2017). The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not provided. This is one of two reports received from the same reporter. As of 28-NOV-2016 All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 28-NOV-2016 from a physician referring to a 17 year old female with Poland Syndrome and learning/cognitive difficulties. On 03-OCT-2016 9:03 am, the patient was vaccinated with GARDASIL 9 lot number L04321 intramuscularly in the right deltoid. On 03-OCT-2016, the patient experienced a tingling sensation up into her neck on side where injection was given during a 15 minute waiting period. On 03-OCT-2016, the sensation resolved prior to the patient leaving the office. The outcome of tingling sensation was reported as resolved on 03-OCT-2016. An investigation into the manufacture of lot L04321 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: US-009507513-1610USA003491: MERCK 1610USA002868: Mfr number.
Chills, fever and malaise developed w/in hours of injections (11/19). Office visit 11/22 w/ headache, temp, red swollen area (R) upper arm - chest feeling tight and dry cough. One day later temp to 102.7 w/ increased chest symptoms. Given doxycycline, MEDROL dose pak and TESSALON PERLES - chest symptoms of tightness, cough continued - 2nd MEDROL dose pak given 12/2/13.
Saturday when I woke up I had tightness in my chest. I went to work, came home, and I ended up that night from chest pain to abdominal pain. Sunday I had a tight cramping in stomach but still went to work. I had mild cough, mild fever, but no body aches until Monday when I woke up. I was fatigued with abdominal pain, nausea, diarrhea, and vomiting. Tuesday and Wednesday was the same thing and I still have mild abdominal pain but my stomach is bloated and everything is turning to liquid in my gut with diarrhea. I'm taking Zofran, Tylenol, and Pepcid to try and help bring me back. I have lower back pain, joint pain, and not as much abdominal pain but I still have it. It's moving up and all the way down.
99.4 temperature for 1 day Headache at back of head for 1 day Red, burning and itching rash on feet/body for 2 days Swelling of partial bottom lip for 2 days
Pt c/o pain & stiffness in L/arm, 2 days post/vax. Admitted to hospital on 2/20/00 with acute cellulitis. Onset sx's included fever, tenderness & redness in left arm. Given IV Ancef in hosp. Rx: Keflex x 7 days, elevate & use warm compress.60 day follow-up dated 06/29/00 states the pt suffers from loss of strength, severe eye pain, blurred vision, fatigue, frequent headaches, short term memory loss and weight fluctuations.
RECEIVED A INFLUENZA VACCINE AT 1:30PM, 10 HOURS LATER, 11:30PM STARTED FEELING MUSCULAR SEVERE PAIN IN BOTH LEGS. ON A SCALE OF 1-10, PAIN FELT LIKE 7-8. A BURNING PAIN  LASTED 2-DAYS, BOTH LEGS LOST STRENGTH. WAS UNABLE TO LIFT MYSELF OF THE TOILET SEAT, WAS IN BED FOR TWO DAYS. PAIN RESOLVED ON ITS OWN AFTER SECOND DAY ARRIVED AT CLINIC TO SEEK MEDICAL ASSISTANCE PAIN WAS THEN AT A 1-2 LEVEL.  MY PCP'S  PARTNER REFERRED ME TO A NEUROLOGIST, UNDER WENT NEUROLOGICAL TESTING.
Pt recv vax on 3/30/98; 24 hrs later pt exp unconsolable crying; tx=Tylenol, pt seen by Dr.
Sudden vertigo four days after vaccination. Vertigo lasted a few hours and then I felt off the rest of the day. Felt better until I had another sudden case of vertigo 12 days after vaccination. Same experience - lasted a few hours and then I've felt off the rest of the day. Vertigo included dizziness, room spinning and was worse when I laid down.
Two minutes after receiving his vaccine he started to get lightheaded and dizzy, cold sweats, nausea, and he was bradycardic. Ammonia was used while he was in the POD.  He was removed from the cell and brought to the medical observation area. His blood pressure on arrival  was 119/68, heart rate 71, pulse ox on room air was 99%. Patient was placed in trendelenberg  for about 10 minutes. His follow up blood pressure was 113/68 @ 2:49. About 5 minutes later hw as placed in a semi fowlers position with his follow up blood pressure was 127/62, HR 72. , subsequent in a sitting position was 113/68 HR 74, and in a standing position 125/64. Patient reported his symptoms have resolved.
CHILD HAD COVID VACCINE, FEW MINUTES LATER LOST CONSCIOUSNESS, HIT HER HEAD, THEN HAD TONIC LIKE SEIZURE, WOKE UP AND PASSED OUT SEVERAL MINUTES LATER AND HAD MORE TONIC ACTIVITY AND WAS TAKEN TO ER
fever; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional information: Events was experienced day and night. The reporter would like to know if the patient should take the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. Patient was experiencing a headache on 11Apr2021. Patient would like to know if he can take aspirin for his headache. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
hives, tightness in chest, SOB, anxiety; EMS activated-natl orthopedic hosp