chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/19/21 : 81-year-old female presents to the clinic with complaint of redness and itching at injection site. She received COVID-19 vaccination 1 week ago. She says she has had some arm soreness at the site. Last night she noticed that the area was red and somewhat itchy. She reports scratching the area several times. Says that it was warm to the touch this morning and she became concerned. No fevers. No drainage from the site.  May take OTC Benadryl for itching, Avoid scratching, Cool compresses PRN, Return for development of fluid collection or drainage. 1/25/21 Patient reports increased redness and warmth. Prednisone 20 mg po daily x 5 days, Apply triamcinolone cream to the affected area three times per day, May take OTC Benadryl for itching, Avoid scratching, Cool compresses PRN, Follow-up on Thursday if symptoms worsen or do not improve.
"On 2-28-11 at 4p-noticed mosquito like bite to arm that got bigger & bigger, was itchy & bright red". Nurse observed a scarcely noted 15mm induration with redness extending to 31mm, mildly warm area. Pt. c/o tenderness to site.
GOT FLU VACCINE AT 1445 ON THE UNIT.  ABOUT 15 MINUTES AFTER, i FELT SLIGHTLY DIZZY, AND SLEEPY WITH A MILD HEADACHE, AT LEAVING TIME i STARTED TO COUGH AND FEEL CONGESTION.  i TOOK A BENADRYL AROUND 5PM DUE TO PREVIOUS REACTIONS.  aT HOME I FELT VERY TIRED AND COLD, TEMP OF 37.1, I TOOK ANOTHER BENADRYL AT 10 PM BEFORE I WENT TO BED.  i WOKE IN THE MORNING WITH A VERY SWOLLEN FACE AND THROAT, WENT ABOUT MY DAY AND TOOK ANOTHER BENADRYL BEFORE BED.  aFTER I WENT TO SLEEP i HAD A 2-3 MINUTE SEIZURE, AS REPORTED BY MY DOMESTIC PARTNER.  i WENT TO WORK BECAUSE i DIDNT KNOW UNTIL IT WAS TIME TO LEAVE FOR WORK, THEN LATER ON THE 17 TH i HAD AN APPOINTMENT WITH MY PROVIDER.
Blood work done every three months showed a significant increase in C-Reactive Protein. Since 2005, C-Reactive Protein levels have been <0.8 mg/L.  Forty-Six days after my second vaccination dose of Pfizer vaccine, my scheduled blood work showed a C-Reactive Protein level of 3.4 mg/L, which is a significant change from the normal <0.8. No other parameter of my normal blood work testing showed any significant changes.
I have had all 5 shots. After the second shot I got very ill. Spent a couple of days in bed with fever and congestion. Then in September I got the regular flu shot. Before I had third Covid shot I developed vertigo and went to emergency. Then went to and ENT, he gave me meclazine for help with the dizziness. I had never in my life had vertigo and was quite surprised by it as to how dizzy I felt. After the 4th shot 4/19/22, again I developed vertigo, but I was emotionally better prepared to handle the dizziness. My regular doctor suggested seeing and ENT again.  In October, I was exposed to Covid and got it October 22. Called Doctor she gave me Paxlovid to get me through the illness. After that is when I notice the noise in my ears. Right ear is so loud the it interferes with me falling to sleep at night. My hearing loss is getting worse in that ear. I have had a slight hearing loss since childhood but all this medicine and getting Covid has brought on the Tinnitis I am experiencing. I went to my audiologist and she suggessted using a white noise to help me fall asleep. That doesn't work,  I tried Ginkgo Biloba that did help some but I did not like the way I felt while taking it.  So it is my understanding that there is nothing that can be done for TINNITIS. I am miserable, cranky and tired. I firmly believe with all the medicine I had taken for the Covid has impacted my ears. I guess I am doomed....
Fever; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of fever in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2HC47, expiry date 13th December 2020) for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On an unknown date, the patient received Pediarix. On an unknown date, less than a year after receiving Pediarix, the patient experienced fever and drug dose administration interval too short. On an unknown date, the outcome of the fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Pediarix with batch number 9A2KC and Exp date 3rd July 2020. Eight days after initial dose, the patient inadvertently received another dose of Pediarix, which led to shortening of vaccination schedule. The reporter ask about any information on 2 doses given close (8 days apart) would cause the fever to be higher.
Day after vaccine had chills and a fever, did not take temperature 2 days after vaccine, diffuse joint pain, petechial rash on lower extremities severe raynauds left pointer finger, ischemic pain due to digital infarct given a course of prednisone 60 mg daily x 2d, tapering by 10 mg every 2 days until off- started 11/19- improvement but not complete second course of prednisone, same as above, started 12/3. resolution of petechiae,  now has ischemic infarct left pointer finger, small infarcts on left 3rd and 4th finger.
Extreme swollen lymph nodes on both sides of neck and arms. Searing pain in jaw and collar bones. Neck stiffness
About 12 hours exactly after getting the 2nd dose I got extreme POTS flare up and a mild occular migraine.  I had a fever that kept going from the mid 99s to the 101s for 36 hrs.  Was freezing and burning and had lots of joint and body pain.  Most people I know had all of that, but the reason I?m reporting is the tachycardia.  My tachy has been fairly well controlled with meds and after my second dose it was so bad any time I sat up, I couldn?t breath, my tachy got so bad, my heart rate would jump from up to 70bpms, just sitting up.  My resting heart rate on meds has been 60-80, and for those 36 hours was 80-110.  Anytime I did anything my heart rate would jump to 130-150 and I could NOT BREATH.  My SpO2 was fine, so I know that the issue was my POTS flaring up and that it was the tachy.  I just want to report that it could cause issues with people with dysautonomia, so they don?t freak out if it happens.  My heart rate is still elevated, but is slowly going back down.
Fever of 102.6 and redness and swelling of local vaccination area, muscle aches.
Heart issue; Severe chest pain; Inappropriate route of vaccination; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9LU-18343-69467) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia, Hypertension and Asthma.  On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 29-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On an unknown date, the patient experienced CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, CARDIAC FLUTTER (Heart fluttering) was resolving, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain) outcome was unknown. Not Provided   mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.  Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment - Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received included new event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.
I had little chill and fever after receiving the vaccine for about two days. I developed numbness and tingling in my right foot the end of 10/2022. I went to my doctor, and I was referred to a neurologist. I don't have an appointment yet but hopefully soon. It is very annoying and nothing really helps to relieve the symptoms.
pain; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), CHILLS (chills) and MYALGIA (aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included AMLODIPINE BESILATE (NORVASC), SIMVASTATIN, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB), ACETYLSALICYLIC ACID (ASPIRIN) and NAPROXEN for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), CHILLS (chills) and MYALGIA (aches). At the time of the report, PAIN (pain), CHILLS (chills) and MYALGIA (aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  The caller want's to know when he can get the 2nd shot as he got positive COVID result on 1Sep2021 after received the 1st shot on 5Aug2021.
None. Pt received PEDIARIX and Hep B (single dose) on 11-03-08.
Pt is a 18 yo F. Came for 1st dose of Moderna vaccination. Pt had an episode of Vasovagal (syncoy) reaction at 10:55 about 10 minutes after being vaccinated. Episode lasted for about  4 seconds, this nurse lay her down for 5 minutes on the bed and elevated her leg, took vitals while lying down ( 107/68 72 99% RA 18), then have her sit for another 5 minutes (113/68 71 100% RA 16) water was given. Pt recovered without difficulties, ER precaution given, pt acknowledge understanding. Pt was observed for another 15 minutes, and showed no symptom, then was let go
Has Eosinophilic Esophagitis. Had a flare up today; sore arm; felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Eosinophilic esophagitis.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy). At the time of the report, OESOPHAGITIS (Has Eosinophilic Esophagitis. Had a flare up today), PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (felt sleepy) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The patient experienced pain and was worsened then expected. It felt like cellulitis. The patient normally took methyl prednisone and wanted to know if he can take it.  No concomitant medication reported.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
COVID despite having both doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID despite having both doses). At the time of the report, COVID-19 (COVID despite having both doses) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown. This case concerns a male patient of unknown age, with no medical history provided, who experienced the non-serious unexpected AESI of COVID 19. The event occurred on an unknown date after receiving the second dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the nature of the event. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report. Case processed with very limited information and no consent for follow up has been granted so no further information is expected. Reporter did not allow further contact.
Died 3-5 days after getting the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (Pfizer COVID vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that her aunt, who was going to be 100 years old, died 3-5 days after getting the Pfizer COVID vaccine. Consumer stated that they were healthy people. She stated that she is a transfusion medical specialist. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on lot/batch number has been requested.; Reported Cause(s) of Death: Died 3-5 days after getting the Pfizer COVID vaccine
6 days later began having heart problems. First onset  test on AFib, went to ER. AFib confirmed by EKG. Symptoms resolved after receiving diltiazem. Later that week had normal stress test and normal echo. Ruled out heart attack.
Individual reported to clinic on 10/15/2018 stating that he began to get a pruritic rash the evening of the day he received influenza vaccine at the influenza vaccine campaign for employees that occurred on10/11/2018. He stated that the rash spread down the left arm and to his right forearm, with some discrete spots on abdomen and upper back. He experienced no other symptoms. Denies any allergies or exposures to other potential allergens or work or environmental triggers. He applied aloe vera and hydrocortisone cream to affected areas. He has had influenza vaccine in the past 7 years annually with no reactions to the vaccine. No recent travel hx, no hx of ABX use, no one else in the household experiencing similar symptoms. He is otherwise well and healthy today. Follow-up appointment on 10/18/2018 to evaluate rash sites. Signficantly improved compared to 10/15/2018.
Patient's Covid-Test was positive on April 13 . she was in sub intensive unit from April 20 to May 12. the I dose received of Vaccine was Astrazeneca brand
Pt was administered FLUZONE 2010-2011 at approximately 10:00 AM and pt c/o low grad fever, shivers, flu like symptoms at about 9:00 pm the same night of injection. Pt came in 10/4/10 and c/o of symptoms last nigh (10/3).
Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.
sx of acute asthma, starting 29JUN93 w/tightness in chest & increasing 26JUN - 30JUN; treated by MD 29JUN93 Amoxicillin & Tassalon w/o relief; 30JUN93 marked wheezing w/dyspnea;
Patient called onsite registered nurse on 15MAR21 to report injection site pain, swelling, redness and itchy (right deltoid).
I contracted COVID. In 11/22/22 I felt a scratchy feeling in my upper chest, and I thought it was acid reflux so I took tums. My sinuses felt heavy and stuffy, but I did not have a runny nose. I have seasonal allergies so I did not think anything of it. The next day I developed a dry cough and the day after a fever, which varied from 99.5 to 100.5, The next day I called my doctor who gave me Paxlovid, which I took from 11/26 to 11/30. From 12/3/22 I took a home test and was negative. On 12/9 my sinuses bothered me and I started coughing so I took another test and was positive again, so I did rebound. I did not take the Paxlovid again and just waited it out. I was not real sick, and by December 11th, I was negative again. The only other symptom I had both times was mild fatigue.
got sick; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Global Digital Media through social media.  This case is linked to cases 2020SA300020 (same reporter).  This case involves a patient of unknown age got sick (illness), while patient was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Client was given DTaP and IPV in LUA and LLA respectively (03/24/2003). This morning, mother noted large area of erythema left arm and shoulder area. Area warm to touch. Ibuprofen 2 times. No reaction today. Told follow up with PMD and see if he was having allergic reaction or possible severe abscess.
Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Pt experienced headache and dizziness post vaccination.  Pt has Hx of HA on & off, possible migraine per PCP.  Pt also did not have breakfast and has hx of anxiety.  (BP 112/63; HR 82; RR 18; T 97.3; AOx3). 10 min later pt denied dizziness & HA had improved (BP 102/59; HR 78; RR 18; T 97.4). Pt was stable & released from vaccination site.
Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 8 month old, male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL: lot number C3545AA received on 10 December 2009, lot number C3451AA received on 12 March 2010, and lot number C3588AA received on 26 April 2010 (route and site of administration not reported). Approximately 2 months after the last dose, the subject developed a cough on 26 June 2010. Four days later, the subject developed a paroxysmal cough with whoop and posttussive vomiting. The subject also experienced symptoms of cold-like illness and sleep disturbance (dates not reported). Laboratory testing included positive PCR on 30 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of a single dose of azithromycin on 30 June 2010. The subject was not hospitalized. At the time of final contact on 05 August 2010, the subject's cough had resolved. The duration of the cough was reported at the time as 20 days. Investigator causality assessment is not required as per protocol.
Swelling, edema, heat, firm cellulitis (scapula, shoulder and arm) to left arm. Shots given one on top of each other.
Fever, chills, severe shakes.  Began at 6:00 PM.  Intensified at 8:00 PM (~ 12 hours after shot).  Continued for 5 hours until 3:00 AM.  Prevented sleep.  Following day, minor chills, no major impact.
I started to have a dry mouth and high heart rate within a few minutes of the vaccine. I then started to sweat and shake profusely, and I had splotchy skin on my arms and legs. I was given Epinephrine and I went to the Hospital by ambulance. I was treated and released that day. The next evening I was having difficulty breathing and I used my inhaler and it cleared it up. The following day I had difficulty breathing again but my inhaler did not work. I went to the Emergency Room. I was treated with IV Steroids, and I am taking a prescription for Prednisone. It has been four days since my Asthma attack and I feel better but I am still shaky.
pt w/demylinating lesion dx wk p/oral typhoid vax; MS neg w/ VEP neg; & MRI neg BAER neg; opitc neuritis; ANA neg & neg lyme; dx of tranverse myelitis ? etiology; ? viral
Left thigh red, tender and swollen. 3.5cm larger than right leg. Large vesicle/bulba on top of left thigh the size of a quarter.