chrisvoncsefalvay/vaers-outcomes huggingface dataset:
still having issues with her right ear due to hearing/she cannot hear as well as she could prior to the 1st vaccine; feels like her forehead is hot but doesn't have a fever; ear was red and itrritated; ear got sore pain radiated down her neck; pain radiated down her neck; piece outside of her ear swelled up; tiny bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (tiny bit of a sore arm), EAR PAIN (ear got sore pain radiated down her neck), PAIN (pain radiated down her neck), EAR SWELLING (piece outside of her ear swelled up) and ERYTHEMA (ear was red and itrritated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (tiny bit of a sore arm). On 19-Mar-2021, the patient experienced EAR PAIN (ear got sore pain radiated down her neck), PAIN (pain radiated down her neck) and EAR SWELLING (piece outside of her ear swelled up). On 16-Apr-2021, the patient experienced ERYTHEMA (ear was red and itrritated). On 22-Apr-2021, the patient experienced FEELING HOT (feels like her forehead is hot but doesn't have a fever). On an unknown date, the patient experienced HYPOACUSIS (still having issues with her right ear due to hearing/she cannot hear as well as she could prior to the 1st vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 23-Mar-2021, PAIN IN EXTREMITY (tiny bit of a sore arm), EAR PAIN (ear got sore pain radiated down her neck), PAIN (pain radiated down her neck) and EAR SWELLING (piece outside of her ear swelled up) had resolved. At the time of the report, ERYTHEMA (ear was red and itrritated), FEELING HOT (feels like her forehead is hot but doesn't have a fever) and HYPOACUSIS (still having issues with her right ear due to hearing/she cannot hear as well as she could prior to the 1st vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 99 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  On 16 Apr 2021, the patient went to her doctor.Treatment for the events included unspecified ear drops.   This case was linked to MOD-2021-276330, MOD-2021-276330 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received and contained significant information updated new event she cannot hear well as she could prior to the 1st vaccine.
Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose.; Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose.; flushing; This is a spontaneous report from a contactable consumer. A female patient (consumer's daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified age, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller's daughter had her appointment for the second dose of the Pfizer covid vaccine cancelled twice and it has almost been a month and a half since her first dose. Caller wanted to know how long the second dose of the vaccine may be given for it to be considered effective and asked do you have any information on the effectiveness of the vaccine if only one dose was received. Caller mentioned that she experienced some flushing after receiving the first dose on an unspecified date and wanted to know if this has been reported prior. She stated that this has been the third person she was transferred to, potential duplicate AE report filed and asked was it okay to get the vaccine if you have a cold. Outcome of the events was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Post vax, the pt was fussy for 2 days, had a stomach ache, crying and screaming, episodes of body stiffening, excessive sleeping, fever. This child complained of crampy abdominal pain, cramping so severe it would cause the child to become pale and have periods of lethargy.  At that point there was a large filling defect at the ileococal valve with a rim of barium suggesting the ileum present. Dx of intussusception was made.
Prior to this: In December of 20201 - I had a rapid heart rate of over 130 beats per minute  (with a blood oximeter) for maybe a half an hour. They gave me an EKG - my heart rate at that point was normal.  I went to Urgent department on September 19th because my heart was beating fast.  They sent me to a Cardiologist - set me up with a tech who gave me the monitor before I see him. Two weeks ago I had a rapid heart rate  - at home EKG - Cardia - 130 beats per minute for over an hour.   I wore a heart monitor for 2 weeks and I just turned that in today. They did blood tests and everything on those was normal. No treatment as of yet.
Abnormal bleeding began the following morning after vaccination, on November 17th. It was not time for my cycle. Bleeding continued for approximately 7 days with the passing of clots. This was documented with my OBGYN. Taste became distorted on November 19th, three days after vaccination, and to date has gotten progressively worse. Taste and smell is that of a strong chemical. On and off chest pain has occurred over the course of the last 3 weeks. Lips are tingly and swollen on the left side, where prior allergic reactions have occurred.
Pt call on 10-15-15 said arm was red, hot and swelling, call was about 7:00 pm, was told to try BENADRYL and Ibu and if not better in morning to see a doctor.
Patient came to the ED with generalized weakness and nausea.  Patient admitted to the hospital with Covid and treated with remdesivir.
pt exp tonic clonic sz activity of unclear duration; pt had fever morning of admission; in ER lethargic consistent w/post ictal state; WBC 17,700 w/nl diff; pt had another sz; final dx grand mal sz & acute post pertussis vax encephalitis;
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis Per COVID-19 Vaccination Card patient received Pfizer vaccine dose #1 on 5/19/21, and Pfizer dose #2 on 6/9/21. Patient presented to Hospital on 6/11/2021 and was transferred.  On the evening of 6/9 patient began to experience mild chest pain with headache. On 6/10 the pain increased to an intesity of 8/10, and on 6/11 the pain became unbearable.  Pain is described as sharp, squeezing, and constant.
p/vax pt suddenly went into sz w/stiffness of upper & lower extremities, spinal column was aching forward;pt was assisted to floor to avoid falling;P120, eyes rolled upwards, shaking whole body;
Progressive Diarrhea, Vomiting, Back Pain, Body Aches, HA.  From 033009 --> 033109 To ER Admitted Observation.  Discharged 040109.  To School 040209.4/15/09-records received-for DOS 3/31/-4/1/09-DC DX: Adverse reaction to meningitis vaccination. Allergic rhinitis. Presented to ED with C/O severe achiness, discomfort, crying from discomfort, feeling nauseous, admitted. Symptoms began with sore throat and tightness in throat, achy all over, pain in low back and neck. Diarrhea and feeling chilled with some rigors. Mild cough.One episode of vomiting. At time of discharge back to normal self.
Guillain-Barre Syndrome; LE weakness, gait difficulty; she is admitted to hospital and is receiving receiving IVIG
tingling in her arm; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly in left arm on 26Dec2020 18:30 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient was not pregnant when receiving the vaccine. If COVID prior vaccination: No. If COVID tested post vaccination: No. Concomitant medication in two weeks included ibuprofen, lansoprazole, levocetirizine. The patient experienced tingling in her arm on 26Dec2020 with outcome of not recovered. After the injection the patient experienced tingling in her arm which she described as "the patient thought they hit a nerve. That's what it felt like." The tingling was "kind a constant very full light tingling most of the day/constant." No treatment received for the event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
"Light headed and felt a little warm." Patient was transported to ER and reported to start to feel a little better when arriving.
Area (left upper arm) where Moderna Covid 19 was administered, I've had palpitations, tingling with electric shock in that area, leaving my arm numb
Seizure that lasted about 3-5 minutes , has history of Epilepsy  with last seizure about 8 months ago
SORE ARM; FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: flu (Early 30's the patient almost died from the flu). The patient previously received first dose and second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 1). The patient previously received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported administered for covid-19 prophylaxis. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 2). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and fatigue (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fatigue and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221131432.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot# R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes. Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number NJ37L, expiry date 30th June 2019) for prophylaxis. On 4th October 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 4th October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALNET 2018-2019 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2018-2019 season on left arm. The pharmacist reported that the patient was seen by her physician.
This case was reported by a consumer via interactive digital media and described the occurrence of kawasaki's disease in a 11-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, 7 days after receiving Meningococcal B vaccine, the patient experienced kawasaki's disease (serious criteria hospitalization and GSK medically significant) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the kawasaki's disease and sickness were unknown. It was unknown if the reporter considered the kawasaki's disease and sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: The reporter stated that, my oldest daughter got the meningococcal b vaccine when she was 11 to start fifth grade. A week later, she was sicker than she ever been in her entire life and a few days after that she was being admitted to the children hospital with all the symptoms of Kawasakis disease. The reporter stated that I owe this vaccine a giant thank you for opening my eyes.
she got sick for 12 hours; Part of her body was hot and part was cold.; Part of her body was hot and part was cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, Covid-19 First dose: , Lot: EL9265, Expiry date: 31May2021, Dose Unknown, injection in the left arm for all 3 doses.), administration date: 05Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Caller said that with the first dose she had nothing". The following information was reported: FEELING HOT (non-serious), FEELING COLD (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Part of her body was hot and part was cold."; ILLNESS (non-serious) with onset 26Feb2021, outcome "recovered" (26Feb2021), described as "she got sick for 12 hours". Therapeutic measures were taken as a result of feeling hot, feeling cold.  Follow-up attempts are completed. No further information is expected.
Fever; Muscle aches; Not feeling well; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis.   On 26th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, muscle pain and feeling unwell. On an unknown date, the outcome of the fever, muscle pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The patient noticed after dose 1 of Shingrix muscle aches, not feeling well, and fever. The healthcare professional reported events lasted 2 to 3 days after dose 1 and then completely resolved.
Drug side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Drug side effect) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Drug side effect). At the time of the report, ADVERSE DRUG REACTION (Drug side effect) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Causality for co-suspect product (HUMIRA) was reported as probable.  No concomitant medication information was provided. No treatment medication were provided.
Patient developed purpuric rash 2 weeks after given Hep B vaccine on 7 Feb 2008.  Over subsequent 2 weeks developed edema and red colored urine and he developed acute respiratory distress 19 March.  Pt was then admitted through 28Mar to MC and underwent bronchoscopy which revealed hemosiderin laden macrophages c/w DAH.  Pt underwent renal bx 21Mar08 and was diagnosed with a crescentric glomerulonephropathy > 60% crescents, marked interstitial edema, non-specific immune staining for IgA, IgG and C3, no TRI's. Pt's clinical symptoms were both nephritic and nephrotic, (nephritic sediment with > 9 g protein excreted daily).   ANA/ENA, dsDNA, ANCAs, anti-GBM, Hep C viral load, HIV all negative.  C3 low, C4 normal, C2 low.    Patient underwent pulse Solumedrol 1 gram IV x 3 days, then 60 mg oral qd.  Patient readmitted 2-7 April for worsening edema and dyspnea.  Evaluation at that time revealed worsening nephrosis, serum albumin 1.5, massive anasarca, pleural effusions, ascites, and creatinine 3.0 mg%.  Patient pulsed again with 500 mg Solumedrol x 3 and given 1.0 grams cyclophosphamide IV on 4 April.   Pt has had progressive anasarca and treated with lasix, albumin and metolazone on 17Apr08. Continued on prednisone 200 mg qod. Began plasmapheresis on 24Apr08 1.25 plasma volumes x 3 sessions.  07/11/2008 MR received for 2 admissions DOS 3/19-28/2008 and 3/28-29/2008 with D/C DX:  Henoch-Schonlein Purpura and Microangiopathic Hemolytic Anemia. Subendocardial ischemia. Pt initially presented as an outpt with c/o 3 week hx of bilateral lower extremity swelling with rash around the ankles which began 3 days s/p Hep B vax. Thought to be HSP and treated with steroids, although full course not taken.  pt presented for admission with dyspnea, non-productive cough, chills and hot spells. Pt still with c/o swelling of feet and rash which had decreased from thigh level back to ankles.  PE (+) for 4/5 strength, tremor with arm raise, 3+ pedal edema to ankle bilat. Coarse breath sounds noted. Purpuric rash now macular to medial ankles. Pt admitted in Acute Renal Failure showing early respiratory distress and worsening renal failure from shock vs multilobar pneumonia. Renal fxn declined during admit. Tx with Solumedrol with improving respiratory fxn. D/C for outpt plasma apheresis, however halfway through tx pt developed sharp, substernal chest pain and light-headedness and SOB. Pt hypertensive.  Admitted again for PRBC transfusion with improvement in sx.
Administered varicella in R deltoid at 1626 immediately pt states "itching at 1630, pt deltoid muscle swollen and redness around site.
36 hours with fever, dizziness, diarrhea, cramps, chills, difficulty breathing, tightness in throat, bad taste in mouth, head congestion, coughing, bloody nose
Flu/flu like symptoms; got the sicker than hell; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves patient (unknown demography) who got flu/flu like symptoms (influenza) and got the sickest have ever been after (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date 17 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu/flu like symptoms (influenza) and got the sickest have ever been after, sicker like heck (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of the events was unknown.  There will be no information available on the lot number for this case.
Sudden onset of chronic diarrhea 6 weeks after shot. No previous history of GI issues.  Conditions still currently persist.
I had a sore throat. It moved into my sinus the next day and my nose was running. Didn't feel like doing anything. I had a fever 101.0. My sinus problem lasted for days.
Vaccine expired on 8/31/2022; vaccine administered on 9/2/2022. No known adverse reaction.
Shingles vaccination #1 of 2 - upper left arm. Administered:  11/18/19: 5:00p - received vaccination 7:00p - pain increasing at injection site 9:00p - feeling feverish 11/19/19: 9:00a - temperature 100; body aches; more pain at injection site. 2 Advil 7:00p - body aches, feverish, pain in upper arms, 1 Advil 11/20/19: Slept 11 hours. Chills and feverish during night; redness at injection site 9:00a - temp 97 11:00a - temp 98.6 2:00p - feeling better.  8:00p - 1 Advil, pain decreased at injection site. 11/21/19: 7:00a - feeling better, about 90% back to normal; redness at injection site; pain decreased.
Patient presented to drive-through requesting a Janssen COVID vaccine. She replied yes when asked if she was getting her first COVID vaccine today, and answered "no" to "Have you ever received a COVID-19 vaccine?" on her paperwork.  After assessment, she received her vaccine without incident, and subsequently waited 15 minutes with no problems.  It was discovered while entering data in database that the patient had received a dose of Janssen vaccine on 04/08/2021.  The patient was contacted by RN, who verified that she did receive the vaccine on that date.  She also stated that the vaccination provider recommended an additional dose of Janssen in six months.