chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 41 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: NYQUIL, start date: 22Apr2022, stop date: 24Apr2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: tested: (02May2022) Positive, notes: tested positive for COVID again. Therapeutic measures were taken as a result of Covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
pt recvd flu vax & w/in 48 hrs the pt developed soreness @ the inject site;
COVID after COVID Vaccines; COVID after COVID Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 3 (booster), single (Lot number: FD0809) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Lot number: EW0178) and on 24Jun2021 as dose 2, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history included: "Heart Stent placement", start date: 2016 (unspecified if ongoing), notes: Caller states that her husband had 2 stents placed in 2016 and one placed in 2017; "Heart Stent placement", start date: 2017 (unspecified if ongoing), notes: Caller states that her husband had 2 stents placed in 2016 and one placed in 2017; "Heart", start date: 2016 (unspecified if ongoing); "Heart", start date: 2017, stop date: 2018; "Blood pressure" (unspecified if ongoing); "Heartburn" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies; "Neuropathy in feet" (unspecified if ongoing), notes: Neuropathy in feet. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID] taken for cardiac disorder, start date: 2017 (ongoing); BREO ELLIPTA taken for asthma (ongoing); ESOMEPRAZOLE MAGNESIUM DIHYDRATE taken for dyspepsia (ongoing); EZETIMIBE taken for blood cholesterol (ongoing); FLUOXETINE HCL DAEWHA taken for depression (ongoing); FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity (ongoing); GABAPENTIN taken for neuropathy peripheral (ongoing); INCRUSE ELLIPTA taken for asthma (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); NITROGLYCERIN taken for cardiac disorder, start date: 2016 (ongoing); PROAIR HFA taken for asthma (ongoing). Past drug history included: Brilinta, reaction(s): "allergic to the medication Brilinta", notes: Her husband is allergic to the medication Brilinta. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Nov2022, outcome "unknown" and all described as "COVID after COVID Vaccines". Caller denies any labs, testing, or treatments relevant to these events (as reported).
Began Saturday, 2/26/2011. Woke up nauseous with funny feeling in head and not feeling good. Then she thought she might be hungry or cold. She ate and put on her robe but the illness got worse. Felt hot and cold, achy, tired. Feeling more lightheaded. Got worse with laying down the rest of the day.  On Sunday, coughing very bad and through up from that. Started having dizziness on standing up. Still had really bad body aches, hot and cold. Constant headache. Noticed right ear hurt a little on and off. Lost her voice that day.   As of 2/28/2011, had blurred vision in addition. Slept all day. Ear pain continued.    On 3/1/2011, voice worse, hoarse, still having hot and cold feelings, scratchy irritated throat.  Photophobic and sensitive to motion.
SWELLING OF LEFT LEG FROM UPPER THIGH TO KNEE LASTING 3 DAYS. ADVISED GIVE OTC MOTRIN, TYLENOL FOR RELIEF OF PAIN SWELLING. MONITOR IS SWELLING INCREASES OR CONTINUES FOR LONGER THAN 5-7 DAYS CALL OFFICE FOR FURTHER INSTRUCTIONS.
When it was first noticed.  Tic of left eye that has gotten progressively worse.  Vaccines given against my judgement, despite my concerns for neurological adverse events given the history of sensory integration issues and apraxia, as well as undiagnosed signs and symptoms of autism spectrum disorder when he was younger.  Patient also developed a bad cough that lasted for 5 weeks following immunization (and this child has not been sick with a cold or cough in years!)
Injection site reactions: pain, tenderness and swelling (hardness), and redness(spread btw day 2 & day 3) ; the swelling spread from the injection site down to the inside of my arm(the swelling spread outside the area that was red); arm soreness + Weakness; tingling and numbness down my arm; sensitive to the touch; throbbing would hurt sometimes; area was hot to the touch, area would feel like it was on fire; extreme itchiness; Overall the swelling/redness got worse Day2 and Day3, and little by little the area/arm started to feel and look better day by day after day7 the area looks like a big bruise. General side effects: extreme fatigue, headache, muscle pain, body aches, chills, was really cold, nothing would warm me up; No appetite; (these symptoms were Day#2 + Day#3) mild congested cough; coughing fits day #2 + Day#3, then lingering cough here and there; (coughing was 3-4 days)
Severe fever and chills, flu like symptoms approx. 8 hours after injection lasting approx. 36 hrs.
Had a sore injection arm after his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose). At the time of the report, VACCINATION SITE PAIN (Had a sore injection arm after his 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Swelling and redness at injection site; temperature of 100.9 for 1.5 days; sever headache for 3 days.
PATIENT CALLED @9:30AM 10/7 AND STATED THAT SHE HAD CHILLS AND WAS HOT AND COLD BUT NO FEVER @6PM ON 10/6, THE DATE SHE RECIEVED HER SHOT. SHE TOOK TYLENOL AND THEN AGAIN 4 HOURS LATER. SHE HAD A HEADACHE THIS MORNING AND TOOK TYLENOL AGAIN. CHECKED BACK IN WITH PATIENT AROUND 6PM AND SHE STATED HER SYMPTONS RESOLVED
local induration 8/6/1CM tenderness & redness x 5 days;local ice & APAP
Patient returned to clinic after administration with swelling to injection site. Ice pack was applied. No erythema or hardness. Denies dizziness, nausea, headache or any other adverse effects. Swelling reduced with ice- advised to continue to ice site and take OTC analgesic if needed- stated understanding.
Adult formulation of Pfizer given.  11 years old, should have received the Pfizer 5-11 formulation
barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent.  A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a  headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered.  The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.
Two inches below injection site, Experienced large knot and intense redness about 3"inches in diameter. Duration one week. Have darkness remaining a site which gets very red in shower.
For 2 days he felt very sick, low grade fever for short time, aches, pain, tired, flu like symptoms and then he was fine.
Patient was nauseated within 15 minutes of receiving first dose of Moderna vaccine, patient  waited another 20 minutes while companion gave her a sprite and a benadryl tablet.  At the end of that time patient was feeling better and decided to leave with her companion.
I was on Day 4 of my menstrual cycle when I was vaccinated. My cycle ended on 1/16 (Day 6). On 1/27/21, I started my menstrual cycle again and reported this to my Family Nurse Practitioner on 2/2/21 which was Day 7 of the irregular cycle. I now have polyps for which I need to have surgery to remove them in February 2023.
Red, itchy  rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone  60 mg x 5 days and  trimcinolon 0.025% topically
Presented to ER on 12/15/21. brought in for the evaluation of generalized weakness and AMS since Sunday.  Most of the history is gathered from chart and ED physician.  Patient is not fully cooperative with interview.  As per daughter patient has not been behaving herself lately since Sunday.  Patient denies any cough, fever, chest pain, palpitations, abdominal pain, urinary problems but patient is seems very unreliable with her history given her non cooperation.  As per daughter patient has history of dementia. Started on azithromycin, ceftriaxone, and remdesivir. Was on 2L NC. Discharged on 12/28/21
Temperature 101, body aches, chills, headache short of breath, fatigue, sensitivity to light and sound
lt arm swollen & red from inject site down to below elbow; pt favoring arm; mom reports temp of 101 on 13APR94; arm swollen on 14APR94 but improving;
Redness 3x5 inches circular around injection site; hot to touch. Gave patient Benadryl and cold compress.
Fine, red rash appear to abdomen, arms, chest within 3 hrs after vaccine administration.
Within approximately five minutes of injection, I experienced increased sweating, light headedness, and difficulty seeing  until I passed out unconscious for a minute or two.  When I awoke I was still sweating and cold for the next five to ten minutes.  Paramedics checked my vital signs onsite afterwards (blood pressure, sugar levels, and pulse) and everything appeared to be normal.  I was able to drive home 30 minutes later after making sure that all side effects subsided.  I have not experienced any other side effects from the vaccine.
Severe Tinnitus (low pitch, buzzing) in right ear.  Evaluated by ENT MD.  No treatment.  Improved somewhat after 3-4 weeks but still present.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-MAY-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 03-SEP-2016, the patient was treated by a physician assistant for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
STREAKY LINEAL MASS ON RIGHT SIDE AXILLA; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced inappropriate route of vaccination. On 25-MAR-2021, the subject experienced streaky lineal mass on right side axilla. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from streaky lineal mass on right side axilla, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious.
Moderna Bivalent pediatric 0.2ml was given instead of new guidlines of Moderna Bivalent adult  .25ml.
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear.   By 2:00 pm that day was experiencing  a dull headache centering on my temple.  I went home from work to lie down.  The headache and numbness lasted into the next day.  At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
Day of 2nd vaccination (3/15/21) arm hurt and by the second day I noticed limited motion with pain.
Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No risk factors for DVT.  Unknown lot number for vaccine. Not done at my faciluty
A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient went to get the shot on 26Apr2021 and on 28Apr2021 he was diagnosed with COVID. They wanted to know if they need to get the second shot or delay it. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms started 12 hours after vaccination, and persisted until 36 hours.
shivering like crazy; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovering/resolving.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that had the second shot and had a fever and shivering chills like crazy throughout the night. The patient stated that was feeling better on the day of reporting. The patient had a question for the boyfriend who was 55 years old and need his 2nd shot and has to pay out of pocket and was there and discount he can get. The patient work in a medical field and with animals and know the important to let people know when there is reaction.
The same day coming from Laredo, TX to Midland, TX exp body aches in my back. I started feeling cold chills took 2 Tylenol on that Monday. On Tuesday around 3:00 am started chills (bilateral hands), body felt cold and very hard for me to walk. Due to the chills I was taking warm  showers (10 mins) for my body to get to regular temp. I went to Urgent Care get tested. The following Friday I felt really,really bad I thought something else was going on with me. I called the Urgent Care again I began to have fever was told might be side effects from vaccine. I followed up with PCP on 1/14 advised to take the second dose and continue taking vitamins.
right facial bells paulsey; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jan2021 for covid-19 immunisation. The patient experienced right facial bells paulsey on Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  Information of Lot /batch number has been requested.
COPD/asthma Exacerbation. New deeper bronchial cough started about 10/22/1023. Consulted facility/Dr on 10/27. Saw Dr at Facility on 10/27 who diagnosed it as a COPD/asthma Exacerbation. He prescribed an antibiotic and Prednisone. This reduced the new cough by 10/30. The COPD breathing and cough symptoms persist at a level a little worse than previously.
Patient felt feverish, chills at 12:00 am.  Headache, backache, weakness in arms and legs, dizziness, tightness in chest - difficulty breathing at 6 am.  Given hot shower,  Tylenol 650mg, Gatorade.  Motrin also given.
Client received zoster vaccine 11-27-12. Reports she has shingles pain on forehead into (R) ear. Denies having vesicles. Reports PP will put her on acyclovir. Denies being immunocompromised or on immunosuppression therapy. States she had chicken pox scars from childhood.
Pt vaccinated with Pneumococcal vaccine, attorney alleges that as a result of immunization, pt developed Guillain-Barre Synd and is partially paralyzed.
Headache Chills then fever Body ache Sneezing Duration: 3 PM to Midnight (sleep)
Vocal tic (repeated word and throat clearing) numerous times a day (approximately 75-100) every day.
pt recv vax FEB97 & devel yellow sclera;pt presented to school nurse;pt MD dx hepatitis;pt was OK @ time of vax but the yellow sclera persisted;
Headache onset 12 hours after shot  Body aches about 24 hours after shot Fatigue - lethargy for the next 48 hours Still feeling tired/lethargic over a week later
I am a breastfeeding mom. I woke up with pain in my left breast and symptoms of a fever. I realized I had a clogged duct. I notified my doctor. I have been breastfeeding for 13 months and never had a clogged duct before. I used natural remedies and was better within 48 hours.
Vision is left eye was odd for about 5 minutes and slowly went back to normal within 5 minutes.  Best way to describe is my vision out of my left eye was slightly impaired as if I were holding an eyeglass lense up to my left eye that was slightly different from my prescription  so that my vision and spatial orientation was a little bit off with that eye.  Another analogy is if you were wearing your reading glasses walking around the house so that your distance vision s a bit off.  Vision wasn't foggy or blurry.  I could still see out of the left eye, but it just had that minor impairment
Red rash on arm, a few inches away from actual injection site. Swelling, tender, pain.
Dr. called us informing the pharmacy that the patient was experiencing pain that radiates from the injection site on the deltoid to the elbow upon pressure on the site. The patient told the doctor that she experienced the pain after she received the injection and went to the doctor today (12/19/17) when the pain got worse. The patient inquired with the doctor whether it was normal to have the pain last for that long to which the doctor stated that he told her "no." The doctor stated that the patient received the injection on the left arm but the documentation made by the pharmacist who gave the shot said right arm. I could not talk to the doctor for too long the first or second time due to him having other patients to see. Therefore, this is the extent to the information I could gather. I could not reach the patient in any of the three phone numbers we had available. Dr. asked the patient to come to the pharmacy. I tried reaching the doctor again for further information on the patient's medications and about the injection site but he was busy with patients so the pharmacy had to leave a message. The pharmacy could only infer the conditions of the patient based on the medications she receives regularly at the pharmacy.
Tingling and burning in hands and feet; dizziness; body parts numb at night (e.g., hands, feet, face, shoulder, torso).