chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had severe shoulder pain the afternoon of and next day after the shot, which is generally a normal reaction. But, a few days later, I was massaging the shoulder where I had the shot (this was my first dose) and I felt a small bump under the skin right where the shot had been given. I pushed on it a little and it felt like something squishy moved around (my first thought, though probably silly, was that it was some residual vaccine component that had gotten "stuck" at the injection site and now I was dislodging it). After that, and continuing through now (over a week later) that shoulder has had a dull ache. I haven't done anything differently than before I got the shot (for ex., no exercising or injury that would have caused an ache in that shoulder).
10 minutes after vaccine she became lightheaded, fainted, tingling in both legs HR:100, 40 minutes after vaccine, sore throat, neck rash itchy
This spontaneous report was received from a nurse practitioner and refers to a 13-year-old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 04-MAY-2018, the patient was was inadvertently given an adult dose of VAQTA 50/1.0 U/ml injection, lot number N028743 with an expiration date 23-NOV-2018 for prophylaxis (route of administration and anatomical location were not reported). There was no adverse effects reported.
WITHIN 4 DAYS AFTER THE COVID 19 (PFIZER/BioNTech) BOOSTER, I DEVELOPED SEVERE BILATERAL SHOULDER AND ARM PAIN WITH LIMITED RANGE OF MOTION. I WENT TO ORTHOPEDIC AND SPINCE CLINIC AND SAW DR ON 09/7/2021 AND HE DIAGNOSED ME WITH BILATERAL ROTATOR CUFF TENDINITIS. TREATMENT: S/P TO BILATERALSUBACROMIAL SPACE WITH 40 MG KENALOG B/L SHOULDER BURSER ON 9/27/21. EXTREME PAIN RETURNED AND TREATMENT REPEATED WITH 40 MG KENALOG B.L SHOULDER BURSER ON 11/17/21 AND AGAIN IN 2/16/22. PRESCRIBED DICLOFENAC 75MG BID AS NEEDED. PHYSICAL THERAPY WILL START NEXT WEEK AND IF SYSMTOM RETURN, FR. WILL ORDER AN MRI
Pain is so bad / had an episode of passing out; Severe pain behind her right knee; Severe pain / left bicep; Unable to walk without a walker; Swelling behind her right knee; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In November 2020, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria hospitalization and GSK medically significant), knee pain (serious criteria hospitalization), muscle pain (serious criteria hospitalization), unable to walk (serious criteria hospitalization) and swelling of knees (serious criteria hospitalization). On 4th January 2021, the outcome of the knee pain, muscle pain and unable to walk were recovered/resolved. On an unknown date, the outcome of the passed out was recovered/resolved and the outcome of the swelling of knees was unknown.   It was unknown if the reporter considered the passed out, knee pain, muscle pain, unable to walk and swelling of knees to be related to Shingrix.  Additional details were reported as follows: The case is reported by husband of patient. He stated that his wife received the second dose of Shingrix and about 3 to 4 days later, she began to experience severe pain behind her right knee and left bicep. She also had swelling behind her right knee. The pain was so bad, she had an episode of passing out. She went to the emergency room and was kept overnight for observation and then discharged.  She was unable to walk without a walker. Provided medical disclaimer and advised to follow up with his wife's health care professional.  The reporter did not consent to follow-up. Note: Reaction end date is given for pain and swelling behind right knee and pain in left bicep but outcome given as not recovered. Captured outcome as recovered as reaction end date is given.  Discrepant information reported in XML and narrative for onset date of events. Events onset date captured as per narrative.
Decavac given 4/13/06, no reaction noted by pt until 4/20/06 am woke with approx 6cm x 8cm raised, reddened, warm touch, itchy, pain with pressure area at place on right deltoid where vaccine was given no bite, mark or lesion noted at the site.
bullseye rash at the injection site. The injection site was hard and warm to the touch with a bullseye rash.
This spontaneous report was received from a physician via a company representative and refers to a non-pregnant, 13 or 14 years old female patient. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On approximately 04-DEC-2017 (reported as "either on 04-DEC-2017 or 05-DEC-2017"), the patient was  vaccinated with GARDASIL 9 injection, intramuscularly for human papilloma virus (HPV) prevention (dose, lot # and expiration date were not reported). It was unknown which dose in the vaccination series of GARDASIL 9 this patient received. On approximately 05-DEC-2017 (reported as "either on 05-DEC-2017 or 06-DEC-2017"), the patient developed a rash that was itchy on an unspecified part of the body. The patient sought medical attention by visiting a pediatrician. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not assessed by the reporter.
On the same afternoon, 3hrs after the Covid booster Moderna, I developed sore throat followed by nasal congestion.  I had some thick green plaque nasal drainage.  That night I had some chills and sweats followed by coughing.  I also noted my heart rate was rapid. I could not fall asleep at all.  These symptoms persisted over 18 days and still on-going.  On January 3rd I actually felt worse with a lot of sneezing and increasing nasal discharge and excessive sputum production.  The cough was much worse.  Sometimes the cough was so bad that I could not stop coughing over 10 minutes and I did have some posttussive vomiting.  On Jan 14th I did a telehealth visit with her PCP.  They prescribed me doxycycline and Tessalon Perles.  Besides the increased heart rate,  I occasionally feel some pulling on the left side of my chest which is worse with movement or coughing.  On Jan 15th, I visited the urgent care and emergency room, took an EKG and a chest xray.  The doctor stated that I had strong immune reaction to the booster shot, and prescribed albuterol 90 mcg/actuation inhaler with assist device for inhaler.   I had a negative COVID test prior to the booster and subsequently has had a PCR test which was negative.
rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.
Constant deep massive aching pain in shoulders upper arms. Muscle wasting. Motor skill not functioning properly weak. Thought I was going paralyzed an that I was going to die. Terribly tearfully, painful, even on pain killers. Pain even doing nothing. Physically, psychologically damaging. Loss of sleep and work and exercise. Taking pain killers, sleeping pills and anti depressants. Still not better. Not 100%.
Extreme headache; Sick; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on an unknown date in Jul2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown start date and unknown if ongoing. On an unknown date in Jul2021, about 10 mins after receiving the first dose, the patient experienced extreme headache. It was making the patient sick and was right behind the ears and the patient had never had a headache here before and that bad. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme headache and sick was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
severe diarrhea; vomiting; Generalised rash; Accidental exposure; Exposure via skin contact; This literature marketed report has been received from the authors of a published literature article, titled as stated below concerning to 30- year-old female patient. The patient's concurrent conditions included breast-feeding and Crohn's disease. No information was provided regarding the patient's medical history, previous drug reactions, allergies and concomitant medications.  On an unknown date, the patient's three-month-old infant was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (also reported as "RV5") for prophylaxis (strength, dose, lot number and expiration date were not reported).   On an unknown date, within a few hours after her three-month-old infant received the vaccine (also reported as "potential indirect exposure"), the patient developed a generalized rash. She also developed severe diarrhea and vomiting and was hospitalized due to these events. The outcome was not reported.   Potentially, due to the indirect exposure, the authors considered the patient's events to be related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  A copy of the published article is attached as further documentation of the patient's experience.
chills, headache, nausea, tiredness, allergic reactions( primarily on left side of head, swollen ear, jaw, neck, rash on scalp, some weakness and dizziness)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 14:00 as dose 1, single (Lot number: EP6955) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bladder Cancer" (unspecified if ongoing); "Anterior left hip replacement" (unspecified if ongoing), notes: Anterior left hip replacement. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid tablets from 01Feb2023.  Clinical information: No known allergies were reported.
Lips become puffy/inflamed. Visited ER based on phone nurse recommendation to get evaluated.
Diarrhea starting 7/22/22 and continuing through 7/28/22
Generalized redness at site of injection and surrounding area, hardened, whitish area near injection site, area warm to touch.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 25-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt received Pfizer dose 1, in waiting area pt reported feeling unwell. Pt was diaphoretic, pale, reported feeling light headed, dizziness, nausea, and saw stars. Pt reported feeling as if he "couldn't see or hear", tingling in extremities.  Pt denied any SOB/difficulty breathing, pt reported no PMH or medication/substance use. Pt did not faint or vomit. Measured BP with SBP in 80s with nadir at 60/57 at 10 minutes post injection. Pt given water and monitored closely. EMS contacted, when EMS arrived and assessed pt, at which point SBP returned to normal and pt went home with mother.
Localized swelling & inflammation to site tx 10 days later w/Cortisone IM & antihistamines;
I contracted COVID-19. I started with a sore throat. That night it had turned into a really sharp sore throat. The next morning my sore throat was gone, but it was croaky. The next week I still had a croaky voice, coughing, runny nose, and tiredness. On day 7, 8, or 9 all my COVID-19 symptoms were gone. My doctor told me to quarantine. I took some cough medicine and TYLENOL. I never had a fever.
sm raised reddened area bilat on legs; none noted on trunk or inc ext; sent to ER non present hwen seen in ER; 15min p/initial event;
Uveitis; Full body inflammation, especially along spine; Full body inflammation, especially along spine; Joint pain; Spine pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Lot number: ER8732) at the age of 37 years as dose 1, single and administration date 14Apr2021 (Lot number: ER0729) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Latex allergy/Nitrile allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: UVEITIS (medically significant) with onset 2021, outcome "not recovered", described as "Uveitis"; INFLAMMATION (non-serious), SPONDYLITIS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Full body inflammation, especially along spine"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain"; SPINAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Spine pain". The events "uveitis", "full body inflammation, especially along spine", "full body inflammation, especially along spine", "joint pain" and "spine pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uveitis, inflammation, spondylitis, arthralgia, spinal pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Left thigh, area approx size of 50 cent piece, slightly swollen and red. No pain noted. Appeared 2nd day after injections. Instructed mother to contact family physician. 8/29/03 TC to mother, red area almost gone the next day (8/21/03). Did see Dr and no treatment.
This is a spontaneous report from Pfizer sponsored program. A  contactable Pharmacist reported that a female patient of an unspecified age and ethnicity suffering from Rosacea received the first TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pain and redness at the injection site on an unspecified date with outcome of unknown. The reporter commented that this likely to be worse in patients with Rosacea.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with no pertinent medical history and drug allergies reported, who on 01-DEC-2012, was vaccinated with ZOSTAVAX (lot #, dose and route note provided). No concomitant medications were reported. The pharmacist stated that on unspecified date, a patient who received ZOSTAVAX on 01-DEC-2012 presented to the pharmacy to fill a prescription for Prednisone 60 mg daily for 5 days and an unspecified antibiotic to treat a respiratory infection. There was not specified if the patient developed the symptoms after receipt of ZOSTAVAX. The pharmacist stated that the patient's respiratory infection was not related to the receipt of ZOSTAVAX. The patient sought medical attention by physician examination. The outcome of respiratory tract infection was reported as not recovered/not resolved. Additional information has been requested.
A MD reported 14yr old male revaccinated w/a booster dose of MMR developed epididymitis & orchitis. He was hospitalized & later recovered.
Much heavier than normal menstrual cycle and fatigue 3 weeks after 1st Moderna vaccination.  Soreness at injection site in 2-3 days following vaccine, but nothing else immediately.
Information was received on 17-MAY-2017 from a nurse who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that an unspecified patient potentially received one or more doses of the three dose vaccination of GARDASIL 9 (lot, expiration, dose and site unknown) after 26 years of age. The nurse reported that she received all three doses of the three dose series at an unspecified physician's practice (vaccination dates not reported). No adverse effects reported. Additional information has been requested.
Spouse took me to the walk-in clinic  about 6:30 pm today after I had a near-fainting spell around 5 pm. I was working on the floor and had a very dizzy spell when I stood up and had to sit for awhile. I took one 325 mg aspirin as a precautionary measure. My BP at home ranged from 137/73 pulse 53 to 109/61 pulse 47. Pulse was as low as 44 at one time. My BP was even lower at the clinic. Clinic did an EKG and it looked identical to the one taken 6 months ago. The clinic physician decided to prescribe half the dose of Verapamil thinking that the low pulse may be due to the medication. He told me to follow up w/my cardiologist. The only thing I did differently today was having a snack rather that a full lunch. I drove back from the beach yesterday where we biked a few times and swam some in the resort pools. I had no issues until this afternoon.
I had a little bit of a fever which prompted me to test at home. I had really bad coughing and lack of energy. My O2 stats went down to the low 90s. My peak flow dropped almost to half. I contacted my PCP she recommended I go to the ER. The ER treated my asthma with a treatment and my O2 stats went back up.
experienced numbness and tingling on her left side, which is the side she has terrible palsy; experienced numbness and tingling on her left side, which is the side she has terrible palsy; experienced numbness and tingling on her left side, which is the side she has terrible palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Exposure to COVID-19", start date: 06Jan2022 (unspecified if ongoing), notes: Caller said that she was exposed on the 06Jan but she don't experience any symptoms. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 03Feb2022, outcome "unknown" and all described as "experienced numbness and tingling on her left side, which is the side she has terrible palsy".  Clinical course reported as the patient received the Pfizer covid-19 vaccine booster shot on 25Jan. she has a underlying terrible palsy. she experienced numbness and tingling on her left side, which is the side she has terrible palsy. she wanted to know if the side effect was from the booster. she was exposed on the 06Jan but she don't experience any symptoms. She wanted to know if she needed to take a test for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache (migraine), nausea, Body Aches,  fatigue, chills
Information has been received from a physician concerning a 6-12 week old patient who was vaccinated orally with a first dose of ROTATEQ.  On an unspecified date the patient experienced bloody stools.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Upon internal review, "bloody stools" was considered an other medically important event (OME).  This is one of several reports received from the same source.  Additional information has been requested.