chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That afternoon I experienced usually pain(not the usually discomfort you feel with a flu shoot)  in my left arm at site of injection,  felt like the needle was still there. Kind of burning and throbbing, pain continued to intensify. The pan traveled into the shoulder and down the arm. That night I was feeling more pain and had some difficulty  falling asleep.  The pain continued the next day and the left shoulder felt a throbbing pain and again still felt the injection site. Also I started to have swollen areas on my left arm as well as hives, that were becoming itchy. The pain in arm become intense and I was unable to lift it up or move it much, the pain become a 8 and I was totally unable to sleep. I went back to same doctor on 10/30 for the pain and swollen arm. Was prescribed Prednisone for 5 days, this helped a bit, but only while medication was in my system.  Once the s days past the pain went right back to a 5-8. I'm unable to take Advil or other pain medications due to CKD. I was now suffering with pain all day and specially at night. I continued to use ice and heat to relieve the pain and to be able to move my left arm. I went back to same doctor again on 11/15 and was diagnosis with frozen shoulder (Adhesive Capsulitis of the left shoulder/Cervical Lymphadenopathy) I will start physical therapy next week, in hope this will help me be able to move my left arm without pain. The pain is still there and goes from a 4 to an 8 at night.
Muscle and joint aches, shot site ache, headache, chills, fatigue, no appetite Treating with Tylenol. No abatement yet (9 hours later)
Reports feeling dizzy right after administration but it passed. Next day (during the night or within 12 hours of administration) felt chills,  sore throat described as hard to swallow; nausea in the night but it passed; no vomiting. Symptoms had passed by start of next work day.
pt recvd 3rd vax of Hep B between AUG90 - NOV90 from expired lot.
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Vaccine brand unknown and Vaccine lot unknown: False, Vaccine dose number unknown: False), on 17Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 07Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Murmur Since Birth" (unspecified if ongoing), notes: No underlying conditions; "borderline high blood pressure" (unspecified if ongoing), notes: No underlying conditions; "misc surgeries" (unspecified if ongoing), notes: No underlying conditions. There were no concomitant medications in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Positive; (24Apr2022) Negative; (02May2022) Positive; (04May2022) Negative; (05May2022) Negative; (06May2022) Negative; (07May2022) Negative; (08May2022) Negative; (09May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event: Recurrence of COVID-19 symptoms on Day 19: runny nose, sinus pressure, fatigue. Day 0 of mild COVID symptoms 22Apr2022; tested positive 23Apr2022; started Paxlovid 23Apr2022; still-mild symptoms resolved 24Apr2022; tested neg 25Apr2022; symptoms recurred 02May2022; tested pos 04May2022-09May2022; tested neg 10May2022; symptoms resolved by 13May2022. Rebound symptoms significantly worse (though still clinically mild) than initial Day 0-2.  Known allergies: No. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 23Apr2022, Treatment stop date: 27Apr2022, Lot number: FY8914, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown and expiry; Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient felt very sick with Corona virus (Covid-19), (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189626. This case, from the same reporter is linked to 20210824869 and 20210821314.; Sender's Comments: V0: 20210824895-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received form a physician via a company representative refers to an elderly (greater than 65-year-old) female patient. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming unit (PFU) injection, 0.65 ml, subcutaneously (lot# and expiry date unspecified). No concomitant medications were reported. Subsequently, on an unspecified date (reported as: "2 days later" after vaccination), the patient sought medical attention and consulted the physician because she was experiencing an injection site adverse effect. The physician reported that she determined that the patient's injection site appeared to have "25 zoster-like blisters", and she diagnosed the condition as shingles. The physician collected an unspecified specimen from the patient's vesicles, and she submitted the specimen for confirmation of shingles to an unspecified laboratory. The physician prescribed unspecified antibiotic and an unspecified antiviral medication for treatment of the patient's vesicles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Patient started feeling woozy, dizzy, slurring words and fatigued around 11:30am. By the afternoon he was extremely fatigued and barely ate lunch or dinner. He went to bed at 9:30pm. By 1:30am, he woke up and urinated the bed because he couldn't get his urinal in place. He was extremely weak and shaking, and could barely hold his body upright when I used the lift to get him out of bed. He was not making coherent sense when he spoke, though his words and sentences were sensical, it made no sense in context.  We sent him to the ER on recommendation of the advice nurse and 4:30am. He was checked in and showed low levels of sodium and potassium. They gave him an IV and he began to feel better very soon, though he remained weak and woozy and nauseous.  He returned home in early afternoon, but remained weak for over 2 weeks afterward, slurring words and having trouble lifting his arms, though mental  function returned by that same day. The doctors believe that he had a TIA, though no evidence of a clot showed up. They did discover that he has atrial fibrillation, though they had never detected that before on the heart exams following his heart attack.
Exteme Fatigue, muscle weakness in both legs and arms, unsteady gait, difficulty breathing anx swallowing, lower back pain, changes in voice Numbness om various body parts including left side of face.  Changes in hearing on left ear
Approximately 6 hours after the 2nd injection my shins were hurting. By 9PM  I had all over body aches and I had a slight fever (99.1). I took 2 extra strength acetaminophen.  At 6:30 am  the next morning I had a fever of 101 and I woke up drenched in sweat. I took 2 extra strength acetaminophen and slept until 3 pm.  My fever was gone and my body aches were greatly reduced. I drank  a couple of glasses of water and took 2 more extra strength acetaminophen. By 9 pm  I had no more issues.
Extreme exhaustion, body aches, spine and joint pain, throbbing headaches, numbness & tingling in hands and arms,  nausea, lightheadedness
Information has been received through the pregnancy registry concerning a 22 year old female patient with no known drug allergies and no medical history reported, who on 11-DEC-2007 and 01-APR-2008 was vaccinated with the first and second doses of GARDASIL respectively.  There was no concomitant medication.  The patient reported that after receiving the second dose of GARDASIL she found out she was pregnant.  She reported that her last menstrual period was from 02-FEB-2008 till around 14-FEB-2008 and that she was eight weeks and three days pregnant.  She also reported that after receiving the second dose, on approximately 01-APR-2008, of GARDASIL her head, stomach and her arm hurt at the injection site.  Unspecified medical attention was sought.  Diagnostic laboratory studies included a pregnancy test.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
93-year-old male with past medical history for hypertension, type 2 diabetes, hyperlipidemia coronary disease who presented emergency department 11/3 with 7 day course of cough, shortness of breath. Found to be hypoxic in the emergency department was placed on oxygen. COVID PCR returned positive. Chest x-ray showed airspace disease compatible with COVID pneumonia. Started on Decadron and admitted to Medicine Service for further assessment and management. Patient is vaccinated with Pfizer vaccine, received 2 doses. He was also started on remdesivir. Over the course of the next 2 days, patient was able to wean off oxygen to room air. During this time he was found to have severely high blood pressures, he was started on low-dose losartan which he will continue discharge. He appeared comfortable and was speaking full sentences easily. He was discharged home and will complete a 10 day course of steroids with Decadron. He has been advised to follow-up with primary care physician, particularly to monitor blood pressure as he has been started on low-dose losartan in the hospital. Patient is being discharged in stable and improved condition.
Patient was a new employee of the hospital. Her varicella titer was negative - requiring vaccination. she received it on 10/30/15. LMP was 10/10/15. She did not know she was pregnant at the time of the vaccination.
Abrupt onset of severe disabling dizziness, I believe it was not vertigo. I was seated at home, my head crashed to the table and I was unable to lift my head up because of dizziness for 4.5 hours; vomited once, regretted lunch, nausea. If I had been driving, I would have crashed. If I had been in public, I would have been carted off to a hospital. Not a stroke, not the flu. Recovered by today with slight residual nausea and slight dizziness.
Information has been received from a licensed practical nurse (LPN) concerning a 7 year old black male with no pertinent medical history or allergies  who on 22-MAY1993 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (Oka/Merck) Lot #6266688/0650H). There was no illness at the time of the vaccination. There was no  concomitant therapy. The LPN reported that on 12-APR-2006, the patient developed an itchy rash of red raised spots and pustules on his face, neck,  back and arms. The patient presented to a walk-in facility. No laboratory/diagnostic tests were performed. On 16-APR-2006, the patient's rash resolved. Additional  information is  not expected.
Since Sep2019, did not return for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Upon arrival a 14 y/o male with the chief complaint of general weakness and dizziness was found sitting upright in a POV. Vitals were as followed B/P 84/58, HR 68 O2 97%. A second ser of vitals were taken as followed B/P 120/75 HR 70 O2 99%. Lung sounds were clear and equal bilaterally, PERRL was present, PT skin was warm and dry. PT was COAx4. EMS personnel observed PT until he was stable and was returned to parental care.
Case number PHEH2015US015245 is an initial spontaneous report from a physician via a pharmaceutical company (reference nr. A201401552) received on 03 Aug 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: not reported) on an unknown date. Post vaccination the patient presented with fever and flu like symptoms. The outcome, seriousness and causality of the events were not reported.
Patient came in for her second Hep B shot when patient was in the room she showed me pictures of a rash that had developed the day after the shot. I has a doctor examine the pictures. Patient was not given another dose. Patient stated that she had not come in for the reaction on the day of because she was unsure.
I NOTICED THAT ALL OF A SUDDEN MY LEFT EYE BECAME VERY BLURRY AND IT JUST GOT WORSE. I MADE AN APPOINTMENT FOR MY YEARLY EYE EXAM AND EXPLAINED MY ISSUE WITH MY LEFT EYE. AFTER THE EXAM AND DILATION IT WAS DIAGNOSED AS A CATARACT. I HAVE SINCE MADE AN APPOINTMENT WITH A SURGEON TO HAVE THIS OPERATED ON. I AM CONCERNED WITH HOW FAST THIS OCCURED AS I THOUGHT CATARACTS STARTED AND PROGRESSED SLOWLY, THIS JUST SEEMS TO BE GETTING WORSE BY THE DAY.
First 36 hour period, ending approximately 1:00am on Wednesday 4/14, dizzy feeling, very tired requiring 2 naps on 4/13, headache, mild sore throat. chills, then sweating at night.  On Wed 4/14 from 7:00am - time of this submission (8:00pm same day) red looking rash which feels sore and tender, appeared 1 inch below the vaccination site.
hot to touch bump at injection site; bump at injection site; one inch swollen at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 07-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 VACCINATION SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site).   At the time of the report, VACCINATION SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Information was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 injection (lot# L012042, expired on 18-NOV-2016) once intramuscularly (dose unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
25 y/o female present in clinic requesting to have left axillary lymph node examined at time of encounter. Pt states that she received her first Moderna Bi-Valent booster injection on 12/02 and began to notice a tender, sore area to axilla on 12/03. Pt states that by 12/04, she noticed that there was a swollen, tender lymph node present to the left axilla when she applied her deodorant. Denies fever or any other s/s at this time and reports feeling well. Denies OTC medications. Denies having lymph node swelling in the past with previous vaccines.
This report was received from GlaxoSmithKline and was assigned manufacturer report number A1014786A for FLUARIX. This case described the occurrence of injection site cellulitis in a 33 year old male subject who was vaccinated with a dose of PNEUMOVAX 23 (lot# H014653) and a dose of FLUARIX (lot # AFLUA716BA). Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25-FEB-2013, for pneumonia. On 26-FEB-2013, at 11:06, the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26-FEB-2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25-FEB-2013. On 26-FEB-2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26-FEB-2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26-FEB-2013, and the adverse events were local injection site reactions. On 27-FEB-2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified. This was originally reported by a nurse. Additional information is not expected.
Received the first COVID vaccine Pfizer  on 06/14/21. The client presented for his 2nd COVID vaccine Pfizer today with his brother. The client alerted RN that he developed a "rash" following receiving the 1st COVID vaccine Pfizer. RN responded to the client. The client reported developing a "rash while walking to the observation area" following his 1st COVID vaccine Pfizer. The client stated the rash was a "red around where I got the vaccine." The client stated the rash was intermittently itchy. The client stated his mom put a "cream" over the rash, but did not know what kind of cream it was. The client stated his symptoms lasted for several hours. The client denied any s/s of anaphylaxis following the 1st COVID Vaccine Pfizer. The client did not seek any medical care following the initial rash. RN submitted a medical consult via text message. Approval to proceed with the 2nd COVID vaccine Pfizer was received from Vaccine Operations. RN educated the client regarding approval to receive the 2nd COVID vaccine Pfizer, s/s of anaphylaxis, when to seek EMS, to follow up with PCP regarding initial reaction symptoms, V-safe. The client was instructed to complete a 30 minute observation period. The client and his brother voiced understanding of this. The client received the 2nd COVID vaccine Pfizer on 07/06/21 Lot#EW0191 exp 09/21 at 3:01 PM. The client tolerated the vaccination well. The client did not alert the EMTs of any adverse reactions during the observation period.
leg was swollen for about 3d, tender to touch, limped, irritable, had a rash on leg; called dial-a nurse, then called MD; told to let it run its course unless it got worse
Information hs been received from a physician and a licensed practical nurse, concerning a 14 year old female patient with no pertinent medical history, allergies or drug reactions, who on 18-SEP-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot #0996), subcutaneously in her left arm, at 4:00pm. The physician reported that the patient experienced injection site reaction after receiving the vaccine; on follow-up, the nurse reported that on 09-SEP-2008 the patient experienced redness and swelling at injection site. No laboratory diagnostic studies were performed. At the time of the report the patient had recovered. The patient sought unspecified medical attention. There were no illnesses at time of vaccination. This is one of several reports received from the same source. No further information is available.
Pfizer (adult vaccine vial) was stored in freezer past stability date of 11/23/2021 and administered to patient on 12/2/2021.
Patient received Moderna COVID vaccine on 4/12/21 and 5/18/21. Patient was previously diagnosed with COVID pneumonia on 2/25/22 and was admitted at an outside facility. On 3/7/22, patient is admitted to our facility with acute respiratory failure (likely secondary to recent COVID-19 pneumonia) and alcohol withdrawal.  As of today (3/11/22), patient is still admitted in our med/surg unit.
HAD SEVERE (8-9 SCALE) NECK PAIN 4-5 DAYS POST VACCINATION #2 AND #3 OF HEPATITIS B VACCINE
Patient received COVID vaccine on 6/30/21.  She had been experiencing chronic dyspnea, lower extremity edema.  On 7/7 had some nausea, vomiting at home.  Found unconscious by her spouse a few hours later and subsequently died.
on 11/10/10 experienced body aches on 11/11/10 awakened covered in red spots on her arms, stomach and chest
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393: US-009507513-1806USA001032.