chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client stated feeling warmth and flushed face after receiving Pfizer Covid-19 vaccine, dose. Client was sitting in post vaccine waiting area. At 1023 EMT noticed client appeared uncomfortable in chair and asked how we was feeling. Client stated feeling warm and EMT saw face was flushed. PHN was alerted. When PHN arrived, client was sitting near doorway, face flushed, and was speaking with EMTs. Client alert and oriented, stated feeling warm and sweaty. EMT  assisted client to remove jacket to take vitals. 1027 vitals:blood pressure 145/90, pulse 66, o2 97, respirations 16. Client denied shortness of breath, chest pain, dizziness, headache. Flushed face, did not radiate past face, no swelling noted or rash. Allergy to penicillin and client was already aware to wait 30min after vaccine. Per client did not take blood pressure medication this morning. List of medications: allopurinol, toprol, pantoprazole, colchicine, lasix, potassium, crestor, vitamin D, praluent, eliquis, spironalactone, nitroglycerin and hydrocodone. Client given water and instructed to take small sips at a time. Client informed he would be observed for 30 minutes. Vitals 1034: blood pressure 150/70, pulse 60. Flushed face same, not improving. PHN offered client if he would like benadryl, client denied. Vitals 1040: blood pressure:130/90, pulse 61, o2 95 , respiration 16. Client stated symptoms improving. Last set of vitals at 1053: blood pressure 120/80, pulse 60, o2 95, respiration 18. Client alert and oriented, stated warmth feeling improved, face still flushed, not worsening. Client advised to speak with provider prior to receiving second dose. ER precautions given, wife driving client home. Client left facility with steady gait.
One hour after my shot I started with dizziness and  I felt like I was going to pass out. I felt like my blood pressure was low, but it was really high 160/90. My heart rate was up in the 160's. This continued all day the first day and still continues randomly to today. Yesterday I had a random migraine , and today I am running a 100.2 temperature.
SIRVA; A contactable nurse and pharmacist reported for a patient of unspecified age and gender who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a first responder received a vaccine too high in the shoulder from a volunteer nurse, leading to physician confirmation of SIRVA (Shoulder injury related to vaccine administration) requiring possible surgical repair. The first responder's supervisor did not report the event to FDA. Five weeks later, the patient was still in pain and had limited mobility of the arm or shoulder. Outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The reported shoulder injury related to vaccine administration (SIRVA) with pain and limited mobility of the arm or shoulder, was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
That Sunday night i felt off.  Monday morning I had a irritated throat, and had a sinus headache.  I felt very tired.  I also felt feverish from really hot to really cold.  I did have a temperature that night to 101 degrees.  The next day I got a rapid COVID test which was negative.   I had a virtual visit with my PCP and he diagnosed it as a sinus infection.  He prescribed medicine and a few days later I felt back to normal.
Rapid heart rate of 116-120 about 15 min post vaccine.  Scratchy throat about 30 min post vaccine. Sensation of throat closing (lump in throat and getting harder to swallow).  My husband dropped me at Emergency room.  I was triaged into a room within a few minutes.  Started to have a little shortness of breath.  Exam performed and 1 liter normal saline given IV.  25mg Benedryl given IV about 3pm.  Certirizine HCL 10mg given orally 3:46pm. Prednisone 40mg tab given orally 3:47 pm.  Monitored for 4 hours and then discharged home to continue certirizine orally daily for next 2 days along with 40mg pred orally for next 2 days if needed.  I took some sunday but not Monday.  Did okay with on off hot/cold chills monday and tuesday but now ongoing hives.
Nystagmus about 5 minutes after vaccine. Self resolved and patient able to leave on her own.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Nov2021 as dose 2, single (Batch/Lot number: unknown) and in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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. Additional information: Paxlovid was given as treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Severe, Additional Details: pt walking in the aisle during the 15 minute requirement before leaving the pharmacy, his friend yelled he had fainted when out pt came back through didnt realize he fainted. he was given water and stayed for an additonal 30 minutes. said he felt fine had no more issues and left.
Nausea, lightheadedness, headache, fatigue, sore/swollen arm
pt recv vax 4JAN96 & pt exp muscle pain/aches in ankles, knees & back & a gen rash;f/u from MD 21FEB96 pt exp abd pain;22FEB96 pt devel strep infect in throat;23FEB96 devel a papular pruritic, pimple-like rash;exp joint pain dx arthralgia,
no adverse effect; vaccine administered to patient of inappropiate age; This spontaneous report was received from a pharmacist via company representative refers to an unspecified patient who was over 50 years of age with unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in January 2020 (reported as "may be a month ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, route, vaccination site, # lot, expiry date unspecified) (product administered to patient of inappropriate age). No additional adverse effect was reported. Product quality complaint (PQC) was not involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA010791:
In January, 2000, pt began complaining of muscle weakness in lower legs. Observed by school nurse in February, 2000 after marked lower leg weakness. Parents notified and medical attention sought with MD. Weakness spread to upper body and sought treatment at USAD. Later with another MD and was dx'd with Gullain-Barre Syndrome. 60 Day FU states doctor has stated GB/CIDP probably caused from Hep B given in Oct & Nov of 99. He probably has permanent nerve damage in legs.
Pt had blisters of different sizes on arm. Pt received booster shot on Friday but did not notice the blisters till Sunday.  Area around blisters were red and warm to the touch. Recommended pt to keep an eye on the blisters/size and to take ibuprofen to help with the inflammation around blisters
after vaccination, patient felt better than she had in months since struggling with post-viral syndrome and began running again. some time after in the coming week/days, her heart rate began to fall out of control again and she had to be restarted on colchicine. unknown just how related to the vaccine.
strange symptoms/Side effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 25-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (strange symptoms/Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (strange symptoms/Side effect). At the time of the report, VACCINATION COMPLICATION (strange symptoms/Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment drugs included no concomitant drugs included
Information has been received from a physician and her assistant concerning  23 year old female who on an unknown date was vaccinated with a first dose of GARDASIL vaccine and a second dose of GARDASIL vaccine on 12-JAN-2009, lot number 661766/0652X. It was reported that the patient experienced dizziness and blurry vision after receiving the first dose of GARDASIL vaccine. On 12-JAN-2009 the patient felt like her throat was closing and took BENADRYL. On 14-JAN-2009 the patient called the office and reported her left leg and arm were numb, right hand was tingling and she was still experiencing intermittent blurry vision. The physician prescribed ZYRTEC for the next week to treat what she feels may be an allergic reaction to the vaccine. Her outcome is unknown. Follow-up information received from physician's assistant indicated that the patient was vaccinated with the first dose of GARDASIL vaccine on 28-OCT-2008, lot number 661530/0575X. Concomitant medication include FENCOM for birth control. It was reported that the patient called the office on 15-JAN-2008 to report that she was experiencing hives. Follow up information was received from the physician who noted that the patient has a long-standing "histrionic personality" and an anxiety disorder for which she takes KLONOPIN as needed. She claims to have experienced some throat tightness after dose 1, but did not report this to her physician until after his occurred with dose 2. She has had multiple symptoms of numbness, tingling and weakness of the extremities (of note, the injection was given in the right arm but complaining have been on the left side initially, then bilaterally); however, she has been able to go to work as a hairdresser. Since the development of hives, the patient has not been seen in the office and has not responded to phone messages from the physician's office. No further doses of GARDASIL are planned, given the concern about hypersensitivity. Follow-up information received from her physician indicated that the patient called the office on 15-JAN-2008 to report that she had hives and then called the office again on 16-JAN-2008 to report that she did not have hives. Additional information has been requested.
HOSPITAL COURSE: Pt. is a 74 y.o. female with PMH of CHF, COPD not on home O2, ESRD on dialysis T/Th/Sa, Afib not on anticoagulation, HTN, T2DM, and vascular dementia, who presented with SOB concerning for CHF exacerbation. She was found to have COVID pneumonia. Patient is fully vaccinated, but has not yet received a booster. After being on RA at admission, she acutely decompensated and required BiPAP. She stabilized over the course of a week and was eventually discharge on RA.  She underwent dialysis while at the hospital and was set up with followup at a dialysis center that would accept COVID+ patients.
goose egg swelling; damaged left arm; Flu shot was given wrong; Initial information received on 03-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographic) who experienced goose egg swelling (hematoma), damaged left arm (limb injury) after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was given wrong (wrong technique in product usage process).  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency, 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 developed serious goose egg swelling (hematoma) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event assessed as medically significant.  On an unknown date the patient had damaged left arm (limb injury) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   It was an actual medication error case due to wrong injection technique (latency: same day)  There were no lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   It was not reported if the patient received a corrective treatment for the events (goose egg swelling, Flu shot was given wrong, damaged left arm).  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  The patient was recovering from hematoma at the time of reporting (patient was glad as hematoma went down ).  The event outcome was unknown for limb injury.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns patient who experienced hematoma and limb injury after the vaccination with INFLUENZA VACCINE (unknown manufacturer) which was given wrongly. Time of onset is unknown. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.
Pt given 2 month vaccines and pt was only 1 month old; miscalculation in age. No adverse reactions. Pt must wait until after November 12, to start immunizations series again.
Swelling and sores on cheeks along w/ bumps on the back of tongue, shortness of air, but still able to breathe, itching around mouth.
Moderate fatigue beginning about 24 hours after vaccination.  Moderate joint and muscle pain throughout body.  Significant pain, redness and swelling at injection site - skin inflammation area has grown in diameter over time and pain at injection site is most significant today, three days post-vaccination.  Painful skin sensation, almost like all of my skin was being shrink-wrapped around me - hard to precisely describe the feeling, but it was very uncomfortable and lasted about 24 hours.  Sporadic shooting pains in left shoulder, decreasing in severity over time but not completely abated at the time of this report.  Symptoms not severe, just very abnormal to prior vaccination experiences.
Pain at injection site; Mild flu-like symptoms; Mild fever; Sore neck; Generalized myalgia; Shot felt as though it went too high into their shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix, the patient experienced injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, flu-like symptoms, fever, neck pain, polymyalgia and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, flu-like symptoms, fever, neck pain and polymyalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 4 to 6 hours after administration of the vaccine, the patient started to experience symptoms.  He had pain at injection site with moderate intensity, mild flu like symptoms which included a mild fever, sore neck, generalized myalgia.  The patient also reported, that the shot felt as though it went too high into their shoulder but in the heart of their deltoid muscle, which led to vaccine administered at inappropriate site. The pharmacist was standing and he was sitting when the dose was administered. The reporter consented to follow up.
The patient had an allergic reaction to ZOSTAVAX. She complained of dizziness, nausea, chest tightness, hot feeling right. We called her husband and 911 and she was transported to the hospital.
Hit a nerve when administering; Tingling down her arm and tingling in 3 fingers; This is a spontaneous case from initially received from pharmacist on 10-Oct-2019 via agency (reference number: SEQ19-04441), concerning a female patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.    On 10-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid left, dose, batch number and expiry date: not reported] for an influenza prophylaxis.  On the same day, approximately one hour after vaccination, the patient developed tingling down her arm and tingling in 3 fingers. Patient stated that she thought that they hit a nerve when administering.  At the time of this follow up, the patient she was fine and recovered.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow up received from pharmacist on 23-Oct-2019: The outcome for the events was provided and changed to resolved. Route of administration and anatomical location for vaccine were added. The narrative was amended accordingly.  Company comment: The patient experienced paraesthesia and administration site nerve damage, approximately one hour after administration of the suspect product, Flucelvax QIV. Chronology is plausible. More information regarding underlying medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced paraesthesia and administration site nerve damage, approximately one hour after administration of the suspect product, Flucelvax QIV. Chronology is plausible. More information regarding underlying medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
Information has been received from a 26 year old female patient for GARDASIL, a Pregnancy Registry product, concerning herself with no drug reaction/allergy and a medical history of O negative who on 26-OCT-2011 was vaccinated with a 0.5 ml dose of GARDASIL. Concomitant therapy included iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified) (reported as prenatal Vitamins). Subsequently the patient was found pregnant. There was a laboratory studies performed on 23-NOV-2011 and the result was unknown. The patient sought unspecified medical attention and was given no treatment for AE. At the time of the report, the patient was 6 weeks and 3 days pregnant. The LMP was 17-OCT-2011 (also reported as 15-OCT-2011), estimated delivery date is 24-JUL-2012. The therapy of GARDASIL was discontinued. Follow up was received that this case had mail that was returned as non-deliverable and a memo that noted the physician was not with the practice and the patient was not registered with the practice. Pregnancy outcome was lost to follow up. The case was lost of follow up. Additional information is not expected.
Since receiving my first Pfizer Covid vaccine on March 18th, 2021, I have experienced nearly non-stop tinnitus in both ears. I still went and received my second dose on April 9th, 2021. I am still experiencing the tinnitus and have an appointment with an ENT today, April 23rd.
Patient got her first Moderna COVID 19 vaccination and then did not want to wait 15 min in pharmacy area, but to walk around the store.  Patient returned 5 minutes later, reporting she vomited in the bathroom.  Patient states she didn't know if it was due to the vaccination or due to the anxiety of getting the shot.  Vital signs assessed: 126/100, P 120, Resp - normal, skin- warm, dry, pt was anxious while receiving the vaccine, tensing up her arm, did relax it prior to getting vaccine.  Pt was monitored for 10 minutes, then felt fine and left with family.
I'm having a terrible reaction to my first covid shot that I got on 1/28.  It's itchy, hot to the touch, hard, the swelling is the size of a baseball.  I have headache, I'm super tired, my pinky finger is hot and numb And my neck hurts.  I saw the dr this morning and she says it's called "covid arm" it will most likely spread down my arm and up to my neck.  I have to be careful that it doesn't turn into cellulitis
For 2 nights following the immunization, starting the night of the shot, bleeding from the injection site occurred, overnight. In the morning, her entire arm was covered in blood and her sheets wet. Her husband cleaned her up, and the next day, she did not have any bleeding.  But then the second night, again overnight, she bled heavily and woke up with her arm covered in blood and sheets wet with blood.  She also experienced leg pain so bad that she couldn't walk.  This happened after she had done some leg exercises in which she used a tension band.
Pt felt she was going to faint, had a white skin, pale and almost passed out after getting the shot, paramedics came pt's vitals were ok when they came. Mom said paramedics advised to call pediatrician since mom had a history of Basal Vagal she said and most likely her daughter might have it too.
About 6 hours post injection started feeling chills, body aches, foggy, head ache. Was in and out of state of consciousness sleeping between 8pm-1130pm 4/8/2021. Fever as high as 103 f. Wasn?t able to move felt like pins and needles over my whole body. Felt like I was on fire. Feeling as if I was outside my own body watching myself suffer. Lowest fever was 101.4 around 1am finally able to get up out of bed and feeling not so out of it. Still had chills and body aches until 6am. Lingering head ache and feeling tired and wore out as of 11am 4/9/2021