chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NUMBNESS ON FOOT; LEG PAIN; This spontaneous report received from a consumer concerned a female of unspecified age (race and ethnicity not reported). The patient's height, and weight were not reported. The patient's concurrent conditions included low platelet count.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, ) dose, 1 total, administered ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter mentioned of blood clots in the news and was concerned due to having leg pain and numbness on her foot with history of low platelet count.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events leg pain and numbness on foot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: The case concerned a female patient of unspecified age (race and ethnicity not reported) who developed important medical events of a leg pain and numbness of foot unspecified time after receiving the Janssen Covid-19 vaccine, for prophylaxis of symptomatic SARS.COV2 S infection. The patient's height, and weight were not reported. The patient's concurrent condition included low platelet count. The outcome of the events leg pain and numbness on foot was not reported. Additional information (e.g. height, weight, full medical history, social history, family history, concomitant medications, specific platelet levels, peripheral smear, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, radiologic diagnostic test results such as ultrasound, CT, MRI, angiogram, or venogram) was not provided. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the relationship of leg pain and numbness of foot to vaccination is considered unclassifiable (BC Criteria level 5) due to insufficient information. Additional information has been requested for further assessment.
Rapid heart beat, shortness of breath, soreness at injection site, general feeling of malaise, fatigue (lasted several days, gradually resolved on its own)
Blood vessels bursting in right eye.  It is continuing to worsen on second day, today.
Patient received half of the recommended dose for the second booster shot (25 ug instead of 50 ug). There were no adverse reactions to the vaccine.
Excessive shivering/shaking;  weakening of lower legs;  spiked high temp during the night into the next day.  102, finally lowered 48 hours later.  Nausea; massive headache;  complete body pain in muscles and joints, including jaws and eye sockets.  exhaustion, fast hearbeat; no injection site swelling or pain.   Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less.  I do feel it was worth it.
Took shot at 10:44am. Intense muscle soreness (more intense than others reporting it) by 10:00pm. By midnight, I got chills. 12:15am I took my temperature and it was 99.8. I went to bed. Woke up again at 5:00am with intense headache and unable to move due to strong joint and back pain. Temperature taken again and it was 100.9. Took Excedrin and continued to lay down. By 2:00pm on 1/12/21,  fever was  100.8 but overall head felt better but still joint pain.
Information has been received from a registered nurse concerning a 24 year old female who on 13, Sep 2006 and 08, Nov 2006 was vaccinated intramuscularly with a first and second 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0640F). There was no concomitant medication. In approximately November 2006, the patient became pregnant about 3 weeks before she was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient's last menstrual period was 15, Oct 2006 and her estimated due data is 22, Jul 2007. No symptoms were noted. The patient sought unspecified medical attention. Other medications used during pregnancy included amoxicillin (+) clavolanate potassium (AUGMENTIX) started on 28, Nov 2006 875mg, twice a day for otitis media, ampicillin started on 04, Dec 2006 500 mg once a day administered for nausea due to amoxicillin (+) clevulanate potassium (AUGMENTIN), and prenatal vitamins started on 28, Nov 2006. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a registered nurse concerning a 24 year old female with a history one previous pregnancy and one live birth, who on 13-SEP-2006 and 08-NOV-2006 was vaccinated intramuscularly with a first and second 0.5 ml dose of GARDASIL (Lot# 653650/0640F). There was no concomitant medication. In approximately November 2006, the patient became pregnant about 3 weeks before she was vaccinated with her second dose of GARDASIL. The patient's last menstrual period was 15-OCT-2006 and her estimated due date is 22-JUL-2007. On approximately 28-NOV-2006 the patient experienced otitis media. On approximately 04-DEC-2006 the patient was nauseated. On 09-FEB-2007, the patient had an ultrasound which was within normal limits. The patient sought unspecified medical attention. Other medications used during pregnancy included AUGMENTIN, started on 28-NOV-2006, 875 mg, twice a day for otitis media, ampicillin started on 04-DEC-2006, 500 mg once a day administered for nausea due to AUGMENTIN, and prenatal vitamins started on 28-NOV-2006. Additional information is not expected.
got the shot, got up to walk to the waiting area but I didn't make it; pulling my mask off, like I wasn't getting enough air; dizzy; B/P was high at 158/86; my legs were really shaky; This is a spontaneous report from a Pfizer-sponsored program . A female patient of an unspecified age (Age: 58; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. Medical history included allergies to seafood and fish and carries an EpiPen. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced she got the shot, got up to walk to the waiting area but didn't make it, pulling her mask off, like she wasn't getting enough air, got dizzy, b/p was high at 158/86, her legs were really shaky.  The patient underwent lab tests and procedures which included blood pressure measurement: 158/86 on 06Mar2021. Patient wanted to know if she can get the 2nd or not. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M006731, expiration date 09-FEB-2018, lot # M024675, expiration date 18-MAY-2018; dose and route were unknown). No adverse effects had been reported. The temperature excursion included 6.3 Fahrenheit degree for 2 hours and 48 minutes, 9.2 Fahrenheit degree for 13 hours and 57 minutes, 20 Fahrenheit degree for 8 hours and 24 minutes, 18 Fahrenheit degree for 1 hour and 28 minutes, 5.2 Fahrenheit degree for 6 minutes, 19.8 Fahrenheit degree for 11 hours and 13 minutes, 9 Fahrenheit degree for 7 hours and 37 minutes, 15.8 Fahrenheit degree for 1 hour and 19 minutes, 23.8 Fahrenheit degree for 4 hours and 52 minutes, 13.7 Fahrenheit degree for 9 hours and 18 minutes, 8.5 Fahrenheit degree for 20 hours and 27 minutes, 7.7 Fahrenheit degree for 24 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Left arm - felt hot burning at site. Could not stretch arm (extend) severe swelling. Red from shoulder to 2 inches below elbow. Chest, neck, stomach red rash (hives likely).
Fluzone High Dose was inadvertently given to a 62 year old patient, no AE; Fluzone High Dose was inadvertently given to a 62 year old patient, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, Exp. Date 01-May-2020) via unknown route in the left deltoid on 16-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications administered.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, patient did not had any reactions.  This suspected adverse reaction report is 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.
He had electrical shocks throughout his body; experience a prickly/tingling feeling in his arms and upper torso/the sensation migrate to his whole upper body where he felt paresthesia; sore arm; his vision was interrupted where he could see grey like on a TV screen when you do not have a channel - grey static - and it kept happening; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jun2021 at single dose in left arm for COVID-19 immunisation at the age of 59-year-old. Lot number was EW0191. Medical history and concomitant medications were none. The patient received vaccine dose on 06Jun2021 in the left arm. Later that day he started to experience a prickly/ tingling feeling in his arms and upper torso. It varied in intensity and has continued since receiving the vaccine. Patient received his first shot back on 06Jun2021 and afterward he had the typical sore arm and then it kind of migrated into paresthesia, like a prickly, tingly feeling in his arm. It lasted for a couple of weeks and was varying in intensity. On 24Jun2021, the sensation migrated to his whole upper body where he felt paresthesia in his upper torso. When, it was never a certain movement, but when he moved at all he would receive an electrical shock throughout his whole body in Jun2021. It was not that he was under paralysis, but his vision was interrupted where he could see grey like on a TV screen when you do not have a channel, grey static and it kept happening in Jun2021. The tingling had radiated in his arm throughout his body and he knew it had to do with the shot. This was new, nothing he had experienced before. Vision loss was considered medically significant. He had electrical shocks throughout his body and it would happen several times, dozens of times throughout the day and it happened just say 30 times, then the next day 15 times, then probably 10 times. Now he was just still with paresthesia throughout his upper body and a tingling feeling. The patient was not treated for the events. The outcome of the events was unknown.
swelling in his arm pit/swollen lymph node; swelling in his arm pit and pain; Nausea; Headache; did not feel well; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200028767.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 13May2021 (Lot number: EW0162) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tourette's disorder" (unspecified if ongoing), notes: diagnosed when he was 5 or 6 years old. There were no concomitant medications. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "Nausea"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; MALAISE (non-serious), outcome "recovered", described as "did not feel well"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling in his arm pit/swollen lymph node"; AXILLARY PAIN (non-serious), outcome "unknown", described as "swelling in his arm pit and pain". Clinical course: Patient experienced some headache, nausea and did not feel well for about 5 hours. Then he was fine. He did have swelling in his arm pit and pain with first dose. A lot of pain was really bad and could feel a swollen lymph node after his first dose. On 03jun2021, the patient second dose of Pfizer covid-19 vaccine and on 06Jan2022, the patient received third dose of booster.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. The patient was administered with first dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in November 2014, second dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in June 2016, and third dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in July 2017 for prophylaxis (Inappropriate schedule of vaccine administered). On 14-AUG-2017, The patient was administered a fourth dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) for prophylaxis (extra dose administered). No adverse effects were reported.
I started getting symptoms of sore throat that I thought was allergies. That evening, I started getting a cough that was deep and painful. I had a headache and was tired and achy. I went to bed early and got up that morning feeling worse. I took an at home COVID-19 test that was positive. I went to a clinic due to my symptoms getting worse. I was taking ADVIL and TYLENOL combined. I felt feverish with a low grade fever. I was prescribed ritonavir and nirmatrelvir. My symptoms went until 6/28/2022. Then the next day, I still felt fatigued. I almost feel normal now except for low energy.
Shortly after 1st dose of Pfizer Biontech, pt. c/o "tightness of throat, pressure in left cheek and ear, nasal congestion, blurred vision. BP 140/98-77, pulse ox 98%.  Was offered & declined Benadryl.  Sx's improved in 1 hour at the POD.  States sx's completely abated 1 hour after arriving home.  Did not seek further tx.  Pt. has asthma and takes Brio and an inhaler prn.  She has had "a few high BP readings in past" but is not on med.
I received the COVID-19 booster shot at 4:00pm on 12/2/21. At first, I was perfectly fine, with only a little fatigue and a headache. However, I woke up at 5am on 12/3/21 and felt my heart racing and my stomach hurting. I got up to go get some water, and almost collapsed ~15 feet into my walk. I was able to get help and drink some water, but the feeling didn't really go away. Once I was fully awake at 8am, I had an eye doctor's appointment at 9:30am. I was still unsteady when I went through the exam, and when waiting for dilation drops to kick in, I started feeling like I was going to throw up. I made my way to the restroom as quickly as possible, but collapsed before I reached the door (in the waiting room). My mother tried to lift me, but I was  basically a "ragdoll" as she tried. I had to be helped into the bathroom, where I threw up 3 or so times, partially some bile. After throwing up I felt better, but not perfect.  In addition to these episodes, I also experienced fatigue, headaches, chills, sweating, slight chest pain, arm soreness, and sore muscles (other than my arm). It has been 24 hours since the booster, and I still am having some of these symptoms in varying levels.
Pain from shoulder to fingers in injected arm; Full-body itchy skin but no visible rash; This is a spontaneous report from a contactable consumer reported for herself. A 26-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6208) via an unspecified route of administration in arm left on 10Mar2021 as dose 1, single (age at vaccination: 26 years) for COVID-19 immunisation. Medical history included none relevant history. Concomitant medications included spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. Other medications in two weeks were birth control and spironolactone. No COVID prior vaccination and did not tested COVID post vaccination. No known allergies. On 10Mar2021, the patient experienced full-body itchy skin but no visible rash, pain from shoulder to fingers injected arm. No treatment was received. The clinical outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Within 2 hours-burning eyes.  Then red, itchy face and forehead.  6-8 hours later slight wheeze.  Tapering at 72 hours.
body aches, swollen lymph nodes, sore throat 7d after injection; 10 days after injection papular skin eruption starting on trunk then spreading to arms, back, legs and feet over 48 hours. rash then began itching. this was followed by hives which lasted 24h relieved by benadryl and topical triamcinolone cream
Cardiac abnormalities....arrhythmia and tachycardia still ongoing though improved ; neurological abnormalities vertigo/disorientation/ ataxia for 3 or 4 months; HSV 1   8 episodes within 3 month period of injections,, while normal is 1 to two times a year; bad rash all over body with itchiness and pain for 6 weeks;  muscular pain issues....acute and chronic neural and muscular pain that is intense...still ongoing; depression/anxiety; insomnia still ongoing
3 days after taking FLU MIST he developed facial tics and excessive blinking. Sx seemed to be improving as of 11/20/15.
Symtoms of bad cold, sneezing, sinus congestion, headaches, coughing, nasal discharge.
Sore arm, redness at the injection site with pain. Flu-like symptoms. MD visit required which resulted in antibiotic prescribed.
On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
9 days after receiving   first dose of the Moderna Vaccine left arm was itchy and a rash broke out at injection and just below it.
Onset of sx 48 hrs post vax generalized malaise, fever; later that day devel neck stiffness, cervical & axillary lymphadenopathy; Achy all over, especially in back & knees, irritable; sx continued for a full ten days; Had no energy for work
Pain in whole body; Pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) and PAIN (Pain in whole body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia (Patient has pre existing medical condition of fibromyalgia.). Concomitant products included DULOXETINE for General body pain, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Pain.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). On 29-Jan-2021, the patient experienced PAIN (Pain in whole body). On 28-Jan-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved. On 29-Jan-2021, PAIN (Pain in whole body) had resolved.            Treatment details included -Ice pack for pain in arm, Cymbalta,Duloxetine for whole body pain.  Action taken with mRNA-1273 in response to the events was not applicable.
Upon injection of the vaccine into the patient's left deltoid, the solution leaked before any could be administered to patient.
At 5:23 PM patients mom spoke with on call doctor and reported that patient had swelling up and down arm and a welt on abdomen. No lip swelling or difficulty breathing. On call doctor advised to give 2 teaspoons of Benadryl and go to ER. Mom verbalized understanding. Patient seen in ER at 7:00 PM. Rash had improved, no further treatment/medication given at ER. Instructed to follow up with allergist in 2-3 days or return to ER if worse in any way.
Rash (red spots, not raised, not itchy) all over abdomen, stomach, a bit on arms, and some on thighs. This rash appeared within a week or so of getting the first dose of the Pfizer COVID vaccine. Over the next few weeks the rash slowly faded (not completely, though). When I woke up the morning after receiving the second dose of the vaccine, the rash doubled in coverage in the same areas of my body.   Around the time the rash showed up, I also began experiencing lower to mid-back pain, which grew more severe over time. The back pain is worst in the morning after sleeping, or after sitting/resting for longer periods of time. I've been taking Ibuprofen and Aleve, which helps, as does being active. The back pain did not noticeably worsen after the second dose, but it is just as severe.   Currently, the rash has faded (not completely), and my back pain is still quite bothersome.
35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hives.  50 minutes later eye itchiness and swelling in left eye, throat felt weird (swelling), dizziness, change in voice, wheezing (not severe, but could tell breathing was more restricted than before shot). Almost went to ER, but symptoms subsided without any medication in 2 hours. Did not go to hospital or ER.
Client received the COVID vaccine Janssen first dose (Lot# 1855191 exp. 04/11/2022) at 4:53 PM administered . While reviewing the participant forms, RN noted the vaccine was administered 53 minutes after beyond use date (time) of 4:00 PM. RN  verified with the vaccine preparer the beyond use date (time) was 4:00PM and the vial was punctured at 10:00AM. RN elevated the information to Clinical Project Coordinators. The Clinical Project Coordinators elevated the information to the manufacturer Janssen and consulted with our medical team. The medical consult team's recommendation was to not proceed with a repeat dose.
Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # and dose unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.