chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Legs were swollen like water retention; Legs became increasingly sore throughout day; Get up and go to the bathroom like a racehorse; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day), DIARRHOEA (Get up and go to the bathroom like a racehorse) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included Trigeminal neuralgia in May 2021. Previously administered products included for an unreported indication: Moderna COVID-19 Vaccine (nasal swab.) in October 2020. Concurrent medical conditions included Penicillin allergy. Concomitant products included LOSARTAN for Elevated blood pressure reading without diagnosis of hypertension.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day) and DIARRHOEA (Get up and go to the bathroom like a racehorse). The patient was treated with OXCARBAZEPINE (TRILEPTAL) ongoing from February 2013 for Pain, at a dose of UNK, qd. On 31-Mar-2021, PERIPHERAL SWELLING (Legs were swollen like water retention), PAIN IN EXTREMITY (Legs became increasingly sore throughout day) and DIARRHOEA (Get up and go to the bathroom like a racehorse) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Follow up received  patient demographic details , historical disease , concomitant medications, treatment medications, dose batch no  , dosage regimens are updated.
Received varicella vaccine 7-1-08 and shortly thereafter developed c/w Henoch Schoenlein Purpura complicated with testicular pain on 7/12/08 and on 7/29/08 had severe abdominal pain and leg pain and unable to ambulate. Hospitalized about 48 hours and started on steroids and tapered over one month and now much improved, Off steroids.  10/24/2008 MR received for DOS 7/29-31/2008 with D/C DX:  Henoch-Schlonlein Purpura.  Abdominal Pain. Leg Pain. Pt presented with worsening abdominal and L calf pain following an outpt dx of HSP. Pt developed testicular and ankle swelling 2' to HSP. He was later seen for worsening peri-umbilical pain and emesis.  Started on steroids with some improvement in sx and rash resolving. At f/u visit 7/31/08 pt reported 4 day hx of worsening abdominal pain, spreading rash and difficulty walking 2' to calf pain. Pt admitted. Admission PE (+) for calf pain and tearfulness 2' to pain with (-) Homan's, periumbilical tenderness, L calf tenderness, multiple petechial and purpuric skin lesions, with excoriation, dryness, and scabbing of old lesions.  High dose steroids initiated x 1 month.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I was taking an antibiotic so I couldn't get the dose; I was taking an antibiotic so I couldn't get the dose when it was due; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) and PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due). On an unknown date, the patient experienced ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose). On 14-Sep-2021, PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) had resolved. At the time of the report, ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. On 23-Aug-2021, Original 2nd dose was due. On 03-Sep-2021, patient completed antibiotic therapy.
leg swelling above thigh circumference 3/4cm greater than rt no erythema & warmth;no mass, nodule & pustule;mildly tender would walk w/sl limp;
I started having a lot of nausea, backpain and migraine headaches. I went to the Dr and was diagnosed with allergy to meats and this is new diagnosis since after the 6th dose because I was tested in July and was negative.
Congestion the next morning general malaise not quite feeling like myself felt like I had a leftover flu cold. No aches or body pains though just not quite right and extremely sore arm for 72 hours
Received the injections in my left arm and had symptoms for over 3 months after the injection. I could not lift my left arm above my shoulder, had numbness and tingling down my arm, fingers and my left leg down to my toes. The left side of my back felt hot to the touch. All these symtoms lastest the entire 3 months.
I had a Left KNEE replacement on February 23, 2021 right after the shot there was a tingling sensation right to my left knee.  I had been doing Great walking with no issues. Now my knee is stiff and swallow everyday and I am having issues walking.  My knee has not been the same. Saw the Dr. and I am taking anti flammatory meds which should not be.
Approximately one hour after the vaccination, I began to experience chest pains. These pains continued to get worse over the next few days, so that my husband had to take me to the Emergency Room at Medical Center. They ran some tests, admitted me to the hospital, and the next day transported me by ambulance to Hospital in city where I underwent open heart surgery the same afternoon, to repair two coronary arteries and replace my Mitral Valve.  On 19 April 2021, I underwent another surgery to implant a pacemaker/defibrillator. I have been recuperating from these surgeries for the past year.
24 hours after injection had chills, fever(100-101) and fatigue.  Lasted until 4:00 am next morning.  I was fine after that, got up walked 3 miles as I have been doing.  Continued to feel fine until 10:pm that night, fever(100), chills and fatigue again until about 5:00 am next morning.  No  symptoms since.  No Tylenol first night, did take it with second round.
Initial report received from a consumer on 23 Dec 2010: This patient was vaccinated with first dose of post-exposure series of RABAVERT (batch number unknown) on 16 Dec 2010. Same day, the patient suffered from fever, diarrhea and feelings of anxiety at night. These symptoms never abated. She was vaccinated with second dose of RABAVERT on 19 Dec 2010. Immediately after vaccination, she experienced diarrhea, anxiety, muscles twitching and swollen tongue. She felt like her body being "on fire". The symptoms worsened at time of this report and she was taking treatment (unspecified) at local emergency room. Follow up information received from the consumer on 19 Jan 2010: The patient had medical history of hypothyroidism, allergies and gastro-esophageal reflux disease (GERD). The patient also received HYPERRAB (1620 U) and intramuscularly on 16 Dec 2010. The patient also experienced palpitation and decreased sensation in lower extremities on 19 Dec 2010. Palpitations and diarrhoea resolved on 26 Dec 2010 while tongue swelling and decreased sensation were improving. The physician assessed tongues swelling, palpitations, muscle twitching, and diarrhea and decreased sensation in lower extremities as medically significant and related to RABAVERT.
Had a temperature of 101.6F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a temperature of 101.6F) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 1985 and Atrial flutter since 2017. Concomitant products included FLECAINIDE from August 2017 to an unknown date and APIXABAN (ELIQUIS) from January 2017 to an unknown date for Atrial flutter, LISINOPRIL from 1987 to an unknown date and AMLODIPINE MALEATE (AMLODIPINE A) from 2010 to an unknown date for Blood pressure high.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Had a temperature of 101.6F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 10-Nov-2021, PYREXIA (Had a temperature of 101.6F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 101.6 (High) fever of 101.6 F.         This case was linked to MOD-2021-382261 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up includes patients demographics, current conditions, concomitant drugs and Reporters causality.
After 20-25 minutes dizzyness set in along with some sense of impending doom or low blood pressure feeling. As I type that fogginess has lifted, but left hand has some remaining tingles. The effect comes in goes. Some pressure in left pectoral.
heart fluttering and dizziness 2nd day after the vaccination; heart fluttering and dizziness 2nd day after the vaccination; 6th day after the shot she had hot flashes and swelling; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 as SINGLE DOSE for COVID-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. Medical history included allergies to penicillin and some other things. There were no concomitant medications. The patient experienced heart fluttering and dizziness 2nd day after the vaccination; repeated 3rd day after the shot; 6th day after the shot she had hot flashes and swelling; 2 weeks later had tiredness and dizziness. All events started in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given for the events. The outcome of all events was unknown.  Information on the lot/ batch number has been requested.
Patient developed facial numbness and "sagging" about 1-1.5 hours after receiving vaccine. She proceeded to ER for evaluation. ER diagnosed as Bells Palsy.
Report A0366404A describes limb swelling in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received his fifth injection of Infanrix in his left arm. An unspecified time later that week, he experienced redness and swelling from the left deltoid to the left elbow. Treatment and outcome were not provided. The vaccine provider considered the events to be probably related to Infanrix administration. Please refer to case numbers A0366401A and A0366403A by the same reporter.
I woke up on Friday, February 7th feeling good. At around noon i shoveled the snow off my neighbors driveway and it was a little while after i got done and went inside that I felt an itch on my back and on my forehead. I thought they were just pimples at first, but then my face slowly felt more tight/swollen. I looked in the mirror and there were a few dime-sized welts on my forehead and cheeks. They werent very itchy at all, Over the next few hours a few more pimple like bumps appeared on my face. Most of my face was red, like hives or poison ivy. Since i felt ok in the head, i didnt go to urgent care or the E.R. I decided to take benadryl and see if it helps. The bumps stayed on my face all night until i went to sleep. I woke up the next day and they are almost fully gone. I still feel good. And that is the point im at while writing this report. A few more notes. My sister has a 1 year old i spend time around and got scratched by him the day before the rash. And also my sister gave birth on February 3rd. Their baby was premature so has been in the hospital for a week. So my sister, brother-in-law, and parents have been switching off going to the hospital every day to be with the baby. I live with my parents. And also i live with a cat (the cat goes outside) and a dog.
Vomiting, nausea, stomach ache, pain where shot was given, body aches, weakness. Vomiting lasted throughout the night. Weakness, nausea, pain in arm continued throughout all next day (10/29).
Fainting; Blacking out; Booster; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:00 (Lot number: FD0809) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25Feb2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK4176, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 04Feb2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021 12:00, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 28Nov2021 06:00, outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 06:00, outcome "unknown", described as "Blacking out". The events "fainting" and "blacking out" were evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 11 year female patient who received QUADRACEL (batch number C5248AA, expiry date 21 Aug 2019, intramuscularly via right arm) instead of PENTACEL on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation; MENINGOCOCCAL C VACCINE for Immunisation; and HPV VACCINE for Immunisation. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred. 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.
4 cm localized redness, warmth, induration at injection site post Varicella vaccination 2 days ago. Unknown onset of symptoms.  Follow up - The actual onset of symptoms was not available but was reported to MD on 5/3/10, no specific time was given.
Injection site is in red; Injection site arm got swollen; Injection site arm got very hot; Itching on the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site arm got very hot), VACCINATION SITE PRURITUS (Itching on the injection site arm), VACCINATION SITE ERYTHEMA (Injection site is in red) and VACCINATION SITE SWELLING (Injection site arm got swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site arm). On 29-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site arm got very hot) and VACCINATION SITE SWELLING (Injection site arm got swollen). On 30-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is in red). On 24-Mar-2021, VACCINATION SITE PRURITUS (Itching on the injection site arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site arm got very hot), VACCINATION SITE ERYTHEMA (Injection site is in red) and VACCINATION SITE SWELLING (Injection site arm got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received TWINRIX. Previously administered products included TWINRIX with an associated reaction of pain (1st dose (refer case US2018068949)). On 19th April 2018, the patient received the 2nd dose of TWINRIX. On 19th April 2018, immediately after receiving TWINRIX, the patient experienced injection site pain and inappropriate reconstitution technique. On an unknown date, the outcome of the injection site pain and inappropriate reconstitution technique were unknown. It was unknown if the reporter considered the injection site pain to be related to TWINRIX. Additional details were reported as follows: Age at vaccination was not reported. After 2nd dose, the patient hurt like normal. She was concerned because she read the PI information about administering the vaccine prior to getting vaccine and how there may be 2 layers and the vaccine should be shaken until it had a uniform, hazy, white appearance. When she saw the dose that the medical assistant was about to administer to her she could clearly see a white layer and a separate clear layer still present in the syringe. She told the medical assistant that the vaccine needed to be shaken, and the medical assistant did shake it a little after that, but not as much as recommended in the PI. The dose was then administered. This led to inappropriate reconstitution technique. The patient was not sure if the vaccine was shaken enough, and does not know if the vaccine was ever shaken with the first dose. The caller declined to participate in the report.
pt recv vax 19APR96 & became pregnant (LMP 5APR96);pregnancy was confirmed w/ultrasound;10 wk from LMP pt underwent an elective abortion;it wa noted that lab eval was negative for varicella antibodies;no further info was provided;
Pretty certain it is myocarditis  Symptoms include tightness in chest, shortness of breath, fatigue
Rec'd FLUMIST approximately 530p, lips swelling 600pm. To ER. Rec'd BENADRYL elixir 30mg x1 and Ranitidine 150mg/10ml 90 mg once and sent home with Rx to be taken BID. Ice to lips.
Swollen cervical lymph node on my left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen cervical lymph node on my left side) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen cervical lymph node on my left side). At the time of the report, LYMPHADENOPATHY (Swollen cervical lymph node on my left side) outcome was unknown.            Lab work was done and was normal and unspecified antigen testing was performed(results are unknown).  No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-222001 (Patient Link).
Local reaction at injection site: induration, redness and swelling at injection site. 3.5x3 cm induration on left thigh anteriorly blanches with prounce
On day 11 following SV (PV) developed headache and macular-papular rash on upper trunk, chest, upper extremities, side and back that is now forming 3-5 pustules. Seen today Dx-Non Viral Pustulasis. Rx with increased dose Allegra for itching.  Rash, headache, malaise day 11 following SP vaccination. Primary vaccine who presents c/o erythermatous, non pruritic scattered rash on his torso. Pt received SP vaccine on his left upper arm on 21 Feb 03 seperate from any other vaccine. He also reports 1-2 days of "flu like symptoms" headache and  malaise.
Headache, Myalgia, Arthralgia & Diarrhea Narrative:  Resolved symptoms in 3 days
First symptoms came in the first 72 hours - chills, aches and headaches - ended after 2-3 days  Second event came on day 8:   - red itchy 2-3 inch rash at the injection site - disappeared after 3 days..  Headaches, chills and body aches - for 6 days,   chills, fever, and slightly elevated heart rate 3 days,,