chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 24 year old female with a history of previous pregnancy and elective termination and no know drug allergies who on 05-FEB-2007 was vaccinated with a 0.5 mL first dose of Gardasil (Lot # 654741/0013U) while being pregnant. Concomitant therapy included PRIMACARE ONE during pregnancy. The patient's last menstrual period was 16-JAN-2007 and her estimated date of delivery is 23-OCT-2007. There were no adverse events. The patient sought unspecified medical treatment. On 01-MAR-2007, an ultrasound was performed which showed a normal fetal heart rate. No product quality complaint was involved. On 26-OCT-2007 (40 weeks 3 days from LMP), the patient gave birth to a 8 lb 8 oz normal, male infant with no congenital anomalies. However, it was noted that during labor/delivery the baby had shoulder dystocia and was born with a clavicle fracture. There were no complications or illnesses/infections during pregnancy. Additional information is not expected.
Breakthrough case admission after four vaccines  Pfizer 2/19/21 Lot# EN620;  Pfizer 3/12/21 Lot# En6199;  Pfizer 9/26/21 Lot# FE3592;  Pfizer 5/2/22 Lot# FP4554
Started with sore throat and headache approx 2:30 pm.  Shortness of breath and trouble taking a deep breath at 3:00pm.  3:30 pm increase in shortness of breath.  Patient called Employee health and then PCP and directed to go to ED.  Patient short of breath just talking while on the way to the ED.  Light headed and dizzy while in the ED.  Heaviness in chest and feeling of throat constricting.  Treated in ED with Benadryl po and albuterol inhaler.  No EPI Pen given.  EKG and CXR and Blood work and UA done and were negative.  Patient sent home with Albuterol inhaler and told to use Benadryl PRN.  Patient still using inhaler and Benadryl today.
I was feeling feverish with a sore arm the night of the booster. I had an upset stomach. I stayed in bed most of the following day with nausea and fatigue. My prescription medication for my GERD began to burn my stomach and throat.  I called my doctor.  My nausea lasted almost all of December.  I ended up getting shingles on 12/11.  I got medication for Shingles and nausea.
started with immediate and severe chest pain during exercise in late august of 2021 culminating with physical collapse from intense pain well performing sprints. I attempted to use vaers but upon entering my symptoms I was instructed to contact a medical professional. Upon reaching out to primary care provider was told I could not be seen due upcoming time, during time attempted to receive treatment but was told facilities weren't available in country. during time experienced less frequent chest pain but onset of fatigue and heart palpitations and had an EKG performed that showed an irregular heartbeat. Upon returning I sought medical attention again and was told that if it wasn't life threatening i would not be seen for chest pain. I went to an outside provider and test revealed i no longer had an irregular heartbeat but that i had an developed an early heart beat occurring at low frequency with no explanation as to why. Chest is far less frequent but still present and heart palpations occur after periods of intense exercise. No cause as to why has been discovered yet.
skin and scalp on the left side of my body hurts and is sensitive to touch, even by clothing. I get this approximately 6-10 times per year and it may be unrelated, but it is very, very rare to have it on an entire side of my body. It is usually a lot more localized (scalp and arm, or an area of my leg and arm.
mom first noticed child lt leg c/o have a dimple or sunken area on DEC97;mom wonders if this could be scar tissue from immun;remembers this area to have felt hard but does not remember area to be inflamed;
Severe dizziness/disorientation.  Similar to vertigo due to inner ear infection.
double pneumonia; respiratory things; breathing issues; an elephant on my chest; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "an elephant on my chest"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "breathing issues"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "double pneumonia"; RESPIRATORY DISORDER (non-serious) with onset 2021, outcome "unknown", described as "respiratory things". Clinical course: She had a severe reaction after her first dose that started "2 or 3 hours after." She had "respiratory things, double pneumonia, breathing issues, and it felt like I had an elephant on my chest."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201191760 same reporter/patient/vaccine, different dose/event;
rash on her stomach; itchy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leukemia, shingles (healing, outbreak with PHN) and post herpetic neuralgia (pre-vaccination). Concurrent medical conditions included immunocompromised. Concomitant products included allergy medication {nos} (Allergy Pill) and silver (Silver Solution).   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced itchy rash. On 3rd May 2019, the patient experienced rash. On an unknown date, the outcome of the itchy rash and rash were unknown.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On next day of receiving Shingrix, the patient developed an intermittently itchy rash on her entire left arm. At the time of call, the patient reported that she had a rash on her stomach of unknown cause. At the time of the call, the symptoms were not reported to be resolved. The reporter given the permission for physician contact.
Vaccine given by staff in upper left arm,  Symptoms: pain, soreness, redness, swelling at location of injection  Duration: several days Treatment: rest, ice, compression, heat, elevation
headaches; Severe lightheadedness/ dizzy; could not walk/ stagger with a couple steps/ could not walk without help; soreness in her arm; Vomited/ threw up liquid; Little Lazy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LAZINESS (Little Lazy), DIZZINESS (Severe lightheadedness/ dizzy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arteriovenous malformation (AVM (Arteriovenous malformation) near the thalamus).   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced DIZZINESS (Severe lightheadedness/ dizzy). In March 2021, the patient experienced LAZINESS (Little Lazy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid). On an unknown date, the patient experienced HEADACHE (headaches). In March 2021, LAZINESS (Little Lazy) and DIZZINESS (Severe lightheadedness/ dizzy) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) had resolved and HEADACHE (headaches) outcome was unknown. Not Provided          Patient spent six hours in the Emergency room and had tests done to rule out heart failure and blood clots. All tests are normal and heart is fine.Patient had a CT scan.     Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021 and contact information was updated On 10-Aug-2021: Significant follow-up received on 10-AUG-2021 included medical history of arteriovenous malformation near the thalamus was updated. additional ne event of headache was added and event LLT pain in arm was changed to vaccination site pain.
Pt has hives on arm between the shoulder and the elbow, reports itching. States it has been like this for "a few days". Sore for 2 days before it started itching.
Dizziness at 20 minute, then at 35 min, stiffness travelling up from injection site to shoulder, up neck, across both brows, both cheeks, around eyes, tip of ears, jaw joint, the tip of nose upper lip, upper gums, down to tips of front teeth.  Stiffness was severe and was increasing to more aras until i took 25 mg of benadryl which relieved spread of stiffness with in 10 minutes of taking pill.  I remained for oberservation for 2 /12 hours after shot until stiffness receded.  After 6 hours, only my nose and gums felt stiff and teeth felt stiff too.
Information has been received from a registered  nurse concerning a 19 year old female with no known allergies and no reported medical history who on 09-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659055/1522U) intramuscularly. On 09-JAN-2008 the patient developed severe pain on both legs. The pain had not been resolved. No other details were reported. Additional information has been requested.
I tested positive for Covid-19 had a bad headache and sore throat; I was prescribed PAXLOVID symptoms reduced after 3-4 days.
Information has been received from a physician concerning an 85 year old female who was vaccinated with a dose of ZOSTAVAX vaccine (Merck) 0.65 ml. About 5 months after receiving ZOSTAVAX vaccine (Merck), the patient experienced a "severe" case of shingles. At the time of reporting, the patient was having "trouble with her right eye" and was still in a lot of pain. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been received from a physician. There was no collection of lesions for PCR. No direct fluorescent antibody test was performed. The physician reported that the patient is an 81 year old female (previously reported as 85 year old) with a history of chickenpox as youngster and allergy to sulfa, rofecoxib (MSD), statins and AVELOX. On 03-APR-2008, the patient was vaccinated with a "standard" dose of ZOSTAVAX vaccine (Merck) (lot# 659268/1430U) into her left upper arm. Concomitant medication included diltiazem-HCL, NEXIUM, aspirin, CENTRUM, calcium (unspecified) (+) vitamin D (unspecified), and an unspecified vitamins therapy. The physician reported that the patient developed a severe case of shingles "8 months after vaccination" on 23-DEC-2008. It was reported that the rash did not occur at the site of injection within 42 days of the vaccination. The patient developed a shingles type rash with several lesions on her right side face, eye, ear, neck and forehead. The patient assessed pain as 10, the most painful in a scale from 1 to 10. It was reported that the patient had very severe prolonged symptoms and now with partial right ptosis. There was no recent exposure to chickenpox. The physician reported that at the time of reporting, the patient was still recovering. The patient had a history of allergy while on prior therapy with statin (manufacturer unspecified) (WAES: 0905USA02615) and VIOXX (MSD, WAES 0905USA02616). No further information is available.
1/8/2021 tachycardia Pulse 140, Fever T99.4 then 100.2  Lethargy, Somewhat Altered Mental status
5 mins post 1st dose vaccination patient began feeling nauseous, throat felt tight with mild pain when swallowing, tingling sensation from the chest down to her toes, facial flushing, and dizziness. She states these symptoms are common due to her history of EDS but today they are slightly worse since she got the vaccine. She was brought to the medical evaluation area via wheelchair and evaluated by us and EMS. Patient was administered Benardyl 50mg and provided orange juice and water. Vitals taken throughout and were slightly high in the beginning and then stabilized. Patient states her throat felt better and the tingling localized to her hands after 5 mins. Patient was monitored for over 45 mins. She was instructed to contact her PCP and her allergist to be cleared for her second vaccine dose. She was informed her 2nd dose should be administered at a facility where she can be observed closely. She declined transport to the hospital but agreed to follow up to the ER with any worsening signs of anaphylaxis. The nausea resolved and she felt less groggy upon leaving with her boyfriend.
site of injection - pain level #8/10 with limited mobility of Left arm  severe diarrhea Thursday and Friday unable to work today - lost wages
After dose 1, I had an itchy red rash about the size of a quarter appear near the injection site approximately one week after the shot (8 days).  After dose 2, I had a very large angry rash appear on my arm near the injection site within 24 hours of the Shot. The reaction is much worse than with dose 1. The area is very large, hot, swollen, and itchy. The rash was worst 2 days post shot. It is slightly better today (3 days post), but remains itchy, hard, and hot to the touch.  I had a tiny bit of "clouded thinking" with dose 1 but that's about it. I have been very tired, achy, and woozy after dose 2.  I'm managing, though.
Had what seemed like cramps in both legs upper theigh closest to groin. Difficulty to put weight on legs. Was sweating badley, All happened about 12 hours after having hi-dose fluzone .7ml admistered. Lasted about 20 minutes. Cramps were very painfull. This happened about 1030pm. Woke me up with pain. Went back to sleep about 1 hour later. Had no symptoms when I woke up in the morning. Feeling great now 16 hrs later
Approximately 5 months after my booster shot (Dose 3) I contracted COVID-19 and experienced the following symptoms: Low grade fever, Chills, Body aches, Cough, Sinus congestion, Post nasal drip, Fatigue. I did not take any treatment of my own but called my doctor and was prescribed with Paxlovid and took 3 doses for 1 day - but I also got a bad reaction from that (Diarrhea, Rotten taste in my mouth) so I stopped taking it and just let my symptoms run its course. As of today 05/24/2022 I have fully recovered from my symptoms.
This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender. On 09-JAN-2014 the patient received first dose of PNEUMOVAX23 (lot # 2017AE; exp date: 22-AUG-2103) 0.5 ml, intramuscular (site of administration was not reported) and it was expired. No adverse effects were reported. Additional information has been requested.
At midnight I     awoke with severe ataxia which lasted all night( i get uup every      2 hrs to void),     by morning i was free of ataxia but was quite somnolent all day.
ABNORMAL BEHAVIOR, ERYTHEMA TO INJECTION SITE, FACIAL FLUSH, TACHYCARDIA.
Patient was fully vaccinated with J&J on 8/3/21. Patient started with symptoms 12/7/21  she stated that she was having nausea vomiting diarrhea fever and chills.  She also complained of a cough and chest pain when she coughs. Patient was febrile and had infiltrates. Patient was admitted 12/13/21 and is still admitted with COVID
My A1c went from prediabetic to diabetic at age 65. My A1c was normally reading at 6.4 with a fasting blood test after receiving the last vaccine my fasting A1c is now at 7.0. I have been prescribed TRULICITY as I was not taking this before the vaccine.
Patient reports systemic reaction of whole body rash the day after receiving FLUVIRIN on 10/11/13.
sick to his stomach; itching on his hand and made it down to his feet; feet are tingly (bottom of feet and can't walk on carpet); little bumps on body; gets red and itch when exposed to the sun; itching; hands getting super tingly; legs start itching; Patient did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body) and ERYTHEMA (gets red and itch when exposed to the sun) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 09-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 ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly), PRURITUS (legs start itching) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to his stomach), PRURITUS (itching on his hand and made it down to his feet), PARAESTHESIA (feet are tingly (bottom of feet and can't walk on carpet)), SWELLING (little bumps on body), ERYTHEMA (gets red and itch when exposed to the sun), PRURITUS (itching), PARAESTHESIA (hands getting super tingly) and PRURITUS (legs start itching) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that his face and arm were tanned, he could tolerate the sun. The patient reported his feet felt cold but not actually cold when he touched them. The patient reported going to the doctor and being prescribed something but he was unsure of the name of the medication because he had not picked it up yet.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the known information regarding the vaccine not containing the virus, the event is assessed as unlikely related to mRNA-1273.
Severe shivering in the middle of the night. I woke up with a terrible headache and stuffy nose. Fever of 100.2 for almost 24 hours. Fatigue and chills.
lost my appetite for food; Pain in left arm at the injection site; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I began to feel very dizzy, fatigued and nauceous like my equilibrium was off; I will have hot sweats; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to a lot of plants, allergy to grass, latex and trees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took silicones nos (MANUFACTURER UNKNOWN) (reported as silicone) for unspecified indication from unknown date and experienced drug allergy on unknown date. On 07May2021 at 15:00, after the first dose of the Pfizer vaccine, the patient experienced pain in left arm at the injection site. The patient began to feel very dizzy, fatigued and nauseous like equilibrium was off. On 11May2021, the patient still felt dizzy, fatigued, nauseous and the patient had lost appetite for food and sometimes patient had hot sweats but patient did not have a fever. The current day (this was day 4), the patient 's arm was no longer sore, but still felt fatigue, dizziness and nauseous. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain in left arm at the injection site was recovered on an unknown date in May2021. The clinical outcome of the events felt very dizzy, fatigued, nauseous, equilibrium was off, lost appetite and hot sweats was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a Hepatitis B shot that she did not need. She had already completed the shot series 3/25/2011. We transferred to the area 2 months ago and shots were transcribed into the system and they were not transcribed properly. The technician did not verify that everything had transferred over and told me that she needed this shot. Later that day she developed a rash on her leg from the shot. It was very red, hot and itchy. The rash stayed there for over 2 weeks.
9/17/12 Tdap given at 4:32 pm. 9/18/12 2 am developed fever 102.6 F, chills, body aches, moderate left arm pain, swelling & dizziness. Tx: IVF NS 1 liter, TYLENOL, ice pack to left arm. Pt felt much better T 98.7.
Burning, under right arm down right side from shoulder blade to chest. I have burning inside, with no breakout of rash. There is swelling of the area, and when I get out of a hot shower you can see a slight redness and outline of the painful area. The pain is steady and strong and I have trouble sleeping and miss work. My pain is most severe where my arm hits my side and hurts when I breath.