chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke resulting in temporary double vision during the night on 9/09-10/2021 Went to Urgent Care on 9/12/2021  Went to ER on 09/13/2021 received CT Angio Head/Neck w and w/o  IV contrast scans showing no acute intracranial process, no intracranial vessel stenosis, vascular malformation or aneurysm  MRI's of brain showed no evidence of acute intracranial abnormality, showed nonspecific T2/FLAIR hyperintense patchy signal within the pons which could reflect microvascular ischemic changes Went to Ophthalmologist 09/16/2021 Exam with full EOMs, 1 PD of right hypotropia, commitant in all fields of gaze, and no torsion on double maddox rod testing. Findings are most consistent with skew deviation from lesion in pons. Additional information for Item 18: Went to Neurologist 09/24/2021 58 year old male presenting with abnormal MRI and sudden onset diplopia, agree with optho re central etiology, no significant risk factors for microvascular CN, most likely ischemia given sudden onset followed by gradual improvement.  Unfortunately other MRI sequences than flair do not visualize the pons well; would recommend repeat at RUMC affiliated imaging, with and without (lower suspicion for inflammatory/malignany demlyination given course), differential may also include symptomatic pontine telangectasia, but high enough suspicion for continued workup of ischemic stroke and risk reduction, would continue antiplatelet (consider full dose asa), statin, BP at goal. prescribed Echo Cardiogram and another MRI of brain and 14 day heart monitor, investigating possible cause of suspected stroke or TIA   Had Echo Transthoracic Complete 10/07/2021 1. Left ventricle: The cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55-60%. Left ventricular diastolic function parameters are normal. 2. Atrial septum: Agitated saline contrast study in the baseline state, shows a small right-to-left shunt at the level of the inter atrial septum.  Had MRI w/o and w IV Contrast 10/14/2021 Minimal FLAIR abnormality in the brainstem, likely due to changes of chronic small vessel disease. Otherwise unremarkable brain MRI.  Double vision improving, mostly peripheral double vision now
Here is some other information. My first Moderna shot for the Covid 19, was on  April 22nd. Approximately 12 noon. This shot was also in my upper left arm. A few days later, I developed an allergic reaction in the form of a "rash". I did not have any other symptoms. I waited a few days and then went to my doctor. She told me to take a Benadryl on the day of the second shot. I did so on the morning of the second shot (before I went for the second shot). The lot number was: B40B21A.  My second shot was May 20th at approximately noon. I was fine for the rest of the day and night. Then at approximately 3:30AM on May 21st, I woke up and was extremely thirsty. I drank some Gatorade and went back to be. I got up at approximately 7AM. I started sweating, feeling faint and then passed out.  I also now have "swelling: around the right side of my neck area. It feels "puffy". I went back to my doctor and she sent me for a carotid artery test. It was negative. However, the "swelling" is still there. I wonder and hope the "swelling" will go away.
(L) arm swelling 1st & with increasing redness over 3 days Treated with antibiotics for possible cellulitis 9/21/07
Extreme Pain in the right shoulder and arm.  Fatigue, joint pain, nausea and dizziness was felt the morning after the first dose. Redness at and around the injection site began aroungd 72 hours after injection. A hard lump an swelling appeared that day that was about baseball size.A rash appeared as a hives like appearance that migrated down the arm and eventually stopped around the antecubital area. Redness persists at the site of injection that is about the size of a grapefruit today which is 6 days later.   Pain was treated with ibuprofen and has improved but is still present. Itching and burning sensation at the bicep persists.
This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified). On an unknown date the patient developed a shingles rash in her mouth 2-3 years after receiving the vaccine. The outcome of shingles rash in her mouth was unknown. The patient was treated with VALTREX. Additional information is not expected.
This case was reported by a other health professional and described the occurrence of headache in a 55-year-old female patient who received FLUARIX (batch number GA22N, expiry date 30th June 2015). Previously administered products included FLUARIX with an associated reaction of inflammation (with headache, wheezing, muscle aches, elevated CRP and ANA). Concurrent medical conditions included hypothyroidism. On 21st November 2014, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to FLUARIX. Additional information received: Last year received FLUARIX and had Inflammatory response with headache, wheezing, muscle aches, elevated C-Reactive Protein and ANA. She visited her doctor for this and was told it might be Lupus but no official diagnosis has been made. Due to her history it was recommended that she get latex free and thimerosal free flu vaccine, which she did last year, but still had the same reaction. Caller feels that she might get the same reaction after today's vaccination.
Soreness in the shoulder following the injection. The night after receiving the vaccine, at 02:30 am, I woke up in the middle of the night with chills despite being under a blanket that went away after putting on a sweatshirt and going back to bed. The following morning, I had general malaise and body aches which have remained throughout the day. In the evening of Day 2 (present time), my throat started feeling scratchy.
Muscle pain; Fatigue; Chills; Nausea; Injection site redness; Injection site swelling; vomiting; Agitated; broke out in to a sweat and went to the bathroom; Heart was racing; Injection site pain; This spontaneous case was reported by a nurse and describes the occurrence of AGITATION (Agitated), HYPERHIDROSIS (broke out in to a sweat and went to the bathroom), HEART RATE INCREASED (Heart was racing), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis liver. Concurrent medical conditions included Obesity, Diabetes, Drug allergy (NSAIDs), Drug allergy (Patient is allergic to Tequin.), Drug allergy (Patient is allergic to Levaquin.), Drug allergy (Patient is allergic to Cardizem.) and Drug allergy (Patient is allergic to Lyrica.).    On 09-Mar-2021 at 11:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced AGITATION (Agitated), HYPERHIDROSIS (broke out in to a sweat and went to the bathroom), HEART RATE INCREASED (Heart was racing) and INJECTION SITE PAIN (Injection site pain). On 11-Mar-2021, the patient experienced MYALGIA (Muscle pain), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of unknown. At the time of the report, AGITATION (Agitated), HYPERHIDROSIS (broke out in to a sweat and went to the bathroom), HEART RATE INCREASED (Heart was racing), MYALGIA (Muscle pain), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: patient medical history has been updated.
mild swelling of left side of face and redness on upper chest area. Denies SOB, chest pain, denies swallowing problem. Seen and cleared by EMS
Case number PHEH2012US022821, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 with the follow-up received from a healthcare professional on 17 Dec 2012. This report refers to 27 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11071, expiry date: Dec 2013) 0.5 ml, in the left deltoid intramuscular on 07 Nov 2012 at 12:33 PM. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported. Follow-up received on 17 Dec 2012: Updated batch number, time of vaccination and site of vaccination.
t 38C, 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (t 38C, 2 days) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced PYREXIA (t 38C, 2 days). In January 2023, PYREXIA (t 38C, 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Body temperature: 38 degree Celsius.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Patient had negative reaction to anthrax vaccine SEPT 2017. This nurse noted reaction but it was recorded in EMR as patient did not go to HP. Lasting for approx 1 week, rash about 15 inches from shoulder to forearm, swollen around circumference of shot, area reddened and hardened. Patient felt week and myalgia lasting one week. Recommend patient not receive Anthrax vaccine in future.
After receiving flu and varicella vaccines pt. stood up and stiffened and fainted and fell to floor. She around almost immediately, color pale. Blood sugar done, p.o. fluids given, rested briefly, discharged home.
Patient vomited a few minutes after receiving the Janssen Covid 19 vaccine. He rested for 30 minutes and felt fine then. No SOB, or difficult breathing.
Patient called to report he was dizzy and "woozy" for 2 hour period after getting injection.
F rom elbow to shoulder of my right arm, I can not raise my arm to the back of my head or try to reach something to my right without pain.
Extremely tired, mild fever, hot flashes, muscle  aches, nausea; today arm red and swollen at injection site
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. No medical history of concurrent conditions reported. On 11-APR-2014, the patient was inadvertently vaccinated with ROTATEQ (dose, strength and lot number not provided). No co-suspect or concomitant therapies were reported. The reporter stated that ROTATEQ vaccine had been improperly stored. At the time of the report, the outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Muscle aches and pain included tingling or numbness started June 1st 2021. A couple days later, I did the CDC Checker. It stated I had the flu and to quarantine for 10days and take influenza vaccination. Pain started at 11 on 1 to 10 scale. Today, it?s at 1 on a scale of 1 to 10. Mostly pain, a lot of sweating, nausea, vomited 4 times and everything else is over.  I did a TeleDoc visit, however, it was an LPN versus doctor. So I didn?t take her advice and go to hospital. When I could drive went to CVS drivethru minute clinic
elbow joint hurts when I move it; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (elbow joint hurts when I move it) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (elbow joint hurts when I move it). At the time of the report, ARTHRALGIA (elbow joint hurts when I move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Severe fever, intense headaches for 24 hours straight, chills and sweating, nausea, incredibly terrible muscle aches over entire body (most painful on legs). Extremely sore neck and arms, swollen lymph nodes, dizziness, icepick headaches even 48 hours after the injection. Sharp chest pain and burning, shortness of breath, fatigue and low stamina 55 hours after injection. Spine pain, stomach pain, ovary pain.
WOKE UP 10 HOURS AFTER THE SHOT AND HAD CHILLS FOR OVER 4 HOURS AND RUNNING 103 FEVER. COULD NOT GET WARMED UP. THURSDAY RAN FRIDAY MORNING AT 1;00 AM. I ROTATED TY FEVER ALL DAY ANYWHERE FROM 100-102. FEVER FINALLY BROKE . I TOOK TYLENOL EVERY 4 HOURS TO KEEP FEVER DOWN.  TODAY IS FRIDAY AND SWEATING. THIS WAS WORST HAN THE FLU.
Pt fainted after shot while ambulating.  She fell forward face down rolling onto her shoulder.  Mom picked up patient from floor, placed on exam table on back.  We removed sock and shoes, turned on fan, patient woke up within seconds crying.  Juice and popsicle given vitals were HR 116 SPO2 99%.  Observed for > than 30 minutes patient ambulated without difficulties.  Spoke with mom 2 days later.  States she spoke with pediatrician no need for office visit.  States child has normal behavior no further reactions or evidence of injury.  No further care was needed.
a shipment of Priorix was put into the freezer/storage and handling information of the vaccine at below recommended temperatures; This non-serious case was reported by a consumer via sales rep and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On 27-JUL-2023, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: a shipment of Priorix was put into the freezer/storage and handling information of the vaccine at below recommended temperatures). The outcome of the incorrect storage of drug was unknown.   This report is made by company without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 31-JUL-2023 The reporter reported that a shipment of Priorix was put into the freezer at this upon arrival on Thursday, 27 July 2023. It was discovered on Monday, 31 July 2023 and the Director contacted the reporter on Monday July 31 to ask about storage and handling information of the vaccine at below recommended temperatures.  The reporter immediately contacted company who reached out to the reporter to discuss the storage and handling and to Immediately send a Medical Information letter in follow up regarding the below recommended temperature information.  Priorix was put into the freezer which led to incorrect storage of drug. The reporter agree to follow up and had follow up same day.
Pain started around 9/7/15. Rash was visible around 9/10/15.
I seen a doctor for possible issues concerning my throat. At a family practice, had a CoVid test and Strep test done. Both came back negative.  No treatment issued. No OTC suggested.
PPSV 23 has caused very swollen arm from shoulder to hand Still frightfully swollen 3 days after injection Low grade fever, muscle ache was first day & a half; unable to use arm to get out of bed night of the shot (Chills & discomfort began in evening day of shot) PCV13 rec'd 4.5 yrs ago without incident* Arm swollen & painful unable to get out of bed - red, hot, swelling The slight fever & chills went away after a day. But swollen, hot, red painful arm for 2 days. Pain disapated but swollen arm continues even with icing & antiinfamatory meds. 3 days later is still BADLY SWOLLEN
PT REC'D ENGERIX-B SHOWED SLIGHT SIGNS OF A FIT; GOT HEAVILY DRUNK; FELT TIRED; DAY AFTER RECEIVED A SECOND DOSE WENT ON EXCURSION AND GOT HEAVILY DRUNK. HOSPITALIZED  FOR OBSERVATION. REC DIAZEPAM.  f/u 03mar91:  hosp X 3 days, outcome unk
WITHIN 5 MINUTES AFTER RECEIVING SHOTS, RASH AND ITCHING BEGAN ON HANDS, WRISTS, AND ARMS (SMALL, RED, RAISED BUMPS) 25 MG BENADRYL PO VITAL SIGNS P68, RR14, BP 110/70. OBSERVATIONS FOR 1 HOUR POST VACCINATION WITH NO WHEEZING OR DISTRESS NOTED.  SYMPTOMS SUBSIDED WITH BENADRYL.
Menstrual cycle irregular; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to gluten(celiac). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced menstrual cycle irregular. The event did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the event. On an unknown date, the patient underwent COVID-19 virus test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event menstrual cycle irregular was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHEST PAIN; COUGH; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced fatigue. On 14-JUN-2021, the subject experienced muscle aches. On 14-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced chest pain. On 15-JUN-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest pain, cough, fatigue, and muscle aches, and the outcome of fever was not reported. This report was non-serious.
itching all over; her tongue swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up). At the time of the report, PRURITUS (itching all over) and SWOLLEN TONGUE (her tongue swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment included Benadryl
Initial symptoms - left arm pain for 3 days, headache, nausea, fatigue, pain in left arm, back of neck, up back of neck and across shoulder - all within 24 hours.  2nd day tingling in arms, hands, legs and feet. As of 12/11/2021 - I continue to have tingling in left arm, left hand and both legs and feet, fatigue continues and nausea continues.  I have no other illnesses and I am not pregnant.
pre-drawn syringe stored in refrigartor for more than 12hrs; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The reporter stated that the patient did not have any symptoms after the first dose.  No treatment of events was reported.
hasn't been able to hold anything down, just sips of water; Has been running a fever consistently since 22Jul2021 until now, 27Jul2021 of 101; This is a spontaneous report from a contactable nurse. This nurse reported similar event for two patient. This is the 2nd of 2 reports. This nurse reported for a male patient (husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number and expiry date was not provided) via an unspecified route of administration, on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that both the patient and the patient's husband received the first dose Pfizer Covid Vaccine on the same day. Since 22Jul2021, the patient had been running a fever consistently until now, 27Jul2021 of 101. The fever has been consistent for many days for the husband. The patient underwent lab tests and procedures which included body temperature resulted as 101 on 27Jul2021. On an unspecified date, the patient experienced had not been able to hold anything down, just sips of water. The outcome of the event pyrexia was not recovered, and dysphagia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.