chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SICKNESS; SEVERE MIGRAINE THAT FLARED UP WITH CONSTANT PAIN AND EXTREME LIGHT SENSITIVITY THAT AFFECTED THE VISION AND ABILITY TO TEACH, WRITE OR LOOKING AT THE SCREEN; ENERGY AFFECTED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced sickness, severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected, and the outcome of sickness was not reported. This report was non-serious. This parent/child case is linked to 20210632026.
Patient broke out in hives after 10 minutes. Nurse gave her some BENADRYL for the hives.
Lip swelling, low heart rate, dizziness. Took patient to the ER for evaluation.
Pain in the right Throat and Neck area, slightly swollen. pain in the Throat when swallowing. No fever, is ongoing for 2 days now.
pt recv vax 6NOV97 & on 24NOV97 pt devel chickenpox;
Problems sleeping caused by pain; Could barely walk/preventing from walking right; Pain at the lower back; Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain at the lower back), PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)), INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced BACK PAIN (Pain at the lower back) and PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)). On 06-Sep-2021, the patient experienced INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain at the lower back), PAIN IN EXTREMITY (Severe pain in the right leg/Pain in right thigh/It hurts all the time (referring  to the leg)), INSOMNIA (Problems sleeping caused by pain) and GAIT DISTURBANCE (Could barely walk/preventing from walking right) outcome was unknown.        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.   No concomitant medications provided.  Patient went to the emergency room in two instances and no cause of the pain could be found.   Patient prescribed Norco, Vicodin and Prednisone but she has not used the Vicodin yet.
Huge hot red itchy rash persistent for over 4 days. Growing in size. Spreading down and up arm.
REDNESS NEAR VACCINATED AREA, NODE ON R LEG, WARM TO TOUCH, OCCURED DAY AFTER VACCINATION, AREA WAS 2 QUARTER SIZES BIG
Inflamed mouth; One of his rear teeth became inflamed and had to be removed; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Inflamed mouth) and PULPITIS DENTAL (One of his rear teeth became inflamed and had to be removed) in a male 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 an unknown date, the patient experienced STOMATITIS (Inflamed mouth) and PULPITIS DENTAL (One of his rear teeth became inflamed and had to be removed). At the time of the report, STOMATITIS (Inflamed mouth) outcome was unknown and PULPITIS DENTAL (One of his rear teeth became inflamed and had to be removed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
ER visit due to injured arm; Pregnancy confirmed at ER Visit 7-28-08
ACUTE PULMONARY EMBOLISM 11/26/2021 OSTEOPENIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 OSTEOPENIA ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 OSTEOPENIA ACUTE RESPIRATORY FAILURE 11/10/2021 OSTEOPENIA HYPOXIA 10/15/2021 OSTEOPENIA ACUTE PULMONARY EMBOLISM 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 METABOLIC ENCEPHALOPATHY ACUTE RESPIRATORY FAILURE 11/10/2021 METABOLIC ENCEPHALOPATHY HYPOXIA 10/15/2021 METABOLIC ENCEPHALOPATHY ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE RESPIRATORY FAILURE HYPOXIA 10/15/2021 ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE DVT OF RIGHT POPLITEAL VEIN 11/26/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN HYPOXIA 10/15/2021 ACUTE DVT OF RIGHT POPLITEAL VEIN
Headache and nausea after 15 mins of vaccine. Headache lasted all day, even with taken 1000mg of Tylenol. On 12/23/2020 around 7:30 PM my left arm was extremely sensitive and sore. I could not lay on the arm or touch it. Very hard. This morning when I woke, I had ability to move the arm slightly more than day before. Now my arm is hard and injection sight is red measuring 3 inches wide and 1 inch long. It hurts to touch the upper arm. I cannot stretch my arm all the way or rotate it as normal.
Hospitalized 9.28 (NOT due to COVID);  found to be COVID positive during hospitalization) (10.6); fully vaccinated  Admission Date: 9/28/2021 Discharge Date: Oct 11, 2021 PRESENTING PROBLEM: Blood loss anemia [D50.0] Gross hematuria [R31.0] Hematuria, unspecified type [R31.9] HOSPITAL COURSE: Patient is a 72-year-old with past medical history significant for persistent AFib (on Xarelto), coronary artery disease status post PCI, severe aortic stenosis status post TAVR, ischemic cardiomyopathy (EF of 25%), prostate cancer status post radiation therapy who presented to the emergency department on 09/28/2021 for evaluation of hematuria and dysuria. Of note patient has been having ongoing hematuria for about 2 weeks.  PT and OT recommended subacute rehab.  Prior to discharge to subacute rehab COVID screening test was ordered and positive. As patient was totally asymptomatic he did not meet criteria for monoclonal antibody.  As he was not hypoxic no steroids were started
Mother states no side effects. "No fever, no redness, no soreness, no problems."
Fever, chills, bodyaches muscle and bone. Only for one day, missed worked 7/08/2021 call in.
Information has been received from a female consumer in her 70's with drug hypersensitivity who was vaccinated with a dose of PNEUMOVAX 23 (name and manufacturer unspecified) about 4 years ago, in approximately 2005. Concomitant therapy included influenza virus vaccine (unspecified). In approximately 2005 the patient experienced swelling, itching and burning on her inner forearm of the arm that she received the vaccine. The patient saw her physician who gave her a steroid (name and manufacturer unspecified) and several days later she had recovered. The patient also mentioned that she experienced soreness at the injection site after receiving the influenza virus vaccine (unspecified) about 4 years ago, in approximately 2005. No further information is available.
GARDASIL 9 Dosing Schedule specific to the completion of the interrupted, original GARDASIL Dose Series; No additional AE reported.; Patient who was 1st administered GARDASIL in 2010 when corresponding Patient was 11 Years Old was administered a GARDASIL 9 dose in 2016 when corresponding Patient was 17 Years Old; This spontaneous report was received from a medical assistant, referring to a currently 23-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in 2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis when patient was 11 years old (inappropriate schedule of product administration). On an unknown date in 2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis when patient was 17 years old (interchange of vaccine products). No additional adverse event reported.
No additional adverse effects reported; improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.   On 29-JUN-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025912, expiration date 20-AUG-2021, 1 dosage form (route of administration not provided) for prophylaxis    Temperature: 22.3 Fahrenheit degrees (°F) ; Timeframe: 4 hours 25 minutes; previous temperature excursions: 8.6 Fahrenheit degrees (°F) for 1 hour 51 minutes. The call was made due to Digital data logger. No adverse events were reported.
Patient came to pharmacy describing effects she is experiencing after her shingrix vaccination on Tuesday at store. She experienced most of the side effects listed in the VIS including: tiredness, muscle aches, headache, stomach pain, nausea, sore arm. She also experienced wooziness/ diziness/unsteadiness two days after the vaccine was administered. She says that it is not severe. I told her to report to her Dr. if her symptoms did not improve.
redness all over body; hands shaky; feels generaly weak; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 07-FEB-2023, 33 days after receiving Shingrix, the patient experienced weakness (Verbatim: feels generaly weak). On 14-FEB-2023, the patient experienced tremor of hands (Verbatim: hands shaky). On 25-FEB-2023, the patient experienced erythema (Verbatim: redness all over body). The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Claritin (Nos)). On 26-FEB-2023, the outcome of the erythema was recovered/resolved (duration 1 day). The outcome of the tremor of hands and weakness were not recovered/not resolved.   It was not reported if the reporter considered the erythema, tremor of hands and weakness to be related to Shingrix.     It was not reported if the company considered the erythema, tremor of hands and weakness to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-FEB-2023 The reporter was the patient. There was redness all over the patient's body, she went to the emergency room and the doctor gave her Benadryl and Claritin and sent her home. The redness on her body resolved by Sunday morning. The reporter mentioned that, for the past two weeks (from the reporting date) her hands were shaky and past few weeks she felt generally weak. The shaky hands and general weakness had not resolved. The reporter gave permission for GSK to contact her doctor. The reporter consented to follow up. Time to onset of tremor of hands was 40 days and erythema was 51 days with Shingrix.
This spontaneous report was received from a office manager(also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of PEDVAXHIB, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
MDM: Patient is a 62 year old female presenting to Urgent Care with an allergic  reaction approximately 30 minutes after receiving her first Moderna COVID-19  vaccination. Patient was monitored for 15 minutes, drove away, and began to get  itchy. She felt her face and lips swelling. She normally carries an EpiPen, but  did not have it with her today. Patient very uncomfortable upon arrival with  flushed face and upper and lower lip swelling. No respiratory distress. No nausea  or vomiting. IM EpiPen given soon after arrival, with significant relief of  symptoms. Patient also given dexamethasone 10 mg, famotidine 20 mg, and  diphenhydramine 50 mg, all IV. Plan to monitor until 1430 and discharge with  steroids, diphenhydramine, famotidine, and refill of EpiPen assuming no reaction  recurrance.
10 x 4cm mild erythema to left upper arm. OTC Ibuprofen - warm compress.
Extreme fatigue, chills, fever and headache all came on 9 hrs after the injection. Extreme chills, and shaking. Severe headache. Unable to work the next day or get out of bed. Fever started again by evening on 1-14 and got to 101.7. Vomiting occurred, along w the same symptoms as described. Today, 1-15, I am feeling SLIGHTLY better. Still have slight headache and sore body. Rash under the arm of where I had the injection. (Weird?) I have Lyme disease, maybe that is why I reacted w an adverse event? I am about half scared to get the second injection.
Could not stand up his own; Can not perform his routine activities; Nerve problem in his neck then to Spine/Become worst; Constant pain; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (Could not stand up his own), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) and PAIN (Constant pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced DYSSTASIA (Could not stand up his own) (seriousness criterion disability), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities) (seriousness criterion disability), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) (seriousness criterion disability) and PAIN (Constant pain) (seriousness criterion disability). At the time of the report, DYSSTASIA (Could not stand up his own), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) and PAIN (Constant pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: unknown (Inconclusive) physician said this is coincidence..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       His father has to help him to put on wheelchair. Patient was having constant pain for that he was taking pain medicine.  MRI was scheduled for 05-Jun-2021.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pt recvd 1st dose of Hep B vax 11JAN91 & devel viral synd on 18JAN91 that lasted until 21JAN91; pt recovered;
10/29/2021 the onset of the diarrhea again ( this occurred after the Moderna Dose 2 I had never had this severe diarrhea) a little bit everyday. 11/06/2021- diarrhea 3 times a day. After 11/06/2021 it seemed to have resolved with Imodium AD. 11/19/2021- I got a little nauseated. 11/22/2021- half my eye was bloody and it got worse for the next 2 or days and the doctor  told me to come in if I had any pain. I did not have any sharp or throbbing pain. It was just a bruise type of  pain. The red got out of the eye last week, 12/01/2021- it pretty much cleared up on it's own. The doctor gave me allergy drops to stop the irritation.
After the vaccine Saturday at 11am I felt good until early Sunday when I had a lot of chills and woke up Sunday morning with no appetite and with a headache. Monday midnight I felt tachycardia and a little shortness of breath until today. Tuesday, the tachycardia is mild and intermittent but every time I have tachycardia, I feel short of breath and my chest feels a little tight and uncomfortable.
Shot given on 7/12/05 and by 7/15/05, child was covered in hives all over body. Child was seen in office on 7/19/05.
Young patient felt very nervous prior to the shot, was hyperventilating during the shot, and then threw up shortly after the shot. Likely due to anxiety, not the vaccine itself.
accidentally injected expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial). On 14-Aug-2021, EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that the vial still had the same milky looking appearance and no visual changes. The patient did not experience any side effects.
Was seen in urgent care 4/23/21 with shortness of breath, cough, congestion.  Was tested for COVID which was negative and given rx for albuterol and Tessalon perles.  Had Pfizer vaccine 4/28 and subsequently developed chest discomfort 2 days later, along with shortness of breath, productive cough and sinus congestion.  ESR elevated at 15 though CRP was normal at 0.5.  Troponin normal.  ECG showing diffuse ST elevation.  Chest x-ray negative.  He was started on indomethacin 25 mg 3 times daily.  Seen by cardiology  5/4/21 with ongoing chest discomfort and shortness of breath.  He was started on colchicine. BNP, and d-dimer were checked which were normal.  CXR normal.  He was subsequently admitted 5/9-5/11 with transient left sided numbness.  TTE showing normal LV function, no hemodynamically significant valvular abnormalities, normal CVP, and no interatrial communication.
Information has been received from a female , for GARDASIL who in December 2008, was vaccinated with GARDASIL (number in series not reported). Two days later the patient started to bleed for two weeks. The consumer reported she just took two home pregnancy test and both came out positive, but she was scheduled to go to see her physician this week to find out if she really was pregnant. No further information is available.
At 4:55, patient received a COVID-19 Pfizer vaccine. At the time of administration patient expressed she had experienced a previous reaction to a pneumonia vaccination (unknown time frame) and that she did not like to receive shots. She requested that the person administering the vaccine count down before giving shot. Patient appeared nervous and was breathing heavily before she received her vaccine. Patient was instructed to sit and wait 15 mins. after vaccine administration in case of an adverse reaction. At time of check-out from the pharmacy (15 mins. after vaccination), patient expressed to pharmacy intern that she felt a "little dizzy" and that she had experienced "slurred speech" immediately after having received the vaccine, however had not communicated this to pharmacy staff. Pharmacy intern immediately took patients blood pressure and it was 176/99 mmHg and 162/101 mmHg during first two blood pressure checks. The pharmacy staff requested patient to remain within the pharmacy premises so that she could be monitored for more time. She then was checked every 5-10 minutes for approximately 2 hours. During this time, she described vision changes, dizziness, and a strange "fogginess" around her head. Additional blood pressure monitoring was conducted for results of 158/100 mmHg and 195/100 mmHg. Pharmacy Manager discussed options with patient, including having her go to an Urgent Care facility or calling 911, so that paramedics could assess her. patient expressed she wanted to be taken to the hospital, therefore intern called 911. Paramedics arrived shortly after and determined patient had not experienced a stroke. Her neurological exam was negative. Paramedics stated that patient was most likely experiencing an allergic reaction. The paramedics then proceeded to take patient to the hospital at her request around 7:00 PM. Multiple pharmacists and pharmacy interns spoke with her during this time frame of ~2-2.5 hours, took her blood pressure, and assessed her condition.
severe allergic reaction with rash and large welts ...angio edema....had 4 prescriptions of steroids over 6 weeks and Benadryl, Allegra, Pepcid.  Welts are large, painful, itchy, red and have not gone away.  Was referred to Dr. Had a video conference.  Her treatment was the same as, prednisone, antihistimines, and Pepcid.  Suggested an experimental drug called Xolair.  Have not take it.  $2300 and shot and adverse effects too dangerous.
Patient received her 1st Covid vaccine today, with a known history of anaphylaxis to the flu shot 6 months prior. She was assigned a 30 minute wait time. She received her vaccine at 1225 on 14May2021, and approximately 15 minutes later developed itchiness around her mouth and face. She reported this felt similar to the beginning of her prior episode. Physician and nurse were notified, who evaluated patient. Patient?s airway was clear, respirations unlabored and normal to auscultation. Vitals were within normal limits. EMS was notified, and 50mg Benadryl was given at 1255. At this time patient?s reaction appeared minor and stable, so epipen was at patient?s side however not given yet. EMS arrived rapidly, and repeated eval, confirming same evaluation and history. Patient was transferred in stable condition to the ER for extended monitoring.