chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of dizziness approximately 5 minutes after receiving vaccine. Experienced transient loss of consciousness 2 minutes later while seated. Transferred to the floor and laid flat immediately after episode. Regained consciousness upon laying flat. Allowed to lay flat for about 10 minutes. Nurse practitioner took blood pressure after having patient sit up. Recorded as 120/80. Patient appeared pale. Encouraged to drink water.  EMS arrived approx. 15min after episode. Took blood pressure and checked pulse. BP recorded as 118/84. Patient indicated that he has similar episodes prior after receiving a flu shot and having blood taken. Refused to be transported to hospital facility. Allowed to continue to rest for an additional 30 min after which he was picked up by spouse.
Extreme swelling at injection site that has spread to size of saucer. It is sore, tight, itchy, hot to touch and has a knot.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with GARDASIL (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
Patient received moderna vaccine on 3/9/21, 4/9/21 and 11/10/21. Presented to ER on 5/28/22. Found to be COVID positive. admitted to hospital for acute on chronic hypoxic respiratory failure. On initial presentation, patient was saturating at 83% on home oxygen 3LNC. Patient continued to desaturation and oxygen requirements increased to high flow nasal cannula. Patient received a dose of solu-medrol and duoneb. CBC was unremarkable, hemoglobin of 8.3 (baseline 8-9), CRP 28.4, negative procal, blood cultures showed no growth. Sputum cultures showed normal respiratory flora and a light growth of yeast. Negative strep and legionella. BNP 141, negative troponin, ABG: pH(7.41, pCO2(39), pO2(55), CO2(26). CTA showed no PE, multifocal pneumonia. Patient was admitted to unit for treatment for acute on chronic hypoxic respiratory failure. Patient continued all other home therapies for COPD and started on antibiotics and steroids. During patients hospital course, her respiratory status began to decline and pulmonology was consulted. Pulmonology was consulted and patient was intubated on 6/1 and transferred to ICU. Patient received therapeutic bronchoscope with BAL, started on solu-medrol 62.5 mcg bid, continued on duonebs scheduled mucomyst and vest therapy. BAL cultures were negative. Patient was extubated on 6/2/2022. Patient was able to return to home oxygen baseline (3LNC). Pulmonology provided recommendations, which included the use of Vest PT, duonebs, prednisone taper, mucomyst, nasal hypertonic, flutter valve, albuterol, mucinex, trelegy, and mucinex. Patient was approached during admission for the possibility needing BIPAP/AVAPs nightly. Patient declined the recommendation, due to not being able to sleep. Pulmonolgy was contacted in regards to recommendation and stated that BIPAP/AVAPs would be beneficial for the patient, but did not qualify due to the results of ABGs during hospital admission. Patients respiratory status was stable and patient remained stable on home oxygen of 3L NC.  Discharged on 6/6/22
Anaphylaxis - epi pen X 2, transported to the ED for evaluation and further treatment.
Fever of 103 for 2 days. After fever subsided, he became very limited in what he would eat. Eye contact went away and over the next 12 months I continued to see a period of decline in responsiveness as well as an increase in obsessive behavior from no longer playing with toys but lining them up as well as staring episodes at no one or anything in particular. Eventually he stop responding to his name being called and words he once knew well (Mommy, Daddy, etc.) slowly disseminated. He showed little to no interest in siblings anymore and did not acknowledge our dogs anymore.
After 30 minutes, I developed nausea, a severe headache, chills, sever body aches, and muscle weakness. The headache and nausea went away approximately 24 hours later, however; the chills, body aches and muscle weakness took 5 days to recover from the date of injection.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was unknown. It was reported that vials had not undergone any temperature excursion. No treatment medication were reported.   This case was linked to MOD-2022-585393 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 10-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2007). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 4/14/21 I started having chest pain and pressure.  I was seen in Urgent Care that day and an EKG, Chest xray, and lab work was preformed.  Everything was normal and I was sent home to monitor.  I continued having chest pain 4/14-4/17.  On 4/17 I was having chest pain and then started having numbness in the left side of my face.  I proceeded to have left sided weakness,  difficulty speaking, slurred speech, and loss of motor skills.  I was taken to the ER.  They did a CT scan, blood work, and an ekg.  All were normal.  I was admitted to the hospital and they did MRI or the head, MRA of the neck, MRI of the neck and spine, Echocardiogram, Stress test, and further blood work.  Everything came back normal.  I saw Neurology inpatient and was discharged to follow up outpatient.  I still have coordination  difficulty and I do not have all of my motor skills back yet.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Mild, Additional Details: Patient had fading consciousness 5 minutes after vaccine administration.  When patient became unresponsive to questions and care, Epipen was administered.  Patient recovered quickly, ambulance was called.  Patient went with ambulance.
Itchy rash; rashes up and down and right her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE RASH (rashes up and down and right her arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2015, Stent placement since 01-Jul-2016, High cholesterol since 2016 and Depression since 1997. Concomitant products included LOSARTAN POTASSIUM for Blood pressure high, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, ATORVASTATIN from 01-Jul-2016 to an unknown date for High cholesterol, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Sep-2016 to an unknown date for Stent placement, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) for unknown.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced RASH PRURITIC (Itchy rash) and VACCINATION SITE RASH (rashes up and down and right her arm). On 15-Sep-2021, RASH PRURITIC (Itchy rash) had resolved. At the time of the report, VACCINATION SITE RASH (rashes up and down and right her arm) 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.   Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant: HCP reporter added, Vaccine start date added, Demographic details added, Medical history added, concomitant drugs added
Patient (nurse) called on 11/16/11 pm complained that Dr. (deulist) since he got his shot his arm has been hurting him & few days ago he had stiffness in his neck used hot compresses (does not help) very sore & painful. Need to report that & that someone from the company needs to call her.
Patient was admitted to the hospital and taken to the operating room where patient underwent a revision left total knee arthroplasty. Patient tolerated the procedure well with no apparent complications. Patient was transferred to the floor where patient remained afebrile with stable vitals signs. Hospital admission within 6 weeks of receiving the COVID vaccine.
myasthenia gravis/ it's symptoms flared up; Had uncontrollable shakes; She was burning up; Her skin was so hot; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up) and TREMOR (Had uncontrollable shakes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0SZM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myasthenia gravis (a neuromuscular condition).   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Mar-2021, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up) (seriousness criterion medically significant), BURNING SENSATION (She was burning up), SKIN WARM (Her skin was so hot), TREMOR (Had uncontrollable shakes) (seriousness criterion medically significant) and ASTHENIA (Weakness). At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis/ it's symptoms flared up), BURNING SENSATION (She was burning up), SKIN WARM (Her skin was so hot), TREMOR (Had uncontrollable shakes) and ASTHENIA (Weakness) had resolved.            No relevant concomitant medications were reported. Patient reported that She took no treatment and just went to bed.  Company Comment: This case concerns a 81 year old female patient, with medical history of Myasthenia gravis who experienced serious unexpected event of Myasthenia gravis aggravated  after second dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is unknown since event outcome is recovered and event occurred after second dose. Patient's previous diagnosis of myasthenia gravis is a contributing factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 81 year old female patient, with medical history of Myasthenia gravis who experienced serious unexpected event of Myasthenia gravis aggravated  after second dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is unknown since event outcome is recovered and event occurred after second dose. Patient's previous diagnosis of myasthenia gravis is a contributing factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Hi,  I thought I would report what happened after my shingles shot. The night of when I got my shot (October 11 by then because it was midnight)  I started getting the shivers and was very cold for about 4 hours from about midnight til 4 am. Then on Oct 12th at about 2pm I was itchy on the right ankle. That evening around 9pm I took shoes off and had a red rash on top of my feet.  I had difficulty sleeping because it burned. The rest of my skin off and on felt funny maybe pins and needly but not bad. My face felt that the most. But the next day the issue was primarily my feet. I still have the rash on the feet. Just thought I would share as I looked it up and it said it is rare, but I thought maybe it is because people dont let you know. I gave myself a rapid COVID test because I looked that up and it said you might have a rash as your only COVID symptom but that was negative. My question is whether it is advisabke for me to get the second shot or not because of my reaction. Also, how much protection does the first shot give you?
This is a description of events prior to the reaction experienced December 16,2005. What if any relationship there is I do not know, but I do have some thoughts about possible ones. (1) I requested an appointment with my physician during the early part of Dec. 2005 to determine the reason for continuing pain in the right nipple on my chest. The appointment was for 9:30 am Dec 16 at the facility (UHS). (2) I was taken to an exam room to wait for the doctor. Shortly thereafter the nurse came in, and stated "Medicare wants all seniors to receive an update of the pneumonia vaccine," then proceeded to fill the syringe from a small bottle. I was given the shot at the very top of my arm, at the shoulder. I had no objection as I could not remember how long it had been since receiving the vaccine. (This occurred prior to the Doctors examination). (3) After the examination Dr. requested X rays (mammogram) be made. Subsequently Dr. and the Radiologist determined the problem was due to an infection. (As I was told, and with relief to me). This X ray exam and waiting took up a good part of the afternoon. (4) I was given a prescription for IC Erythromycin 250mg FILMTABABB. (per the unit #4351 prescription) by Dr. The prescription was filled after 5:00 pm. (5) The first pill was taken at dinner at about 6:30 pm. (6) About 8:00 pm I took my evening dose of METHYLDOPA 250mg (for high blood pressure) with a small amount of food. (7) About 10:30 pm I took one aspirin for arthritis due to the days activities. (8) I went to bed about 11:15 pm. (9) About 2:00 am (per the clock Saturday morning December 17,2005) I awoke with a pain in my stomach and the need to urinate. I go up and went to the bathroom, drank a small cup of water, then went back to bed. (10) Almost immediately I felt a very violent pain in my stomach, along with an extraordinarily violent headache. Which steadily became worst, (the worst headache I have ever experienced in my entire life, also my head felt very hot. (11) My nasal (passages began swelling and closing. I could feel the same sensation in all the sinus cavities as well. Some closing and swelling was occurring in the throat. (12) I just laid there thinking I would die, and hoping I would, to eliminate all the excessive pains. It seemed like a long time but I could not (and still cannot) determine how long this lasted. Apparently I went to sleep. I did not wake my wife., which I should have but there was no thought of this. (13) I called the doctors office Saturday (I recall) getting a message signal to record a message, which I did, describing some of the above. I have no ideal if anything was received as I have had no reply from there. This could have been Monday am, but things were still fuzzy. While cleaning up and sorting older medical records 3 days ago (We keep everything) I found a copy of a pneumococcal 7-29-97 vaccine information statement given to my wife by another provider several years ago. Following it's instructions this is why I am writing in January 2006 and not December 2005.
Started as itching on the feet and hands and progressed to my entire body. Started taking  benadryl yesterday evening and it helped stop the itching.
In the ED, patient was noted to have elevated troponin, she was in A. fib but not in RVR, subsequently admitted to hospital. implantation of pacemaker and AV node ablation performed and discharged to rehab. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a pharmacy technician refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
No additional adverse events reported; Expired vaccine used; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 23-SEP-2021 (also reported as today), the patient was vaccinated with an expired dose of  varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose (strength, formulation, indication, vaccination scheme, route and anatomical location of administration were not provided; lot # S020464 upon internal review determined as valid, and expiration date established as 02-JUL-2021) for prophylaxis (expired product administered).  No additional adverse events reported
Within 10-15 minutes started experiencing swelling of the tongue and lips. Was taken to the local ER where I was treated with steroids, benadryl. I was monitored for any other adverse reactions and released hours later once reaction resolved.
Felt like an allergy; little cough; Bone pain; Tasteless as if he was not eating anything; Can't smell anything and he has not got back the sense of smell yet; Phlegm; Felt bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything) and ANOSMIA (Can't smell anything and he has not got back the sense of smell yet) in a 64-year-old male patient 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 information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Felt like an allergy), COUGH (little cough), BONE PAIN (Bone pain), AGEUSIA (Tasteless as if he was not eating anything), ANOSMIA (Can't smell anything and he has not got back the sense of smell yet), PRODUCTIVE COUGH (Phlegm), FEELING ABNORMAL (Felt bad) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab test: SARS-CoV-2 test: positive (Positive) Positive after first dose of vaccine  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
24hrs after getting Hep B shot pt felt left leg arm sensation "ardor" 2 days later she noticed itching and now has rash-located on left inner upper forearm and left lateral palm area. Pain and itching continues.
Flushing; felt like I had the flu; I had 101.8 fever; Numbness and tingling in my mouth, neck, throat; Numbness and tingling in my mouth, neck, throat / Pin prick sensations going up my arms; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness and tingling in my mouth, neck, throat), PARAESTHESIA (Numbness and tingling in my mouth, neck, throat / Pin prick sensations going up my arms), FLUSHING (Flushing), INFLUENZA LIKE ILLNESS (felt like I had the flu) and PYREXIA (I had 101.8 fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025J20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included HCTZ, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and ESTRADIOL (VIVELLE [ESTRADIOL]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in my mouth, neck, throat) and PARAESTHESIA (Numbness and tingling in my mouth, neck, throat / Pin prick sensations going up my arms). On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like I had the flu) and PYREXIA (I had 101.8 fever). On an unknown date, the patient experienced FLUSHING (Flushing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg. On 14-Feb-2021, HYPOAESTHESIA (Numbness and tingling in my mouth, neck, throat), PARAESTHESIA (Numbness and tingling in my mouth, neck, throat / Pin prick sensations going up my arms), INFLUENZA LIKE ILLNESS (felt like I had the flu) and PYREXIA (I had 101.8 fever) had resolved. At the time of the report, FLUSHING (Flushing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 101.8 (High) 101.8 Fever.         This case was linked to MOD-2021-021154 (Patient Link).
This initial spontaneous case, initially received on 21-Feb-2018, reported by other non-health professional, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacture: not reported). On an unspecified date, after the administration of vaccine, the patient experienced increased pain and swelling of the left shoulder at the injection site. At the time of this report, the outcome of the events was not reported.