chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004467: US-009507513-1704USA004466: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004517.
Sore arm; Eyes swelled up; Lips swelled up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelled up), LIP SWELLING (Lips swelled up), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID pneumonia) in September 2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 23-Jan-2021, the patient experienced EYE SWELLING (Eyes swelled up) and LIP SWELLING (Lips swelled up). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, EYE SWELLING (Eyes swelled up), LIP SWELLING (Lips swelled up), PYREXIA (Fever) and CHILLS (Chills) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment for the event included diphenhydramine (Benadryl)   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: New event Sore arm reported.
itchy; Swollen; allergic bump; A spontaneous report was received from a consumer who was a 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an itchy, swollen and allergic bump.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On the morning of 05 Jan 2021, the patient started to have an itchy, swollen and allergic bump. She did not apply any treatment medication as the itchy, swollen, allergic bump did not bother her, however she was concerned about the delayed reaction.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events itchy, swollen and allergic bump was not reported.; Reporter's Comments: This case concerns a 30-year old female patient with unknown medical history and concomitant medications. The patient experienced a non serious event of an itchy, swollen and allergic bump 6 days after the administration of first of 2 planned doses of the mRNA-1273 (Lot #: 039K202A).Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded
Patient presents for a emergent visit. She sent me a message yesterday through the portal explaining that she had the Shingrix vaccine on Wednesday and had concerning neurological symptoms later that day. She and her daughter were talking on the phone and her daughter explained to her that her speech was a little slurred. Patient felt very tired and weak which she attributed to the vaccine. She did not have specific extremity weakness, just overall felt weak. When she got home her daughter called her again and thought that she sounded better. Her husband was home and did not think she had any facial droop or change in mental status. She also complains of intermittent chest pain. It is not exertional. It occurs when she is sitting watching TV or doing nothing at all. Feels little short of breath with it. Denies diaphoresis or nausea. Denies radiating pain. She had a nuclear stress test done a little over 2 years ago for bilateral knee surgery. She is been having the chest pain off and on for 1 month. She tells me that she experiences shortness of breath with cleaning but can exercise and do speed walking without shortness of breath. She has been stressed lately. Her brother was diagnosed with testicular cancer. She herself had breast cancer last year and has ongoing issues with fatigue
Patient fainted for 1 minute light headed. Had patient lay down. gave ice pack and water for treatment.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 24-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
right hand: some swelling; joint swelling in left foot; pain and stiffness in knees; possible psoriatic arthritis; Neck stiffness and pain; Neck stiffness and pain; pain and stiffness in knees; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 10Nov2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Apr2021 09:30 (at the age of 46 years) (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Medical history included clinical depression from Oct2017 and ongoing and gold and nickel metals allergy. Concomitant medications included bupropion taken for depression from Oct2017 and ongoing; curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported; and vit D [vitamin D nos] taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 15:30 (at the age of 46 years) (Batch number: EP6955) administered in the right arm for COVID-19 immunization. In Jun2021, the patient began having neck stiffness and pain, joint swelling in left foot, and pain and stiffness in knees. In Sep2021, the patient went to the rheumatologist and was diagnosed with possible psoriatic arthritis although x-rays and blood tests were inconclusive. Events joint swelling, joint pain, and psoriatic arthritis were reported with an onset of 01Jun2021, requiring visit to physician office, and with seriousness criteria: persistent/significant disability. No treatment was received for the events. COVID booster was recommended by the doctor as well as change of diet to anti inflammatory diet. She received the COVID booster on 16Oct2021 and the next day all joints were very swollen and in pain, could not walk, could not close right hand. She made an appointment with the rheumatologist. She said to report it as adverse reaction to vaccine and the patient was started on prednisone, methotrexate and folic acid. The pain and swelling were still out of control 17 days later. The patient underwent tests and procedures which included X-ray on 20Sep2021 with comment: right hand: some swelling and blood test on 21Sep2021 with comment: elevated inflammatory markers. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264), via an unspecified route of administration at the left arm on 31Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation, pre-diabetic, and high blood pressure. The patient's concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO) on Oct2020 for heart failure, metoprolol on an unspecified date for atrial fibrillation, and apixaban (ELIQUIS) on an unspecified date in 2018 for blood thinner. The patient experienced shortness of breath on 31Jan2021 20:00. The vaccination facility type was not a military facility. The outcome of the event was recovering.
Tighter chest; Something with my breathing; Head felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tighter chest), DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CHEST DISCOMFORT (Tighter chest), DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy). On 23-Mar-2021, DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy) had resolved. At the time of the report, CHEST DISCOMFORT (Tighter chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Initially, soreness in upper right chest. On 10/17/16, observed first red patch on right chest. On 10/18/16, red patches increased on and were on upper right back. Soreness in chest and back increased. On 10/20/16, went to a dermatologist who diagnosed the then-blistering rashes as Shingles probably as a reaction to FLUZONE HIGH DOSE vaccination on 10/12/16; also had the PREVNAR 13 vaccination on 10/12/16. Dr. prescribed Valacyclovir 1 gram tablets.
RIGHT AXILLARY LYMPH NODE SWELLING APPROX SIZE OF GOLF BALL,  DIZZINESS, ABNORMAL LABS PT PRESENTED TO ER WITH C/O OF FEELING WEAK AND DIZZY X 1 WK, WORSE TODAY, LEFT SIDED HEADACHE,  ADMITTED TO HOSPITAL FOR INPT DUE TO AKI, NEAR SYNCOPE , DEHYDRATION, ACUTE LEUKEMIA, UTI GIVEN FLUIDS AND ANTIBIOTICS STARTED
1-2 days of slight soreness and swelling at injection site.  However, exactly 14 days later, tight chest, front and back ribs, spine and all back muscles hurt with unusual severe pain.  Loss of appetite and "tingling" as well as elevated blood pressure and "wierd" feeling irregular heart rhythm.  This lasted exactly 5 days.  6th day, fortunately the other symptoms seemed much better, but now occasionally there is a "tingling" sensation throughout my entire nervous system... in other words I feel it in my chest, arms, legs.  There has been no dizziness associated with any of these symptoms.  Had I felt any difficulty breathing I would have immediately gone to the hospital or emergency room, but that never occured.  I told my husband, I felt (based on what you hear) like the symptoms were "covid" but no fever, no nausea and no lung issues... just really strange pain.  Today, 17th of March, I am feeling better (I have also been off work), but I am concerned as I am scheduled in less than 10 days for a second moderna vaccine, and I am uncertain what to do.
Sudden severe headache and shaking. Nausea for 2 days. Jaundice.  Liver counts high platelets low for a week.  Continuing . . .
arm began to swell & itch;w/in 30min exp light-headedness, n, hypotens;red  & turned pale;pt weak;exp cerebral anoxia r/t anaphylaxis;bradycardia, GI dis poss gluten-sensitive enteropathy;bronchial spasm,dec memory;CNS damage;
Mother reports child having seizure that lasted 30 seconds-1 minute - low grade temp of 98.9 hx of febrile seizures. (Mom called local ED - child not seen).
Eight days following injection I developed a red rash around injection site. Rash is warm to the touch and itchy. Rash has continued to spread on arm.
Per Foster parents child was fussy after shots then all of a sudden got very quite and started shaking all over lasted approx 3-5 min. Unconsolable cry before seizure.
My brother had his last COVID 19 shot in March 2022.  By May/June he began feeling bad. Tired, fatigued.  On 11 July 2022 he woke up in severe pain in the stomach and called my mom.  She took him to the ER and they said he had a blockage in his intestine and sent him to his kidney hospital.  The doctors operated the next morning and found a tumor mass that had ruptured.  A few days later found out it was small cell cancer; which the doctors were in shock as it is extremely rare to find small cell cancer in the colon.  Medical care was horrible after that and no one would give us any answers.  During the surgery the cancer had spread to his pancreas which they removed with half of his colon.  He had an illiotamy.  The doctors never called in hospice or even told us a prognosis.  They sent him home and he was back in the hospital in a few days.  He went back to the hospital 3 times before he passed 5 weeks later on 16 Aug 2022.  The last visit to the ER; about 5 days before he passed.  He tested positive for COVID. The isolated him and did not allow him to go to dialysis.  They sent him home and of course listed COVID as one of the causes of death.
11:15am burning in stomach, clammy/sweaty, vomiting x3, numbness on arms and hands (all within 20 minutes).
Entire body was 'buzzing' while experiencing heart palpitations (while at rest), ranging from 90 in excess of 110 BPM lasting 10-15 minutes, 2 rapid heart rate intervals within 30 minute time frame. Labored breathing. Tight diaphragm feeling.
Arm pain and fatigue right away; January 4th I noticed I was bleeding - I had a miscarriage.  Went to doctor the next day and they did lab tests and confirmed I had a miscarriage. Pregnancy - 3rd pregnancy; and it was my second miscarriage. I was about seven weeks pregnant.
This non-serious initial spontaneous case, was received from pharmacist on 13-Oct-2017, concerning a 68-year-old male patient. The patient's medical history included insomnia (on an unspecified date), arrhythmia (on an unspecified date) and HTN (hypertension, on an unspecified date). The patient's concomitant medications included amlodipine, tramadol, losartan/hydrochlorothiazide, temazepam and sotalol. On 11-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch number: 179402, route of administration: intramuscular, anatomical location: left deltoid, expiry date: Jun-2018). On 12-Oct-2017, after 1 day of vaccination, the patient had dark redness, which was 3 inches in diameter and warmth around the injection site. No treatment was taken for the events. The patient was recovered from the events within 2 to 5 days. Follow up report received on 23-Oct-2017: The outcome of the event from not recovered to recovered within 2 to 5 days was updated. The narrative was amended accordingly.
1130PM 101 fever gave APAP 120mg w/bath 7MAR91 4am 104 fever, cont APAP & bathing then would decrease to around 102, 7MAR fever would cont to reach 104R; 8MAR91 730AM 105R fever 1 hr p/APAP; Given antibiotic;
Pt. states that after receiving the 1st dose of J&J 10/27/2021, started experiencing symptoms immediately of convulsing seizure lasting a little over a minute. 911 dialed  Fire Department arrived and examined, pt. was transported by acquaintance for Observation within household. Primary visit 11/01/2021 Blood Work ran (Abnormal) White Blood Cells clotting.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 75-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because  facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No Treatment medication reported.
Initial report received on 29 September 2006 from the patient. A 29 year old female patient had received a first dose, intramuscular, left deltoid injection of Adacel, lot number not provided. on  19 September 2006. Eight to twelve hours later, the patient experience flu like signs and symptoms, fever, congestion, cough, and soreness and redness at the injection site. The patient also experienced a small dry area of skin above the injection site. The patient recovered from these events. It was also determined that the patient was pregnant. Her LMP was 29 August 2006, and her estimated date of delivery is 31 May 2007.
PATIENT REPORTED "BAD HEADACHE" AND FEVER OF 100.3F THE DAY FOLLOW ADMINISTRATION OF MODERNA COVID VACCINE. HE CLAIMS TO HAVE SOUGHT MEDICATION ATTENTION FROM HOSPITAL AND WAS TREATED WITH TYLENOL AND MOTRIN AND RELEASED THE SAME DAY.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Additional Details: pain and redness getting worse with time.
Within 12 hours of vaccine, infant had increase in work of breathing and required increased respiratory support.
Patient returned to counter within 10 minutes of receiving vaccination to say her pinky and ring finger on right arm were tingling/stinging.   Called patient later in the evening and she said her finger was slightly discolored, and that her arm was heavy. She said her hand was slightly numb, but that has happened before.  She was advised to go to the emergency room.  She said she would head to urgent care, but she thought it was improving.  She will call us tomorrow with update.
Patient was seen at Emergency room on 9-22-19, diagnose with cellulitis in Both arms near vaccines sites; He follow up with us on 9/23/19; patient was improving both arms were still swell and redness.
COVID-19; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and SINUSITIS (Sinus infection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was Unknown if patient had received any other vaccine within 1 month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Seasonal allergy (Seasonal allergies) and Myasthenia gravis (Since she was in her 20's, under control). Concomitant products included GAMMA GLOBULIN for Myasthenia gravis.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (COVID-19) and SINUSITIS (Sinus infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. On 27-Aug-2022, COVID-19 (COVID-19) and SINUSITIS (Sinus infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Patient received 4 doses of Moderna COVID-19 Vaccine but did not remember dates. Patient did not experienced any adverse events after any of the vaccines. Adverse event caused patient to seek medical care. Patient visited doctor.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-651177 (E2B Linked Report).; Sender's Comments:  MOD-2022-651177:Husband's case
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.