chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 4 weeks after receiving the Booster shot, I developed a blood clot in both lungs and my leg.  My feet and legs continued to swell and I was having difficulty breathing.  My PCP told me to go to urgent care because she thought it could be CHF.  After several tests were done it was found that I had DVT/PE and was admitted to the hospital.  I was placed on blood thinners (Lovenox and Warfarin) and oxygen.  I was discharged to home to continue using the blood thinners and oxygen.  As of 5/5/2022, I am still on Warfarin.
Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 29-AUG-2013 the patient was vaccinated with a 0.5 ml dose of expired PNEUMOVAX23 (lot # 1071AA, expired on 20-MAR-2013) (route not reported). No adverse effect reported. This is one of several reports received from the same source. It was linked to MARRS#1309USA001808. Additional information has been requested.
joint pain especially in hands, difficulty bending fingers, joint pain extending down to knees, sever headaches.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 06-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received seasonal flu vaccine, stood and within 5 minutes experienced syncope with jerking. She fell down to the ground. After a few minutes she came back to consciousness and resumed normal functions.
No additional AE's were reported; ROTATEQ administered to a patient on 22-SEP-2020 that was expired on 16-SEP-2020; This spontaneous report has been received from a nurse concerning a patient of unknown age and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 22-SEP-2020, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL (vial tube) lot # 1660148 expired on 16-SEP-2020, 1 vaccination time) orally, for prophylaxis. The reporter stated realizing that the vaccine was expired (6 days past) after it was given to the patient; and inquired about any known adverse events (AE's) associated with revaccination, or further recommendations for revaccination with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) in order to know how to proceed with the dosage regimen. The patient had an appropriate age (unspecified) at the time of vaccination and no AEs were reported by the patient's family.
COVID 19 Treatment; COVID 19 Treatment; Moderna dose 21May2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21May2022, outcome "unknown", described as "Moderna dose 21May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20May2023 to 25May2023. Additional information: No known allergies. Patient received Moderna covid-19 Vaccine on 05Jun2023 at Left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX) (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck 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 source. Sender's Comments: US-009507513-1802USA001558:
Weak legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak legs) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Weak legs). At the time of the report, MUSCULAR WEAKNESS (Weak legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment medicines were reported.
Information has been received from a health professional concerning a 13 year old male who "about 6 years ago" in approximately 2000 was vaccinated with a dose of Varivax. Subsequently "about 6 years ago" in approximately 2000 the patient experienced breakthrough chickenpox. It was not known if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0607USA04566) and sister (WAES# 0605USA04472) developed similar adverse experienced after vaccination with Varivax. Additional information has been requested.
Headache, aching, 3 or 4 days later cough, congestion.
Initial report received from a consumer who is also patient's parent on 17 April 2013. A 12 year-old female patient, had received a dose of ADACEL vaccine (lot number, dose number, route of vaccination were not reported) in left deltoid on 15 April 2013. The patient had "allergies acting" at the time of vaccination and her medical history and concomitant medications was not reported. On 15 April 2013 in the evening, the patient had fever of 102 (Unit not reported). The patient was treated with Ibuprofen. On 16 April 2013, the patient went to school but had shivering and the fever went to "04.2". At the time of this report, the fever had declined to 101 (Unit not reported). Laboratory investigations were not done and corrective treatments included Ibuprofen. The patient's outcome was not recovered. Documents held by sender: none.
Patient was given booster (3rd) dose of Moderna covid 19 vaccine. approximately 10 minutes after administration she started getting faint, and said "the room is spinning". I put a cold pack on the back of her neck and checked her blood pressure it was approximately 165/110. She never lost consciousness, but reported being very sleepy. She started to report that her throat hurt and her lips were tingling. With patients husbands permission we called 911. The operator asked if she had an epi-pen, her husband reported she did and pulled it out of her bag, he gave her the epi-pen on the advice of the 911 operator, at that point the EMT arrived and took over and transported her to the hospital.
24 hours post vax the pt experienced flu like symptoms, entire back pain, possible fever, had chills and hot feeling. Arthritic pain in all joints, no headache. Slept 10 hours each day for 2 days.
passed out on bed; eyes were spinning around; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache). On 05-Apr-2021, LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       CC: This is a spontaneous case concerning a 81-year-old female patient with Hashimoto´s disease, who experienced the non-serious unexpected event loss of consciousness, the same day after receiving the first dose of mRNA-1273. Patient describes that the reaction lasted for about 10-15 minutes and felt better the following day. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No treatment medications were provided.  The patient received the first dose on 05-Apr-2021and the second one on 05-May-2021 (Lot: 005C21A, Expiration date: Unknown).The patient had a reaction to the first dose. The day she received the first dose, she started experiencing a headache and passed out on her bed. Her eyes were spinning around. The reactions lasted for about 10-15 minutes and she felt better the following day. She stated that she doesn't think she needs the booster. She had read about the Moderna vaccine and that it was still experimental. She also reported that because she had a reaction to the first dose, she doesn't think she should get the booster shot of Moderna.   This case was linked to MOD-2021-403727 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 81-year-old female patient with Hashimoto´s disease, who experienced the non-serious unexpected event loss of consciousness, the same day after receiving the first dose of mRNA-1273. Patient describes that the reaction lasted for about 10-15 minutes and felt better the following day. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I was pretty sick for the first two shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was pretty sick for the first two shots) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was pretty sick for the first two shots). At the time of the report, ILLNESS (I was pretty sick for the first two shots) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not reported.
hard knot under inj site notice by pt 2 days p/vax growing to quarter size by 4 days p/vax;pt also states soreness in arm;today 6 days post vax soreness is better but cont to have quarter sized knot under inj site;
The patient states that she reported to pharmacy to receive her Prevnar-13 vaccine and after she received the vaccine she was making her way out of the store when the patient reported severe low back pain localized on the spine that left her breathless.  She states the pain started to radiate up her spine and to her neck.  On physical examination the day she presented to the clinic she had point tenderness to the T12- L1  and evidence of muscle spasm to the low back.  Her VS done on 08/26/2020, the date she sought medical evaluation, were: temp: 97.5, HR 73, BP: 187/95
Discharge Provider:  MD Primary Care Provider at Discharge: MD  Admission Date: 9/9/2022 Discharge Date: 9/10/2022  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE:      An 80 years old gentleman who presented to the Health emergency department on 9/9/2022 because of fever and chills after he underwent successful DC cardioversion for atrial fibrillation early in the day on the 9th. His work-up in the emergency department was found to have fever 38.9, and the initial workup showed positive COVID-19 PCR rapid test, elevated troponin 31, and elevated creatinine 1.9 with known baseline 1.2 and an elevated potassium of 5.2.   The chest x-ray did not show any acute cardiopulmonary process and the urinalysis was unremarkable for any evidence of infection.  He was admitted for COVID-19 with sepsis. In the ED the patient developed hypoxia with exertion down to 84% on room air. His procal was unremarkable at 0.08 and CRP only minimally elevated 12.9. He was started on decadron and IV fluids during the stay and his home lisinopril was help due to AKI/hyperkalemia and hypotension. He was started on norvasc 5mg during the stay.  The patient's renal function improved however his potassium up trended to 5.5. He was given a dose of lokelma and a repeat BMP was ordered prior to discharge. Will stop decadron as this is not indicated for patients with COVID without hypoxia.    Upon initial presentation troponin elevated to 31 down trended to 22. He denies chest pain. Given cardioversion prior tin the day suspect this was demand ischemia vs AKI.  No evidence of ST elevation or depression on 12 lead electrocardiogram.   The patient had successful DC cardioversion. The patient is still on Eliquis and will remain on the Zio patch.   Recommend post-hospitalization follow-up with PCP 1-week following discharge and a repeat BMP in 1 week to reassess renal function and potassium.
I just got my second COVID vaccine shot yesterday 5/12. My first shot was on 04/19. Both were Pfizer. After both my first shot and second shots I've had an elevated heart rate.  My resting heart rate is usually between 60 and 80. About 12-15 hours after the shots it shoots up to 90-130. The first time I got the shot it went away within a few days.
Chest Tightness VS 186/84, 87 O2 sat 97 % . Transported to medical facility for assessment. Treated with Nitroglycerine
Cardiopulmonary Arrest/ Cardiac Death/Myocardial Rupture
Case previously recorded as MA2009-4218. Initial case report received from a registered nurse via agency, on 11 NOV 2009. It was reported that 13 children under the age of four were accidentally vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 Nov 2009. No adverse effect was reported. Agency reference no.:NA09-008010.
No adverse events were reported or observed.  Given by error and "off label" use.  Maximum age is 12years old, patient was 15 years old at time of vaccination.
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the third (3rd) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Office of the Regulatory Authority reported to the Dept. of Health that this patient had a "sudden collapse witnessed by a friend" approximately one hour after receiving vaccine. Notified in March. At that time no VAERS reports found or noted by CDC. As of today, no VAERS received from CDC for this patient so submitting the limited information available. Final findings were released on 7/18/21 (decided on 7/16/21) were:  "CAUSE A: Anaphylaxis CAUSE B: Status post COVID vaccination Should you have any questions about this case please contact Dr. Please note he is leaving state service at the end of this month."
Pt recv vax on 7/28/98; on same day pt exp itching then welts on her back; hives over her body except fact; mental fogginess; tx=steroids & Benadryl w/ no results; then antihistamine & "blocker"
Excruciating and debilitating shoulder pain at injection site that started within two hours after the injection and has lasted over 48 hours (and continuing). Pain killers have little to no effect on dulling/minimizing the pain. Ice/heat dull for the initial 5 minutes of use, but cease to be effective longer than 5-10 minutes.  Within 24 hours I had a fever that would last 2-3 hours, go away, and then return with the highest temperature of 101.3. 48 hours later the fever did not exceed 100 degrees. I?m very tired 48 hours later, but this may also be from the inability to sleep with the excruciating shoulder pain.
Slight reaction to the first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (patient received the flu shot 2months ago and had a pretty bad reaction to the flu shot where she had fever, aches, pain and leg weakness and stated that she can hardly walk and stated that it was major.) in 2021. Past adverse reactions to the above products included Adverse reaction to product with Flu shot. Concurrent medical conditions included Blood pressure, Cancer and Thyroid disorder.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine) had resolved.            Concomitant medication includes 20 medications for blood pressure, cancer, and thyroid.  Eevnt was minor and lasted a day or two and was better.
Just abnormal symptoms for few days; Tiredness; Arm is really sore; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat), FEELING ABNORMAL (Just abnormal symptoms for few days) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tiredness). On an unknown date, the patient experienced FEELING ABNORMAL (Just abnormal symptoms for few days). At the time of the report, PAIN IN EXTREMITY (Arm is really sore), OROPHARYNGEAL PAIN (Sore throat), FEELING ABNORMAL (Just abnormal symptoms for few days) and FATIGUE (Tiredness) outcome was unknown.        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 relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow up received on 2-jun-2021 :new event was added
Post vax, the pt was seen in the ER for increased temperature. Dx with pneumonia and placed on Duricef.